Please refer to Docket ID NRC-2009-0359 when contacting the NRC about the availability of information regarding this document. You may access information related to this document, which the NRC possesses and is publicly available, by any of the following methods:

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Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.

Please include Docket ID NRC-2009-0359 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in you comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

The NRC is issuing for public comment three DGs in the NRC's “Regulatory Guide” series. In a notice of proposed rulemaking, “Approval of American Society of Mechanical Engineers' Code Cases” (RIN 3150-AI72; NRC-2009-0359), published elsewhere in the Proposed Rules section of today's Federal Register (the “underlying proposed rule”), the NRC is proposing to incorporate by reference these three DGs into the Commission's regulations at § 50.55a of Title 10 of the Code of Federal Regulations (10 CFR). The underlying proposed rule would allow nuclear power plant applicants and licensees, and applicants for standard design certifications, and standard design approvals to use the Code Cases listed in these three DGs as alternatives to requirements in those Editions and Addenda of the ASME BPV and OM Codes which the NRC has incorporated by reference into 10 CFR 50.55a.

Code Cases provide ASME approved voluntary alternatives to the BPV and OM Codes. The DGs are incorporated by reference in 10 CFR 50.55a. The NRC-approved Code Cases provide an acceptable voluntary alternative to the mandatory ASME Code provisions, but all of the provisions of a Code Case must be used, with any identified limitations or modifications, if implemented by an applicant or licensee. The NRC approves Code Cases in the three DGs described below regarding the construction, in-service inspection, and in-service testing of nuclear power plant components.

The DG entitled, “Design, Fabrication and Materials Code Case Acceptability, ASME Section III,” is temporarily identified by its task number, DG-1230 (ADAMS Accession No. ML102590003). The DG-1230 is proposed Revision 36 of Regulatory Guide 1.84. Revision 35 of Regulatory Guide 1.84 was published in October 2010 (ADAMS Accession No. ML101800532).

The DG entitled, “Inservice Inspection Code Case Acceptability, ASME Section XI, Division1,” is temporarily identified by its task number, DG-1231 (ADAMS Accession No. ML102590004). The DG-1231 is proposed Revision 17 of Regulatory Guide 1.147. Revision 16 of Regulatory Guide 1.147 was published in October 2010 (ADAMS Accession No. ML101800536).

The DG entitled, “Operation and Maintenance code Case, Acceptability, ASME OM Code,” is temporarily identified by its task number, DG-1232 (ADAMS Accession No. ML102600001). The DG-1232 is proposed Revision 1 of Regulatory Guide 1.192. Revision 0 of Regulatory Guide 1.192 was published in June 2003 (ADAMS Accession No. ML030730430).

The DG-1230 lists the new and revised ASME BPV Section III, “Rules for Construction of Nuclear Power Plant Components,” Code Cases that the NRC has approved for use. The DG-1231 lists the new and revised ASME BPV Section XI, “Rules for Inservice Inspection of Nuclear Power Plant Components,” Code Cases that the NRC has approved for use. The new and revised OM Code Cases that the NRC has approved for use are listed in DG-1232, “Operation and Maintenance Code Case Acceptability, ASME OM Code.” For these regulatory guide revisions, the NRC reviewed the Code Cases listed in Supplements 1 through 10 to the 2007 Edition of the ASME BPV Code and the 2002 through 2006 Addenda of OM Code.

The regulatory analysis for the underlying proposed rule also addresses these three DGs. Therefore, the NRC did not prepare a separate regulatory analysis for these DGs. The NRC is proposing to incorporate by reference these DGs into 10 CFR 50.55a, “Codes and standards” in of the aforementioned proposed rulemaking published elsewhere in the Proposed Rules section of today's Federal Register.

These regulatory guides would approve for use (at the option of nuclear power plant applicants and licensees) the ASME Code Cases listed in the applicable regulatory guide. In some cases, the NRC's approval is conditioned on meeting certain requirements or prerequisites (“conditions”). The NRC is proposing to incorporate by reference these DGs, with conditions, into 10 CFR 50.55a, Codes and standards, in the aforementioned proposed rulemaking published elsewhere in the Proposed Rules section of today's Federal Register.

These DGs, if finalized, do not constitute backfitting as defined in 10 CFR 50.109 (the Backfit Rule) and are not otherwise inconsistent with the issue finality provisions in 10 CFR Part 52, “Licenses, Certifications and Approvals for Nuclear Power Plants.” The backfitting and issue finality considerations for these regulatory guides are addressed in the Federal Register notice for the underlying proposed rule, and introduces no new backfitting or issue finality matters not already addressed in that Federal Register notice. Therefore, the NRC's consideration of backfitting and issue finality matters for the underlying proposed rule also serves as the NRC's consideration of the same backfitting and issue finality matters for the issuance of these DGs.

In addition, these DGs identify NRC-approved ASME Code Cases which applicants and licensees may voluntarily utilize as way of meeting the NRC requirements in 10 CFR 50.55a. An applicant's and/or licensees' voluntary application of an approved Code Case does not constitute backfitting, inasmuch as there is no imposition of a new requirement or new position. Similarly, voluntary application of an approved Code Case by a 10 CFR Part 52 applicant or licensee does not represent NRC imposition of a requirement or action which is inconsistent with any issue finality provision in 10 CFR Part 52. Therefore, the NRC concludes that these DGs, if finalized, do not constitute backfitting as defined in 10 CFR 50.109 and are not otherwise inconsistent with the issue finality provisions in 10 CFR Part 52.

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 (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.

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) (http://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.

Proposed § 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 § 1010.1 (21 CFR 1010.1), Scope, is amended to update the reference to the legal authority for these regulations and amendments.

Proposed §§ 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 § 1040.5 (21 CFR 1040.5) incorporates by reference into §§ 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 § 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 § 1040.10(b)(4). LEDs do not typically meet the definition of laser 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 § 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 § 1040.10(a)(3)(iii) would require that the seller document that the purchaser meets the definition of manufacturer in § 1000.3(n) (21 CFR 1000.3(n)) or that the purchaser is excluded from applicability of the standard in accordance with § 1040.10(a)(1) or § 1040.10(a)(2). The provision also would require the seller to maintain such documentation as specified in § 1002.31 (21 CFR 1002.31). FDA is seeking comments on our proposed approach to addressing this issue.

Proposed § 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 § 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 § 1040.10(b)(8) seeks to avoid confusion and clarifies that the terms must as used in §§ 1040.10 and 1040.11 and shall as used in §§ 1040.10 and 1040.11 and the IEC standards are equivalent in meaning and signify a requirement.

Proposed § 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 § 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 § 1040.10(b)(12) and the requirements of both current and proposed § 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 (http://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 § 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 § 1040.10(c) incorporates by reference the hazard classifications of the IEC standard IEC 60825-1:2007.

Proposed § 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 § 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 § 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 § 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 § 1040.10(f)(6) for CDRH to approve alternate means of safety in lieu of a beam attenuator. Proposed § 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 § 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 § 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 § 1040.10(d)(2). This requirement is necessary to assure the safety of laser product users because the IEC standard allows the use of protective housing to be at the discretion of the manufacturer, rather than a safety requirement.

Proposed § 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 § 1040.10(h)(1) includes minor conforming changes. Proposed § 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 § 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 § 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 § 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 § 1040.10(d) and (e).

FDA is also proposing to amend § 1040.11 by adding a new paragraph (d). Proposed § 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 § 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094416.htm.

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.

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.

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.

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.

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.

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.

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

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 http://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.

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.

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.

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 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.

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.

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

The estimated one-time cost for classification 334511 for this provision is approximately $1.8 million ($55,400 per product × 33 affected products). The estimated recurring costs are approximately $229,000 ($7,000 per product × 33 products). The estimated one-time cost for classification 334519 is $6.3 million ($55,400 per product × 113 products) and the recurring costs are $792,000 ($7,000 per product × 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, the inflation-adjusted cost is $2.4 million, and at 3 percent the cost is $2.2 million.

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.

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.

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 § 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 § 1000.3(n) or that the purchaser is excluded from the standard in accordance with § 1040.10(a)(1) or § 1040.10(a)(2). The provision would also require the seller to maintain documentation as specified in § 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.

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.

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 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.

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.

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.

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 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 × 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 × 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.

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).

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.

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 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.

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.

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 § 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 § 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:

Reporting Burden: For § 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 § 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 § 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 § 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 § 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 § 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)).

Interested persons may submit either electronic comments regarding this document to http://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 http://www.regulations.gov.

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 http://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 after this document publishes in the Federal Register.)

