On January 13, 2011 (76 FR 2243), the NRC published a direct final rule amending its regulations at 10 CFR 72.214 to include Amendment No. 1 to CoC No. 1030. Amendment No. 1 will revise the definitions for Damaged Fuel Assembly and Transfer Operations; add definitions for Fuel Class and Reconstituted Fuel Assembly; add Combustion Engineering 16x16 class fuel assemblies as authorized contents; reduce the minimum off-normal ambient temperature from −20 °F to −21 °F; expand the authorized contents of the NUHOMS® HD System to include pressurized water reactor fuel assemblies with control components; reduce the minimum initial enrichment of fuel assemblies from 1.5 weight percent uranium-235 to 0.2 weight percent uranium-235; clarify the requirements of reconstituted fuel assemblies; add requirements to qualify metal matrix composite neutron absorbers with integral aluminum cladding; clarify the requirements for neutron absorber tests; delete use of nitrogen for draining the water from the dry shielded canister (DSC), and allow only helium as a cover gas during DSC cavity water removal operations; and make corresponding changes to the technical specifications. In the direct final rule, NRC stated that if no significant adverse comments were received, the direct final rule would become final on March 29, 2011.

The NRC did not receive any comments on the direct final rule. Therefore, this rule will become effective as scheduled.

Title III of the Energy Policy and Conservation Act (42 U.S.C. 6291 et seq.; “EPCA” or, in context, “the Act”) sets forth a variety of provisions designed to improve energy efficiency. Part B of Title III ((42 U.S.C. 6291-6309) establishes the “Energy Conservation Program for Consumer Products Other Than Automobiles,” including microwave ovens (all of which are referred to below as “covered products”.)  1 (42 U.S.C. 6291(1)-(2) and 6292(a)(10))

Under the Act, this program consists essentially of three parts: (1) Testing; (2) labeling; and (3) establishing Federal energy conservation standards. Pursuant to EPCA, the testing requirements consist of test procedures that manufacturers of covered products must use as the basis for certifying to DOE that their products comply with applicable energy conservation standards adopted under EPCA and for representations about the efficiency of those products. Similarly, DOE must use these test requirements to determine whether the products comply with EPCA standards. Under 42 U.S.C. 6293, EPCA sets forth criteria and procedures for DOE's adoption and amendment of such test procedures. EPCA provides that any test procedures prescribed or amended under this section shall 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, as determined by the Secretary of Energy, and shall not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

Finally, in any rulemaking to amend a test procedure, DOE must determine to what extent, if any, the proposed test procedure would alter the measured energy efficiency of any covered product as determined under the existing test procedure. (42 U.S.C. 6293(e)(1)) If DOE determines that the amended test procedure would alter the measured efficiency of a covered product, DOE must amend the applicable energy conservation standard accordingly. In determining the amended energy conservation standard, the Secretary shall measure, pursuant to the amended test procedure, the energy efficiency, energy use, or water use of a representative sample of covered products that minimally comply with the existing standard. The average of such energy efficiency, energy use, or water use levels determined under the amended test procedure shall constitute the amended energy conservation standard for the applicable covered products. (42 U.S.C. 6293(e)(2)) EPCA also states that models of covered products in use before the date on which the amended energy conservation standard becomes effective (or revisions of such models that come into use after such date and have the same energy efficiency, energy use, or water use characteristics) that comply with the energy conservation standard applicable to such covered products on the day before such date shall be deemed to comply with the amended energy conservation standard. (42 U.S.C. 6293(e)(3))

DOE is also required to amend the test procedures for covered products to address standby mode and off mode energy consumption and to integrate such energy consumption into the energy descriptor for that product unless the current test procedures already fully account for such consumption. If integration is technically infeasible, DOE must prescribe a separate standby mode and off mode energy use test procedure, if technically feasible. (42 U.S.C. 6295(gg)(2)(A)) Any such amendment must consider the most current versions of IEC Standards 62301 “Household electrical appliances—Measurement of standby power,” First Edition 2005-06 (IEC Standard 62301 (First Edition))  2 and IEC Standard 62087 “Methods of measurement for the power consumption of audio, video, and related equipment,” Second Edition 2008-09. Id. For microwave ovens, DOE must prescribe any such amendment by March 31, 2011. (42 U.S.C. 6295(gg)(2)(B)(vi))

Historically, DOE's active mode test procedure for microwave ovens appeared at appendix I to subpart B of Title 10 of the Code of Federal Regulations (CFR). 3 That test procedure was part of an October 3, 1997 final rule that also revised the test procedures for other cooking products to measure their efficiency and energy use more accurately. 62 FR 51976. That final rule incorporated portions of IEC Standard 705-1998 and Amendment 2-1993, “Methods for Measuring the Performance of Microwave Ovens for Households and Similar Purposes” to measure microwave oven cooking efficiency, but did not address energy use in the standby or off modes. Id.

DOE published a notice of proposed rulemaking (NOPR) on October 17, 2008 (hereafter referred to as the October 2008 TP NOPR), in which it proposed incorporating provisions from IEC Standard 62301 (First Edition) into the DOE active mode test procedure, as well as language to clarify application of these provisions for measuring standby mode and off mode power in microwave ovens. 73 FR 62134. DOE held a public meeting on November 14, 2008 (hereafter referred to as the November 2008 public meeting) to hear oral comments on and solicit information relevant to the October 2008 TP NOPR. Interested parties remarked upon, among other things, harmonization of standards and test procedures with those of other countries and international agencies. In particular commenters urged DOE to consider IEC Standard 62301 (Second Edition), which was in the process of being finalized and published.

EPCA requires DOE to consider the most recent version of IEC Standard 62301. After the October 2008 TP NOPR was published, DOE determined that it would consider the revised version of IEC Standard 62301 ( i.e., IEC Standard 62301 (Second Edition)), in the microwave oven test procedure rulemaking. The revised version was expected in July 2009. DOE anticipated, based on review of drafts of the updated IEC Standard 62301, that the revisions could include different mode definitions. IEC Standard 62301 (Second Edition) was not published, however, until January 27, 2011.

Because the Energy Independence and Security Act (EISA) of 2007 amendments to EPCA require DOE to establish test procedures for standby mode and off mode by March 31, 2011, and because DOE is conducting a concurrent energy conservation standards rulemaking for standby and off mode energy use, discussed below, DOE published a supplemental notice of proposed rulemaking (SNOPR) on July 22, 2010 (hereafter referred to as the July 2010 TP SNOPR) proposing mode definitions based on those in the then current draft version of IEC Standard 62301 (Second Edition), designated as IEC Standard 62301 Second Edition, Committee Draft for Vote (IEC Standard 62301 (CDV)). 75 FR 42612, 42620-23 (July 22, 2010). DOE noted in the July 2010 TP SNOPR that IEC Standard 62301 (CDV) contains proposed amendments to IEC Standard 62301 (First Edition), including new mode definitions based on those proposed in IEC Standard 62301 (Second Edition), Committee Draft 2 (IEC Standard 62301 (CD2))  4 and which address comments received by interested parties in response to IEC Standard 62301 (CD2). As a result of this continued refinement on the basis of public comment, DOE stated that it believes that these most recent mode definitions represent the best definitions available for the analysis in support of this rulemaking. 75 FR 42612, 42621.

DOE held a public meeting on September 16, 2010 (hereafter referred to as the September 2010 public meeting), to hear oral comments on and solicit information relevant to the July 2010 TP SNOPR. Interested parties remarked upon, among other things, covered products, incorporation of IEC Standard 62301 (First Edition), mode definitions, and testing procedures. On October 29, 2010, the IEC released a finalized draft version of IEC Standard 62301 (Second Edition), IEC Standard 62301 (FDIS).

As stated in the previous paragraph, DOE is considering amended microwave oven energy conservation standards addressing standby and off mode energy use concurrently with the test procedure rulemaking process. The National Appliance Energy Conservation Act of 1987 (NAECA; Pub. L. 100-12), which amended EPCA, established prescriptive standards for kitchen ranges and ovens, but no standards were established for microwave ovens. (42 U.S.C. 6295(h)) The NAECA amendments also required DOE to conduct two cycles of rulemakings to determine whether to revise the standard. (42 U.S.C. 6295(h)(2)) DOE undertook the first cycle of these rulemakings and issued a final rule on September 8, 1998 (63 FR 48038), in which DOE found that no amended standards were justified for electric cooking products, including microwave ovens.

DOE initiated the second cycle of energy conservation standards rulemakings for cooking products by publishing a framework document covering, in part, microwave ovens, and giving notice of a public meeting and the availability of the document. 71 FR 15059 (March 27, 2006). In its subsequent advance notice of proposed rulemaking (ANOPR) (72 FR 64432, Nov. 15, 2007) (hereafter the November 2007 ANOPR) concerning energy conservation standards for commercial clothes washers and residential dishwashers, dehumidifiers, and cooking products, including microwave ovens (collectively, appliance standards), DOE determined that energy consumption by microwave ovens in the standby mode represents a significant portion of microwave oven energy use, and that a standard regulating such energy consumption would likely have significant energy savings. 72 FR 64432, 64441-42. Before standby power could be included in an efficiency standard for microwave ovens, however, test procedures for the measurement of standby power would be required. Id.

On December 13, 2007, DOE held a public meeting to receive and discuss comments on the November 2007 ANOPR (hereafter referred to as the December 2007 public meeting). At the December 2007 public meeting, DOE presented for discussion the possibility that test standard IEC Standard 62301 (First Edition) could be incorporated by reference into DOE's microwave oven test procedure to measure standby power. DOE also discussed clarifications to the IEC Standard 62301 (First Edition) test conditions at the December 2007 public meeting, including a requirement that, if the measured power is not stable, the standby mode power test would be run for a period of 12 hours with an initial clock setting of 12 a.m. This would permit more accurate measurement of average standby power consumption.

DOE published a NOPR for the appliance standards rulemaking on October 17, 2008, in which it tentatively concluded that a standard for microwave oven standby mode and off mode energy consumption would be technologically feasible and economically justified. 73 FR 62034. DOE received responses to the NOPR from interested parties regarding the harmonization of standards and test procedures with those of other countries and international agencies. As a result of these comments, DOE decided to consider the revised version of IEC Standard 62301 ( i.e., IEC Standard 62301 (Second Edition)), which is a widely accepted international test procedure, in the development of energy conservation standards for the standby mode and off mode power consumption of microwave ovens. As stated above, issuance of the revised version was expected in July 2009 but did not occur until January 27, 2011; as a result, DOE considered the most recent draft at the time, version IEC Standard 62301 (CDV), for the July 2010 TP SNOPR. 75 FR 42612, 42614.

In today's interim final rule, DOE is amending its test procedures for microwave ovens to:

(1) Address the statutory requirement to establish procedures for the measurement of standby mode and off mode power consumption.

(2) Support the concurrent development of energy conservation standards that address use of standby mode and off mode power by this product.

In today's interim final rule, DOE is incorporating by reference specific clauses from IEC Standard 62301 (First Edition) regarding test conditions and testing procedures for measuring the average standby mode and average off mode power consumption into the microwave oven test procedure. DOE is also adopting in the microwave oven test procedure definitions of “active mode,” “standby mode,” and “off mode” that are based on the definitions provided in IEC Standard 62301 (FDIS). DOE further adopts language to clarify the application of clauses from IEC Standard 62301 (First Edition) for measuring standby mode and off mode power in this interim final rule. Specifically, DOE is defining the test duration for cases in which the measured power is not stable ( i.e., varies over a cycle), recognizing that the power consumption of microwave oven displays can vary based on the displayed clock time.

The EISA 2007 amendments to EPCA direct DOE to amend the microwave oven test procedure to integrate energy consumption in standby mode and off mode into the overall energy descriptor. (42 U.S.C. 6295(gg)(2)(A)) If that is technically infeasible, DOE must instead prescribe a separate standby mode and off mode energy use test procedure, if technically feasible. Id.

As noted above, EPCA requires that DOE determine whether a proposed test procedure amendment would alter the measured efficiency of a product, thereby requiring adjustment of existing standards. (42 U.S.C. 6293(e)) Because there are currently no Federal energy conservation standards for microwave ovens (including energy use in the standby and off modes), such requirement does not apply to this rulemaking. DOE is conducting a concurrent rulemaking process to consider standby and off mode energy conservation standards and will consider this test procedure rulemaking as any standards are developed.

This rule amends the test procedures for microwave ovens to include test procedures for the measurement of standby mode and off mode power use. This rule also clarifies that the definition of “microwave oven” in 10 CFR 430.2 includes microwave ovens with or without thermal elements designed for surface browning of food and combination ovens.

DOE defines “microwave oven” as a class of kitchen ranges and ovens which is a household cooking appliance consisting of a compartment designed to cook or heat food by means of microwave energy. 10 CFR 430.2 In the October 2008 TP NOPR, DOE stated that the proposed amendments would establish test procedures for all microwave ovens for which the primary source of heating energy is electromagnetic (microwave) energy, including microwave ovens with or without thermal elements designed for surface browning of food. DOE stated that the proposal did not address test procedures for combination ovens ( i.e., ovens consisting of a single compartment in which microwave energy and one or more other technologies, such as thermal or halogen cooking elements or convection systems, contribute to cooking the food). DOE noted that the proposal also did not propose test procedures for the type of cooking appliance classified by DOE regulations as a microwave/conventional range, which has separate compartments or components consisting of a microwave oven, a conventional oven, and a conventional cooking top. DOE requested data on the efficiency characteristics of combination ovens in the November 2007 ANOPR, but did not receive any information. DOE also noted in the October 2008 TP NOPR that if this information is made available at a later date, DOE may consider combination ovens in future proceedings. 73 FR 62134, 62137. In response to the October 2008 TP NOPR, interested parties commented that the proposed definition for covered products lacks clarity and is inconsistent with current regulations, and requested clarification on what would be considered covered products.

For the July 2010 TP SNOPR, DOE conducted a survey of microwave oven models currently available on the U.S. market, including countertop, over-the-range, and built-in configurations. DOE determined that fewer than 1 percent of the available models (1 out of 129) have thermal elements for grilling but no convection capability (hereafter referred to as “microwaves with thermal elements only”), while 16 percent (21 out of 129) are combination units (containing microwave, convection, and possibly thermal elements). 75 FR 42612, 42616 DOE stated that, although it does not have shipment-weighted data regarding the percentage of microwave ovens with thermal elements for grilling or combination ovens, DOE does not believe that including microwave ovens with thermal elements only, with or without further specification of the function of the thermal elements, would substantially affect the number or scope of covered products in this rulemaking. Id. DOE proposed to clarify that microwave ovens with thermal elements only would be considered covered products under the definition provided in 10 CFR 430.2. Id. Based on DOE's product literature review for the single available microwave oven with thermal elements only, DOE stated that it believes that the standby and off mode operation for microwave ovens with thermal elements only does not differ from that of microwave-only units. Id.

DOE also proposed to clarify that combination microwave ovens ( i.e., microwave ovens that incorporate convection features and possibly other means of cooking) would be considered covered products under the regulatory definition in 10 CFR 430.2 because they are capable of cooking or heating food by means of microwave energy. 75 FR 42612, 42616-17. As a result, DOE analyzed the features and operation of these products, conducting in-store surveys and product literature reviews, to determine if additional testing procedures would be required that differ from the testing procedures for microwave-only units. Id. DOE stated that combination ovens may have more sophisticated displays and menu screens, as well as additional features associated with active mode operation ( i.e., fans, heater elements, etc.) that may require larger power supplies than a microwave-only unit and therefore may consume more power in standby or off mode. Id. However, DOE also stated that, based on its preliminary analysis, it believes that the general standby and off mode operation for combination microwave ovens does not differ from that of microwave-only units and microwave ovens with thermal elements only. The standby mode operation for combination microwave ovens, as with other types of microwave ovens, consists of an energized display with a clock. Id.

The July 2010 TP SNOPR did not affect DOE's proposal from the October 2008 TP NOPR that the test procedure would cover microwave ovens with and without browning (thermal) elements. Because DOE tentatively determined that the operation in standby and off mode for microwave-only units, microwave ovens with thermal elements only, and combination microwave ovens is the same, DOE proposed that the same test procedure amendments for standby and off mode testing, be used for all of these product types. Id.

In response to the July 2010 TP SNOPR, DOE received multiple comments on its proposed definition of microwave oven for the purpose of determining covered products. Pacific Gas and Electric Company (PG&E), Southern California Gas Company (SCGC), San Diego Gas and Electric (SDG&E), and Southern California Edison (SCE), jointly (hereafter, “the California Utilities”) the American Council for an Energy Efficient Economy (ACEEE) and the Appliance Standards Awareness Project (ASAP), jointly (hereafter, “ACEEE/ASAP Comment”), and the Northwest Energy Efficiency Alliance (NEEA) supported DOE's definition of microwave ovens with or without thermal elements. (ACEEE/ASAP Comment, No. 20 at p. 1; California Utilities, No. 17 at p. 1; NEEA, No. 16 at p. 2) The Association of Home Appliance Manufacturers (AHAM) stated that it opposed the inclusion of thermal elements designed for surface browning of food in the definition of microwave ovens because there is no repeatable and reproducible test procedure for thermal elements. According to AHAM, those units with thermal elements may use different amounts of energy than units with microwave-only capability, and furthermore, there is no definition of “browning”. (AHAM, No. 19 at p. 2)

In today's interim final rule, DOE is adopting provisions to measure the standby mode and off mode energy use of microwave ovens. The energy use of components necessary for any thermal elements, if present, in standby mode and off mode, would be measured under the amended test procedure. DOE is not adopting at this time any measures addressing energy use of microwave ovens in active mode, including the energy required to activate thermal elements. At the time that DOE considers amending the test procedure to include active mode energy use, DOE will evaluate the measurement of thermal element energy consumption, including methodology to account for the usage of such elements ( i.e., surface browning or convection heating). DOE does not believe that the lack of current means to measure active mode energy use in microwave ovens warrants the exclusion of certain products from coverage under the amended test procedure, which is only addressing standby mode and off mode energy use.

DOE also received multiple comments regarding the definition of combination ovens and their inclusion as covered products. AHAM and Whirlpool Corporation (Whirlpool) objected to the definition in the July 2010 TP SNOPR, stating that it is overly broad and that a free-standing range or built-in oven with a microwave component should not be considered as a combination microwave oven. AHAM and Whirlpool requested clarification as to whether a cooking product that utilizes radiant as well as microwave energy would be a covered product. According to Whirlpool, a cooking product which primarily uses radiant heat for cooking and which is supplemented by microwave energy would be covered as a conventional cooking product and thus should not be a covered product for this rulemaking. (AHAM, No. 19 at p. 2; AHAM, Public Meeting Transcript, No. 26 at pp. 25, 30, 37-38; Whirlpool, No. 18 at p. 2; Whirlpool, Public Meeting Transcript, No. 26 at pp. 36-37) GE Consumer and Industrial (GE) commented that the definition of combination microwave oven may not cover future products, and that evaluation of standby power may need to take into account such features as noise suppression and components to support heating elements. (GE, Public Meeting Transcript, No. 26 at pp. 30-31) AHAM and Whirlpool commented that the definition must be made in consideration of future active mode test procedures and energy conservation standards, as well as the current rulemakings addressing standby mode and off mode. AHAM stated that there is no test procedure for a convection microwave oven, and thus would object to combination microwave oven being a covered product for the standby mode and off mode test procedure because of the implications for active mode. According to AHAM, an active mode test procedure is likely to have inherent complexities and not considering active mode in the definition of covered products would only add to those complexities. (AHAM, No. 19 at p. 2; AHAM, Public Meeting Transcript, No. 26 at pp. 26-27, 33-35; Whirlpool, Public Meeting Transcript, No. 26 at p. 36)

The California Utilities, the ACEEE/ASAP Comment, NEEA, and the Natural Resources Defense Council (NRDC) support DOE's definition of combination ovens and their inclusion as covered products. (California Utilities, No. 17 at p. 1; ACEEE/ASAP Comment, No. 20 at p. 1; NEEA, No. 16 at p. 2; NRDC, No. 21 at p. 1) According to the California Utilities, no test data or information has been provided to suggest that combination microwave ovens have additional standby or off mode operations or features that would require separate test procedures to measure these modes. The California Utilities and NEEA stated that combination ovens are a significant and growing share of the overall microwave oven market, and the California Utilities commented that significant energy savings may be achieved by setting energy conservation standards addressing standby mode and off mode energy use for these products. (California Utilities, No. 17 at p. 1; NEEA, No. 16 at p. 2) ACEEE commented that test procedures should cover a broad range of products to support the energy conservation standards rulemaking process. (ACEEE, Public Meeting Transcript, No. 26 at pp. 28-29) NRDC commented that it agreed with DOE's conclusion in the July 2010 TP SNOPR that standby mode and off mode functions do not vary across the scope of covered products and so there is no justification for different standby mode and off mode test procedures. NRDC also stated that the covered products could be categorized as different product classes for the purposes of energy conservation standards or could be the subject of different active mode test procedures. (NRDC, No. 21 at p. 1)

In further considering the definition of combination microwave oven, DOE reiterates, as stated in the October 2008 TP NOPR, that the proposal would exclude as a covered product the type of cooking appliance classified by DOE regulations as a microwave/conventional range, which has separate compartments or components consisting of a microwave oven, a conventional oven, and a conventional cooking top. Therefore, the proposal would exclude a free-standing range with microwave capability. However, DOE does not have information to suggest that a built-in oven, incorporating both radiant elements and microwave capability, is fundamentally different in cooking functions than a countertop or over-the-range cooking product incorporating similar heating components. DOE tests of combination microwave ovens included several built-in models, and DOE did not observe any different standby or off modes as compared to countertop and over-the-range models. Therefore, DOE believes a built-in combination microwave oven would be a covered product for the purposes of this test procedure. DOE based its analysis on products currently available on the market in the United States. DOE is unable to consider testing procedures for future products until it can review details of the technologies, control strategies, and operating modes of any such microwave ovens or combination microwave ovens.

DOE further considered whether the definition of a combination microwave oven as a covered product hinges on which cooking mode ( i.e., radiant heating or microwave energy) is primary. DOE is not aware of any cooking products with both microwave and radiant heating features which cannot be operated in microwave-only mode, nor does DOE have any information to determine consumer usage of microwave cooking as compared to other cooking modes for such products. Thus, DOE believes that all ovens equipped with microwave capability would be considered a covered product for today's interim final rule. DOE will evaluate any differences among microwave ovens and combination microwave ovens, including installation configurations and heating features that may warrant different product classes or energy conservation standards during its microwave oven standards rulemaking.

DOE notes that defining a covered product for the purposes of measuring standby mode and off mode energy use does not require that active mode provisions be specified for that same product. When considering future active mode test procedure amendments, DOE will evaluate the suitability of separate provisions for combination microwave ovens to measure the energy performance of heating components other than the microwave portion.

AHAM noted the difference between countertop and over-the-range microwaves, and stated it was not sure if the difference should be addressed in the test procedure or by the creation of separate product classes in the energy conservation standards rulemaking.

Limited DOE testing of a small sample of over-the-range microwave ovens, as well as more extensive testing of a sample of over-the-range combination microwave ovens did not identify any different standby or off modes as compared to countertop microwave-only units. Thus, DOE determined that the measures it is adopting in today's interim final rule will provide representative measures of standby mode and off mode energy use in countertop and over-the-range configurations of microwave ovens and combination microwave ovens, and is not providing an exclusion for over-the-range units in the definition of covered products. Differences in energy use in these modes between countertop and over-the-range configurations would be evaluated as part of the energy conservation standards rulemaking addressing standby mode and off mode for microwave ovens.

The effective date of the standby and off mode test procedures for microwave ovens is 30 days after the date of publication of today's interim final rule. However, DOE's amended test procedure regulations codified in the CFR clarify that the procedures and calculations adopted in today's interim final rule need not be performed to determine compliance with energy conservation standards, until compliance with any final rule establishing amended energy conservation standards for microwave ovens in standby mode and off mode is required. However, the standby mode and off mode energy consumption test procedures would need to be used by manufacturers for making any representations on standby and off mode power consumption. Specifically, clarification is provided that, as of 180 days after publication of today's interim final rule, any representations as to the standby mode and off mode energy consumption of the products that are the subject of this rulemaking would need to be based upon results generated under the applicable provisions of this test procedure. (42 U.S.C. 6293(c)(2)) In addition, in order to ensure that the amended test procedure adequately addresses the EISA 2007 requirement to consider the most recent version of IEC Standard 62301, and recognizing that the IEC issued IEC Standard 62301 (Second Edition) in January of 2011, DOE is issuing this microwave oven test procedure as an interim final rule and offering an additional 180-day comment period to consider whether any changes should be made to this interim final rule in light of publication of IEC Standard 62301 (Second Edition). DOE will consider these comments and, to the extent necessary, publish a final rulemaking incorporating any changes.

Whirlpool recommended a minimum 3-year lead time between the issue date of a final rule and the compliance date, stating that this time period is necessary to allow for adequate development, testing, and introduction of the new electronic controls that will likely be needed to meet the requirements. (Whirlpool, No. 18 at p. 5) Although Whirlpool did not specify in its comments whether the dates referred to corresponded to the test procedure or energy conservation standards rulemaking, DOE notes that the amended test procedure in today's interim final rule need not be performed by manufacturers until the compliance date of any amended energy conservation standards for microwave ovens addressing standby mode and off mode energy use.

AHAM requested clarification regarding representations of energy use of a microwave oven model on the retail packaging. (AHAM, Public Meeting Transcript, No. 26 at pp. 59-61) As noted above, as of 180 days after publication of today's interim final rule, any representations as to the standby mode and off mode energy consumption of the products that are the subject of this rulemaking would need to be based upon results generated under the applicable provisions of this test procedure. Such representations include those made in writing, including on a label, and in any broadcast advertisement. (42 U.S.C. 6293(c)(1)(B)) Because the provisions adopted in today's interim final rule address microwave oven standby mode and off mode energy use, and because DOE is not adopting measures addressing active mode energy use, representations as to active mode energy use ( e.g., the wattage of the product in cooking mode) are not subject to the requirements of 42 U.S.C. 6293(c)(2).

Historically, DOE's microwave oven test procedure provided for the calculation of several measures of energy consumption, including cooking efficiency, energy factor (EF), and annual energy consumption, and DOE's rulemaking analyses have used EF as the energy conservation metric for microwave ovens. 5

A number of interested parties provided input on the integration of standby and off mode test procedures in response to the October 2008 TP NOPR, in which DOE proposed separate metrics (average standby mode power (P SB ) in watts (W) and average off mode power (P OFF ) in W, distinct from EF) to measure standby mode and off mode power given the measurement variability in the active mode test procedure and related concerns. 73 FR 62134, 62139 (Oct. 17, 2008).

DOE addressed the issues with the cooking efficiency measurement in the July 2010 TP Final Rule and notice announcing a public meeting to discuss the development of new active mode test procedure. 75 FR 42579 (July 22, 2010) and 75 FR 42611 (July 22, 2010), respectively. DOE proposed only to establish the test procedure for microwave ovens to address standby mode and off mode energy consumption. 75 FR 42612, 42618. However, DOE also requested consumer usage data on representative food loads, as well as data indicating how changes to the test load would affect the measured EF and on the repeatability of such test results for consideration in an active mode test procedure rulemaking. Id.

NEEA commented that, although an energy efficiency descriptor for standby mode and/or off mode and a separate energy efficiency descriptor for active cooking mode for microwave ovens is acceptable, it is not strongly supportive of that approach. NEEA stated that it is not troubled by the possibility that standby energy use could reverse the efficiency rankings of some products if a combined active and standby mode energy use descriptor were used. According to NEEA, if standby energy use is a large fraction of a product's annual energy use, then the standby energy's weight in the calculation of an annual energy use descriptor should be relatively large. NEEA also stated that if cooking efficiency results are not meaningful for microwave ovens, then this issue should be addressed in the active mode test procedure and energy conservation standards rulemakings. However, NEEA further stated that the current microwave descriptor is an EF metric, and that the most appropriate measure of standby and off mode energy consumption is annual energy use. For this reason, NEEA commented that not combining these two measures of efficiency is the simplest way to proceed with the microwave oven test procedure rulemaking, and therefore, NEEA accepts DOE's proposal for separate metrics for active mode and standby and off mode energy use. (NEEA, No. 16 at pp. 1-2).

AHAM, GE, and Whirlpool commented that they are unaware of any existing test procedures for measuring active mode energy consumption that are repeatable and reproducible. (AHAM, No. 19 at p. 6; AHAM, Public Meeting Transcript, No. 26 at pp. 58-59; GE, Public Meeting Transcript, No. 26 at p. 61; Whirlpool, No. 18 at p. 2) AHAM also stated that it is unaware of any existing test procedure that has successfully incorporated actual food loads, and if DOE decides to move forward with an active mode test procedure, it should collect data on food loads. Several interested parties provided comments on the methods by which active mode could be tested. (AHAM, No. 19 at p. 6; Whirlpool, No. 18 at p. 2; NRDC, No. 21 at pp. 1-2).

DOE acknowledges these comments, and notes that the absence of active mode provisions results in a de facto separate energy use descriptor for microwave oven standby mode and off mode energy use. The consideration of active mode provisions, including a representative food load, is outside the scope of today's interim final rule, which is addressing only standby mode and off mode energy use. DOE determined it would not be feasible to develop such active mode provisions in a time frame that would allow it to consider an integrated metric for this rulemaking. DOE will consider these comments separately as part of an active mode test procedure rulemaking for microwave ovens, which DOE announced it was considering in the notice of public meeting published in the Federal Register on July 22, 2010. 75 FR 42611.

EPCA, as amended by EISA 2007, requires that DOE consider the most current versions of IEC Standards 62301 and 62087 when amending test procedures to include standby mode and off mode energy consumption. 6 (42 U.S.C. 6295(gg)(2)(A))

DOE noted in the October 2008 TP NOPR that IEC Standard 62301 (First Edition) provides for the measurement of standby power in electrical appliances, including microwave ovens, and thus, is applicable to the proposed amendments to the test procedure. 73 FR 62134, 62139-41 (Oct. 17, 2008). The July 2010 TP SNOPR did not affect DOE's proposal of the clauses from sections 4 and 5 of IEC Standard 62301 (First Edition) ( i.e., paragraphs 4.2, 4.4, 4.5, 5.1 (Note 1), and 5.3) identified in the October 2008 TP NOPR, but proposed to incorporate by reference an additional paragraph of IEC Standard 62301 (First Edition) in response to comments. 75 FR 42612, 42618-19.

Specifically, DOE stated in the July 2010 TP SNOPR that incorporating paragraph 5.2, “Selection and preparation of appliance or equipment,” of IEC Standard 62301 (First Edition) provides clarification to the installation requirements for standby mode and off mode energy consumption testing. DOE also stated that paragraph 5.2 of IEC Standard 62301 (First Edition) provides additional guidance regarding specifications for test setup that would result in a measure of standby and off mode energy consumption that best replicates actual consumer usage. Therefore, DOE proposed in the July 2010 TP SNOPR to incorporate by reference paragraph 5.2 of IEC Standard 62301 (First Edition). 75 FR 42612, 42619.

DOE also noted in the July 2010 TP SNOPR that paragraph 4.3 of IEC Standard 62301 (First Edition) specifies the electrical supply requirements, stating that “where this standard is referenced by an external standard or regulation that specifies a test voltage and frequency, the test voltage and frequency so defined. Where the test voltage and frequency are not defined by an external standard, the test voltage and test frequency shall be * * *” 115 volts (V) ± 1 percent and 60 Hz ± 1 percent for North America. In addition, paragraph 4.3 of IEC Standard 62301 (First Edition) specifies that some single phase voltages can be double the nominal voltage specified for that region, which would result in a voltage requirement of 230V ± 1 percent for North America. DOE stated in the July 2010 TP SNOPR that it believes that the accuracy of the electrical supply, including voltage and frequency, specified in IEC Standard 62301 (First Edition) are generally recognized as suitable for producing robust standby and off mode power measurements in microwave ovens. However, DOE conducted a product literature review to analyze the electrical supply requirements for microwave ovens available on the U.S. market and determined that all microwave ovens specify a rated voltage of 120V or 240V (for a small number of combination microwave ovens) and a frequency of 60 Hertz (Hz). For this reason, DOE proposed in the July 2010 TP SNOPR to specify electrical supply requirements of 120/240 V ± 1 percent and 60 Hz ± 1 percent in section 2.2.1 of the DOE microwave oven test procedure. As noted in paragraph 4.3 of IEC Standard 62301 (First Edition), the proposed voltage requirement of 120/240 V for standby and off mode testing would supersede the requirement of 115/230 V specified in IEC Standard 62301 (First Edition). 75 FR 42612, 42619.

As discussed above in section III.A, because DOE tentatively concluded in the July 2010 TP SNOPR that the operation in standby and off mode is the same for microwave-only units, microwave ovens with thermal elements only, and combination microwave ovens, DOE proposed that the same test procedure amendments for standby and off mode testing discussed in this section be used for all of these product types. 75 FR 42612, 42620.

DOE received comments from interested parties regarding the consideration of IEC Standard 62301 (First Edition) as the most current version according to the EPCA requirement. (42 U.S.C. 6295(gg)(2)(A)) NRDC supports the incorporation of IEC Standard 62301 (without specification of the version) into to the regulations and believes this version is adequate for measuring the standby mode and off mode power of microwave ovens. (NRDC, No. 21 at p. 2) NEEA stated that it supports DOE's use of the most current version of IEC Standard 62301 to the maximum extent possible, especially for definitions and measurement protocols. NEEA commented that it agrees that products that are sold into such a broad variety of international markets should be subject to consistent testing. NEEA also stated, however, that DOE does not make use of the guidance provided in the annexes in IEC Standard 62301, and that DOE should be as specific as possible in adopting or incorporating by reference sections of this IEC standard. (NEEA, No. 16 at p. 3)

AHAM and Whirlpool stated that DOE should use the provisions from the then most recent draft version of IEC Standard 62301 (Second Edition)—IEC Standard 62301 (FDIS)—for optimum international harmonization and to decrease test burden. (AHAM, No. 19 at p. 3, Whirlpool, No. 18 at p. 3) According to AHAM, microwave oven manufacturers build these products for worldwide distribution, requiring that manufacturers have the ability to build one microwave for distribution everywhere. AHAM commented that, while it supports DOE's proposals regarding measurement of standby and off modes, DOE should reference IEC Standard 62301 (FDIS) instead of IEC Standard 62301 (First Edition) or IEC Standard 62301 (CDV), and that IEC Standard 62301 (FDIS) would soon be publicly available and formally adopted by IEC. AHAM stated that the modes and the definitions in the CDV and in the FDIS are essentially the same, but that IEC Standard 62301 (FDIS) contains many new sections that produce more accurate testing and measurements, including new or expanded sections on measurement of power uncertainty, crest factor, power measurement frequency response, sampling methods, average reading methods for non-cyclic loads, and instrument measurement methods. AHAM stated that these provisions are critical for third-party testing and verification testing of the very small amounts of energy use in standby mode. According to AHAM, all other governmental bodies that consider IEC standards are able to reference an FDIS version in their regulations because only grammatical corrections can be made between the FDIS stage and the final version. AHAM noted that IEC Standard 62301 (FDIS) will have to go out to committee members for a vote, but having passed at the CDV stage, AHAM believes IEC Standard 62301 (FDIS) will garner the necessary number of votes to be issued. AHAM further stated that if DOE decides not to incorporate IEC Standard 62301 (FDIS) by reference, it should use its language in full. AHAM does not support incorporation by reference of IEC Standard 62301 (First Edition) combined with only some provisions from IEC Standard 62301 (CDV). AHAM commented that, for example, definitions from IEC Standard 62301 (CDV) do not have the same meaning when combined with provisions from IEC Standard 62301 (First Edition), and that definitions for network mode are not provided in IEC Standard 62301 (First Edition). Finally, AHAM stated that, if DOE chooses neither to incorporate the language of IEC Standard 62301 (FDIS) by reference nor to use its language in full, DOE should incorporate by reference or use the full language of IEC Standard 62301 (CDV). (AHAM, No. 19 at p. 3; AHAM, Public Meeting Transcript, No. 26 at pp. 41-45, 47-49).

IEC published the final version of IEC Standard 62301 (Second Edition) on January 27, 2011. Therefore, the second edition is now available for DOE's consideration or incorporation by reference. DOE is aware that there are significant differences between IEC Standard 62301 (First Edition) and IEC Standard 62301 (FDIS), which was the latest draft version of IEC Standard 62301 (Second Edition) available during the drafting of this interim final rule. For example, IEC Standard 62301 (FDIS) clarifies certain provisions, such as the definition of “standby mode” and “off mode” to allow for the measurement of multiple standby power modes. DOE notes that other significant changes in the methodology were first introduced only at the IEC Standard 62301 (FDIS) stage. These changes have not been the subject of significant comment from interested parties, nor has DOE had the opportunity to conduct a thorough analysis of those provisions. Consequently, the merits of these latest changes have not been fully vetted to demonstrate that they are preferable to the existing methodological provisions in the current version of the IEC standard.

For the reasons discussed in section III.E, DOE did narrowly consider the language from IEC Standard 62301 (FDIS) for mode definitions to address specific concerns raised by interested parties. Given the pending statutory deadline for issuance of a microwave oven standard and the recent adoption of IEC Standard 62301 (Second Edition), DOE has decided to base the test procedure amendments it is adopting in today's interim final rule (other than the mode definitions, which are discussed in section III.E) on the provisions of IEC Standard 62301 (First Edition), but to seek comment on the merits of adopting additional provisions of IEC Standard 62301 (Second Edition).

As noted above, the July 2010 TP SNOPR proposed to incorporate by reference the clauses from sections 4 and 5 of IEC Standard 62301 (First Edition) as proposed in the October 2008 TP NOPR, along with paragraph 5.2. 75 FR 42612, 42618-19. AHAM commented that it supports DOE's proposal to incorporate by reference the electrical supply requirements in paragraph 4.3 and the testing conditions in paragraph 5.2 of IEC Standard 62301 (without specification of the version of this IEC standard). (AHAM, No. 19 at pp. 3-4; AHAM, Public Meeting Transcript, No. 26 at pp. 66, 71-73) AHAM further stated that, in accordance with paragraph 5.2 of IEC Standard 62301 (FDIS), the appliance should be tested at factory or “default” settings, and that where there are no indications for such setting, the appliance should be tested as shipped. (AHAM, No. 19 at p. 4) ACEEE and the California Utilities objected to the proposal to test standby power at the factory or “default” settings. ACEEE asserted that it would allow the potential for “gaming,” by which manufacturers could ship products with settings that use minimal power that consumers could easily switch out of and that therefore these settings would not be representative of typical use. The California Utilities recommended that DOE not incorporate paragraph 5.2 of IEC Standard 62301 because, according to them, there are no data indicating that factory default modes are uniform or typically used by consumers. ACEEE and the California Utilities stated that DOE should require products to be set up for testing with the settings that produce the highest standby power consumption, ensuring that products in the field do not consume more standby power than the tested value. (ACEEE/ASAP, No. 20 at p. 1; California Utilities, No. 17 at p. 2) NEEA stated that section 5.3.1 of IEC Standard 62301 is explicit with regard to getting a repeatable measurement of average power over an extended time period and minimum number of what NEEA termed as “instability cycles,” and that the procedures in section 5 and additional information in annexes A and B of IEC Standard 62301 would be adequate for testing microwave oven standby power, as well as that of most other products. NEEA acknowledged the occasional need for specific testing guidance. According to NEEA, DOE might require the highest display mode power setting to be used during standby measurement, and if DOE does this for one product type, it should impose the same requirement for most other products. In cases where there is only one display mode, NEEA stated that this is not an issue, but for products in which display brightness and metrics can be adjusted by the consumer for other than very short-term use, the highest energy use mode should be tested. NEEA further stated that if these functions automatically revert to a lower power mode in a short time ( i.e., less than one or two minutes), or the functions do not have a higher power consumption mode, then NEEA would support testing in “as-shipped” or “normal” mode. (NEEA, No. 16 at pp. 2-3)

In response, DOE first clarifies that, although it inadvertently stated in the July 2010 TP SNOPR that it was proposing to incorporate by reference two additional clauses from IEC Standard 62301 (First Edition) as compared to the provisions it proposed to incorporate by reference in the October 2008 TP NOPR, it in fact only proposed regulatory language to additionally incorporate by reference paragraph 5.2 in the July 2010 TP SNOPR along with the paragraphs proposed to be incorporated by reference in the October 2008 TP NOPR. In the July 2010 TP SNOPR, DOE also considered incorporating by reference paragraph 4.3 of IEC Standard 62301 (First Edition), but instead proposed voltage requirements that would supersede any requirements that would be imposed by the IEC Standard 62301 (First Edition) provisions. 75 FR 42612, 42619-20.

In considering testing conditions, DOE notes that its test procedures are developed to measure representative energy use for the typical consumer and cannot capture all possible consumer actions and appliance usage patterns that might increase energy use. For example, certain products featuring a display power-down may allow consumers to alter the display settings to increase the amount of time in the high-power state, or to make the high-power state permanent. However, DOE believes in the absence of information indicating otherwise that the typical consumer will not alter the standard or default settings. DOE also did not receive data to support a determination that standby and off mode power measurements made at the highest power settings would be more representative of actual consumer use than measurements using the default settings. Thus, in today's interim final rule, DOE is incorporating by reference section 5.2 of IEC Standard 62301 (First Edition), with the stipulation that standby mode and off mode measurements be made using the “default” or “as-shipped” settings in the absence of specific manufacturer instructions.

DOE did not receive comments on the suitability of incorporating in its microwave oven test procedure the other specific paragraphs for testing conditions and methods from IEC Standard 62301 (First Edition) that were proposed in the July 2010 TP SNOPR. In the absence of any comments objecting to those specific paragraphs, and for the reasons discussed above relating to the current version of IEC Standard 62301, DOE is adopting in today's interim final rule the provisions from IEC Standard 62301 (First Edition) that were proposed in the July 2010 TP SNOPR ( i.e., paragraphs 4.2, 4.4, 4.5, 5.1 (Note 1), and 5.3), along with paragraph 5.2 of IEC Standard 62301 (First Edition).

DOE proposed using the EPCA definitions of “active mode,” “standby mode,” and “off mode” in 42 U.S.C. 6295(gg)(1)(A) in the October 2008 TP NOPR. As discussed in the October 2008 TP NOPR, DOE considers “main functions” for a microwave oven to be those operations in which the magnetron and/or thermal element is energized for at least a portion of the time for purposes of heating, cooking, defrosting the load, or some combination of these. 73 FR 62134, 62141 (Oct. 17, 2008). DOE noted that a microwave oven with a continuously energized display or cooking sensor, or a microwave oven that automatically powers down certain energy-consuming components after a cooking cycle and waits to detect an event to trigger re-energization of these components, would be considered capable of operation in standby mode but not off mode because activation of the higher-power state would be achieved by means of an internal sensor. DOE additionally clarified whether the presence of a manual power on-off switch would be considered to potentially put the microwave oven in standby mode or off mode. DOE noted that if the microwave oven is equipped with a manual power on-off switch, which completely cuts off power to the appliance ( i.e., removes or interrupts all connections to the main power source, in the same manner as unplugging the appliance), the microwave oven would not be in the “off mode” when the switch is in the “off” position. Id.

DOE stated in the July 2010 TP SNOPR that it believes the definitions of standby mode, off mode, and active mode provided in IEC Standard 62301 (CDV), which at that time was the latest draft version, expand upon the EPCA mode definitions and provide additional guidance as to what functions are associated with each mode. DOE also stated that the comments received by IEC on IEC Standard 62301 (CD2), and the resulting amended mode definitions proposed in IEC Standard 62301 (CDV), demonstrate significant participation of interested parties in the development of the best possible definitions. For these reasons, DOE proposed definitions of standby mode, off mode, and active mode based on the definitions provided in IEC Standard 62301 (CDV) in the July 2010 TP SNOPR. DOE stated that it believes that the mode definitions in the draft versions of IEC Standard 62301 (Second Edition) represent a substantial improvement over those in IEC Standard 62301 (First Edition), and represent the best available definitions at this time as confirmed by the review and inputs from interested parties as part of the IEC rulemaking process. DOE also stated in the July 2010 TP SNOPR that it believes that the proposed definitions of standby, off, and active mode would be applied to microwave-only units, microwave ovens with only thermal elements, and combination microwave ovens. 75 FR 42612, 42620-21.

DOE proposed in the July 2010 TP SNOPR to define “standby mode” as the condition in which an energy-using product is connected to a mains power source and offers one or more of the following user oriented or protective functions which may persist for an indefinite time:  7 A remote switch (including a remote control), internal sensor, or timer to facilitate the activation of other modes (including activation or deactivation of active mode); and continuous functions, including information or status displays (including clocks) or sensor-based functions. 75 FR 42612, 42621.

DOE proposed in the July 2010 TP SNOPR an additional clarification for standby mode that continuous clock functions include a timer that operates continuously, provides regular scheduled tasks ( e.g. switching), and may or may not be associated with a display. This definition was developed based on the definitions provided in IEC Standard 62301 (CDV), and expands upon the EPCA mode definitions to provide additional clarifications as to which functions are associated with each mode. Under this definition of standby mode, remote controls and low voltage power supplies for controls, switches, memories, and clocks would be considered as operating in standby mode. Id.

DOE proposed in the July 2010 TP SNOPR to define off mode as the condition in which the energy-using product is connected to a mains power source, is not providing any active or standby mode function, and may persist for an indefinite time. 8 Off mode would also include an indicator that shows the user only that the product is in the off position. Under this proposed definition, an energized LED or other indication that shows the user only that the product is in the off position would be considered part of off mode, provided that no other standby or active mode functions are energized. However, if any energy is consumed by the appliance in the presence of a one-way remote control, the unit would be considered to be operating in standby mode because the remote control would be used to deactivate other mode(s). Electrical leakage and any energy consumed for electrical noise reduction, which are not specifically categorized as standby power functions, would be indicative of off mode. 75 FR 42612, 42622.

As part of the July 2010 TP SNOPR, DOE examined the issue of how to classify a microwave oven that is plugged into the main power supply but is not consuming energy due to the presence of an on/off switch. DOE first reviewed the discussion provided in annex A of IEC Standard 62301 (CDV) and according to section A.2, disconnected mode is included as a mode definition because many products are removed by users from mains power sources for substantial periods of time. DOE interprets this condition to refer to the power cord being unplugged from the power source. Section A.2 further states that “[a] product may have several off modes or it may have no off mode. Switches on products that are labeled as power, on/off, or standby may not reflect the mode classification based on the actual functions active in that mode.” Although this statement does not definitively establish a means by which to treat the presence of a power or on/off switch, DOE infers it to mean that products equipped with such switches can operate in off or standby mode(s) depending on what components may remain energized with the switch in the “off” position. However, the discussion is silent on whether activation of an on/off switch can place the product in disconnected mode. Considering the entirety of section A.2 in total, DOE concluded in the July 2010 TP SNOPR that the disconnected mode for microwave ovens would be associated only with the removal of the power cord from the power source. Based on this review and acknowledging that classification of an on/off switch as operating in off mode in the absence of other energy use associated with standby mode would encourage manufacturers to provide such an energy-saving feature, DOE revised its determination proposed in the October 2008 TP NOPR and tentatively concluded in the July 2010 TP SNOPR that zero energy consumption due to activation of an on/off switch would be indicative of off mode rather than a disconnected mode. Id.

In response to interested parties' question of whether testing would be required for a device with off mode capability even though there is no reporting requirement or standard, DOE noted, in the July 2010 TP SNOPR, that any representations as to the standby and off mode energy consumption for microwave ovens would need to be based upon results generated under the applicable provisions of the test procedure that is the subject of this rulemaking. 75 FR 42612, 42622-23.

Finally, DOE proposed in the July 2010 TP SNOPR to define active mode as the condition in which the energy-using product “is connected to a mains power source, has been activated, and provides one or more main functions,” with the additional clarification that “delay start mode is a “one-off”, user-initiated, short-duration function that is associated with an active mode.” DOE noted that IEC Standard 62301 (CD2) provided additional clarification that “delay start mode is a one off user initiated short duration function that is associated with an active mode.” IEC Standard 62301 (CDV) eliminated this clarification. In response to comments on IEC Standard 62301 (CD2) that led to IEC Standard 62301 (CDV), IEC stated, however, that delay start mode is a “one-off” function of limited duration, which suggests that IEC does not consider it as part of standby mode although no conclusion is made as to whether it would be considered part of active mode. 75 FR 42612, 42623.

DOE tentatively proposed in the July 2010 TP SNOPR to consider delay start mode as part of active mode because it is a condition of finite duration that is user-initiated and uniquely associated with a cooking cycle. DOE determined that cooking or warming food would be considered active mode functions as well.

DOE also noted that section 3.9 of IEC Standard 62301 (CDV) defines disconnected mode as “the status in which all connections to mains power sources of the energy using product are removed or interrupted.” IEC Standard 62301 (CDV) also adds a note that common terms such as “unplugged” or “cut off from mains” also describe this mode and that this mode is not part of the low power mode category. DOE stated in the July 2010 TP SNOPR that it believes that there would be no energy use in a “disconnected mode,” and therefore did not propose a definition or testing methods for such a mode in the DOE test procedure for microwave ovens. Id.

The California Utilities and NRDC support DOE's proposal to adopt the definitions of active, standby, and off modes from IEC Standard 62301 (CDV). (California Utilities, No. 17 at p. 2; NRDC, No. 21 at p. 2) AHAM commented that the mode definitions in IEC Standard 62301 (CDV) and IEC Standard 62301 (FDIS) are not going to vary. AHAM initially stated that DOE should move forward using the definitions that are in IEC Standard 62301 (CDV), but later clarified its statements to recommend that DOE reference IEC Standard 62301 (FDIS) for the mode definitions. Whirlpool also stated that DOE should adopt mode definitions from IEC Standard 62301 (FDIS). (AHAM, No. 19 at p. 4; AHAM, Public Meeting Transcript, No. 26 at p. 45; Whirlpool, No. 18 at p. 3)

DOE has reviewed IEC Standard 62301 (FDIS) and anticipates that the newly finalized IEC Standard 62301 (Second Edition) defines the various modes differently than IEC Standard 62301 (First Edition). IEC Standard 62301 (FDIS) incorporates responses to comments from multiple national committees from member countries on several previous draft versions, and thus, DOE believes it provides the best available mode definitions. DOE has decided to consider the substance of the new operational mode definitions from the draft version IEC Standard 62301 (FDIS). DOE notes that the mode definitions in IEC Standard 62301 (FDIS) are substantively similar to those in the previous draft version (IEC Standard 62301 (CDV)), which were the subject of extensive comments from interested parties, both as noted above and during recent DOE test procedure rulemakings addressing standby mode and off mode energy use in other products ( i.e., clothes dryers and room air conditioners). In those instances, interested parties indicated general support for adopting the mode definitions provided in IEC Standard 62301 (CDV). Due to the effective equivalence of the mode definitions in IEC Standard 62301 (CDV) and IEC Standard 62301 (FDIS), DOE believes the public comment support expressed for the mode definitions in IEC Standard 62301 (CDV) would extend to those in IEC Standard 62301 (FDIS).

AHAM commented that the definition of “standby mode” should include a requirement that all products will default to the product's standby mode as delivered from the factory. According to AHAM and Whirlpool, products may have provisions for the consumer to add or delete product functions that alter the as-shipped energy mode. AHAM stated that the power consumption in these user-selected modes may exceed the power consumption in the lowest power-consumption mode, and that the consumer must be informed as to how to make these selections and that their selection(s) would override the lowest power-consumption mode. (AHAM, No. 19 at p. 4; Whirlpool, No. 18 at p. 3) DOE notes that design and labeling requirements are outside the scope of this test procedure rulemaking, thus DOE is not adopting, in today's interim final rule, any measures specifying the default operation or provisions regarding consumer information, although potential design requirements may be considered in the microwave oven energy conservation standards rulemaking addressing standby mode and off mode energy use. DOE is, however, addressing the settings for standby mode and off mode testing in section III.F of today's interim final rule.

Whirlpool requested clarification on whether the use of an “Energy Save” pushbutton to enter a lower consumption state (such as by turning off a clock) is consistent with the definition of standby mode proposed by DOE, as allowed by the IEC Standard 62301 (FDIS) definition. Whirlpool stated it prefers harmonization wherever practicable. Whirlpool also questioned whether the switch to standby power could be automatic. (Whirlpool, No. 18 at p. 3) DOE agrees that such a pushbutton would be considered an internal sensor that would activate this lower consumption state, which could be considered either another standby mode or an off mode, depending on the components energized. As noted above, DOE is not addressing design requirements as part of this test procedure rulemaking. DOE will consider any such requirements for standby mode and off mode energy use as part of its energy conservation standards rulemaking for microwave ovens.

Whirlpool and AHAM commented that they do not support the inclusion of power consumed by one-way remote controls in the definition of standby mode. (Whirlpool, No. 18 at p. 4; AHAM, No. 19 at p. 5) According to AHAM, although EPCA defines standby mode to include activation by remote control, one-way remotes do not meet the intent of the statute. AHAM and Whirlpool stated that a standard remote, when it powers a product “off”, actually powers the product down, not off, such that it can be turned on again via remote control, and therefore would be classified as consuming standby power. AHAM and Whirlpool contrasted that with a one-way remote that turns the product completely off such that it cannot be turned on again through the use of the remote. Thus, AHAM commented that a one-way remote does not put the product into standby mode and should not be incorporated into standby mode. AHAM noted that there are few, if any, one-way remotes in the United States, but AHAM stated that including one-way remotes as part of off mode rather than standby mode would encourage manufacturers to design products with them and could result in decreased energy use. (AHAM, No. 19 at p. 5; Whirlpool, No. 18 at p. 4)

DOE notes that the definition of standby mode proposed in the July 2010 TP SNOPR states that standby mode includes user-oriented or protective functions to facilitate the activation of other modes (including activation or deactivation of active mode) by remote switch (including remote control), internal sensor, or timer. DOE believes that if the product is consuming energy to power an infrared sensor used to receive signals from a remote control (while not operating in the active mode), such a function would be considered part of standby mode, regardless of whether the remote is classified as “one-way” or “two-way,” because of the function to facilitate the deactivation of another mode by remote switch (including remote control), internal sensor, or timer. However, if a “one-way” remote control powers the product down, including turning off any infrared sensors to receive signals from a remote control, then the product would be operating in the off mode when it is powered down, given that no other standby mode functions within the product are energized.

AHAM also commented that DOE should consider additional provisions from paragraph 3.1 of IEC Standard 62301 (FDIS) that define functions broadly, within which the specific modes are defined. AHAM stated that such additional references are necessary to provide context for the mode definitions. (AHAM, Public Meeting Transcript, No. 26 at pp. 70-71) Paragraph 3.1 of IEC Standard 62301 (FDIS) defines a function as a predetermined operation undertaken by the energy-using product, and would be classified as: (1) A user-oriented secondary function (standby mode); (2) a network-related secondary function (network mode); (3) a primary function (active mode); and (4) other functions. DOE believes that the definitions of standby mode, off mode, and active mode in IEC Standard 62301 (FDIS) sufficiently describe all states of operation which are covered under the EPCA requirements in 42 U.S.C. 6295(gg). As discussed later in this section, DOE is not adopting provisions to measure energy use in network mode. Thus, DOE is not adopting language in today's interim final rule from paragraph 3.1 of IEC Standard 62301 (FDIS).

DOE received several comments on the definition of off mode and the conditions under which a microwave oven would be considered to be in disconnected mode. The California Utilities agreed with DOE's proposal that the disconnected mode for microwave ovens would be associated only with the removal of the power cord from the power source, and that zero energy consumption due to the activation of an on-off switch would be indicative of off mode rather than a disconnected mode. (California Utilities, No. 17 at p. 2) Whirlpool supported DOE's proposed definition of off mode. (Whirlpool, No. 18 at p. 3) GE questioned whether DOE was aware of any studies or information on a 240 volt microwave oven with multiple energy feeds but one on-off switch in the circuitry. (GE, Public Meeting Transcript, No. 26 at p. 83) DOE is not aware of such information, but believes that the provisions it is adopting today for measuring standby mode and off mode energy use would be applicable to a 240 volt microwave oven, regardless of any action of an on-off switch. If, with the switch in the “off” position, any components as described in the definition of standby mode were energized, the microwave oven would be considered to be operating in standby mode.

AHAM commented that it agrees with DOE's proposal that delay start mode should not be considered standby mode, and should instead be considered active mode. AHAM noted that the European Union (EU) also considers delay start mode part of active mode in its regulations. (AHAM, No. 19 at p. 5; AHAM, Public Meeting Transcript, No. 26 at p. 82)

After considering the most current version of IEC Standard 62301 ( i.e., the First Edition) and the draft version of IEC Standard 62301 ( i.e., FDIS), DOE has concluded that the definitions of “standby mode,” “off mode,” and “active mode” provided in IEC Standard 62301 (FDIS) are the most useful, in that they expand upon the EPCA mode definitions and provide additional guidance as to which functions are associated with each mode. Therefore, DOE is adopting definitions of “standby mode,” “off mode,” and “active mode” based on the definitions provided in IEC Standard 62301 (FDIS), as follows:

• “Standby mode” means the product mode where the microwave oven is connected to a mains power source and offers one or more of the following user-oriented or protective functions which usually persist:

• To facilitate the activation of other modes (including activation or deactivation of active mode) by remote switch (including remote control), internal sensor, or timer;

• Continuous function: information or status displays including clocks or sensor-based functions.

DOE is also adopting in its amendments to the test procedure the clarification, provided as a note accompanying the definition of standby mode in IEC Standard 62301 (FDIS), that a timer is a continuous clock function (which may or may not be associated with a display) that provides regular scheduled tasks ( e.g. switching) and that operates on a continuous basis.

• “Off mode” means a product mode where the microwave oven is connected to a mains power source and is not providing any standby mode or active mode function and where the mode usually persists. An indicator that only shows the user that the product is in the off position is included within the classification of off mode.

DOE notes that the definition of off mode in IEC Standard 62301 (FDIS) also includes the qualification that it is not providing any network mode function. However, for the reasons discussed below DOE is not including a definition of network mode in the amended microwave oven test procedure, DOE did not include reference to network mode in the definition of off mode for today's interim final rule.

• “Active mode(s)” means a product mode where the energy-using product is connected to a mains power source and at least one primary function is activated.

Multiple interested parties submitted comments on the possibility of defining an additional “network mode”. The California Utilities, NEEA, and the ACEEE/ASAP Comment commented that DOE should adopt a definition of network mode in the microwave oven test procedure, (California Utilities, No. 17 at p. 2; NEEA, No. 16 at p. 2; ACEEE/ASAP Comment, No. 20 at p. 2) AHAM stated that, although there are not a sufficient number of products currently available on the market from which to gather data regarding network mode, DOE should define a network mode even if it cannot be measured, because leaving it out would hinder manufacturers' development of products with network mode capabilities in the future. In the event DOE decides to address network mode at that time, AHAM stated it would not support including network mode in standby or off mode. According to AHAM, network mode and the energy use associated with “smart” appliances should be treated as a distinct energy use that enhances electrical grid system efficiencies that save energy and reduce carbon emissions. (AHAM, No. 19 at p. 5; AHAM, Public Meeting Transcript, No. 26 at pp. 73-76) The California Utilities stated that manufacturers have noted that they are developing products with networking capability, and that DOE should include the IEC standard definition of network mode in the microwave oven test procedure. The California Utilities also commented that DOE should collect test data from manufacturers of network-equipped products and develop a test procedure that measures energy use in this mode consistently and appropriately. (California Utilities, No. 17 at p. 2) The ACEEE/ASAP Comment expressed concern that, without provisions in the microwave oven test procedure for network mode, manufacturers could develop products that are always in network mode and therefore could be considered to have no standby power consumption. The ACEEE/ASAP Comment also stated that energy use in network mode could be significant. (ACEEE/ASAP Comment, No. 20 at p. 2) NEEA stated that it was unlikely to be Congress' intent to exclude network mode when mandating DOE to establish test procedures and standards for standby mode and off mode energy use for a broad array of products. According to NEEA, even though very few products may have this mode or function built in (or operating) presently, there is no reason to leave this mode out in the test procedure rulemaking, especially since it would be straightforward to include based on the IEC Standard 62301 approach. NEEA commented that if a network mode microprocessor in a home appliance functions as it does in a number of other products, it will spend almost all of its time in its own standby mode and almost no time in its active mode, placing network mode energy use in the same category as a clock or control circuit energy use. NEEA further commented that it is likely that the network mode processor(s) could significantly increase the standby energy use of many products, warranting its inclusion in the microwave oven test procedure. (NEEA, No. 16 at p. 2)

NRDC and Whirlpool do not support including a definition of network mode in the microwave oven test procedure at this time. NRDC stated that it is unaware of what network mode would entail for a microwave oven and that it is skeptical of its potential benefits. According to NRDC, microwave ovens are a convenience product that consumers generally want to use at a certain time when they want food heated quickly. Thus, NRDC stated, it is unlikely that the active mode function would be able to be delayed by a network mode function. NRDC further noted that network mode could be used to power down displays and other standby functions, but questioned whether this function would be accomplished by occupancy sensors or automatic power-down after a certain period of user inactivity. NRDC requested more data on network mode functions and potential benefits in microwave ovens. (NRDC, No. 21 at p. 2) Whirlpool stated that, although network mode will become vital with the future development of “Smart Grid” appliances, such products do not exist today outside of development laboratories. Whirlpool commented that DOE should retain this mode as separate and distinct from other modes, but that DOE should not adopt standards or test procedures for network mode until manufacturers have sufficient quantities of Smart Grid models in production to support comprehensive testing and measurement. (Whirlpool, No. 18 at p. 4)

Section 3.7 of IEC Standard 62301 (FDIS) also defines “network mode” as a mode category that includes “any product modes where the energy using product is connected to a mains power source and at least one network function is activated (such as reactivation via network command or network integrity communication), but where the primary function is not active.” Section 3.7 of IEC Standard 62301 (FDIS) also provides a note, stating that “[w]here a network function is provided but is not active and/or not connected to a network, then this mode is not applicable. A network function could become active intermittently according to a fixed schedule or in response to a network requirement. A `network' in this context includes communication between two or more separate independently powered devices or products. A network does not include one or more controls which are dedicated to a single product. Network mode may include one or more standby functions.”

DOE notes that, in the absence of data on the operation and functionality of network mode, it is unable to define appropriate testing conditions and procedures for accurately measuring the energy use of microwave ovens capable of functioning in network mode. This lack of data also prevents DOE from evaluating how these products will develop in the future. Also, because DOE does not have sufficient data on the operation and functionality of network mode, it is not making a determination as to whether network mode would be included as part of standby or active mode. DOE may consider amendments to the microwave oven test procedure when products capable of functioning in network mode are in production and commercially available. At that time, comprehensive analysis can determine appropriate testing conditions and procedures for accurately measuring network mode and energy use.

DOE noted in the October 2008 TP NOPR that, because IEC Standard 62301 (First Edition) is written to provide a certain degree of flexibility so that the test standard can be used to measure standby mode and off mode power for most household electrical appliances (including microwave ovens), it does not specify the test method for measuring the power consumption in cases in which the measured power is not stable. Section 5.3.2 of IEC Standard 62301 (First Edition) states that “[i]f the power varies over a cycle ( i.e., a regular sequence of power states that occur over several minutes or hours), the period selected to average power or accumulate energy shall be one or more complete cycles in order to get a representative average value.” 73 FR 62134, 62141 (Oct. 17, 2008). For the October 2008 TP NOPR, DOE investigated the possible regular sequences of power states for microwave ovens in order to propose clarifying language to IEC Standard 62301 (First Edition) that would provide accurate and repeatable test measurements. DOE's testing of standby power led it to propose the test period in cases in which the power is not stable as “a 12-hour ± 30-second period” to assure comparable and valid results. Id.

As part of the July 2010 TP SNOPR, DOE investigated test methods to determine standby power over a shorter period than 12 hours. DOE first considered representing the average standby power over a 12-hour cycle by calculating a weighted average of power measurements at 18 different clock display times. This approach was discussed in detail in appendix 5B of the November 2007 ANOPR technical support document (TSD). Using this method, the standby power consumption and line voltage are measured as the clock is cycled through all the possible digit combinations (in terms of active elements) and then a regression analysis is performed to quantify the impact of the number of lit elements (by digit) and voltage on power consumption. The results were then integrated across the number of minutes that each active element combination is “on” through the course of the 12 hours. As noted in chapter 5 of the November 2007 ANOPR TSD, the results for average standby power consumption using the methodology described above produced results that were within 1 to 2 percent of the 12-hour test results. 75 FR 42612, 42624.

For the July 2010 TP SNOPR, DOE also investigated whether a single 10-minute measurement period with a starting clock time of 3:33 would be a reasonable proxy for the 12-hour standby power measurement in the event that power consumption is not stable. DOE analysis indicates that the proportion of time that each possible number of segments in a 7-segment LED display that are lit over the 10-minute time period from 3:33 to 3:42 is representative of the distribution of lit segments over a 12-hour period with an arbitrary starting time and would produce average standby power measurements comparable to those taken over 12 hours. Table 1 shows the comparison of average standby power measured for 11 units in DOE's microwave oven test sample using the 18-point, and 10-minute methodologies as compared to the 12-hour test. Id.

Within DOE's limited test sample, the average standby power measured over the specified 10-minute test period agrees within ±2 percent with average standby power measured over 12 hours. Therefore, DOE tentatively concluded in the July 2010 TP SNOPR that a 10-minute measurement period with a starting time of 3:33 provides a valid measure of standby energy use for those microwave ovens with power consumption varying according to the time displayed on the clock. DOE proposed in the July 2010 TP SNOPR to specify that, for microwave ovens for which standby power consumption is not stable, the clock display shall be set at 3:33 at the conclusion of the stabilization period and the test period shall be 10 minutes. Id.

DOE noted in the July 2010 TP SNOPR that both the 18-point and 10-minute approaches for accelerated standby testing offer the possibility that a microwave oven could be programmed to alter its behavior when such a test is detected in order to minimize measured standby power consumption. For example, a microwave oven could be programmed to turn off its cooking sensors and/or dim its display only during the display times associated with the 18 measurement points or between display times 3:33 and 3:42. 75 FR 42612, 42624-25.

DOE stated in the July 2010 TP SNOPR that the microwave oven test procedure is designed to provide a measurement representative of average consumer use of the product, even if the test conditions and procedures may not be identical to average consumer use ( for example, specified display times). DOE's proposal reflected the statutory requirement, and the Department's longstanding view, that the overall objective of the test procedure is to measure the product's energy consumption during a representative average use cycle or period of use. 42 U.S.C. 6293(b)(3). Further, the test procedure requires specific conditions during testing that are designed to ensure repeatability while avoiding excessive testing burdens. Although certain test conditions specified in the test procedure may deviate from representative use, such deviations are carefully designed and circumscribed in order to attain an overall calculated measurement of the energy consumption during representative use. Thus, it is—and has always been—DOE's view that products should not be designed such that the energy consumption drops during test condition settings in ways that would bias the overall measurement to make it unrepresentative of average consumer use. DOE proposed in the July 2010 TP SNOPR to address this issue through this test procedure and related certification requirements. Accordingly, DOE's proposed language both (1) made explicit in the regulatory text the Department's long held interpretation that the purpose of the test procedure is to measure representative use and (2) proposed a specific mechanism—the waiver process—as a mandatory requirement for all products for which the test procedure would not properly capture the energy consumption during representative use. The language did not identify specific product characteristics that could make the test procedure unsuitable for testing certain products ( e.g. modification of operation based on display time) but rather described such characteristics generally, in order to assure that the language can apply to any potential features that would yield measurements unrepresentative of the product's energy consumption during a representative use cycle.

AHAM commented that DOE's proposal should be clarified to state that the test is to be started when the display is at its lowest power consumption mode. (AHAM, No. 19 at p. 5) Initially, AHAM suggested that the clock display should be set 5 or 10 minutes earlier than 3:33, then wait until the display time reaches 3:33 to start the test period. According to AHAM, this would allow the clock display, which may get brighter when the time is set, to dim and thus reach its low power state before the standby power measurement is made. AHAM stated that this approach would be more representative of actual consumer use. (AHAM, Public Meeting Transcript, No. 26 at pp. 91-93) AHAM clarified its comments to state that the stabilization period should be conditions-based, meaning the clock display would be set to 3:33 minus whatever time it takes for that product to reach its stabilization period. According to AHAM, such an approach would allow each manufacturer to determine the amount of time to subtract with minimal additional test burden, and would produce the most repeatable and reproducible results. AHAM noted that the topic of test stabilization periods is covered in IEC Standard 62301 (FDIS) section 5.3.1 on sampling methods. That section of IEC Standard 62301 (FDIS) is specifically meant to deal with the issue of noncyclical loads or activities where the power is not stable over a period of time. (AHAM, No. 19 at pp. 5-6; AHAM, Public Meeting Transcript, No. 26 at pp. 94-95) Whirlpool commented that it supports a standby power test cycle which after a period of stabilization, begins at a clock display time of 3:33 and extends for 10 minutes. Whirlpool further suggested allowing a 30-minute stabilization period by setting the clock display at 3:03 and initiating the test measurement 30 minutes later (at 3:33), then measuring energy consumption for the 10-minute period. (Whirlpool, No. 18 at p. 4) In addition, AHAM and Whirlpool stated that controls which sense the test procedure and behave differently under those circumstances are not consistent with the intent of the test procedure. According to Whirlpool, such controls should either not be allowed or should require a waiver under which such different behavior is offset. AHAM and Whirlpool requested that, in the event that waivers are sought, DOE should develop a more expedient means of addressing and issuing waivers, as the current process is too long and cumbersome. AHAM further stated that the length of the waiver process delays time to market. (AHAM, No. 19 at p. 6; AHAM, Public Meeting Transcript, No. 26 at pp. 97-98; Whirlpool, No. 18 at p. 4)

The California Utilities commented that it supports the proposed clarification to the test procedure in which DOE specifies a test period of 10 minutes with an initial clock display time of 3:33 for microwave ovens. However, it asked DOE to require this 10-minute test procedure for all microwave ovens, irrespective of whether the standby power consumption is stable. According to the California Utilities, DOE has not clearly defined what constitutes an “unstable” standby power consumption. The California Utilities stated that, to ensure testing and reporting consistency, and in the absence of test data, DOE should require a test cycle of 10 minutes for all microwave ovens. The California Utilities asserted that this clarification that all products be tested for 10 minutes would not substantially add to manufacturer test burden. (California Utilities, No. 17 at pp. 2-3)

NRDC stated that it prefers the 12-hour test cycle methodology, but is open to considering the use of the 10-minute method, as it produces results that are accurate within 2 percent and provides a significantly smaller testing burden for manufacturers. NRDC expressed concern that the 10-minute method does not account for how quickly a microwave oven reaches the “stabilized” standby state, and that the term “stabilization period” is not well defined and needs to be further clarified. NRDC further commented that, if the 10-minute method is used, a maximum time should be allowed for stabilization, to encourage products to reach their lowest power mode quickly. NRDC also stated that it was concerned that, despite the waiver process proposed by DOE, the 10-minute method is inherently more vulnerable to gaming than the 12-hour test cycle. NRDC did not provide suggestions on what measures beyond the proposed waiver could be instated to prevent gaming, but it stated that the concern about potential gaming is secondary to the stabilization concern, and that NRDC would support the 10-minute method as long as the stabilization period is addressed. (NRDC, No. 21 at p. 2)

Section 5.3.1 of IEC Standard 62301 (First Edition) states that, a mode is stable if the measured power varies less than 5 percent over a minimum 5-minute period, after which the power is measured after an additional period of at least 5 minutes. Thus, these provisions would require a total test time of at least 10 minutes. Therefore, DOE believes it is clear what constitutes the test for whether the standby power consumption is stable or unstable.

Upon review of comments from interested parties, DOE concludes that a 12-hour test requirement would represent a significant burden to manufacturers, and that the alternative 10-minute method would minimize additional test burden. DOE agrees, however, that certain microwave oven displays may enter a higher-power state for a short period after the display time is set, after which the power may drop to a lower level that is more representative of actual use. Thus, DOE determined that the display time should be set in advance of the time required at the start of the measurement period, and that a stabilization period in the interim would allow the microwave oven to enter a lower-power state prior to the standby power measurement. DOE does not believe, however, that allowing the manufacturers to individually determine the stabilization period, would optimize the accuracy and repeatability of the test procedure. Based on DOE's testing, which showed that all microwave ovens in its test sample dropped to the lower power state in less than 10 minutes and the fact that a stabilization period of 30 minutes would effectively double the total test time, DOE believes that a requirement to set the display time to 3:23 and allowing a 10-minute stabilization period prior to a 10-minute measurement period would best balance the need for reproducibility of the test procedure with the burden placed on manufacturers.

DOE notes that the microwave oven test procedure is designed to provide an energy efficiency measurement consistent with representative average consumer use of these products, even if the test conditions and/or procedures may not themselves all be representative of average consumer use ( e.g., testing with a display of only 3:33 to 3:42). DOE's amendments reflect the statutory requirement, and the Department's longstanding view, that the overall objective of the test procedure is to measure the product's energy consumption during a representative average use cycle or period of use. (42 U.S.C. 6293(b)(3)) Further, the test procedure requires specific conditions during testing that are designed to ensure repeatability while avoiding excessive testing burdens. Although certain test conditions specified in the test procedure may deviate from representative use, such deviations are carefully designed and circumscribed in order to attain an overall calculated measurement of the energy consumption during representative use. Thus, it is—and has always been—DOE's view that products should not be designed such that the energy consumption drops during test condition settings in ways that would bias the overall measurement, thereby making it unrepresentative of average consumer use. If a manufacturer incorporates a power-saving mode as part of the appliance's routine operation, DOE's test procedure would produce a representative measure of average consumer use if the unit powered down during the 10-minute test period for the same percentage of time that such powering down would be expected to occur during a typical 12-hour period, and thus, such operation would be permissible. It has been the Department's long-held interpretation that the purpose of the test procedure is to measure representative use. Ultimately, if DOE identifies a broad pattern of behavior which has the effect of circumventing its test procedure provisions, the Department may consider reopening the microwave oven test procedure for further rulemaking. DOE also notes it has made improvements in its response time to waiver requests, and will continue to strive for increased efficiency in this regard.

DOE proposed in the October 2008 TP NOPR to change the value of a conversion factor used in the microwave oven active mode calculations to correct an erroneous value. 73 FR 62134, 62141-42 (Oct. 17, 2008). As noted in the July 2010 TP SNOPR (75 FR 42612, 42625), the active mode provisions were removed from the microwave oven test procedure in the July 2010 TP Final Rule. Thus, the need for the technical correction is obviated and no such amendments are adopted in today's interim final rule.

Section 323(b)(3) of EPCA requires that test procedures shall 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. Test procedures must also not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3)).

DOE stated in the October 2008 TP NOPR that it believed that the incorporation of clauses regarding test conditions and methods in IEC Standard 62301 (First Edition), along with the modifications described above, would satisfy this requirement. DOE also noted that the proposed amendments to the DOE test procedure incorporate a test standard that is widely used and accepted internationally to measure power use in standby mode and off mode. Based on DOE testing and analysis of IEC Standard 62301 (First Edition), DOE determined in the October 2008 TP NOPR that the proposed amendments to the microwave oven test procedure produce standby mode and off mode average power consumption measurements that represent an average use cycle both for cases in which the measured power is stable, as well as for when the measured power is unstable ( i.e., varies over a cycle). DOE also stated that because the test methods and equipment that the amendments would require for measuring standby power in microwave ovens do not differ substantially from the test methods and equipment required under the previous test procedure, manufacturers would not be required to make a major investment in test facilities and new equipment. For these reasons, DOE concluded in the October 2008 TP NOPR that the amended test procedure would produce test results that measure the power consumption of a covered product during a representative average use cycle as well as annual energy consumption, and that the test procedure would not be unduly burdensome to conduct. 73 FR 62134, 62142 (Oct. 17, 2008).

Additionally, for reasons similar to those stated above, DOE stated in the July 2010 TP SNOPR that the proposed amendments to measure the standby and off mode power consumption of microwave ovens would not require manufacturers to make major investments in test facilities and new equipment, and would not be unduly burdensome to conduct. DOE proposed a significantly shorter test duration than the 12 hours that was proposed in the October 2008 TP NOPR—a 5-minute stabilization period and a 5-minute or 10-minute test time, depending on whether the standby power consumption is stable. DOE stated in the July 2010 TP SNOPR that it believes that the number of units to be tested, according to the sampling requirements in 10 CFR 430.24(i), is reasonable and, along with the shorter test duration, would not substantially add to manufacturer test burden and would allow manufacturers that conduct quality assurance testing on the production line to continue to do so. 75 FR 42612, 42625.

DOE received comments on manufacturer test burden as discussed above in section III.F, and has determined that, although the test duration is slightly longer than that proposed in the July 2010 TP SNOPR because the initial stabilization period is 10 minutes rather than 5 minutes, the methodology adopted in today's interim final rule is otherwise largely similar and will not be unduly burdensome for manufacturers. DOE also continues to believe that the provisions to measure standby mode and off mode energy use would not require manufacturers to make major investments in test facilities and new equipment.

Today's regulatory action is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). Accordingly, this 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 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 rulemaking process. 68 FR 7990. DOE's procedures and policies may be viewed on the Office of the General Counsel's Web site ( http://www.gc.doe.gov ). DOE reviewed today's interim final rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003.

In conducting this review, DOE first determined the potential number of affected small entities. The Small Business Administration (SBA) considers an entity to be a small business if, together with its affiliates, it employs fewer than the threshold number of workers specified in 13 CFR part 121 according to the North American Industry Classification System (NAICS) codes. The SBA's Table of Size Standards is available at: http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf. The threshold number for NAICS classification 335221, Household Cooking Appliance Manufacturers, which includes microwave oven manufacturers, is 750 employees. DOE surveyed the AHAM member directory to identify manufacturers of microwave ovens. In addition, as part of the appliance standards rulemaking, DOE asked interested parties and AHAM representatives within the microwave oven industry if they were aware of any small business manufacturers. DOE consulted publicly available data, purchased company reports from sources such as Dun & Bradstreet, and contacted manufacturers, where needed, to determine if they meet the SBA's definition of a small business manufacturing facility and have their manufacturing facilities located within the United States. Based on this analysis, DOE understands that only multinational companies with more than 750 employees, and their wholly owned subsidiaries, exist in this industry. As a result, DOE does not expect any small businesses to be impacted by the interim final rule.

For these reasons, DOE concludes that the interim final rule would not have a significant economic impact on a substantial number of small entities, and has sent a certification to this effect to the SBA. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking.

This rule contains a collection-of-information requirement subject to the Paperwork Reduction Act (PRA) which has been approved by OMB under control number 1910-1400. Public reporting burden for compliance reporting for energy and water conservation standards is estimated to average 30 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. Send comments regarding this burden estimate—or any other aspect of this data collection, including suggestions for reducing the burden—to DOE ( see ADDRESSES ) or by e-mail to Christine_J._Kymn@omb.eop.gov.

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 interim final rule, DOE is adopting test procedure amendments that it expects will be used to develop and implement future energy conservation standards for microwave ovens. 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 (42 U.S.C. 4321 et seq. ) and DOE's implementing regulations at 10 CFR part 1021. Specifically, this rule amends an existing rule without changing its environmental effect and, therefore, is covered by the Categorical Exclusion in 10 CFR part 1021, subpart D, paragraph A5. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

Executive Order 13132, “Federalism,” imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. 64 FR 43255 (August 4, 1999). 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 that it will follow in developing such regulations. 65 FR 13735. DOE examined this interim final rule and determined that it would not preempt State law and would not have a substantial direct effect on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to the test procedures that are the subject of today's interim final rule. States can petition DOE for a waiver of such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297) Executive Order 13132 requires no further action.

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 specifies the following: (1) The preemptive effect, if any; (2) any effect on existing Federal law or regulation; (3) a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) the retroactive effect, if any; (5) definitions of key terms; and (6) 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 interim final rule meets the relevant standards of Executive Order 12988.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. For a 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 estimates of the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) 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.” UMRA 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 such governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. (The policy is also available at http://www.gc.doe.gov. ) Today's interim final rule contains neither an intergovernmental mandate nor a mandate that may result in an expenditure of $100 million or more in any year, so these requirements do not apply.

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. Today's interim final rule would have no 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 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 (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 rule and concluded that it is consistent with applicable policies in the OMB and DOE 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 OIRA a Statement of Energy Effects for any significant energy action. The definition of a “significant energy action” is 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 significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use if the regulation is implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. Today's regulatory action is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of OIRA also did not designate the interim final rule as a significant energy action. Therefore, it is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

Under section 301 of the DOE Organization Act (Pub. L. 95-91), DOE must comply with section 32 of the Federal Energy Administration Act of 1974 (Pub. L. 93-275), as amended by the Federal Energy Administration Authorization Act of 1977 (FEAA; Pub. L. 95-70) (15 U.S.C. 788). Section 32 essentially provides that, where a rule authorizes or requires use of commercial standards, the 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 interim final rule incorporates testing methods contained in sections 4 and 5 (paragraphs 4.2, 4.4, 4.5, 5.1 (Note 1), 5.2, and 5.3) of the commercial standard, IEC Standard 62301 (First Edition). DOE has evaluated this standard and is unable to conclude whether it fully complies with the requirements of section 32(b) of the FEAA, i.e., whether it was 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 about the impact on competition of using the methods contained in this standard and will address any concerns when it publishes a response to the public comments on this interim final rule.

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of today's rule before its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 801(2).

DOE will accept comments, data, and information regarding the interim final rule no later than the date provided in the DATES section at the beginning of this rule. Interested parties may submit comments using any of the methods described in the ADDRESSES section at the beginning of this rule.

Submitting comments via regulations.gov. The 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 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 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 below.

DOE processes submissions made through 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 regulations.gov provides after you have successfully uploaded your comment.

Submitting comments via e-mail, hand delivery, or mail. Comments and documents submitted via e-mail, hand delivery, or mail also will be posted to 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, e-mail 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 CD, if feasible. It is not necessary to submit printed copies. No facsimiles (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. According 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 e-mail, 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 e-mail 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).

The Secretary of Energy has approved publication of today's interim final rule.

For the reasons stated in the preamble, part 430 of chapter II of title 10, Code of Federal Regulations, is amended as set forth below:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on December 30, 2010 (75 FR 82335). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 28 products of U.S. registry. We also estimate that it will take about 3 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $100 per product.

Based on these figures, we estimate the cost of this AD to the U.S. operators to be $9,940 or $355 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will 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.

For the reasons discussed above, I certify this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866;

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD Docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

FDA is amending 21 CFR 201.25(d)(2) to update the address for submitting bar code exemption requests to CDER. The new address for these submissions is Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002. This action is being taken to ensure accuracy and clarity in the Agency's regulations.

Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulations provides only technical changes to update an address for submitting bar code exemption requests to CDER.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 201 is amended as follows:

Electronic Access

An electronic copy of this document may be downloaded from the Office of the Federal Register's home page at: http://www.archives.gov and the Government Printing Office's Web page at: http://www.gpoaccess.gov/nara.

This rule makes a technical correction to the regulations that govern the public road mileage for apportionment of highway safety funds. These regulations, found at 23 CFR part 460, were drafted in 1975. The definition of “State” found at 23 CFR 460.2(e) was intended to mirror the definition of “State” for the Highway Safety Program contained in 23 U.S.C. 401. Later, the Surface Transportation and Uniform Relocation Assistance Act of 1987 (Pub. L. 100-17, Apr. 2, 1987, 101 Stat. 132) substituted “American Samoa, and the Commonwealth of the Northern Mariana Islands” for “and American Samoa” in the language found at 23 U.S.C. 401. The regulations were not updated to reflect the change to the statutory definition. While the FHWA has used the definition found at 23 U.S.C. 401, the omission of the Commonwealth of the Northern Mariana Islands could cause confusion. As such, the FHWA is updating the definition of “State” at 460.2(e) to reflect the statutory language of 23 U.S.C. 401.

Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. The FHWA finds that notice and comment for this rule is unnecessary and contrary to the public interest because it will have no substantive impact, is technical in nature, and relates only to management, organization, procedure, and practice. The FHWA does not anticipate receiving meaningful comments on it. States, local governments, and their consultants rely upon the regulations corrected by this action. This correction will reduce confusion for these entities and should not be unnecessarily delayed. Accordingly, for the reasons listed above, the agencies find good cause under 5 U.S.C. 553(b)(3)(B) to waive notice and opportunity for comment.

The FHWA has determined that this action is not a significant regulatory action within the meaning of Executive Order 12866 or significant within the meaning of U.S. Department of Transportation regulatory policies and procedures. It is anticipated that the economic impact of this rulemaking will be minimal. This rule only entails minor corrections that will not in any way alter the regulatory effect of 23 CFR part 460. Thus, this final rule will not adversely affect, in a material way, any sector of the economy. In addition, these changes will not interfere with any action taken or planned by another agency and will not materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs.

In compliance with the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 60l-612) the FHWA has evaluated the effects of this action on small entities and have determined that the action will not have a significant economic impact on a substantial number of small entities. This final rule will not make any substantive changes to our regulations or in the way that our regulations affect small entities; it merely corrects technical errors. For this reason, the FHWA certifies that this action will not have a significant economic impact on a substantial number of small entities.

This rule does not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995, 109 Stat. 48). This rule does not impose any requirements on State, local, or tribal governments, or the private sector and, thus, will not require those entities to expend any funds.

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, and the FHWA has determined that this action does not have sufficient federalism implications to warrant the preparation of a federalism assessment. The FHWA has also determined that this action does not preempt any State law or State regulation or affect the States' ability to discharge traditional State governmental functions.

The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to these programs.

This action does not create any new information collection requirements for which a Paperwork Reduction Act submission to the Office of Management and Budget would be needed under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.

The FHWA has analyzed this action for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4347) and has determined that this action will not have any effect on the quality of the environment.

The FHWA has analyzed this action under Executive Order 13175, dated November 6, 2000, and concluded that this rule will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal government; and will not preempt tribal law. There are no requirements set forth in this rule that directly affect one or more Indian tribes. Therefore, a tribal summary impact statement is not required.

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

Under Executive Order 13045, Protection of Children from Environmental Health and Safety Risks, this final rule is not economically significant and does not involve an environmental risk to health and safety that may disproportionally affect children.

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

This final rule has been analyzed under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The FHWA has determined that it is not a significant energy action under that order because it is not a significant regulatory action under Executive Order 12866 and this final rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RINs contained in the heading of this document can be used to cross reference this action with the Unified Agenda.

In consideration of the foregoing, 23 CFR part 460 is amended as set forth below.

I. Background on the Kentucky Program II. Description of the Amendment III. OSM's Findings IV. Summary and Disposition of Comments V. OSM's Decision VI. Procedural Determinations I. Background on the Kentucky Program

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act * * * and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Kentucky program on May 18, 1982. You can find background information on the Kentucky program, including the Secretary's findings, the disposition of comments, and conditions of approval of the Kentucky program in the May 18, 1982, Federal Register (47 FR 21434). You can also find later actions concerning Kentucky's program and program amendments at 30 CFR 917.11, 917.12, 917.13, 917.15, 917.16, and 917.17.

By letter dated September 14, 2009, Kentucky submitted an amendment to its program (Administrative Record No. 1659), under SMCRA (30 U.S.C. 1201 et seq. ). Kentucky sent the amendment in response to a May 27, 1997, letter (Administrative Record No. KY-1400) that we sent in accordance with 30 CFR 732.17(c) requesting that changes be made in order to be consistent with the Federal regulations. The provisions of Kentucky rules that Kentucky proposed to revise are: Kentucky Administrative Regulations (KAR) No. 405 KAR 16:140 and 405 KAR 18:140 with respect to the disposal of coal mine waste.

We announced receipt of the proposed amendment in the November 27, 2009, Federal Register (74 FR 62266). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting (Administrative Record No. KY-1661). We did not hold a public hearing or meeting because no one requested one. The public comment period ended on December 14, 2009. We did not receive any comments.

Kentucky sent the amendment in response to a May 27, 1997, letter that we sent in accordance with 30 CFR 732.17(c) requesting that changes be made in order to be consistent with the Federal regulations. In that letter, OSM referred to its revised regulations at 30 CFR 816.81 (Surface Mining—Coal mine waste: General Requirements) and 817.81 (Underground Mining—Coal mine waste: General requirements) that required that coal mine waste be “hauled or conveyed” instead of just requiring that it be “placed.” In addition, Kentucky also made changes at its own initiative.

Kentucky proposed to make substantially identical changes to administrative regulations pertaining to surface and underground mining: 405 KAR 16:140 Disposal of Coal Mine Waste (surface mining) and 405 KAR 18:140 Disposal of Coal Mine Waste (underground mining). The text of the Kentucky regulations can be found in the administrative record and online at Regulations.gov

Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment. Any revisions that we do not specifically discuss below concern nonsubstantive wording or editorial changes.

The Federal regulations at 30 CFR 816.81(a) and 817.81(a) state in part that “coal mine waste shall be hauled or conveyed and placed for final placement in a controlled manner.” In 405 KAR 16:140 Section 1 (1) and 18:140 Section 1(1), the phrase “transported and placed,” as it refers to coal mine waste, is replaced by “hauled and conveyed in a controlled (manner)” so that the first sentence of Section 1 of these Kentucky regulations now reads that “All coal mine waste shall be hauled and conveyed in a controlled manner approved by the cabinet in disposal areas approved by the cabinet for this purpose.”

Kentucky's existing regulations at 405 KAR 16:140 Section 1 (1)(a) and 18:140 Section 1 (1)(a) also require that the coal waste disposal area shall be designed, constructed, and maintained in accordance with 405 KAR 16:130 Sections 1 and 2 and 18:130 Sections 1 and 2, respectively. Section 1 of both 405 KAR 16:130 and 18:130 requires among other things that excess spoil, which by definition includes coal mine waste, “shall be placed in designated disposal areas within a permit area, in a controlled manner.” We find that the amended language at 405 KAR 16:140 Section 1 (1) and 18:140 Section 1 (1) read in conjunction with existing language 405 KAR 16:140 Section 1 (1)(a) and 18:140 Section 1 (1)(a) and 405 KAR 16:130 Section 1 (1) and 18:130 Section 1 (1) is no less effective than the counterpart Federal regulations at 30 CFR 816.81(a) and 817.81(a) pertaining to coal mine waste disposal. This constitutes satisfaction of the last coal mine waste issue found in the May 27, 1997, 732 letter.

In Section 2 of 405 KAR 16:140 and 18:140 the Kentucky rules require that either a qualified professional engineer or other qualified person under the direct supervision of the responsible professional engineer must inspect all coal mine waste banks. Kentucky replaced the term “registered professional engineer” with “professional engineer.” Kentucky Revised Statute (KRS) section 322.010 defines “professional engineer” to mean “a person who is a licensed professional engineer by the board.” The board is the State Board of Licensure for Professional Engineers and Land Surveyors. In 1999, Kentucky changed its registration procedures to licensing procedures. See, KRS section 322.015. Kentucky prohibits the practice of engineering or land surveying without a license. KRS 322.020. The Federal regulations at 30 CFR 816.83(d) (Surface Mining—Coal mine waste: Refuse Piles) and 817.83(d) (Underground Mining—Coal mine waste: Refuse Piles) require that a qualified registered professional engineer or other qualified professional specialist under the direction of the professional engineer shall inspect the refuse pile during construction. Both the Federal and Kentucky rules require inspection by an engineer that is approved by an appropriate regulatory body as qualified to be an engineer. Accordingly, we find that the proposed changes to Kentucky regulations are no less effective than the Federal regulations at 30 CFR 816.83(d) and 817.83(d).

Section 6 of 405 KAR 16:140 and 18:140 requires that a qualified professional engineer must prepare a plan for the removal of any burned coal mine waste or other material from the permitted disposal area. Kentucky replaced the term “registered professional engineer” with “professional engineer.” As cited above, KRS section 322.010 defines “professional engineer” to mean “a person who is a licensed professional engineer by the board.” The Federal regulations at 30 CFR 780.14(c) (Surface Mining—Operation plan: Maps and plans) and 784.23(c) (Underground Mining—Operation plan: Maps and plans) require that cross sections, maps, and plans shall be prepared, by or under the direction of, and certified by a qualified registered professional engineer, a professional geologist, etc. Both the Federal and Kentucky rules require plan preparation by an engineer that is approved by an appropriate regulatory body as qualified to be an engineer. Accordingly, we find that the proposed changes to Kentucky regulations are consistent with the Federal regulations at 30 CFR 780.14(c) and 784.23(c).

Throughout the Kentucky regulations, the term “coal processing waste” is replaced by “coal mine waste.” The Federal definition of “coal mine waste” at 30 CFR 701.5 (Definitions) means “coal processing waste and underground development waste.” The Kentucky definitions of coal mine waste at 405 KAR 16:001 (18) and 18:001 (19) define “coal mine waste” as “coal processing waste and underground development waste.” The Federal regulations at 30 CFR 816.81, 817.81, 816.83, and 817.83 use the term “coal mine waste.” Kentucky's regulations at 405 KAR 16:140 and 18:140 also use this term. Since Kentucky defines the term the same as the Federal regulations and appropriately uses the term “coal mine waste” at 405 KAR 16:140 and 18:140, we find the Kentucky proposed language is no less effective than the Federal regulations at 30 CFR 816.81 and 817.81 and 816.83 and 817.83.

We are also revising section 917.16 (Kentucky—Required regulatory program amendments) to correct a codification error which occurred in 2002. The required amendment at 405 KAR 20.060 section 3 (3)(b) was submitted by the State and the OSM approval was published on June 19, 2002, at 67 FR 41622, 41625, but the requirement was not removed from 30 CFR 917.16(d)(5) as it should have been. We are now removing 30 CFR 917.16(d)(5).

We asked for public comments on the amendment (Administrative Record No. 1661), but did not receive any.

Under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Kentucky program (KY-1662). No comments were received.

Under 30 CFR 732.17(h)(11)(i) and (ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ).

None of the provisions that Kentucky proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment.

Based on the above findings, we approve the amendment Kentucky sent to us on September 14, 2009. To implement this decision, we are amending the Federal regulations at 30 CFR part 917 which codify decisions concerning the Kentucky program. Pursuant to 5 U.S.C. 553(d)(3), an agency may, upon a showing of good cause, waive the 30 day delay of the effective date of a substantive rule following publication in the Federal Register , thereby making the final rule effective immediately.

We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Because Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes, making this regulation effective immediately will expedite that process.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule is exempted from review by the Office of Management and Budget under Executive Order 12866.

The Department of the Interior has conducted the reviews required by Section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of Subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under Sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and Section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. The basis for this determination is that our decision is on a State Regulatory program and does not involve a Federal Regulation involving Indian Lands.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of Section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does 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. This determination is based upon the fact that the Kentucky submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the Kentucky submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.

For the reasons set out in the preamble, 30 CFR part 917 is amended as set forth below:

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Louisiana program effective October 10, 1980. You can find background information on the Louisiana program, including the Secretary's findings, the disposition of comments, and the conditions of approval of the Louisiana program in the October 10, 1980, Federal Register (45 FR 67340). You can also find later actions concerning the Louisiana program and program amendments at 30 CFR 918.10, 918.15 and 918.16.

The Abandoned Mine Land Reclamation Program was established by Title IV of the Act in response to concerns over extensive environmental damage caused by past coal mining activities. The program is funded by a reclamation fee collected on each ton of coal that is produced. The money collected is used to finance the reclamation of abandoned coal mines and for other authorized activities. Section 405 of the Act allows States and Indian Tribes to assume exclusive responsibility for reclamation activity within the State or on Indian lands if they develop and submit to the Secretary of the Interior for approval, a program (often referred to as a plan) for the reclamation of abandoned coal mines. On the basis of these criteria, the Secretary of the Interior approved the Louisiana plan on November 10, 1986. You can find background information on the Louisiana plan, including the Secretary's findings, the disposition of comments, and the approval of the plan in the November 10, 1986, Federal Register (51 FR 40795). You can find later actions concerning the Louisiana plan and amendments to the plan at 30 CFR 918.25.

By letter dated March 4, 2010 (Administrative Record No. LA-369), Louisiana sent us an amendment to its program under SMCRA (30 U.S.C. 1201 et seq. ). Louisiana submitted its proposed amendment in response to a September 30, 2009, letter (Administrative Record No. LA-368) that OSM sent to Louisiana in accordance with 30 CFR 732.17(c). Louisiana proposed revisions to the Louisiana Surface Mining Regulations found in the Louisiana Administrative Code, Title 43, Part XV (LAC) concerning definitions; lands eligible for remining; general provisions for review of permit application information and entry of information into AVS; review of applicant, operator, and ownership and control information; review of permit history; review of compliance history; permit eligibility determination; unanticipated events or conditions at remining sites; eligibility for provisionally issued permits; written findings for permit application approval; initial review and finding requirements for improvidently issued permits; suspension or rescission requirements for improvidently issued permits; who may challenge ownership or control listings and findings; how to challenge an ownership or control listing or finding; burden of proof for ownership or control challenges; written agency decision on challenges to ownership or control listings or findings; post-permit issuance requirements for regulatory authorities and other actions based on ownership, control, and violation information; post-permit issuance information requirements for permittees; transfer, assignment, or sale of permit rights; certifying and updating existing permit application information; providing applicant and operator information; providing permit history information; providing violation information; backfilling and grading: previously mined areas; cessation orders; and contractor eligibility.

We announced receipt of the proposed amendment in the September 30, 2010, Federal Register (75 FR 60373). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on November 1, 2010. We did not receive any public comments.

We are approving the amendment as described below. The following are the findings we made concerning the amendments unde SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17, and 30 CFR 884.14 and 884.15.

Louisiana added definitions for Applicant/Violator System or AVS; Knowing or knowingly; Control or controller; Own, owner, or ownership; and Willful or willfully.

We find that Louisiana's new definitions are substantively the same as the counterpart Federal regulations at 30 CFR 701.5. The full text of the new definitions can be found in the administrative record or online at Regulations.gov.

Louisiana deleted the definitions for Knowingly; Owned or Controlled and Owns or Controls; Willfully; and Willful Violation.

We find that these deletions will not make Louisiana's regulations less effective than the Federal counterparts because these definitions were incorporated into other definitions to more closely follow the Federal counterpart. The full text of the deleted definitions can be found in the administrative record or online at Regulations.gov.

Louisiana amended the definition Transfer, Assignment or Sale of Rights from.

We find that Louisiana's new definition is substantively the same as the counterpart Federal regulation at 30 CFR 701.5.

Louisiana added a new definition For Violation, the full text of the new definition can be found in the administrative record or online at Regulations.gov.

We find that Louisiana's new definition is substantively the same as the counterpart Federal regulation at 30 CFR 701.5 with the exception of not including a State counterpart to paragraph (C) related to an alternative bonding system which is not needed since Louisiana does not use an alternative bonding system. We find that this change, including the exception, will not make Louisiana's regulations less effective than the Federal counterpart.

Based on the above findings, we are approving Louisiana's proposed regulations at Section 105, Definitions.

Louisiana added a new section with permitting requirements for lands eligible for remining.

We find that Louisiana's Section 2913 is substantively the same as the counterpart Federal regulation at 30 CFR 785.25. Therefore, we are approving it. The full text of the new section can be found in the administrative record or online at Regulations.gov.

Louisiana added a new paragraph C pertaining to entry of information into AVS.

We find that Louisiana's Section 3113, paragraph C is substantively the same as the counterpart Federal regulation at 30 CFR 773.8. Therefore, we are approving it. The full text of the new paragraph can be found in the administrative record or online at Regulations.gov.

Louisiana added a new paragraph D for the review of applicant, operator, and ownership and control information.

We find that Louisiana's Section 3113, paragraph D is substantively the same as the counterpart Federal regulation at 30 CFR 773.9. Therefore, we are approving it. The full text of the new paragraph can be found in the administrative record or online at Regulations.gov.

Louisiana added a new paragraph E to include provisions for the review of permit history.

We find that Louisiana's Section 3113, paragraph E is substantively the same as the counterpart Federal regulation at 30 CFR 773.10. Therefore, we are approving it. The full text of the new paragraph can be found in the administrative record or online at Regulations.gov.

Louisiana added a new paragraph F to include provisions for the review of compliance history.

We find that Louisiana's Section 3113, paragraph F is substantively the same as the counterpart Federal regulation at 30 CFR 773.11. Therefore, we are approving it. The full text of the new paragraph can be found in the administrative record or online at Regulations.gov.

Louisiana added a new paragraph G pertaining to permit eligibility determinations.

We find that Louisiana's Section 3113, paragraph G is substantively the same as the counterpart Federal regulation at 30 CFR 773.12. Therefore, we are approving it. The full text of the new paragraph can be found in the administrative record or online at Regulations.gov.

Louisiana added a new paragraph H to include provisions for unanticipated events or conditions at remining sites.

We find that Louisiana's Section 3113, paragraph H is substantively the same as the counterpart Federal regulation at 30 CFR 773.13. Therefore, we are approving it. The full text of the new paragraph can be found in the administrative record or online at Regulations.gov.

Louisiana deleted paragraphs C, D, E, and F related to reviews of violations, permit issuance related to correction or appeal of violations, and final compliance reviews.

We find that the deletion of these four paragraphs (C., D., E., and F.) will not make Louisiana's regulations less effective than the Federal counterpart because these were incorporated into new paragraphs to more closely follow the Federal counterpart as listed above. Therefore, we are approving it. The full text of the deleted paragraphs can be found in the administrative record or online at Regulations.gov.

Louisiana added new paragraphs A, B, and C to include requirements for the issuance of a provisional permit when a notice of violation has been issued and the abatement period has yet to expire, or a violation is unabated or uncorrected beyond the abatement or correction period.

We find that Louisiana's Section 3114 is substantively the same as the counterpart Federal regulation at 30 CFR 773.14. Therefore, we are approving it. The full text of the new paragraphs can be found in the administrative record or online at Regulations.gov.

Louisiana added paragraphs A. 17, 18, and 19 for proposed remining operations, permit application requirements, and eligibility requirements.

We find that Louisiana's Section 3115 is no less effective than the counterpart Federal regulation at 30 CFR 773.15. Therefore, we are approving it. The full text of the new paragraphs can be found in the administrative record or online at Regulations.gov.

Louisiana revised this section by deleting the existing paragraphs A, B, and C and replacing them with new paragraphs A, B, C, D, and E for improvidently issued permits.

We find that the deletion of the three paragraphs (A, B, and C) will not make Louisiana's regulations less effective than the Federal counterpart because these were incorporated into new paragraphs (A, B, C, D, and E) to more closely follow the Federal counterparts. We find that Louisiana's new Section 3127 is substantively the same as the counterpart Federal regulation at 30 CFR 773.21. Therefore, we are approving it. The full text of the revised section can be found in the administrative record or online at Regulations.gov.

Louisiana revised this section by adding “Suspension or” to the title and by replacing paragraph A, revising sub-paragraphs of A via several editorial changes, and by adding a new section A. 3 to closely follow 30 CFR 773.23.

We find that Louisiana's Section 3129 closely follows the counterpart Federal regulation at 30 CFR 773.23 and is no less effective. Therefore, we are approving it. The full text of the revised section can be found in the administrative record or online at Regulations.gov.

Louisiana added this new section to establish the requirements of who can challenge a listing or finding of ownership or control.

We find that Louisiana's Section 3131 is substantively the same as the counterpart Federal regulation at 30 CFR 773.25. Therefore, we are approving it. The full text of the new section can be found in the administrative record or online at Regulations.gov.

Louisiana added this new section to provide provisions for the applicant to challenge an ownership or control listing or finding.

We find that Louisiana's Section 3133 is substantively the same as the counterpart Federal regulation at 30 CFR 773.26. Therefore, we are approving it. The full text of the new section can be found in the administrative record or online at Regulations.gov.

Louisiana added this new section to include requirements for meeting the burden of proof by the applicant.

We find that Louisiana's Section 3135 is substantively the same as the counterpart Federal regulation at 30 CFR 773.27. Therefore, we are approving it. The full text of the new section can be found in the administrative record or online at Regulations.gov.

Louisiana added this new section to include requirements for the regulatory authority to review and investigate the evidence and explanatory materials submitted by the applicant when challenging ownership or control listings or findings.

We find that Louisiana's Section 3137 is substantively the same as the counterpart Federal regulation at 30 CFR 773.28. Therefore, we are approving it. The full text of the new section can be found in the administrative record or online at Regulations.gov.

Louisiana amended the wording of this title to read as follows:

We find that Louisiana's title change is substantively the same as the Federal counterpart title for part 774. Therefore, we are approving it.

Louisiana added this new section to include requirements for when the regulatory authority has to enter information into AVS.

We find that Louisiana's Section 3521 is substantively the same as the counterpart Federal regulation at 30 CFR 774.11. Therefore, we are approving it. The full text of the new section can be found in the administrative record or online at Regulations.gov.

Louisiana added this new section to include requirements for the permittee in relation to cessation orders.

We find that Louisiana's Section 3523 is substantively the same as the counterpart Federal regulation at 30 CFR 774.12. Therefore, we are approving it. The full text of the new section can be found in the administrative record or online at Regulations.gov.

Louisiana amended paragraph C.1. by changing a reference to Section 3113.G and 3115.

We find that Louisiana's revision to Section 3517 does not make this section less effective than the counterpart Federal regulations at § 774.17. Therefore, we are approving it. The full text of the revised paragraph can be found in the administrative record or online at Regulations.gov.

Louisiana added this new section to include provisions for updating information contained in AVS.

We find that Louisiana's Section 2304 is substantively the same as the counterpart Federal regulation at 30 CFR 778.9. Therefore, we are approving it. The full text of the new section can be found in the administrative record or online at Regulations.gov.

Louisiana amended paragraphs A.1, 2, 3, and 4 to closely follow 30 CFR 778.11 and 778.12. We find that Louisiana's revision to Section 2305 does not make this section less effective than the counterpart Federal regulations at §§ 778.11 and 778.12. Therefore, we are approving it. The text of the revised paragraphs can be found in the administrative record or online at Regulations.gov.

Louisiana amended paragraphs A.1 and 3 to closely follow 30 CFR 778.14. We find that Louisiana's revision to Section 2307 does not make this section less effective than the counterpart Federal regulations at § 778.14. Therefore, we are approving it. The full text of the revised paragraphs can be found in the administrative record or online at Regulations.gov.

Louisiana added this new section to include requirements for backfilling and grading on remining operations.

We find that Louisiana's Section 5414 is substantively the same as the counterpart Federal regulation at 30 CFR 816.106. Therefore, we are approving it. The full text of the new section can be found in the administrative record or online at Regulations.gov.

Louisiana amended paragraph G to closely follow 30 CFR 843.11. We find that Louisiana's Section 6501 is substantively the same as the counterpart Federal regulation at 30 CFR 843.11. Therefore, we are approving it. The full text of the revised paragraph can be found in the administrative record or online at Regulations.gov.

Louisiana added this new section to include requirements for contractor eligibility to successfully bid for an AML contract.

We find that Louisiana's Section 8509 is substantively the same as the counterpart Federal regulation at 30 CFR 874.16. Therefore, we are approving it. The full text of the new section can be found in the administrative record or online at Regulations.gov.

We asked for public comments on the amendment, but did not receive any.

On April 6, 2010, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Louisiana program (Administrative Record No. LA-369.01). We did not receive any comments.

Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions that Louisiana proposed to make in this amendment pertains to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment. However, on April 6, 2010, under 30 CFR 732.17(h)(11)(i), we requested comments on the amendment from the EPA (Administrative Record No. LA-369.01). The EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On April 6, 2010, we requested comments on Louisiana' amendment (Administrative Record No. LA-369.01), but neither responded to our request.

Based on the above findings, we approve the amendment Louisiana sent us on March 4, 2010.

To implement this decision, we are amending the Federal regulations at 30 CFR part 918, which codify decisions concerning the Louisiana program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this rule effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10) decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. This determination is based on the fact that the Louisiana program does not regulate coal exploration and surface coal mining and reclamation operations on Indian lands. Therefore, the Louisiana program has no effect on Federally-recognized Indian tribes.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does 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. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.

For the reasons set out in the preamble, 30 CFR part 918 is amended as set forth below:

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Montana program on April 1, 1980. You can find background information on the Montana program, including the Secretary's findings, the disposition of comments, and conditions of approval in the April 1, 1980, Federal Register (45 FR 21560). You can also find later actions concerning Montana's program and program amendments at 30 CFR 926.15, 926.16, and 926.30.

By letter dated July 14, 2010, Montana sent us an amendment to its program (Administrative Record Docket ID: OSM-2010-0010) under SMCRA (30 U.S.C. 1201 et seq. ). Montana sent the amendment to include the changes made at its own initiative. The amendment changes a condition for irrevocable letters of credit issued by banks as collateral in order to correct an error in the definition.

Specifically, in ARM 17.24.1109(1)(e)(iii), Montana (1) substitutes “capital stock” for “shareholder equity” to tailor the definition of “total stockholder's equity” to that used by the banking industry; and (2) deletes the criterion to evaluate the financial strength of a bank issuing a letter of credit set forth in ARM 17.24.1109(1)(f). The deletion of requirements in subsection (1)(f) recognizes that credit rating agencies change over time and that not all credit rating agencies use a rating scale that includes a `B+' rating as required by the regulation. In addition, credit rating agencies rate national banks and not state chartered banks. The deletion of subsection (1)(f) now allows qualifying state chartered banks to issue letters of credit as collateral for reclamation bonds. With the deletion of subsection (f), (g) through (j)(iii) will remain the same, but are renumbered (f) through (i)(iii).

We announced receipt of the proposed amendment in the October 5, 2010, Federal Register (Vol. 75, No. 192 FR 61366). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the amendment's adequacy (Administrative Record No. OSM-2010-0010-0004).

We did not receive any comments. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on November 4, 2010.

Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment as described below.

The following are proposed revisions to the Montana regulations that have no corresponding Federal regulation.

Administrative Rules of Montana (ARM) 17.24.1109, BONDING: LETTERS OF CREDIT.

The substitution of the term “capital stock” for “shareholders equity” brings subsection (1)(e)(iii) in line with the standard definition used by the banking and financial institutions.

The deletion of the requirements in subsection (1)(f) recognizes that credit rating agencies change over time and that not all credit rating agencies use a rating scale that includes a B+ rating as required by the regulation. In addition, credit rating agencies rate national banks and not state chartered banks. The deletion of subsection (1)(f) now allows qualifying state chartered banks to issue letters of credit as collateral for reclamation bonds.

We find that Montana's revision of ARM 17.24.1109 BONDING: LETTERS OF CREDIT adds specificity beyond that contained in the Federal regulations and is no less effective. Accordingly, we are approving Montana's revision.

We asked for public comments on the amendment (Administrative Record Docket ID: OSM-2010-0010), but did not receive any.

Under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Montana program (Administrative Record No. OSM-2010-0010-0003), but did not receive any.

Under 30 CFR 732.17(h)(11)(i) and (ii), we are required to get concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ).

We note that none of the proposed changes relate to air or water quality standards. Nevertheless, under 30 CFR 732.17(h)(11)(ii), OSM requested comments on the amendment from EPA (Administrative Record No. OSM-2010-0010-0003). EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On July 26, 2010, we requested comments on Montana's amendment (Administrative Record No. OSM-2010-0010-0003), but neither responded to our request.

Based on the above finding, we approve Montana's July 14, 2010, amendment.

To implement this decision, we are amending the Federal regulations at 30 CFR part 926, which codify decisions concerning the Montana program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrates that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this regulation effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866 (Regulatory Planning and Review).

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally recognized Indian Tribes and have determined that the rule does not have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes. The rule does not involve or affect Indian Tribes in any way.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 CFR U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C) et seq. ).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal, which is the subject of this rule, is based upon Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), of the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million.

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

c. Does 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.

This determination is based upon the fact that the State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose an unfunded Mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.

For the reasons set out in the preamble, 30 CFR part 926 is amended as set forth below:

Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.

This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that certain vessels of the SSN Class are vessels of the Navy which, due to their special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with their special function as naval ships: Rule 21 (a) pertaining to the centerline position of the masthead lights. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on these vessels in a manner differently from that prescribed herein will adversely affect the vessels' ability to perform their military functions.

For the reasons set forth in the preamble, the Navy amends part 706 of title 32 of the CFR as follows:

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

This SUPPLEMENTARY INFORMATION section is arranged as follows:

EPA is determining that the Louisville PM 2.5 annual NAAQS nonattainment area (which includes Jefferson and Bullitt Counties in Kentucky and Clark and Floyd Counties and the Madison Township of Jefferson County in Indiana) has attained the 1997 annual PM 2.5 NAAQS. This determination is based upon complete, quality-assured, and certified ambient air monitoring data for the 2007-2009 monitoring period that show that the area has monitored attainment of the 1997 annual PM 2.5 NAAQS. Preliminary data available for 2010 are consistent with continued attainment.

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 three-year average of annual mean PM 2.5 concentrations. At that time, EPA also established a 24-hour standard of 65 μg/m 3 (today's action does not address the 24-hour standard). 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 Louisville area was designated nonattainment for the 1997 PM 2.5 NAAQS. See 40 CFR 81.315 (Indiana) and 40 CFR 81.318 (Kentucky).

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

In response to legal challenges of the annual standards promulgated in 2006, the U.S. Court of Appeals for the District of Columbia Circuit (DC Circuit) remanded these standards 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 standards are essentially identical, attainment of the 1997 annual standards would also indicate attainment of the remanded 2006 annual standards.

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 standards. This rule, at 40 CFR 51.1004(c), specifies some of the regulatory consequences of attaining the standards, as discussed below.

EPA proposed that the Louisville area (including portions in Indiana and Kentucky) has attained the 1997 PM 2.5 NAAQS. EPA published this proposed determination on September 14, 2010, at 75 FR 55725. Further details regarding the proposal are available in the proposed rule. EPA's proposed action provided a 30-day public comment period. We did not receive any comments.

EPA examined monitoring data for 2010 that are available to date in the EPA Air Quality System (AQS) database, but not yet certified. While these data are insufficient to represent full year average concentrations, all sites within the area average below 15.0 μg/m 3 and thus the available data suggest that this area continues to attain the 1997 annual PM 2.5 NAAQS.

On the basis of this review, EPA has determined that the Louisville area has attained the 1997 annual PM 2.5 NAAQS based on complete, quality-assured and certified 2007-2009 data. Data available for 2010 that are in the EPA AQS database but not yet certified suggest that the area continues to attain the 1997 annual PM 2.5 NAAQS. As a result of this determination, under the provisions of EPA's PM 2.5 implementation rule ( see 40 CFR 51.1004(c)), the requirements for Indiana and Kentucky to submit attainment demonstrations and associated RACM, RFP plans, contingency measures, and any other planning SIPs related to attainment of the 1997 annual PM 2.5 NAAQS for the Louisville PM 2.5 nonattainment area are suspended for so long as the area continues to attain the 1997 annual PM 2.5 NAAQS. This suspension will continue until such time, if any, that EPA subsequently determines that the area has violated the 1997 annual PM 2.5 NAAQS.

If EPA subsequently determines, after notice-and-comment rulemaking in the Federal Register , that the area has violated the 1997 annual PM 2.5 NAAQS, the basis for the suspension of the specific requirements, set forth at 40 CFR 51.1004(c), would no longer exist for the pertinent area, and EPA would take action to withdraw the determination and direct the pertinent area to address the suspended requirements.

The determination that the air quality data show attainment of the 1997 annual PM 2.5 NAAQS is not equivalent to the redesignation of the area to attainment for the 1997 annual PM 2.5 NAAQS under section 107(d)(3) of the Clean Air Act (CAA). Further, finalizing this action does not involve approving maintenance plans for the area as required under section 175A of the CAA, nor does it involve a determination that the area has met all requirements for a redesignation. The designation status of the area will 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 for that standard.

EPA finds that there is good cause for this determination to become effective on the date of publication of this action in the Federal Register , because a delayed effective date is unnecessary due to the nature of the action. The expedited effective date for this action is authorized under both 5 U.S.C. 553(d)(1), which provides that rule actions may become effective less than 30 days after publication if the rule “grants or recognizes an exemption or relieves a restriction,” and 5 U.S.C. 553(d)(3), which allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” As noted above, this determination of attainment will result in a suspension of the requirements for the Louisville area to submit an attainment demonstration, a RFP plan, section 172(c)(9) contingency measures, and any other planning SIPs related to attainment of the 1997 annual PM 2.5 NAAQS for so long as the area continues to attain the PM 2.5 NAAQS. The suspension of these requirements is sufficient reason to allow an expedited effective date of this rule under 5 U.S.C. 553(d)(1). In addition, the suspension of the obligations of Indiana and Kentucky to make submissions for these requirements provides good cause to make this rule effective on the date of publication of this action in the Federal Register , pursuant to 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period prescribed in 5 U.S.C. 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Where, as here, the final rule suspends requirements rather than imposing obligations, affected parties, such as the Louisville area, do not need time to adjust and prepare before the rule takes effect.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action makes a determination based on air quality data and results in the suspension of certain Federal requirements. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule makes a determination based on air quality data, and results in the suspension of certain Federal requirements, it 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).

This rule also does not have tribal applications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely makes a determination based on air quality data and results in the suspension of certain Federal requirements, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks” (62 FR 19885, April 23, 1997) because it determines that air quality in the affected area is meeting Federal standards.

The requirements of 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply because it would be inconsistent with applicable law for EPA, when determining the attainment status of an area, to use voluntary consensus standards in place of promulgated air quality standards and monitoring procedures to otherwise satisfy the provisions of the CAA. This rule does not impose an information collection burden under the provisions of the Paper Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Under Executive Order 12898, EPA finds that this rule, pertaining to the determination of attainment of the fine particle standards for the Louisville (Indiana and Kentucky) area, involves determination of attainment based on air quality data and will not have disproportionately high and adverse human health or environmental effects on any communities in the area, including minority and low-income communities.

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because there is no federally recognized Indian country located in the states, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of these actions must be filed in the United States Court of Appeals for the appropriate circuit by May 9, 2011. Filing a petition for reconsideration by the Administrator of these final rules does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. These actions may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Organization of This Document. The following outline is provided to aid in locating information in the preamble.

On August 20, 2010 (75 FR 51570), EPA issued final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Stationary Reciprocating Internal Combustion Engines (RICE). EPA has subsequently determined, following discussions with affected parties, that the final rule warrants clarification in certain areas. First, certain portions of the operation and maintenance requirements for continuous parameter monitoring systems (CPMS) are unclear. Second, sources asked for guidance regarding the requirement to conduct a temperature measurement calibration check. Finally, EPA is correcting an inadvertent error in the definition for “spark ignition.” This action makes these clarifications and corrects these errors.

EPA is issuing the amendments as a direct final rule, without a prior proposal, because we view the revisions as noncontroversial and anticipate no adverse comment. However, in the Proposed Rules section of this Federal Register notice, EPA is publishing a separate document that will serve as the proposal to amend the RICE NESHAP if significant adverse comments are filed. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. EPA would address all public comments in any subsequent final rule based on the proposed rule.

This direct final rule clarifies the provisions related to the data collection requirements for CPMS. After promulgation of the August 20, 2010, final rule, affected sources indicated that the CPMS operation, maintenance, and data collection requirements in 40 CFR 63.6625(b) were unclear. In particular, sources were not clear about the intent of the requirements for minimum availability of data. This action clarifies those requirements. It specifies that the requirement to monitor operating parameters on a continuous basis applies at all times the process is operating, except for periods of monitoring system malfunctions, repairs associated with monitoring system malfunctions, and required monitoring system quality assurance or quality control activities. This direct final rule also corrects an inadvertent error in the averaging time for the operating parameter data. Paragraph 40 CFR 63.6625(b)(4) required sources to determine a 3-hour block average of the parameter, which was not consistent with the requirements in Table 6 of 40 CFR part 63, subpart ZZZZ to determine a 4-hour rolling average. This action clarifies that sources should determine the 4-hour rolling average as specified in Table 6 to 40 CFR part 63, subpart ZZZZ and removes the reference to a 3-hour block average in 40 CFR 63.6625(b). The operating parameter data should be reduced to 1-hour averages, and the 4-hour rolling average should be determined using the rolling average of the four hourly averages.

Affected sources were also unclear regarding the requirement in 40 CFR 63.6625(k)(4) to conduct a temperature measurement calibration check at least every 3 months, and asked EPA for guidance on appropriate methods for conducting the calibration check. More specifically, sources struggled with the intention of the term “calibration check,” wondering whether classical techniques such as the use of ice and boiling water baths would be the sole acceptable means of demonstrating a “calibration check.” In addition, sources wondered whether just the sensor or the entire system should be subject to a “calibration check.” This action replaces the term “calibration check” with “system accuracy audit” to better reflect EPA's intent. EPA recognizes that there are many ways for a source to demonstrate that its measurement system—as opposed to individual sensors—are producing and should be expected to continue producing valid data, and EPA affords sources the ability to tailor their monitoring plans to accommodate their system accuracy audit preferences. System accuracy audit techniques could include, but are not limited to, the use of redundant sensors or the use of a reference temperature gauge inserted in a thermal well co-located with the CPMS sensor. In both of the examples given above, each sensor would provide an assessment of the other's operation as demonstrated through a comparison of their individual values, and, when coupled with the other parts of a system accuracy audit and approved by EPA, could fulfill the rule requirements. Affected sources also indicated that the requirement to conduct quarterly checks of the temperature measurement device was unreasonable because engines may be located in remote locations that could be difficult for personnel trained in the equipment performance check procedures to reach on a quarterly basis. EPA recognizes that for these sources, the requirement to conduct quarterly checks may be too burdensome given the remote location of the engines, and has determined that annual checks of the temperature measurement device equipment are acceptable for stationary engines to ensure the equipment is producing valid data. EPA therefore is amending the requirement to specify that the temperature measurement device checks must be performed on an annual basis rather than quarterly.

The August 20, 2010, final amendments specified that the engine owner/operator must develop and submit for approval a site-specific monitoring plan for each CPMS. The monitoring plan must address elements of monitoring system design, performance, and data quality assurance and quality control consistent with the general provisions in part 63 and requirements of 40 CFR part 63, subpart ZZZZ. EPA notes that 40 CFR 63.8(f)(4) of the General Provisions allows the source to use the monitoring plan development and approval process to propose and apply alternatives to CPMS quality assurance and quality control requirements identified in the rule.

Affected sources also indicated that there was insufficient time for sources that were already subject to 40 CFR part 63 subpart ZZZZ to comply with the CPMS operation and maintenance requirements established in the August 20, 2010, final rule. EPA agrees that it is appropriate to provide a period of lead time for sources that would have been immediately affected by the new specifications for CPMS operation and maintenance. EPA is therefore amending the final rule to provide an additional 180 days before sources must comply with the CPMS operation and maintenance procedures in 40 CFR 63.6625(b).

This action also corrects an inadvertent error in 40 CFR 63.6603(a), which should have referenced Table 1b to 40 CFR part 63, subpart ZZZZ in addition to Table 2b. Table 1b includes the operating limitation requirements for existing stationary spark ignition four-stroke rich burn engines greater than 500 horsepower (HP) located at area sources of hazardous air pollutants. The introductory text to Tables 1b and 2b should also have contained a reference to 40 CFR 63.6603, and this action corrects that inadvertent error. This action also corrects an inadvertent error in Table 1b to 40 CFR part 63, subpart ZZZZ. The last line of Item 2 in Table 6 should have read “* * * and not using NSCR,” and this action corrects that inadvertent error.

This action also clarifies the initial compliance requirements in Table 5 to 40 CFR part 63, subpart ZZZZ. The table as finalized did not clearly indicate the initial compliance requirements for existing non-emergency stationary engines larger than 500 HP complying with the option to limit the concentration of carbon monoxide (CO) or formaldehyde. The requirements were only shown for existing non-emergency stationary engines larger than 500 HP complying with the option to meet a percent reduction requirement for CO or formaldehyde. The requirements for those engines meeting a concentration limit are the same as those meeting a percent reduction limit, except that for those engines meeting a concentration limit, emissions are not required to be measured at the inlet of the emission control device as well as the outlet. This action also corrects an inadvertent error in Table 6 to 40 CFR part 63, subpart ZZZZ. Item 13.a. in Table 6 should have read “* * * and not using an oxidation catalyst or NSCR,” and this action corrects that inadvertent error.

Finally, this action corrects the definition for “Spark ignition.” The word “with” was inadvertently omitted from the definition, and EPA is amending the definition to insert “with” immediately following the phrase “A gasoline-fueled engine; or any other type of engine. * * *”

Under Executive Order 12866, Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is, therefore, not subject to review by the Office of Management and Budget (OMB). This action is a clarification of and correction to certain text in the final rule and is not a “major rule” as defined by 5 U.S.C. 804(2). However, the final rule promulgated on August 20, 2010, was reviewed by OMB.

This action does not impose any new information collection burden. This action adds clarifications and corrections to the final standards. However, OMB has previously approved the information collection requirements contained in the existing regulation under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-0548. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impact of this rule on small entities, small entity is defined as: (1) A small business as defined by Small Business Administration (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impact of this direct final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small because it does not add any additional regulatory requirements because this action only clarifies the existing compliance requirements and corrects typographical errors.

Title II of the Unfunded Mandates Reform Act (UMRA), 2 U.S.C 1531-1538, requires Federal agencies, unless otherwise prohibited by law, to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Federal agencies must also develop a plan to provide notice to small governments that might be significantly or uniquely affected by any regulatory requirements. The plan must enable officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates and must inform, educate, and advise small governments on compliance with the regulatory requirements.

This direct final rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. Thus, this final rule is not subject to the requirements of section 202 and 205 of the UMRA.

This final action is also not subject to the requirements of section 203 of the UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This final action contains no requirements that apply to such governments, imposes no obligations upon them, and will not result in expenditures by them of $100 million or more in any one year or any disproportionate impacts on them.

Executive Order 13132 (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects 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.”

This direct final rule does not have federalism implications. It will not have substantial direct effects 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, as specified in Executive Order 13132. None of the affected facilities are owned or operated by State governments. Thus, Executive Order 13132 does not apply to these final rules.

Subject to the Executive Order 13175 (65 FR 67249, November 9, 2000) EPA may not issue a regulation that has tribal implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by tribal governments, or EPA consults with tribal officials early in the process of developing the regulation and develops a tribal summary impact statement.

This direct final rule does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. The final rule imposes no new requirements on the one tribally owned facility. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it is based solely on technology performance.

This action is not subject to Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113 (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards (VCS) in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. VCS are technical standards ( e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by VCS bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable VCS.

This action does not involve changes to the technical standards related to test methods or monitoring methods; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply.

Executive Order 12898 (59 FR 7629) (February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

The direct final rule does not involve special consideration of environmental justice-related issues as required by Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), because it does not change any regulatory requirements. This action merely corrects and clarifies existing requirements.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action is effective May 9, 2011.

For the reasons stated in the preamble, title 40, chapter I, part 63 of the Code of Federal Regulations is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0117 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 9, 2011. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0117, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of February 6, 2008 (73 FR 6964) (FRL-8350-9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 7E7241) by Landis International, on behalf of Whitmire Micro-Gen, 3185 Madison Highway, P.O. Box 5126, Valdosta, GA 31603-5126, under docket ID number EPA-HQ-OPP-2008-0040. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of potassium benzoate (Cas No. 582-25-2) when used as an inert ingredient (preservative) in pesticide formulations applied pre- and post-harvest. In the Federal Register of June 4, 2008 (73 FR 31862) (FRL-8365-3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 8E7333) by Landis International, on behalf of Whitmire Micro-Gen, 3185 Madison Highway, P.O. Box 5126, Valdosta, GA 31603-5126, under docket ID number EPA-HQ-OPP-2008-0059. The petition requested that 40 CFR 180.930 be amended by establishing an exemption from the requirement of a tolerance for residues of potassium benzoate (Cas No. 582-25-2) when used as an inert ingredient (preservative) in pesticide formulations applied to animals. Both notices referenced a summary of the petition prepared by Landis International, on behalf of Whitmire Micro-Gen, the petitioner, which is available in the docket, http://www.regulations.gov. Two comments were received in the docket for PP 7E7241, however they are unrelated to potassium benzoate and the Agency believes they were placed in this docket in error by the commenters. There were no comments received in response to the notice of filing for PP 8E7333.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical res idue * * *.”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with section 408(c)(2)(A) of FFDCA, and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for potassium benzoate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with potassium benzoate follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Potassium benzoate is an approved food preservative, similar in structure and reactivity to the more widely used sodium benzoate. Both are classified by the U.S. Food and Drug Administration (FDA) as Generally Recognized as Safe (GRAS). In conducting this assessment, toxicity data on potassium benzoate and the surrogate chemicals sodium benzoate and benzoic acid were used. Both potassium benzoate and sodium benzoate are salts of benzoic acid. Because all benzoates, in particular benzoic acid and sodium benzoate, react similarly to potassium benzoate, they were used as surrogates in the development of this profile.

Available data show that the acute toxicity of potassium benzoate is negligible, having an oral median lethal dose (LD 50 ) of >10,000 milligrams per kilogram body weight (mg/kg/bw). Acute dermal and inhalation toxicity is low as indicated by the >2,000 mg/kg/bw LD 50 and >12.2 milligrams per liter (mg/L) median lethal concentration (LC 50 ) of benzoic acid. Sodium benzoate was not irritating to the skin and induced only slight eye irritation in rabbits. Sodium benzoate and benzoic acid were non-sensitizing in animal tests but showed a very low incidence of sensitization in humans patch tested. Both sodium benzoate and benzoic acid are known to induce non-immunogenic contact reactions, and that is the likely explanation for the low positive response.

Subacute, subchronic and chronic toxicity data also indicate that potassium benzoate should be relatively nontoxic. Available oral and dermal studies had a no-observed-adverse-effect-level (NOAEL) ≥2,000 mg/kg/bw and the inhalation study had a NOAEL >25 milligrams per cubic meter (mg/m 3 ). Sodium benzoate was not carcinogenic in a lifetime mouse feeding study and there is no indication that potassium benzoate should be neurotoxic. Genotoxicity studies indicate the benzoates are not mutagenic; however chromosomal aberration studies gave ambiguous results. Benzoic acid did not induce reproductive toxicity in a 4-generation study. In the human body under normal physiological conditions, potassium benzoate changes from the ionized form to the undissociated benzoic acid. Benzoic acid and its salts are rapidly absorbed by mammals, conjugated with glycine, and rapidly excreted in the urine as hippuric acid. There is no reported accumulation of benzoate in the body. However, the ability to conjugate benzoic acid depends upon adequate liver function and nutritional supply of glycine.

All data indicates that potassium benzoate is relatively non-toxic as are the other benzoates. No toxicity would be expected from potassium benzoate when used at low concentrations in pesticides.

No developmental toxicity studies are available in the database. However, no systemic toxicity was observed at doses up to 750 mg/kg/day, the highest dose tested (HDT), in a 4-generation reproductive study with benzoic acid. In addition, no systemic toxicity was observed in the laboratory animals at high doses >2,000 mg/kg/day of potassium benzoate and benzoates indicating relatively low hazard potential.

Specific information on the studies received and the nature of the adverse effects caused by potassium benzoate as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document “PC Code 709103: Potassium Benzoate (CAS Reg. No. 582-25-2); Human Health Risk Assessment and Ecological Effects Assessment to the Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” page 7 docket ID number EPA-HQ-OPP-2011-0117.

Subacute, subchronic and chronic toxicity data indicate that potassium benzoate is relatively nontoxic. Available oral and dermal toxicity studies had a NOAEL greater than or equal to 2,000 mg/kg/day and the inhalation study had a NOAEL greater than 25 mg/m 3 . Sodium benzoate was not shown to be carcinogenic and there is no indication that potassium benzoate will be neurotoxic. Studies also indicate that benzoates are not mutagenic and benzoic acid did not induce reproductive toxicity in a 4-generation study. Since no toxicity was observed at high doses, quantitative risk assessment is deemed unnecessary.

No hazard was identified for the acute and chronic dietary assessment (food and drinking water), or for the short, intermediate, and long term residential assessments, therefore no aggregate risk assessments were performed. Available toxicological studies indicate lack of systemic toxicity at doses up to 2,000 mg/kg/day. Therefore, no quantitative dietary or occupational and residential risk assessment was conducted.

1. Dietary exposure from food and feed uses and drinking water. In evaluating dietary exposure to potassium benzoate, EPA considered exposure under the proposed exemption from the requirement of a tolerance. Since toxicity was seen only at doses greater than 2,000 mg/kg/day for potassium benzoate, a quantitative exposure assessment for potassium benzoate was not conducted. Any possible dietary exposure to potassium benzoate from its use as an inert ingredient in pesticide products would be through consumption of food to which pesticide products containing it have been applied and possibly through drinking water (from runoff). Metabolism data indicates that potassium benzoate would be rapidly absorbed, metabolized, and excreted.

2. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Potassium benzoate is used in pharmaceuticals and cosmetics. It can also be used in nonfood use pesticide products. Considering the low toxicity of potassium benzoate, residues of concern are not anticipated from residential exposures (inhalation and dermal) and therefore a quantitative aggregate risk assessment was not performed.

3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found potassium benzoate to share a common mechanism of toxicity with any other substances, and potassium benzoate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that potassium benzoate does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

No developmental toxicity studies are available in the database. However, no systemic toxicity was observed at doses up to 750 mg/kg/day in a 4-generation reproductive study with benzoic acid. In addition, no systemic toxicity was observed in the laboratory animals at high doses >2,000 mg/kg/day of potassium benzoate and benzoates indicating relatively low hazard potential. There was no evidence of clinical signs of neurotoxicity, therefore, a developmental neurotoxicity study is not required. In addition, no evidence of immunotoxicity is available in the database, therefore, an immunotoxicity study is not required. In terms of hazard, there are low concerns and low residual uncertainties regarding prenatal and/or postnatal toxicity. Based on this information, there is no concern at this time for increased sensitivity to infants and children to potassium benzoate when used as an inert ingredient in pesticide formulations and a safety factor analysis has not been used to assess risk. For the same reason, EPA has determined that an additional safety factor is not needed to protect the safety of infants and children.

Given the lack of concern for hazard posed by potassium benzoate, EPA concludes that there are no dietary or aggregate dietary/non-dietary risks of concern as a result of exposure to potassium benzoate in food and water or from residential exposure. Residues of concern are not anticipated for dietary exposure (food and drinking water) or for residential exposure (dermal and inhalation) from the use of potassium benzoate as an inert ingredient in pesticide products. As discussed in this unit, EPA expects aggregate exposure to potassium benzoate to pose no appreciable dietary risk given that the data show a lack of any systemic toxicity at doses up to 2,000 mg/kg/day and a lack of any apparent developmental effects.

Taking into consideration all available information on potassium benzoate, EPA has determined that there is a reasonable certainty that no harm to any population subgroup, including infants and children, will result from aggregate exposure to potassium benzoate under reasonably foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.910 for residues of potassium benzoate when used as an inert ingredient in pesticide formulations applied pre- and post-harvest and under 40 CFR 180.930 for residues of potassium benzoate when used as an inert ingredient in pesticide formulations applied to animals, is safe under FFDCA section 408.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for potassium benzoate.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 and 40 CFR 180.930 for potassium benzoate when used as an inert ingredient (preservative) in pesticide formulations applied pre- and post-harvest and applied to animals.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2010-0122 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 9, 2011. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0122, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Registers of September 4, 2009 (74 FR 45848) (FRL-8434-4) and March 19, 2010 (75 FR 13277) (FRL-8813-2), EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 9F7563 and PP 9F7667) by Syngenta Crop Protection, Inc., PO Box 18300, Greensboro, NC 27419-8300. The petitions requested that 40 CFR 180.433 be amended by establishing tolerances for residues of the herbicide fomesafen, 5-[2-cloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide, in or on potato and tomato (PP 9F7563); and pepper (PP 9F7667) at 0.025 parts per million (ppm). Those notices referenced summaries of the petitions prepared by Syngenta Crop Protection, Inc., the registrant, which are available in the dockets, http://www.regulations.gov. There were no comments received in response to the notice of filing of PP 9F7563. Comments were received on the notice of filing of PP 9F7667. EPA's response to these comments is discussed in Unit IV.C.

EPA has revised the proposed tolerance expression and the commodity terms for peppers in accordance with current Agency policy. These revisions are discussed in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fomesafen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fomesafen follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Fomesafen has a low order of acute toxicity by the oral route of exposure, is severely irritating to the eye, and is moderately irritating to the skin. In the subchronic and chronic toxicity studies in rats and mice, food consumption or food efficiency, body weight/body weight gain, and histopathological changes in the liver were the parameters that were most often affected. Dogs and mice also showed hematological changes ( e.g., decreased erythrocyte count, hemoglobin, or hematocrit). There was no evidence of neurotoxicity or immunotoxicity in the toxicological studies with fomesafen. There was no evidence that fomesafen results in increased susceptibility of rat or rabbit fetuses in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

There was no evidence of carcinogenicity in the rat chronic toxicity/carcinogenicity study. Liver tumors were produced in the mouse carcinogenicity study; however, EPA classified fomesafen as “Not Likely to be Carcinogenic to Humans,” based on the weight-of-evidence supporting activation of peroxisome proliferator-activated receptor alpha (PPARα) as the mode of action for fomesafen-induced hepatocarcinogenesis in mice. The data did not support either mutagenesis or cytotoxicity followed by regenerative proliferation as alternative modes of action. While the proposed mode of action for liver tumors in mice is theoretically plausible in humans, it is unlikely to take place in humans based on quantitative species differences in PPARα activation and toxicokinetics. Detailed information on the factors EPA considered in making this determination can be found at http://www.regulations.gov in the document “FOMESAFEN: Second Report of the Cancer Assessment Review Committee” in docket ID number EPA-HQ-OPP-2010-0122.

Specific information on the studies received and the nature of the adverse effects caused by fomesafen as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document “Fomesafen Sodium: Human Health Risk Assessment for the Establishment of Tolerances and Registration of New Uses of Fomesafen Sodium on Potatoes and Peppers,” p. 30 in docket ID number EPA-HQ-OPP-2010-0122.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for fomesafen used for human risk assessment is shown the Table of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fomesafen, EPA considered exposure under the petitioned-for tolerances as well as all existing fomesafen tolerances in 40 CFR 180.433. EPA assessed dietary exposures from fomesafen in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for fomesafen; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, EPA assumed that residues would be present in all commodities at the tolerance level and that 100% of all crops are treated with fomesafen. Dietary Exposure Evaluation Model/Food Commodity Intake Database (DEEM-FCID TM ), Version 2.03, default processing factors were used to determine residues in processed commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fomesafen does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for fomesafen. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used a screening-level water exposure model to estimate residues of fomesafen in surface water. This simulation model, the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), takes into account data on the physical, chemical, and fate/transport characteristics of fomesafen. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

Based on the model results, the estimated drinking water concentration (EDWC) of fomesafen for chronic exposures for non-cancer assessments is estimated to be 10.535 parts per billion (ppb) for surface water.

The Agency estimated residues of fomesafen in ground water based on the results of a prospective ground water monitoring study, submitted by the registrant, Syngenta Crop Protection, Inc. The maximum residue found in the study, which was conducted on a vulnerable North Carolina soil using a soybean cropping system, was 1 ppb, an order of magnitude lower than the modeled estimate for surface water.

The modeled estimate of fomesafen in surface water was used in the dietary exposure analysis and risk assessment for fomesafen in drinking water. For chronic dietary risk assessment, the water concentration of value 10.535 ppb was directly entered into the dietary exposure model to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fomesafen is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Fomesafen is a member of the diphenyl ether chemical family. The common toxicity that these compounds share is induction of liver effects (liver hypertrophy, increase in liver weight, tumors). Members of this class have been shown to induce rodent liver effects/tumors through the activation of the peroxisome proliferator-activated receptor (PPARα). It should be noted that liver hypertrophy and increases in liver weight are part of the range of morphological changes that result from chemically-mediated effects on the PPARα receptor and hepatocarcinogenesis. Although PPARα agonists can induce liver rodent tumors, the potential for PPARα agonists to induce liver tumors in other species, including humans, appears to be unlikely. This is because evidence shows that these other species are quantitatively less sensitive to the effects of PPARα agonism due to toxicodynamic differences between the human and rodent nuclear PPARα receptor. Thus, while this mode of action for liver tumors in rodent is qualitatively possible in humans, it is unlikely to take place in humans based on quantitative species differences in PPARα activation and toxicokinetics. Accordingly, although members of the diphenyl ether family, as well as other classes of compounds, may share a common hepatocarcinogenic mode of action, cumulative exposure to PPARα agonists is unlikely to induce liver carcinogenesis in humans.

For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The pre- and postnatal database for fomesafen includes a prenatal developmental toxicity study in rabbits, two prenatal developmental toxicity studies in rats, and a 2-generation reproduction toxicity study in rats. The rabbit developmental study was classified as unacceptable because of bacterial infection in the colony; however, the study provided information to assess potential developmental toxicity in rabbits. There was no significant difference between the treated and control animals for developmental abnormalities in the rabbit study. In the two rat developmental studies (considered together), developmental effects (postimplantation loss) occurred at the same dose causing maternal toxicity (staining of the ventral fur and significantly decreased body weight gain (>10%)). In the rat reproduction study, offspring effects (increased incidence of liver hyalinization in males) occurred at the same dose causing parental effects (liver histopathology in males and females of both generations).

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings:

i. The toxicity database for fomesafen is largely complete, lacking only immunotoxicity and acute and subchronic neurotoxicity studies. EPA has evaluated the available toxicity data for fomesafen and determined that an additional database uncertainty factor is not needed to account for the lack of these studies. As stated in Unit III.A, fomesafen primarily impacts the parameters of food consumption or food efficiency, body weight/body weight gain, and histopathological changes in the liver. There is no evidence that fomesafen causes immunotoxic or neurotoxic effects in any of the available toxicity studies, and EPA does not believe that conducting immunotoxicity and acute/subchronic neurotoxicity testing will result in a NOAEL less than 0.25 mg/kg/day, which is presently used as the point of departure for chronic risk assessment.

ii. There is no indication that fomesafen is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that fomesafen results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the surface water modeling used to assess exposure to fomesafen in drinking water. These assessments will not underestimate the exposure and risks posed by fomesafen.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, fomesafen is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fomesafen from food and water will utilize 32% of the cPAD for infants, less than 1 year old, the population group receiving the greatest exposure. There are no residential uses for fomesafen.

3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- or intermediate-term residential exposure plus chronic exposure from food and water (considered to be a background exposure level). Short-/intermediate-term adverse effects (hyalinization of hepatocytes, increased eosinophilia, reduced granulation, increased liver weights in males and females, and increases in plasma alkaline phosphatase, alanine transminase and aspartate transaminase in males in the 90-day rat feeding study) were identified; however, fomesafen is not registered for any use patterns that would result in short- or intermediate-term residential exposure. Short- and intermediate-term risks are assessed based on short- or intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for fomesafen.

4. Aggregate cancer risk for U.S. population. As explained in Unit III.A, EPA has concluded that the mode of action for fomesafen-induced hepatocarcinogenesis in mice is unlikely to take place in humans; therefore, fomesafen is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fomesafen residues.

Adequate enforcement methodology (high performance liquid chromatography with tandem mass spectrometry detection (HPLC/MS/MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for fomesafen on pepper, potato, or tomato.

An anonymous citizen objected to the presence of any pesticide residues on food. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned completely. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) contemplates that tolerances greater than zero may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.

In its petition PP 9F7667, the registrant proposed a tolerance of 0.025 ppm for residues of fomesafen in or on the commodity “pepper.” Consistent with recommendations in the Agency's Food and Feed Commodity Vocabulary, EPA is establishing separate tolerances for “pepper, bell” and “pepper, non-bell” at 0.025 ppm each.

EPA is also revising the requested tolerance expression to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be measured. The revised tolerance expression makes clear that the tolerances cover residues of the herbicide fomesafen, including its metabolites and degradates, but that compliance with the tolerance levels is to be determined by measuring only fomesafen, 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide.

Therefore, tolerances are established for residues of fomesafen, including its metabolites and degradates, in or on pepper, bell; pepper, non-bell; potato; and tomato at 0.025 ppm. Compliance with the tolerance levels is to be determined by measuring only fomesafen, 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the national government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

The snapper-grouper fishery of the South Atlantic is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act by regulations at 50 CFR part 622.

The commercial quota for golden tilefish in the South Atlantic is 282,819 lb (128,284 kg) for the current fishing year, January 1 through December 31, 2011, as specified in 50 CFR 622.42(e)(2).

Under 50 CFR 622.43(a), NMFS is required to close the commercial sector for golden tilefish when its quota has been reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial quota for South Atlantic golden tilefish will have been reached by March 9, 2011. Accordingly, the commercial sector for South Atlantic golden tilefish is closed effective 12:01 a.m., local time, March 9, 2011, until 12:01 a.m., local time, January 1, 2012.

The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having golden tilefish onboard must have landed and bartered, traded, or sold such golden tilefish prior to 12:01 a.m., local time, March 9, 2011. During the closure, the bag limit and possession limits specified in 50 CFR 622.39(d)(1)(ii) and (d)(2), respectively, apply to all harvest or possession of golden tilefish in or from the South Atlantic EEZ, and the sale or purchase of golden tilefish taken from the EEZ is prohibited. The prohibition on sale or purchase does not apply to the sale or purchase of golden tilefish that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, March 9, 2011, and were held in cold storage by a dealer or processor. For a person on board a vessel for which a Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued, the sale and purchase provisions of the commercial closure for golden tilefish would apply regardless of whether the fish are harvested in State or Federal waters, as specified in 50 CFR 622.43(a)(5)(ii).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds that the need to immediately implement this action to close the commercial sector for golden tilefish constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure.

Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect the fishery since the capacity of the fishing fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established quota.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.

The snapper-grouper fishery of the South Atlantic is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act by regulations at 50 CFR part 622.

The commercial quota for vermilion snapper in the South Atlantic is 315,523 lb (143,119 kg) for the current fishing period, January 1 through June 30, 2011, as specified in 50 CFR 622.42(e)(4)(i).

Under 50 CFR 622.43(a), NMFS is required to close the commercial sector for vermilion snapper when its quota has been reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial quota for South Atlantic vermilion snapper will have been reached by March 10, 2011. Accordingly, the commercial sector for South Atlantic vermilion snapper is closed effective 12:01 a.m., local time, March 10, 2011, until 12:01 a.m., local time, July 1, 2011.

The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having vermilion snapper onboard must have landed and bartered, traded, or sold such vermilion snapper prior to 12:01 a.m., local time, March 10, 2011. During the closure, the bag limit and possession limits specified in 50 CFR 622.39(d)(1)(v) and (d)(2), respectively, apply to all harvest or possession of vermilion snapper in or from the South Atlantic EEZ, and the sale or purchase of vermilion snapper taken from the EEZ is prohibited. The prohibition on sale or purchase does not apply to the sale or purchase of vermilion snapper that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, March 10, 2011, and were held in cold storage by a dealer or processor. For a person on board a vessel for which a Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued, the sale and purchase provisions of the commercial closure for vermilion snapper would apply regardless of whether the fish are harvested in state or Federal waters, as specified in 50 CFR 622.43(a)(5)(ii).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds that the need to immediately implement this action to close the commercial sector for vermilion snapper constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure.

Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect the fishery since the capacity of the fishing fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established quota.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.

NMFS manages the U.S. groundfish fisheries in the Exclusive Economic Zone of the Bering Sea and Aleutian Islands Management Area under the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP). The North Pacific Fishery Management Council (Council) prepared the FMP under the Magnuson-Stevens Act. Regulations implementing the FMP appear at subpart F of 50 CFR part 679. General regulations that pertain to U.S. fisheries appear at subpart H of 50 CFR part 600.

In October 1998, Congress enacted the American Fisheries Act (AFA), 16 U.S.C. 1851, which “rationalized” the Bering Sea pollock fishery by identifying the vessels and processors eligible to participate in the fishery and allocating pollock among those eligible participants. The AFA allocates 10 percent of the Bering Sea pollock total allowable catch to the Western Alaska Community Development Quota (CDQ) Program. After subtracting the CDQ Program allocation, and an amount set aside for the catch of pollock in other Bering Sea fisheries, the AFA allocates the remaining available pollock quota (the “directed fishing allowance”) among the AFA inshore sector (50 percent), the AFA catcher/processor sector (40 percent), and the AFA mothership sector (10 percent).

The AFA allowed for development of pollock fishing cooperatives in the non-CDQ sectors. Thirteen cooperatives were developed under the AFA: Ten inshore catcher vessel cooperatives, two offshore catcher/processor cooperatives, and one mothership cooperative. After NMFS allocates pollock quota to each of the inshore catcher vessel cooperatives, the cooperatives further subdivide each cooperative's pollock allocation among vessel owners in the cooperative through private contractual agreements. The cooperatives manage these allocations to optimize their harvest and to ensure that individual vessels and companies do not harvest more than their agreed upon share of pollock. The cooperatives also enforce contract provisions and participate in a cooperative agreement to reduce salmon bycatch by the directed pollock fishery.

The regulations establishing the AFA cooperative reporting requirements were published on December 30, 2002 (67 FR 79692). These regulations required that each cooperative prepare preliminary and final annual reports describing the cooperative's harvest of pollock, prohibited species, and non-pollock groundfish, including species for which NMFS establishes annual sideboards that limit incidental catch by AFA participants. The purpose of the annual reports was “to assist the Council and NMFS in meeting the requirements of paragraph 210(a)(1) of the AFA, which requires that NMFS make such information available to the public in a manner that NMFS and the Council decide is appropriate” (67 FR 79692). Another purpose of the AFA cooperative annual report was to provide the Council information upon which it could make decisions on cooperative allocations and sideboard protection measures.

Prior to this action, all AFA cooperatives were required to submit both preliminary and final annual written reports on directed pollock fishing activity to the Council. The preliminary report was due on December 1, one month after the pollock fishery's closure on November 1, while the final report was due on April 1 of the following year. The two reports resulted from the Council's recognition that one month following the fishery's closure may not be enough time for the AFA cooperative representatives to compile all of the required information for the annual report. Requiring cooperatives to file a second report also allowed cooperatives to update catch and bycatch data after the end of the year.

In recent years, the Council has found that the preliminary AFA cooperative report is no longer necessary to develop recommendations on final groundfish specifications or on cooperative allocations and sideboard protection measures. The Council instead uses the Stock Assessment and Fishery Evaluation (SAFE) Reports provided by the Council's Bering Sea and Aleutian Islands Management Area Groundfish Plan Team, and the total allowable catch (TAC) recommendations provided at the December Council meeting to develop these recommendations. The data in the SAFE Reports are more encompassing than the data found in the preliminary AFA cooperative reports.

The SAFE Reports for the groundfish fisheries managed by the Council are compiled by the respective Plan Teams from chapters contributed by scientists at the NMFS Alaska Fisheries Science Center and the Alaska Department of Fish and Game. These SAFE Reports include separate stock assessment and fishery evaluation sections. The stock assessment section includes recommended acceptable biological catch (ABC) levels for each stock and stock complex managed under the FMP. For purposes of determining TACs, the data provided in these reports is a sufficient substitute for that which has been provided by the preliminary reports on the pollock fishery from the cooperatives. The Council considers the ABC recommendations, together with social and economic factors, in determining TACs and other management strategies for the fisheries.

At its June 2010 meeting, the Council determined that, combined with the SAFE Report and TAC recommendations, a single annual report from each AFA cooperative, renamed the “annual AFA cooperative report,” will provide sufficient information to the Council, the industry, and the public about the directed fisheries for pollock in the Bering Sea. Under this rule, the cooperatives will be required to submit one report containing the same information previously contained in two reports.

Each AFA cooperative annual report will continue to be required to provide the following information:

• How the cooperative allocated pollock, other groundfish species, and prohibited species catch among the vessels in the cooperative;

• The catch and discard of these species by area for each vessel in the cooperative;

• How the cooperative monitored fisheries in which its members participate;

• A description of any actions taken by the cooperative in response to any vessel that exceeded the allocations made to the vessel by the cooperative;

• The total weight of pollock landed outside the State of Alaska on a vessel-by-vessel basis; and

• The number of salmon taken by species and season, and list each vessel's number of appearances on the weekly dirty 20 lists for non-Chinook salmon.

This action does not result in a substantial change in the reporting requirements. Some decrease in miscellaneous costs might occur due to postage cost differences. It is also possible that the burden will decrease due to planning and writing of one report instead of two reports, one revising the other.

NMFS published the proposed rule for this action in the Federal Register on December 20, 2010 (75 FR 79330), with a public comment period that closed January 4, 2011. No comments were received during this comment period.

NMFS made the following change from the proposed rule to the final rule. In the final rule, NMFS changes the proposed report submittal language at § 679.61(f)(1) to maintain the regulatory language currently in use. The proposed rule stated “Annual reports must be postmarked or received by the submission deadline.” This text is revised to read “Annual reports must be postmarked by the submission deadline or received by a private courier service by the submission deadline.”

This change gives equal treatment to cooperatives that send the annual report via postal service and those that send the report via private courier. As compared to the proposed rule, the final rule allows a cooperative that uses a private courier service a small amount of additional time to complete and send the report; however, this change does not necessarily delay the Council's receipt of the report or its availability to the public.

The NMFS Assistant Administrator for Fisheries has determined that this rule is necessary for the conservation and management of the Bering Sea and Aleutian Islands groundfish fisheries and that it is consistent with the FMP, the national standards, and other provisions of the Magnuson-Stevens Act and other applicable laws.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action will not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here.

No comments were received regarding this certification, and no changes have been made from the proposed rule. As a result, a regulatory flexibility analysis was not required and none was prepared.

This action will not increase recordkeeping and reporting costs.

This rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA), and which have been approved by the Office of Management and Budget (OMB) under OMB Control Number 0648-0401.

Public reporting burden per response is estimated to average 8 hours for an AFA preliminary annual report and 4 hours for an AFA final annual report under old requirements. This rule removes the AFA preliminary annual report and renames the AFA final annual report as the AFA cooperative annual report, which is estimated to average 8 hours per response. This rule reduces the reporting burden without imposing any new, additional reporting burden.

These estimates of public reporting burden include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection-of-information.

Send comments regarding this burden estimate or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS ( see ADDRESSES ); e-mail to OIRA_Submission@omb.eop.gov or fax to 202-395-7285.

Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to 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.

For the reasons set out in the preamble, 50 CFR part 679 is amended as follows: