Title III, Part B  1 of the Energy Policy and Conservation Act of 1975 (EPCA or the Act), Public Law 94-163 (42 U.S.C. 6291-6309, as codified) sets forth a variety of provisions designed to improve energy efficiency and established the Energy Conservation Program for Consumer Products Other Than Automobiles, a program covering most major household appliances. These include general service fluorescent lamps (GSFLs), general service incandescent lamps (GSILs), and incandescent reflector lamps (IRLs), the subject of today's notice (referred to below as one of the “covered products”). 2 (42 U.S.C. 6292(a)(14) and 6295(i))

Under the Act, this program generally consists of four parts: (1) Testing; (2) labeling; and (3) establishing Federal energy conservation standards and (4) certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products must use: (1) As the basis for certifying to DOE that their products comply with the applicable energy conservation standards adopted pursuant to EPCA, and (2) for making representations about the efficiency of those products. (42 U.S.C. 6293(c); 42 U.S.C. 6295(s)) Similarly, DOE must use these test requirements in determining whether covered products comply with any relevant energy conservation standards promulgated under EPCA. (42 U.S.C. 6295(s))

Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures that DOE must follow when prescribing or amending test procedures for covered products. EPCA provides in relevant part that any test procedures prescribed or amended under this section must be reasonably designed to produce test results which measure energy efficiency, energy use, or estimated annual operating cost of a covered product during a representative average use cycle or period of use and not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6293(b)(2)) Finally, in any rulemaking to amend a test procedure, DOE must determine the extent to which the proposed test procedure would alter the measured energy efficiency. (42 U.S.C. 6293(e)(1)) If DOE determines that the amended test procedure would alter significantly the measured efficiency of a covered product, DOE must amend the applicable energy conservation standard accordingly. (42 U.S.C. 6293(e)(2))

Relevant to this rulemaking, EPCA, as codified, directs DOE to prescribe test procedures for GSFLs and IRLs to which energy conservation standards are applicable, taking into consideration the applicable standards of the Illuminating Engineering Society of North America  3 (IESNA) or the American National Standards Institute  4 (ANSI). (42 U.S.C. 6293(b)(6))

In addition, on December 19, 2007, the Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140, was enacted. Section 321 of EISA 2007 amended EPCA, in relevant part, to prescribe energy conservation standards for GSILs that included maximum rated wattage and minimum rated lifetime requirements for several different lumen ranges; these standards will be phased in between 2012 and 2014. (42 U.S.C. 6295(i)) Section 302 of EISA 2007 also amended EPCA to require DOE to review test procedures for all covered products at least once every seven years. DOE must either amend the test procedures or publish notice in the Federal Register of any determination not to amend a test procedure. (42 U.S.C. 6293(b)(1)(A))

Accordingly, to fulfill these statutory requirements for periodic review, in this NOPR, DOE invites comment on all aspects of the existing test procedures for GSFLs, GSILs, and IRLs that appear at Title 10 of the Code of Federal Regulations (CFR): 10 CFR 429.27 (“General service fluorescent lamps, general service incandescent lamps, and incandescent reflector lamps”), 10 CFR 430.2 (“Definitions”), 10 CFR 430.3 (“Materials incorporated by reference”), 10 CFR 430.23 (“Test procedures for the measurement of energy and water consumption”), 10 CFR 430.25 (“Laboratory Accreditation Program”), and 10 CFR part 430 subpart B, Appendix R (“Uniform Test Method for Measuring Average Lamp Efficacy (LE), Color Rendering Index (CRI), and Correlated Color Temperature (CCT) of Electric Lamps”).

To address prior EPCA requirements for GSFLs, GSILs, and IRLs, DOE has undertaken a number of rulemaking actions pertaining to the test procedures for these products. On September 28, 1994, DOE published in the Federal Register an Interim Final Rule on Test Procedures for Fluorescent and Incandescent Lamps that established test procedures for GSFLs, medium-base compact fluorescent lamps (CFLs), IRLs, and GSILs. 59 FR 49468 (establishing 10 CFR part 430, subpart B, Appendix R). On May 29, 1997, DOE published a final rule in the Federal Register on Test Procedures for Fluorescent and Incandescent Lamps that revised some definitions and calculation methods and updated several references to industry standards adopted in the September 1994 Interim Final Rule. 62 FR 29222.

Subsequently, DOE amended its GSFL, GSIL, and IRL test procedures in a final rule published in the Federal Register on July 6, 2009 (hereinafter referred to as the 2009 Lamps Test Procedure). 74 FR 31829. This final rule made the following technical modifications to the test procedures: (1) Required testing of GSFLs to be based on low-frequency reference ballasts, except for those lamps that can only be tested on high-frequency ballasts; (2) required lamp efficacy for GSFLs to be rounded to the nearest tenth of a lumen per watt, rather than the nearest whole number; (3) adopted a test method for measuring and calculating correlated color temperature (CCT) for fluorescent lamps and incandescent lamps; and (4) updated citations and references to industry standards referenced in DOE's test procedures. Additionally, because EISA 2007 promulgated energy conservation standards for certain GSILs, DOE also amended its test procedures for GSILs by: (1) Specifying the units to be tested; (2) defining the “basic model” for GSILs; and (3) providing a method for calculating annual energy consumption and efficacy of GSILs.

In a separate rulemaking that amended GSFL and IRL energy conservation standards, DOE adopted standards for additional general service fluorescent lamp types and also established test procedures for those lamps. These test procedure amendments included specific reference ballast settings for testing those additional GSFLs. 74 FR 34080, 34095-96 (July 14, 2009).

The current test procedures for GSFLs, GSILs, and IRLs are specified in various sections of the CFR and are based on the 1997 and 2009 final rules addressing test procedures for fluorescent and incandescent lamps. 62 FR 29222 (May 29, 1997); 74 FR 31829 (July 6, 2009); 74 FR 34080 (July 14, 2009). Calculations for lamp efficacy of GSFLs, GSILs, and IRLs and for color rendering index of GSFLs are discussed in 10 CFR 430.23, which references 10 CFR part 430, subpart B, Appendix R. Appendix R also specifies several IESNA and ANSI standards to use for test conditions and procedures. For GSFLs, it references measurement procedures set forth in IESNA LM-9-1999. 5 Additionally, GSFL are to be operated according to general procedures for taking electrical measurements described in ANSI C78.375-1997, 6 and at the voltage and current conditions described in ANSI C78.81-2005 (double-based lamps)  7 or ANSI C78.901-2005 (single-based lamps), 8 and using the reference ballast at input voltage specified by the reference circuit in ANSI C82.3-2002. 9 Appendix R also notes that the measurement procedures for GSILs and IRLs are set forth in IESNA LM-45-2000  10 and IESNA LM-20-1994, 11 respectively.

In overview, in addition to requesting comment on all aspects of the current GSFL, GSIL, and IRL test procedures, this NOPR proposes to amend DOE's current test procedures for GSFLs and GSILs based on DOE's review of the existing test procedures. These amendments would achieve two objectives: (1) To update test procedures by incorporating certain lighting industry standards by reference in order to adopt current best practices and technological developments and (2) to adopt a new test procedure for determining GSIL rated lifetime. If the revisions and additions proposed by this test procedure NOPR were adopted, their use would be required for standards compliance purposes upon the effective date of the test procedure final rule ( i.e., 30 days after its publication).

Regarding the first objective ( i.e., updating references in DOE's existing test procedures to incorporate current best practices and technological developments), today's notice proposes updating references for the industry standards incorporated by reference to the latest versions of those documents. For GSFLs, DOE is proposing to update references ANSI C78.81-2005 to ANSI C78.81-2010  12 and from IESNA LM-9-1999 to IES LM-9-2009  13 for measuring the electrical and photometric attributes. For GSILs, DOE proposes updating references from IESNA LM-45-2000 to IES LM-45-2009  14 for measuring their electrical and photometric attributes. This NOPR is not proposing changes to the current IRL test procedures, because no updated version of the relevant industry standard, IESNA LM-20-1994, has been published, nor do current best practices and technological developments appear to warrant such an update.

DOE has identified and outlined in section III.B the modifications and clarifications found in the most recent versions of the industry standards for GSFLs and GSILs, as compared to the versions of those same standards currently incorporated by reference in DOE's test procedures. These changes will not, in DOE's view, significantly alter reported lamp efficacy values.

Regarding the second objective ( i.e., adoption of a GSIL rated lifetime test procedure), today's notice proposes incorporating by reference industry standard, IESNA LM-49-2001. 15 As noted above, EISA 2007 amended EPCA, in part, by establishing energy conservation standards for GSILs which include for the first time minimum rated lifetime requirements that are to be phased in between January 2012 and January 2014. DOE must now address GSIL lifetimes in an amended test procedure for GSILs. EPCA's definition of lamp “life” and “lifetime” requires that DOE make this amendment in accordance with test procedures described in the IES Lighting Handbook—Reference Volume. (42 U.S.C. 6291(30)(P))

To initiate the development of a test procedure for determining GSIL rated lifetime, DOE conducted literature research and interviews with several GSIL lifetime testing facilities and determined that IESNA LM-49-2001 aligns with guidance in the IESNA Lighting Handbook, and is also the industry standard for GSIL lifetime testing. Additionally, DOE has tentatively concluded this industry standard adequately covers the test setup, conditions, and procedures for GSIL lifetime testing. Therefore, in order to meet the EISA 2007 requirements for GSIL lifetimes that will begin going into effect in January 2012, this notice proposes to incorporate by reference IESNA LM-49-2001 to establish the test procedure for determining rated lifetime of GSILs.

The following sections detail changes associated with the revised versions of the applicable industry standards incorporated by reference (IES LM-9-2009 and IES LM-45-2009) and summarize DOE's proposed test procedure for the GSIL rated lifetime.

Lastly, DOE discusses the compliance date for use of the amended test procedure and certifying compliance with DOE's energy conservation standards.

In undertaking this rulemaking, DOE is fulfilling its statutory obligation under section 302 of EISA 2007 to review its test procedures for all covered products, including GSFL, GSIL, and IRL, at least once every seven years. (42 U.S.C. 6293(b)(1)(A)) DOE must either: (1) Amend the test procedure to improve its measurement representativeness or accuracy or reduce its burden, or (2) determine that such amendments are unnecessary. Id. Although DOE is proposing revisions to only certain parts of the existing test procedures (see sections III.A.1, III.A.2, and III.A.3), DOE invites comments on all aspects of DOE's test procedures for GSFL, GSIL, and IRL, including those provisions appearing at 10 CFR 429.27, 10 CFR 430.2, 10 CFR 430.23, 10 CFR 430.25, and 10 CFR 430, subpart B, Appendix R. (See Issue 1 in section V.E), as well as comments on current best practices and technological developments that may warrant amendments.

Because the current GSFL, GSIL, and IRL test procedures are based mainly on references to industry standards, this review, in part, consists of determining whether or not to adopt the updated version of these standards. Industry periodically updates its test procedure standards to account for changes in product lines and/or developments in test methodology and equipment. In its review of these industry standards, DOE compared updated and current versions to determine, as directed by EPCA, whether adopting the latest industry standards would alter measured energy efficiency. (42 U.S.C. 6293(e)(1)) In addition, in considering whether to adopt an updated standard, DOE must ensure that a revision to DOE's regulations would not result in a test procedure that is unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

After reviewing the industry standards incorporated by reference for the existing GSFL, GSIL, and IRL test procedures as well as current best practices and technological developments, DOE tentatively identified appropriate updates for the GSFL and GSIL test procedures, but no updates for the IRL test procedure. For GSFLs, DOE is proposing to update references to the 1999 version of IES LM-9 to the 2009 version and references to the 2005 version of ANSI C78.81 to the 2010 version. For GSILs, DOE proposes to update references to the 2000 version of IES LM-45 to the 2009 version. DOE is proposing to adopt the latest versions of IES LM-9 and IES LM-45, as they include requirements that will increase the precision of measurements and clarifications of existing test setup and methodology. The updated version of ANSI C78.81 provides lamp specifications for additional lamp types that may become useful in the future. Adoption of these latest versions will also better align DOE test procedures with industry practice, thereby potentially reducing testing burden.

Generally, DOE has determined that the changes associated with adoption of the updated versions of industry standards referenced in the existing test procedures for the products that are the subject of this NOPR would not be unduly burdensome for manufacturers, nor would they result in a change in measured lamp efficacy values, as they are not making substantive changes to test setup and methodology. In its review of the updated versions of industry standards, DOE identified some provisions in the revised industry test procedures that could potentially result in small changes in lamp efficacy values ( e.g., modifications to impedance thresholds, voltage and current regulations). However, DOE tentatively determined that these potential changes in lamp efficacy values from the modified provisions would not be significant. 16 Nevertheless, DOE requests comments on its assessment (see Issues 2 and 3 in section V.E). The following sections discuss in more detail each of the updated industry standards and their provisions that could potentially result in small changes in lamp efficacy values.

The existing GSFL test procedure at 10 CFR part 430, subpart B, Appendix R incorporates by reference ANSI C78.81-2005, addressing dimensional and electrical characteristics for double-capped fluorescent lamps. This 2005 standard, a revision to ANSI C78.81-2003, is also referenced in DOE's definitions of “cold-temperature fluorescent lamp” and “rated wattage.” (See 10 CFR 430.2) In addition, ANSI C78.81-2003 is currently referenced in parts of DOE's test procedure for fluorescent lamp ballasts. (See 10 CFR part 430, subpart B, Appendix Q) In this NOPR, DOE proposes to update all reference to ANSI C78.81 (both 2003 and 2005) to now reference ANSI C78.81-2010 in DOE's test procedures and definitions relating to GSFLs and fluorescent lamp ballasts. The 2010 version adds high-frequency and low-frequency lamp specifications for reduced-wattage 4-foot T8 medium bipin lamps. While DOE's current test procedures do not require the use of these specifications, they may become relevant in DOE's ongoing assessment of whether industry has provided high-frequency lamps specifications for all GSFL covered by standards and subsequently, if DOE should consider requiring GSFLs be tested using high-frequency ballasts. Furthermore, if upcoming GSFL energy conservation standards rulemakings adopt additional lamp types, incorporating the latest version of ANSI C78.81 may necessitate little or no changes to DOE test procedures in terms of specifications for the new lamp types.

Section 1 (“Definitions”) of Appendix Q (“Uniform Test Method for Measuring Energy Consumption of Fluorescent Lamp Ballasts”) to the DOE test procedure refers to specific datasheets in ANSI C78.81-2003 to identify dimensional and electrical characteristics for the following lamps: F40T12, F96T12, F96T12HO, F34T12, F96T12ES, F96T12HO/ES. DOE has determined that 2003 datasheets referenced in Appendix Q are identical to the corresponding datasheets in the 2010 version of ANSI C78.81. As updating references to ANSI C78.81-2003 to ANSI C78.81-2010 in Appendix Q does not constitute a substantive change to the fluorescent lamp ballast test procedure, DOE concludes that such amendments would not result in any changes in testing burden or a change in measured energy consumption as compared to the current DOE test procedure.

In comparing ANSI C78.81-2010 to the 2005 version of the standard, DOE notes that the only change is to include high-frequency and low-frequency lamp specifications for 25W, 28W, and 30W, reduced-wattage 4-foot T8 medium bipin lamps. These lamps, commonly used as replacements for a 32W 4-foot T8 medium lamp, are newer products and only recently have been added to the ANSI standard. The low-frequency reference ballast specifications in ANSI C78.81-2010 for these lamps are identical to the specifications DOE currently directs manufacturers to use for those fluorescent lamps in section 4.1.2.1 of Appendix R. 17 Therefore, neither measured efficacy nor testing burden would be affected by updating the current references in the DOE test procedure to ANSI C78.81-2010. Thus, DOE proposes to update all references to ANSI C78.81 (both the 2003 and 2005 version) in 10 CFR part 430 to the 2010 version of the standard.

IESNA LM-9-1999 specifies procedures for measuring the efficacy of GSFLs. As discussed above, this industry standard has been updated with a 2009 edition. DOE is proposing to update references to IESNA LM-9-1999 to the more recent 2009 version of the standard. 18 A review indicates that incorporating the 2009 edition of IES LM-9 could provide further clarification of the test procedure and improve the test methodology and test instrumentation setup and specifications. DOE has identified the following four key updates in the 2009 edition of IES LM-9 and discusses them in greater detail below. Specifically, IES LM-9-2009:

• Adds information on conducting tests under high-frequency conditions;

• Modifies the lamp stabilization method;

• Specifies temperature and orientation for stabilization of T5 lamps; and

• Specifies impedance  19 thresholds for the multipurpose volt, amperes, and watts (VAW) meter and power source, where previously only general guidance was provided.

One of the key updates in IES LM-9-2009 is the addition of guidance on taking measurements under high-frequency conditions when using high-frequency ballasts. Because high-frequency test specifications are not available for all lamp types and in order to maintain consistency and comparability across testing, DOE required testing of GSFLs using low-frequency ballasts where possible in the 2009 Lamps Test Procedure final rule. 20 74 FR 31829, 31835 (July 6, 2009). This NOPR does not propose to change this requirement. Because 8-foot T8 recessed double-contact high-output and 4-foot T5 miniature bipin standard and high-output lamps only have high-frequency reference ballasts specifications available, the DOE test procedure directs manufacturers to use high-frequency test conditions for these lamps.