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:

Throughout this document, “we,” “us” and “our” refer to EPA.

On July 18, 1997 (62 FR 36852), EPA established new national ambient air quality standards (NAAQS) for PM2.5, particulate matter with a diameter of 2.5 microns or less, including annual standards of 15.0 micrograms per cubic meter (µg/m3) based on a 3-year average of annual mean PM2.5 concentrations, and 24-hour (daily) standards of 65 µg/m3 based on a 3-year average of the 98th percentile of 24-hour concentrations. 40 CFR 50.7. Effective April 5, 2005, EPA designated the “Los Angeles-South Coast Air Basin” in California (South Coast), including Orange County, the southwestern two-thirds of Los Angeles County, southwestern San Bernardino County, and western Riverside County, as nonattainment for the 1997 24-hour and annual PM2.5 standards. See 70 FR 944 (January 5, 2005) and 40 CFR 81.305.1 The local air district with primary responsibility for developing a plan to attain the PM2.5 NAAQS in this area is the South Coast Air Quality Management District (SCAQMD or District).

California has made numerous SIP submittals to address the South Coast area's nonattainment designation for the 1997 PM2.5 NAAQS. The two principal ones are the SCAQMD's “Final 2007 Air Quality Management Plan” (South Coast 2007 AQMP), submitted on November 28, 2007, and the California Air Resources Board's (CARB's) “State Strategy for California's 2007 State Implementation Plan” (2007 State Strategy), submitted on November 16, 2007 and revised in 2009 and 2011 through CARB's “2009 State Strategy Status Report” and “2011 Progress Report.”

On November 9, 2011, EPA partially approved and partially disapproved the South Coast 2007 AQMP and the 2007 State Strategy (collectively the “South Coast PM2.5 SIP”). 76 FR 69928. As part of this action, EPA disapproved the contingency measure provisions in the South Coast PM2.5 SIP as failing to meet the requirements of CAA section 172(c)(9) and 40 CFR 51.1012, which require that the SIP for each PM2.5 nonattainment area contain contingency measures to be implemented if the area fails to make reasonable further progress (RFP) or to attain the NAAQS by the applicable attainment date. See 76 FR 41578-41580 (July 14, 2011) and 76 FR 69947 (November 9, 2011). EPA found that the suggested contingency measures contained in the South Coast PM2.5 SIP did not meet the minimum CAA requirements because, among other things, the measures were not fully adopted and the District had failed to quantify the SIP-creditable emission reductions they would achieve. Id.

As EPA explained in the proposed rule, contingency measures must be fully adopted rules or control measures that are ready to be implemented quickly without significant additional action by the State, must be measures not relied on in the plan to demonstrate RFP or attainment, and should provide SIP-creditable emissions reductions equivalent to one year of RFP. See 76 FR 41652 (July 14, 2011) at 41578; see also “Final Technical Support Document and Response to Comments, Final Rulemaking Action on the South Coast 2007 AQMP for PM2.5 and the South Coast Portions of the Revised 2007 State Strategy,” Air Division, U.S. EPA Region 9, September 30, 2011 (“Final TSD for South Coast PM2.5 SIP”) at pp. 123-130. Additionally, the SIP should contain trigger mechanisms for the contingency measures and specify a schedule for their implementation. Id.

Although CARB's 2011 Progress Report demonstrated that existing CARB mobile source measures would achieve 24 tons per day (tpd) of NOX reductions and 13 tpd of VOC reductions in 2015, the year after the attainment year, EPA found that these measures alone were not adequate to satisfy the Act's contingency measure requirements. See 76 FR 41478-80 and 76 FR 69947-8, 69952. Specifically, EPA reviewed the information provided in the 2011 Progress Report and found that these post-attainment year emission reductions were not sufficient to achieve one year's worth of RFP on a pollutant-specific basis.2 76 FR 41579-41580. EPA also found that the South Coast PM2.5 SIP did not address the contingency measure requirement for the 2012 RFP year. Id. at Table 9. Accordingly, EPA disapproved the contingency measure provisions in the South Coast PM2.5 SIP for failure to satisfy the Act's contingency measure requirements for the 2012 RFP year and for the 2015 attainment date. Id. at 41580 and 76 FR 69952.

On November 14, 2011, CARB submitted the “South Coast Air Quality Management District Proposed Contingency Measures for the 2007 PM2.5 SIP” (dated October 2011) (“Contingency Measures SIP”) as a revision to the California SIP. The November 14, 2011 submittal includes a copy of the Contingency Measures SIP itself; a letter dated November 14, 2011 from James N. Goldstene, Executive Officer, California Air Resources Board, to Jared Blumenfeld, Regional Administrator, U.S. Environmental Protection Agency Region 9, submitting the adopted Contingency Measures SIP for EPA review; CARB Executive Order S-11-023 adopting the Contingency Measures SIP; a letter dated October 26, 2011 from Barry R. Wallerstein, Executive Officer, SCAQMD, to James Goldstene, Executive Officer, CARB, submitting the adopted Contingency Measures SIP for CARB review and approval; SCAQMD Resolution No. 11-24 approving the Contingency Measures SIP; and public process documentation.

On April 24, 2013, the District submitted a technical clarification to the Contingency Measures SIP, including updated emissions data for 2012. See letter dated April 24, 2013, from Elaine Chang, Deputy Executive Officer, SCAQMD, to Deborah Jordan, Director, Air Division, EPA Region 9, Re: “Update of the 2012 RFP Emissions and 2015 Reductions from Contingency Measures for the 2007 Annual PM2.5 Air Quality Management Plan for the South Coast Air Basin,” including attachments (hereinafter “2013 Supplement”).

The Contingency Measures SIP, as supplemented in 2013, contains: (1) The District's demonstration that actual emission levels in the South Coast in 2012 were below the RFP “benchmarks” for the 2012 RFP year; (2) identification of SIP-creditable control measures that will provide emission reductions in 2015 in excess of those relied on to demonstrate RFP and attainment; and (3) the SCAQMD's analysis of significant air quality improvements in the South Coast area that the District believes EPA should take into account in its review of and action on the SIP submission.

CAA sections 110(a) and 110(l) require that revisions to a SIP be adopted by the State after reasonable notice and public hearing. EPA has promulgated specific procedural requirements for SIP revisions in 40 CFR part 51, subpart F. These requirements include publication of notices, by prominent advertisement in the relevant geographic area, of a public hearing on the proposed revisions, a public comment period of at least 30 days, and an opportunity for a public hearing.

CARB's SIP submission includes public process documentation for the Contingency Measures SIP, including documentation of a duly noticed public hearing held by the District on October 7, 2011 on the proposed Contingency Measures SIP. On November 14, 2011, CARB adopted the Contingency Measures SIP as a revision to the California SIP and submitted it to EPA for action pursuant to CAA section 110(k).3 We find that the process followed by CARB and the District in adopting the Contingency Measures SIP complies with the procedural requirements for SIP revisions under CAA section 110 and EPA's implementing regulations.

Section 172(c)(9) of the CAA requires that the SIP for each nonattainment area “provide for the implementation of specific measures to be undertaken if the area fails to make reasonable further progress, or to attain the [NAAQS] by the attainment date applicable under [part D of title I]” and requires that these measures “take effect without further action by the State or EPA.” The Act does not specify how many contingency measures are required or the magnitude of emissions reductions that must be provided by these measures. Consistent with the text of section 172(c)(9), however, these measures must be specific, adopted measures that are ready to be implemented quickly upon failure to meet RFP or failure of the area to meet the standard by its attainment date.4

EPA provided guidance on the section 172(c)(9) contingency measure requirement in an interpretative document entitled “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992) (“General Preamble”). As EPA explained in the General Preamble, “contingency measures should, at a minimum, ensure that an appropriate level of emissions reduction progress continues to be made if attainment [or] RFP is not achieved and additional planning by the State is needed.” 57 FR 13511. These emission reductions would be in addition to those that were already scheduled to occur in accordance with the plan for the area. Id. at n. 2 and 13543-544. Additionally, States must show that their contingency measures can be implemented with minimal further action on their part and with no additional rulemaking actions such as public hearings or legislative review. In general, EPA expects all actions needed to effect full implementation of the measures to occur within 60 days after EPA notifies the State of its failure. 57 FR 13512 and 13543-544; see also 59 FR 41998 at 42014-42015 (August 16, 1994)(“PM-10 Addendum”).

Consistent with these longstanding interpretations of the Act, EPA explained in the preamble to its 2007 implementation rule for the 1997 PM2.5 NAAQS that the SIP should contain trigger mechanisms for the contingency measures, specify a schedule for implementation, and indicate that the measures will be implemented without significant further action by the State or EPA. See 72 FR 20586 at 20642-20645 (April 25, 2007) and 40 CFR 51.1012.5

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. Information is organized as follows:

Clean Air Act (CAA) section 110(a)(2)(C) requires states to develop and submit to EPA for approval into the state SIP preconstruction review and permitting programs applicable to certain new and modified stationary sources of air pollutants. There are three separate programs: Prevention of Significant Deterioration (PSD), Nonattainment New Source Review (NNSR), and Minor NSR. The PSD program is established in part C of title I of the CAA and applies in areas that meet the National Ambient Air Quality Standards (NAAQS)—“attainment areas”—as well as areas where there is insufficient information to determine if the area meets the NAAQS—“unclassifiable areas.” The NNSR program is established in part D of title I of the CAA and applies in areas that are not in attainment of the NAAQS—“nonattainment areas.” The Minor NSR program (1) addresses construction or modification activities that do not emit, or have the potential to emit, beyond certain major source thresholds and thus do not qualify as “major” and (2) applies regardless of the designation of the area in which a source is located. EPA regulations governing the criteria that states must satisfy for EPA approval of the NSR programs as part of the SIP are contained in 40 CFR sections 51.160—51.166.

Wyoming submitted on March 8, 2013 a collection of regulations for approval by EPA into the Wyoming SIP, including some regulations specific to the Wyoming PSD permitting program. The March 8, 2013 SIP submittal includes PSD permitting provisions that (1) Establish that GHG is a regulated pollutant under the PSD program, (2) establish emission thresholds for determining which new stationary sources and modification projects become subject to Wyoming's PSD permitting requirements for their GHG emissions consistent with the “PSD and Title V Greenhouse Gas Tailoring Final Rule” (75 FR 31514) hereafter referred to as the “Tailoring Rule”, and (3) defer the application of the PSD requirements to biogenic carbon dioxide emissions from bioenergy and other biogenic stationary sources consistent with the EPA's final rule “Deferral for CO2 Emissions from Bioenergy and other Biogenic Sources under the Prevention of Significant Deterioration (PSD) and Title V Programs” (76 FR 43490). More details of the submittal are provided in sections II and III below.

Today's proposed action presents our rationale for approving these regulations as meeting the minimum federal requirements for the adoption and implementation of the PSD SIP permitting programs. In addition, Wyoming is currently subject to the GHG PSD FIP at 40 CFR 52.37(b)(2). See 75 FR 82246, December 10, 2010. We are also proposing to rescind the GHG PSD FIP for Wyoming when we approve Wyoming's submittal.

This section briefly summarizes EPA's recent GHG-related actions that provide the background for this action. Please see the preambles for the identified GHG-related rulemakings for more information.

Beginning in 2010, EPA undertook a series of actions pertaining to the regulation of GHGs that established the overall framework for today's final action on the Wyoming SIP. These actions include, as they are commonly called, the “Endangerment Finding” and “Cause or Contribute Finding,” which EPA issued in a single final action,1 the “Johnson Memo Reconsideration,” 2 the “Light-Duty Vehicle Rule,” 3 and the “Tailoring Rule.” 4 Taken together and in conjunction with the CAA, these actions established regulatory requirements for GHGs emitted from new motor vehicles and new motor vehicle engines; determined that such regulations, when they took effect on January 2, 2011, subjected GHGs emitted from stationary sources to PSD requirements; and limited the applicability of PSD requirements to GHG sources on a phased-in basis. EPA took this last action in the Tailoring Rule, which, more specifically, established appropriate GHG emission thresholds for determining the applicability of PSD requirements to GHG-emitting sources.

In December 2010, EPA promulgated several rules to implement the new GHG PSD SIP program. Recognizing that some states had approved SIP PSD programs that did not apply PSD to GHGs, EPA issued a SIP call on December 13, 2010, that would require those states to submit a SIP revision providing such authority.5 The State of Wyoming, along with several other states, did not submit a corrective SIP revision to apply their CAA PSD programs to sources of GHG emissions by the established deadline. EPA published a finding of failure to submit the required SIP revision by the specified deadline and then promulgated the GHG PSD FIP to ensure the availability of a permitting authority for GHG emitting sources in Wyoming and the other states.6 7

At the same time, EPA recognized that many other states had approved SIP PSD programs that do apply PSD to GHGs, but that do so for sources that emit as little as 100 or 250 tons per year (tpy) of GHG, and that do not limit PSD applicability to GHGs to the higher thresholds in the Tailoring Rule. Therefore, EPA issued the GHG PSD SIP Narrowing Rule,8 under which, EPA converted its previous full approval of the affected SIPs to a partial approval and partial disapproval, to the extent those SIPs covered GHG-emitting sources below the Tailoring Rule thresholds. EPA based its action primarily on the “error correction” provisions of CAA section 110(k)(6). Many of those states have since submitted SIP revisions that have established the Tailoring Rule thresholds, and EPA has approved those SIP revisions and rescinded the partial disapprovals.

On July 20, 2011, EPA promulgated the final “Deferral for CO2 Emissions from Bioenergy and other Biogenic Sources Under the Prevention of Significant Deterioration (PSD) and Title V Programs” (Biomass Deferral Rule). Following is a brief discussion of the deferral. For a full discussion of EPA's rationale for the rule, see the notice of final rulemaking at 76 FR 43490.

The biomass deferral delays until July 21, 2014 the consideration of Carbon Dioxide (CO2) emissions from bioenergy and other biogenic sources (hereinafter referred to as “biogenic CO2 emissions”) when determining whether a stationary source meets the PSD and Title V applicability thresholds, including those for the application of Best Available Control Technology (BACT). As with the Tailoring Rule, the Biomass Deferral addresses both PSD and Title V requirements. However, EPA is taking action on only Wyoming's PSD program as part of this action. Stationary sources that combust biomass (or otherwise emit biogenic CO2 emissions) and construct or modify during the deferral period will avoid the application of PSD to the biogenic CO2 emissions resulting from those actions. The deferral applies only to biogenic CO2 emissions and does not affect non-GHG pollutants or other GHGs (e.g., methane (CH4) and nitrous oxide (N2O)) emitted from the combustion of biomass fuel. Also, the deferral only pertains to biogenic CO2 emissions in the PSD and Title V programs and does not pertain to any other EPA programs such as the GHG Reporting Program. Biogenic CO2 emissions are defined as emissions of CO2 from a stationary source directly resulting from the combustion or decomposition of biologically-based materials other than fossil fuels and mineral sources of carbon. Examples of “biogenic CO2 emissions” include, but are not limited to:

• CO2 generated from the biological decomposition of waste in landfills, wastewater treatment or manure management processes;

• CO2 from the combustion of biogas collected from biological decomposition of waste in landfills, wastewater treatment or manure management processes;

• CO2 from fermentation during ethanol production or other industrial fermentation processes;

• CO2 from combustion of the biological fraction of municipal solid waste or biosolids;

• CO2 from combustion of the biological fraction of tire-derived fuel; and

• CO2 derived from combustion of biological material, including all types of wood and wood waste, forest residue, and agricultural material.

The three-year deferral period was put in place as a temporary measure, to allow time for EPA to complete its science and technical review and promulgate any follow-on rulemakings based on EPA's conclusions concerning the proper treatment of biogenic CO2 emissions in the PSD and Title V programs. In the event that EPA takes action that supersedes the biomass deferral in fewer than three years, Wyoming should revise its SIP accordingly.

For stationary sources co-firing fossil fuel and biologically-based fuel, and/or combusting mixed fuels (e.g., tire derived fuels, municipal solid waste (MSW)), the biogenic CO2 emissions from that combustion are included in the biomass deferral. However, the fossil CO2 emissions are not. Emissions of CO2 from processing of mineral feedstocks (e.g., calcium carbonate) are also not included in the deferral. Various methods are available to calculate both the biogenic and fossil portions of CO2 emissions, including those methods contained in the GHG Reporting Program (40 CFR Part 98). Consistent with the other pollutants in PSD and Title V, there are no requirements to use a particular method in determining biogenic and fossil CO2 emissions.

EPA's final biomass deferral rule is an interim deferral for biogenic CO2 emissions only and does not relieve sources of the obligation to meet the PSD and Title V permitting requirements for other pollutant emissions that are otherwise applicable to the source during the deferral period or that may be applicable to the source at a future date pending the results of EPA's study and subsequent rulemaking action. This means, for example, that if the deferral is applicable to biogenic CO2 emissions from a particular source during the three-year effective period and the study and future rulemaking do not provide for a permanent exemption from PSD and Title V permitting requirements for the biogenic CO2 emissions from a source with particular characteristics, then the deferral would end for that type of source and its biogenic CO2 emissions would have to be appropriately considered in any applicability determinations that the source may need to conduct for future stationary source permitting purposes, consistent with that subsequent rulemaking and the Final Tailoring Rule (e.g., a major source determination for Title V purposes or a major modification determination for PSD purposes).

EPA also wishes to clarify that we did not require that a PSD permit issued during the deferral period be amended or that any PSD requirements in a PSD permit existing at the time the deferral took effect, such as BACT limitations, be revised or removed from an effective PSD permit for any reason related to the deferral or when the deferral period expires. Section 52.21(w) of 40 CFR requires that any PSD permit shall remain in effect, unless and until it expires or it is rescinded, under the limited conditions specified in that provision. Thus, a PSD permit that is issued to a source while the deferral was effective need not be reopened or amended if the source is no longer eligible to exclude its biogenic CO2 emissions from PSD applicability after the deferral expires. However, if such a source undertakes a modification that could potentially require a PSD permit and the source is not eligible to continue excluding its biogenic CO2 emissions after the deferral expires, the source will need to consider its biogenic CO2 emissions in assessing whether it needs a PSD permit to authorize the modification.

Any future actions to modify, shorten, or make permanent the deferral for biogenic sources are beyond the scope of the biomass deferral action and this proposed approval of the deferral into the Wyoming SIP, and will be addressed through subsequent rulemaking. The results of EPA's ongoing review of the science related to net atmospheric impacts of biogenic CO2 are incomplete. The framework to properly account for such emissions in Title V and PSD permitting programs based on the study is also incomplete. Thus, we are unable to determine which biogenic CO2 sources currently subject to the deferral would be subject to any permanent exemptions, or would be potentially required to account for their emissions after a future rulemaking by EPA. Once EPA has taken any future rulemaking, Wyoming should address related revisions to its SIP.

As noted, on June 3, 2010, EPA promulgated the Tailoring Rule, setting out requirements for application of PSD to emissions sources of GHGs. Previously, updates to Wyoming's PSD permit program had been most recently approved by EPA on July 16, 2008. As described in our notice of approval (73 FR 40750), Wyoming's PSD program at that date met the general requirements of CAA section 110(a)(2)(C).

On December 13, 2010, EPA published a finding of substantial inadequacy and a SIP call for 13 states and localities, including Wyoming, on the basis, as described above, that the states' SIP-approved PSD programs did not apply PSD to GHG-emitting sources as required. EPA included Wyoming on the basis of comments from Wyoming that state law (specifically, Wyoming Statutes section 35-11-213) prevented it from revising its SIP to incorporate the GHG provisions of the Tailoring Rule. Seven of those states, including Wyoming, received a deadline of December 22, 2010 to submit the required SIP revisions, after indicating that they would not oppose EPA's imposition of that deadline. On December 29, 2010, EPA published a finding that Wyoming and the other six states had failed to submit the required SIP revisions (75 FR 81874). Finally, on December 30, 2010, EPA published a FIP for Wyoming and the other six states to ensure that PSD permits for sources emitting GHGs could be issued and that incorporated the Tailoring Rule thresholds (75 FR 82246). EPA made clear in the SIP call and FIP rulemakings that the purpose of the rulemakings and their expedited schedules was to ensure that GHG-emitting sources in the affected states would have available a permitting authority to act on the GHG PSD permit applications by the January 2, 2011 date that GHGs became subject to PSD. EPA also emphasized that its “overarching goal is to assure that in every instance, it will be the state that will be the permitting authority,” and that as a result, EPA sought to return permitting authority to the states as soon as possible. 75 FR at 77717 (SIP call final rule).

Since then, Wyoming's Legislature has twice amended Wyoming Statutes section 35-11-213 to allow for regulation of GHGs. First, during the 2012 legislative session, the Wyoming Legislature directed the Wyoming DEQ and the Wyoming Environmental Quality Council to “adopt regulations to amend Wyoming's Clean Air Act state implementation plan and Wyoming's Title V operating permit program to the extent necessary to obtain state primacy over the regulation of greenhouse gases by the U.S. EPA.” Then, during the 2013 legislative session, the Wyoming Legislature authorized the Wyoming DEQ to “submit an amended state implementation plan providing for regulation of greenhouse gases to the U.S. EPA for approval.” Once the second bill was signed into law, Wyoming's rule revisions for its PSD program became effective on February 14, 2013. Wyoming DEQ submitted the revisions to EPA on March 8, 2013.

Wyoming has adopted and submitted regulations that are substantively similar to the federal requirements for the permitting of GHG-emitting sources subject to PSD. We propose to conclude that the revisions are consistent with the requirements of 40 CFR 51.166, in particular requirements set out in EPA's final GHG Tailoring Rule, and that the revisions should be approved into Wyoming's SIP.

Section 3 of Chapter 1, Common Provisions, was revised to add a definition of “greenhouse gases (GHGs).” This definition is used in new Section 7, Greenhouse Gases, to specify that preconstruction permits for GHGs are only required under the PSD permitting program, thus exempting minor sources from GHG permitting. Section 4 of Chapter 6, Permitting Requirements, was modified to establish thresholds for permitting of GHGs under the PSD program. Definitions for the terms “GHGs,” “emissions increase” and “tpy CO2 equivalent emissions (CO2e)” with exclusions for biogenic sources, were added to this section. Applicability thresholds for several different types of permitting scenarios were also added. Changes were made to the PSD definition of “Major source” to avoid triggering applicability for minor sources. Chapter 6, Section 14, Incorporation by Reference was revised to generally incorporate by reference federal regulations, such as PSD and NSR, as published on July 1, 2010, with the exception of references to GHG-related regulations that were published after that date.

Wyoming organized its revisions to its PSD program somewhat differently than EPA's Tailoring Rule revisions to 40 CFR 51.166. In particular, Wyoming did not define the term “subject to regulation”; instead Wyoming separately defined the term “greenhouse gases.” In the definition of “greenhouse gases,” Wyoming established thresholds for application of PSD to sources of GHGs that are consistent with the thresholds established in the Tailoring Rule. In particular, within the definition of “greenhouse gases,” Wyoming provided a definition of “tpy CO2 equivalent emissions” and a modified definition of “emissions increase” consistent with the use of those terms in 40 CFR 51.166(b)(48)(ii) and (iii). Wyoming also modified the definition of “major stationary source” to directly account for sources of GHGs. The net effect of Wyoming's approach is that, if a new pollutant (other than GHGs) becomes subject to regulation under the definition of “subject to regulation” in 40 CFR 51.166(b)(48), Wyoming must update its PSD program again to reflect the requirement to regulate that new pollutant. However, Wyoming's SIP revision is consistent with current requirements for PSD programs.

We also propose to conclude that the revisions appropriately defer the applicability of the Tailoring Rule thresholds for biogenic CO2 emissions from bioenergy and other biogenic stationary sources consistent with EPA's Biomass Deferral Final Rule. The deferral is provided for in subsection (i)(C) of Wyoming's definition of “greenhouse gases.”

Finally, we are not proposing action at this time on Wyoming's revision to Chapter 6, Permitting Requirements, Section 14, Incorporation by Reference. The revision to this provision updates the date of incorporation by reference of federal Regulations, such as PSD and NSR, to July 1, 2010. Because this update applies throughout Chapter 6, it affects other portions of Chapter 6, including Wyoming's pending May 11, 2011 nonattainment NSR program submittal that we are not proposing to act on today. We intend to act on the March 8, 2013 revision to Chapter 6, Section 14 in tandem with our action on the May 11, 2011 submittal, in order to ensure that the update to the incorporation by reference date is applied to all pending submittals. The portions of the March 8, 2013 submittal we propose to act on today directly specify the version of the CFR to which they refer, so it is not necessary to act on the revision to Chapter 6, Section 14 at this time.

EPA proposes to approve portions of the March 8, 2013 submittal for incorporation into the SIP. Specifically, EPA proposes to approve revisions to Chapter 1, Common Provisions, Section 3, and Chapter 6, Permitting Requirements, Section 4, Prevention of Significant Deterioration, and the addition of Chapter 1, Common Provisions, Section 7, Greenhouse Gases. EPA has made the preliminary determination that these March 8, 2013 revisions are approvable because they were adopted and submitted in accordance with the CAA and EPA regulations regarding PSD permitting for GHGs. We are not proposing at this time to act on the revision to Chapter 6, Permitting Requirements, Section 14, Incorporation by Reference.

As explained in today's proposed notice, Wyoming is currently subject to a FIP for PSD permitting of GHG emissions. This GHG PSD FIP remains in place, and EPA remains the PSD permitting authority for GHG-emitting sources in Wyoming, until EPA finalizes our proposed approval of the March 8, 2013 submitted revision to the Wyoming SIP. At that point, the Wyoming SIP will contain a full GHG PSD program. We therefore propose that upon finalization of today's SIP approval action, EPA will rescind the GHG PSD FIP for Wyoming.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely approves some state law as meeting federal requirements; it does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rules addressed by this proposal with the dates that they were adopted by the local air agency and submitted by the California Air Resources Board (CARB). Rule 444 subdivision (g) and Rule 445 subdivision (h), related to fees and penalties respectively, were excluded from the versions of the rules submitted for consideration by the EPA for SIP approval.

We find that the submittal for SCAQMD Rules 444 and 445 meets the completeness criteria in 40 CFR Part 51 Appendix V, which must be met before formal EPA review.

We approved earlier versions of Rule 444 and Rule 445 into the SIP on April 8, 2002 (67 FR 16644) and June 11, 2009 (74 FR 27716) respectively. The SCAQMD adopted revisions to Rule 444 on November 7, 2008, but did not submit them to us. The SCAQMD adopted additional revisions to Rule 444 and revisions to Rule 445 on May 3, 2013, and CARB submitted these revised rules to us on June 11, 2013.

Emissions of VOCs and NOX help produce ground-level ozone, smog and particulate matter (PM), which harm human health and the environment. PM emissions contribute to effects that are harmful to human health and the environment, including premature mortality, aggravation of respiratory and cardiovascular disease, decreased lung function, visibility impairment, and damage to vegetation and ecosystems. Section 110(a) of the CAA requires States to submit regulations that control NOX, VOC and PM emissions.

Rule 444 is designed to minimize the impacts of smoke and other air pollutants generated by open burning conducted within the SCAQMD. Changes from the SIP approved rule include the following: (a) Forecast criteria for issuing permissive, marginal, and no-burn days was modified to be based on the Air Quality Index rather than on 1-hour ozone forecasted values; (b) forecast criteria for allowing a permissive burn day was amended to exclude days in which a “Mandatory Winter Burning Curtailment” day is in effect, as provided in Rule 445; (c) limited exemptions were added for burning to protect crops from freezing and for product testing; (d) daily maximum agricultural and prescribed burning acreage was increased to account for less permissive burn days resulting from the new no burn day forecast criteria (total emissions over the season/year remain the same); (e) new requirements were added for burning associated with pyrotechnics used in filmmaking, fire prevention/suppression training, prescribed burning and agricultural burning; (f) definitions were added or amended for clarity; and (g) other minor editorial changes and clarifications were made to the rule.

Rule 445 is designed to minimize the impacts of smoke and other air pollutants generated during the use of wood burning devices. The rule establishes requirements for the sale, operation, and installation of such devices. Changes from the SIP approved rule include the following: (a) The “Mandatory Winter Burning Curtailment” provision was modified to reduce the forecast threshold for a given source/receptor area from 35 to 30 µg/m3 and to add a new provision describing when such curtailment would apply basin-wide; (b) new wood-labeling requirements for wood suppliers were added; (c) a provision was removed which allowed uncertified wood-burning devices to be installed in existing homes if emission equivalency could be demonstrated; (d) modifications were made to clarify that cookstove and wood labeling exemptions apply only to commercial cooking; and (e) the definition of “Wood Burning Device” was modified to include both open and enclosed devices. EPA's technical support documents (TSDs) contain more detailed information about these rules.

Generally, SIP rules must be enforceable (see section 110(a) of the Act) and must not relax existing requirements (see sections 110(l) and 193).

Guidance and policy documents that we use to evaluate enforceability requirements consistently include the following:

1. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations; Clarification to Appendix D of November 24, 1987 Federal Register Notice,” (Blue Book), notice of availability published in the May 25, 1988 Federal Register.

2. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).

Section 172(c)(1) of the CAA requires nonattainment areas to implement all reasonably available control measures (RACM), including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology (RACT), as expeditiously as practicable. The Los Angeles-South Coast Air Basin (South Coast) is currently designated as an extreme 1-hr ozone nonattainment area and an extreme 8-hr ozone nonattainment area, and is also designated nonattainment for the 1997 annual, 1997 24-hour, and 2006 24-hour fine particulate matter (PM2.5) standards (40 CFR 81.305). Open burning emits direct PM2.5, as well as volatile organic compounds (VOCs) and oxides of nitrogen (NOX), which are regulated as precursors to PM2.5 and ozone in the South Coast. Therefore, SCAQMD must implement RACM for open burning and residential wood burning if those measures will advance attainment of the National Ambient Air Quality Standard (NAAQS) for PM2.5 or ozone in the South Coast, when considered collectively with other reasonable measures. Additional control measures may be required pursuant to CAA section 172(c)(1) if both: (1) Additional measures are reasonably available; and (2) these additional reasonably available measures will advance attainment in the area when considered collectively.

The South Coast is also currently designated as a serious nonattainment area for the PM-10 NAAQS (40 CFR 81.305). On June 12, 2013, however, EPA signed a final rule to redesignate the area to attainment for the PM-10 NAAQS, which will become effective 30 days after publication in the Federal Register. See “Approval and Promulgation of Implementation Plans; Designation of Areas for Air Quality Planning Purposes; California; South Coast Air Basin; Approval of PM10 Maintenance Plan and Redesignation to Attainment for the PM10 Standard,” pre-publication final rule signed June 12, 2013. Thus, we are not evaluating Rule 444 and 445 for compliance with BACT/BACM requirements in this rulemaking.

We believe these rules are consistent with the statutory requirements concerning enforceability and SIP relaxations as interpreted in EPA guidance. Rule 444 and 445 are generally as stringent as or more stringent than analogous rules in other California Districts. As necessary, in separate rulemakings, EPA will take action on the State's RACM demonstrations for PM2.5 and ozone based on evaluation of the control measures submitted as a whole and their overall potential to advance the applicable attainment dates in the South Coast. See 40 CFR 51.1010, 51.912(d). Our TSDs have more information on our evaluation and recommendations for additional control measures which may be reasonably available.

The TSDs describe additional rule revisions that we recommend for the next time the local agency modifies the rules but are not currently the basis for rule disapproval.

Because EPA believes the submitted rules fulfill all applicable requirements, we are proposing to fully approve them as described in section 110(k)(3) of the Act. We will accept comments from the public on this proposal for the next 30 days. Unless we receive convincing new information during the comment period, we intend to publish a final approval action that will incorporate these rules into the federally enforceable SIP.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely proposes to approve State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this proposed action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• does not provide EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).

The proposed rule and draft EIS may both be obtained via the Internet at http://www.epa.gov/region6/water/ecopro/current_action.html or the Federal e-Rulemaking Portal: http://www.regulations.gov. To obtain hardcopies of these documents please contact Dr. Jessica Franks using the contact information provided above.

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking (USCG-2012-0850), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. We recommend that you include your name and a mailing address, an email address, or a phone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov and insert “USCG-2012-0850” in the “Search” box. Click on “Submit a Comment” in the “Actions” column. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope.

We will consider all comments and material received during the comment period and may change this proposed rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov and insert “USCG-2012-0850” in the “Search” box. Click “Search.” Click the “Open Docket Folder” in the “Actions” column. If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We do not now plan to hold a public meeting. You may submit a request for one to the docket using one of the methods specified under ADDRESSES. In your request, explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register.

On September 9, 2011, the Coast Guard published the final action memo (FAM) by the Commandant on the recommendations of its investigation into the explosion, fire, and sinking of the Mobile Offshore Drilling Unit (MODU) DEEPWATER HORIZON and the resulting loss of 11 of its crew members. One key finding of the Coast Guard's investigation of the DEEPWATER HORIZON emphasized the importance of proper electrical equipment installations in hazardous locations during oil drilling exploration on U.S. and foreign MODUs. The ignition or explosion hazards posed by electrical equipment installations during Outer Continental Shelf (OCS) activities involving storage, production and processing of hydrocarbons were also considered in the report. You may view a copy of the FAM and the investigation online by going to the Coast Guard's Web site at http://uscg.mil/hq/cg5/cg545 and clicking on the Deepwater Horizon-exhibits-transcripts-video link. The Coast Guard, therefore, reviewed the existing regulations for hazardous locations, specifically the requirements for electrical equipment testing and certification as well as the referenced standards applicable to U.S. and foreign MODUs, floating OCS facilities, and vessels that engage in OCS activities.

Currently, electrical equipment on U.S. vessels and floating facilities that operate in the OCS must comply with 46 CFR subpart 111.105. This subpart adopts international and national standards and requires the equipment to be tested and certified by a Coast Guard accepted independent third-party laboratory.

In contrast, foreign vessels and floating facilities that engage in OCS activities must meet the requirements of 33 CFR subchapter N. While foreign floating OCS facilities must meet the same engineering standards as U.S. floating OCS facilities, foreign vessels generally meet the standards of their flag administration. Their compliance with international standards, such as the IMO MODU Code, is subject to the interpretation of the applicable flag administration. With respect to explosion protection standards, this can result in the installation of equipment on vessels that has not been tested by an independent third-party laboratory. The Coast Guard believes that U.S. and foreign vessels and floating facilities that engage in OCS activities for the first time, after the effective date of the regulations, should have equivalent standards. The Coast Guard, therefore, proposes to require third-party testing and certification of electrical equipment in hazardous locations in order to achieve an equivalency of standards between U.S. and foreign vessels and floating facilities.

The Coast Guard identified an international certification system that requires full testing to the IEC 60079 series of explosion protection standards. The IECEx System pertains to “Certification to Standards Relating to Equipment for Use in Explosive Atmospheres” which requires full testing to the applicable IEC 60079 standard by an explosive atmospheres (Ex) Testing Laboratory (ExTL) and issuance of certification (Certificate of Conformity) by an Ex Certification Body (ExCB). The ExTL and ExCB are accepted under the IECEx system after meeting the competency requirements established by the International Organization for Standardization (ISO)/IEC Standard 17025 and related IECEx Operational Documents and Rules of Procedure. Some foreign flag administrations do not impose the IEC 60079 series of standards, and instead accept an “EC Type Examination Certificate” issued under the European Commission Directive (94/9/EC) on Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres (ATEX Directive) for EU member nations. In contrast to IECEx, certification under the ATEX Directive show compliance with the Essential Health and Safety Requirements of the ATEX directive for which full or partial compliance with an IEC harmonized standard, may be used, but it does not specifically require full testing and certification by an independent third party laboratory. Accordingly, to adequately address the DEEPWATER HORIZON report's recommendations identified above, the Coast Guard proposes to amend the hazardous locations regulations to include the IECEx System. Additionally, the Coast Guard proposes to expand the list of national and international explosion protection standards deemed acceptable.

The Coast Guard proposes to add a new subpart, 46 CFR subpart 111.108, that would require foreign MODUs, floating OCS facilities, and vessels that engage in OCS activities for the first time after the effective date of the regulations, to have a level of safety equivalent to the certification regime required under subpart 111.105. Currently, these vessels and floating OCS facilities must comply with 33 CFR subchapter N. We propose to amend 33 CFR 143.120, add 143.208, and add 143.302 to require newly built foreign vessels and floating OCS facilities and existing foreign vessels and floating facilities that have never operated on the OCS to meet the proposed subpart 46 CFR 111.108.

Foreign vessels and floating facilities operating on the OCS at the time of the effective date of the final rule will not be required to meet the requirements of this proposed rule because they are already subject to the existing applicable international standards and have been inspected by the Coast Guard in accordance with 33 CFR subchapter N. Through its existing inspection authorities, the Coast Guard is examining electrical installations in hazardous locations on these vessels and floating OCS facilities to ensure they meet the appropriate standards. While this existing compliance scheme is workable, it is less than ideal as it leads to a patchwork of different standards across the OCS, which makes inspection by port state control officers and compliance by owners and operators more difficult because it requires familiarity with multiple standards and certification schemes. The Coast Guard has determined that the benefit of a consistently applied standard is preferable and its requirements can be followed at little to no cost (see discussion of costs below).

This proposed subpart would also apply to newly constructed U.S. MODUs, floating facilities, and vessels, excluding offshore supply vessels (OSVs) 1 . Additionally, this proposed rule would provide owners and operators of existing U.S. MODUs, floating OCS facilities, and vessels, other than OSVs, that engage in OCS activities and U.S. tank vessels that carry flammable or combustible cargoes the option of choosing between the compliance regime contained in existing subpart 111.105 or the one in proposed subpart 111.108. Note, this proposed rule would not affect any existing domestic-flagged vessels or facilities that have not already operated on the OCS as they comply with subpart 111.105.

This proposed rule would allow the use of the latest editions of the North American Nationally Recognized Testing Laboratory (NRTL) standards, the American National Standards Institute/International Society of Automation (ANSI/ISA) 60079 series of standards referenced in Article 505 of the National Electrical Code (NEC), and the international consensus standards, International Electrotechnical Commission (IEC) 60079 Series. Further, the proposed regulations would permit the use of an internationally accepted certification system, the IECEx System.

The term “hazardous location” is broadly understood as a location where concentrations of flammable gases, vapors, or dusts (commonly referred to as explosive atmospheres) occur or may be present. Electrical equipment in these locations are specifically designed, tested, certified, or listed, and installed to ensure that explosions due to equipment arcing or high surface temperature do not occur. Hazardous locations may be classified by Class/Division or by Zone; thus the definitions of these terms would be included in the proposed revisions to § 110.15-1.

The Coast Guard proposes to add provisions specific to U.S. and foreign MODUs, floating OCS facilities, vessels (excluding U.S. OSVs) engaged in OCS activities, and U.S. tank vessels that carry flammable and combustible cargoes. These provisions would prescribe the use of the latest editions of widely accepted NRTL or international consensus standards.

With respect to U.S. industry standards, these proposed regulations would allow U.S. and foreign MODUs, floating OCS facilities, vessels (excluding U.S. OSVs) engaged in OCS activities, and existing U.S. MODUs, floating OCS facilities, and vessels, other than OSVs, that engage in OCS activities and U.S. tank vessels carrying flammable and combustible cargoes to comply with either of two hazardous locations classification systems found in the NEC, also known as National Fire Protection Association 70 (NFPA 70). Both of these systems classify hazardous locations according to the likely presence of explosive atmospheres. Hazardous locations may comply with Articles 500 through 504 of NFPA 70, expressed in Class and Divisions, or may comply with Article 505 of NFPA 70, expressed in Class and Zones. Articles 501 and 505 provide guidance in combining listed or certified equipment for use in Division or Zone hazardous locations. In order to delineate areas within a Class I, Division 1 location where explosive atmospheres are always present (i.e., equivalent to Zone 0 in Article 505 of NFPA 70), the Coast Guard decided to use the term “Class I, Special Division 1.” This term is based on the American Petroleum Institute Recommended Practice (API RP) 500. Regardless of which Article of NFPA 70 is followed, the proposed regulations in § 111.108-3(b)(1) and (b)(2) would require the equipment to be tested and listed or certified by a Coast Guard-accepted independent laboratory. A list of Coast Guard-accepted independent laboratories can be found at http://cgmix.uscg.mil/.

As an alternative to the North American NRTL standards, the proposed regulations for hazardous locations would allow U.S. and foreign MODUs, floating OCS facilities and vessels engaged in OCS activities, existing U.S. MODUs, floating OCS facilities, and vessels, other than OSVs, that engage in OCS activities, and U.S. tank vessels carrying flammable and combustible cargoes to comply with the widely accepted international standards IEC 61892-7 or IEC 60092-502. Consistent with the North American NRTL standards, the proposed regulations in § 111.108-3(b)(3) would require electrical equipment to be tested and approved or certified by a Coast Guard-accepted independent laboratory in order to meet the provisions of Clause 6 of IEC 61892-7 or Clause 6 of IEC 600092-502, as applicable.

The Coast Guard believes it is a vitally important and appropriate safety measure for the testing laboratory and certification body to follow published procedures established under an international certification scheme and conformity assessment system when performing the various testing and certification of electrical equipment for use in hazardous locations. Under the existing international regulatory standards governing foreign vessels and floating facilities engaged in OCS activities, however, equipment could be installed in hazardous locations that meets the IEC 60079 explosion protection standards but has not been tested and certified by an independent body. For this reason, the Coast Guard, through this NPRM, proposes to adopt the international certification system, the IECEx System, which implements the IEC 60079 series of standards. Additionally, the proposed regulations would add a new paragraph (q) in § 110.25-1, “Plans and information required for new construction,” which would specify submittal of IECEx certification.

The IECEx System is an internationally accepted certification system, widely used throughout the industry, that ensures electrical equipment is manufactured, tested, marked, installed, and certified for full compliance with the applicable IEC 60079 standards by a competent authority. Approval under the IECEx System involves an Ex Certification Body (ExCB) and an Ex Testing Laboratory (ExTL) that have been accepted into the IECEx System after meeting competence requirements found in the International Organization for Standardization ISO/IEC Standard 17025 and related IECEx procedures. The ExTL tests the subject equipment and drafts an Ex Test Report (ExTR) to document the test results. The ExCB reviews the manufacturing quality assurance process and issues an IECEx Quality Assessment Report (QAR). Based on the QAR and ExTR, the ExCB issues an IECEx Certification of Conformity for the equipment.

For protections not covered by the standards discussed above, this proposed rule would incorporate existing requirements for other large vessels. For example, proposed § 111.108-3 contains submerged pump motor requirements based on existing Subpart 111.105 and tank barge regulations. It also incorporates ASTM International (ASTM) F2876-10, “Standard Practice for Thermal Rating and Installation of Internal Combustion Engine Packages for Use in Hazardous Locations in Marine Applications,” to address the growing use of engines with electronic controls that could cause arcing or sparking in hazardous locations.

Material proposed for incorporation by reference appears in 46 CFR 110.10. You may inspect this material at U.S. Coast Guard Headquarters where indicated under ADDRESSES. Copies of the material are available from the sources listed in § 110.10-1.

Before publishing a binding rule, we will submit this material to the Director of the Federal Register for approval of the incorporation by reference.

We developed this proposed rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes or executive orders.

Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Two additional executive orders were recently published to promote the goals of Executive Order 13563: Executive Orders 13609 (“Promoting International Regulatory Cooperation”) and 13610 (“Indentifying and Reducing Regulatory Burdens”). Executive Order 13609 targets international regulatory cooperation to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. Executive Order 13610 aims to modernize the regulatory systems and to reduce unjustified regulatory burdens and costs on the public.

This proposed rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget (OMB) has not reviewed it under that Order. Nonetheless, we developed an analysis of the costs and benefits of the proposed rule to ascertain its probable impacts on industry. We consider all estimates and analysis in this Regulatory Analysis to be draft and subject to change in consideration of public comments.

A summary of the draft Regulatory Assessment follows:

A breakdown of the population, the effect of the proposed rule on said population, and the number of vessels included in each vessel class follows in Table 1.

We do not anticipate any costs to be borne by the U.S.-flagged vessels that would be affected by this proposed rule. The proposed rule would require that all U.S. vessels, excluding OSVs, comply with the newly created subpart 111.108. Our analysis is simplified due to the population demographics, which are filtered to include only those vessels which would (a) be on the OCS in pursuit of OCS activities as defined by this proposed rule, and (b) contain a hazardous area. Evaluation of vessel population data maintained by the Coast Guard and contained in the Marine Information for Safety and Law Enforcement (MISLE) database allows us to determine a potential 297 vessels that would fall under the umbrella of this proposed rule. All of these vessels are of the oil recovery type.

Proposed subpart 111.108 would not impose any burden on U.S. vessels due to the nature of the standards being incorporated. For example, existing subpart 111.105 refers to Articles 500-505 of the NEC (2002) while proposed subpart 111.108 would refer to NEC (2011) Articles 500-505. Because North American certification of electrical equipment is generally to the most current edition of the published reference standards,9 we do not anticipate new equipment will be tested and certified to the standards referenced in subpart 111.105 when more current, updated editions of the standards are available. The Coast Guard strives to incorporate updated standards after publication by the standards development organizations. During the time between the publication date of the updated standard and the date it is incorporated into Coast Guard regulations, certifying laboratories evaluate new equipment using the updated standard. Because all of the vessels affected by this proposed rule would be newly built and the equipment will be certified before being installed on these vessels, all vessels affected by this proposed rule would be required to be in compliance with the updated standards proposed in subpart 111.108.

The logic applied to U.S. vessels, excluding OSVs, applies to U.S. MODUs and floating OCS facilities as well. We do not anticipate any cost burden associated with this proposed rule to be imposed on this vessel class. We believe this because the affected population is entirely found under the `new build' designation. As discussed earlier, these new builds would be required to comply with proposed subpart 111.108, a subpart that contains the updated standards to which new equipment would be certified. As with the vessels discussed earlier, in the absence of proposed subpart 111.108, new equipment would be built to the most current standards as a matter of industry practice. Over the 10-year period during which the population data for this vessel class was compiled, 24 new MODUs were built and a single U.S. MODU entered the OCS from a foreign location. Under the proposed rule, this scenario would not require any costs to the vessel owner as there is no change in the regulatory environment for these existing vessels.

The proposed rule contains language pertinent to existing U.S. MODUs, floating OCS facilities, and vessels, other than OSVs, that engage in OCS activities, and U.S. tank vessels, but we do not foresee any associated costs to the owners of these vessels and facilities. Currently, the regulations for electrical installations in hazardous locations are contained in subpart 111.105. The proposed regulation will expand the available subparts to include proposed subpart 111.108, while still allowing owners and operators, the option to remain subject to existing subpart 111.105.

Currently, foreign vessels are required to comply with the regulations governing electrical installations in hazardous locations of the nation under whose flag they operate. This proposed rule would require foreign vessels new to the OCS to comply with proposed subpart 111.108. Our analysis is simplified due to the population that the proposed regulation is expected to affect. Based on historical information found in the Ship Arrival Notification System (SANS) 10 database, we are able to ascertain the number of foreign vessels that have engaged in OCS activities. After filtering this population data for vessels with prior visits to the OCS, we anticipate the affected foreign vessel population that is new to the OCS to be zero. Additionally, there were no new arrivals on the OCS by foreign vessels built within the ten year period, 2002-2011, that would be affected by the proposed rule. It is for these reasons that there is no anticipated cost burden on vessels within this class. Foreign MODUs, however, require special consideration, which is provided in the following section.

Currently, foreign MODUs & floating facilities that engage in OCS activities are subject to the regulatory schemes accepted by the nation under whose flag they operate. Equipment certified and accepted by a flag administration may or may not include evaluation by an accepted third-party laboratory. The Coast Guard seeks to address this potential safety gap by requiring that electrical installations on foreign MODUs & floating facilities conform to the required third-party certification processes accepted under proposed subpart 111.108. Those foreign MODUs & floating facilities that have engaged in documented OCS activities prior to implementation of the proposed rule would be exempt from proposed subpart 111.108, which would allow them to continue to operate without changes. The foreign MODUs & floating facilities that will be affected by this proposed rule are those vessels that are new to the OCS. Over a 10-year period between 2002 and 2011, 16 foreign-flagged MODUs & floating facilities that would be affected by this proposed rule have entered the OCS. This equates to an average yearly rate of 1.6 11 vessels seeking entrance into U.S. waters in pursuit of engaging in OCS activities. We assume that this rate will stay constant into the future.

Vessels that seek to engage in OCS activities for the first time that are not in compliance with the proposed rules have two options. The vessel owners can either replace the electrical equipment with equipment certified under a permissible scheme or seek recertification from a Coast Guard-approved third-party laboratory. As a conservative estimate, we constructed calculations for full replacement or recertification of all electrical equipment in hazardous areas present on the vessel, as the potential for partial replacement or recertification of non-conforming equipment will be determined on a vessel specific basis.

We constructed cost estimates for both of these options after discussion with experts. We estimate that it would cost a vessel owner $500,000 12 per vessel for full replacement of electrical equipment in hazardous areas. The second option, recertification of the equipment covered by this proposed rule, may be lower in cost. Additionally, it may be the preferred option for some vessel owners looking to comply with the regulation proposed in this NPRM. For the purposes of our analysis, pertaining to the recertification option, significant information gaps exist regarding its implementation. A discussion of the shortcomings of said data follows.

Recertification of equipment would begin with evaluation of existing laboratory documentation, if available, to ascertain the gap between what is acceptable to an ATEX certifying laboratory and what is acceptable to an IECEx certifying laboratory, for example. After the initial evaluation is completed, the next step would be a decision regarding acceptance, recertification, or replacement of the equipment. The cost estimate provided includes in-office labor for the initial evaluation, travel and labor time to complete a physical inspection, and final evaluation and document preparation by the certifying laboratory.

The cost for recertification on a MODU is estimated to begin at $35,000.13 The estimated cost range for a given vessel to comply with the proposed regulation is between $35,000 to $500,000, depending on the composition and the extent of equipment replacement. The myriad types of MODUs and facilities operating on the OCS may contain a diverse range of equipment, with some equipment requiring replacement in order to comply with the proposed rulemaking, while other equipment may be able to be recertified after evaluation by a certified laboratory. A vessel found to have all equipment in compliance with the proposed regulation could conceivably proceed with recertification, for an estimated $35,000. However, because vessel specific information is unavailable, we estimate the cost of the proposed rulemaking conservatively at $500,000 per vessel, which reflects the cost associated with full replacement of electrical equipment on a vessel. At an entry rate of 1.6 per year and a cost of $500,000 per vessel & facility, the yearly cost for compliance for the industry is projected to be $800,000, as presented in Table 2.

The Coast Guard is unable to monetize benefits. We can find no casualties that would have been prevented with recertification. However, the importance of third-party testing and certification for critical equipment, such as electrical equipment intended for use in hazardous locations, addresses a potentially catastrophic hazard consisting of an explosive gas/vapor combined with an electrical ignition source, and is generally understood by industry as an appropriate measure that enhances safety and protects life, the environment, and property.

We considered four alternatives when evaluating the effects of this proposed rule. The first, abstaining from action, was deemed to leave a significant hazard not addressed. Further, it allows a regulatory imbalance to exist because foreign vessels and facilities operating on the OCS would not be required to meet the same standards for explosion protection and independent third-party certification as those of U.S. vessels and facilities operating in the same service.

The second alternative we considered was to require both U.S. and foreign-flagged vessels and facilities to adhere to the existing international standards. This alternative was deemed insufficient because compliance with international standards, such as the IMO Code, is subject to the interpretation of the applicable flag administration. An example of an undesired consequence of this alternative would be the acceptance of ATEX certified equipment. The Coast Guard, however, will not accept ATEX certifications because evidence of full testing to the applicable harmonized 60079 series of standards by an independent third-party laboratory is not guaranteed. Consistent with preexisting Coast Guard practices, third-party testing and certification for critical equipment is generally required.

The third alternative we considered was to require foreign vessels and floating facilities to meet current U.S. standards. This alternative was not selected because we believe that requiring compliance with U.S. standards is unnecessary when there are specific, comparable international standards acceptable to the Coast Guard. Because these latest editions of internationally recognized standards for explosion protection and independent third-party certification offer owners and operators greater flexibility while also avoiding the costs of coastal state specific requirements, the Coast Guard proposes to expand the list of international explosion protection standards deemed acceptable.

The final alternative, implementing the proposed regulation, would put in place a regulatory regime that would allow for both the U.S., as the coastal state, and industry to be confident in the certification and assessment of electrical equipment intended for use in hazardous locations. This would be achieved through the use of the most current, internationally recognized standards for explosion protection and independent third-party certification. Lastly, the proposed regulation would expand the list of national and international explosion protection standards deemed acceptable for U.S. operators.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

We do not anticipate any effect on small entities. As noted in the previous discussion, there is no anticipated cost burden placed on U.S. entities by this proposed rule and, as such, we do not anticipate any effect on small entities that would be addressed by this section.

Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment to the Docket Management Facility at the address under ADDRESSES. In your comment, explain why you think it qualifies and how and to what degree this rule would economically affect it.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This proposed rule does not increase the burden under a current a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). As defined in 5 CFR 1320.3(c), “collection of information” comprises reporting, recordkeeping, monitoring, posting, labeling, and other, similar actions. The title and description of the information collections, a description of those who must collect the information, and an estimate of the total annual burden follow. The estimate covers the time for reviewing instructions, searching existing sources of data, gathering and maintaining the data needed, and completing and reviewing the collection.

Title: Plan Approval and Records for Electrical Engineering Regulations—Title 46 CFR Subchapter J.

OMB Control Number: 1625-0031.

Summary of the Collection of Information: The information sought here is needed to ensure compliance with our rules on electrical engineering for the design and construction of U.S.-flag commercial vessels.

Need For Information: These regulations contain the primary standards for the review of electrical installations on all new U.S. Coast Guard certificated vessels except small passenger vessels. Recent amendments to the regulations clarify the regulations, bring them up to date, and delete unnecessary requirements. The revisions to Subchapter J reduced the reliance on domestic standards and adopted SOLAS and other international standards developed through consensus by the international maritime community. The information collection requirements described in this supporting statement are necessary to implement the regulations in 46 CFR Parts 110 through 113.

The Coast Guard requires industry complete electrical engineering plans to meet performance requirements on new-built vessels. These requirements help resolve much of the confusion during inspections that has risen due to the varying special missions of modern merchant vessels.

The collection of information is needed to demonstrate that certain specific regulations implement the international requirements. The requirements generally reflect routine practices for U.S. merchant companies.

Proposed Use of Information: The purpose of the information collection is to ensure compliance with electrical safety regulations. Through the review of the plans prior to construction, the vessel owner of builder may be assured that the vessel, if built in accordance with the plans, will meet regulatory standards.

Description of the Respondents: Owners, operators, and builders of vessels.

Number of Respondents: 186.

Frequency of Response: On occasion.

Burden of Response: Hour Burden: 4,754 hours. Cost burden: $399,336.

Estimate of Total Annual Burden: The estimated annual hour burden is 4,754 hours. The estimated annual cost burden is $399,336.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we will submit a copy of this proposed rule to the Office of Management and Budget (OMB) for its review of the collection of information.

We ask for public comment on the proposed collection of information to help us determine how useful the information is; whether it can help us perform our functions better; whether it is readily available elsewhere; how accurate our estimate of the burden of collection is; how valid our methods for determining burden are; how we can improve the quality, usefulness, and clarity of the information; and how we can minimize the burden of collection.

If you submit comments on the collection of information, submit them both to OMB and to the Docket Management Facility where indicated under ADDRESSES, by the date under DATES.

You need not respond to a collection of information unless it displays a currently valid control number from OMB. Before the Coast Guard could enforce the collection of information requirements in this proposed rule, OMB would need to approve the Coast Guard's request to collect this information.

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

It is well settled that States may not regulate in categories reserved for regulation by the Coast Guard. It is also well settled, now, that all of the categories covered in 46 U.S.C. 3306, 3703, 7101, and 8101 (design, construction, alteration, repair, maintenance, operation, equipping, personnel qualification, and manning of vessels), as well as the reporting of casualties and any other category in which Congress intended the Coast Guard to be the sole source of a vessel's obligations, are within the field foreclosed from regulation by the States. (See the decision of the Supreme Court in the consolidated cases of United States v. Locke and Intertanko v. Locke, 529 U.S. 89, 120 S.Ct. 1135 (March 6, 2000).) This rule addresses the design, construction, alteration, repair, maintenance, operation, and equipping, of vessels and facilities engaged in OCS activities. Because the States may not regulate within these categories, preemption under Executive Order 13132 is not an issue.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This proposed rule would not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This proposed rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.

This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order. This proposed rule is not a “significant regulatory action” under Executive Order 12866, and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This proposed rule uses the following voluntary consensus standards:

The proposed sections that reference these standards and the locations where these standards are available are listed in 46 CFR 110.10-1.

This proposed rule also uses a technical standard other than voluntary consensus standards:

• IMO Resolution A.1023(26), Code for the Construction and Equipment of Mobile Offshore Drilling Units, 2009 (“2009 IMO MODU Code”)

The proposed section that references this standard and the locations where this standard is available are listed in 46 CFR 110.10-1. They are used because we did not find voluntary consensus standards that are applicable to this proposed rule. If you are aware of voluntary consensus standards that might apply, please identify them by sending a comment to the docket using one of the methods under ADDRESSES. In your comment, please explain why you think the standards might apply.

If you disagree with our analysis of the voluntary consensus standards listed above or are aware of voluntary consensus standards that might apply but are not listed, please send a comment to the docket using one of the methods under ADDRESSES. In your comment, please explain why you disagree with our analysis and/or identify voluntary consensus standards we have not listed that might apply.

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. A preliminary environmental analysis checklist supporting this determination is available in the docket where indicated under the “Public Participation and Request for Comments” section of this preamble. This proposed rule is likely to be categorically excluded under section 2.B.2, figure 2-1, paragraphs (34)(d) and (e) of the Instruction and under section 6(a) of the “Appendix to National Environmental Policy Act: Coast Guard Procedures for Categorical Exclusions, Notice of Final Agency Policy” (67 FR 48243, July 23, 2002). This rule involves regulations concerning inspection and equipping of vessels; regulations concerning equipment approval and carriage requirements; and regulations concerning vessel operation safety standards. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 143 and 46 CFR parts 110 and 111 as follows: