This final rule incorporates by reference into part 430 the following industry standards:

(1) ANSI C78.81-2010, American National Standard for Electric Lamps—Double-Capped Fluorescent Lamps—Dimensional and Electrical Characteristics, approved January 14, 2010; IBR approved for Appendix Q and Appendix Q1 to Subpart B.

(2) ANSI C82.1-2004 (“ANSI C82.1”), American National Standard for Lamp Ballast—Line-Frequency Fluorescent Lamp Ballast, approved November 19, 2004; IBR approved for Appendix Q and Appendix Q1 to Subpart B.

(3) ANSI C82.11 Consolidated-2002 (“ANSI C82.11”), American National Standard for Lamp Ballasts—High-frequency Fluorescent Lamp Ballasts—Supplements, approved March 11, 1999, August 5, 1999 and January 17, 2002; IBR approved for Appendix Q and Appendix Q1 to Subpart B.

(4) ANSI C82.13-2002 (“ANSI C82.13”), American National Standard for Lamp Ballasts—Definitions for Fluorescent Lamps and Ballasts, approved July 23, 2002; IBR approved for Appendix Q and Appendix Q1 to Subpart B.

These standards are available athttp://webstore.ansi.org/.You can also view copies of these standards at the U.S. Department of Energy, Resource Room of the Building Technologies Program, 950 L'Enfant Plaza, SW., 6th Floor, Washington, DC 20024, (202) 586-2945, between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

Title III of the Energy Policy and Conservation Act (42 U.S.C. 6291,et seq.;“EPCA” or, “the Act”) sets forth a variety of provisions designed to improve energy efficiency. (All references to EPCA refer to the statute as amended through the Energy Independence and Security Act of 2007 (EISA 2007), Pub. L. 110-140 (Dec. 19, 2007)). Part B of title III (42 U.S.C. 6291-6309), which was re-designated as Part A on codification in the U.S. Code for editorial reasons, establishes the “Energy Conservation Program for Consumer Products Other Than Automobiles.” These include fluorescent lamp ballasts, the subject of today's notice. (42 U.S.C. 6291(1), (2) and 6292(a)(13))

Under EPCA, this program consists essentially of three parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. The testing requirements consist of test procedures that manufacturers of covered products must use (1) as the basis for certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA, and (2) for making representations about the efficiency of those products. Similarly, DOE must use these test requirements to determine whether the products comply with any relevant standards promulgated under EPCA.

The Energy Independence and Security Act of 2007 also amended EPCA to require DOE to review test procedures for all covered products at least once every seven years. DOE must either amend the test procedures or publish notice in theFederal Registerof any determination not to amend a test procedure. (42 U.S.C. 6293(b)(1)(A)) To fulfill this periodic review requirement, DOE invited comment on all aspects of the existing test procedures for fluorescent lamp ballasts that appear at Title 10 of the CFR part 430, Subpart B, Appendix Q (“Uniform Test Method for Measuring the Energy Consumption of Fluorescent Lamp Ballasts”).

In a separate rulemaking proceeding, DOE is considering amending energy conservation standards for fluorescent lamp ballasts (docket number EERE-2007-BT-STD- 0016; hereinafter referred to as the “standards rulemaking”). DOE initiated that rulemaking by publishing aFederal Register(FR) notice announcing a public meeting and availability of the framework document (“Energy Efficiency Program for Consumer Products: Public Meeting and Availability of the Framework Document for Fluorescent Lamp Ballasts”) on January 22, 2008. 73 FR 3653. On February 6, 2008, DOE held a public meeting in Washington, DC to discuss the framework document for the standards rulemaking (hereinafter referred to as the “2008 public meeting”). At that meeting, attendees also discussed potential revisions to the test procedure for active mode energy consumption relevant to this test procedure rulemaking. On March 24, 2010, DOE published a notice of public meeting and availability of the preliminary technical support document (TSD) for the standards rulemaking. 75 FR 14319. On April 26, 2010, DOE held a public meeting to discuss the standards preliminary analysis and the proposed test procedure discussed below. On April 11, 2011, DOE published a notice of public rulemaking (NOPR) for the fluorescent lamp ballast standards rulemaking. 76 FR 20090.

For the test procedure, DOE published a NOPR on March 24, 2010. 75 FR 14288. As indicated above, on April 26, 2010, DOE held a public meeting to discuss the test procedure proposals in the NOPR and the preliminary TSD for the standards rulemaking (hereafter “NOPR public meeting”). DOE modified the test procedure based on the comments it received on the NOPR. On November 24, 2010, DOE published a test procedure supplemental notice of proposed rulemaking (SNOPR). 75 FR 71570. All comments on the fluorescent lamp ballast test procedure SNOPR are discussed in section III of this rulemaking.

As discussed in the SNOPR, DOE has also established a standby mode and off mode test procedure. The Energy Independence and Security Act of 2007 (Pub. L. 110-140) amended EPCA to require that, for each covered product for which DOE's current test procedures do not fully account for standby mode and off mode energy consumption, DOE amend the test procedures to include standby mode and off mode energy consumption into the overall energy efficiency, energy consumption, or other energy descriptor for that product. If an integrated test procedure 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)) DOE published a final rule addressing standby mode and off mode energy consumption for fluorescent lamp ballasts in theFederal Registeron October 22, 2009. 74 FR 54445. This final rulemaking does not include any changes to the measurement of standby and off mode energy consumption for fluorescent lamp ballasts.

Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. EPCA requires that any test procedures prescribed or amended under this section be reasonably designed to produce test results that 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. Test procedures must also not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6293(b)(2)) Finally, in any rulemaking to amend a test procedure, DOE must determine whether 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. (42 U.S.C. 6293(e)(2)).

In today's final rule, DOE institutes a new test procedure that measures a different metric than the test procedure at Appendix Q. The new metric is the BLE metric described in section III.B.1. The new test procedure will be used only with any standards developed orrevised using data collected with the new test procedure.

In this test procedure final rule, DOE amends the current procedures for fluorescent lamp ballasts to reduce measurement variation and testing burden. These changes eliminate photometric measurements and prescribe the use of electrical measurements of a lamp-and-ballast system. In addition, this test procedure measures a new metric, ballast luminous efficiency (BLE), which more directly assesses the electrical losses in a ballast compared to the existing ballast efficacy factor (BEF) metric. DOE also establishes a minor update to the existing test procedure in appendix Q. The following paragraphs summarize these changes.

In the SNOPR, DOE proposed to measure ballast input power and lamp arc power using only electrical measurements of a lamp-and-ballast system. Variation in the measured power of a reference lamp was minimized by the calculation of ballast luminous efficiency, where BLE was equal to total lamp arc power divided by ballast input power. This proposal remains unchanged in this final rule. To account for the increase in lamp efficacy associated with high-frequency lamp operation versus low-frequency, DOE also proposed an adjustment to the BLE of low-frequency systems. DOE proposed that low-frequency BLE be multiplied by 0.9 to account for the approximately 10% increase in lighting efficacy associated with high-frequency lamp operation. For the final rule, DOE assigns specific lamp operating frequency adjustment factors for each ballast type considered. The adjustment factors more accurately approximate the increase in lighting efficacy associated with high-frequency lamp operation. In the SNOPR, DOE also proposed a method for calculating the ballast factor (BF) of a ballast by dividing the measured lamp arc power on the test ballast by the measured lamp arc power on a reference ballast. In cases where reference ballast operating conditions were unavailable, the SNOPR provided a reference lamp power (specific to the ballast type) from ANSI standard C78.81-2010 or from empirical results. In this final rule, DOE is not defining a BF measurement process because the standards NOPR does not use BF to define product classes.

The final test procedure includes specific provisions for the testing of ballasts identified in the proposed scope of coverage for the standards NOPR. If the scope of coverage changes in later stages of the standards rulemaking, DOE will by rule add or remove provisions from the test procedure so that it is consistent with the final scope of coverage. See section III.G for further detail.

In any rulemaking to amend a test procedure, DOE must determine whether 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. (42 U.S.C. 6293(e)(2)) The new test procedure will describe the efficiency of a ballast in terms of a new metric, BLE. To ensure that the standards developed in the ongoing standards rulemaking account for any changes to the test procedure, DOE is developing the standards based on the measured BLE generated by the active mode test procedure established in this rulemaking. The revised test procedure, to be published as Appendix Q1 of 10 CFR part 430 Subpart B, will be required concurrent with the compliance date of any upcoming amendments to the fluorescent lamp ballast standards. DOE is required by a consent decree to issue any amended fluorescent lamp ballast standards by June 30, 2011.

Until use of Appendix Q1 is required, manufacturers should continue testing these ballasts using the test procedure at Appendix Q to determine compliance with existing standards. In the SNOPR, DOE proposed to make minor updates to the existing test procedure, published at Appendix Q to Subpart B of part 430. The final rule does not affect this proposal. DOE is amending the reference to ANSI C82.2-1984 in the existing test procedure (appendix Q) to ANSI C82.2-2002. DOE does not believe the updated standard will impose increased testing burden or alter the measured BEF of fluorescent lamp ballasts. The amendments to Appendix Q are effective on June 3, 2011, and manufacturers may not make any representation regarding fluorescent lamp ballast efficiency unless such ballast has been tested in accordance with the final rule provisions in Appendix Q after October 31, 2011. See 42 U.S.C. 6293(c).

In addition, the test procedures for any ballasts that operate in standby mode are also located in Appendix Q. Manufacturers must continue to use the standby and off mode procedures in Appendix Q for certification purposes at this time. DOE has also included the test procedures for any ballasts that operate in standby mode in Appendix Q1. When use of the procedures in Appendix Q1 are required for certification, manufacturers can continue to use the same procedure in Appendix Q1 and will no longer need to refer to Appendix Q for that procedure.

The ballast test procedure (in Appendix Q to Subpart B of 10 CFR part 430 determines the performance of a fluorescent lamp ballast based on light output measurements and ballast input power. The metric used is called ballast efficacy factor (BEF). BEF is relative light output divided by the power input of a fluorescent lamp ballast, as measured under test conditions specified in ANSI standard C82.2-1984, or as may be prescribed by the Secretary. (42 U.S.C. 6291(29)(C))

The BEF metric uses light output of the lamp-and-ballast system instead of ballast electrical output power in its calculation of the performance of a ballast. To measure relative light output, ANSI C82.2-1984 directs the user to measure the photocell output of the test ballast operating a reference lamp and the light output of a reference ballast operating the same reference lamp. Dividing photocell output of the test ballast system by the photocell output of the reference ballast system yields relative light output or ballast factor. Concurrent with measuring relative light output, the user is directed to measure ballast input power. BEF is then calculated by dividing relative light output by input power and multiplying by 100. A ballast that produces same light output as another ballast (operating the same lamp type and number of lamps) with less input power will have a larger BEF.

In the SNOPR, DOE proposed a new metric to describe the efficiency of a ballast called ballast luminous efficiency (BLE). The BLE metric and test procedure were based on the NEMA lamp-based ballast efficiency (BE) test procedure considered in the test procedure NOPR. The BLE metric is equal to ballast input power divided by the lamp arc power of a lamp-and-ballast system. DOE also proposed that for low-frequency ballasts the quantity ballast input power divided by lamp arc power be multiplied by 0.9 to account for the approximately 10% increase in lighting efficacy associated with high-frequency lamp operation. In this final rule, DOE establishes lamp specific low-frequency adjustment factors to more accurately approximate this increase in lighting efficacy. DOE continues to use the definition of high frequency in ANSI C82.13-2002, which includes ballasts operating at frequencies of 10 kHz or more.

DOE proposed the BLE test procedure because it reduced measurement variation and testing burden compared to the existing test procedure and other alternatives. In contrast to BEF and relative system efficacy (RSE), the BLE metric could be used to compare the efficiency across many different types of ballasts. RSE and BEF can only be used to make direct comparisons between ballasts that operate certain lamp types, while BLE can be used for comparisons among ballasts that operate all lamp types. DOE believed that the use of a lamp-and-ballast system allowed the ballast to operate at its natural operating point and would more accurately assess ballast performance than other methods in which the ballast test load is a resistor. DOE also believed that the use of electrical measurements and the calculation of BLE reduced the impact of lamp manufacturing variation on the efficiency descriptor compared to the existing test procedure.

NEMA commented on the assignment of an adjustment factor based on lamp operating frequency, stating that low frequency should be defined as 60 Hertz (Hz) and high frequency should be defined as equal to or higher than 25 kHz. NEMA stated that it knows of no ballasts that operate between 10 and 25 kHz, and that most ballasts operate above 40 kHz to avoid frequencies used by other devices between 32 and 40 kHz and anti-theft devices above 50 kHz. NEMA also commented that luminaire manufacturers have defined a specification for high frequency ballasts that avoid frequencies of concern. (NEMA, No. 20 at p. 31 )

In its test data, DOE identified ten electronic ballasts (manufactured by five different companies) that operate between 20 and 25 kHz, and intends to include these ballasts in the high frequency category. These ballasts operate F96T12/ES, F96T8HO, F96T8HO/ES, and F96T12HO cold temperature lamps. Therefore, DOE continues to use the definition of high frequency provided by ANSI C82.13-2002, which includes ballasts operating at frequencies of 10 kHz or more. DOE is not changing its proposed definition for low-frequency ballasts, which is defined as a ballast that operates at a supply frequency of 50 to 60 Hz and operates the lamp at the same frequency as the supply.

Other than the high frequency issue discussed above, comments received on the metric changes proposed in the SNOPR were generally positive. Though the CA IOUs and NEEA noted their preference for a test procedure that continued to relate energy consumption to the light output of the lamp and ballast system, they supported the SNOPR proposal of lamp-based BLE. The California IOUs (CA IOUs) commented that the test procedure proposed in the SNOPR represented a significant improvement over the procedure proposed in the NOPR, and the Northwest Energy Efficiency Alliance (NEEA) fully supported DOE's proposal of a metric and test procedure that focus on the electrical inputs and outputs of the ballast. (CA IOUs, No. 19 at p. 1, 2; NEEA, No. 18 at p. 1, 4) The CA IOUs and NEEA concurred with DOE's observations and arguments regarding the drawbacks of the resistor-based test procedure and the advantages of the proposed lamp-based ballast efficiency test procedure. (CA IOUs, No. 19 at p. 2; NEEA, No. 18 at p. 2) The Natural Resources Defense Council (NRDC) also supported DOE's proposal to measure lamp arc power rather than using resistor banks to simulate lamps because it will yield more accurate and consistent results across ballast types. (NRDC, No. 21 at p. 1) The CA IOUs and the NRDC also agreed with DOE that the new metric will allow for increased comparison among ballasts of different ballast factors and among ballasts intended for operation with different numbers of lamps. Both organizations believe this will make the new metric more useful in designing and implementing rebate programs, and will also make it much easier to set standard levels of compliance for government or non-government procurement policies that specify high efficiency ballasts. (CA IOUs, No. 19 at p. 2; NRDC, No. 21 at p. 1) Based on the general support for the BLE metric and its use of lamp loads rather than resistor loads, DOE establishes use of the BLE metric in the final rule.

DOE also received comment on whether the proposed name of the metric accurately conveys what ballast properties the metric describes. NEEA, the CA IOUs, and NRDC were dissatisfied with the name “ballast luminous efficiency” suggested for the new metric. The new method adjusts the ratio of lamp arc power to ballast input power for low-frequency ballasts to account for the reduced light output per unit of power input for those ballasts but does not involve the measurement of light output. These organizations commented that the term “luminous” suggests the continued use of light output as part of the test procedure and is thus misleading. (NEEA, No. 18 at p. 1; CA IOUs, No. 19 at p. 1; and NRDC, No. 21 at p. 1) NEEA suggested that the alternate names “ballast electrical efficiency”, “ballast component efficiency”, and “ballast-lamp efficiency” would be more descriptive of the proposed metric since the operating frequency of the ballast is an electrical characteristic with inherent lamp/ballast system efficiency impacts. (NEEA, No. 18 at p. 1) The CA IOUs suggested the names “ballast lamp efficiency” and “ballast arc efficiency” as more accurate conveyors of the basis of the test measurement. (CA IOUs, No. 19 at p. 1)

DOE disagrees with NEEA, NRDC, and the CA IOUs and believes ballast luminous efficiency is the best description of the metric. In addition to describing electrical losses, the BLE metric also accounts for the lamp efficacy difference between low and high frequency operation. The term “luminous” relates to BLE's treatment of lamp operating frequency's impact on lamp efficacy, and the term “efficiency” relates to BLE's treatment of electrical losses within the ballast. The other names suggested do not describe both of these elements. Therefore, DOE uses the term ballast luminous efficiency in this final rule.

In the SNOPR, DOE proposed a method for correlating the existing BEF standards to BLE. Part of this correlation includes accounting for a frequency adjustment factor (the SNOPR proposed 0.9 for low frequency ballasts) DOE included in its BLE proposal. When converting a low-frequency BEF to BLE, the SNOPR proposed BEF must be multiplied by 0.9 to convert to BLE. NEMA commented that DOE may be incorrectly using the 0.9 factor in its calculations of high frequency gains in efficiency. NEMA stated that different arc powers specified for high frequency and low frequency operation on the same lamp are specified at the same light output, which implies that there is no further need to correct for high frequency gains because these are already accounted for in the different arc power specifications. (NEMA, No.20 at p. 2) NEMA also commented that DOE multiplied the low frequency BLE by 0.9 when it should have divided it by 0.9 to generate the required BLE needed to attain the same light output and hence BEF because low frequency operation has lower luminous efficacy. (NEMA, No. 20 at p. 2)

DOE believes there is some confusion concerning the lamp arc wattages and adjustment factor used in the calculation of BLE from BEF. A single BEF standard is more stringent for low frequency systems than for high frequency systems. Therefore, if the low and high frequency system have the same BEF and BF, the quantity lamp arc power divided by ballast input power would be larger for the low frequency system than for the high frequency system. In DOE's conversion technique, multiplication by different reference lamp arc powers results in a higher lamp arc power divided by ballast input power quantity for the low frequency system. However, DOE has defined BLE to include an adjustment factor based on lamp operating frequency. DOE multiplies the quantity lamp arc power divided by ballast input power by the adjustment factor to calculate BLE. This adjustment factor accounts for the difference in lamp efficacy between low and high frequency operation (because lamp efficacy cannot be assessed through electrical measurements of the ballast). Though the BLE corresponding to a low frequency BEF may be smaller than a BLE corresponding to a high frequency BEF, the low-frequency BLE is still more stringent because of the adjustment factor. The adjustment factor allows a single BLE standard to be more stringent for low frequency systems than for high frequency systems, consistent with the implications of a single BEF standard.

NEEA stated that while they understand DOE's proposal (and industry's assertions) with regard to the ability to derive BEF ratings from the proposed BLE ratings, they would like some assurance about the continuing availability of the BEF ratings, and the integrity of whatever values are reported when they are not certified values. The NEEA urged the DOE to establish the appropriate inputs for the calculations of other metrics (e.g.BE and BEF) from the measured proposed BLE metric before the new test procedure goes into effect. (NEEA, No. 18 at p. 2) The CA IOUs and NRDC commented that the SNOPR did not contain evidence that DOE has conducted significant testing of ballasts to compare their BEF results with their BLE results to confirm the accuracy of DOE's proposed method for conversions. These organizations recommended that such testing be done before DOE issues the NOPR for ballast efficiency standards. (CA IOUs, No. 19 at p. 2; NRDC, No. 21 at p. 1)

The conversion of BEF to BLE and vice versa was necessary for DOE to confirm that any proposed standards in the standards rulemaking were more stringent than existing standards (i.e.,to avoid backsliding), consistent with 42 USC 6295(o)(1). The standards rulemaking will provide more details on DOE's analysis of backsliding. DOE analyzed its BEF to BLE conversion results and presents the comparison in this test procedure final rule. DOE converted the tested BLE data for all of its test ballasts to BEF using the final rule method of conversion and compared the calculated BEF values to measured BEF values. DOE found that the average BEF converted from BLE was 2.3 percent higher than the average tested BEF. The standard deviation of the population of percent differences between converted and tested BEFs was 0.043. DOE believes that the variation around this average can be explained by the expected variation in the BEF test method and the BLE test method. DOE notes that manufacturers and industry members can continue to measure BEF or can develop their own conversion methods for use in lighting design. DOE also understands that NEMA is independently developing its own BLE to BEF conversion technique.

In the SNOPR, DOE proposed a method for calculating the ballast factor (BF) of a system by dividing the measured lamp arc power on the test ballast by the measured lamp arc power on a reference ballast. In cases where reference ballast operating conditions were unavailable, the SNOPR provided a reference lamp power (specific to the ballast type and operating frequency) from an ANSI standard or from empirical results. The ballast factor measurement was described in detail in section III.D of the SNOPR. Particular lamp and ballast pairings were specified for both the BLE and BF measurements.

Lighting designers commonly use the BF specification to calculate the total system lumen output for their projects. NEEA and the CA IOUs commented that with the proposed test method, calculation of lamp and ballast system lumens by multiplying the rated lamp lumen output by the candidate ballast BF would not be valid for lamps that were rated with a low frequency reference ballast, such as full wattage 4-foot T8s. Both organizations suggested that this problem could be addressed by simultaneously updating the reference ballasts for full wattage T8 lamps to a high frequency ballast but stated that this is probably not possible in this rulemaking because a change in the way rated lamp lumen output is measured would require a new and separate rulemaking. NEEA and the CA IOUs recommended that DOE not change the BF calculation method unless it is able to address the stakeholder concerns. (NEEA, No. 18 at pp. 2-3; CA IOUs, No. 19 at pp. 3-4)

The CA IOUs asked for guidance concerning when a reference ballast should be used to determine BF versus when a number from the proposed Table A (which contains the reference arc power values provided in ANSI C78.81-2010 and IEC 60081 Ed. 5.0) could be used for BF calculation, and requested more information about how the values in the Table A were developed. The CA IOUs also commented that some values in the proposed Table A have two significant digits while others have none, and suggested this be corrected so all values have the same number of significant digits. The CA IOUs suggested DOE conduct research to obtain additional reference ballast operating characteristics at both low and high frequency for key lamp types that are currently lacking this information in ANSI C78.81-2010. This would include high frequency reference ballast operating characteristics for F32T8 lamps. (CA IOUs, No. 19 at p. 4) NRDC supported the CA IOUs' recommendation to find an alternative to Table A. (NRDC, No. 21 at p. 2)

The CA IOUs agreed with DOE that it is important to measure lamp arc power on the test ballast and the reference ballast with the same lamp because of manufacturing variation in the lamps, and commented that using a fixed denominator would unnecessarily decrease the accuracy of the ballast factor test. (CA IOUs, No. 19 at p. 4) NEEA and the CA IOUs expressed concern that the proposed test procedure introduces variability by forcing a comparison of measured test values against fixed integer referencelamp arc values in the proposed Table A. (CA IOUs, No. 19 at p. 4) NEEA commented that this seemed incongruous with DOE's goal of reducing testing variability. NEEA also pointed out that DOE had itself expressed reservations about the procedure and agreed with DOE's preference for measuring lamp arc power under both reference and test ballast/lamp conditions. (NEEA, No. 18 at pp. 2-3)

NEMA disagreed with NEEA and the CA IOUs, expressing concern about DOE's proposal to have BF equal the ratio of measured lamp arc powers on test and reference ballasts, stating that ballasts will respond to each lamp differently because every lamp has a characteristic power output. NEMA also commented that determining a reference lamp by light output and not a predetermined wattage introduces photometric variation, and suggested use of a predetermined wattage to give a BF of one from which everything should be determined. NEMA commented that if a center point wattage across all manufacturers' lamps were found, it should be the value used for BF equal to one. NEMA suggested this wattage could be 29 W for a full-wattage 32 W T8 lamp operated on a high frequency electronic ballast. NEMA recognized that variations in reference lamp parameters will affect BF calculations in some cases, but stated that the error introduced into a BF calculation by the variations should not be enough to influence which classification a ballast design falls into. (NEMA, No. 20 at p. 3)

The CA IOUs expressed concern that DOE's proposal to change the way BF is calculated has not been adequately vetted by the lighting industry. The CA IOUs commented on the lack of evidence that DOE has conducted significant testing to compare the proposed ballast factor correction method with the current one, and suggested DOE conduct the testing and publish the results to demonstrate the impacts of the new procedure. (CA IOUs, No. 19 at p. 3) The CA IOUs also commented that significant change to the ballast factor metric could affect its utility in lighting design, and recommended that DOE schedule a public meeting in early 2011 to discuss this issue. NEEA stated that lighting designers, who will be the most affected by the ballast factor calculation change, have not been sufficiently included in the discussion. NEEA and the CA IOUs suggested that DOE consult representatives of the International Association of Lighting Designers (IALD) and the Illuminating Engineering Society of North America (IESNA). (NEEA, No. 18 at p. 3; CA IOUs, No 19 at p. 3)

DOE believes there may have been some misunderstanding of the SNOPR BF calculation method. If a candidate ballast operates at high frequency, then a high frequency reference arc power value would be used to calculate ballast factor. If the candidate ballast operates at low frequency, then a low frequency reference lamp arc power value would be used. In addition, DOE proposed that if ANSI C78.81 provided reference ballast operating conditions at the same frequency as the candidate ballast, then the reference lamp arc power value could be measured directly. Based on these proposals, reference lamp arc power values always correspond to the same operating frequency as the candidate ballast. Nevertheless, in the fluorescent lamp ballast standards NOPR, DOE proposed a new product class structure that no longer makes use of BF. (76 FR 20090, April 11, 2011) In this final rule, therefore, DOE is not prescribing a BF measurement methodology. DOE notes that manufacturers and industry members can continue to measure BF using their preferred methods depending on the demands of the market and industry.

In the SNOPR, DOE proposed that testing be conducted at 25 degrees Celsius ± 2.0 degrees and in a draft-free environment according to ANSI C78.375-1997.2 These conditions provide for mostly uniform electrical operating characteristics for the lamp-and-ballast system. In addition, DOE proposed that ballasts be tested using the electrical supply characteristics found in section 4 of ANSI C82.2-2002 with the following changes: (1) Ballasts capable of operating at a single voltage would be tested at the rated ballast input voltage; (2) users of universal voltage ballasts would disregard the input voltage directions in section 4.1 of ANSI C82.2-2002 that indicate a ballast capable of operating at multiple voltages should be tested at both the lowest and highest USA design center voltage; and (3) manufacturers use particular revisions to the normative references associated with ANSI C82.2-2002 (see section III.D.6 for additional detail). Instead of testing universal voltage ballasts at the voltages indicated in ANSI C82.2-2002, DOE proposed that testing ballasts at a single voltage would be more appropriate and less burdensome. DOE noted that 277 V is the most common input voltage for commercial ballasts and that 120 V is the most common for residential ballasts and commercial cold-temperature outdoor sign ballasts. Therefore, DOE proposed that all universal voltage commercial ballasts be tested at 277 V and that universal voltage residential and commercial cold-temperature outdoor sign ballasts be tested at 120 V.

The CA IOUs approved of DOE's proposal that the BLE calculation for universal voltage commercial ballasts be based on testing at 277 volts and testing of universal voltage residential ballasts and outdoor cold temperature sign ballasts be conducted at 120 volts. They believe this will add clarity to the test procedure because the value reported for compliance purposes is now specified. However, the CA IOUs commented that manufacturers of universal voltage ballasts should be required to publish input wattage for operation at both the upper and lower range of universal voltage ballasts in their product literature because some commercial spaces have 120 volt service in significant portions of the building, such as bathrooms. Since input watts can vary by one to two watts depending on the voltage, the CA IOUs believe it would be useful in lighting design to consider input watts at both 277 and 120 volts. (CA IOUs, No. 19 at pp. 2-3)

Because DOE has not received adverse comment to its test conditions proposal in the SNOPR, the test condition requirements for this final rule are unchanged. With regards to the comment concerning the publication of input wattage for operation at both the upper and lower range of universal voltage ballasts, the Federal Trade Commission has statutory authority to establish labeling requirements for fluorescent lamp ballasts. Manufacturers are also prohibited from making any representation regarding the energy efficiency of a product unless the product has been tested according to the DOE test procedure and the representation fairly discloses the results of such testing. (42 U.S.C. 6293(c)).

NEEA, the CA IOUs, and NRDC supported the proposed method of test wiring for programmed and rapid start ballasts without cathode cut-out. These organizations concurred with DOE's observation that the proposed procedure isolates lamp arc voltage by capturing heating energy in the input power measurement, but not in the outputpower measurement, and will appropriately measure the relative efficiency of ballasts with cathode heating. (NEEA, No. 18 at p. 2; CA IOUs, No. 19 at p. 2; and NRDC, No. 21 at p. 2) Based on the comments received in support of the SNOPR test setup proposal, the setup required in the final rule does not change.

DOE is adding one clarification to its SNOPR setup proposal with regards to the lamp type paired with sign ballasts. In the SNOPR, DOE proposed that all ballasts, including sign ballasts, be tested with the most common wattage lamp typically used with that ballast type. For sign ballasts, DOE identified 110 W 8-foot T12 lamps and 86 W 8-foot T8 lamps as being the most common. However, DOE notes that some sign ballasts are capable of operating both T12 and T8 lamps. Based on interviews with manufacturers, DOE believes the T12 lamp pairing is the most common. Therefore, in the final rule, sign ballasts capable of operating T12 and T8 lamps shall be paired with a 110 W 8-foot T12 lamp for the purposes of determining compliance with energy conservation standards. Sign ballasts capable of only operating T8 or only T12 lamps shall be operated with the diameter lamp they are designed to operate.

The test method required in the final rule is unchanged from the SNOPR proposal. Once the lamp-and-ballast system is connected and attached to the measurement instrumentation, the ballast must operate a fluorescent lamp for a minimum of fifteen minutes to a maximum of one hour until stability is reached. Measurements of lamp arc voltage, lamp arc current, and lamp arc power must be taken every one second during the stabilization period. Once the percent difference between the minimum and maximum values for voltage, current, and power do not exceed one percent over a four minute moving window, the system is considered stable. Allowing the lamp and ballast system to reach its steady state operating point will provide a more accurate assessment of ballast performance in the field. If the system does not stabilize, a new ballast sample is selected and the test is repeated.

After the system has stabilized, the measured input parameters are voltage (RMS3),current (RMS), power, and power factor measured in accordance with ANSI C82.2-2002. The measured output parameters include lamp arc voltage, current, and power. Lamp arc current and voltage measurements are taken at the specified locations according to the test setup. Frequency of the output waveform delivered to the lamp by the ballast is also measured.

NEMA commented that a text correction is needed on page 71578 of the SNOPR, in the section describing lamp arc voltage measurement in the test circuit setup. DOE stated that during lamp arc voltage measurement, it is assumed the arc begins near the center of the ballast cathodes. The sentence should read: “The voltage divider would provide a position in the circuit to measure the lamp arc voltage assuming the arc begins near the center of the lamp (instead of ballast) cathodes.” (NEMA, No. 20 at p. 4) DOE agrees with NEMA that the sentence should have referenced lamp cathodes rather than ballast cathodes.

As described in Equation 1 below, ballast luminous efficiency is equal to total lamp arc power, divided by ballast input power, multiplied by 100, and then multiplied by a lamp operating frequency correction factor (β).

In the SNOPR, DOE proposed that the symbol β be equal to 0.9 for low-frequency ballasts and equal to 1.0 for high-frequency ballasts. NEMA commented that because the 0.9 correction factor for low frequency ballasts is based on the IESNA handbook reference to F40T12 lamps, it should not be applied broadly to all lamp types. The 10 percent gain for the F40T12 is due to a decrease in “end losses” and an increase in column efficacy due to a lower operating power. NEMA commented that the proportional gain in efficacy due to decreased “end losses” will be different for different lamp types because of differences in column voltage. Additionally, the increase in column efficacy from a reduction in column power may not apply to all other lamps. NEMA stated that it would submit additional comments after it had time to verify if a 0.93 correction factor would be appropriate for T8 lamps, and that no correction factor should be needed for T5 lamps because they are designed only for high frequency operation. DOE did not receive these additional comments from NEMA on appropriate frequency adjustment factors. Finally, NEMA stated that for ballasts meeting ANSI C82.11 and C82.1, there should be no other appreciable effect on fluorescent lamp efficacy from lamp current crest factor, wave form, and lamp operating frequency. (NEMA, No. 20 at pp. 2-3)

The CA IOUs and NRDC stated that DOE's proposal to apply a factor of 0.9 to the efficiency measurements of low frequency ballasts is an acceptable proxy for light measurements to assess the benefits of high frequency operation. The CA IOUs commented that they do not have data to indicate that the variation in lamp light output due to variations in crest factor or wave shape during high frequency operation is significant. (CA IOUs, No. 19 at p. 2 and NRDC, No. 21 at p. 2)

In light of NEMA's comments, DOE establishes different low frequency correction factors for the different lamp types operated by ballasts within the scope of this final rule. DOE believes that these factors more accurately represent the difference in arc power between high frequency and low frequency operation for the same light output. The adjustment factor is equal to high frequency lamp arc power divided by low frequency lamp arc power—specific to each lamp type. DOE used ANSI lamp data when available and empirical data when it was not. To derive correction factors for when ANSI lamp data is unavailable for both high and low frequency, DOE operated a lamp using the ANSI reference ballast settings at the given rating frequency (either high or low frequency) and recorded the light output. DOE then switched the same lamp to a reference ballast of the frequency type not provided by ANSI and adjusted the ballast settings to match the light outputwith the output obtained using the first ballast. DOE recorded the lamp arc power once the light output was matched.

DOE is not changing the proposed updates to the existing test procedure from the SNOPR in this final rule. DOE is updating the references to ANSI standards for the existing light-output-based test procedure. DOE is using the most recent versions of these standards, namely ANSI C82.2-2002, ANSI C82.11-20024 , and ANSI C82.1-2004. The amendments to the existing test procedure in Appendix Q to Subpart B of 10 CFR part 430 will be effective 30 days after publication of the test procedure final rule.

DOE is not changing its proposals regarding the specification of normative references to be used with ANSI C82.2-2002 from the SNOPR in this final rule. DOE is amending the existing fluorescent lamp ballast test procedure in Appendix Q to incorporate references to ANSI C82.2-2002 and including references to ANSI C82.2-2002 in the new appendix Q1. In examining the ANSI standard, DOE found that within ANSI C82.2-2002, there are references to other ANSI standards. In particular, section 2 of ANSI C82.2-2002 states that “when American National Standards referred to in this document [ANSI C82.2-2002] are superseded by a revision approved by the American National Standards Institute, Inc. the revision shall apply.” Revisions to these normative standards could potentially impact compliance with energy conservation standards by changing the tested value for energy efficiency. Therefore, DOE is specifying the particular versions of the ANSI standards that will be used in conjunction with ANSI C82.2-2002. DOE is using ANSI C78.81-2010, ANSI C82.1-2004, ANSI C82.11-2002, and ANSI C82.13-2002 in support of ANSI C82.2-2002. All other normative references are as directly specified in ANSI C82.2-2002. These specifications will apply to the ANSI C82.2-2002 references in Appendix Q and to the ANSI C82.2-2002 references in Appendix Q1.

EPCA requires that any test procedures prescribed or amended under this section be reasonably designed to produce test results that 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)). Today's final test procedure measures the performance of a ballast by computing the ratio of lamp arc power to ballast input power and adjusting for lamp operating frequency. The test procedure is less burdensome than the existing procedure largely because of the simplicity of electrical measurements compared to photometric measurements. In addition, the lamp loads are less expensive than precision resistor loads proposed in the NOPR and are already a common item used in test facilities. The assessment of testing burden is discussed in more detail with reference to small businesses in section IV.B. NEEA commented that it waspleased with the basics of the proposed test procedure and supported a test procedure that does not unduly burden manufacturers. (NEEA, No. 18 at p. 1)

To further ensure that the test procedure in this final rule is not unduly burdensome to conduct, DOE is not changing the minimum sample size (four) for generating a reported value or to the reported value itself. Currently, to demonstrate compliance with energy conservation standards, manufacturers must first test four examples of the basic model. The reported value of BLE is then equal to either the lower 99% confidence interval limit divided by 0.99 or the mean of the four values, whichever is smaller.

In any rulemaking to amend a test procedure, DOE must determine whether 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. (42 U.S.C. 6293(e)(2)) This final rule active mode test procedure changes the metric used to describe the energy efficiency of a ballast. DOE is currently amending energy conservation standards for fluorescent lamp ballasts in the standards rulemaking. In that rulemaking, DOE is considering standards based on the measured efficiency of the ballast in accordance with the test procedure prescribed in this active mode test procedure rulemaking. The BLE test procedure final rule will not affect compliance with existing energy conservation standards because manufacturers will not be required to use the new test procedure until the date manufacturers are required to comply with any amended standards.

Today's test procedure final rule is applicable to the fluorescent lamp ballasts covered in the proposed scope of coverage outlined in the fluorescent lamp ballast standard NOPR, which includes ballasts that operate F32T8, F34T12, F28T5SO, F54T5HO, F96T8/ES, F96T12/ES, F96T8HO, F96T12HO/ES, and F96T12HO lamps. 76 FR 20090 (April 11, 2011). These ballasts can operate between one and six lamps and are used in commercial, residential, and cold-temperature outdoor sign applications. For the test procedure in this rulemaking, DOE is establishing particular test setups and calculations depending on type of ballast, as described in more detail in section III.D. For example, DOE is specifying certain fluorescent lamps and numbers of these lamps to be paired with certain ballasts for determining ballast performance.

In the test procedure SNOPR, DOE proposed the measurement of BLE using electrical measurements of a lamp and ballast system. DOE believes this test procedure to be clearer and less burdensome to conduct compared to the existing method which may result in increased compliance. DOE also proposed that test facilities conducting compliance testing in accordance with amended standards promulgated by the ongoing standards rulemaking be National Volunteer Laboratory Accreditation Program (NVLAP) accredited, a program administered by the National Institute of Standards and Technology (NIST), or accredited by an organization recognized by NVLAP.

NVLAP accreditation is a finding of laboratory competence, certifying that a laboratory operates in accordance with NVLAP management and technical requirements. The NVLAP program is described in 15 CFR part 285, and encompasses the requirements of ISO/IEC 17025.5 NVLAP (or an organization recognized by NVLAP) accreditation is currently required for laboratories providing certification and compliance data for general service fluorescent, general service incandescent, and incandescent reflector lamps. In the SNOPR, DOE stated that either of these accreditation requirements would ensure that all the data DOE uses in its rulemaking comes from standardized and quality controlled sources, increasing confidence in the precision of the data and limiting variations due to differences between testing laboratories. DOE determined that NVLAP imposes fees of $9000 and $8000 on years one and two of accreditation. For the years following, the fees alternate between $5000 and $8000, with the $8000 fee corresponding to the on-site evaluation required every other year. Fees for other accreditation organizations are expected to be similar. DOE invited comment on the benefits and burden imposed by the requirement that certification and compliance data come from an NVLAP or NVLAP recognized organization accredited laboratory.

NEMA agreed with DOE that there should be an accreditation requirement for laboratories generating certification and compliance data, but does not believe NVLAP accreditation or recognition should be the only option. NEMA recommended that the accreditation requirements should read: “Laboratory accreditation is by ISO17025 accreditation on ballast energy efficiency procedures such as Underwriter Laboratories, Council of Canada, etc * * *” (NEMA, No. 20 at p. 4).

NEEA and NRDC strongly supported the proposed requirement that all certification and compliance testing be done at NVLAP accredited or recognized laboratories to establish a testing regime that will produce accurate and repeatable results. (NEEA, No. 18 at p. 4 and NRDC, No. 21 at p. 2) The CA IOUs also agreed with DOE, noting that the overwhelming majority of ballasts tested by DOE showed significantly higher measured BEFs than their reported catalog values. The CA IOUs believe that requiring testing from accredited third party labs will help ensure testing consistency. (CA IOUs, No. 19 at p. 5) Earthjustice agreed with DOE that requiring NVLAP accreditation or recognition for labs that do certification and compliance data will increase the integrity of test data, adding that this requirement is especially important given DOE's proposal to allow manufacturers to manufacture and test their own products. Earthjustice believes that the benefits of the requirement outweigh any potential burdens because the added per-unit cost would be a negligible fraction of a penny. (Earthjustice, No. 22 at p. 1)

In this final rule, DOE is amending the laboratory accreditation requirements to be by ISO17025 accreditation on ballast energy efficiency procedures. Accreditation must be done by NVLAP or a NVLAP-recognized organization, Underwriter Laboratories, or Council of Canada. DOE invites interested parties to suggest whether organizations should be added or removed from the list of accepted accrediting bodies which could be incorporated in a future test procedure amendment. During manufacturer interviews, DOE learned that gaining NVLAP accreditation could take between six months and two years. This final rule imposes laboratory accreditation requirements only for compliance testing using Appendix Q1.

The Office of Management and Budget has determined that test procedure rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). Accordingly, this 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. 601et seq.) requires preparation of an initial regulatory flexibility analysis (IFRA) for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (August 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the DOE rulemaking process. 68 FR 7990. DOE has made its procedures and policies available on the Office of the General Counsel's Web site:http://www.gc.doe.gov.

DOE certified to the Office of Advocacy of the Small Business Administration (SBA) that the proposed test procedure for ballasts would not have a significant economic impact on a substantial number of small entities, and updated that certification in the SNOPR. The factual basis for that certification is as follows:

The SBA has set a size threshold for manufacturers of fluorescent lamp ballasts that defines those entities classified as “small businesses” for the purposes of the Regulatory Flexibility Analysis. DOE used the SBA's small business size standards to determine whether any small manufacturers of fluorescent lamp ballasts would be subject to the requirements of the rule. 65 FR 30836, 30850 (May 15, 2000), as amended at 65 FR 53533, 53545 (September 5, 2000) and codified at 13 CFR part 121. The size standards are listed by North American Industry Classification System (NAICS) code and industry description and are available athttp://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf.Fluorescent lamp ballast manufacturing is classified under NAICS 335311, “Power, Distribution, & Specialty Transformer Manufacturing.” The SBA sets a threshold of 750 employees or less for an entity to be considered as a small business for this category.

To identify potential small manufacturers as defined by SBA, DOE conducted a market survey using all available public information. DOE's research involved several industry trade association membership directories, product databases, individual company Web sites, and marketing research tools (e.g.,Dun and Bradstreet reports) to create a list of every company that manufactures or sells fluorescent lamp ballasts covered by this rulemaking. DOE reviewed all publicly-available data and contacted companies on its list, as necessary, to determine whether they met the SBA's definition of a small business manufacturer of covered fluorescent lamp ballasts. DOE screened out companies that did not offer fluorescent lamp ballasts covered by this rulemaking, did not meet the definition of a “small business,” or are foreign owned and operated. Ultimately, DOE identified approximately 10 fluorescent lamp ballast manufacturers that produce covered fluorescent lamp ballasts and can potentially be considered small businesses out of the at least 54 ballast manufacturers identified in the fluorescent lamp ballast standards NOPR.

The final rule includes revisions to appendix Q and a new appendix Q1. The revisions to appendix Q update an industry reference and do not change the test method or increase testing burden. The only difference between the two test procedures relates to the interference of testing instrumentation. Specifically, the input power measurement of ANSI C82.2-2002 reduces the interference of instrumentation on the input power measurement as compared to ANSI C82.2-1984. The vast majority of companies and testing facilities, however, already employ modern instrumentation that does not significantly interfere with input power measurements. Thus, updating this industry reference would not impose additional financial burden in terms of labor or materials. As described in more detail in section III.D, the amended test procedure for appendix Q1 is generally less burdensome compared to the existing test procedure, while reducing measurement variation. This procedure uses only electrical measurements which are generally simpler and more quickly carried out than photometric measurements. The final test procedure only uses a reference ballast once every 24 hours, rather than during the performance evaluation of each individual ballast. This change reduces the number of measurements necessary for assigning a BLE to a ballast compared to the number of measurements necessary for BEF under the existing test procedure. In addition, the final test method specifies a shorter lamp seasoning period (12 hours versus 100 hours) because the lamp's electrical characteristics stabilize sooner than its photometric characteristics.

To analyze the testing burden impacts described above on small business manufacturers, DOE first sought to examine publically available financial data for those companies identified as small businesses to compare the estimated revenue and profit of these businesses to the anticipated testing burden associated with this final test procedure. In the SNOPR, DOE determined that all the identified small business manufacturers were privately owned, and as a result, financial data was not publically available. DOE estimates that the incremental testing costs for an average small business would be no more and likely less than testing costs under the existing BEF test procedure for the reasons set forth in the following paragraph.

The BLE procedure requires no additional equipment compared to the existing test procedure and eliminates the usage of photocells or an integrating sphere. In addition, the existing BEF test procedure requires measurements of lamp light output on a reference ballast and measurements on a test ballast during each test. Light output measurements and electrical measurements of the reference system can require one to two hours depending on the number of reference ballasts available and the speed at which the lamp reaches photometric stability. Light output and electrical measurements of the test ballast are taken immediately after switching the lamps from the reference to the test system. In contrast, the BLE procedure in this final rule requires the reference lamps to be measured and stabilized on a reference ballast only once every twenty four hours. After this stabilization, subsequent testing of the ballasts of interest can take between 15 and 60 minutes. In the SNOPR, DOE estimated that between 4 and 8 ballast samples could be completed in an eight hour period using the existing BEF test procedure, while between 8 and 16 tests could be completed using the BLE test procedure. Therefore, DOE estimated the BLE procedure could result in anincremental reduction in testing time of about 50%. Assuming the labor rate for carrying out either procedure is $100 per hour, the BLE procedure could reduce testing costs by $50 to $100 dollars per test. DOE noted that depending on setup, some facilities may see less of a reduction in testing time or potentially no change in testing time. Finally, as presented in the SNOPR, DOE believes the cost of test laboratory accreditation is approximately $8000 per year, which DOE believes would not be a significant impact.

On the basis of the foregoing, DOE concluded that this final rule would not have a significant impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE has provided its certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b).

Manufacturers of fluorescent lamp ballasts must certify to DOE that their product complies with any applicable energy conservation standard. In certifying compliance, manufacturers must test their product according to the DOE test procedure for fluorescent lamp ballasts, including any amendments adopted for that test procedure. DOE has proposed regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment, including fluorescent lamp ballasts. 75 FR 56796 (Sept. 16, 2010). The collection-of-information requirement for the certification and recordkeeping has been approved by OMB under control number 1910-1400. As described in the NOPR, the public reporting burden for the certification is estimated to average 20 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Public comment is sought regarding: whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to Tina Kaarsberg (seeADDRESSES) and by e-mail toChristine_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 final rule, DOE amends its test procedure for fluorescent lamp ballasts. 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. 4321et seq.) and DOE's implementing regulations at 10 CFR part 1021. Specifically, this rule amends an existing rule without affecting the amount, quality or distribution of energy usage, and, therefore, will not result in any environmental impacts. Thus, this rulemaking is covered by Categorical Exclusion A5 under 10 CFR part 1021, subpart D, which applies to any rulemaking that interprets or amends an existing rule without changing the environmental effect of that rule. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE examined this final rule and determined that it 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. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of today's final rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.

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

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a regulatory action resulting in a rule that may cause the expenditure by State, local, and Tribal governments, in theaggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820; also available athttp://www.gc.doe.gov.DOE examined today's final rule according to UMRA and its statement of policy and determined that the rule contains neither an intergovernmental mandate, nor a mandate that may result in the expenditure of $100 million or more in any year, 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 final rule will not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988), that this regulation will 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 final rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any 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, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.

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

This final test procedure incorporates testing methods contained in the following commercial standards: ANSI C78.81-2010, Revision of ANSI C78.81-2005 (“ANSI C78.81-2010”), American National Standard for Electric Lamps—Double-Capped Fluorescent Lamps—Dimensional and Electrical Characteristics; ANSI C82.1-2004, Revision of ANSI C82.1-1997 (“ANSI C82.1”), American National Standard for Lamp Ballast—Line-Frequency Fluorescent Lamp Ballast; ANSI C82.2-2002, Revision of ANSI C82.2-1994 (R1995), American National Standard for Lamp Ballasts-Method of Measurement of Fluorescent Ballasts; ANSI C82.11-2002, Revision of ANSI C82.11-1993 (“ANSI C82.11”), American National Standard for Lamp Ballasts—High-frequency Fluorescent Lamp Ballasts; ANSI C82.13-2002 (“ANSI C82.13”), American National Standard for Lamp Ballasts—Definitions for Fluorescent Lamps and Ballasts; ANSI C78.375-1997, Revision of ANSI C78.375-1991 (“ANSI C78.375”), American National Standard for Fluorescent Lamps—Guide for Electrical Measurements, first edition; ANSI C82.3-2002, Revision of ANSI C82.3-1983 (R 1995) (“ANSI C82.3”), American National Standard for Reference Ballasts for Fluorescent Lamps. DOE has evaluated these standards and was unable to conclude whether they fully comply 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 has consulted with both the Attorney General and the Chairman of the FTC about the impact on competition of using the methods contained in these standards and has received no comments objecting to their use.

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. 804(2).

The Secretary of Energy has approved publication of this final rule.

For the reasons stated in the preamble, DOE amends part 430 of Chapter II of Title 10, Code of Federal Regulations as set forth below:

The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions are impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel about these special conditions. You can inspect the docket before and after the comment closing date. If you wish to review the docket in person, go to the address in theADDRESSESsection of this preamble between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

If you want us to acknowledge receipt of your comments on these special conditions, include with your comments a self-addressed, stamped postcard on which you have written the docket number. We will stamp the date on the postcard and mail it back to you.

On March 30, 2006, GALP applied for a type certificate for their new Model G250. The Model G250 is an 8-10 passenger (19 maximum), twin-engine airplane with a 41,000-foot cruise altitude, maximum operating altitude of 45,000 feet, and a range of approximately 3,400 nautical miles. Airplane dimensions are 61.69-foot wing span, 66.6-foot overall length, and 20.8-foot tail height. Maximum takeoff weight is 39,600 pounds and maximum landing weight 32,700 pounds. Maximum cruise speed is mach 0.85, dive speed is mach 0.92. The avionics suite will be the Rockwell Collins Pro Line Fusion.

Under the provisions of 14 CFR 21.17, GALP must show that the Model G250meets the applicable provisions of part 25 as amended by Amendments 25-1 through 25-117.

If the Administrator finds that the applicable airworthiness regulations (i.e.,14 CFR part 25) do not contain adequate or appropriate safety standards for the Model G250 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, the special conditions would also apply to the other model.

In addition to the applicable airworthiness regulations and special conditions, the Model G250 airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36; and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under 14 CFR 21.17(a)(2).

The Model G250 will incorporate the following novel or unusual design features:

GALP proposes installing side-facing, single-occupant seats in the Model G250 airplane. FAA has determined that the existing regulations do not provide adequate or appropriate safety standards for occupants of side-facing, single-occupant seats. Therefore, in accordance with § 21.16, special conditions need to be developed to establish a level of safety equivalent to that established in the regulations.

Amendment 25-64 to 14 CFR part 25 was issued June 16, 1988, to revise the emergency-landing conditions that must be considered in the design of an airplane. Amendment 25-64 revised the static-load conditions in § 25.561, and added a new § 25.562 that required dynamic testing of all seats approved for occupancy during takeoff and landing. The intent of Amendment 25-64 was to provide an improved level of safety for occupants on transport-category airplanes. Because most seating is forward/aft facing on transport-category airplanes, the pass/fail criteria developed in Amendment 25-64 focused primarily on these seats. Side-facing seat installations were not adequately taken into account for transport-category airplanes when this amendment was issued. Therefore, in November of 1997, the FAA issued Memorandum “Side-Facing Seats on Transport Category Airplanes” and draft Issue Paper “Dynamic Test Requirements for Single Place Side-Facing Seats” to address the dynamic certification of side-facing seats. The memorandum and the issue paper introduced requirements for Thoracic Trauma Index (TTI) and lateral pelvic acceleration, which were in addition to the existing injury criteria requirements of § 25.562(c). The specified conditions are required to be measured during dynamic testing of the side-facing seats and in compliance with the limitations to be demonstrated.

As discussed above, these special conditions are applicable to the Model G250. Should GALP apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability.

Under standard practice, the effective date of final special conditions would be 30 days after the date of publication in theFederal Register. However, as the certification date for the Model G250 is imminent, the FAA finds that good cause exists to make these special conditions effective upon issuance.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type-certification basis for GALP Model G250 airplanes.

In addition to the airworthiness standards in §§ 25.562 and 25.785, the following special conditions provide injury criteria and installation/testing guidelines that represent the minimum acceptable airworthiness standard for side-facing, single-occupant seats:

(a)Existing Criteria:All injury protection criteria of § 25.562(c)(1) through (c)(6) apply to the occupant of a side-facing seat. Head-injury criterion (HIC) assessments are only required for head contact with the seat and/or adjacent structures.

(b)Body-to-Wall/Furnishing Contact:The seat must be installed aft of a structure, such as an interior wall or furnishing, that will support the pelvis, upper arm, chest, and head of an occupant seated next to the structure. A conservative representation of the structure and its stiffness must be included in the tests. It is recommended, but not required, that the contact surface of this structure be covered with at least two inches of energy-absorbing protective padding (foam or equivalent) such as Ensolite.

(c)Thoracic Trauma:TTI injury criterion must be substantiated by dynamic test or by rational analysis based on previous test(s) of a similar seat installation. Testing must be conducted with a Side Impact Dummy (SID) Anthropomorphic Test Device (ATD), as defined by 49 CFR part 572, Subpart F, or its equivalent. TTI must be less than 85, as defined in 49 CFR part 572, subpart F. SID TTI data must be processed as defined in Federal Motor Vehicle Safety Standard (FMVSS) part 571.214, section S6.13.5.

(d)Pelvis:Lateral pelvic acceleration must be shown by dynamic test or by rational analysis, based on previous test(s) of a similar seat installation, to not exceed 130g. Pelvic acceleration data must be processed as defined in FMVSS part 571.214, section S6.13.5.

(e)Shoulder Strap Loads:Where upper-torso straps (shoulder straps) are used for occupants, tension loads in individual straps must not exceed 1,750 pounds. If dual straps are used for restraining the upper torso, the total strap-tension loads must not exceed 2,000 pounds.

(a)One longitudinal test with the SID ATDor its equivalent, undeformed floor, no yaw, and with all lateral structural supports (armrests/walls).

Pass/fail injury assessments: TTI and pelvic acceleration.

(b)One longitudinal test with the Hybrid II ATD,deformed floor, with 10 degrees yaw, and with all lateral structural supports (armrests/walls).

Pass/fail injury assessments: HIC; and upper-torso-restraint load, restraint-system retention, and pelvic acceleration.

(c)A vertical (14G) testis to be conducted with modified Hybrid II ATDs with existing pass/fail criteria.

This rule amends Title 14, Code of Federal Regulations, part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of Title 14 of the Code of Federal Regulations.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in theFederal Registerexpensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAP and the corresponding effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs.

The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involvesan established body of technical regulations for which frequentand routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR11034; February 26, 1979); and (3) does not warrant preparationof a regulatory evaluation as the anticipated impact is sominimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, 14 CFR part 97, is amended by amending Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows:

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS. The complete regulators description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in theFederal Registerexpensive and impractical. Furthermore, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their depiction on charts printed by publishers of aeronautical materials. The advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA forms is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs and the effective dates of the, associated Takeoff Minimums and ODPs. This amendment also identifies the airport and its location, the procedure, and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as contained in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPS and Takeoff Minimums and ODPS, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPS contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPS and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedures before adopting these SIAPS, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(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)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure Procedures effective at 0902 UTC on the dates specified, as follows:

In a notice published in theFederal Registerof November 18, 2009 (74 FR 59560), FDA announced that a color additive petition (CAP 8C0287) had been filed by Sauflon Pharmaceuticals Ltd., 49-53 York St., Twickenham, Middlesex, TW1 3LP, United Kingdom. The petition proposed to amend the color additive regulations in part 73 (21 CFR part 73), subpart D,Medical Devices,to provide for the safe use of disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (Reactive Blue 69) (CAS Reg. No. 70209-99-3, Colour Index No. 612037) as a color additive in contact lenses. The petition was filed under section 721 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e).

Under section 721(b)(4) of the FD&C Act, a color additive may not be listed for a particular use unless a fair evaluation of the data and information available to FDA establishes that the color additive is safe for that use. FDA's color additive regulations at 21 CFR 70.3(i) define safe to mean that there is “convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.”

During its review of the safety of the use of Reactive Blue 69 pigment in contact lenses, the Agency considered the exposure to the color additive from the petitioned use. Based on information submitted in the petition, the Agency notes that it is highly unlikely that Reactive Blue 69 will migrate out of the contact lens into the aqueous environment of the eye because the color additive is covalently incorporated (copolymerized) into the polymeric lens matrix. Therefore, the Agency concludes that the exposure to the color additive, including any impurities that may be present in it,from the petitioned use would be negligible (Ref. 1).

To establish that Reactive Blue 69 is safe for use in contact lenses, the petitioner submitted toxicity data from various studies. In a primary ocular irritation study in rabbits, there was no evidence of ocular irritation from saline and cottonseed oil extracts of the tinted lens material. The petitioner also conducted tests on lens extracts systemically injected into mice and cytotoxicity studies of lens extracts using L-959 mouse fibroblast cells. Neither study produced any evidence of toxicity (Ref. 2).

Based on the data contained in the petition and other available relevant material, FDA concludes that the petitioned use of the color additive in contact lenses is safe and that the color additive will achieve its intended technical effect. FDA also concludes that there is no need for imposing a limitation on the amount of the color additive that may be present in the lens, beyond the limitation that only the amount necessary to accomplish the intended technical effect may be used. Therefore, the regulations in part 73 should be amended as set forth in this document. In addition, based upon the factors listed in 21 CFR 71.20(b), the Agency concludes that certification of Reactive Blue 69 is not necessary for the protection of the public health.

In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition will be made available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (seeFOR FURTHER INFORMATION CONTACT). As provided in § 71.15, the Agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

The Agency has previously considered the environmental effect of this rule as announced in the notice of filing for CAP 8C0287 (74 FR 59560, November 18, 2009). No new information or comments have been received that would affect the Agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

This rule is effective as shown in theDATESsection of this document; except as to any provisions that may be stayed by the filing of proper objections. Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (seeADDRESSES) either electronic or written objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. It is only necessary to send one set of documents. It is no longer necessary to send three copies of all documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will publish notice of the objections that the Agency has received or lack thereof in theFederal Register.

The following references have been placed on display in the Division of Dockets Management (seeADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 73 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 underFOR 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 athttp://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-2007-1077 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 July 5, 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 78, 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-2007-1077, 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 theFederal Registerof December 22, 2010 (75 FR 80489) (FRL-8857-8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 0E7811) by Whitmire Micro-Gen Research Laboratories, Inc., c/o Landis International, Inc., P.O. Box 5126, Valdosta, GA 31603-5126. The petition requested that 40 CFR 180.910 and 40 CFR 180.930 be amended by establishing an exemption from the requirement of a tolerance for residues of carbon dioxide (CAS Reg. No. 124-38-9) when used as an inert ingredient as a propellant in pesticide formulations applied pre-harvest and post-harvest under 40 CFR 180.910 and applied to animals under 40 CFR 180.930. That notice referenced a summary of the petition prepared by Whitmire Micro-Gen Research Laboratories, Inc., c/o Landis International, Inc., the petitioner, which is available in the docket,http://www.regulations.gov.(Docket ID number EPA-HQ-OPP-2007-1077). There were no comments received in response to the notice of filing.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but arenot 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 residue. * * *”

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 carbon dioxide including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with carbon dioxide follows.

EPA has evaluated the available toxicity data for carbon dioxide 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. The primary sources of data for this assessment are the U.S. EPA's 1991, Reregistration Eligibility Decision document (RED) that included carbon dioxide (US EPA RED, 1991), and the Report of the FQPA Tolerance Reassessment Progress and Risk Management Decision (TRED) for Carbon Dioxide issued by EPA in 2004. The Agency has not found any more recent information that would change the conclusions found in these documents. Therefore, these documents are being used to evaluate the proposed exemption from the requirement of a tolerance for use as an inert ingredient as a propellant applied pre-harvest and post-harvest under 40 CFR 180.910 and applied to animals under 40 CFR 180.930. Specific information on the studies received and the nature of the adverse effects caused by carbon dioxide can be found in these documents athttp://www.regulations.gov,“Reregristration Eligibility Document (RED) for Carbon and Carbon Dioxide”, “Lower Risk Pesticide Chemical Focus Group's Assessment for Carbon Dioxide Tolerance Reassessment (TRED)”, and “PC code 800029; Decision Document for Pesticide Petition 0E7811; Carbon Dioxide (CAS Reg. No. 124-38-9) for Use as an Inert Ingredient as a Propellant Applied Pre-Harvest and Post-Harvest Under 40 CFR 180.910 and For Use on Animals Under 40 CFR 180.930.” found in docket ID number EPA-HQ-OPP-2007-1077.

The toxicology data for carbon dioxide are all derived from inhalation studies using high concentrations of carbon dioxide. Although these data show carbon dioxide does pose some hazard at concentrations well above normal atmospheric levels, these data have limited relevance to evaluating the safety of carbon dioxide residues in food. Because it is a gas, carbon dioxide would be expected to leave little or no residues on plant commodities, and, to the extent carbon dioxide is absorbed by the plant, it would likely be converted by the photosynthesis process into sugars and other organic compounds that are not of toxicological concern.

In evaluating the human toxicity of carbon dioxide, it is relevant to consider that “carbon dioxide is produced by the body's metabolism and is always present in the body at about 6 percent concentration. An average adult human will produce more than 500g of carbon dioxide daily under resting conditions, and will produce much more when active.” (US EPA RED, 1991). It is on this basis that the Food and Drug Administration has classified carbon dioxide as Generally Recognized As Safe (21 CFR 184.1240) as a direct food additive. As the discussion in Unit IV.D. on exposure reveals, even worst case theoretical levels of carbon dioxide residues in food would be dwarfed by normal body levels of carbon dioxide.

Considering its presence in the environment and in the human body, the additional toxicological contribution of carbon dioxide through the proposed use is expected to be minimal. Therefore, the Agency has determined that a qualitative assessment for all pathways of human exposure to carbon dioxide (food, drinking water, and residential) is appropriate.

1. Dietary exposures (from food and drinking water).In evaluating dietary exposure to carbon dioxide, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from carbon dioxide in food and drinking water as follows:

No residue data were submitted for carbon dioxide; however, carbon dioxide is not expected to accumulate in treated raw agricultural commodities, rather, it will diffuse into the atmosphere following application due to its physical and chemical properties. In the absence of reliable data regarding dietary exposures to carbon dioxide, theAgency assessed dietary exposure using its highly conservative Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM, Version 2.03). This approach uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found athttp://www.regulations.govin docket ID number EPA-HQ-OPP-2008-0738.

The Agency believes the assumptions used to estimate dietary exposures led to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. For example, the model assumes that the inert ingredients are used on all commodities and that residues will be present for every consumed commodity at the highest tolerance level residue for all food forms (including meat, milk, poultry, and eggs), using default processing factors for dried commodities and assuming that 100% of all crops are “treated” with the inert ingredient. In addition, a default concentration of 100 parts per billion (ppb) was assumed for the inert ingredient residues in drinking water. Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data. Even with the extremely conservative nature of this screening level model, the estimated dietary (food and drinking water) exposures from carbon dioxide when used in pesticide formulations are 10,000 fold less than the amount of carbon dioxide naturally produced by the human body each day.

2. 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). Obviously, humans are exposed through respiration to carbon dioxide in the atmosphere. Dietary exposure from naturally-carbonated and artificially-carbonated beverages is also ubiquitous. The discussion in this Unit focuses on additional exposures from use of carbon dioxide as a propellant in pesticide products.

i. Dermal exposure.In evaluating the potential for exposure from the use of carbon dioxide in residential pesticide products, dermal exposures of concern are not anticipated due to its physical and chemical properties and dissipating nature.

ii. Inhalation exposures.Inhalation is the primary route of exposure from carbon dioxide because of its high vapor pressure. Because of the potential increased risk to acute inhalation exposure from indoor uses, EPA used its conservative Exposure and Fate Assessment Screening Tool (E-FAST v.2.0) screening level model to estimate the potential for inhalation exposures from indoor uses of carbon dioxide as a propellant in residential pesticide products. E-Fast was developed by EPA's Office of Pollution, Prevention and Toxics as a tool to estimate concentrations of chemicals released from consumer products. Modeled estimates of concentrations and doses are designed to significantly overestimate exposures for use in a screening level assessment. For carbon dioxide, E-FAST's aerosol paint scenario was selected because it potentially resembles a use of a residential pesticide product using carbon dioxide as a propellant. This scenario estimates potential acute inhalation exposure over 20 minutes of aerosol paint use in an enclosed utility room. The Agency considers an acute inhalation exposure to be a single event occurring over a period of less than 24 hours. In this case, the E-FAST model generated estimates of exposure are expected to be greater than what is reasonably anticipated from the use of carbon dioxide as an inert ingredient in residential-use pesticide products. The concentration of carbon dioxide in aerosol paint products used in the E-FAST model was 100%. The results of the conservative E-FAST modeling show a peak concentration potential of 4,923 parts per million (ppm) (8,860 mg/m3). EPA does not expect actual exposure from residential use of carbon dioxide as a propellant as an inert ingredient in pesticide products to exceed these modeling estimates (peak concentration potential of 4,923 ppm (8,860 mg/m3)) and expects that outdoor exposure concentrations would also be lower.

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 carbon dioxide to share a common mechanism of toxicity with any other substances, and carbon dioxide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that carbon dioxide 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 athttp://www.epa.gov/pesticides/cumulative.

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.

EPA has not used a quantitative risk assessment approach based on safety factors for carbon dioxide residues given that normal atmospheric levels of carbon dioxide do not pose a hazard, carbon dioxide is necessary to the proper functioning of the human body, and exposure to carbon dioxide residues from use in pesticide products is miniscule compared to existing environmental levels. For the same reasons, an additional safety factor to protect children is not needed.

EPA expects aggregate exposure to carbon dioxide residues to pose no appreciable risk to human health given that normal atmospheric levels of carbon dioxide do not pose a hazard. Carbon dioxide is necessary to the proper functioning of the human body, and it is unlikely that the use of carbondioxide as an inert ingredient as a propellant in pesticide products will result in residues in food that measurably add to carbon dioxide exposure. Even potential non-dietary acute inhalation exposure from indoor uses was conducted using the extremely conservative E-FAST screening level model (described under Unit IV.C.2b), showed maximum levels of exposure of 4,923 ppm, well below the maximum permitted exposure limits established as safe by Office of Safety Health Administration (OSHA) or National Institute of Occupational and Health (NIOSH) (30,000 ppm).

Taking into consideration all available information on carbon dioxide, 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 carbon dioxide under reasonably foreseeable circumstances. Therefore, the establishment of an exemption from tolerance for residues of carbon dioxide (CAS Reg. No. 124-38-9) when used as an inert ingredient as a propellant in pesticide formulations applied pre- and post-harvest under 40 CFR 180.910 and when applied to animals under 40 CFR 180.930 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 carbon dioxide.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 and 40 CFR 180.930 for residues of carbon dioxide (CAS Reg. No. 124-38-9) when used as an inert ingredient in pesticide formulations as a propellant in pre- and post-harvest applications under 40 CFR 180.910 and when applied to animals under 40 CFR 180.930.

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, entitledRegulatory 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, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection 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. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitledFederal 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. 601et 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, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation 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. 801et 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 theFederal Register. This final rule is not by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

I. General Information A. Does this action apply to me?

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 underFOR 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 cite athttp://www.gpoaccess.gov/ecfr.

Under section 408(g) of FFDCA, 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-2008-0771 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before July 5, 2011.

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 that is described inADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2008-0771, 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 theFederal Registerof June 23, 2010 (75 FR 35803) (FRL-8831-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F7712) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.586 be amended by establishing tolerances for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on mustard, seed at 0.01 parts per million (ppm). That notice referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available to the public in the docket,http://www.regulations.gov.There were no comments received in response to the notice of filing.

Bayer CropScience requested tolerances for residues of clothianidin to support mustard, seed treatment uses.

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 the petitioned-for tolerances for clothianidin. EPA's assessment of exposures and risks associated with clothianidin 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.

EPA considered the toxicity of clothianidin as well as several metabolites and degradates in conducting this risk assessment. Metabolites/degradates of concern in plants include parent and TMG for leafy and root and tuber vegetables; parent-only for other crops; and parent, TZNG and MNG for rotational crops. For livestock commodities, the metabolites/degradates of concern include: Parent and TZU, TZG, TZNG and ATMG-pyruvate for ruminants; and parent and TZU, TZG, TZNG, and ATG-acetate for poultry. Acute toxicity and genotoxicity data are available for several metabolites/degradates of clothianidin. Given that the points of departure (POD) used for risk assessment are well below the LD50levels observed in the acute toxicology studies and that clothianidin and its metabolites/degradates of toxicological concern are similar in structure, EPA is assuming that these compounds are toxicologically equivalent to clothianidin with respect to the endpoints being used for risk assessment.

Clothianidin and its metabolites and degradates have relatively low acute toxicity via oral, dermal and inhalation routes of exposure; however, acute oral administration of clothianidin in mouse and the TMG metabolite in rat showed evidence of increased relative toxicity. There is no evidence of dermal sensitization or eye irritation with the exception of the clothianidin-triazan intermediate, which is a dermal sensitizer. The available data indicate that there are no consistent target organs in mammals; however, some effects noted in the liver, hematopoietic system and kidney are similar to effects from other neonicotinoid insecticides.

In subchronic oral studies, the dog seemed to be more sensitive to clothianidin than the rat. In addition to decreases in body weight and body weight gains observed in both animals, dogs also displayed decreased white blood cells, albumin and total protein, as well as some anemia. Long-term dietary administration of clothianidin did not result in a wider spectrum of effects in the dog; in contrast, the chronic feeding studies in rats showed additional effects in the liver, ovaries and kidneys. In the mouse chronic oral study, increases in vocalization and decreases in body weight and body weight gain were noted.

Based on the lack of significant tumor increases in two adequate rodent carcinogenicity studies, EPA has classified clothianidin as “not likely to be carcinogenic to humans.” A bone marrow micronucleus assay in mice showed that clothianidin is neither clastogenic nor aneugenic up to a toxic oral dose. Additionally, a study on the livers of Wistar male mice showed no induction of unscheduled DNA sysnthesis up to the limit dose; therefore, mutagenicity is not of concern.

Clinical signs of neurotoxicity were exhibited in both rats (decreased arousal, motor activity and locomotor activity) and mice (decreased spontaneous motor activity, tremors and deep respirations) in acute neurotoxicity studies following exposure by gavage; however, no indications of neurotoxicity were observed following dietary exposure in the subchronic neurotoxicity study in rats.

There was no evidence of increased quantitative or qualitative susceptibility of rat or rabbit fetuses followingin uteroexposure to clothianidin in developmental studies; however, increased quantitative susceptibility of rat pups was seen in both the reproduction and developmental neurotoxicity studies. In the rat reproduction study, offspring toxicity (decreased body weight gains and absolute thymus weights in pups, delayed sexual maturation and an increase in stillbirths) was observed in the absence of maternal effects. In the developmental neurotoxicity study in rats, offspring effects (decreased bodyweights, body weight gains, motor activity and acoustic startle response amplitude) were noted at doses lower than those resulting in maternal toxicity.

Decreased absolute and relative thymus and spleen weights were observed in multiple studies; these studies showed possible evidence of effects on the immune system. In addition, juvenile rats in the rat reproduction study appeared to be more susceptible to these effects. However, a guideline immunotoxicity study showed no evidence of clothianidin-mediated immunotoxicity in adult rats and a developmental immunotoxicity study demonstrated no increased susceptibility for offspring with regard to immunotoxicity.

Specific information on the studies received and the nature of the adverse effects caused by clothianidin 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 athttp://www.regulations.govin document “Clothianidin: Human Health Risk Assessment for Proposed Uses on Berries (Group 13-07H), Brassica Vegetables (Group 5), Cotton, Cucurbit Vegetables (Group 9), Fig, Fruiting Vegetables (Group 8), Leafy Green Vegetables (Group 4A), Peach, Pomegranate, Soybean, Tree Nuts (Group 14), and Tuberous and Corm Vegetables (Group 1C)” in docket ID number EPA-HQ-OPP-2008-0945.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological 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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

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

Background

The ocean salmon fisheries in the EEZ off Washington, Oregon, and California are managed under a “framework” fishery management plan entitled the Pacific Coast Salmon Fishery Management Plan (Salmon FMP). Regulations at 50 CFR part 660, subpart H, provide the mechanism for making preseason and inseason adjustments to the management measures, within limits set by the Salmon FMP, by notification in theFederal Register.

The management measures for the 2011 and pre-May 2012 ocean salmon fisheries that are implemented in this final rule were recommended by the Pacific Fishery Management Council (Council) at its April 9 to 15, 2011, meeting.

The Council announced its annual preseason management process for the 2011 ocean salmon fisheries in theFederal Registeron December 21, 2010 (75 FR 80041), and on the Council's Web site at (http://www.pcouncil.org). This notice announced the availability of Council documents as well as the dates and locations of Council meetings and public hearings comprising the Council's complete schedule of events for determining the annual proposed and final modifications to ocean salmon fishery management measures. The agendas for the March and April Council meetings were published in theFederal Registerand posted on the Council's Web site prior to the actual meetings.

In accordance with the Salmon FMP, the Council's Salmon Technical Team (STT) and staff economist prepared four reports for the Council, its advisors, and the public. All four reports were posted on the Council's Web site and otherwise made available to the Council, its advisors, and the public upon their completion. The first of the reports, “Review of 2010 Ocean Salmon Fisheries,” was prepared in February when the scientific information necessary for crafting management measures for the 2011 and pre-May 2012 ocean salmon fishery first became available. The first report summarizes biological and socio-economic data for the 2010 ocean salmon fisheries and assesses how well the Council's 2010 management objectives were met. The second report, “Preseason Report I Stock Abundance Analysis and Environmental Assessment Part 1 for 2011 Ocean Salmon Fishery Regulations” (PRE I), provides the 2011 salmon stock abundance projections and analyzes the impacts on the stocks and Council management goals if the 2010 regulations and regulatory procedures were applied to the projected 2011 stock abundances. The completion of PRE I is the initial step in evaluating the full suite of preseason alternatives.

Following completion of the first two reports, the Council met in Vancouver, WA from March 5 to 11, 2011, to develop 2011 management alternatives for proposal to the public. The Council proposed three alternatives for commercial and recreational fisheries management for analysis and public comment. These alternatives consisted of various combinations of management measures designed to protect weak stocks of coho and Chinook salmon, and to provide for ocean harvests of more abundant stocks. After the March Council meeting, the Council's STT and staff economist prepared a third report, “Preseason Report II Proposed Alternatives and Environmental Assessment Part 2 for 2011 Ocean Salmon Fishery Regulations” (PRE II), which analyzes the effects of the proposed 2011 management options.

Public hearings, sponsored by the Council, to receive testimony on the proposed alternatives were held on March 28, 2011, in Westport, WA and Coos Bay, OR; and March 29, 2011, in Eureka, CA. The States of Washington, Oregon, and California sponsored meetings in various forums that also collected public testimony, which was then presented to the Council by each state's Council representative. The Council also received public testimony at both the March and April meetings and received written comments at the Council office.

The Council met from April 9 to 15, 2011, in San Mateo, CA to adopt its final 2011 recommendations. Following the April Council meeting, the Council's STT and staff economist prepared a fourth report, “Preseason Report III Analysis of Council-Adopted Management Measures for 2011 Ocean Salmon Fisheries” (PRE III), which analyzes the environmental and socio-economic effects of the Council's final recommendations. After the Council took final action on the annual ocean salmon specifications in April, it published the recommended management measures in its newsletter and also posted them on the Council Web site (http://www.pcouncil.org).

The Council's documents described above (PRE I, PRE II, and PRE III) collectively comprise the Environmental Assessment (EA) for this action, providing analysis of environmental and socioeconomic effects under the National Environmental Policy Act (NEPA). The EA and its related Finding of No Significant Impact (FONSI) are posted on the NMFS Northwest Region Web site (http://www.nwr.noaa.gov).

Fisheries south of Cape Falcon, OR are limited primarily by the status of Sacramento River winter Chinook salmon and California Coastal Chinook salmon, which are both evolutionarily significant units (ESU) listed under the Endangered Species Act (ESA), and Klamath River fall Chinook salmon. Fisheries north of Cape Falcon are limited by Lower Columbia River Chinook salmon and Lower Columbia River coho salmon, stocks which are also listed under the ESA, and by Thompson River coho from Canada. At the start of the preseason planning process for the 2011 management season, NMFS provided a letter to the Council, dated March 3, 2011, summarizing its ESA consultation standards for listed species as required by the Salmon FMP. The Council's recommended management measures comply with NMFS ESA consultation standards and guidance for those listed salmon species that may be affected by Council fisheries. In most cases, the recommended measures are more restrictive than NMFS's ESA requirements.

The Sacramento River fall Chinook salmon stock (SRFC) is the major contributing stock to ocean Chinook salmon fisheries off Oregon and California. Chinook salmon fisheries south of Cape Falcon were largely closed in 2008 and 2009 to conserve SRFC in response to low preseason abundance forecasts. In 2010, animproved stock forecast of 245,000 supported limited fisheries south of Cape Falcon. 2010 spawning escapement for SRFC was 125,353, which, while lower than projected, met the stock's conservation objective of 122,000-180,000 adult natural and hatchery spawners. Preseason forecasts for 2011 project a SRFC stock abundance of 729,900 adults.

In 2010, NMFS consulted under ESA section 7 and provided guidance to the Council regarding the effects of Council area fisheries on the Sacramento River winter Chinook salmon ESU. NMFS completed a Biological Opinion that includes a reasonable and prudent alternative (RPA) to avoid jeopardizing the continued existence of this ESU. The RPA includes management area specific fishing season openings and closures, and minimum size limits for both commercial and recreational fisheries. The Council incorporated the RPA into their recommended 2011 management measures.

NMFS last consulted under ESA section 7 regarding the effects of Council area fisheries on California Coastal Chinook salmon in 2005. Klamath River fall Chinook are used as a surrogate to set limits on ocean harvest impacts. The Biological Opinion requires that management measures result in an age-4 ocean harvest rate of no greater than 16%. This objective is met by the Council's recommended 2011 management measures.

Klamath River Fall Chinook (KRFC) were determined to be overfished based on escapement levels below the conservation objective of an average escapement of 33-34% of potential spawners and no fewer than 35,000 naturally spawning adults in 2004, 2005 and 2006. The Council developed and has implemented a rebuilding plan for the past several years, requiring that the fishery be managed for an escapement of the SMSYlevel of 40,700 (SMSYis the spawning escapement level that is expected to produce the maximum sustainable yield, MSY). Prior to the start of the 2011 preseason planning process, NMFS assessed the status of KRFC and determined that they are rebuilt based on observed escapements from 2007-2010 relative to the SMSYlevel. Therefore, KRFC are managed in 2011 subject to the conservation objective in the FMP.

In 2010, NMFS consulted under ESA section 7 and provided guidance to the Council regarding the effects of Council area fisheries on the Lower Columbia River (LCR) Chinook salmon ESU. NMFS completed a Biological Opinion that applies to fisheries in 2010 and 2011 concluding that the proposed 2011 fisheries, if managed consistent with the terms of the Biological Opinion, are not likely to jeopardize the continued existence of LCR Chinook. The LCR Chinook salmon ESU is comprised of a spring component, a “far-north” migrating bright component, and a component of north migrating tules. The bright and tule components both have fall run timing. There are twenty-one separate populations within the tule component of this ESU. Unlike the spring or bright populations of the ESU, LCR tule populations are caught in large numbers in Council fisheries, as well as fisheries to the north and in the Columbia River. Therefore, this component of the ESU is the one most likely to constrain Council area fisheries. Total exploitation rate on tule populations has been reduced from 49 percent in 2006, to 42 percent in 2007, 41 percent in 2008, 38 percent in 2009 and 2010, and then to 37 percent in 2011.

In 2008, NMFS conducted an ESA section 7 consultation and issued a biological opinion regarding the effects of Council fisheries and fisheries in the Columbia River on Lower Columbia River (LCR) coho. The states of Oregon and Washington use a harvest matrix for LCR coho, developed by Oregon, following their listing under Oregon's State ESA. Under the matrix the allowable harvest in a given year depends on indicators of marine survival and brood year escapement. The matrix has both ocean and in-river components which can be combined to define a total exploitation rate limit for all ocean and in-river fisheries. Generally speaking, NMFS supports use of management planning tools that allow harvest to vary depending on the year-specific circumstances. Conceptually, we think Oregon's approach is a good one. However, NMFS has taken a more conservative approach for LCR coho in recent years because of unresolved issues related to application of the matrix. NMFS will continue to apply the matrix as we have in the past, by limiting the total harvest to that allowed in the portion of the matrix that applies to ocean fisheries. As a consequence, ocean salmon fisheries under the Council's jurisdiction in 2011, and commercial and recreational salmon fisheries in the mainstem Columbia River, including select area fisheries (e.g.,Youngs Bay), must be managed subject to a total exploitation rate limit on LCR coho not to exceed 15 percent. The recommended management measures that would affect LCR coho are consistent with this requirement.

The ESA listing status of Oregon Coast (OC) coho has changed over the years. On February 11, 2008, NMFS again listed OC coho as threatened under the ESA (73 FR 7816 February 11, 2008). Regardless of their listing status, the Council has managed OC coho consistent with the terms of Amendment 13 of the Salmon FMP as modified by the expert advice provided by the 2000 ad hoc Work Group appointed by the Council. NMFS approved the management provisions for OC coho through its section 7 consultation on Amendment 13 in 1999, and has since supported use of the expert advice provided by the Council's ad hoc Work Group. For the 2011 season, the applicable spawner status is in the “high” category, but marine survival index is in the “low” category. Under this circumstance, the Work Group report requires that the exploitation rate be limited to no more than 15 percent. The recommended management measures that would affect OC coho are consistent with this requirement.

Interior Fraser (Thompson River) coho, a Canadian stock, continues to be depressed, remaining in the “low” status category under the Pacific Salmon Treaty and, along with LCR coho, is the coho stock most limiting the 2011 ocean fisheries north of Cape Falcon. The recommended management measures for 2011 satisfy the maximum 10.0 percent total U.S. exploitation rate called for by the Pacific Salmon Treaty agreements and the Salmon FMP.

The Council-recommended ocean harvest levels and management measures for the 2011 fisheries are designed to apportion the burden of protecting the weak stocks identified and discussed in PRE I equitably among ocean fisheries and to allow maximum harvest of natural and hatchery runs surplus to inside fishery and spawning needs. NMFS finds the Council's recommendations responsive to the goals of the Salmon FMP, the requirements of the resource, and the socioeconomic factors affecting resource users. The recommendations are consistent with the requirements of the Magnuson-Stevens Fishery Conservation and Management Act and U.S. obligations to Indian Tribes with Federally recognized fishing rights, and U.S. international obligations regarding Pacific salmon. Accordingly, NMFS has adopted them.

North of Cape Falcon, the 2011 management measures for non-Indian commercial troll and recreationalfisheries have a significantly lower Chinook salmon quota and a similar coho quota relative to the 2010 season. While Chinook abundance in this area is generally improved in 2011 relative to 2010, restrictions are necessary to meet the exploitation rate limit under ESA consultation for Lower Columbia River (LCR) tule Chinook, which is 37 percent in 2011 compared to 38 percent in 2010. In addition, higher fishing levels are expected in Alaskan and Canadian fisheries, resulting in higher impacts on LCR tule Chinook. The North of Falcon fisheries are also managed to protect threatened Lower Columbia River coho, threatened Oregon Coastal Natural coho, and coho salmon from the Thompson River in Canada. Washington coastal and Puget Sound Chinook generally migrate to the far north and are not significantly affected by ocean salmon harvests from Cape Falcon, OR, to the U.S.-Canada border. Nevertheless, ocean fisheries in combination with fisheries inside Puget Sound are restricted in order to meet ESA related conservation objectives for Puget Sound Chinook. North of Cape Alava, WA, the Council recommended a provision prohibiting retention of chum salmon in the salmon fisheries during August and September to protect ESA listed Hood Canal summer chum. The Council has recommended such a prohibition since 2002 (67 FR 30616, May 7, 2002).

South of Cape Falcon, the commercial salmon fishery will have area specific openings throughout the season for all salmon except coho. As in 2010, there will not be a commercial salmon fishery for coho south of Cape Falcon in 2011. Recreational fisheries south of Cape Falcon will be primarily directed at Chinook salmon, with opportunity for coho limited to the area between Cape Falcon and Humbug Mountain, OR. Recreational fisheries south of Cape Falcon will have area specific openings throughout the season. As noted above, the projected abundance of Sacramento River Fall Chinook is significantly higher in 2011 than in 2010. In consideration of the scientific uncertainty in forecasting SRFC stock abundance, the Council designed management measures for fisheries south of Cape Falcon with the goal of achieving the upper end of the conservation objective escapement of 180,000. In fact, under the management measures in this final rule, and including anticipated in-river fishery impacts, spawning escapement for SRFC is projected at 377,000.

The treaty-Indian commercial troll fishery quota for 2011 is 41,000 Chinook salmon in ocean management areas and Washington State Statistical Area 4B combined. This quota is lower than the 55,000 Chinook salmon quota in 2010, for the same reasons discussed above for the non-Tribal fishery. The treaty-Indian commercial troll fisheries include a Chinook-directed fishery in May and June with a quota of 19,750 Chinook salmon, and an all-salmon season beginning July 1 with a 21,250 Chinook salmon sub-quota. The coho quota for the treaty-Indian troll fishery in ocean management areas, including Washington State Statistical Area 4B, for the July-September period is 42,000 coho, similar to the 41,500 coho quota in 2010.

The timing of the March and April Council meetings makes it impracticable for the Council to recommend fishing seasons that begin before May 1 of the same year. Therefore, this action also establishes the 2012 fishing seasons that open earlier than May 1. The Council recommended, and NMFS concurs, that the commercial season off Oregon from Cape Falcon to Humbug Mountain, from Humbug Mountain to the Oregon/California border, the recreational season off Oregon from Cape Falcon to Humbug Mountain, and the recreational season off California from Horse Mountain to the U.S./Mexico border will open in 2012 as indicated in the Season Description section of this document. At the March 2012 meeting, the Council may consider inseason recommendations to adjust the commercial season prior to May 1 in the areas off Oregon and the recreational season off Oregon and California.

The following sections set out the management regime for the salmon fishery. Open seasons and days are described in Sections 1, 2, and 3 of the 2011 management measures. Inseason closures in the commercial and recreational fisheries are announced on the NMFS hotline and through the U.S. Coast Guard Notice to Mariners as described in Section 6. Other inseason adjustments to management measures are also announced on the hotline and through the Notice to Mariners. Inseason actions will also be published in theFederal Registeras soon as practicable.

The following are the management measures recommended by the Council and approved and implemented here for 2011 and, as specified, for 2012.

Parts A, B, and C of this section contain restrictions that must be followed for lawful participation in the fishery. Part A identifies each fishing area and provides the geographic boundaries from north to south, the open seasons for the area, the salmon species allowed to be caught during the seasons, and any other special restrictions effective in the area. Part B specifies minimum size limits. Part C specifies special requirements, definitions, restrictions and exceptions.

May 1 through earlier of June 30 or 20,600 Chinook quota. Seven days per week (C.1). All salmon except coho (C.7). Cape Flattery, Mandatory Yelloweye Rockfish Conservation Area, and Columbia Control Zones closed (C.5). See gear restrictions and definitions (C.2, C.3). An inseason conference call will occur when it is projected that 13,700 Chinook have been landed to consider modifying the open period to five days per week and adding landing and possession limits to ensure the guideline is not exceeded.

July 1 through earlier of September 15 or 10,300 preseason Chinook guideline (C.8) or a 12,800 marked coho quota (C.8.d). Friday through Tuesday; landing and possession limit of 50 Chinook and 50 coho per vessel per open period north of Leadbetter Point or 50 Chinook and 50 coho south of Leadbetter Point (C.1). All Salmon except no chum retention north of Cape Alava, Washington in August and September (C.7). All coho must be marked (C.8.d). See gear restrictions and definitions (C.2, C.3). Cape Flattery, Mandatory Yelloweye Rockfish Conservation Area, and Columbia Control Zones closed; Grays Harbor Control Zone closed in August and September (C.5).

Vessels must land and deliver their fish within 24 hours of any closure of this fishery. Under state law, vessels must report their catch on a state fish receiving ticket. Vessels fishing or in possession of salmon while fishing north of Leadbetter Point must land and deliver their fish within the area and north of Leadbetter Point. Vessels fishing or in possession of salmon while fishing south of Leadbetter Point must land and deliver their fish within the area and south of Leadbetter Point, except that Oregon permitted vesselsmay also land their fish in Garibaldi, Oregon. Oregon State regulations require all fishers landing salmon into Oregon from any fishery between Leadbetter Point, Washington and Cape Falcon, Oregon must notify ODFW within one hour of delivery or prior to transport away from the port of landing by either calling 541-867-0300 Ext. 271 or sending notification via e-mail tonfalcon.trollreport@state.or.us.Notification shall include vessel name and number, number of salmon by species, port of landing and location of delivery, and estimated time of delivery. Inseason actions may modify harvest guidelines in later fisheries to achieve or prevent exceeding the overall allowable troll harvest impacts (C.8).

April 15 through July 9, July 17 through August 31, October 1-31. (C.9). Seven days per week. All salmon except coho; landing and possession limit of 50 Chinook per vessel per calendar week in October (C.7). All vessels fishing in the area must land their fish in the State of Oregon. See gear restrictions and definitions (C.2, C.3) and Oregon State regulations for a description of special regulations at the mouth of Tillamook Bay.

In 2012, the season will open March 15 for all salmon except coho. This opening may be modified following Council review at its March 2012 meeting.

May 1-31;

June 1 through earlier of June 30, or a 1,500 Chinook quota;

July 1 through earlier of July 31, or a 1,200 Chinook quota;

Aug. 1 through earlier of Aug. 31, or a 1,000 Chinook quota (C.9).

In 2012, the season will open March 15 for all salmon except coho, with a 28 inch Chinook minimum size limit. This opening may be modified following Council review at its March 2012 meeting.

July 2 through the earlier of July 20 or a 1,400 Chinook quota, Saturday to Wednesday;

Aug. 1 through earlier of Aug. 15 or a 1,000 Chinook quota, seven days per week (C.9).

California State regulations require all salmon be made available to a CDFG representative for sampling immediately at port of landing. Any person in possession of a salmon with a missing adipose fin, upon request by an authorized agent or employee of the CDFG, shall immediately relinquish the head of the salmon to the state (California Fish and Game Code § 8226).

Closed.

July 23-27; July 29 through Aug. 29; Sept. 1-30 (C.9).

California State regulations require all salmon be made available to a CDFG representative for sampling immediately at port of landing. Any person in possession of a salmon with a missing adipose fin, upon request by an authorized agent or employee of the CDFG, shall immediately relinquish the head of the salmon to the state (California Fish and Game Code § 8226).

May 1-31 seven days per week;

June 25 through July 5 seven days per week;

July 9-27 Saturday through Wednesday;

July 29 through Aug. 29 seven days per week;

September 1-30 seven days per week (C.9).

October 3-14. Monday through Friday. All salmon except coho (C.1). Chinook minimum size limit 27 inches total length (B). All vessels fishing in this area must land and deliver all fish between Point Arena and Pigeon Point (C.1, C.6). See gear restrictions and definitions (C.2, C.3).

California State regulations require all salmon be made available to a CDFG representative for sampling immediately at port of landing. Any person in possession of a salmon with a missing adipose fin, upon request by an authorized agent or employee of the CDFG, shall immediately relinquish thehead of the salmon to the state (California Fish and Game Code § 8226).

May 1-31 seven days per week;

June 25 through July 5 seven days per week;

July 9-27 Saturday through Wednesday;

July 29 through Aug. 29 seven days per week;

September 1-30 seven days per week (C.9).

California State regulations require all salmon be made available to a CDFG representative for sampling immediately at port of landing. Any person in possession of a salmon with a missing adipose fin, upon request by an authorized agent or employee of the CDFG, shall immediately relinquish the head of the salmon to the state (California Fish and Game Code § 8226).

May 1 through July 5 seven days per week;

July 9-27 Saturday through Wednesday;

July 29 through Aug. 29 seven days per week (C.9).

California State regulations require that all salmon be made available to a CDFG representative for sampling immediately at port of landing. Any person in possession of a salmon with a missing adipose fin, upon request by an authorized agent or employee of the CDFG, shall immediately relinquish the head of the salmon to the state (California Fish and Game Code § 8226).

All salmon on board a vessel must meet the minimum size, landing/possession limit, or other special requirements for the area being fished and the area in which they are landed if the area is open. Salmon may be landed in an area that has been closed more than 96 hours only if the salmon meet the minimum size, landing/possession limit, or other special requirements for the area in which they were caught. Salmon may be landed in an area that has been closed less than 96 hours only if the salmon meet the minimum size, landing/possession limit, or other special requirements for the areas in which they were caught and landed.

States may require fish landing/receiving tickets to be kept on board the vessel for 90 days after landing to account for all previous salmon landings.

a. Salmon may be taken only by hook and line using single point, single shank, barbless hooks.

b. Cape Falcon, Oregon, to the OR/CA border: No more than 4 spreads are allowed per line.

c. OR/CA border to U.S./Mexico border: No more than 6 lines are allowed per vessel, and barbless circle hooks are required when fishing with bait by any means other than trolling.

Trolling defined:Fishing from a boat or floating device that is making way by means of a source of power, other than drifting by means of the prevailing water current or weather conditions.

Troll fishing gear defined:One or more lines that drag hooks behind a moving fishing vessel. In that portion of the fishery management area (FMA) off Oregon and Washington, the line or lines must be affixed to the vessel and must not be intentionally disengaged from the vessel at any time during the fishing operation.

Spread defined:A single leader connected to an individual lure or bait.

Circle hook defined:A hook with a generally circular shape and a point which turns inward, pointing directly to the shank at a 90°angle.

It is unlawful for a vessel to have troll or recreational gear in the water while transiting any area closed to fishing for a certain species of salmon, while possessing that species of salmon; however, fishing for species other than salmon is not prohibited if the area is open for such species, and no salmon are in possession.

a. Cape Flattery Control Zone—The area from Cape Flattery (48°23′00″ N. lat.) to the northern boundary of the U.S. EEZ; and the area from Cape Flattery south to Cape Alava (48°10′00″ N. lat.) and east of 125°05′00″ W. long.

b. Mandatory Yelloweye Rockfish Conservation Area—The area in Washington Marine Catch Area 3 from 48°00.00′ N. lat.; 125°14.00′ W. long. to 48°02.00′ N. lat.; 125°14.00′ W. long. to 48°02.00′ N. lat.; 125°16.50′ W. long. to 48°00.00′ N. lat.; 125°16.50′ W. long. and connecting back to 48°00.00′ N. lat.; 125°14.00′ W. long.

c. Grays Harbor Control Zone—The area defined by a line drawn from the Westport Lighthouse (46°53′18″ N. lat., 124°07′01″ W. long.) to Buoy #2 (46°52′42″ N. lat., 124°12′42″ W. long.) to Buoy #3 (46°55′00″ N. lat., 124°14′48″ W. long.) to the Grays Harbor north jetty (46°36′00″ N. lat., 124°10′51″ W. long.).

d. Columbia Control Zone—An area at the Columbia River mouth, bounded on the west by a line running northeast/southwest between the red lighted Buoy #4 (46°13′35″ N. lat., 124°06′50″ W. long.) and the green lighted Buoy #7 (46°15′09′ N. lat., 124°06′16″ W. long.); on the east, by the Buoy #10 line which bears north/south at 357° true from the south jetty at 46°14′00″ N.lat.,124°03′07″ W. long. to its intersection with the north jetty; on the north, by a line running northeast/southwest between the green lighted Buoy #7 to the tip of the north jetty (46°15′48″ N. lat., 124°05′20″ W. long.), and then along the north jetty to the point of intersection with the Buoy #10 line; and, on the south, by a line running northeast/southwest between the red lighted Buoy #4 and tip of the south jetty (46°14′03″ N. lat., 124°04′05″ W. long.), and then along the south jetty to the point of intersection with the Buoy #10 line.

e. Klamath Control Zone—The ocean area at the Klamath River mouth bounded on the north by 41°38′48″ N. lat. (approximately six nautical miles north of the Klamath River mouth); on the west, by 124°23′00″ W. long. (approximately 12 nautical miles off shore); and on the south, by 41°26′48″ N. lat. (approximately six nautical miles south of the Klamath River mouth).

If prevented by unsafe weather conditions or mechanical problems from meeting special management area landing restrictions, vessels must notify the U.S. Coast Guard and receive acknowledgment of such notification prior to leaving the area. This notification shall include the name of the vessel, port where delivery will be made, approximate amount of salmon (by species) on board, the estimated time of arrival, and the specific reason the vessel is not able to meet special management area landing restrictions.

In addition to contacting the U.S. Coast Guard, vessels fishing south of the Oregon/California border must notify CDFG within one hour of leaving the management area by calling 800-889-8346 and providing the same information as reported to the U.S. Coast Guard. All salmon must be offloaded within 24 hours of reaching port.

During authorized periods, the operator of a vessel that has been issued an incidental halibut harvest license may retain Pacific halibut caught incidentally in Area 2A while trolling for salmon. Halibut retained must be no less than 32 inches (81.28 cm) in total length, measured from the tip of the lower jaw with the mouth closed to the extreme end of the middle of the tail, and must be landed with the head on. License applications for incidental harvest must be obtained from the International Pacific Halibut Commission (IPHC) (phone: 206-634-1838). Applicants must apply prior to April 1 of each year. Incidental harvest is authorized only during May and June troll seasons and after June 30 if quota remains and if announced on the NMFS hotline (phone: 800-662-9825). ODFW and Washington Department of Fish and Wildlife (WDFW) will monitor landings. If the landings are projected to exceed the 28,126 pound preseason allocation or the total Area 2A non-Indian commercial halibut allocation, NMFS will take inseason action to prohibit retention of halibut in the non-Indian salmon troll fishery.

Beginning May 1, IPHC license holders may possess or land no more than one Pacific halibut per each three Chinook, except one Pacific halibut may be possessed or landed without meeting the ratio requirement, and no more than 35 halibut may be possessed or landed per trip. Pacific halibut retained must be no less than 32 inches in total length (with head on).

A “C-shaped” yelloweye rockfish conservation area (YRCA) is an area to be voluntarily avoided for salmon trolling. NMFS and the Council request salmon trollers voluntarily avoid this area in order to protect yelloweye rockfish. The area is defined in the west coast groundfish regulations at 50 CFR 660.70(c) and in West Coast salmon regulations at 50 CFR 660.405, with the following coordinates in the order listed:

In addition to standard inseason actions or modifications already noted under the season description, the following inseason guidance applies:

a. Chinook remaining from the May through June non-Indian commercial troll harvest guideline north of Cape Falcon may be transferred to the July through September harvest guideline on a fishery impact equivalent basis.

b. Chinook remaining from the June and/or July non-Indian commercial troll quotas in the Oregon KMZ may be transferred to the Chinook quota for the next open period on a fishery impact equivalent basis.

c. Chinook remaining from the July non-Indian commercial troll quota in the California KMZ area may be transferred to the August quota on a fishery impact equivalent basis.

d. NMFS may transfer fish between the recreational and commercial fisheries north of Cape Falcon on a fishery impact neutral, fishery equivalent basis if there is agreement among the areas' representatives on the Salmon Advisory Subpanel (SAS).

e. At the March 2012 meeting, the Council will consider inseason recommendations for special regulations for any experimental fisheries (proposals must meet Council protocol and be received in November 2011).

f. If retention of unmarked coho is permitted by inseason action, the allowable coho quota will be adjusted to ensure preseason projected mortality of critical stocks is not exceeded.

g. Landing limits may be modified inseason to sustain season length and keep harvest within overall quotas.

Consistent with Council management objectives:

a. The State of Oregon may establish additional late-season fisheries in state waters.

b. The State of California may establish limited fisheries in selected state waters. Check state regulations for details.

Parts A, B, and C of this section contain restrictions that must be followed for lawful participation in the fishery. Part A identifies each fishing area and provides the geographic boundaries from north to south, the open seasons for the area, the salmon species allowed to be caught during the seasons, and any other special restrictions effective in the area. Part B specifies minimum size limits. Part C specifies special requirements, definitions, restrictions and exceptions.

June 18 through earlier of June 25 or a coastwide marked Chinook quota of 4,800 (C.5).

June 26 through earlier of September 18 or 6,990 marked coho subarea quota with a subarea guideline of 3,200 Chinook. (C.5).

June 26 through earlier of September 18 or 1,700 marked coho subarea quota with a subarea guideline of 1,350 Chinook. (C.5).

September 24 through earlier of October 9 or 50 marked coho quota or 50 Chinook quota (C.5) in the area north of 47°50′00 N. lat. and south of 48°00′00″ N. lat.

June 26 through earlier of September 18 or 24,860 marked coho subarea quota with a subarea guideline of 16,900 Chinook (C.5).

June 26 through earlier of September 30 or 33,600 marked coho subarea quota with a subarea guideline of 7,400 Chinook (C.5).

Except as provided below during the all-salmon mark-selective and non-mark-selective coho fisheries, the season will be March 15 through September 30 (C.6).

Cape Falcon to Humbug Mountain all-salmon mark-selective coho fishery: July 2 through earlier of August 13 or a landed catch of 15,000 marked coho.

Cape Falcon to Humbug Mountain non-mark-selective coho fishery: September 1 through the earlier of September 10 or a landed catch of 3,000 non-mark-selective coho quota (C.5).

Fishing in the Stonewall Bank yelloweye rockfish conservation area restricted to trolling only on days the all depth recreational halibut fishery is open (call the halibut fishing hotline 1-800-662-9825 for specific dates) (C.3.b, C.4.d).

In 2012, the season between Cape Falcon and Humbug Mountain will open March 15 for all salmon except coho, two fish per day (B, C.1, C.2, C.3).

May 14 through September 5 (C.6).

May 14 through September 5 (C.6).

California State regulations require that all salmon be made available to a CDFG representative for sampling immediately at port of landing. Any person in possession of a salmon with a missing adipose fin, upon request by an authorized agent or employee of the CDFG, shall immediately relinquish the head of the salmon to the state (California Fish and Game Code § 8226).

April 2 through October 30.

In 2012, season opens April 7 for all salmon except coho, two fish per day (C.1). Chinook minimum size limit of 24 inches total length (B); and the same gear restrictions as in 2011 (C.2, C.3).

California State regulations require that all salmon be made available to a CDFG representative for sampling immediately at port of landing. Any person in possession of a salmon with a missing adipose fin, upon request by an authorized agent or employee of the CDFG, shall immediately relinquish the head of the salmon to the state (California Fish and Game Code § 8226).

April 2 through October 30.

In 2012, season opens April 7 for all salmon except coho, two fish per day (C.1). Chinook minimum size limit of 24inches total length (B); and the same gear restrictions as in 2011 (C.2, C.3).

California State regulations require that all salmon be made available to a CDFG representative for sampling immediately at port of landing. Any person in possession of a salmon with a missing adipose fin, upon request by an authorized agent or employee of the CDFG, shall immediately relinquish the head of the salmon to the state (California Fish and Game Code § 8226).

April 2 through September 18.

In 2012, season opens April 7 for all salmon except coho, two fish per day (C.1). Chinook minimum size limit of 24 inches total length (B); and the same gear restrictions as in 2011 (C.2, C.3).

California State regulations require that all salmon be made available to a CDFG representative for sampling immediately at port of landing. Any person in possession of a salmon with a missing adipose fin, upon request by an authorized agent or employee of the CDFG, shall immediately relinquish the head of the salmon to the state (California Fish and Game Code § 8226).

All salmon on board a vessel must meet the minimum size or other special requirements for the area being fished and the area in which they are landed if that area is open. Salmon may be landed in an area that is closed only if they meet the minimum size or other special requirements for the area in which they were caught.

Ocean Boat Limits: Off the coast of Washington, Oregon, and California, each fisher aboard a vessel may continue to use angling gear until the combined daily limits of salmon for all licensed and juvenile anglers aboard has been attained (additional state restrictions may apply).

Salmon may be taken only by hook and line using barbless hooks. All persons fishing for salmon, and all persons fishing from a boat with salmon on board, must meet the gear restrictions listed below for specific areas or seasons.

a. U.S./Canada Border to Point Conception, California: No more than one rod may be used per angler; and no more than two single point, single shank barbless hooks are required for all fishing gear. [Note:ODFW regulations in the state-water fishery off Tillamook Bay may allow the use of barbed hooks to be consistent with inside regulations.]

b. Horse Mt., California, to Point Conception, California: Single point, single shank, barbless circle hooks (see gear definitions below) are required when fishing with bait by any means other than trolling, and no more than two such hooks shall be used. When angling with two hooks, the distance between the hooks must not exceed five inches when measured from the top of the eye of the top hook to the inner base of the curve of the lower hook, and both hooks must be permanently tied in place (hard tied). Circle hooks are not required when artificial lures are used without bait.

a.Recreational fishing gear defined:Angling tackle consisting of a line with no more than one artificial lure or natural bait attached. Off Oregon and Washington, the line must be attached to a rod and reel held by hand or closely attended; the rod and reel must be held by hand while playing a hooked fish. No person may use more than one rod and line while fishing off Oregon or Washington. Off California, the line must be attached to a rod and reel held by hand or closely attended. Weights directly attached to a line may not exceed four pounds (1.8 kg). While fishing off California north of Point Conception, no person fishing for salmon, and no person fishing from a boat with salmon on board, may use more than one rod and line. Fishing includes any activity which can reasonably be expected to result in the catching, taking, or harvesting of fish.

b.Trolling defined:Angling from a boat or floating device that is making way by means of a source of power, other than drifting by means of the prevailing water current or weather conditions.

c.Circle hook defined:A hook with a generally circular shape and a point which turns inward, pointing directly to the shank at a 90° angle.

a. The Bonilla-Tatoosh Line: A line running from the western end of Cape Flattery to Tatoosh Island Lighthouse (48°23′30″ N. lat., 124°44′12″ W. long.) to the buoy adjacent to Duntze Rock (48°28′00″ N. lat., 124°45′00″ W. long.), then in a straight line to Bonilla Point (48°35′30″ N. lat., 124°43′00″ W. long.) on Vancouver Island, British Columbia.

b. Grays Harbor Control Zone—The area defined by a line drawn from the Westport Lighthouse (46°53′18″ N. lat., 124°07′01″ W. long.) to Buoy #2 (46°52′42″ N. lat., 124°12′42″ W. long.) to Buoy #3 (46°55′00″ N. lat., 124°14′48″ W. long.) to the Grays Harbor north jetty (46°36′00″ N. lat., 124°10′51″ W. long.).

c. Columbia Control Zone: An area at the Columbia River mouth, bounded on the west by a line running northeast/southwest between the red lighted Buoy #4 (46°13′35″ N. lat., 124°06′50″ W. long.) and the green lighted Buoy #7 (46°15′09″ N. lat., 124°06′16″ W. long.); on the east, by the Buoy #10 line which bears north/south at 357° true from the south jetty at 46°14′00″ N. lat., 124°03′07″ W. long. to its intersection with the north jetty; on the north, by a line running northeast/southwest between the green lighted Buoy #7 to the tip of the north jetty (46°15′48″ N. lat., 124°05′20″ W. long.) and then along the north jetty to the point of intersection with the Buoy #10 line; and on the south, by a line running northeast/southwest between the red lighted Buoy #4 and tip of the south jetty (46°14′03″ N. lat., 124°04′05″ W. long.), and then along the south jetty to the point of intersection with the Buoy #10 line.

d. Stonewall Bank Yelloweye Rockfish Conservation Area: The areadefined by the following coordinates in the order listed:

e. Klamath Control Zone: The ocean area at the Klamath River mouth bounded on the north by 41°38′48″ N. lat. (approximately six nautical miles north of the Klamath River mouth); on the west, by 124°23′00″ W. long. (approximately 12 nautical miles off shore); and, on the south, by 41°26′48″ N. lat. (approximately 6 nautical miles south of the Klamath River mouth).

Regulatory modifications may become necessary inseason to meet preseason management objectives such as quotas, harvest guidelines, and season duration. In addition to standard inseason actions or modifications already noted under the season description, the following inseason guidance is provided to NMFS:

a. Actions could include modifications to bag limits, or days open to fishing, and extensions or reductions in areas open to fishing.

b. Coho may be transferred inseason among recreational subareas north of Cape Falcon on a fishery impact equivalent basis to help meet the recreational season duration objectives (for each subarea) after conferring with representatives of the affected ports and the Council's SAS recreational representatives north of Cape Falcon.

c. Chinook and coho may be transferred between the recreational and commercial fisheries north of Cape Falcon on a fishery impact equivalent basis if there is agreement among the representatives of the Salmon Advisory Subpanel (SAS).

d. If retention of unmarked coho is permitted in the area from the U.S./Canada border to Cape Falcon, Oregon, by inseason action, the allowable coho quota will be adjusted to ensure preseason projected mortality of critical stocks is not exceeded.

e. Marked coho remaining from the June/July through August Cape Falcon to Oregon/California border recreational coho quota may be transferred inseason to the September Cape Falcon to Humbug Mountain non-mark-selective recreational fishery on a fishery impact equivalent basis.

Consistent with Council management objectives, the states of Washington, Oregon, and California may establish limited seasons in state waters. Check state regulations for details.

Parts A, B, and C of this section contain requirements that must be followed for lawful participation in the fishery.

May 1 through the earlier of June 30 or 19,750 Chinook quota. All salmon except coho. If the Chinook quota for the May-June fishery is not fully utilized, the excess fish cannot be transferred into the later all-salmon season. If the Chinook quota is exceeded, the excess will be deducted from the later all-salmon season. See size limit (B) and other restrictions (C).

July 1 through the earlier of September 15, or 21,250 preseason Chinook quota, or 42,000 coho quota. All salmon. See size limit (B) and other restrictions (C).

All boundaries may be changed to include such other areas as may hereafter be authorized by a Federal court for that Tribe's treaty fishery.

S'KLALLAM—Washington State Statistical Area 4B (All).

MAKAH—Washington State Statistical Area 4B and that portion of the FMA north of 48°02′15″ N. lat. (Norwegian Memorial) and east of 125°44′00″ W. long.

QUILEUTE—That portion of the FMA between 48°07′36″ N. lat. (Sand Pt.) and 47°31′42″ N. lat. (Queets River) and east of 125°44′00″ W. long.

HOH—That portion of the FMA between 47°54′18″ N. lat. (Quillayute River) and 47°21′00″ N. lat. (Quinault River) and east of 125°44′00″ W. long.

QUINAULT—That portion of the FMA between 47°40′06″ N. lat. (Destruction Island) and 46°53′18″ N. lat. (Point Chehalis) and east of 125°44′00″ W. long.

a. Single point, single shank, barbless hooks are required in all fisheries.

b. No more than eight fixed lines per boat.

c. No more than four hand held lines per person in the Makah area fishery (Washington State Statistical Area 4B and that portion of the FMA north of 48°02′15″ N. lat. (Norwegian Memorial) and east of 125°44′00″ W. long.)

a. The quotas include troll catches by the S'Klallam and Makah Tribes in Washington State Statistical Area 4B from May 1 through September 15.

b. The Quileute Tribe will continue a ceremonial and subsistence fishery during the time frame of September 15 through October 15. Fish taken during this fishery are to be counted against treaty troll quotas established for the 2011 season (estimated harvest during the October ceremonial and subsistence fishery: 100 Chinook; 200 coho).

a. The area within a six nautical mile radius of the mouths of the Queets River (47°31′42″ N. lat.) and the Hoh River (47°45′12″ N. lat.) will be closed to commercial fishing.

b. A closure within two nautical miles of the mouth of the Quinault River (47°21′00″ N. lat.) may be enacted by the Quinault Nation and/or the State of Washington and will not adversely affect the Secretary of Commerce's management regime.

Under the authority of the Northern Pacific Halibut Act, NMFS promulgated regulations governing the Pacific halibut fishery, which appear at 50 CFR part 300, subpart E. On March 16, 2011, NMFS published a final rule (76 FR 14300) to implement the IPHC'srecommendations, to announce fishery regulations for U.S. waters off Alaska and fishery regulations for treaty commercial and ceremonial and subsistence fisheries, some regulations for non-treaty commercial fisheries for U.S. waters off the West Coast, and approval of and implementation of the Area 2A Pacific halibut Catch Sharing Plan and the Area 2A management measures for 2011. The regulations and management measures provide that vessels participating in the salmon troll fishery in Area 2A (all waters off the States of Washington, Oregon, and California), which have obtained the appropriate IPHC license, may retain halibut caught incidentally during authorized periods in conformance with provisions published with the annual salmon management measures. A salmon troller may participate in the halibut incidental catch fishery during the salmon troll season or in the directed commercial fishery targeting halibut, but not both.

The following measures have been approved by the IPHC, and implemented by NMFS. During authorized periods, the operator of a vessel that has been issued an incidental halibut harvest license may retain Pacific halibut caught incidentally in Area 2A while trolling for salmon. Halibut retained must be no less than 32 inches (81.28 cm) in total length, measured from the tip of the lower jaw with the mouth closed to the extreme end of the middle of the tail, and must be landed with the head on. License applications for incidental harvest must be obtained from the International Pacific Halibut Commission (phone: 206-634-1838). Applicants must apply prior to April 1 of each year. Incidental harvest is authorized only during May and June troll seasons and after June 30 if quota remains and if announced on the NMFS hotline (phone: 800-662-9825). ODFW and WDFW will monitor landings. If the landings are projected to exceed the 28,126 pound preseason allocation or the total Area 2A non-Indian commercial halibut allocation, NMFS will take inseason action to close the incidental halibut fishery.

Beginning May 1, IPHC license holders may possess or land no more than one Pacific halibut per each three Chinook, except one Pacific halibut may be possessed or landed without meeting the ratio requirement, and no more than 35 halibut may be possessed or landed per trip. Pacific halibut retained must be no less than 32 inches in total length (with head on).

NMFS and the Council request that salmon trollers voluntarily avoid a “C-shaped” YRCA (North Coast Recreational YRCA, also known as the Salmon Troll YRCA) in order to protect yelloweye rockfish. Coordinates for the Salmon Troll YRCA are specified in groundfish regulations at 50 CFR660.70(c), and in salmon regulations at 50 CFR 660.405. See Section 1.C.7. in this document for the coordinates.

Wherever the words “nautical miles off shore” are used in this document, the distance is measured from the baseline from which the territorial sea is measured.

Geographical landmarks referenced in this document are at the following locations:

Actual notice of inseason management actions will be provided by a telephone hotline administered by the Northwest Region, NMFS, 206-526-6667 or 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts. These broadcasts are announced on Channel 16 VHF-FM and 2182 KHz at frequent intervals. The announcements designate the channel or frequency over which the Notice to Mariners will be immediately broadcast. Inseason actions will also be filed with theFederal Registeras soon as practicable. Since provisions of these management measures may be altered by inseason actions, fishermen should monitor either the telephone hotline or Coast Guard broadcasts for current information for the area in which they are fishing.

This final rule is necessary for conservation and management and is consistent with the Magnuson-Stevens Act. These regulations are being promulgated under the authority of 16 U.S.C. 1855 (d) and 16 U.S.C. 773(c).

This notification of annual management measures is exempt from review under Executive Order 12866.

The provisions of 50 CFR 660.411 state that if, for good cause, an action must be filed without affording a prior opportunity for public comment, the measures will become effective; however, public comments on the action will be received for a period of 15 days after the date of publication in theFederal Register. NMFS will receive public comments on this action until May 19, 2011. These regulations are being promulgated under the authority of 16 U.S.C. 1855 (d) and 16 U.S.C. 773(c).

The Assistant Administrator for Fisheries, NOAA (AA) finds good cause under 5 U.S.C. 553(b)(B), to waive the requirement for prior notice and opportunity for public comment, as such procedures are impracticable and contrary to the public interest.

The annual salmon management cycle begins May 1 and continues through April 30 of the following year. May 1 was chosen because the pre-May harvests constitute a relatively small portion of the annual catch. The time-frame of the preseason process for determining the annual modifications to ocean salmon fishery management measures depends on when the pertinent biological data are available. Salmon stocks are managed to meet annual spawning escapement goals or specific exploitation rates. Achieving either of these objectives requires designing management measures that are appropriate for the ocean abundance predicted for that year. These pre-season abundance forecasts, which are derived from the previous year's observed spawning escapement, vary substantially from year to year, and are not available until January and February because spawning escapement continues through the fall.

The preseason planning and public review process associated with developing Council recommendations is initiated in February as soon as the forecast information becomes available. The public planning process requires coordination of management actions of four states, numerous Indian Tribes, and the Federal Government, all of which have management authority over the stocks. This complex process includes the affected user groups, as well as the general public. The process is compressed into a 2-month period which culminates at the April Council meeting at which the Council adopts a recommendation that is forwarded to NMFS for review, approval and implementation of fishing regulations effective on May 1.

Providing opportunity for prior notice and public comments on the Council's recommended measures through aproposed and final rulemaking process would require 30 to 60 days in addition to the two-month period required for development of the regulations. Delaying implementation of annual fishing regulations, which are based on the current stock abundance projections, for an additional 60 days would require that fishing regulations for May and June be set in the previous year, without the information regarding current stock status. For the 2011 fishing regulations, the current stock status was not available to the Council until February. Because the May and June salmon fisheries are relatively substantial fisheries, managing them with measures developed using the prior year's data could have significant adverse effects on the managed stocks, including ESA-listed stocks. Although salmon fisheries that open prior to May are managed under the prior year's measures, as modified by the Council at its March meeting, relatively little harvest occurs during that period (e.g.,on average, less than 5 percent of commercial and recreational harvest occurred prior to May 1 during the years 2001 through 2010). Allowing the much more substantial harvest levels normally associated with the May and June salmon seasons to be promulgated under the prior year's regulations would impair NMFS' ability to protect weak and ESA listed salmon stocks that are impacted by the fishery, and to provide harvest opportunity where appropriate. The choice of May 1 as the beginning of the regulatory season balances the need to gather and analyze the data needed to meet the management objectives of the Salmon FMP and the need to manage the fishery using the best available scientific information.

If these measures are not in place on May 1, the previous year's management measures will continue to apply in most areas. For fisheries south of Cape Falcon, Oregon, this would result in lost fishing opportunities, primarily for commercial fisheries which were more restrictive in 2010 than proposed for 2011. In 2010, commercial fisheries did not open south of Cape Falcon until July, whereas in 2011 these fisheries were opened in April under inseason action, and would remain open beginning May 1 under 2011 management measures. North of Cape Falcon, if 2011 measures are not in place on May 1, there would be excessive harvest of Chinook salmon, as the Chinook salmon quota for commercial fisheries in May and June is half of the 2010 quota for this fishery to protect ESA listed salmon in the Columbia River.

Overall, the annual population dynamics of the various salmon stocks require managers to vary the season structure of the various West Coast area fisheries to both protect weaker stocks and give fishers access to stronger salmon stocks, particularly hatchery produced fish. Failure to implement these measures immediately could compromise the status of certain stocks, or result in foregone opportunity to harvest stocks whose abundance has increased relative to the previous year thereby undermining the purpose of this agency action. Based upon the above-described need to have these measures effective on May 1 and the fact that there is limited time available to implement these new measures after the final Council meeting in April and before the commencement of the ocean salmon fishing year on May 1, NMFS has concluded it is impracticable and contrary to the public interest to provide an opportunity for prior notice and public comment under 5 U.S.C. 553(b)(B).

The Assistant Administrator for Fisheries (AA) also finds that good cause exists under 5 U.S.C. 553(d)(3), to waive the 30-day delay in effectiveness of this final rule. As previously discussed, data are not available until February and management measures not finalized until mid-April. These measures are essential to conserve threatened and endangered ocean salmon stocks, and to provide for harvest of more abundant stocks. Failure to implement these measures immediately could compromise the ability of some stocks to attain their conservation objectives preclude harvest opportunity, and negatively impact anticipated international, state, and Tribal salmon fisheries, thereby undermining the purposes of this agency action.

To enhance notification of the fishing industry of these new measures, NMFS is announcing the new measures over the telephone hotline used for inseason management actions and is also posting the regulations on both of its West Coast regional Web sites (http://www.nwr.noaa.govandhttp://swr.nmfs.noaa.gov). NMFS is also advising the States of Washington, Oregon, and California on the new management measures. These states announce the seasons for applicable state and Federal fisheries through their own public notification systems.

This action 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 control number 0648-0433. The public reporting burden for providing notifications if landing area restrictions cannot be met is estimated to average 15 minutes per response. This estimate includes 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 (seeADDRESSES) and by e-mail toOIRA.Submission@omb.eop.gov,or fax to 202-395-7285.

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.

NMFS has current ESA biological opinions that cover fishing under these regulations on all listed salmon species. NMFS reiterated their consultation standards for all ESA listed salmon and steelhead species in their annual Guidance letter to the Council dated March 3, 2011. Some of NMFS past biological opinions have found no jeopardy, and others have found jeopardy, but provided reasonable and prudent alternatives to avoid jeopardy. The management measures for 2011 are consistent with the biological opinions that found no jeopardy, and with the reasonable and prudent alternatives in the jeopardy biological opinions. NMFS consulted in 2010 on the effects of the 2011 annual regulations on LCR Chinook salmon. NMFS concluded that the proposed 2011 fisheries are not likely to jeopardize the continued existence of LCR Chinook salmon. NMFS also consulted in 2010 on the effects of the 2011 annual regulations on Sacramento River winter Chinook salmon. NMFS provided a reasonable and prudent alternative in its jeopardy biological opinion, and the 2011 annual regulations are consistent with that RPA. The Council's recommended management measures therefore comply with NMFS' consultation standards and guidance for all listed salmon species which may be affected by Council fisheries. In some cases, the recommended measures result in impacts that are more restrictive than NMFS' ESA requirements.

In 2009, NMFS consulted on the effects of fishing under the Salmon FMP on the endangered Southern Resident Killer Whale Distinct Population Segment (SRKW) and concluded the salmon fisheries were not likely tojeopardize SRKW. The 2011 salmon management measures are consistent with the terms of that biological opinion.

This final rule was developed after meaningful consultation and collaboration with the affected Tribes. The Tribal representative on the Council made the motion for the regulations that apply to the Tribal vessels.