IES LM-9-2009 now provides some guidance for testing in high-frequency situations, specifically regarding instrument thresholds and circuit setup. As noted above, DOE requires GSFLs testing using low-frequency ballasts where possible. However, the high-frequency guidance in IES LM-9-2009 would be applicable for lamps that only have high-frequency ballast specifications available and, therefore, cannot be tested using low-frequency ballasts. IES LM-9-2009 specifies for high-frequency measurements that root mean square (RMS) voltage applied to the test lamp be regulated to within ± 1.0 percent of the reference ballast voltage setting and that instruments have a frequency response  21 of at least 100 kilohertz (kHz). For measurements under high-frequency operation, the industry standard specifies that lamps be operated in series with a non-inductive reference resistor ballast, 22 as specified in ANSI C78.81-2010. IES LM-9-2009 also states that when the impedance is not specified in a standard, the value is to be set to one half of the lamp impedance under high-frequency conditions. High-frequency-specific impedance, along with current and input voltage for reference ballasts, are necessary parameters for testing under high-frequency conditions. The industry standard also clarifies that for high-frequency circuits, cathode heating should not be used when the lamp is in operation. DOE has tentatively concluded that for lamps that can only be tested at high frequency, the impact of the new guidance provided in IES LM-9-2009 regarding high-frequency testing would be useful, and it would not significantly impact lamp efficacy measurements (which would likely be within the margin of measurement error). Furthermore, DOE's analyses indicate that most modern equipment would accommodate the thresholds specified in IES LM-9-2009 for high-frequency testing, and, thus, they would not impose an additional testing burden on manufacturers since new testing instruments would not be required to run the test. DOE requests comment on whether the clarification on high-frequency testing provided would affect lamp efficacy values and/or significantly increase the testing burden (see Issue 2 in section V.E).

In addition, IES LM-9-2009 includes modifications to the lamp stabilization methodology. IES LM-9-2009 now prescribes six (instead of four) measurements at one-minute intervals for a total of five (instead of three) minutes. It also removes the requirement that the stability percentage be two percent for lamps with cold spots/chambers, leaving only the general one-percent stability threshold. Additionally, IES LM-9-2009 requires that stabilization measurements continue until six consecutive measurements meet the stabilization criteria. These modifications to the lamp stabilization method allow for more accurate and consistent measurements of lamp efficacy. After review, DOE has tentatively concluded that the 2009 version provides a stricter stabilization method, but one that is consistent with industry standards. DOE requests comments on the impact of these proposed changes in stabilization methodology on lamp efficacy values (see Issue 2 in section V.E).

IES LM-9-2009 also prescribes lamp stabilization characteristics unique to T5 linear fluorescent lamps. To obtain stable photometric results in 25 °C (77 °F) air, it recommends keeping the mercury dose in the test lamp close to the equilibrium temperature and vapor pressure. IES LM-9-2009 also specifies that T5 lamps are to be seasoned  23 in the vertical orientation, even though they are measured horizontally. Stable light output is reached when all the liquid mercury is in the cold spot, which by industry convention is at the monogrammed end of the lamp. Therefore, T5 lamps are operated in a vertical position to keep the mercury dose at one end of the lamp. IES LM-9-2009 references IESNA LM-54-1999  24 for further guidance on this procedure. Upon review, DOE has tentatively concluded that the addition of the T5 lamp stabilization method, as proposed, would address stability characteristics specific to these lamp types, but it would not be expected to alter measured lamp efficacy.

IES LM-9-2009 also specifies impedance thresholds for the multipurpose volt, amperes, and watts (VAW) meter and power source. The VAW meter voltage input must have input impedance greater than one megaohm; and the electrical current input impedances may not exceed 10 milliohms. 25 IES LM-9-2009 also prohibits power source impedance greater than two percent of the ballast impedance. For high-frequency power supplies, the 2009 version adds the note that it is impossible to meet this power source impedance limit internally, so external control circuits are used to keep the output voltage at the desired level. This modification addresses the need for low impedance in order to ensure accurate measurements, but DOE does not expect that it would significantly affect lamp efficacy measurements. DOE has tentatively concluded that because the updates to impedance limitations mainly affect error correction and ensure accurate measurements, these changes would not be expected to affect lamp efficacy values. In addition, DOE's research indicates that manufacturers' existing instrument setups should meet the impedance thresholds prescribed and, therefore, would not pose an additional testing burden.

In addition to the above mentioned updates, IES LM-9-2009 provides recommendations and further guidance that remove a number of ambiguities in the previous version ( e.g., updates to sources of measurement errors, definitions, and references). Because these proposed updates do not involve substantive changes to the test setup and methodology, but rather just clarification, DOE has tentatively concluded they would not affect lamp efficacy measurements or pose an additional testing burden.

For the reasons discussed above, DOE has tentatively concluded that substituting the 2009 version of IES LM-9 for the version (1999) currently incorporated in the DOE test procedure for GSFLs would generally result in more precise measurements and provide further clarification to the DOE test procedures. It would also align DOE's requirements with current industry standards, thereby potentially reducing testing burden. The proposed amendments would not be expected to significantly affect measured lamp efficacy. DOE requests comments on its proposed incorporation of IES LM-9-2009 and its tentative conclusion that the update would have an insignificant impact on lamp efficacy values (see Issue 2 in section V.E).

The existing GSIL test procedure at 10 CFR part 430, subpart B, Appendix R incorporates by reference IESNA LM-45-2000 and specifies its use for measuring efficacy of GSILs. As discussed above, this industry standard has been updated with a 2009 edition which is labeled as IES instead of IESNA. DOE is considering updating references from IESNA LM-45-2000 to the 2009 version of the standard. A review indicates that incorporating the 2009 edition of IES LM-45 could provide further clarification of the test procedure and improvements in test methodology. DOE has identified the following five key updates in the 2009 edition of LM-45 and discusses them in greater detail below:

• Modifies the lamp stabilization method;

• Modifies voltage and current regulation tolerances of the alternating current (AC) power source;

• Modifies instrument tolerance for AC voltage, current, and wattage;

• Specifies impedance tolerances for instruments;

• Specifies the tolerance of the spectral response of the photo detector;

The first key update in IES LM-45-2009 is clarification of the lamp stabilization methodology. IES LM-45-2009 specifies that the stability percentage should be calculated by dividing the difference between the maximum and minimum of the five consecutive measurements by the average value of the measurements. IES LM-45-2009 also states that measurements must continue at 15-second intervals until five consecutive measurements meet the stability criteria. These additional specifications in IES LM-45-2009 provide a more precise definition of stabilization, which may improve consistency of test results.

IES LM-45-2009 also contains modified requirements for voltage and current regulation of the AC power source. It specifies that RMS voltage or current is to be regulated to within ± 0.1 percent instead of ± 0.02 percent. The revised standard also changed the instrument tolerances for voltage, current, and wattage measurements for AC, specifying ± 0.5 percent or less for voltage and current and ± 0.75 percent or less for wattage as allowable accuracies. IES LM-45-2000 had stated that uncertainty of voltage and current shall not exceed ± 0.05 for both DC and AC circuits. All else held equal, uncertainty for AC measurements tends to be higher than DC measurements, due to the time-varying properties of AC signals.

While the above mentioned changes in power source regulation and in instrument tolerances could introduce slightly more variation in lamp efficacy measurements, DOE does not expect that these proposed changes would have a significant impact on reported lamp efficacy values, which are based on testing of 21 samples. Additionally, the revised tolerances are closer to those achievable by today's commercially-available equipment being used industry-wide, and, therefore, they would not pose an additional testing burden.

IES LM-45-2009 also adds upper and lower input impedance thresholds for the voltage and the current inputs of the multimeter used for measurements. Under the revised version of the industry standard, the input impedance for the voltage input to the multifunction meter must exceed one megaohm, and the input impedance for the current inputs must be less than 10 milliohms. DOE has tentatively concluded that these changes would have an insignificant impact on lamp efficacy values. The updates to impedance thresholds mainly affect error correction and ensure accurate measurements. In addition, this change would not pose an additional testing burden, as DOE's research indicates that manufacturers' existing instrument setups should meet the impedance thresholds prescribed.

Both versions of IES LM-45 include a requirement that the photo-detector have a relative spectral responsivity which approximates V(λ), the photopic luminous efficiency function. 26 The V(λ) function represents the response curve of a standard observer, which quantifies the visual sensitivity of the human eye to light at different wavelengths. IES LM-45-2009 adds the specification that the V(λ) parameter, f1′, be less than five percent. The parameter f1′ describes the degree of spectral match of the photo-detector measurements to the V(λ) function. DOE's research indicates that industry commonly considers a value for f1′ of less than five percent good commercial quality and a value of less than three percent good laboratory/research quality. DOE has tentatively concluded that the additional specification of the spectral response tolerance of the photo-detector would not affect lamp efficacy measurements. In addition, DOE research shows that manufacturers already employ at least commercial-grade instruments, and, therefore, this specification would not pose an additional test burden. However, it is useful to explicitly specify the allowable error in spectral response to ensure a certain accuracy of photometric measurements.

For the reasons discussed above, DOE has tentatively concluded that substituting the 2009 version of IES LM-45 for the 2000 version currently incorporated in the DOE test procedure for GSILs would result in more precise measurements and provide further clarification to the DOE test procedures. Updating to the latest version would also better align DOE's requirements with current industry standards and best practices. The proposed amendments would not be expected to significantly affect measured lamp efficacy. DOE requests comments on its proposed incorporation of LM-45-2009 and its tentative conclusion that the update would have an insignificant impact on lamp efficacy values and testing burden (see Issue 3 in section V.E).

The existing IRL test procedure at 10 CFR part 430, subpart B, Appendix R incorporates by reference IESNA LM-20-1994  27 for measuring efficacy of IRLs. At the time of publication of this NOPR, a revised edition of this standard had not been published. Upon review DOE has determined that existing test procedures for IRLs are appropriate for measuring efficacy and continue to not impose an undue testing burden. Further, DOE is not aware of any current best practice or technical development that necessitates modifications to the existing test procedure. Therefore, no amendments to IRL test procedures are proposed. DOE requests comment on its assessment that no updates to the IRL test procedure are needed and welcomes any suggestions for amendments (see Issue 4 in section V.E).

Section 321 of EISA 2007 amended EPCA by prescribing for the first time for GSILs, minimum rated lifetime  28 requirements to be phased in between January 2012 and January 2014 (codified at 42 U.S.C. 6295(i)(1)). EPCA defines “life” and “lifetime” as the length of operating time of a statistically large group of lamps between first use and failure of 50 percent of the group, in accordance with test procedures described in the IESNA Lighting Handbook Reference Volume. (42 U.S.C. 6291(30)(P))

The rated lifetime of a general service incandescent lamp depends mainly on the rate of vaporization of the surface of the tungsten filament due to the high filament temperatures required during lamp operation. The tungsten filament generates the light in incandescent lamps when a current is passed through it, which heats the filament by electrical resistance. As the filament evaporates and shrinks, its resistance increases, thereby reducing current, power, and light in multiple circuits. 29 Light output is also reduced by the deposit of light-absorbing tungsten particles on the bulb surface. When the filament breaks, it interrupts the electrical circuit, thereby resulting in an inoperable lamp.

As stated above, EPCA defines the term “lifetime” in part by referencing test procedures in the IESNA Lighting Handbook. 30 The IESNA Lighting Handbook provides guidance on two methods of testing GSIL lifetime: (1) At rated voltage; and (2) at overvoltage (also known as accelerated lifetime testing). DOE notes that the rated voltage testing guidance in the IESNA Lighting Handbook generally coincides with IESNA LM-49-2001. (See discussion in section III.D.3 below for further details on accelerated lifetime testing.) In light of its common usage in the industry and its similarity to the test procedure in the IESNA Lighting Handbook, DOE is proposing to incorporate by reference IESNA LM-49-2001, “IESNA Approved Method for Life Testing of Incandescent Filament Lamps” (approved Dec. 1, 2001), into the DOE test procedure for measuring GSIL lifetime, in order for there to be an appropriate test method in place by the compliance date for the GSIL minimum lifetime standard levels established by EISA 2007.

DOE notes, however, that the IESNA Lighting Handbook test procedures depart from those described in IESNA LM-49-2001 in one way: the IESNA Lighting Handbook requires test voltage or current be held within ± 0.25 percent of rated voltage/current, whereas IESNA LM-49-2001 requires test voltage or current be held within ± 0.5 percent of rated RMS values. As IESNA LM-49-2001 is the more commonly used reference for GSIL lifetime testing, DOE is proposing to stay with the voltage/current regulation prescribed in IESNA LM-49-2001. DOE also has tentatively concluded that this difference in voltage regulation specification would have an insignificant impact on lifetime testing and would reduce testing burden by providing a somewhat wider tolerance.

DOE also considered IEC 60064-2005  31 which contains similar test conditions and procedures as IESNA LM-49-2001. After speaking to representatives from major lighting testing facilities, however, DOE found that IESNA LM-49-2001 is the more common reference for GSIL lifetime testing, which suggests it is the more workable approach. Further evidence of the IESNA standard's usage is the Federal Trade Commission (FTC) reference to IESNA LM-49 in its regulations for product labeling of GSILs. 16 CFR 305.5(b). By adopting the same industry standard for purposes of compliance with energy conservation standards and FTC labeling, DOE would minimize the need for additional testing. IESNA LM-49-2001 adequately covers ambient conditions, test setup (lamp orientation, power supply specifications, instrumentation), and operating cycle methodology, thereby providing a comprehensive test procedure for testing GSIL lifetime. DOE requests comments on its proposal to adopt IESNA LM-49-2001 as the standard for GSIL lifetime testing (see Issue 5 in section V.E). The following section describes the test procedures laid out in IESNA LM-49-2001.

Similar to EPCA, section 1.2 of IESNA LM-49-2001 defines “rated lifetime” as the statistically-determined estimate of median operational lifetime, where median is the total operating time under which, at normal operating conditions, 50 percent of a large group of initially installed lamps is expected to be still operating. IESNA LM-49-2001 prescribes testing lifetime of an incandescent lamp at its rated voltage, and it requires the lamp to be checked for failure at certain intervals and to be cooled on a daily basis.

Section 3.2 of IESNA LM-49-2001 provides instrument specifications that require lamps to be operated at their rated voltage for voltage-rated lamps or at their rated current for current-rated lamps, and at 60 Hertz (Hz). When using an AC power supply, the voltage wave shape is to be such that total harmonic distortion does not exceed three percent of the fundamental. As mentioned previously, the referenced industry standard also specifies that regardless of whether AC or DC power supply is used, voltage or current must be regulated to within ± 0.5 percent of its rated RMS value for the duration of the lifetime test as a design consideration for the lifetime test system. IESNA LM-49-2001 specifies test conditions for vibration, temperature, and airflow. It addresses orientation, spacing, handling, and marking of the lamps, as well as specifications for the lamp holders.

The method for lamp lifetime testing detailed in IESNA LM-49-2001 allows for an elapsed time meter to monitor operating time. The referenced industry standard further states that it is permissible to use video monitoring, current monitoring, or other means that are designed to provide sufficient temporal accuracy. The procedure specifies that lamp failure is determined by either visual observation or automatic monitoring at intervals of no more than 0.5 percent of the rated lifetime. It requires that for normal lifetime testing, lamps be cooled to ambient temperature once per day and specifies cooling time as usually 15 to 30 minutes per day.

IESNA LM-49-2001 permits accelerated lifetime testing for non-halogen GSILs. In principle, an accelerated lifetime test measures a shortened lamp lifetime and scales it to determine the full lifetime of the lamp, thereby reducing total testing time required and overall test burden. DOE has tentatively determined, however, that industry lacks a consistent methodology for developing GSIL scaling factors for halogen lamps (which are expected to comprise the vast majority of compliant GSILs). Thus, as detailed in the next section, DOE has tentatively decided not to allow the use of accelerated lifetime testing for GSILs as part of this test procedure.

Accelerated lifetime testing involves operating lamps at higher than rated voltage, thereby forcing the lamp to fail faster. A scaling factor is used to correlate the measured accelerated lifetime to the lifetime at the rated voltage. The appropriate scaling factor, critical in obtaining accurate accelerated lifetime results, is determined by conducting a certain number of comparison parallel lifetime tests at rated voltage and overvoltage. The IESNA Lighting Handbook notes that scaling factors are empirical and that their determination requires many comparison tests at rated voltages. 32

Additionally, IESNA LM-49-2001 limits accelerated lifetime testing methodology to non-halogen lamps. Accurate accelerated lifetime testing can be difficult to conduct for halogen lamps due to the tungsten-halogen regenerative cycle. This cycle, intended to increase lamp lifetime by redepositing evaporated tungsten back onto the filament, is designed around certain operating temperatures; deviations from the rated voltage would change the operating temperature and potentially alter or introduce new modes of lamp failure. Even if accurate scaling factors (to relate overvoltage lifetime testing to rated voltage lifetime testing) could be empirically derived for halogen lamps, unique scaling factors would likely need to be developed for each lamp design. Alterations in filament or halogen capsule designs could affect the tungsten-halogen regenerative cycle and, therefore, the scaling factor. Due to the extensive testing necessary to develop these scaling factors for each basic model, DOE tentatively concludes that accelerated lifetime testing for halogen lamps would not significantly reduce testing burden.

Since few non-halogen GSILs will meet the 2012 energy conservation standards, and given the minimal impact on testing burden and potential inaccuracies introduced, DOE has tentatively decided to disallow the use of accelerated lifetime testing for GSILs as part of this test procedure. DOE requests comments on its assessment that accelerated lifetime test should not be incorporated as part of the DOE test procedure (see Issue 6 in section V.E).

For GSIL lifetime measurements, DOE is proposing a minimum sampling size of 20 lamps: a minimum of two lamps per month for seven months of production out of a 12-month period. If lamp production occurs in fewer than seven months out of the year, two or more lamps will be selected for each month that production exists as evenly as possible to meet the minimum 20 sample requirement. These seven months do not need to be consecutive and can be any combination of seven months out of the twelve available. DOE has tentatively concluded that 20 samples is consistent with the statutory definition of “lifetime,” that requires that such sample be based on “statistically large group of lamps.” This selection of 20 lamps as the sample size is also consistent with DOE's regulations for measuring lamp efficacy, which currently specify a sampling size of a minimum of three lamps for each month of production for a minimum of seven months (not necessarily consecutive) out of the 12-month period, totaling a minimum of 21 lamps. 10 CFR 429.27 This 21-lamp sample size was selected to promote statistically valid results without imposing an undue testing burden on manufacturers. 62 FR 29222, 29229 (May 29, 1997) DOE has chosen 20 samples (an even number) instead of 21 samples in order to facilitate the calculation of the 50 percent failure rate. This sample size also allows manufacturers the opportunity to test the same sample set for measurements of lumen output, wattage, and lifetime, thereby potentially reducing testing burden. DOE requests comments on this assessment and whether alternative sample sizes should be used instead (see Issue 7 in section V.E).

In addition to incorporating by reference IESNA LM-49-2001 as the test procedure for GSIL lifetime testing, DOE is also proposing to define “rated lifetime” as the parameter that should be used to determine whether the lamp meets minimum rated lifetime standards. The rated lifetime for general service incandescent lamps will be defined as the length of operating time between first use and failure of 50 percent of the sample size in accordance with test procedures described in IESNA LM-49-2001. This proposed definition of “rated lifetime” is consistent with the existing statutory definition of “life” or “lifetime,” which describes this parameter as the length of operating time of a statistically large group of lamps between first use and failure of 50 percent of the group in accordance with test procedures described in the IES Lighting Handbook. (42 U.S.C. 6291(30)(P)) Since DOE is proposing to adopt IESNA LM-49-2001 as the standard industry reference for GSIL lifetime testing, the GSIL “rated lifetime” definition will reference IESNA LM-49-2001 rather than the IES Lighting Handbook.

10 CFR 429.12(e) specifies that for most covered products, including GSILs, certification reports of new models must be submitted before products are distributed into commerce. However, for GSFLs and IRLs, because reported values are based on testing of samples over a 12-month period of production, DOE requires manufacturers to submit an initial certification report prior to or concurrent with distribution of the new model. This initial certification report filing, describing how the manufacturer has determined that the new model meets or exceeds energy conservation standards, allows manufacturers to distribute new models while completing the 12-month sampling requirement for certification of GSFLs and IRLs. This initial report is then followed by a final certification report, based on the full sampling provisions, to be submitted a year after the first date of manufacture of the new model.

Since DOE also requires a 12-month sampling period for certification of GSILs, today's notice is proposing to implement new model filing requirements, similar to those for GSFLs and IRLs, for GSILs. Just as with GSFLs and IRLs, DOE is proposing to require that the final certification report be submitted one year following the start of manufacturing of the new model. DOE proposes this time period for final certification for GSIL testing to account for the time it takes to measure lamp lifetime as part of GSIL testing. Lifetime testing of a 1000-hour rated lamp (the minimum rated lifetime standard) would require lamp operation for a minimum of 42 days. Since the sample is taken over a 12-month span and only requires sampling from 7 months of the year, DOE believes that several months after the last month of the sampling period are necessary to complete testing, given that some GSILs have rated lifetimes longer than 1000 hours. Consequently, DOE is proposing a total of 12 months after the date of manufacture of the new model, allowing manufacturers sufficient time to conduct lifetime testing for all GSILs manufactured in a 12-month production period. DOE requests comment on its proposal regarding GSIL certification filing requirements. (See Issue 8 in section V.E).

Additionally, when conducting compliance testing for GSIL lifetime, DOE proposes to require that such testing be conducted by a facility accredited by the National Volunteer Laboratory Accreditation Program (NVLAP)  33 or by an organization recognized by NVLAP. NVLAP accreditation is a finding of laboratory competence, certifying that a laboratory operates in accordance with NVLAP management and technical requirements. The NVLAP program is described in 15 CFR part 285, and it encompasses the requirements of ISO/IEC 17025. 34 DOE has determined that NVLAP imposes fees of $9,000 and $8,000 on years one and two of accreditation. For the years following, the fees alternate between $5,000 and $8,000, with the $8,000 fee corresponding to the on-site evaluation required every other year. Fees for other accreditation organizations are expected to be similar. DOE does not expect this requirement for GSIL lifetime testing to impose a significant burden for most manufacturers, because efficacy testing of GSILs is already required to take place at a laboratory that is accredited by either NVLAP or an NVLAP-recognized organization. Accordingly, manufacturers should be able to meet this requirement with minimal change or incremental burden.

The effective date for these test procedure amendments would be 30 days after publication of the test procedure final rule in the Federal Register . At that time, manufacturers and importers of covered GSFLs, IRLs, and GSILs may use the amended test procedure for making representations of the energy efficiency of each basic model. Additionally for GSFLs and IRLs, manufacturers may use the amended test procedure or the existing test procedures to certify compliance with DOE's test procedure. Should manufacturers or importers elect to use the new test procedure and applicable sampling plans prior to the compliance date of the amended test procedure, this would need to be noted on the certification report.

The compliance date for certifying compliance with the Department's regulations and for making any representations of the energy efficiency derived from the revised version of the test procedure for GSFLs, IRLs, and GSILs is 180 days from the date of publication of the test procedure final rule in the Federal Register . On or after that date, any such representations, including those made on marketing materials and product labels, must be based upon results generated under these amended test procedures and the applicable sampling plans. At that time, manufacturers and importers of covered GSFLs, IRLs, and GSILs must use the amended test procedures when certifying compliance to the Department. For example, for GSFLs and IRLs after the compliance date, if the test procedure amendments in conjunction with the applicable sampling plans proposed today alter the energy use in a manner which results in the basic model being less efficient, then the manufacturer or importer would be required to revise the existing certification. Otherwise, any changes to the certified ratings for GSFLs and IRLs may be submitted in the next annual certification filing due on the 1st of March.

To reduce confusion, DOE is proposing to amend the initial compliance date for submitting GSIL certification reports for those products subject to standards on January 1, 2012, by approximately 5 months so as to be concurrent with the compliance date of the amended test procedure. Thus, under this proposal, for GSILs that have energy conservation standards effective January 1, 2012, certification would not be required until 180 days after publication of the test procedure final rule in the Federal Register . At that time, these test procedure amendments and sampling plans, including the new lifetime requirements, would need to be used to develop the certified ratings in order to certify compliance 180 days after publication of the test procedure final rule in the Federal Register .

The Office of Management and Budget has determined that test procedure rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, “Regulatory Planning and Review.” 58 FR 51735 (Oct. 4, 1993). Accordingly, this regulatory action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB).

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires preparation of an initial regulatory flexibility analysis (IFRA) for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (August 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the DOE rulemaking process. 68 FR 7990. DOE has made its procedures and policies available on the Office of the General Counsel's Web site: http://www.gc.doe.gov.

Today's proposed rule would adopt test procedure provisions for GSFLs and GSILs, primarily through updates to current active industry testing standards, as well as specification of a procedure for testing GSIL lifetime. In referencing the updated versions of the industry test method, DOE anticipates that there would be no incremental increase in testing cost or burden for covered products, because the updated versions are not making substantial changes to test setup or methodology. In this NOPR, DOE is also proposing to establish a test procedure for GSIL lifetime testing and recommending the incorporation by reference of IESNA LM-49-2001 as the basis for this test procedure. The proposed GSIL lifetime test procedure will provide an appropriate test method for the purposes of compliance with the GSIL minimum lifetime standard levels established by EISA 2007. DOE has tentatively determined that the proposed GSIL lifetime test procedure would not pose undue testing costs or burdens on manufacturers of covered products. DOE has reviewed the proposed rule under the provisions of the Regulatory Flexibility Act and the policies and procedures published on February 19, 2003. For the reasons explained below, DOE concludes and certifies that this test procedure rulemaking would not have a significant economic impact on a substantial number of small entities.

The Small Business Administration (SBA) has set a size threshold for manufacturers of GSFLs, GSILs, and IRLs that defines those entities classified as “small businesses” for the purposes of the Regulatory Flexibility Analysis. DOE used the SBA's small business size standards to determine whether any small manufacturers of GSFLs, GSILs, and IRLs would be subject to the requirements of the rule. 65 FR 30836, 30849 (May 15, 2000), as amended at 65 FR 53533, 53545 (Sept. 5, 2000) and codified at 13 CFR part 121. The size standards are listed by North American Industry Classification System (NAICS) code and industry description and are available at http://www.sba.gov/sites/default/files/Size_Standards_Table.pdf. GSFL, GSIL, and IRL manufacturing is classified under NAICS 335110, “Electric Lamp Bulb and Part Manufacturing.” The SBA sets a threshold of 1,000 employees or less for an entity to be considered as a small business for this category.

In the 2009 rulemaking that set standards for GSFLs and IRLs, DOE identified 12 companies as potential small business manufacturers of GSFLs and IRLs covered by standards. After further research including interviews with companies, DOE identified only one company as a small business manufacturer of covered GSFLs and no company as a small business manufacturer of covered IRLs. 74 FR 34080, 34174 (July 14, 2009) Through an analysis conducted in this rulemaking, DOE identified six small business manufacturers of covered GSILs (see below for further details). Since DOE does not anticipate the proposed incorporation of updated versions of the industry test methods for GSFLs, GSILs, and IRLs would result in significant changes in test setup and methodology, DOE does not expect a significant economic impact on small business manufacturers of GSFLs, GSILs and IRLs.

DOE conducted further analysis to determine that the proposed new test procedure provisions for testing GSIL lifetime would not have a significant impact on small business manufacturers of GSILs. DOE compiled a preliminary list of potential small business manufacturers of GSILs by searching Hoover's and the SBA databases and referencing a list of small business manufacturers for GSILs identified in the 2009 rulemaking for GSFLs and IRLs. 35 DOE then determined if the companies actually manufactured GSILs by reviewing the company Web site and/or calling the company. Through this process, DOE was able to identify six small business U.S. manufacturers of GSILs.

DOE then estimated the cost of testing GSIL lifetime for a certain number of lamps. The initial setup for lamp lifetime testing can take from one day (if using sockets attached to an Edison plug and power strips) to two weeks (for a custom-built rack). The cost for a custom-built rack that can accommodate up to 100 lamps could be about $3,000. DOE understands that manufacturers of GSILs would already have the other necessary testing instrumentation, because this same equipment is used for determination of GSIL efficacy.

In addition to materials, labor also contributes to the overall testing burden of GSIL lifetime testing. The GSIL lifetime test procedure requires accurate monitoring of operating time and checking for lamp failure at intervals of 0.5 percent of the rated lifetime ( e.g., five-hour intervals for a lamp with a rated lifetime of 1000 hours). Rather than have a technician inspect the lamp at the end of each interval, a still camera with a programmable snapshot system to record lamp operation can reduce the labor cost. Alternatively, a test lab could monitor operating time using a baffled photodiode pointing at each lamp location with a software program reading photodiode signals at regular intervals. This method would increase initial costs by requiring equipment costing about $18,000 to $20,000 per 100 lamps and a one-time setup that could take at least a month with three full-time staff, but which would reduce overall labor costs.

DOE based its estimates of labor costs on the still camera method, as it expects more laboratories to have this capability. About three hours per week would be required to review images of 100 lamps, and assuming the typical average rated lifetime of 1,000 hours, it would require six weeks to conduct a lifetime test of a lamp. Therefore, a total of 18 hours would be required to conduct lifetime testing for 100 lamps. DOE used the labor rate of $100 per hour and a sampling size of 20 lamps (see section III.D). DOE surveyed small manufacturers of GSILs to determine a number of models produced per year by a typical small business. Based on the six responses received, DOE determined that small manufacturers are producing anywhere from four to 50 models of GSILs, with an average of 30 models. 36 Based on these parameters, the labor costs of GSIL lifetime testing for one reporting period is estimated to be $1,800 for four models, $10,800 for 30 models, and $18,000 for 50 models. In addition, if manufacturers need to build 100-lamp custom test racks, the initial cost setup is estimated to be $3,000 for four models (one test rack), $18,000 for 30 models (six test racks), and $30,000 for 50 models (10 test racks). However, DOE believes that most GSIL manufacturers would already have sufficient testing racks for their own internal uses and for FTC labeling requirement testing.

For the maximum number of 50 models, assuming testing apparatus is already available, the labor costs to carry out testing to demonstrate all products comply with standards would be approximately $18,000. In subsequent years, testing costs would be much smaller, likely less than 10 percent of the initial cost, because only new products or redesigned products would need to be tested. Assuming a conservative estimate of $1 million in revenue for a small business, initial testing costs would represent about two percent of revenue, but when amortized over subsequent years with little or no testing, testing costs would represent less than one percent of revenue. In addition, some businesses may already have lifetime data that could be used for compliance purposes from previously completed FTC labeling testing. Based upon its comparison of estimated revenue to estimated testing costs, DOE has tentatively concluded that labor costs would not be significant enough to pose a substantial burden on small manufacturers. DOE requests comments on its analysis of initial setup and labor costs for conducting lifetime testing of GSILs (see Issue 9 in section V.E).

In this NOPR, DOE is also proposing to require test facilities conducting GSIL lifetime and efficacy compliance testing to be NVLAP accredited or accredited by an organization recognized by NVLAP. If accreditation were sought for the first time, DOE has determined that NVLAP imposes fees of $9,000 and $8,000 on years one and two of accreditation. For the years following, the fees alternate between $5,000 and $8,000, with the $8,000 fee corresponding to the on-site evaluation required every other year. However, DOE does not expect this requirement to impose a significant burden for most manufacturers, because efficacy testing of GSILs is already required to take place at a laboratory accredited either by NVLAP or a NVLAP-recognized organization (see section III.D.6).

Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE's certification and supporting statement of factual basis will be provided to the Chief Counsel for Advocacy of the SBA for review under 5 U.S.C. 605(b). DOE certifies that this rule would have no significant impact on a substantial number of small entities. DOE seeks comment regarding whether the proposed amendments in today's rule would have a significant economic impact on any small entities (see Issue 9 in section V.E).

Manufacturers of GSFLs, GSILs, and IRLs must certify to DOE that their products comply with any applicable energy conservation standard. In certifying compliance, manufacturers must test their products according to the DOE test procedure for GSFLs, GSILs, or IRLs, including any amendments adopted for that test procedure. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment, including GSFLs, GSILs, and IRLs. 76 FR 12422 (March 7, 2011). The collection-of-information requirement for the certification and recordkeeping is subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been approved by OMB. Public reporting burden for the certification is estimated to average 20 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

In this proposed rule, DOE proposes test procedure amendments that it expects would be used to develop and implement future energy conservation standards for GSFLs, GSILs, and IRLs. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (Pub. L. 91-190, codified at 42 U.S.C. 4321 et seq. ) and DOE's implementing regulations at 10 CFR part 1021. Specifically, this proposed rule would amend the existing test procedures without affecting the amount, quality, or distribution of energy usage, and, therefore, would not result in any environmental impacts. Thus, this rulemaking is covered by Categorical Exclusion A5 under 10 CFR part 1021, subpart D, Appendix A, which applies to any rulemaking that interprets or amends an existing rule without changing the environmental effect of that rule. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

Executive Order 13132, “Federalism,” 64 FR 43255 (August 10, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this proposed rule and has determined that it would not have 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. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of today's proposed rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.

Regarding the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this rule meets the relevant standards of Executive Order 12988.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4, codified at 2 U.S.C. 1501, et seq. ) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) Section 204 of UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820; also available at http:// www.gc.doe.gov. DOE examined today's proposed rule according to UMRA and its statement of policy and determined that the rule contains neither an intergovernmental mandate, nor a mandate that may result in the expenditure of $100 million or more in any year. Accordingly, no further assessment or analysis is required under the Unfunded Mandates Reform Act of 1995.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This proposed rule to amend DOE test procedures would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

DOE has determined under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988), that this proposed regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

Section 515 of the Treasury and General Government Appropriations Act, 2001 (Pub. L. 106-554, codified at 44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed today's proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OMB a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.

Today's regulatory action to amend the test procedure for measuring the energy efficiency of GSFLs, GSILs, and IRLs is not a significant regulatory action under Executive Order 12866 or any successor order. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, DOE has tentatively determined that this rule is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.

Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91; 42 U.S.C. 7101 et seq. ), DOE must comply with all laws applicable to the former Federal Energy Administration, including section 32 of the Federal Energy Administration Act of 1974, as amended by the Federal Energy Administration Authorization Act of 1977. (15 U.S.C. 788; FEAA) Section 32 essentially provides in relevant part that, where a proposed rule authorizes or requires use of commercial standards, the notice of proposed rulemaking must inform the public of the use and background of such standards. In addition, section 32(c) requires DOE to consult with the Attorney General and the Chairman of the Federal Trade Commission (FTC) concerning the impact of the commercial or industry standards on competition.

The proposed rule would incorporate testing methods contained in the following commercial standards: IES LM-9-2009, “IES Approved Method for Electrical and Photometric Measurements of Fluorescent Lamps;” IES LM-45-2009, “IES Approved Method for Electrical and Photometric Measurement of General Service Incandescent Filament Lamps;” IESNA LM-49-2001, “IESNA Approved Method for Life Testing of Incandescent Filament Lamps;” and ANSI C78.81-2010, “American National Standard for Electric Lamps—Double-Capped Fluorescent Lamps—Dimensional and Electrical Characteristics.” The Department has evaluated these standards and is unable to conclude whether they fully comply with the requirements of section 32(b) of the FEAA, ( i.e., that they were developed in a manner that fully provides for public participation, comment, and review). DOE will consult with the Attorney General and the Chairman of the FTC concerning the impact of these test procedures on competition, prior to prescribing a final rule.

The time, date, and location of the public meeting are listed in the DATES and ADDRESSES sections at the beginning of this document. If you plan to attend the public meeting, please notify Ms. Brenda Edwards at (202) 586-2945 or Brenda.Edwards@ee.doe.gov. Please also note that those wishing to bring laptops into the Forrestal Building will be required to obtain a property pass. Visitors should avoid bringing laptops, or allow an extra 45 minutes. As explained in the ADDRESSES section, foreign nationals visiting DOE Headquarters are subject to advance security screening procedures.

In addition, you can attend the public meeting via webinar. Webinar registration information, participant instructions, and information about the capabilities available to webinar participants will be published on DOE's Web site at: http://www1.eere.energy.gov/buildings/appliance_standards/residential/incandescent_lamps.html. Participants are responsible for ensuring their systems are compatible with the webinar software.

Any person who has an interest in the topics addressed in this notice, or who is a representative of a group or class of persons that has an interest in these issues, may request an opportunity to make an oral presentation at the public meeting. Such persons may hand-deliver requests to speak to the address shown in the ADDRESSES section at the beginning of this notice between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays. Requests may also be sent by mail or email to Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Program, Mailstop EE-2J, 1000 Independence Avenue, SW., Washington, DC 20585-0121, or Brenda.Edwards@ee.doe.gov. Persons who wish to speak should include with their request a computer diskette or CD-ROM in WordPerfect, Microsoft Word, PDF, or text (ASCII) file format that briefly describes the nature of their interest in this rulemaking and the topics they wish to discuss. Such persons should also provide a daytime telephone number where they can be reached.

DOE requests persons selected to make an oral presentation to submit an advance copy of their statements at least one week before the public meeting. DOE may permit persons who cannot supply an advance copy of their statement to participate, if those persons have made advance alternative arrangements with the Building Technologies Program. As necessary, requests to give an oral presentation should ask for such alternative arrangements.

Any person who has plans to present a prepared general statement may request that copies of his or her statement be made available at the public meeting. Such persons may submit requests, along with an advance electronic copy of their statement in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format, to the appropriate address shown in the ADDRESSES section at the beginning of this notice. The request and advance copy of statements must be received at least one week before the public meeting and may be emailed, hand-delivered, or sent by mail. DOE prefers to receive requests and advance copies via email. Please include a telephone number to enable DOE staff to make a follow-up contact, if needed.

DOE will designate a DOE official to preside at the public meeting and may also use a professional facilitator to aid discussion. The meeting will not be a judicial or evidentiary-type public hearing, but DOE will conduct it in accordance with section 336 of EPCA (42 U.S.C. 6306). A court reporter will be present to record the proceedings and prepare a transcript. DOE reserves the right to schedule the order of presentations and to establish the procedures governing the conduct of the public meeting. There shall not be discussion of proprietary information, costs or prices, market share, or other commercial matters regulated by U.S. anti-trust laws. After the public meeting, interested parties may submit further comments on the proceedings as well as on any aspect of the rulemaking until the end of the comment period.

The public meeting will be conducted in an informal, conference style. DOE will present summaries of comments received before the public meeting, allow time for prepared general statements by participants, and encourage all interested parties to share their views on issues affecting this rulemaking. Each participant will be allowed to make a general statement (within time limits determined by DOE), before the discussion of specific topics. DOE will permit, as time permits, other participants to comment briefly on any general statements.

At the end of all prepared statements on a topic, DOE will permit participants to clarify their statements briefly and comment on statements made by others. Participants should be prepared to answer questions by DOE and by other participants concerning these issues. DOE representatives may also ask questions of participants concerning other matters relevant to this rulemaking. The official conducting the public meeting will accept additional comments or questions from those attending, as time permits. The presiding official will announce any further procedural rules or modification of the above procedures that may be needed for the proper conduct of the public meeting.

A transcript of the public meeting will be posted on the DOE Web site and will be included in the docket, which can be viewed as described in the Docket section at the beginning of this notice. In addition, any person may buy a copy of the transcript from the transcribing reporter.

DOE will accept comments, data, and information regarding this proposed rule before or after the public meeting, but no later than the date provided in the DATES section at the beginning of this proposed rule. Interested parties may submit comments using any of the methods described in the ADDRESSES section at the beginning of this notice.

Submitting comments via http:// www.regulations.gov. The http://www.regulations.gov Web page will require you to provide your name and contact information. Your contact information will be viewable to DOE Building Technologies staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). If your comment is not processed properly because of technical difficulties, DOE will use this information to contact you. If DOE cannot read your comment due to technical difficulties and cannot contact you for clarification, DOE may not be able to consider your comment.

However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.

Do not submit to http://www.regulations.gov information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information (CBI)). Comments submitted through http://www.regulations.gov cannot be claimed as CBI. Comments received through the Web site will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section.

DOE processes submissions made through http://www.regulations.gov before posting. Normally, comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that http://www.regulations.gov provides after you have successfully uploaded your comment.

Submitting comments via email, hand delivery, or mail. Comments and documents submitted via email, hand delivery, or mail also will be posted to http://www.regulations.gov. If you do not want your personal contact information to be publicly viewable, do not include it in your comment or any accompanying documents. Instead, provide your contact information on a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.

Include contact information each time you submit comments, data, documents, and other information to DOE. Email submissions are preferred. If you submit via mail or hand delivery, please provide all items on a compact disc (CD), if feasible, in which case it is not necessary to submit printed copies. No telefacsimiles (faxes) will be accepted.

Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English, and are free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.

Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.

Confidential Business Information. Pursuant to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery two well-marked copies: one copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked non-confidential with the information believed to be confidential deleted. Submit these documents via email or on a CD, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person which would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.

It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).

Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:

1. DOE requests comments on all aspects of DOE's test procedures for GSFL, GSIL, and IRL See section III.A for further detail.

2. For GSFL test procedures, DOE requests comments on its proposed incorporation of IES LM-9-2009, and its tentative conclusion that the update would neither significantly affect measured lamp efficacy nor increase testing burden. In particular, DOE requests comments on the impact on lamp efficacy of high-frequency testing amendments and modifications to the lamp stabilization procedure in LM-9-2009. See section III.B.2 for further detail.

3. For GSIL test procedures, DOE requests comments on its proposed incorporation of IES LM-45-2009, and its tentative conclusion that the update would neither significantly affect lamp efficacy values nor impose undue testing burden. See section III.B.3 for further detail.

4. DOE requests comment on whether any amendments to the IRL test procedure are necessary. See section III.C for further detail.

5. For GSIL lifetime test procedures, DOE requests comments on its proposal to incorporate by reference IESNA LM-49-2001 as the basis for GSIL lifetime testing. See section III.D.1 for further detail.

6. For GSIL lifetime test procedures, DOE requests comments on its proposal to disallow accelerated lifetime testing as part of the GSIL test procedure. See section III.D.2 for further detail.

7. DOE requests comments on its proposal to require a minimum sample size of 20 lamps for GSIL lifetime measurements. See section III.D.4 for further detail.

8. For GSIL lifetime test procedures, DOE requests comment on its proposal regarding GSIL certification filing requirements. See section III.D.6 for further detail.

9. DOE seeks comment regarding whether the proposed amendments in today's rule would have a significant economic impact on any small entities. In particular, DOE requests comments on its preliminary analysis of initial setup and labor costs for conducting lifetime testing of GSILs. See section IV.B for further detail.

The Secretary of Energy has approved publication of this notice of proposed rulemaking.

For the reasons stated in the preamble, DOE is proposing to amend parts 429 and 430 of Chapter II of Title 10, Subchapter D of the Code of Federal Regulations to read as set forth below:

Title III of Energy Policy and Conservation Act (EPCA) (42 U.S.C. 6291 et seq. ) sets forth a variety of provisions designed to improve energy efficiency. Part B of Title III (42 U.S.C. 6291-6309) established the “Energy Conservation Program for Consumer Products Other Than Automobiles,” which includes major household appliances. 1 Subsequent amendments expanded Title III of EPCA to include additional consumer products and certain commercial and industrial equipment, including certain fluorescent and incandescent lamps—the products that are the focus of this document. In particular, amendments to EPCA in the Energy Policy Act of 1992 (EPAct 1992), Public Law 102-486, established energy conservation standards for certain classes of GSFLs and IRLs, and required DOE to conduct two rulemaking cycles to determine whether these standards should be amended. (42 U.S.C. 6291(1), 6295(i)(1) and (3)-(4)) EPCA also authorized DOE to adopt standards for additional GSFLs if such standards were warranted. (42 U.S.C. 6295(i)(5))

DOE completed the first cycle of amendments by publishing a final rule in the Federal Register in July 2009 (hereafter referred to as the 2009 Lamps Rule). 74 FR 34080 (July 14, 2009). The 2009 Lamps rule addressed two statutory directives under 42 U.S.C. 6295(i) by amending existing GSFL and IRL energy conservation standards. (42 U.S.C. 6295(i)(3)) and adopting standards for additional GSFLs (42 U.S.C. 6295(i)(5)). This rule also amended the definition of “colored fluorescent lamp” and “rated wattage” and adopted test procedures applicable to the newly covered GSFL. Information regarding the 2009 Lamps Rule can be found on DOE's Web site at: http://www.eere.energy.gov/buildings/appliance_standards/residential/incandescent_lamps.html.

EPAct 1992 amendments to EPCA added as covered products certain IRLs with wattages of 40 watts (W) or higher, and established energy conservation standards for these IRLs. In defining the term “incandescent reflector lamp,” EPAct 1992 excluded lamps with elliptical reflector (ER) and bulged reflector (BR) bulb shapes, and with diameters of 2.75 inches or less. Therefore, such IRLs were neither included as covered products nor subject to EPCA's standards for IRLs.

Section 322(a)(1) of the Energy Independence and Security Act of 2007 (EISA 2007) subsequently amended EPCA to expand the Act's definition of “incandescent reflector lamp” to include lamps with a diameter between 2.25 and 2.75 inches, as well as lamps with ER, BR, bulged parabolic aluminized reflector (BPAR), or similar bulb shapes. (42 U.S.C. 6291(30)(C)(ii) and (F)) Section 322(b) of EISA 2007, in amending EPCA to set forth revised standards for IRLs in new section 325(i)(1)(C), exempted from these standards the following categories of IRLs: (1) Lamps rated 50 watts or less that are ER30, BR30, BR40, or ER40; (2) lamps rated 65 watts that are BR30, BR40, or ER40 lamps; and (3) R20 incandescent reflector lamps rated 45 watts or less. (42 U.S.C. 6295(i)(C)) DOE refers to these three categories of lamps collectively as certain reflector (R), ER and BR IRLs.

DOE has concluded, for the reasons that follow, that it has the authority under EPCA to adopt standards for these R, ER, and BR IRLs, and that these lamps are covered by the directive in 42 U.S.C. 6295(i)(3) to amend EPCA's standards for IRLs. First, by amending the definition of “incandescent reflector lamp” (42 U.S.C. 6291(30)(C)(ii) and (F)), EISA 2007 effectively brought these R, ER and BR IRLs into the Federal energy conservation standards program as covered products, thereby subjecting them to DOE's regulatory authority. Second, although 42 U.S.C. 6295(i)(1)(C) exempts these R, ER and BR IRLs from the standards specified in 42 U.S.C. 6295(i)(1)(B), EPCA directs that DOE amend the standards laid out in 42 U.S.C 6295(i)(1), which includes subparagraph (C). As a result, the statutory text exempted these bulbs only from the standards specified in 42 U.S.C. 6295(i)(1), not from future regulation. Consequently, DOE is considering energy conservation standards for these R, ER and BR IRLs. DOE initiated a new rulemaking for these products by publishing a framework document and publishing a notice announcing its availability. 75 FR 23191 (May 3, 2010). DOE held a public meeting on May 26, 2010 to seek input from interested parties on its methodologies, assumptions, and data sources.

To initiate the second rulemaking cycle to consider amended energy conservation standards for GSFLs and IRLs (other than the certain R, ER and BR IRLs discussed in the preceding paragraphs), DOE has prepared a framework document to explain the issues, analyses, and processes it anticipates using for the development of potential energy efficiency standards for certain GSFLs and IRLs. The framework document is available at http://www.eere.energy.gov/buildings/appliance_standards/residential/incandescent_lamps.html.

In a separate rulemaking proceeding, DOE is also considering amendments to the test procedures used for determining the performance of GSFLs and IRLs. DOEs proposed amendments to the test procedures for GSFLs and IRLs are published elsewhere in today's Federal Register .

As noted in DATES , DOE will hold a public meeting on October 4, 2011 in Washington, DC to discuss the analyses presented and issues identified in the framework document prepared for the development of potential GSFL and IRL energy efficiency standards. At the public meeting, the Department will make a number of presentations, invite discussion on the rulemaking process as it applies to the covered products, and solicit comments, data, and information from participants and other interested parties. The Department encourages those who wish to participate in the public meeting to obtain the framework document and to be prepared to discuss its contents.

Public meeting participants need not limit their comments to the issues identified in the framework document. The Department is also interested in receiving views concerning other relevant issues that participants believe would affect energy conservation standards for these products or the applicable test procedures. Furthermore, the Department welcomes all interested parties, regardless of whether they participate in the public meeting, to submit in writing by the date specified in the DATES section, comments and information on matters addressed in the framework document and on other matters relevant to consideration of standards for GSFL and IRL.

The public meeting will be conducted in an informal, facilitated, conference style. There shall be no discussion of proprietary information, costs or prices, market shares, or other commercial matters regulated by U.S. antitrust laws. A court reporter will record the proceedings of the public meeting, after which a transcript will be made available on DOE's Web site at http://www.eere.energy.gov/buildings/appliance_standards/residential/incandescent_lamps.html.

After the public meeting and the close of the comment period on the framework document, DOE will begin collecting data, conducting the analyses as discussed in the framework document and at the public meeting, and reviewing the comments received.

DOE considers public participation to be a very important part of the process for setting energy conservation standards. DOE actively encourages the participation and interaction of the public during the comment period in each stage of the rulemaking process. Beginning with the framework document, and during each subsequent public meeting and comment period, interactions with and between members of the public provide a balanced discussion of the issues to assist DOE in the standards rulemaking process. Accordingly, anyone who would like to participate in the public meeting, receive meeting materials, or be added to the DOE mailing list to receive future notices and information regarding this rulemaking on GSFL and IRL, should contact Ms. Brenda Edwards at (202) 586-2945, or via e-mail at: Brenda.Edwards@ee.doe.gov .

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2011-0918; Directorate Identifier 2011-NM-090-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2011-0073, dated April 20, 2011 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Airbus has issued the all operators telexes (AOT) listed in the following table.

In the Federal Register of June 17, 2011 (76 FR 35669) (the June 17, 2011, ANPRM), FDA published an ANPRM that requested data and information on OTC sunscreen products marketed without approved applications that are formulated in certain dosage forms. FDA requested these data to help establish OTC monograph conditions, including dosage form specifications, for OTC sunscreen drug products. Among the data requested is data necessary to resolve specific questions about the effectiveness and safety of OTC sunscreens in spray dosage forms.

In response to the June 17, 2011, ANPRM, three submissions (Refs. 1, 2, and 3) requested an extension of the comment period, which will end on September 15, 2011. Two of the submissions requested that FDA extend the comment period by 30 days so that the comment period totals 4 months (Refs. 1 and 2). The other submission requested that FDA extend the comment period by 90 to 180 days so that the comment period totals 6 to 9 months (Ref. 3). The submissions cited the need for additional time to evaluate their available data and to organize and submit the data and information that best addresses FDA's request while simultaneously implementing the new requirements for their sunscreen products imposed by the Labeling and Effectiveness Testing final rule that published in the Federal Register of June 17, 2011 (76 FR 35620).

FDA is extending the comment period to end on October 17, 2011. A total comment period of 4 months is sufficient for the public to submit comments to the ANPRM.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments, data, and information by October 17, 2011. It is only necessary to submit one set of comments, data, and information. It is no longer necessary to two copies of mailed comments, data, and information. Identify submissions with the docket number found in brackets in the heading of this document, and may be accompanied by supporting information. Received submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Information submitted after the closing date will not be considered except by petition under 21 CFR 10.30.

The following references are on display in the Division of Dockets Management (see ADDRESSES ) under Docket No. FDA-1978-N-0018 and may be seen by interested persons between 9  a.m. and 4 p.m., Monday through Friday.

1. Comment No. FDA-1978-N-0018-DRAFT-5225.

2. Comment No. FDA-1978-N-0018-DRAFT-5227.

3. Comment No. FDA-1978-N-0018-DRAFT-5228.

On October 15, 2010, BOEMRE published a final rule that established a new subpart S in part 250, containing SEMS requirements for all OCS operators (75 FR 63610). This proposed rule would add to and amend those requirements. This proposed rule would apply to all OCS oil and gas and sulphur operations and facilities under BOEMRE jurisdiction including drilling, production, construction, well workover, well completion, well servicing, and Department of the Interior (DOI) pipeline activities. Nothing in this proposed rule would affect the Coast Guard's authority with respect to safety regulations and authorities, and jurisdiction over vessels and offshore facilities. Thus, because several other agencies have jurisdiction over certain aspects of OCS activities and some of these agencies require the use of safety management systems, the requirements related to SEMS programs under this subpart do not affect operators' obligations to comply with other regulatory requirements outside of BOEMRE's jurisdiction. For example, if the operator's activities fall within the regulatory purview of another agency (including, e.g., United States Coast Guard, Department of Homeland Security), the operator is also required to follow that agency's regulations. Operations and activities that are regulated under BOEMREs jurisdiction and that should be identified/discussed in an operators SEMS plan cover industrial activities. These cover such activities as, mineral exploration, development, pipeline transportation, storage, production, drilling, completion and workover. A system/sub-system breakdown of what is regulated under BOEMREs jurisdiction can be found in Annex 1 of MMS/USCG MOA: OCS-01 and in the MMS/USCG MOA: OCS-04 (these documents have been placed in the public docket). Operators should refer to these documents when developing, implementing and auditing their SEMS plan.

The importance of this proposed rule is highlighted by the Deepwater Horizon event on April 20, 2010. The blowout of the BP Macondo well, and the resulting explosion on the Deepwater Horizon drilling rig, resulted in the deaths of 11 workers, the loss of the Deepwater Horizon, and an oil spill of national significance. Although the causes of the event continue to be under investigation, the event further illustrates the importance of ensuring safe operations on the OCS. BOEMRE therefore intends to continue to evaluate findings from ongoing investigations and reviews into the Deepwater Horizon event, as well as other issues related to managing human factors to promote safety and environmental protection for offshore oil, gas, and sulphur development.

This proposed rule will further enhancements to operators' SEMS programs. SEMS programs, properly implemented by the operator, are designed to improve the safety performance of offshore operations. Because SEMS programs focus on the overall safety performance of offshore operations activities that are regulated under BOEMRE jurisdiction, as opposed to compliance with specific prescriptive requirements governing those operations, the success of a SEMS program ultimately depends on how effectively the operator engrains the principles underlying SEMS into the safety culture of their operations. BOEMRE remains actively engaged with industry regarding the substance and implementation of SEMS programs.

BOEMRE will continue to analyze information that becomes available, and to implement standards necessary to make offshore oil and gas activity safer and with appropriate protections for workers and the environment. BOEMRE may consider further safety and environmental protection requirements as well as other measures in future rulemakings. This may include consideration of further interagency coordination, further analysis of performance-based and prescriptive requirements, and maintaining a flexible approach to adopting requirements that can keep up with evolving technologies so as to promote systematic safety and other relevant matters. BOEMRE anticipates, in the near future, issuing an advanced notice of proposed rulemaking (ANPRM) that will solicit public comment regarding potential new safety measures for offshore operations. The ANPRM will include discussion of a range of new measures that are intended to encourage public comment on potential new prescriptive requirements, as well as performance-based standards, designed to further enhance the safety of offshore energy operations and promote appropriate safety culture in those operations.

It is the intention of BOEMRE to share information with the public on aggregated results from SEMS audits. BOEMRE will develop metrics that demonstrate industry's degree of compliance with this new regulatory requirement.

BOEMRE proposes to expand, revise, and add several new requirements necessary for more thorough SEMS programs, and to facilitate BOEMRE oversight. BOEMRE believes the following requirements are necessary provisions to ensure a complete safety management program on OCS facilities that are regulated under BOEMRE jurisdiction. These six additional requirements provide several key ways for offshore employees to help ensure safe operation of activities that are regulated under BOEMRE jurisdiction on the OCS. The addition of a mandatory independent third party auditor brings necessary objectivity to identifying good practices and any deficiencies that may exist in an operator's SEMS program.

(1) Procedures to authorize any and all employees on the facility to implement a Stop Work Authority (SWA) program when witnessing an activity that is regulated under BOEMRE jurisdiction that creates a threat of danger to an individual, property, and/or the environment;

(2) Clearly defined requirements establishing who has the ultimate authority on the facility for operational safety and decision making at any given time;

(3) A plan of action that shows how operator employees are involved in the implementation of the American Petroleum Institute's Recommended Practice for Development of a Safety Environmental Management Program for Offshore Operations and Facilities (API RP 75), as incorporated by reference in the subpart S regulatory requirements in the October 15, 2010, final rule;

(4) Guidelines for reporting unsafe work conditions related to an operators SEMS program, that provide all employees the right to report a possible safety or environmental violation(s) and to request a BOEMRE inspection of the facility if they believe there is a serious threat of danger or their employer is not following BOEMRE regulations;

(5) Revisions that require operators with SEMS programs to engage independent third party auditors to conduct all audits of operators' SEMS programs and that the independent third party auditors must meet the criteria listed in Section 250.1926 of this proposed rule;

(6) Additional requirements for conducting a JSA.

BOEMRE proposes additional requirements to subpart S in this rulemaking. The proposed rule would revise this section to include references to the following proposed new sections and requirements: stop work authority (§ 250.1930), ultimate work authority (§ 250.1931), employee participation (§ 250.1932), and guidelines for reporting unsafe work conditions (§ 250.1933). These new requirements would need to be included in the operator's SEMS program.

BOEMRE proposes to add definitions for management and mobile offshore drilling unit (MODU) in subpart S. Management would mean a team of individuals who have the day-to-day responsibilities for overseeing operations conducted on a facility or providing instruction to operational personnel, including but not limited to employees and contractors working on a facility or in the company's onshore offices; Mobile offshore drilling unit or MODU would mean a vessel capable of engaging in drilling, well workover, well completion or well servicing operations for exploring or exploiting subsea oil, gas or other mineral resources.

BOEMRE proposes additional requirements for conducting a JSA. The proposed requirements would improve the effectiveness of the JSA through better identification of risks and hazards. The operator would be required to ensure a JSA is prepared, conducted, and approved for OCS activities that are regulated under BOEMRE jurisdiction and identified or discussed in the SEMS program. A JSA is a technique used to identify risks to personnel associated with the activity and the appropriate mitigation to reduce these risks. The analysis must include all personnel involved with or affected by the activity being conducted. The JSA must identify, analyze, and record: the steps involved in performing a specific job; the existing or potential safety and health hazards associated with each step; and the recommended action(s) or procedure(s) that will eliminate or reduce these hazards and the risk of a workplace injury or illness. If a particular activity is conducted on a recurring basis, and if the parameters of these recurring activities do not change, then the person in charge of the activity could decide that a JSA for each employee engaged in that activity is not required. The parameters the person in charge would be required to consider in making this determination include, but are not limited to, changes in personnel, procedures, equipment, and/or environmental conditions associated with the activity.

The immediate supervisor of the personnel conducting the work would be required to prepare the JSA, sign the JSA, and ensure that all personnel participating in the job sign the JSA as well. The person onsite designated by the operator as the person in charge of the facility would have to approve and sign the JSA and document the results of the JSA in writing.

The operator must conduct training for all personnel on how to recognize and identify hazards as part of the SEMS program. The operator must provide the training required under this rule to employees within 30 days of employment, and not less than once every 12 months thereafter.

BOEMRE proposes additional requirements for training so that all personnel performing activities on the OCS that are regulated under BOEMRE jurisdiction are trained to work safely and are aware of potential environmental considerations offshore, in accordance with their duties and responsibilities. Training would have to address the methods of recognizing and identifying hazards and how to develop and implement JSAs (§ 250.1911), operating procedures (§ 250.1913), safe work practices (§ 250.1914), emergency response and control measures (§ 250.1918), stop work authority (§ 250.1930), ultimate work authority (§ 250.1931), employee participation program (§ 250.1932), and the reporting of unsafe work conditions (§ 250.1933). Proposed § 250.1915 (c) and (d) would ensure that changes in standards would be communicated to operator personnel and that training for contractor personnel would be verified.

BOEMRE proposes to revise this section by removing the option for the operator to use designated and qualified operator personnel to perform an audit of the SEMS program. Use of an independent third party will provide for increased objectivity in regards to improving personnel safety and achieving environmental protection as compared to utilizing a designated and qualified person of the operator. Therefore, BOEMRE would require that audits of operators SEMS programs be conducted by independent third parties. Independent third parties would be required to meet the qualifications under § 250.1926.

BOEMRE proposes to require the operator to conduct audits using only an independent third party. The proposed rule would revise this section to be consistent with that requirement by removing the option to allow the operator to use designated and qualified operator personnel to perform an audit of the SEMS program. The audit is the initial step to determine if an operator's SEMS program is effective. It will take time to ascertain the ultimate effectiveness of this regulatory requirement. Provisions for submittal of accident and incident information in the initial SEMS rule published in October 2010, will provide metrics that will help demonstrate the effectiveness of this requirement. BOEMRE is also researching additional ways to determine the effectiveness of an operator's SEMS program on an individual company basis.

BOEMRE proposes to revise this section by removing the option for the operator to use designated and qualified operator personnel to perform an audit of the SEMS program. This section also would include new qualifications that the independent third party auditor must meet.

The operator would be required to nominate an independent third party to audit its SEMS program. The independent third party must be capable of performing all tasks associated with an audit. The operator would be required to notify BOEMRE in writing of its nomination and to submit a request to BOEMRE for approval of the proposed third party auditor at least 30 days prior to the next audit. The request must state the name and address of the nominated individual or organization. The request would have to include the following items: Qualifications of the nominated individual or organization relating to education and previous experience with SEMS, or similar management related programs; previous experience with BOEMRE regulatory requirements and procedures; and the educational background and previous experience that qualifies the proposed auditor to understand and evaluate how the operator's offshore activities, raw materials, production methods and equipment, products, byproducts, and business management systems may impact health and safety performance in the workplace. A request would also have to include a signed statement that the independent third party is not owned or controlled by, or otherwise affiliated with, the operator. An operator would also need to have procedures to avoid conflicts of interest related to the development of the operator's SEMS program and the independent third party auditor. The proposed rule would provide that if a third party auditor was involved in developing and/or maintaining the SEMS program, then that person, organization, and/or its subsidiaries could not audit the SEMS program.

Under the proposed rule, after evaluating the third party's qualifications, BOEMRE could accept or not accept the operator's independent third party nomination. If BOEMRE does not accept the nomination of an independent third party, then the operator must submit a new nomination before the audit may go forward.

The audit report, once completed, must be submitted to BOEMRE and the operator. BOEMRE will notify the operator of whether or not the audit report is sufficient and acceptable. Under the proposal, the operator would be responsible for the costs of the audit.

BOEMRE proposes adding additional requirements to subpart S in this rulemaking. In the proposed rule, this section would be revised to include new recordkeeping and documentation requirements. For stop work authority, training and review records would have to be kept at the facility for 30 days, retained for two years, and made available to BOEMRE upon request. The operator would also have to document that all personnel participated in the development and implementation of the SEMS program. Such records would have to be retained for two years and made available to BOEMRE upon request.

BOEMRE proposes to add a new section requiring operators to create and implement an SWA program. This program would ensure that all employees and personnel, including contractors performing activities on the OCS that are regulated under BOEMRE jurisdiction, are given the responsibility and authority to stop work at the facility when such employees or personnel witness an activity that is regulated under BOEMRE jurisdiction that creates an imminent risk or danger to the health or safety of an individual or of the public or to the environment. The SWA would include authority to stop the specific task(s) or activity that poses an imminent risk or danger. Imminent risk or danger would mean any condition, activity, or practice in the workplace that could reasonably be expected to cause: (1) Death or serious physical harm immediately or before the risk or danger can be eliminated through enforcement procedures; or (2) significant, imminent environmental harm to land, air, aquatic, marine or subsea environments or resources. The rule would provide further that individuals who receive notification to stop work must comply with the direction immediately. In supporting the safe execution of work and to promote a culture of safety at work, all personnel should have the responsibility and authority to stop work or decline to perform an assigned task when an immediate risk or danger exists, without fear of reprisal. Persons exercising the SWA should have discussions with co-workers, supervisors, and/or safety representatives to attempt to resolve any safety issues that may be causing the imminent danger or risk. The proposed rule would provide that when a stop work order under an SWA program use is issued, the person in charge of the activity that is subject to the order is responsible for ensuring the work is stopped in an orderly and safe manner. The rule would provide further that work may be resumed upon a determination by the person on the facility with ultimate work authority that the imminent danger or risk does not exist or no longer exists. The decision to resume activities would have to be documented as soon as practicable.

BOEMRE is also proposing a requirement for operators to specify who has the Ultimate Work Authority (UWA) on fixed or floating facilities ( i.e., floating production systems; floating production, storage and offloading facilities; tension-leg platforms; and spars) and on MODUs performing activities under BOEMRE's jurisdiction. The person with the UWA would be the person on the fixed or floating facilities or MODU with the final responsibility for making decisions. Under the proposed rule, the operator's SEMS program must identify all persons that could have UWA and those persons must be designated as such by the operator. Only a single person would have UWA at any given time, so operators must take into consideration all applicable Coast Guard regulations that deal with designating a “person in charge” (in accordance with USCG regulations) of a MODU or OCS floating facility.

The SEMS program would have to define clearly who is in charge at all times, and would ensure that all personnel clearly know who is in charge, including when that responsibility shifts to a different person. The person with UWA must be known by name and be readily identifiable, and accessible by every person on the MODU or fixed and floating facility. This could be done, for instance, by posting a notice including contact information in a public and easily accessible location.

Proposed § 250.1931(c) would make it clear that the operator has the responsibility for ensuring its SEMS program is implemented on fixed and floating facilities, and on MODUs conducting activities under BOEMRE's jurisdiction. The person with the UWA has a key role in assuring that the operator's SEMS program is implemented in a manner that addresses personnel safety and protection of the environment.

Proposed § 250.1931(d) would require the SEMS program to provide that if an emergency occurs that creates an imminent risk or danger to the health or safety of an individual or the public or to the environment (as specified in proposed § 250.1930(a)), the person with the UWA is authorized to pursue any action necessary in that person's judgment to mitigate and abate the conditions, activities or practices causing the emergency. This grant of authority is needed to ensure that necessary actions will be taken to deal with a serious emergency.

BOEMRE proposes to add a new section to the rule that details operators' requirements relating to an employee participation program. Under the proposed rule, an operator's management would be required to consult with its employees that perform activities on the OCS that are regulated under BOEMRE jurisdiction on the development and implementation of the SEMS program. Management would also have to develop a written plan of action regarding how appropriate employees, in both the operator's offices and working on offshore facilities, will participate in the SEMS program development and implementation. The operator would have to provide each employee and contractor employee access to the SEMS program and to all other information required by API RP 75, as incorporated, and the employee participation program. Management must provide BOEMRE a copy of the employee participation program upon request and make it available during an audit.

BOEMRE is proposing guidelines for the reporting of unsafe work conditions, which would permit operator personnel and contractors on any facility engaged in OCS activities under BOEMRE jurisdiction to report to BOEMRE violations of any BOEMRE order or regulation or any other provision of Federal law relating to offshore safety or other hazardous or unsafe working conditions. These procedures must also include the existing Coast Guard unsafe working conditions reporting requirements found in 33 CFR 142.7 and 46 CFR 109.419. The proposed rule would specify that a report should contain sufficient credible information to establish a reasonable basis for BOEMRE to determine whether a violation or other hazardous or unsafe working condition exists. Under the proposed rule, an employee or contractor would not be required to know whether a specific BOEMRE order or regulation has been violated in order to report potentially unsafe conditions. The proposal would provide that the identity of any person making a report under paragraph (c) of this section will not be made available by BOEMRE, without the permission of the reporting person, to anyone other than the employees of BOEMRE who have a need for the record in the performance of their official duties. Under the proposal, after reviewing the report and conducting any necessary investigation, BOEMRE would notify the operator of any deficiency or hazard and initiate enforcement measures as the circumstances warrant.

The report could either be made in writing to the address provided in the regulation or verbally by calling the BOEMRE hotline (1-877-440-0173).

As relates to the reporting of unsafe work conditions, the operator would be responsible for:

(1) Posting a notice explaining personnel rights and remedies in a visible location at the place of employment where employees frequent;

(2) Providing training to personnel about their rights and responsibilities within 30 days of employment, and at least once every 12 months thereafter; and

(3) Providing personnel with a card containing a toll-free telephone number to contact BOEMRE or file a complaint.

This proposed rule is a significant rule as determined by the Office of Management and Budget (OMB) and is subject to review under E.O. 12866.

(1) This proposed rule would not have an annual effect of $100 million or more on the economy. It would not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.

(2) This proposed rule would not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency.

(3) This proposed rule would not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients.

(4) This proposed rule might raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.

BOEMRE has prepared a Regulatory Impact Analysis (RIA) for this rulemaking. The full analysis can be found on Federal eRulemaking Portal: http://www.regulations.gov. In the entry titled “Enter Keyword or ID,” enter BOEM-2011-0003 then click search. Follow the instructions to view the RIA and submit public comments for this rulemaking.

BOEMRE estimates the average annual cost of complying with this rulemaking is $26.9 million, spread across all OCS oil and gas operators with active operations. The benefits of the proposed SEMS provisions in this rulemaking would come from enhanced safety for offshore workers and greater protection of the marine environment. These benefits would be realized through additional employee participation in safety procedures, training programs, notification obligations, as well as strengthened safety and SEMS auditing procedures.

We estimated the costs of this proposed regulation by totaling the costs from both the Paperwork Reduction Act (PRA) burden estimates and the estimated required training costs added through this rulemaking. BOEMRE estimates that the compliance costs for this regulation are $15.2 million for recordkeeping, administration, and related costs and $11.7 million for training costs. This yields a total estimated annual compliance cost for this proposed rule of $26.9 million.

Because OCS operators have until November 15, 2011 to implement to all thirteen elements of the SEMS program per 30 CFR 250.1900(a), the compliance cost estimate for this regulation also considers burden hours for legacy implementation costs covered by the PRA. These legacy PRA costs are estimated to be $40.0 million. If these legacy costs are included the total estimated compliance cost for this proposed rule is $66.9 million ($15.2 + $11.7 + $40.0 = $66.9 million).

The protection of human life and the environment are the top priorities and objectives of this rule. While it is difficult to quantify the benefits of the lives saved and risks avoided due to this proposed regulation, implementation of a comprehensive SEMS program with these newly proposed requirements is intended to further the goal of avoiding accidents that may result in injuries, fatalities, and serious environmental damage.

The compliance cost for managing a comprehensive SEMS program is very minor compared to the costs associated with major accidents. For example, in 1987, prior to industry's development of a safety management template for offshore operations, the Mississippi Canyon 311, A (Bourbon), platform in the Gulf of Mexico was tilted to one side by an extensive underground blowout. The cost associated with this incident alone was $274,000,000. In 1989, a fire associated with a pipeline repair killed 7 people and destroyed a major production facility. The 2010 Macondo blowout event killed 11 people, destroyed the drilling rig and caused billions of dollars in damage. A SEMS program is not a guarantee of avoiding or preventing all accidents, but BOEMRE's intent in requiring a comprehensive SEMS program, which includes all 13 elements in API RP75 and these newly proposed provisions in this rulemaking, is to reduce the likelihood of these types of accidents and incidents and raise the safety awareness of all personnel.

An Initial Regulatory Flexibility Analysis (IRFA) has been prepared for this rulemaking and is available as part of the RIA. The IRFA can be found on Federal eRulemaking Portal: http://www.regulations.gov. In the entry titled “Enter Keyword or ID,” enter BOEM-2011-0003, then click search. Follow the instructions to view the RIA and IRFA and submit public comments for this rulemaking.

The changes proposed in the rule would affect lessees and operators of leases and pipeline right-of-way holders in the OCS. This group could include about 130 active Federal oil and gas lessees. Small lessees that operate under this rule fall under the Small Business Administration's North American Industry Classification System (NAICS) codes 211111, Crude Petroleum and Natural Gas Extraction, and 213111, Drilling Oil and Gas Wells. For these NAICS code classifications, a small company is one with fewer than 500 employees. Based on these criteria, an estimated 65 percent of the affected companies are considered small. This proposed rule, therefore, would affect a substantial number of small entities.

Small entities are represented in all activity levels of OCS operations (high, moderate, and low based on the number of offshore complexes the entity operates). Small companies would bear approximately 40 percent of the costs of this proposed rulemaking. This is approximately $10.7 million of the $26.9 million estimated compliance cost for this proposed rule. If the legacy PRA burden implementation costs are added to the new costs in this proposed rulemaking, small companies' burden is about $27.5 million of the estimated $66.9 million.

While 40 percent is greater than small companies' share of OCS leases, small companies hold 45 percent of leases in the shallow water depths where most production facilities are located (98 percent of active platforms are in shallow water).

The operating risk for small companies to incur safety or environmental accidents is not necessarily lower than it is for larger-sized companies. Offshore operations are highly technical and can be hazardous. Adverse consequences in the event of incidents, are the same regardless of the operator's size. We have evaluated a number of alternatives to accommodate small entities and facilitate compliance with the intent of this rulemaking, but were unable to identify provisions that would achieve the same safety objectives.

Your comments are important. The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small businesses about Federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency's responsiveness to small business. If you wish to comment on the actions of BOEMRE, call 1-888-734-3247. You may comment to the Small Business Administration without fear of retaliation. Allegations of discrimination/retaliation filed with the Small Business Administration will be investigated for appropriate action.

The proposed rule is not a major rule under the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801 et seq. ). This proposed rule:

a. Would not have an annual effect on the economy of $100 million or more.

b. Would not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

c. Would not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. The requirements would apply to all entities operating on the OCS.

This proposed rule would not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. This proposed rule would not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ) is not required.

Under the criteria in E.O. 12630, this proposed rule does not have significant takings implications. The proposed rule is not a governmental action capable of interference with constitutionally protected property rights. A Takings Implication Assessment is not required.

Under the criteria in E.O. 13132, this proposed rule does not have federalism implications. This proposed rule would not substantially and directly affect the relationship between the Federal and State governments. To the extent that State and local governments have a role in OCS activities, this proposed rule would not affect that role. A Federalism Assessment is not required.

This rule complies with the requirements of E.O. 12988. Specifically, this rule:

(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

Under the criteria in E.O. 13175, we have evaluated this proposed rule and determined that it has no substantial effects on federally recognized Indian tribes.

This rulemaking proposes to add new requirements to current regulations under 30 CFR 250, Subpart S, Safety and Environmental Management Systems for Outer Continental Shelf Oil and Gas Operations. Therefore, an information collection request is being submitted to OMB for review and approval under 44 U.S.C. 3501 et seq. The information collection for the current regulations is approved under OMB Control Number 1010-0186 (expiration date 10/31/2013, 465,099 burden hours, $12,933,000 non-hour cost burdens).

As part of our continuing effort to reduce paperwork and respondent burdens, BOEMRE invites the public and other Federal agencies to comment on any aspect of the reporting and recordkeeping burden. If you wish to comment on the information collection aspects of this proposed rule, please send your comments directly to OMB and send a copy of your comments to the Regulations and Standards Branch (see the ADDRESSES section of this notice). Please reference; 30 CFR Part 250, Subpart S, Safety and Environmental Management Systems for Outer Continental Shelf Oil and Gas and Sulphur Operations, 1010-0186 in your comments. You may obtain a copy of the supporting statement for the new collection of information by contacting the Bureau's Information Collection Clearance Officer at (703) 787-1025.

The PRA provides that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB is required to make a decision concerning the collection of information contained in these proposed regulations between 30 to 60 days after publication of this document in the Federal Register . Therefore, a comment to OMB is best assured of having its full effect if OMB receives it by October 14, 2011. This does not affect the deadline for the public to comment to BOEMRE on the proposed regulations.

The title of the collection of information for the rule is 30 CFR part 250, subpart S, Safety and Environmental Management Systems for Outer Continental Shelf Oil and Gas and Sulphur Operations. Respondents are Federal OCS lessees, operators, and independent third-parties. Responses to this collection are mandatory. The frequency of response varies, but is primarily on occasion. The information collection (IC) does not include questions of a sensitive nature. BOEMRE will protect proprietary information according to the Freedom of Information Act (5 U.S.C. 522) and its implementing regulations (43 CFR part 2); 30 CFR 250.197, Data and information to be made available to the public or for limited inspection; and 30 CFR part 252, OCS Oil and Gas Information Program. BOEMRE will use the information to evaluate the effect of industry's continued improvement of OCS safety and environmental management and its compliance with the regulations. It should be noted that while this rulemaking adds additional burden hours to industry, the vast majority of these hours stem from expanding their current SEMS program, along with documenting and recordkeeping relative to these expanded requirements, to address issues raised in testimony, hearings, and reports being released about the Deepwater Horizon explosion and resulting oil spill.

This proposed rulemaking would add 177,077 burden hours through expansion of some existing requirements and through new regulatory requirements to the 465,099 hours already approved for this subpart, for a total of 642,176 hour burdens. The burden table portrays only the Expanded and/or New requirements/burden hours that would be added to those already approved by OMB.

BOEMRE specifically solicits comments on the following questions:

(a) Is the proposed collection of information necessary for BOEMRE to properly perform its functions, and will it be useful?

(b) Are the estimates of the burden hours of the proposed collection reasonable?

(c) Do you have any suggestions that would enhance the quality, clarity, or usefulness of the information to be collected?

(d) Is there a way to minimize the information collection burden on those who are to respond, including the use of appropriate automated electronic, mechanical, or other forms of information technology?

In addition, the PRA requires agencies to estimate the total annual reporting and recordkeeping non-hour cost burden resulting from the collection of information. We have not identified any additional costs in this proposed rulemaking, and we solicit your comments on this item. For reporting and recordkeeping only, your response should split the cost estimate into two components: (a) Total capital and startup cost component, and (b) Annual operation, maintenance, and purchase of services component. Your estimates should consider the costs to generate, maintain, and disclose or provide the information. You should describe the methods you use to estimate major cost factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you incur costs. Generally, your estimates should not include equipment or services purchased:

(1) Before October 1, 1995;

(2) To comply with requirements not associated with the information collection;

(3) For reasons other than to provide information or keep records for the Government; or

(4) As part of customary and usual business or private practices.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. BOEMRE has analyzed this proposed rule under the criteria of the National Environmental Policy Act and 516 Departmental Manual 15. This proposed rule meets the criteria set forth in 43 CFR 46.210 for a Departmental “Categorical Exclusion” in that this rule is “ * * * of an administrative, financial, legal, technical, or procedural nature. * * *” Further, BOEMRE has analyzed this rule to determine if it meets any of the extraordinary circumstances that would require an environmental assessment or an environmental impact statement as set forth in 43 CFR 46.215.

Each section and subsection has also been reviewed to ensure that no potentially relevant extraordinary circumstances apply to the proposed action that would warrant the preparation of an environmental assessment or environmental impact statement. All extraordinary circumstances were considered in accordance with 43 CFR 46.215, but only the following ones are potentially applicable:

a. Have significant and adverse impacts on public health or safety.

b. Establish a precedent for future action or represent a decision in principle about future actions with potentially significant environmental effects.

c. Have a direct relationship to other actions with individually insignificant but cumulatively significant environmental effects.

The first extraordinary circumstance does not apply since rule promulgation would not contribute to any significant and adverse impacts on public health and safety. The SEMS program is likely to improve OCS safety, given the available incident data trends and associated 10 years of analysis. The second extraordinary circumstance does not apply since the promulgation of the rule or the eventual implementation of SEMS by operators does not set precedent for future actions or decisions by BOEMRE. The last extraordinary circumstance does not apply since there is no direct relationship between this rulemaking and other actions that could together contribute to cumulatively significant effects.

Most subsections of the rule address strictly administrative, technical, and/or procedural matters. Specific examples include definitions of terminology, scope and timing of documentation, recordkeeping, and transfer of information, and general descriptions of what is to be included in written procedures. The rule does not create the potential for environmental effects as a result of new technologies, technology configurations, or technological procedures as such measures are not part of the rule. For aspects of the rule dealing with mechanical integrity and inspections, the requirements are procedural and technical as the rule covers the content of the written procedures. While the rule identifies the requirement, it allows the operator to choose the means to achieve compliance as long as the means are consistent with the SEMS requirements.

Other subsections require activities in addition to administrative tasks, advance planning and procedural documentation, such as training and emergency response drills, and require corrective procedural actions that address human errors identified in investigations. These requirements are also considered procedural in nature since the subsections describe general and ordered steps that operators must undertake to have and maintain a compliant SEMS program. Subsections that require training of personnel on conducting drills are procedural in that they target the cognitive skills and knowledge of personnel ( e.g., § 250.1915(b)) and/or clarify the purpose and/or scope of training ( e.g., § 250.1918(c)). For example, in § 250.1918, BOEMRE requires training and drills for personnel to exercise elements in the Emergency Action Plan that focus on response, control, and evacuation procedures and reporting. The principal purpose of this is to ensure retention of and refine the skills, knowledge, and abilities of personnel. BOEMRE concluded that this rule does not meet any of the criteria for extraordinary circumstances as set forth in 43 CFR 46.215.

In developing this rule, we did not conduct or use a study, experiment, or survey requiring peer review under the Data Quality Act (Pub. L. 106-554, app. C § 515, 114 Stat. 2763, 2763A-153-154).

This rule is not a significant energy action under the definition in E.O. 13211. A Statement of Energy Effects is not required.

We are required by E.O. 12866, E.O. 12988, and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(a) Be logically organized;

(b) Use the active voice to address readers directly;

(c) Use clear language rather than jargon;

(d) Be divided into short sections and sentences; and

(e) Use lists and tables wherever possible.

If you feel that we have not met these requirements, send us comments by one of the methods listed in the ADDRESSES section. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that you find unclear, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

For the reasons stated in the preamble, Bureau of Ocean Energy Management, Regulation and Enforcement (BOEMRE) proposes to amend 30 CFR part 250 as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

EPA is proposing to determine, under the Clean Air Act (CAA or “Act”), that three areas previously designated nonattainment for the one-hour ozone NAAQS—the South Coast, the San Joaquin Valley, and the Southeast Desert—failed to attain the NAAQS for one-hour ozone by their applicable one-hour NAAQS attainment dates.

The Act requires us to establish NAAQS for certain widespread pollutants that cause or contribute to air pollution that is reasonably anticipated to endanger public health or welfare (sections 108 and 109 of the Act). In 1979, we promulgated the revised one-hour ozone standard of 0.12 parts per million (ppm) (44 FR 8202, February 8, 1979). 1

An area is considered to have attained the one-hour ozone standard if there are no violations of the standard, as determined in accordance with the regulation codified at 40 CFR 50.9, based on three consecutive calendar years of complete, quality-assured and certified monitoring data. A violation occurs when the ambient ozone air quality monitoring data show greater than one (1.0) “expected number” of exceedances per year at any site in the area, when averaged over three consecutive calendar years. 2 An exceedance occurs when the maximum hourly ozone concentration during any day exceeds 0.124 ppm. For more information, please see “National 1-hour primary and secondary ambient air quality standards for ozone” (40 CFR 50.9) and “Interpretation of the 1-Hour Primary and Secondary National Ambient Air Quality Standards for Ozone” (40 CFR part 50, appendix H).

The Act, as amended in 1990, required EPA to designate as nonattainment any area that was violating the one-hour ozone standard, generally based on air quality monitoring data from the 1987 through 1989 period (section 107(d)(4) of the Act; 56 FR 56694, November 6, 1991). The Act further classified these areas, based on the severity of their nonattainment problem, as Marginal, Moderate, Serious, Severe, or Extreme.

The control requirements and date by which attainment of the one-hour ozone standard was to be achieved varied with an area's classification. Marginal areas were subject to the fewest mandated control requirements and had the earliest attainment date, November 15, 1993, while Severe and Extreme areas were subject to more stringent planning requirements and were provided more time to attain the standard. Two measures that are triggered if a Severe or Extreme area fails to attain the standard by the applicable attainment date are contingency measures [section 172(c)(9)] and a major stationary source fee provision [sections 182(d)(3) and 185)] (“major source fee program” or “section 185 fee program”).

On November 6, 1991, EPA designated the South Coast  3 as “Extreme” nonattainment for the one-hour ozone standard, with an attainment date no later than November 15, 2010 (56 FR 56694). In its November 6, 1991 final rule, EPA designated the San Joaquin Valley  4 as “Serious” nonattainment for the one-hour ozone standard, but later reclassified the valley as “Severe” (66 FR 56476, November 8, 2001), and then as “Extreme” (69 FR 20550, April 16, 2004) for the one-hour ozone standard, with the same attainment date (November 15, 2010) as the South Coast. In its 1991 final rule, EPA designated the Southeast Desert  5 as “Severe-17” nonattainment for the one-hour ozone standard, with an attainment date no later than November 15, 2007.

EPA is proposing to determine that the Atlanta Area (comprised of Barrow, Bartow, Carroll, Cherokee, Clayton, Cobb, Coweta, De Kalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Hall, Heard, Henry, Newton, Paulding, Putnam, Rockdale, Spalding and Walton Counties) has attaining data for the 1997 annual PM 2.5 NAAQS. The proposal is based upon complete, quality-assured and certified ambient air monitoring data for the 2008-2010 monitoring period that show that the Area has monitored attainment of the 1997 annual PM 2.5 NAAQS. EPA is also proposing to determine, in accordance with EPA's PM 2.5 Implementation Rule of April 25, 2007 (72 FR 20664), that the Atlanta Area has attained the 1997 annual PM 2.5 NAAQS by its applicable attainment date of April 5, 2010.

On July 18, 1997 (62 FR 36852), EPA established an annual PM 2.5 NAAQS at 15.0 micrograms per cubic meter (μg/m 3 ) based on a 3-year average of annual mean PM 2.5 concentrations. At that time, EPA also established a 24-hour NAAQS of 65 μg/m 3 . See 40 CFR 50.7. On January 5, 2005 (70 FR 944), EPA published its air quality designations and classifications for the 1997 PM 2.5 NAAQS based upon air quality monitoring data from those monitors for calendar years 2001-2003. These designations became effective on April 5, 2005. The Atlanta Area was designated nonattainment for the 1997 annual PM 2.5 NAAQS. See 40 CFR 81.301.

On October 17, 2006 (71 FR 61144), EPA retained the 1997 annual PM 2.5 NAAQS at 15.0 μg/m 3 based on a 3-year average of annual mean PM 2.5 concentrations, and promulgated a 24-hour NAAQS of 35 μg/m 3 based on a 3-year average of the 98th percentile of 24-hour concentrations. On November 13, 2009, EPA designated the Atlanta Area as nonattainment for the 2006 24-hour NAAQS (74 FR 58688). In that action, EPA also clarified the designations for the NAAQS promulgated in 1997, stating that the Atlanta Area was designated as nonattainment for the annual NAAQS but attainment for the 24-hour NAAQS. Thus, today's action does not address attainment of either the 1997 or the 2006 24-hour NAAQS.

In response to legal challenges of the annual NAAQS promulgated in 2006, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) remanded this NAAQS to EPA for further consideration. See American Farm Bureau Federation and National Pork Producers Council, et al. v. EPA, 559 F.3d 512 (D.C. Cir. 2009). However, given that the 1997 and 2006 annual NAAQS are essentially identical, attainment of the 1997 annual NAAQS would also indicate attainment of the remanded 2006 annual NAAQS.

On April 25, 2007 (72 FR 20664), EPA promulgated its PM 2.5 implementation rule, codified at 40 CFR part 51, subpart Z, in which the Agency provided guidance for state and tribal plans to implement the 1997 PM 2.5 NAAQS. This rule, at 40 CFR 51.1004(c), specifies some of the regulatory consequences of attaining the NAAQS, as discussed below.

Today's proposed rulemaking assesses whether (1) The Atlanta Area has attained the 1997 annual PM 2.5 NAAQS, based on the most recent three years of quality-assured data, and (2) whether the Area attained that NAAQS by its applicable attainment date of April 5, 2010. The Atlanta Area is comprised of Barrow, Bartow, Carroll, Cherokee, Clayton, Cobb, Coweta, De Kalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Hall, Heard, Henry, Newton, Paulding, Putnam, Rockdale, Spalding and Walton Counties.

Under EPA regulations at 40 CFR 50.7, the 1997 annual primary and secondary PM 2.5 standards are met when the annual arithmetic mean concentration, as determined in accordance with 40 CFR part 50, Appendix N, is less than or equal to 15.0 µg/m 3 at all relevant monitoring sites in the subject area.

EPA has reviewed the ambient air monitoring data for the Atlanta Area in accordance with the provisions of 40 CFR part 50, Appendix N. All data considered have been quality-assured, certified, and recorded in EPA's Air Quality System (AQS) database. This review addresses air quality data collected in two 3-year periods. The period 2007-2009 is used for the determination of attainment by attainment date because that was the last period of certified data prior to the required attainment date of April 5, 2010. The period 2008-2010 is used for the determination of attaining data because that is the most recent period of certified data available now available to EPA.

Table 1 and the related discussion below show that, based on EPA's analysis of data for 2007-2009, the Area attained the 1997 annual PM 2.5 standard by its attainment date of April 5, 2010. In addition, Table 2 and the related discussion below show that the Area continues to attain the standard based on available data for 2008-2010. There were data completeness issues at the Powder Springs, E. Rivers School, Fire Station #8/Georgia Tech, Gwinnett Tech, and Yorkville monitors for both the 2007-2009 and 2008-2010 periods. EPA performed a quarterly maximum data substitution test using 40 CFR Part 50 Appendix N and the April 1999 Guideline on Data Handling Conventions for the PM NAAQS ( http://epa.gov/ttncaaa1/t1/memoranda/pmfinal.pdf ) for the monitors with less than 75 percent complete data. Further discussion on the data substitution can be found in the technical support document (TSD) for this proposal. The three year annual design values both with and without data substitution are provided in Table 1 and Table 2 below. EPA's review of these data indicates that the Atlanta Area has met the 1997 annual PM 2.5 NAAQS by the attainment date of April 5, 2010.

The Powder Springs monitor has a 2007-2009 PM 2.5 annual design value of 12.6 μg/m 3 . Since the monitor had one incomplete quarter during the second quarter of 2009, data substitution was conducted. The annual mean was recalculated, and the resulting 2007-2009 PM 2.5 annual design value is 13.1 μg/m 3 . The current 2008-2010 PM 2.5 annual design value is 11.9 μg/m 3 . Data substitution was conducted for the second quarter of 2009. The annual mean was recalculated, and the resulting 2008-2010 PM 2.5 annual design value is 12.3 μg/m 3 . This monitor is considered attaining with design values of 12.6 μg/m 3 and 11.9 μg/m 3 .

The E. Rivers School monitor did not meet data completeness for the second and third quarters of 2009 due to roof repairs during the summer of 2009 that were out of the State's control. Georgia Environmental Protection Division appropriately notified Region 4 of the temporary site closure. Additionally, the fourth quarter in 2008 is also incomplete. The 2007-2009 PM 2.5 annual design value is 13.4 μg/m 3 and the 2008-2010 PM 2.5 annual design value is 12.3 μg/m 3 . Data substitution was conducted and the recalculated annual design values are 14.2 μg/m 3 and 13.0 μg/m 3 respectively. This monitor is considered attaining with design values of 13.4 μg/m 3 for the 2007-2009 monitoring period and 12.3 μg/m 3 for the 2008-2010 monitoring period.

EPA's Office of Air Quality Planning and Standards (OAQPS) conducted an additional statistical analysis for the E. Rivers School monitor which indicates, as a weight of evidence, that despite the prolonged shut-down of the E. Rivers School monitor, the monitor would have attained in the 2007-2009 design value period. To evaluate air quality at the E. Rivers School monitor, EPA applied statistical analysis using data from other sites in the area. The approach, summarized in this section and further described in the TSD, is appropriate for this Area but may or may not be suitable for other areas with less than complete data. EPA will evaluate the appropriateness of this analytical approach on a case-by-case basis for determinations regarding each area with less than complete data.

The first step in the analysis was to assess the correlation of concentrations at the E. Rivers School site with concentrations at other sites in the Area. The monitor in the Area that had the highest correlation with the E. Rivers School site was the Georgia DOT monitor; therefore, subsequent analyses used data from this site. The second step was to develop a regression equation expressing the relationship between concentrations at the E. Rivers School and the Georgia DOT monitors. This regression equation was used to estimate values at the E. Rivers School site on days during quarters with incomplete data when the E. Rivers School site did not measure concentrations. A 2007-2009 design value for the E. Rivers School site was then calculated using these estimated values. Under this method, the 2007-2009 design value for the E. Rivers School site was estimated to be 13.6 μg/m 3 .

This estimated design value was then analyzed using a statistical method, referred to as the “bootstrap method,” that involves the use of regression residuals. In this analysis, EPA repeated the regression analysis 1,000 times with different values within the probability distribution of E. Rivers School concentrations that could be associated with given concentrations at the Georgia DOT monitor. From this analysis, as described in detail in the TSD, EPA determined that the upper end of the range of potential 2007-2009 design values obtained did not exceed the NAAQS. No exceedances of the NAAQS resulted from application of the statistical analysis. Therefore, EPA concluded that for 2007-2009, the annual average concentration of the E. Rivers School monitor is below the NAAQS.

The Fire Station #8 monitor was relocated to the Georgia Tech campus and was assigned a separate AQS number. It was moved back to Fire Station #8 at the end of 2008 and resumed normal operation. There were no data completeness issues at either site during the times each site was operated. The data records of the two sites were combined and resulted in a 13.8 μg/m 3 design value for the 2007-2009 design value period. As an additional weight of evidence, the bootstrap analysis described above for the E. Rivers School site was also conducted for the Fire Station #8 monitor and passed with a 2007-2009 design value of 14.1 μg/m 3 . The South DeKalb monitor had the highest correlation with the Fire Station #8 monitor. This bootstrap analysis is further explained in the TSD for this document. The data records of the two sites were also combined for the 2008-2010 design value period, which resulted in a 13.6 μg/m 3 design value.

The Gwinnett Tech monitor has a 2007-2009 PM 2.5 annual design value of 12.7 μg/m 3 . Since the monitor had one incomplete quarter during the fourth quarter of 2008, data substitution was conducted. The annual mean was recalculated, and the resulting 2007-2009 PM 2.5 annual design value is 13.3 μg/m 3 . The 2008-2010 PM 2.5 annual design value is 12.1 μg/m 3 . Data substitution was conducted for the fourth quarter of 2008. The annual mean was recalculated, and the resulting 2008-2010 PM 2.5 annual design value is 12.5 μg/m 3 . This monitor is considered attaining with design values of 12.7 μg/m 3 and 12.1 μg/m 3 , respectively.

The Gainesville monitor has a 2007-2009 PM 2.5 annual design value of 11.8 μg/m 3 . Since the monitor had two incomplete quarters during the third and fourth quarters of 2008, data substitution was conducted. The annual mean was recalculated, and the resulting 2007-2009 PM 2.5 annual design value is 12.8 μg/m 3 . The current 2008-2010 PM 2.5 annual design value is 11.2 μg/m 3 . Data substitution was conducted for the third and fourth quarters of 2008. The annual mean was recalculated, and the resulting 2008-2010 PM 2.5 annual design value is 11.9 μg/m 3 . This monitor is considered attaining with design values of 11.8 μg/m 3 and 11.2 μg/m 3 .

The Yorkville monitor has a 2007-2009 PM 2.5 annual design value of 12.0 μg/m 3 . Since the monitor had one incomplete quarter during the third quarter of 2009, data substitution was conducted. The annual mean was recalculated, and the resulting 2007-2009 PM 2.5 annual design value is 12.7 μg/m 3 . The current 2008-2010 PM 2.5 annual design value is 11.0 μg/m 3 . Data substitution was conducted for the third quarter of 2009. The annual mean was recalculated, and the resulting 2008-2010 PM 2.5 annual design value is 11.6 μg/m 3 . This monitor is considered attaining with design values of 12.0 μg/m 3 and 11.0 μg/m 3 .

EPA believes that the Atlanta Area is now meeting the 1997 annual PM 2.5 NAAQS. Since few data are available for 2011, the 2008-2010 data represent the most recent available data for EPA to use in its assessment. On the basis of this review, EPA is proposing to determine that the Atlanta Area has attained the 1997 annual PM 2.5 NAAQS. EPA is soliciting public comments on its proposal to determine that the Atlanta Area has attained the 1997 annual PM 2.5 NAAQS with 2007-2009 as well as 2008-2010 data, and attained the 1997 annual PM 2.5 NAAQS by the April 5, 2010, attainment date using 2007-2009 data.

EPA has reviewed the ambient air monitoring data for PM 2.5 , consistent with the requirements contained in 40 CFR part 50 and recorded the data in the EPA AQS database, for the Atlanta Area from 2007 through the present time. On the basis of that review, EPA proposes to determine that this Area has attained and continues to attain the 1997 annual PM 2.5 NAAQS based on the quality-assured data for the 2007-2009 monitoring period, which demonstrates attainment by April 5, 2010, and the 2008-2010 monitoring period. In addition, based on EPA's review of the data for 2007-2009, and in accordance with section 179(c)(1) of the CAA and EPA's regulations, EPA proposes to determine that the Area attained the 1997 annual PM 2.5 NAAQS by its applicable attainment date of April 5, 2010.

If this proposed determination of attaining data is made final, the requirements for the Atlanta Area to submit an attainment demonstration and associated RACM, a RFP plan, contingency measures, and any other planning SIPs related to attainment of the 1997 annual PM 2.5 NAAQS would be suspended for so long as the Area continues to attain the PM 2.5 NAAQS. See 40 CFR 51.1004(c). Notably, as described below, any such determination would not be equivalent to the redesignation of the Area to attainment for the annual PM 2.5 NAAQS.

If this proposed rulemaking is finalized and EPA subsequently determines, after notice-and-comment rulemaking in the Federal Register , that the Area has violated the annual PM 2.5 NAAQS, the basis for the suspension of the specific requirements would no longer exist for the Atlanta Area, and the Area would thereafter have to address the applicable requirements. See 40 CFR 51.1004(c).

Finalizing this proposed action would not constitute a redesignation of the Area to attainment of the annual PM 2.5 NAAQS under section 107(d)(3) of the Clean Air Act (CAA). Further, finalizing this proposed action does not involve approving a maintenance plan for the Area as required under section 175A of the CAA, nor would it find that the Area has met all other requirements for redesignation. Even if EPA finalizes the proposed action, the designation status of the Atlanta Area would remain nonattainment for the 1997 annual PM 2.5 NAAQS until such time as EPA determines that the Area meets the CAA requirements for redesignation to attainment and takes action to redesignate the Area.

This action is only a proposed determination that the Atlanta Area has attained the 1997 annual PM 2.5 NAAQS and has done so by the April 5, 2010, attainment date. Today's action does not address the 24-hour PM 2.5 NAAQS.

If the Atlanta Area continues to monitor attainment of the annual PM 2.5 NAAQS, the requirements for the Atlanta Area to submit an attainment demonstration and associated RACM, a RFP plan, contingency measures, and any other planning SIPs related to attainment of the annual PM 2.5 NAAQS will remain suspended.

In addition, if EPA's separate and independent proposed determination that the Area has attained the 1997 annual PM 2.5 standard by its applicable attainment date (April 5, 2010) is finalized, EPA will have met its requirement pursuant to section 179(c)(1) of the CAA to make a determination based on the Area's air quality data as of the attainment date whether the Area attained the standard by that date.

These two actions described above are proposed determinations regarding the Atlanta Area's attainment only with respect to the 1997 annual PM 2.5 NAAQS. Today's actions do not address the 24-hour PM 2.5 NAAQS.

These actions propose to make determinations of attainment based on air quality, and would, if finalized, result in the suspension of certain federal requirements, and it would not impose additional requirements beyond those imposed by state law. For that reason, these proposed actions:

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

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

• Are 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. );

• Do 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);

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

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

• Are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Are 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 CAA; and

• Do 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, these proposed 1997 annual PM 2.5 NAAQS determinations for the Atlanta Area do 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.

For purposes of judicial review, the two of the these determinations approved by today's action are severable from one another.

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.

On September 17, 2007, EPA determined that the submittal for SJVUAPCD Rule 4565 met the completeness criteria in 40 CFR part 51 appendix V, which must be met before formal EPA review. On May 6, 2011, EPA determined that the submittal for SJVUAPCD Rule 4570 met the completeness criteria.

There are no previous versions of Rule 4565. On January 14, 2010, EPA finalized a limited approval of an earlier version of Rule 4570 into the SIP. Simultaneously, EPA finalized a limited disapproval of the rule for exempting major source poultry operations and for an inadequate RACT analysis for swine and poultry (75 FR 2079). The SJVUAPCD adopted revisions to Rule 4570 on October 21, 2010, partly to address these issues, and we are proposing action on that version of the rule.

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires States to submit regulations that control VOC emissions. Rule 4570 requires management practices to reduce VOCs from dairies, beef feedlots, poultry houses, and other confined animal facilities. Rule 4565 requires management practices to reduce VOC emissions from land-application of biosolids and disposal at landfills and small and medium sized composting/co-composting operations. Rule 4565 also requires add-on controls at large composting/co-composting operations. EPA's technical support documents (TSDs) have more information about these rules.

Generally, SIP rules must be enforceable (see section 110(a) of the Act), must require Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major source in nonattainment areas (see sections 182(a)(2) and (b)(2)), must not interfere with any applicable requirements concerning attainment and reasonable further progress (RFP), and must not relax existing requirements (see sections 110(l) and 193). Section 172(c)(1) of the Act also requires implementation of all reasonably available control measures (RACM) as expeditiously as practicable in nonattainment areas. The SJVUAPCD regulates an ozone nonattainment area (see 40 CFR part 81), so Rules 4565 and 4570 must fulfill RACT. Additionally, the RACM requirement in CAA section 172(c)(1) applies to this area. In this proposal, we are only evaluating RACT. In a separate rulemaking, EPA will take action on the State's RACM demonstrations for the 8-hour ozone NAAQS based on an evaluation of the control measures submitted as a whole and their overall potential to advance the applicable attainment date in the San Joaquin Valley. See 40 CFR 51.912(d) and 51.1010.

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

1. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook).

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

3. Portions of the proposed post-1987 ozone and carbon monoxide policy that concern RACT, 52 FR 45044, November 24, 1987.

4. “State Implementation Plans, General Preamble for the Implementation of Title I of the Clean Air Amendments of 1990,” 57 FR 13498, April 16, 1992.

5. “Preamble, Final Rule to Implement the 8-hour Ozone National Ambient Air Quality Standard,” 70 FR 71612, Nov. 29, 2005.

6. Letter from William T. Hartnett to Regional Air Division Directors, “RACT Qs & As—Reasonable Available Control Technology (RACT) Questions and Answers,” May 18, 2006.

We believe these rules are consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. The revisions to Rule 4570 address the deficiencies we noted in our January 14, 2010 limited disapproval action, and include lowering the rule applicability threshold for poultry facilities to include all major sources and an adequate RACT analysis for swine and poultry facilities. The TSDs have more information on our evaluation.

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 relevant 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. If finalized as proposed, approval of Rule 4570 would terminate all CAA sanction and FIP implications associated with EPA's 2010 limited disapproval of a previous version of this rule.

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).

In addition, this proposed action 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.

States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and request EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 266, 268, 270, 273 and 279.

We conclude that Ohio's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we propose to grant Ohio final authorization to operate its hazardous waste program with the changes described in the authorization application. Ohio has responsibility for permitting treatment, storage, and disposal facilities (TSDFs) within its borders (except in Indian Country) and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, EPA will implement those requirements and prohibitions in Ohio, including issuing permits, until the State is granted authorization to do so.

The effect of this decision, once finalized, is that a facility in Ohio subject to RCRA would have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. Ohio has enforcement responsibilities under its State hazardous waste program for RCRA violations, but EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to:

1. Do inspections, and require monitoring, tests, analyses or reports;

2. Enforce RCRA requirements and suspend or revoke permits; and

3. Take enforcement actions regardless of whether the State has taken its own actions.

This action will not impose additional requirements on the regulated community because the regulations for which Ohio is being authorized are already effective, and will not be changed by EPA's final action.

If EPA receives adverse comments on this authorization, we will address all public comments in a later Federal Register . You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time.

Ohio initially received final authorization on June 28, 1989, effective June 30, 1989 (54 FR 27170) to implement the RCRA hazardous waste management program. We granted authorization for changes to their program on April 8, 1991, effective June 7, 1991 (56 FR 14203) as corrected June 19, 1991, effective August 19, 1991 (56 FR 28088); July 27, 1995, effective September 25, 1995 (60 FR 38502); October 23, 1996, effective December 23, 1996 (61 FR 54950); January 24, 2003, effective January 24, 2003 (68 FR 3429); January 20, 2006, effective January 20, 2006 (71 FR 3220), and October 29, 2007, effective October 29, 2007 (72 FR 61063).

On May 9, 2011, Ohio submitted a final complete program revision application, seeking authorization of their changes in accordance with 40 CFR 271.21. We are now proposing to authorize, subject to receipt of written comments that oppose this action, Ohio's hazardous waste program revision. We propose to grant Ohio final authorization for the following program changes:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) were enacted to establish quality standards for certain laboratory testing. These standards ensure the accuracy, reliability and timeliness of patient test results, regardless of where the test is performed. The standards are based on the complexity of the laboratory test method; the more complicated the test, the more stringent the requirements for the laboratory.

CLIA established three categories of testing based on complexity level. In increasing order of complexity, these categories are waived complexity, moderate complexity which includes the subcategory of provider-performed microscopy (PPM), and high complexity. Laboratories must hold a CLIA certificate for the most complex form of CLIA-regulated testing that they perform.

CLIA covers all phases of laboratory testing, including the reporting out of test results. The CLIA-based limitations that govern to whom a laboratory may issue a test report have become a point of concern. The requirements for a laboratory test report are set forth in 42 CFR 493.1291.

Under the current regulations at § 493.1291(f), CLIA limits a laboratory's disclosure of laboratory test results to three categories of individuals: the “authorized person,” the person responsible for using the test results in the treatment context, and, in the case of reference laboratories, the referring lab. Authorized person is defined in § 493.2 as the individual authorized under State law to order or receive test results, or both. In States that do not provide for individual access to the individual's test results, the individual must receive his or her results through the ordering provider.

While individuals can obtain test results through the ordering provider, we believe that the advent of certain health reform concepts (for example, individualized medicine and an individual's active involvement in his or her own health care) would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results.

Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (The Recovery Act), which was enacted on February 17, 2009, incorporated the Health Information Technology for Economic and Clinical Health (HITECH) Act.

HITECH created a Federal advisory committee known as the Health Information Technology (HIT) Policy Committee. The HIT Policy Committee has broad representation from major health care constituencies and provides recommendations to the Office of the National Coordinator for Health Information Technology (ONC) on issues relating to the implementation of an interoperable, nationwide health information infrastructure. Among other efforts, the HIT Policy Committee has sought to identify barriers to the adoption and use of health information technology. According to the HIT Policy Committee, CLIA regulations are perceived by some stakeholders as imposing barriers to the exchange of health information. These stakeholders include large- and medium-sized laboratories, some public health laboratories, electronic health record (EHR) system vendors, health policy experts, health information exchange organizations (HIOs) and healthcare providers who believe that the individual's access to his or her own records is impeded, preventing patients from a more active role in their personal health care decisions.

CLIA staff worked with the Office of the National Coordinator for Health IT (ONC), and the CMS Office of E-Health Standards and Services (OESS) to ensure an individual's direct access to his or her own medical records through laboratories.

The collaborating offices believe the provision of direct patient access to laboratory test reports would support the commitments and goals of the Secretary of HHS and the CMS Administrator regarding the widespread adoption of EHRs by 2014.

Therefore, in an effort to increase direct patient access rights, we are proposing that, upon a patient's request, CLIA regulations would allow laboratories to provide direct patient access to completed test reports that, using the laboratory's authentication processes, the laboratory can identify as belonging to that patient. We propose to retain the other categories of individuals who are eligible to receive test reports from laboratories, namely the individuals responsible for using the test reports, and, in the case of a reference laboratory, the laboratory that initially requested the test. We also propose certain conforming amendments to the existing regulations. CMS solicits comments from stakeholders regarding the potential impact of this change on improving patients' access to their laboratory results.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Title II, subtitle F—Administrative Simplification, Public Law 104-191, 110 Stat., 2021, provided for the establishment of national standards to protect the privacy and security of personal health information. The Administrative Simplification provisions of HIPAA apply to three types of entities, which are known as “covered entities”: health care providers who conduct covered health care transactions electronically, health plans, and health care clearinghouses.

A laboratory, as a health care provider, is only a covered entity if it conducts electronic transactions (for example, electronic submission of health care claims). The list of HIPAA transactions applicable to providers are:

• Health care claims or equivalent encounter information.

• Coordination of benefits.

• Health care claim status.

• Eligibility for a health plan.

• Referral certification and authorization.

If a laboratory does not conduct any of the above transactions electronically (either because it does not conduct the transactions at all or because it does so via paper), then it is not subject to the HIPAA Privacy Rule. If a laboratory conducts a single transaction electronically, then it becomes a covered entity and is subject to the Privacy Rule with respect to all protected health information that it creates or maintains (that is, the application of the Privacy Rule is not limited to the individuals or records associated with an electronic transaction).

Pursuant to HIPAA, on December 28, 2000, the Department published a final rule in the Federal Register (65 FR 82462) entitled “Standards for Privacy of Individually Identifiable Health Information, known as the “Privacy Rule,” which was amended on August 14, 2002 (67 FR 53182). The Privacy Rule at 45 CFR 164.524 provides individuals with a general right of access to inspect and obtain a copy of protected health information about the individual in a designated record set maintained by or for a covered entity. A “designated record set” is defined at § 164.501 as a group of records maintained by or for a covered entity that is comprised of the medical records and billing records about individuals maintained by or for a covered health care provider; the enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or used, in whole or in part, by or for the covered entity to make decisions about individuals.

The definition of “designated record set” also clarifies that the term “record” means “any item, collection, or grouping of information that includes protected health information and is maintained, collected, used or disseminated by or for a covered entity.” Laboratory test reports maintained by or for a laboratory that is a covered entity fall within the definition of designated record set since they are medical records about individuals.

The right of access under § 164.524 extends not only to individuals, but also to individuals' personal representatives. The rules governing who may act as a personal representative under the Privacy Rule are set forth at § 164.502(g).

While individuals (and personal representatives) generally have the right to inspect and obtain a copy of their protected health information in a designated record set, the Privacy Rule includes a set of exceptions related to CLIA. The right of access under § 164.524 of the Privacy Rule does not apply to: protected health information maintained by a covered entity that is—(1) Subject to CLIA to the extent the provision of access to the individual would be prohibited by law; or (2) exempt from CLIA.

These exceptions at § 164.524(a)(1)(iii) were included in the Privacy Rule because the Department wanted to avoid a conflict with the CLIA requirements that limited patient access to test reports (65 FR 82485). These exceptions only cover test reports at CLIA and CLIA-exempt laboratories; the individual has a right to access the test reports when held by any other type of covered entity (for example, a hospital or treating physician).

Because CMS is proposing to amend the CLIA regulations to allow CLIA-certified laboratories to provide patients with direct access to their test reports, there is no longer a need for the exceptions at § 164.524 for CLIA and CLIA-exempt laboratories. Unless these exceptions are removed from the Privacy Rule, they would serve as a barrier to individuals' right of access to test reports. Failure to eliminate these barriers would be inconsistent with the CMS proposal and the goals of HHS to improve individuals' electronic access to their health information and have widespread adoption of EHRs by 2014. Accordingly, HHS is proposing to remove the exceptions for CLIA and CLIA-exempt laboratories from the right of access at § 164.524.

This rule proposes revisions to § 493.1291 to provide patients, upon request, with direct access to their laboratory test reports. To do so we are proposing to add § 493.1291(l) to specify that, upon a patient's request, the laboratory may provide an individual with access to his or her completed test reports that, using the laboratory's authentication processes, can be identified as belonging to that patient. In using “may,” however, we would highlight the importance of reading the proposed CLIA provisions in concert with the applicable HIPAA provisions. As described in section IIB below, HIPAA generally requires covered entities to give patients access to their records. One exception to this general mandate is a provision that exempts entities subject to CLIA where a law bars disclosure. If finalized, the proposed HIPAA amendments will remove this exception, and covered entity laboratories will be required to provide patients with access to test reports. While a more detailed HIPAA preemption analysis is found in section IIB below, we note that the CLIA “may” plus the HIPAA “must” would result in a “must disclose” for laboratories that are HIPAA covered entities.

We also note that, as proposed, the CLIA regulations would not spell out the mechanism by which patient requests for access would be submitted, processed, or responded to by the laboratories. In providing this latitude, we intend to allow patients and their personal representatives' access to patient test reports in accordance with the requirements of the HIPAA Privacy Rule.

Subject to conforming amendments, we propose to retain the existing requirements at § 493.1291(f) that otherwise limit the release of test reports to authorized persons and, if applicable, the individuals (or their personal representatives) responsible for using the test reports and, in the case of a reference laboratory, the laboratory that initially requested the test.

The Department also proposes to amend the Privacy Rule at § 164.524 to remove the exceptions that relate to CLIA and affect an individual's right of access. This proposal would align the Privacy Rule with CMS' proposed changes and the Department's goal of improving individuals' access to their health information.

As a result of this proposal, HIPAA covered entities that are laboratories subject to CLIA would have the same obligations as other types of covered health care providers with respect to providing individuals with access to their protected health information in accordance with § 164.524. Similarly, HIPAA covered entities that are CLIA-exempt laboratories (as the term is defined at 42 CFR 493.2) would no longer be excepted from HIPAA's right of access under § 164.524(a)(1)(iii)(B). As with other covered entities, HIPAA covered laboratories would be required to provide access to the individual or the individual's personal representative.

The current HIPAA Privacy Rule requires covered entities to provide an individual with access to protected health information in the form or format requested by the individual, if it is readily producible in such form or format. The Privacy Rule permits covered entities to charge a reasonable, cost-based fee to provide individuals with copies of their protected health information. The fee may include only the cost of copying (including supplies and labor) and postage, if the patient requests that the copy be mailed. If the patient has agreed to receive a summary or explanation of his or her protected health information, the covered entity may also charge a fee for preparation of the summary or explanation. The fee may not include costs associated with searching for and retrieving the requested information.

On July 14, 2010, the Department issued a proposed rule to implement most of the privacy and security provisions of the HITECH Act, which included provisions to strengthen an individual's right to receive an electronic copy of his or her protected health information, where such information is maintained electronically in one or more designated record sets. Specifically, the proposed rule would require in such cases that the covered entity provide the individual with access to the electronic information in the electronic form and format requested by the individual, if it is readily producible in such form and format, or, if not, in a readable electronic form and format as agreed to by the covered entity and the individual. Additionally, the Department proposed changes to address and clarify the fees associated with the provision of electronic access. The Department proposed to allow reasonable cost-based fees reflecting the costs of labor for creating the electronic copy of the information and of supplies, such as CDs, if the individual requests that the electronic copy be provided on portable media. HIPAA covered laboratories would be required to comply with the Privacy Rule's provisions regarding form of access provided and fees, as they exist currently and then are ultimately modified by a final rule implementing the HITECH Act. With respect to the provision of electronic access, covered entities that have electronic reporting capabilities are expected to provide the individual with a machine readable or other electronic copy of the individual's protected health information. (The individual always retains the right to request and receive a paper copy, if desired.) The Department considers machine readable data to mean digital information stored in a standard format enabling the information to be processed and analyzed by computer. For example, this would include providing the individual with an electronic copy of the protected health information in the format of MS Word or Excel, text, HTML, or text-based PDF, among other formats. We request comment on the ability of laboratories to provide electronic copies of protected health information in machine readable or other electronic formats.

Under our proposal, § 164.524 would preempt any contrary provisions of State law. HIPAA, at section 1178 of the Social Security Act (the Act), provides that the administrative simplification regulations (“the HIPAA Rules”) preempt any contrary provisions of State law. A provision of State law is “contrary” to a provision of the HIPAA Rules if a covered entity would find it impossible to comply with both the State and Federal requirements; or the provision of State law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of part C of title XI of the Act or section 254 of Public Law 104-191, as applicable.

Pursuant to section 264(c)(2) of HIPAA, the HIPAA Privacy Rule includes an exception from this general preemption if “the provision of State law relates to the privacy of individually identifiable health information and is more stringent than a standard, requirement, or implementation specification adopted under subpart E of part 164 of this subchapter.” With respect to a State law pertaining to an individual's right to access his or her protected health information, a State law is more stringent than the Privacy Rule if the State law “permits greater rights of access or amendment, as applicable” (§ 160.202).

A number of States have laws that prohibit a laboratory from releasing a test report directly to the patient or that prohibit the release without the ordering provider's consent. If adopted, the proposed changes to § 164.524 would preempt any contrary State laws that prohibit the HIPAA-covered laboratory from directly providing access to the individual.

We note that covered entities, including CLIA and CLIA-exempt laboratories under our proposal, must satisfy the verification requirement of § 164.514(h) before providing an individual with access. This requirement is consistent with the proposed change to the CLIA requirements, which would allow a laboratory to provide patients with access to test reports when the laboratory can authenticate that the test report pertains to the patient. We recognize that a laboratory may receive a test order with only an anonymous identifier and thus may be unable to identify the individual who is the subject of the test report. It is not our intent to discourage such anonymous testing. In this case, the laboratory that receives a request for access from an individual but cannot verify that the requesting individual is the subject of a test report is under no obligation to provide access.

We propose that, if finalized, HIPAA-covered laboratories would be required to comply with the revised § 164.524 by no later than 180 days after the effective date of the final rule. The effective date of the final rule would be 60 days after publication in the Federal Register , so laboratories would have a total of 240 days after publication of the final rule to come into compliance. This compliance period is consistent with section 1175(b)(2) of the Act, which provides that the Department must provide covered entities with at least 180 days to come into compliance with modifications to standards under the HIPAA Rules. This compliance period also is consistent with our proposed changes to § 160.105 found in the July 14, 2010 proposed rule (75 FR 40868). That proposal would establish at § 160.105 a 180-day compliance period for future modifications to the HIPAA Rules, unless otherwise specifically provided.

Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We are soliciting public comment on each of these issues for the information collection requirements (ICRs) in the proposals for 42 CFR 493.1291.

Except as provided in § 493.1291(l), test reports must be released only to authorized persons and, if applicable, the individuals (or their personal representative) responsible for using the test reports and, in the case of a reference laboratory, the laboratory that initially requested the test. Under § 493.1291(l), the laboratory may, upon request by the patient, provide access to the patient's test reports that the laboratory can identify as belonging to that patient. The CLIA regulations would not require that CLIA-certified laboratories provide this access—rather, the entities would be allowed to provide for access. We note, however, that CLIA-certified laboratories generally are covered entities under the HIPAA Privacy Rule. That rule also provides for patients' access to their records. CLIA-certified laboratories will need to ensure that their practices conform to CLIA and HIPAA requirements.

We have prepared the Paperwork Reduction Act and the Regulatory Impact Analysis that represents the costs and benefits of the proposed rule based on analysis of identified variables and data sources needed for this proposed change. We identified known data elements (Table 1) and made assumptions on elements where a source could not be identified (Table 2). Our assumptions are based on internal discussions and consultation with two reference laboratories. We request comments on the assumptions used and analyses provided.

The Federal Emergency Management Agency (FEMA) proposes to make determinations of BFEs and modified BFEs for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

These proposed BFEs and modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These proposed elevations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in those buildings.

Comments on any aspect of the Flood Insurance Study and FIRM, other than the proposed BFEs, will be considered. A letter acknowledging receipt of any comments will not be sent.

National Environmental Policy Act. This proposed rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Executive Order 12866, Regulatory Planning and Review. This proposed rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866, as amended.

Executive Order 13132, Federalism. This proposed rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This proposed rule meets the applicable standards of Executive Order 12988.

Accordingly, 44 CFR part 67 is proposed to be amended as follows: