FSIS administers a regulatory program under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) that is intended to ensure that meat and meat food products distributed in commerce are wholesome; not adulterated; and properly marked, labeled, and packaged. As part of its inspection program, FSIS collects samples of these products for laboratory analysis (21 U.S.C. 642(a)).

The Salmonella verification sampling program formally began with the Agency's final rule, entitled “Pathogen Reduction; Hazard Analysis and Critical Control Point (PR/HACCP) Systems,” which FSIS published on July 25, 1996 (61 FR 38805-38989; http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/93-016F.pdf). Among other things, the PR/HACCP rule set Salmonella performance standards for establishments producing selected classes of raw meat products, including ground beef, steers and heifers, and cows and bulls (9 CFR 310.25(b)). In 2011, FSIS stopped sampling and testing for Salmonella in steers and heifers and cows and bulls because percent positive findings were very low (less than one percent), and this carcass sampling was expensive for the Agency. As stated in the PR/HACCP rule (at 61 FR 38835), FSIS selected Salmonella for the performance standard because it is the most common cause of foodborne illness associated with meat and poultry products; it is present to varying degrees in all major species; and the interventions targeted at reducing Salmonella may help reduce contamination by other enteric pathogens.

FSIS uses the Salmonella performance standards to verify process control in slaughter and certain processing operations. The performance standard for ground beef is based on the industry average (percent positive samples) estimated from baseline surveys conducted before PR/HACCP was implemented.

Under the existing Salmonella verification sampling program, the Agency assesses whether establishments meet the Salmonella standard by collecting randomly selected product samples using the risk-based, 3-category establishment classification system announced on February 27, 2006 (71 FR 9772). FSIS inspection program personnel collect samples and submit them to FSIS laboratories for analysis over a defined number of sequential days of production to complete a sample set. As detailed in the February 2006 notice, the maximum number of positive samples per set for the ground beef product category is 5 of 53.

FSIS presently categorizes establishment performance as follows:

FSIS collects ground beef samples under project code “HC01” as part of the Salmonella verification sampling program and under project code “MT43” as part of the E. coli O157:H7 verification sampling program.

Following the implementation of PR/HACCP, FSIS analyzed only one pathogen per sample. Then, in 2008, FSIS began analyzing for Salmonella and E. coli O157:H7 ground beef samples from establishments producing less than 1,000 pounds of product per day (under the MT43S code). Using this approach, FSIS effectively gained sampling efficiencies without overly burdening the establishment with additional sample collection.

Salmonella bacteria are among the most frequently reported causes of foodborne illness. In December 2011, a multi-state outbreak linked to a multi-drug resistant strain of Salmonella sickened 19 people in the Northeast United States ( http://www.cdc.gov/salmonella/typhimurium-groundbeef/010512/index.html ). In June 2012, FSIS was notified of a cluster of Salmonella enteriditis illnesses linked to ground beef consumption with approximately 50 case-patients across nine states ( http://www.cdc.gov/salmonella/enteritidis-07-12/index.html ). The outbreaks referenced here and others suggest that Salmonella in ground beef is a continuing public health concern.

The changes described below will likely improve FSIS's ability to detect Salmonella by increasing the raw ground beef analytic sample portion for Salmonella analysis and increasing the number of establishments being sampled at any given time. As is also discussed below, FSIS intends to develop new performance standards that will likely lead establishments producing ground beef to strengthen their own Salmonella control measures. Such changes at establishments will likely have a positive impact on public health.

Beginning on the date FSIS will announce in the Federal Register notice that responds to any comments on this notice, FSIS will discontinue Salmonella sampling sets (“HC01”) for ground beef product except for establishments in Category 3. At the same time, FSIS will begin analyzing for Salmonella all raw beef samples it collects for STEC testing. Therefore, FSIS will begin analyzing for Salmonella all samples of raw ground beef, beef manufacturing trimmings, bench trim, and other raw ground beef components that its personnel collect for STEC testing, including raw ground beef products FSIS samples at retail stores and ground beef, trim, and other raw ground beef components FSIS samples at import establishments.

Whenever FSIS finds a product sample positive for E. coli O157:H7 or a non-O157 STEC, FSIS conducts follow-up sampling of product from the establishment that produced the positive product and at all suppliers that provided the source materials for the product. When FSIS begins analyzing for Salmonella the product collected for STEC analysis, FSIS will also begin analyzing for Salmonella the follow-up samples it collects in response to STEC positive results.

FSIS analyzes beef manufacturing trimmings for E. coli O157:H7 and the following non-O157 STECs: O26, O45, O103, O111, O121, and O145. FSIS analyzes raw ground beef and raw ground beef components other than beef manufacturing trimmings for E. coli O157:H7 only. FSIS is not making any changes to the STEC sampling and testing programs at this time.

The changes that FSIS is announcing to its Salmonella sampling procedures will permit FSIS to analyze more samples at the same time for lower Agency costs than the present method. Also, as noted above, FSIS stopped testing beef carcasses for Salmonella because the Agency sampling costs did not justify the results FSIS was able to obtain. Through this new approach, FSIS will be able to analyze for Salmonella beef manufacturing trimmings and other raw ground beef components at slaughter establishments. FSIS believes sampling these products will provide FSIS more information about Salmonella at these establishments than FSIS was able to gather through carcass testing.

FSIS will increase the raw ground beef analytic portion for Salmonella analysis from 25 grams to 325 grams to be consistent with the STEC analytic sample portions. To support an increase in the sample size analyzed, FSIS evaluated the FSIS Salmonella detection method (FSIS Microbiology Laboratory Guidebook Chapter 4.06) using 325 gram samples. Based on this analysis, FSIS expects the increase in the analytical portion size to have at least the same, but likely more of a positive, impact on public health because the likelihood of detecting positive samples increases with the analytical portion size. As is explained above, FSIS will continue to schedule sets for raw ground beef in those establishments in Category 3. FSIS laboratories will continue to evaluate raw ground beef product samples collected as part of a set using a 25-gram analytic sample portion.

FSIS intends to enumerate samples that confirm Salmonella -positive using the Most Probable Number (MPN) quantitative procedure. FSIS will continue to evaluate Salmonella isolates from the screen-positive samples for multi-drug resistance, to serotype the samples, and to use pulsed-field gel electrophoresis (PFGE) to identify specific strains of Salmonella.

Through this analysis, FSIS will determine whether Agency-positive Salmonella results are associated with illnesses or serotypes of human health significance. As is currently the case, if FSIS finds that establishments have produced product associated with illness, FSIS will typically conduct an Incident Investigation Team Review or Food Safety Assessment at the establishment.

In developing all of its prevalence estimates, FSIS defines prevalence as the proportion of applicable product that would test positive for a given pathogen if the entire population were sampled and analyzed during a specified time period. Although it provides a useful indication of process control within that establishment, set-based verification sampling that FSIS currently uses for Salmonella sampling and testing in many products is not designed to estimate national prevalence of Salmonella by class of products. As is discussed above, under the set-based approach, FSIS collects samples from the same establishment on a daily basis until it has collected the necessary number of samples in the applicable performance standard. In 2012, FSIS evaluated many of its sampling programs as a means to calculate prevalence estimates for pathogens in FSIS-regulated products ( http://www.fsis.usda.gov/wps/wcm/connect/56b2ccbd-ad57-4311-b6df-289822d28115/Prevalence_Estimates_Report.pdf?MOD=AJPERES ). The Agency concluded, given the construction of the FSIS pathogen verification sampling programs at that time, that it was only possible to utilize the E. coli O157:H7 pathogen verification testing program for raw ground beef (“MT43”) to estimate national prevalence. Since that time, FSIS has redesigned its beef manufacturing trimmings verification sampling program such that, with a larger number of analyzed samples, it too is suitable for estimating prevalence ( http://www.fsis.usda.gov/wps/wcm/connect/15e75329-978f-43f0-b8fe-101845d898f0/Redesign_Beef_Trim_Sampling_Methodology.pdf?MOD=AJPERES ).

When FSIS begins analyzing all STEC samples for Salmonella, FSIS will be able to estimate the prevalence of Salmonella in raw ground beef and beef manufacturing trimmings. Therefore, FSIS will avoid the added expense of conducting separate baseline studies at periodic intervals to determine Salmonella prevalence in these products and will enhance the use of inspection resources. In addition, by using these continuous sampling programs rather than scheduled sets, FSIS will be able to analyze findings over time to determine trends and evaluate program effectiveness.

Because of the limited number of available samples scheduled and collected, FSIS does not believe it is possible to estimate prevalence for Salmonella in raw ground beef components other than beef manufacturing trimmings (such as bench trim).

After collecting at least three months of data using the new sampling and testing procedures, FSIS intends to conduct a risk assessment and develop a revised Salmonella performance standard for raw ground beef at a 325 gram sample size. FSIS will publish the revised Salmonella performance standard in the Federal Register before implementing the standard.

In 2011, FSIS estimated the national prevalence of Salmonella in beef manufacturing trimmings ( http://www.fsis.usda.gov/wps/wcm/connect/f07f5e1d-63f2-4ec8-a83a-e1661307b2c3/Baseline_Data_Domestic_Beef_Trimmings_Rev.pdf?MOD=AJPERES ). After careful consideration, FSIS does not believe the low incidence of Salmonella on beef manufacturing trimmings supports development of a Salmonella performance standard for beef manufacturing trimmings. FSIS is considering using the results of this estimation to develop guidance that will assist establishments in preventing Salmonella contamination in beef manufacturing trimmings.

FSIS recently revised other existing Salmonella performance standards to achieve a public health objective. In July 2011, FSIS implemented new performance standards for both Salmonella and Campylobacter for chilled carcasses in young chicken (broilers) and turkey slaughter establishments (76 FR 15282; March 21, 2011). By December 2011, the young chicken industry was meeting the acceptable Campylobacter percent positive reflected in the new standard at 9.43 percent (10.4 percent acceptable). Should FSIS develop new Salmonella performance standards for ground beef, FSIS believes that ground beef establishments would improve process control to meet the new performance standard in a similar manner.

Except for Category 3 establishments, FSIS will discontinue set testing at least until it establishes a revised Salmonella performance standard for ground beef. Meanwhile, FSIS is considering alternative sampling plans. One option that FSIS is considering is a “moving window” sampling plan in which FSIS would evaluate a set number of sequential results from single establishment to assess process control. For example, if FSIS chose to evaluate 20 results under the moving window approach, FSIS would assess the most recent 20 FSIS results for a particular establishment. This new approach would allow for on-going scheduled FSIS Salmonella sampling, similar to the approach FSIS uses for STEC testing, as compared to a set-based approach in which FSIS schedules a large number of sequential samples at an establishment as part of a set. The “moving window” approach would provide FSIS with more flexibility for scheduling sample collection at different establishments. The Agency requests comment on the “moving window” approach.

Consistent with current sampling procedures, when an establishment either processes all raw ground beef product into ready-to-eat (RTE) product or moves it to another federally-inspected establishment for further processing into RTE product, the product will be excluded from Agency verification sampling for E. coli O157:H7 and Salmonella.

Individual sample results generated from this program will be reported through the Agency's Public Health Information System. FSIS will ensure that result information is made available to establishments. Because FSIS does not recognize Salmonella as a pathogen that would ordinarily render the product injurious to health, and thus as an adulterant within the meaning of 21 U.S.C. 601(m)(1), individual Salmonella sample results will not result in regulatory control actions. Therefore, after receiving STEC (O157:H7 and non-O157) results, establishments will not need to continue to hold product that has tested negative for STEC. If raw, non-intact beef product or raw, intact beef product that is intended for use as raw, non-intact product tests positive for STEC, the product is adulterated within the meaning of 21 U.S.C. 601(m)(1) (76 FR 58157; Sep. 20, 2011) unless further processed to destroy the pathogen.

In addition to ground beef, FSIS is considering moving Salmonella sampling from a set-based approach to a continuous sampling and “moving window” approach for all classes of products subject to FSIS sampling and testing for Salmonella. As is discussed above, this approach will allow FSIS more flexibility in scheduling and collecting samples.

In addition, FSIS is considering implementing new sampling of product classes not subject to FSIS sampling and testing for Salmonella. For example, FSIS is contemplating initiating sampling and testing for Salmonella in pork trim, pork parts, ground pork, chicken parts, and lamb carcasses.

Before FSIS makes any change of this type in its testing, it will provide notice and an opportunity for comment in the Federal Register .

Should FSIS decide to start testing new products for Salmonella, it would begin by sampling to assess the prevalence of Salmonella in each of the new products sampled. Upon completion of the exploratory sampling period (at least three months and possibly longer), FSIS would develop new performance standards. FSIS would announce the tentative standards in the Federal Register and request comment on them before finalizing.

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status. (Not all prohibited bases apply to all programs.)

Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA's Target Center at (202) 720-2600 (voice and TTY).

To file a written complaint of discrimination, write USDA, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250-9410 or call (202) 720-5964 (voice and TTY). USDA is an equal opportunity provider and employer.

FSIS will announce this notice online through the FSIS Web page located at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register .

FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. In addition, FSIS offers an electronic mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://www.fsis.usda.gov/wps/portal/fsis/programs-and-services/email-subscription-service . Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

The NRC published “Notice of Public Meeting and Request for Comment on the BTP on the Import of Non-U.S. Origin Radioactive Sources,” 77 FR 2924 (January 20, 2012), and received five comment letters as a result of that publication. The NRC staff made no substantive changes to the draft BTP based on these comment letters. However, minor editorial changes were made to the draft BTP to provide greater clarity.

The NRC published “Request for Comment on the BTP on the Import of Non-U.S. Origin Radioactive Sources,” 77 FR 64435 (October 22, 2012), and received eight comment letters as a result of that publication. Many of those comments were on the existing regulations (10 CFR part 110) rather than the BTP. This final BTP does not amend the regulations in 10 CFR part 110; rather, it clarifies what is meant by “U.S. origin” and explains how the NRC staff interprets this exclusion to the definition of “radioactive waste” as used in 10 CFR 110.2. The NRC staff response to the eight comment letters can be found in this Federal Register Notice as well as at ML13177A163.

The NRC's regulations in 10 CFR part 110 (Part 110), “Export and Import of Nuclear Equipment and Material,” establish the general and specific export and import licensing requirements for special nuclear, source, and byproduct material including radioactive waste. “Radioactive waste” is defined in 10 CFR 110.2 as:

There are six exclusions in 10 CFR 110.2 to the definition of “radioactive waste.” The sealed source exclusion (exclusion one) is defined as radioactive material that is “[o]f U.S. origin and contained in a sealed source, or device containing a sealed source, that is being returned to a manufacturer, distributor or other entity which is authorized to receive and possess the sealed source or the device containing a sealed source.”  1 Disused sources that satisfy an exclusion to the definition of “radioactive waste” may be imported (returned) under the general license in 10 CFR 110.27, which requires that the U.S. consignee be authorized to receive and possess the material under the relevant NRC or Agreement State regulations and that the importer satisfy the terms for the general license set forth in 10 CFR 110.50.

The NRC staff has developed this BTP to provide guidance to source manufacturers, distributors, or other entities on the NRC's application of the sealed source exclusion to imports into the United States of non-U.S. origin disused sources. 2

On July 28, 2010, the NRC published a final rule in the Federal Register (75 FR 44072) that amended several provisions in 10 CFR part 110 to improve NRC's regulatory framework for the export and import of nuclear equipment, material, and radioactive waste. The sealed source exclusion to the definition of “radioactive waste” was revised, in response to a comment, to confirm that the exclusion only applies to sources of “U.S. origin” being returned to an authorized domestic licensee. The addition of the term “U.S. origin” to the sealed source exclusion was consistent with the original intent of the exclusion, initially adopted in a 1995 rule. 3

In September 1990, the IAEA General Conference adopted the Code of Practice on the International Transboundary Movement of Radioactive Waste (Code of Practice) which provides that “[t]he sending State should take the appropriate steps necessary to permit readmission into its territory of any radioactive waste previously transferred from its territory if such transfer is not or cannot be completed in conformity with this Code . . ., unless an alternate safe arrangement can be made.” This Code of Practice served as a basis for the sealed source exclusion in the 1992 proposed rule (57 FR 17859) that described a United States policy of encouraging the return of disused sources to the country of origin for the purposes of helping to ensure that the sources will be handled responsibly at the end of their life cycle. The regulatory history of this rule, finalized in 1995 (60 FR 375567), was in principal and intent identical to the sealed source exclusion embraced by the proposed rule. In the Statements of Consideration, the NRC described industry practice as limited to return of disused sources to the original supplier or country of origin.

Shortly thereafter, the adoption of the Code of Practice resulted in the international development of the Joint Convention on the Safety of Spent Fuel Management and the Safety of Radioactive Waste Management (Joint Convention) that opened for signature in September 1997 and entered into force in 2001. In terms of this BTP, a key point in the legally-binding Joint Convention to which the United States is a party, is found in Article 28, “Disused Sealed Sources,” which states:

Nearly identical language was included in the non-legally binding Code of Conduct on the Safety and Security of Radioactive Sources (Code of Conduct), along with the supplementary Guidance on Import and Export, that was internationally approved in 2003 and to which the United States made a political commitment in 2004. In accordance with the Code of Practice, the Joint Convention, and the Code of Conduct (including the supplemental Guidance on Import and Export), the NRC believed that encouraging return of disused sources to the country of origin would help prevent sources from becoming “orphaned” by facilitating responsible handling of sources at the end of their life cycle. See Import and Export of Radioactive Waste, 57 FR 17859, 17861 (July 21, 1992) (proposed rule):

The NRC's willingness to embrace this policy was in large part informed by U.S. industry comments that there is a:

See also, e.g., id. at 17861 (“the sale of a source is often conditioned on later return of the source for disposal”). Accordingly, central to the sealed source exclusion was the NRC's understanding, based on U.S. industry representations, that new and disused sources are routinely exchanged on a “one-for-one” basis— i.e., a new source is exchanged for a disused source  4 —with the result that the number of disused sources imported is not greater than the number of new sources exported.

After the addition of “U.S. origin” to the sealed source exclusion in the 2010 rule, it came to the NRC staff's attention that, while it remains a widespread industry practice to exchange new and disused sources on a “one-for-one” basis, the current global supply market does not always allow a supplier to definitively ascertain the origin of a particular disused source that is exchanged for a new one before import and receipt of the disused source. With established customers, the disused sources will generally be of U.S. origin; however, for new customers, some of the sources initially being returned may not be of U.S. origin. The result is still a “one-for-one” exchange, resulting in the number imported not being greater than new sources exported.

Once a source is imported and received, the manufacturer, distributor, or other entity technically has the ability to determine the source's origin. However, the only way for the supplier to accomplish this is by exposing its personnel to additional radiation doses. Specifically, the supplier must use a glove-box to take the source out of its casing to read the serial numbers and correlate those numbers to different manufacturer's coding patterns.

The NRC staff has construed the “U.S. origin” provision in the context of the industry's recent clarification of international source exchange practices. The NRC staff recognizes that in some circumstances it may not be feasible for the importer to determine the country of origin for disused sources it seeks to exchange prior to import. If, after a good faith effort and without exposing personnel to additional doses, the U.S. manufacturer, distributor, or other entity cannot determine whether an imported disused source that has been exchanged for a new source is of U.S. origin, the source in question shall be deemed to be of U.S. origin for the purposes of the sealed source exclusion to the definition of “radioactive waste” in 10 CFR 110.2. 5 This application of the sealed source exclusion is limited to disused sources imported into the United States that have been exchanged for a new source in a foreign country on a “one-for-one” basis. Accordingly, it is the NRC's expectation that the number of disused sources imported by the manufacturer or distributor into the United States must not be greater than the number of new or refurbished sources exported by that manufacturer or distributor.

The NRC staff believes that this application of the sealed source exclusion reasonably balances the interests of public health and safety and international policy interests in responsible handling of sources at the end of their useful life. The approach preserves the fundamental policy rationale underlying the original exclusion—to prevent sources from being dispersed in unregulated locations around the world by facilitating a “one-for-one” exchange of U.S.-supplied new and disused sources—while achieving occupational doses to workers that are as low as reasonably achievable, as specified in 10 CFR 20.1101(b).

The NRC staff expects U.S. manufacturers, distributors, and suppliers to make a good faith effort to determine source origin before an import occurs. A good faith effort by the importer includes, but is not limited to, communication of U.S. import requirements with its foreign customers, examination of a photograph of the source the customer seeks to exchange, and obtaining other relevant information related to the disused sources' origin. It is recommended that U.S. importers retain copies of their communications with their foreign customers regarding U.S. import requirements. At all times, the U.S. importer must comply with the specific license requirement for disused sources known to be of non-U.S. origin prior to import into the United States. The specific license requirements include meeting the provisions/conditions of the material possession license which may limit the quantity/activity held in storage on site. Licensees should consider the potential ramifications and costs of extended storage due to lack of disposal options. Licensees should recognize that the low-level radioactive waste compacts have legal jurisdiction for the availability and access to disposal options.

Consistent with 10 CFR 110.53, the NRC staff may inspect the licensee's records, premises, and activities pertaining to its exports and imports to ensure compliance with the sealed source exclusion to the definition of “radioactive waste.”

This position was distributed to all Agreement States and material licensees as a proposed document for comment and is publicly available for use by all potentially affected parties. Additionally, the NRC staff has coordinated this position with the Department of Energy/National Nuclear Safety Administration's (DOE/NNSA) Global Threat Reduction Initiative (GTRI) and confirmed that NRC does not have jurisdiction over the GTRI program.

This technical position reflects the current NRC staff position on acceptable use of the general license for import of disused radioactive sources. Therefore, except in those cases in which the source manufacturer or distributor proposes an acceptable alternative method for complying with the definition of “radioactive waste” in Section 110.2, the guidance described herein will be used in the evaluation of the use of the general import license for disused sources.

The NRC received responses from eight organizations including States, licensees, and others on the proposed BTP on the Import of Non-U.S. Origin Radioactive Sources, 77 FR 64435 (October 22, 2012) that was published for a 60-day public comment period. The commenters were: the Northwest Interstate Compact on Low-Level Radioactive Waste Management (Northwest Compact), the State of Utah's Department of Environmental Quality (UDEQ), the State of Virginia's Department of Health-Division of Radiological Health (State of Virginia), the Organization of Agreement States (OAS), the Nuclear Energy Institute (NEI), the International Source Suppliers and Producers Association (ISSPA), QSA Global Inc. (QSA), the Low-Level Radioactive Waste Forum Inc.-Disused Sources Working Group (LLW Forum), and International Isotopes Inc. (International Isotopes).

Most of the comments did not disagree with the underlying rationale for the regulation in Part 110 and justification for the BTP's interpretation (i.e., to construe non-U.S. origin disused sources as U.S. origin under certain circumstances for purpose of exclusion one to the definition of radioactive waste in 10 CFR 110.2.) Instead, many of the comments appear to request that NRC revise or clarify the existing exclusions to the definition of radioactive waste in Part 110. Although only minimal changes are being made to the proposed BTP (mainly to provide more historical background and context and to explicitly point out costs and access to limited disposal options), the NRC staff found the comments useful in identifying concerns and is formally responding to those comments in conjunction with publication of the final BTP in the Federal Register .

Comment: Four commenters (NEI, OAS, ISSPA, and the State of Virginia) agreed with the guidance provided in the proposed BTP and urged NRC staff to publish the final document in the Federal Register in the near future.

Response: The comment resolution document will be published in the Federal Register in conjunction with the final BTP.

Comment: International Isotopes and NEI requested that clarification regarding disused sources containing byproduct material as defined under section 11e(3) or section 11e(4) of the Atomic Energy Act be included in the BTP. The commenters asked for “additional language to be added to the BTP to address the import of non-U.S. origin sources containing accelerator produced radioisotopes or Radium-226 which can be disposed of in non-Part 61 or equivalent facilities” as it was unclear to them if “equivalent facility” could include Resource Conservation and Recovery Act (RCRA) facilities.

To address this concern, International Isotopes suggested that a footnote be added to the BTP such as the following:

Response: Any disused source imported for disposal in a RCRA facility would not be treated as “radioactive waste” under NRC's definition of radioactive waste found in 10 CFR part 110.2 since it is not being disposed of in a Part 61, Part 40 (Appendix A) or equivalent facility. Conversely, any disused source imported for disposal in a Part 61 or Part 40 (Appendix A), or equivalent facility, even if it contains section 11e(3) or section 11e(4) material, would qualify as radioactive waste under the Part 110 definition of “radioactive waste” since disposal would “. . . require a specific radioactive material license in accordance with this Chapter and is imported or exported for the purposes of disposal in a land disposal facility . . .” pursuant to NRC's regulations. The term “equivalent facility” used here refers to Part 61 equivalent facilities in foreign countries for export purposes and does not relate to import of disused sources. This clarification is not directly related to the discussion of U.S. origin in the BTP and therefore has been included as a frequently asked question (FAQ) on NRC's Web site at http://www.nrc.gov/about-nrc/ip/faq.html.

Comment: QSA requested that the final BTP include clarification of Footnote 1 in the BTP. 6 Specifically, QSA commented that:

QSA explained that disused sources (both U.S. and foreign origin) are loaded into U.S. shipping containers, presumably when customers order replacement sources and if they have limited or no storage capacity for spent sources. QSA's interpretation of “U.S. origin” devices include U.S. shipping containers. Specifically, QSA uses the terms “device” and “shipping container” interchangeably in the 10 CFR 110.2 definition of “radioactive material.”

The NRC staff believes that the guidance for “U.S. origin” in Footnote 1 is clearly addressing medical, industrial, or other types of sources that are included in devices. For those radiographic exposure devices, as defined in 10 CFR 34.3, which meet the performance requirement of 10 CFR 34.20(b)(2) and qualify as Type B transport containers in accordance with the applicable requirements of 10 CFR part 71, the radiographic exposure device houses the source and is integral to the use of the material for its intended purpose. The sealed source exclusion is applicable as is the “one-for-one” discussion. These are not the same as shipping containers that are used solely for transferring new or used sources. NRC does not consider a Type B shipping container that is not integral to the use of the material for its intended purpose to be a device, as the term is commonly used and understood in NRC's domestic regulatory program. A device typically only contains one source whereas a shipping container can include a number of sources with different origins. All of the sources in the shipping container need to be taken into account in the one-to-one exchange and determining origin.

Comment: The LLW Forum requested that further interactions with the NRC take place regarding the first and sixth exclusions of the definition of “radioactive waste” in 10 CFR 110.2. The first exclusion addresses U.S. origin. The sixth exclusion concerns legitimate recycling of radioactive sources.

Response: As stated in the final rule, the NRC added a sixth exclusion to the definition of “radioactive waste” to clarify that the definition does not include material imported solely for the purposes of recycling and not for waste management or disposal where there is a market for the recycled material and evidence of a contract or business agreement can be produced upon request by the NRC.

In addition to the LLW Forum's comment, the NRC also received several questions from industry regarding the applicability of the sixth exclusion to long-lived isotopes sealed in radioactive sources. Specifically, the NRC has been asked for clarification on the applicability of exclusion six in cases where sources were imported for recovery and reuse of the radioactive material but, upon import, due to the condition of the source or device, it was determined that the material could not be recovered or reused as intended. The NRC staff recognizes that in some circumstances sources imported with the intent to recycle may be discovered to be not recyclable. The NRC staff construes the sixth exclusion in 10 CFR 110.2 to authorize import for recycle and/or reuse under the general license to apply in a situation where, based on the best available information and after a good faith effort to determine recyclability of the source(s) prior to the import taking place, a U.S. company imports a source with the intent of recovering the radioactive material for reuse in another application but upon import discovers that a source is not recyclable. A good faith effort by the importer includes, but is not limited to, communication of U.S. import requirements with its foreign customers, examination of a photograph of the source(s) the customer seeks to exchange, and other relevant information related to the source's recyclability such as current activity level.

At all times, the U.S. importer must comply with the specific license requirement for “radioactive waste” as defined in 10 CFR 110.2. Any person who imports materials under a general license for recycling using exclusion six, but with the intent of disposing of that material in the United States would be subject to NRC enforcement action. In addition, there may be instances in which some small value may be obtained from the materials that are imported, but the primary intention is for disposal. In such cases, to avoid possible enforcement action the NRC staff should be consulted before any such imports are made. It is recommended that U.S. importers retain copies of their communications with their foreign customers regarding U.S. import requirements and records of efforts taken to determine recyclability of the source(s) prior to import. This guidance is also posted as an FAQ on the import/export Web site at http://www.nrc.gov/about-nrc/ip/faq.html.

Comment: The Northwest Compact pointed out that NRC's definition of radioactive waste to exclude U.S. origin disused sources is not consistent with the Compact's definition of radioactive waste in its “Resolution Clarifying the Third Amended Resolution and Order,” which the Compact claims requires treating U.S.-manufactured disused sources that are used outside the U.S. as foreign radioactive waste. According to the Northwest Compact:

The Northwest Compact recommended that the NRC add a statement such as the following to the BTP:

Response: The NRC disagrees that a U.S.-manufactured source that was used outside the U.S. should be treated as foreign-generated radioactive waste for purposes of import under Part 110. As stated in the BTP, facilitating return of U.S.-manufactured disused sources through the use of a general license, among other things, furthers international policy objectives regarding disused sources committed to by the United States, including the United States' implementation of the Code of Conduct. Specifically, paragraph 27 of the Code of Conduct states:

The return of disused sources to the country of origin is a well-established industry practice not only in the United States but in many other countries. Global implementation of the Code of Practice, Joint Convention, and Code of Conduct (including the supplementary Guidance on Import and Export) provides responsible end-of-life management for all international parties (see Background section of BTP for additional details). The practice of allowing return to the U.S. under general license of U.S.-manufactured disused sources has been in use in the United States at least since the mid-1990's.

The NRC staff recognizes that differences in interpretation of the meaning of “foreign” radioactive waste may limit disposal options for licensees. The Northwest Compact's current “Resolution Clarifying the Third Amended Resolution and Order” would appear not to allow sources used in foreign jurisdictions (to the end of useful life) to be disposed of at a Compact facility even if a source originated in a Northwest Compact member state and is considered to be “U.S. origin” and excluded from the definition of radioactive waste by the NRC for purposes of import. The Northwest Compact thus purports to have the authority to prevent return to the U.S. of disused sources originating in the U.S. but used in a foreign country.

The NRC staff believes that the Northwest Compact's interpretation of country of origin and what is “foreign” waste is inconsistent with the commonly understood and accepted interpretation of country of origin for disused sources (i.e., the country where the disused sources were manufactured rather than used) under the international agreements to which the U.S. is a signatory, including the Code of Practice, the Joint Convention, and the Code of Conduct, all of which expect that signatory countries be responsible for the disposition of disused sources originating within their own country.

To the extent that the Northwest Compact is suggesting that its Compact authority may be exercised in a manner that is contrary to federal law, including NRC regulations, and underlying U.S. policy objectives to promote responsible handling of disused sources on an international scale, the NRC staff disagrees. Section 4(b)(4) of the Low Level Radioactive Waste Policy Act of 1985, as amended, provides that, “[e]xcept as expressly provided in this Act, nothing contained in this Act or any compact may be construed to limit the applicability of any Federal law or to diminish or otherwise impair the jurisdiction of any Federal agency. . . .” The NRC staff questions whether application of the Northwest Compact's “Resolution” in a manner that would interfere with the federal scheme for responsible disposition of U.S. origin disused sources used overseas, including disused sources originating within a Northwest Compact member state, would be a permissible exercise of Compact authority consented to by Congress under the Northwest Interstate Compact on Low-Level Radioactive Waste Management. The NRC staff recognizes, however, that legal and policy issues regarding the interface between federal authority and state compact authority have yet to be tested in this particular context and, in any event, are beyond the scope of the BTP. We reiterate that the BTP itself is consistent with the NRC rule regarding import and export of radioactive waste that has been in place since 1995, and, through its limitation to one-for-one exchanges, has a neutral effect on disposal capacity constraints within the U.S. The NRC staff also notes that the other nine Low-Level Waste Compacts and ten unaffiliated States have not expressed specific views on the waste management practices that apply to disused radioactive sources.

By addressing this aspect of the Northwest Compact's comment in this comment resolution document (published at the same time as the BTP), the NRC is reiterating to licensees the potential limits both to disposal options for disused sources and long-term storage capacity at the licensees' respective sites.

Comment: Three commenters (Northwest Compact, LLW Forum and UDEQ) would like additional language added to the BTP to acknowledge the lack of current disposal options for non-U.S. origin disused radioactive sources. UDEQ commented that “[t]he importation of sources/devices not directly attributable to U.S.-origin certainly raises a concern regarding disposal site access in Utah.” UDEQ suggested adding clarification to the BTP to state that where disposal of such sources is not an option, a licensee

UDEQ also suggested adding more explanatory text regarding potential storage and disposal considerations and requirements directly into the BTP as a clarifying footnote. The Northwest Compact and LLW Forum raised similar concerns about potential impacts on capacity for domestic long-term storage and ultimate disposal by NRC and Agreement State licensees. Specifically, the LLW Forum observed that

Response: A specific license for the import of radioactive waste must “. . . name an appropriate facility that has agreed to accept and is authorized to possess the waste for management or disposal . . .” (10 CFR 110.43(d) (emphasis added)) where “management” includes authorization for long-term storage under a company's NRC or Agreement State issued possession license. A general license (10 CFR 110.27) is contingent on “the U.S. consignee [being] authorized to receive and possess the material under a general or specific NRC or Agreement State license . . .” Among other things, the domestic authorization sets possession limits and provisions for long-term storage. The NRC staff is aware that there may not be disposal options for some sources due to current Compact policies on admittance of out-of-Compact waste.

Agreement State and NRC possession license holders historically have not differentiated use or storage of radioactive sources based on origin. In terms of their possession limits and storage capacity, licensees handle the sources identically regardless of origin in order to protect public health and safety. With the “one-for-one” exchange required under the BTP, there should be no increase in the volume of disused sources for management or disposal as a result of the BTP. The application of this BTP is limited to those radioactive sources that have been exchanged on a “one-for-one” basis and after a good faith effort has been made by the importer to determine the origin. Accordingly, it is the NRC's expectation that the number of disused sources imported by the manufacturer or distributor into the United States must not be greater than the number of new or refurbished sources exported by that manufacturer or distributor.

Comment: The Northwest Compact and the UDEQ suggested that the final BTP include language explicitly:

Response: The NRC is aware that the costs of long term storage may be an issue for some licensees. For this reason, NRC has added language to the final BTP to reflect the Northwest Compact and State of Utah concerns regarding the availability and access to the limited disposal options currently available.

Comment: The LLW Forum expressed that “the NRC should show greater deference to the LLW Compacts and host states through earlier and more active involvement in the import of potentially non-U.S. origin radioactive sources for disposal.” They suggest that:

Response: The NRC staff works within the confines of the Atomic Energy Act of 1954, as amended, and recognizes the authorities granted to the States and Compacts in the Low Level Waste Policy Act of 1985. The LLW Compacts are provided multiple opportunities to comment on publications for rulemaking in Part 110, Part 110 specific license applications for import of radioactive waste, and guidance documents such as the BTP (see pre-emption response above).

Comment: International Isotopes suggested that the final BTP should “recognize the practice of a “one-for-one” source exchange and acknowledge that there are complexities associated the radioactive source supply chain.” More specifically, International Isotopes points out that the timing of exports and imports over the course of a timeframe might not align specifically with the “one-for-one” principle on which the BTP is based.

Response: The NRC staff recognizes that importing/exporting trends and an importer's intent are licensee and isotope-specific and will be considered on a case-by-case basis by NRC staff.

Background

On July 15, 2013, the FAA published a final rule entitled, “Pilot Certification and Qualification Requirements for Air Carrier Operations” (78 FR 42324). In that final rule, which became effective July 15, 2013, the FAA amended part 141. The FAA inadvertently listed the incorrect amendment number for part 141 in the header information of the final rule as 141-1. The correct amendment number is 141-17.

In the final rule, FR Doc. 2013-16849, published on July 15, 2013, at 78 FR 42324, make the following correction:

1. On page 42324 in the heading of the final rule, revise “Amdt. No. 141-1” to read as “Amdt. No. 141-17”.

The final regulations (TD 9619) that are the subject of this correction are under section 336(e) of the Code.

As published May 15, 2013 [78 FR 28467] TD 9619 contains errors that may prove to be misleading and is in need of clarification.

Accordingly, the publication of the final regulations [TD 9619], which were the subject of FR Doc. 2013-11522, is corrected as follows:

1. On page 28467, column 2, in the preamble under the caption “Paperwork Reduction Act”, the fourth line from the top, the language, “in §§ 1.336-2(h) and 1.336-4(c)(4). This” is corrected to read “in §§ 1.336-2(h) and 1.336-4(c). This”.

2. On page 28467, column 2, in the preamble under the caption “Background”, second paragraph, fifth line, the language, “947 [73 FR 49965-02]) (the proposed” is corrected to read “947 [73 FR 49965]) (the proposed”.

The final regulations (TD 9619) that are the subject of this correction are under section 336(e) of the Code.

As published May 15, 2013 [78 FR 28467] TD 9619 contains errors that may prove to be misleading and is in need of clarification.

Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:

On May 2, 2013, the Postal Service published a proposed rule (78 FR 25677-25678) inviting comments on revisions to the standards for balloting materials. In response to this proposed rule, the Postal Service received several comments that are summarized and discussed below.

After considering the comments received, the Postal Service will revise the DMM to require that the balloting materials for all types of ballots, whether disseminated hardcopy or electronically, must indicate in a prominent location the proper amount of First-Class Mail® postage that must be paid. This information must be included in the balloting materials (i.e., on the ballot, ballot instructions, mailing instructions, or the envelope) with the marking “First-Class Mail postage must be applied.” Alternatively, the marking “Apply First-Class Mail postage here” could be printed in the upper right corner of the address side of the envelope used by the voter to return the ballot to election officials. The Postal Service will also accept approved variations of the above markings.

Additionally, this final rule requires that the balloting materials indicate in a prominent location the specific amount of First-Class Mail postage required for the return of the ballot to election officials.

The marking requirements will not apply to balloting materials that meet one of the following exceptions:

• The balloting materials are qualified under the special exemption for military and overseas voting.

• The ballot is returned under Business Reply Mail® service.

• Return postage is guaranteed through a postage due account.

• Postage on the ballot is prepaid by stamps, meter, or Permit Reply Mail.

The Postal Service received fourteen formal responses to the proposed rule. Thirteen responses were received from State election officials and one comment was received from a consumer. Several responses included comments about more than one issue. Comments and responses are as follows.

One commenter pointed out that in the preamble the word “sufficient” was included in the markings to indicate that the proper amount of postage must be paid, but was omitted in the proposed text of DMM 703.8.1.2. We regret any confusion, and note that the word “sufficient” will not be required in the markings required by the final rule.

Some commenters indicated that they are already including different variations of the proposed markings. The Postal Service appreciates this proactive approach and will make the necessary changes to also allow the use of approved versions.

One commenter questioned the requirement to indicate the specific amount of postage required, based on the current use of Forever TM stamps. The value of a Forever stamp is widely publicized as the current First-Class Mail single-piece 1-ounce price. When a Forever stamp is used on a piece requiring postage greater than the First-Class Mail single-piece 1-ounce price, additional postage must be affixed.

Other commenters voiced practical concerns about the requirement to indicate the specific amount of postage for the return of the ballot. These concerns included the need to order election envelopes in bulk, management of excess inventory, and the effect of annual price changes. In response to these concerns, the definition of “balloting materials” has been broadened to include “mailing instructions.” This will provide election officials an alternative to printing the markings on the ballot, voting instructions, or return envelope.

Some commenters expressed concerns regarding the ability of election officials to determine the specific postage required to return the ballot. The amount of postage communicated to voters should be based only on what is required to be returned. Local postal personnel are available to work with election officials to determine the amount of postage which should be applied.

One commenter suggested the use of a static URL or telephone number in lieu of the proposed markings. We believe that placing the correct postage due notification in a prominent location within the balloting materials will have higher visibility and encourage voter compliance. A link to an ancillary information source may be provided as a supplement.

One commenter raised concerns over the ability to provide the postage amount for the return of the ballot on electronic ballots that are printed by the voter. The Postal Service recognizes the potential for inconsistency when voters self-print ballots and use unspecified paper and envelope configurations. The Postal Service recommends that election officials include a supplementary notification specifically directed to voters who self-print and return ballots, such as: “Please be sure to affix the correct amount of First-Class Mail postage when returning ballots through the U.S. Mail.”

Some commenters suggested an exception to the proposed requirements should be made based on an arrangement with the USPS® to pay for all ballots returned with insufficient postage. The Postal Service recognizes and appreciates the local partnerships that many election officials have with the Postal Service. Therefore, we have included use of a postage due account to pay postage due on all short-paid ballots as an exception to the markings.

One commenter questioned the means of verification to ensure compliance with the marking requirements. As part of the verification procedure, mailers are required to provide a sample of balloting materials to the Business Mail Entry Unit (BMEU) at the time of mailing. If a sample is not provided, BME staff will contact the mail provider or mail owner and request that the required sample be provided to the BMEU the same day. To ensure consistency and provide clarity, the requirement to provide a sample with each mailing will be added to the DMM.

One commenter questioned the treatment of balloting materials that do not comply with the marking requirements. The Postal Service will actively assist election officials to comply with the applicable postal laws and regulations governing mail preparation and mailability. Information about USPS standards is available from postmasters, BME managers, the Pricing and Classification Service Center manager, and Postal Explorer® at pe.usps.com. Election officials also have the option of using Business Reply Mail service or establishing a “postage due” account in lieu of using the markings.

Some commenters questioned the treatment of ballots returned with insufficient postage. Generally, mail of any class received at either the office of mailing or office of address without enough postage is marked to show the total deficiency of postage and is delivered to the addressee on payment of the charges marked on the mail. If ballots are returned with insufficient postage, the Postal Service will deliver these ballots to election officials and collect postage due from election officials who accept delivery of short paid ballots. The Postal Service recommends that all election officials have a postage due account for the payment of postage due or use Business Reply Mail service. If election officials decline to pay the postage due for short paid ballots, the ballots will be handled under the standards provided in DMM 604.8.0.

One commenter stated that implementation of the new standards would lead not only to increased printing costs, but also to voter disenfranchisement. To the contrary, the Postal Service anticipates that the new standards will improve the vote-by-mail process for all participants, and thus encourage an increase in voter participation. While some election officials have arrangements in place to process ballots with insufficient postage, many do not. Since each election cycle presents a different set of parameters for ballot creation and for the size and weight of the mail piece, we believe that voters need to be better informed of the correct postage required to return a ballot by mail. Informing voters will enhance the vote-by-mail process:

Voters will know what postage is required to return their ballot and will be more likely to apply the correct First-Class Mail postage.

Election officials will incur less expense to pay the postage due on returned ballots.

The Postal Service will be able to process ballots in a timely manner and expedite their return to election officials, without the added delay and expense of calculating and collecting postage due.

One commenter inquired regarding the treatment of matter sent as Free Matter for the Blind and Other Physically Handicapped Persons. Subject to the standards in DMM 703.5.0, acceptable matter sent to the blind or other physically handicapped persons may be entered as domestic mail free of postage. Under DMM 703.5.2, reading matter in braille or 14-point or larger sightsaving type is considered acceptable matter subject to opening and inspection by the USPS. In accordance with DMM 703.5.3 matter may also be mailed free of postage by blind or other physically handicapped persons. This matter includes unsealed letters in braille or in 14-point or larger sightsaving type containing no advertising. Where requested, the Postal Service will cooperate with election officials regarding any modification of the vote-by-mail process to accommodate the needs of blind or other physically handicapped voters.

Some additional comments were received, generally pertaining to mail classification, pricing, special exemptions, delivery, and postage payment methods. These comments have been deemed by the Postal Service to be beyond the scope of this rule.

In addition, based on subsequent communication with election officials, the Postal Service has revised its original proposal to include the prepayment of postage by stamps, meter, or Permit Reply Mail, as an additional exception to the marking standards.

The Postal Service adopts the following changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

Accordingly, 39 CFR part 111 is amended as follows:

Entities potentially affected by this final rule include, but are not necessarily limited to, state and local air pollution control agencies that adopt and implement regulations to control air emissions of VOCs; industries involved in the manufacture or use of refrigerants, aerosol and non-aerosol solvents and blowing agents for insulating foams; and manufacturers of refrigeration equipment, hot water heaters and waste heat recovery equipment. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. This action has no substantial direct effects on industry because it does not impose any new mandates on these entities, but, to the contrary, removes Solstice TM 1233zd(E) from the regulatory definition of VOCs. The use of this compound remains subject to other restrictions under the CAA. Specifically, the use of this compound as an aerosol propellant, blowing agent or refrigerant, or any other use in which it would substitute for chlorofluorocarbons, hydrochlorofluorocarbons or their substitutes, is subject to restrictions under the Significant New Alternatives Policy (SNAP) program (CAA § 612; 40 CFR part 82 subpart G). The SNAP program has issued final approvals for Solstice TM 1233zd(E) as a suitable foam and refrigerant substitute and as a propellant (74 FR 50129, September 30, 2009; 75 FR 34017, June 16, 2010), and as a solvent for metals, electronics, and precision cleaning and in adhesives, coatings, and inks.

Tropospheric ozone, commonly known as smog, is formed when VOCs and nitrogen oxides (NO X ) react in the atmosphere in the presence of sunlight. Because of the harmful health effects of ozone, the EPA and state governments limit the amount of VOCs that can be released into the atmosphere. VOCs are those organic compounds of carbon that form ozone through atmospheric photochemical reactions. Different VOCs have different levels of reactivity. That is, they do not react to form ozone at the same speed or do not form ozone to the same extent. Some VOCs react slowly or form less ozone; therefore, changes in their emissions have less and, in some cases, very limited effects on local or regional ozone pollution episodes. It has been the EPA's policy that organic compounds with a negligible level of reactivity should be excluded from the regulatory definition of VOCs so as to focus VOC control efforts on compounds that do significantly increase ozone concentrations. The EPA also believes that exempting such compounds creates an incentive for industry to use negligibly reactive compounds in place of more highly reactive compounds that are regulated as VOCs. The EPA lists compounds that it has determined to be negligibly reactive in its regulations as being excluded from the regulatory definition of VOCs (40 CFR 51.100(s)).

Section 302(s) of the CAA specifies that the EPA has the authority to define the meaning of “VOC,” and hence what compounds shall be treated as VOCs for regulatory purposes. The policy of excluding negligibly reactive compounds from the regulatory definition of VOCs was first set forth in the “Recommended Policy on Control of Volatile Organic Compounds” (42 FR 35314, July 8, 1977) and was supplemented most recently with the “Interim Guidance on Control of Volatile Organic Compounds in Ozone State Implementation Plans” (Interim Guidance) (70 FR 54046, September 13, 2005). The EPA uses the reactivity of ethane as the threshold for determining whether a compound has negligible reactivity. Compounds that are less reactive than, or equally reactive to, ethane under certain assumed conditions may be deemed negligibly reactive and therefore suitable for exemption from the regulatory definition of VOCs. Compounds that are more reactive than ethane continue to be considered VOCs for regulatory purposes and therefore are subject to control requirements. The selection of ethane as the threshold compound was based on a series of smog chamber experiments that underlay the 1977 policy.

The EPA has used three different metrics to compare the reactivity of a specific compound to that of ethane: (i) The reaction rate constant (known as k OH ) with the hydroxyl radical (OH); (ii) the maximum incremental reactivity (MIR) on a reactivity per unit mass basis; and (iii) the MIR expressed on a reactivity per mole basis. A full description of each metric and how it is derived can be found in the direct final rulemaking (78 FR 11101, February 15, 2013) and is not repeated here.

Honeywell Inc. submitted a petition to the EPA on July 19, 2011, requesting that Solstice TM 1233zd(E) (CAS number 102687-65-0) be exempted from VOC control based on its low reactivity relative to ethane. 1 The petitioner indicated that Solstice TM 1233zd(E) may be used in a variety of applications, including as a solvent in aerosol and non-aerosol applications, as a blowing agent in insulating foams for refrigerators/freezers and hot water heaters and as a refrigerant in commercial chillers and waste heat recovery (Rankin cycle) systems. A fuller description of the petition regarding Solstice TM 1233zd(E), including a discussion of other compounds for which it would substitute, is found in the direct final rulemaking (78 FR 11101, February 15, 2013) and is not repeated here.

Detailed information on the ozone reactivity of Solstice TM 1233zd(E) was presented in the direct final rulemaking (78 FR 11101, February 15, 2013) and is summarized here.

Solstice TM 1233zd(E) has a higher k OH value than ethane, meaning that it initially reacts more quickly in the atmosphere than ethane. However, a molecule of Solstice TM 1233zd(E) is less reactive than a molecule of ethane in terms of complete ozone forming activity as shown by the molar-based MIR (g O 3 /mole VOC) values. Also, a gram of Solstice TM 1233zd(E) has a lower MIR value than a gram of ethane. Thus, under the Interim Guidance, Solstice TM 1233zd(E) is eligible to be exempted from the regulatory definition of VOCs, based on both mass-based and molar-based MIR.

The preamble to the direct final rulemaking (78 FR 11101, February 15, 2013) provided background information on the Premanufacture Notice (PMN) review and SNAP program review of Solstice TM 1233zd(E). That preamble also presented other information relevant to any potential health or environmental risks. This information is summarized here.

As a chemical not yet introduced into commerce, Solstice TM 1233zd(E) completed a PMN review on January 30, 2012. After considering all relevant data currently available, the EPA was unable to find any unreasonable risks to human health or the environment from the expected use of the substance. Based on this finding, the EPA did not find it necessary to take any actions to prevent unreasonable risk under the Toxic Substance Control Act (TSCA).

The SNAP program review of Solstice TM 1233zd(E) described the potential health effects of Solstice TM 1233zd(E) as being common to many refrigerants, foam agents and solvents, including many of those already listed as acceptable under SNAP. Potential health effects of this substitute include serious eye irritation, skin irritation and frostbite. EPA anticipates that users will be able to meet the manufacturer's recommended workplace exposure limit and address potential health risks by following requirements and recommendations in the material safety data sheet and in any other safety precautions common to the refrigeration and air conditioning industry, the foam blowing industry and the solvent-based cleaning industry and common when using adhesives and coatings. 2

Solstice TM 1233zd(E) is not flammable. Solstice TM 1233zd(E) is not expected to undergo wet or dry deposition to an appreciable extent.

Solstice TM 1233zd(E) has a 100-yr global warming potential (GWP) reported as 4.7 to 7 and an atmospheric lifetime of approximately 26 to 31 days or less. The net GWP effect of increased use of Solstice TM 1233zd(E) in place of certain other compounds will be advantageous.

Based on both the mass and molar MIR values for Solstice TM 1233zd(E) being equal to or less than that of ethane, the EPA issued a direct final rule (78 FR 11101, February 15, 2013) and a parallel notice-and-comment proposal (78 FR 11119, February 15, 2013) to find that Solstice TM 1233zd(E) is “negligibly reactive” and to exempt Solstice TM 1233zd(E) from the regulatory definition of VOCs at 40 CFR 51.100(s).

Comments: The EPA received three comments on the parallel notice-and-comment proposal during its comment period. Only one commenter, an individual, expressed reservations about the proposed exemption. 3 This commenter believes that the low ozone reactivity of Solstice TM 1233zd(E) is not sufficient to exempt it from the regulatory definition of VOCs in light of what the commenter says are its hazards to humans and the environment. The commenter characterizes Solstice TM 1233zd(E) as being a toxin and a halogen and notes that it has an occupational exposure limit (OEL) of 300 parts per million (ppm). The commenter says that removing Solstice TM 1233zd(E) from the regulatory definition of VOCs would trivialize the safety hazards posed by its use and that keeping Solstice TM 1233zd(E) within the regulatory definition of VOCs would incline people who work near and on it to treat it with caution.

Two comments, one from the petitioner Honeywell and the other from an individual, supported the proposed exemption. Honeywell's comments directly address the assertions made by the commenter who expressed the reservations noted above. Honeywell notes that Solstice TM 1233zd(E) does not meet the common definition of a “toxin” and that it is not itself a halogen. Honeywell also explains that the OEL of 300 ppm is Honeywell's own recommendation and that this level is higher than three other particular chemicals that have already been excluded from the regulatory definition of VOCs. Honeywell states that Solstice TM 1233zd(E) is not a listed chemical substance in the regulations of the Occupational Safety and Health Administration (OSHA), nor would it be classified as acutely toxic based on OSHA health hazard criteria. Honeywell also notes that Solstice TM 1233zd(E) is not a hazardous air pollutant under the Clean Air Act.

EPA Response: The EPA agrees with the factual information provided in the comments from Honeywell. The EPA notes that the only fact cited in the single adverse comment is that the (Honeywell-recommended) OEL for Solstice TM 1233zd(E) is 300 ppm. The commenter does not argue or present any evidence that exposures to workers or the public will approach this level. The EPA does not agree that keeping Solstice TM 1233zd(E) within the regulatory definition of VOCs would increase worker or public awareness of its potential toxicity at high exposure levels or help them to limit their exposures, in the context of other mechanisms operating to inform and protect workers and the public from high exposures, because such individuals are unlikely to be aware of the details of the EPA's regulatory definition of VOCs and because individuals do not necessarily associate mere qualification as a VOC with hazard. There are more direct and customary ways for people likely to be exposed to the chemical to become aware of needed precautions (e.g., material safety data sheets). Issues of workplace exposure were considered in the EPA's reviews of this compound under the PMN and SNAP program and the EPA felt that existing measures were appropriate to prevent unreasonable risk.

As stated previously, the EPA finds that Solstice TM 1233zd(E) qualifies as negligibly reactive with respect to its contribution to tropospheric ozone formation. In addition, we believe that risks not related to tropospheric ozone associated with currently allowed uses of the chemical are acceptable and that any new or increased risk from potential new uses are adequately addressed by other existing programs and policies, specifically the SNAP program. We also believe that the comparable or lower GWP of Solstice TM 1233zd(E) compared to other acceptable substitutes is an additional reason to approve the Solstice TM 1233zd(E) petition given that applying the Interim Guidance itself supports such approval.

The EPA is taking final action to approve the petition for exemption of Solstice TM 1233zd(E) from the regulatory definition of VOCs.

If an entity uses or produces Solstice TM 1233zd(E) and is subject to the EPA regulations limiting the use of VOC in a product other than an aerosol coating, limiting the VOC emissions from a facility, or otherwise controlling the use of VOC for purposes related to attaining the ozone NAAQS, then the compound will not be counted as a VOC in determining whether these regulatory obligations have been met. Emissions of this compound will not be considered in determining whether a proposed new or modified source triggers the applicability of Prevention of Significant Deterioration (PSD) requirements, in areas where the PSD program is implemented by the EPA or a delegated state, local or tribal agency. This action may also affect whether Solstice TM 1233zd(E) is considered as a VOC for state regulatory purposes to reduce ozone formation, if a state relies on the EPA's regulatory definition of VOCs. States are not obligated to exclude from control as a VOC those compounds that the EPA has found to be negligibly reactive. However, states may not take credit for controlling these compounds in their ozone control strategies.

This action is consistent with the Interim Guidance in that two of the three reactivity metric values for Solstice TM 1233zd(E) compare favorably to the corresponding values for ethane. This action is also supported by our inability in the Premanufacture Notification Review Program to find any unreasonable risks to human health or the environment from the expected use of the substance, our finding in the SNAP program review of this chemical that use of this chemical in currently allowed applications poses lower or comparable overall risk to human health and the environment than other acceptable options for the same uses, and on our confidence that the SNAP program would prevent the use of this chemical in any additional applications subject to review by the SNAP program where such use would pose a significant risk to human health or the environment.

This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b). It does not contain any recordkeeping or reporting requirement.

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

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

After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 USC 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. This final rule removes Solstice TM 1233zd(E) from the regulatory definition of VOCs and thereby relieves users of the compound from requirements to control emissions of the compound. We have, therefore, concluded that today's final rule will relieve regulatory burden for all affected small entities.

This action contains no federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for state, local or tribal governments or the private sector. The action imposes no enforceable duty on any state, local or tribal governments or the private sector. Therefore, this action is not subject to the requirements of sections 202 and 205 of the UMRA.

This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This final rule removes Solstice TM 1233zd(E) from the regulatory definition of VOCs and thereby relieves users of the compound from requirements to control emissions of the compound.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This final rule removes Solstice TM 1233zd(E) from the regulatory definition of VOCs and thereby relieves users from requirements to control emissions of the compound. Thus, Executive Order 13132 does not apply to this rule.

This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It would not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian Tribes, or on the distribution of power and responsibilities between the federal government and Indian Tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

This action is not subject to EO 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in EO 12866. While this final rule is not subject to the Executive Order, the EPA has reason to believe that ozone has a disproportionate effect on active children who play outdoors (62 FR 38856; 38859, July 18, 1997). The EPA has not identified any specific studies on whether or to what extent Solstice TM 1233zd(E) may affect children's health.

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

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

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

The EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it will not affect the level of protection provided to human health or the environment.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective on September 27, 2013.

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit Court within 60 days from the date the final action is published in the Federal Register . Filing a petition for review by the Administrator of this final action does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review must be final, and shall not postpone the effectiveness of such action. Thus, any petitions for review of this action related to the exemption of Solstice TM 1233zd(E) from the regulatory definition of VOCs must be filed in the Court of Appeals for the District of Columbia Circuit within 60 days from the date final action is published in the Federal Register .

For reasons set forth in the preamble, part 51 of chapter I of title 40 of the Code of Federal Regulations is amended as follows:

Throughout this document, “we”, “us”, and “our” refer to the United States Environmental Protection Agency (EPA).

EPA provided a detailed description of the BART requirements of the Regional Haze Rule and our analysis of the Nevada Division of Environmental Protection's (NDEP) BART determination for RGGS elsewhere. See 77 FR 21896 (April 12, 2012). EPA took final action on the BART determination for NO X emissions from Unit 1, 2, and 3 at RGGS on August 23, 2012 (77 FR 50936). On October 19, 2012, Nevada Energy (NV Energy, also known as Nevada Power Company), filed a petition to the EPA Administrator for reconsideration of the BART compliance date. On March 26, 2013, EPA granted the petition for reconsideration and also proposed to extend the BART compliance date for NO X for the affected units by 18 months, from January 1, 2015 to June 30, 2016. The notice of proposed rulemaking published on March 26, 2013, provides additional detail regarding the history of EPA actions related to BART for RGGS, the petition for reconsideration, a summary of supplemental information submitted by NV Energy to demonstrate that the extended compliance date of June 30, 2016, is as expeditious as practicable, and EPA's demonstration that the extension does not interfere with attainment, reasonable further progress, or any other applicable requirement of the Clean Air Act (CAA). This information is not restated here. See 78 FR 18280 (March 26, 2013).

EPA provided a 60-day public comment period for our proposed rulemaking that was scheduled to close on May 28, 2013. On April 4, 2013, EPA provided notice in the Federal Register of a public hearing and a short extension of the comment period to May 30, 2013 (78 FR 20290). The public hearing was held on April 29, 2013, in Moapa, Nevada. EPA received oral comments from 12 individuals during the public hearing. Prior to the close of the public comment period, EPA also received three written comment letters.

Oral comments made during the public hearing are summarized below and are followed by EPA's responses to those comments. In general, comments made during the public hearing expressed concerns related to the health impacts on the Moapa community from RGGS and expressed opposition to the proposed extension of the BART compliance date for NO X . Members of the Moapa Band of Paiute Indians (Moapa Band) and the Sierra Club, as well as legal counsel representing the Moapa Band and the Sierra Club, provided oral testimony during the public hearing. 1 Subsequent to the public hearing, and prior to the close of the comment period, the legal counsel representing the Moapa Band, the Sierra Club, and the National Parks Conservation Association, submitted a written comment letter stating that the groups took no position on the proposed compliance date extension. 2 EPA also received comment letters in support of the proposed extension of the compliance date, from NV Energy and NDEP. 3 NDEP noted that the extended compliance date would still result in the installation and operation of new NO X controls more than 1 year earlier than the 5-year maximum period allowed for BART under the Clean Air Act and the Regional Haze Rule.

In its comment letter to EPA dated May 14, 2013, NV Energy also provided additional information regarding an amendment to Senate Bill 123 introduced to the Nevada Legislature in April, 2013 (known as “NVision”). NVision proposed to retire some of the coal-fired units owned by NV Energy on an accelerated schedule and to replace retired generation with energy from new natural gas-fired units and renewable sources. NVision would require early retirement of Units 1, 2, and 3 at RGGS by the end of 2014, prior to the original compliance date in our August 23, 2012 final rulemaking and the extended compliance date we proposed on March 26, 2013. Because NV Energy must also file its plan to the Nevada Public Utilities Commission for review and approval, NV Energy states that the earliest date it would receive a decision on the plan would be in the first quarter of 2014. Given the current uncertainty regarding approval of NVision, NV Energy stated in its letter that it will continue to move forward on an expeditious schedule to comply with BART emission limits for NO X at RGGS by June 30, 2016. 4

All written comments submitted to EPA express either no position on, or are in support of, our proposed action to extend the BART compliance date. Because our final action extends the compliance date as proposed, we are not providing any further responses to those written comments. Oral comments made during the public hearing express additional concerns related to RGGS and the proposed compliance date extension. We respond below to the comments received during the public hearing that are relevant to our proposed action.

Comment 1: In general, the commenters opposed extending the compliance date for meeting the NO X emission limits at RGGS. A number of commenters indicated that the plant has been in operation for many years and should no longer be allowed to operate without controls. Some commenters stated that an extension is not necessary in light of the plan to shut the plant down next year, and one added that maintaining the current compliance schedule will give NV Energy added incentive to go through with the shutdown.

Response 1: EPA disagrees with the comment that RGGS is operating without controls. RGGS currently operates with SO 2 and particulate matter controls, as well as older low-NO X burners with overfire air. Units 1, 2, and 3 at RGGS are subject to BART based on their age, emissions of visibility-impairing pollutants, and their impact on visibility at Class I areas. The CAA and the Regional Haze Rule require BART controls to be installed as expeditiously as practicable, but in no event later than five years from the date of the final rulemaking. As discussed in greater detail in our notice of reconsideration and proposed rulemaking, our proposed extension of the compliance date by 18 months, from January 1, 2015 to June 30, 2016, is consistent with the CAA and the Regional Haze Rule. The extension is justified by an expeditious schedule for the installation of multiple control technologies that require detailed engineering, procurement, construction, installation, and testing of new controls, as well as regulatory approvals from the Nevada Public Utilities Commission and the Nevada Division of Environmental Protection, with an average time of 14 months per unit to meet new BART emission limits. RGGS is following its plan to install new controls to comply with BART emission limits as expeditiously as practicable and within a timeframe that is less than five years from the final BART rulemaking.

As stated previously, although NV Energy plans to retire Units 1, 2, and 3 at RGGS by the end of 2014, NV Energy must also file its plan to the Nevada Public Utilities Commission for review and approval. NV Energy states that the earliest date it would receive a decision on the plan would be in the first quarter of 2014. Given the current uncertainty regarding the approval of NVision, NV Energy stated in its letter that it continues to move forward on its expeditious schedule to comply with BART emission limits for NO X at RGGS by June 30, 2016. Therefore, EPA's action is still necessary despite NV Energy's plans to retire Units 1, 2 and 3 at RGGS. This final action requires that in the event Units 1, 2, and 3 continue operation and are not retired by the end of 2014, these units must comply with BART emission limits by June 30, 2016, a date which is as expeditious as practicable and within five years of the final rule.

Comment 2: Some commenters expressed skepticism about NV Energy's pledge to retire its coal-fired boilers at RGGS and the passage of pending state legislation, which would codify the proposed retirement schedule. These commenters encouraged the EPA to follow through with the existing compliance schedule in the event that NV Energy does not retire the plant voluntarily or at the behest of state legislation.

Response 2: EPA understands that the NVision plan has been approved by the Nevada Legislature and signed by Governor Brian Sandoval on June 11, 2013. 5 NV Energy must also file its plan that includes early retirement of Units 1, 2, and 3 at RGGS to the Nevada Public Utilities Commission for review and approval.

As stated in Response 1, EPA is taking final action to extend the compliance date by 18 months based on our determination that the schedule for compliance that provides approximately 14 months per unit for the procurement, installation, and testing of new BART controls, is reasonable and as expeditious as practicable. For this reason, the extended compliance date of June 30, 2016 is consistent with the CAA and the Regional Haze Rule.

Comment 3: Several commenters stated that residents of southern Nevada and the Moapa Band of Paiute Indians suffer from a variety of health issues, including asthma attacks, lung disease, cancer, and heart disease, which they believe are attributable to emissions from RGGS. A few commenters recounted their personal experiences with deteriorating health or the health problems of loved ones. Two commenters argued that emissions produced by the RGGS are not restricted to the area around the plant, but impact neighboring cities and states as well.

Response 3: EPA understands that the health of the Moapa community is an important issue. Our final BART determination for RGGS is expected to significantly reduce emissions of NO X. 6 Ozone and fine particles are formed in the atmosphere from reactions between NO X and other pollutants. Nitrogen dioxide, or NO 2, is a component of NO X . Ozone, fine particles and NO 2 have all been associated with various effects on human health and the environment. As discussed in our proposed rulemaking, EPA has promulgated standards, known as the national ambient air quality standards (NAAQS), for seven pollutants, including NO 2, ozone and particulate matter with a diameter less than or equal to 2.5 micrometers (PM 2.5 ). 7 The primary NAAQS standards protect public health, including the health of “sensitive” populations, such as asthmatics, children, and the elderly, while the secondary NAAQS standards protect public welfare, including damage to animals, crops, vegetation, and buildings. Using a process that considers air quality data and other factors, EPA designates areas as “nonattainment” if those areas cause or contribute to violations of a NAAQS.

RGGS is located in Clark County, Nevada. Portions of Clark County (the Las Vegas Valley) have previously been designated nonattainment for PM 10 , carbon monoxide, and the 1997 8-hour ozone standard. RGGS is not located in the portion of Clark County that was designated nonattainment for PM 10 . Additionally, Clark County is now in attainment with the NAAQS for carbon monoxide and ozone. 8 This means that the air quality in the area surrounding RGGS is meeting all the NAAQS set by EPA to protect human health.

Comment 4: Two commenters urged the EPA to consider the broader ramifications of BART controls, warning that more stringent control of air emissions would lead to an increased waste stream and more contaminants flowing into wastewater ponds and eventually into nearby landfills that burden the Moapa community.

Response 4: EPA understands that impacts from the landfills near the Moapa community are important issues. However, EPA's proposed rulemaking addressed only the compliance date by which the affected units at RGGS must meet emission limits required under the BART provisions of the CAA and Regional Haze Rule. Therefore, comments related to additional waste resulting from emission control technologies are not relevant to our current action. Discussions and considerations of non-air quality environmental impacts of potential controls were addressed in the proposed rule dated April 12, 2012 (77 FR 21896) and in the final rulemaking dated August 23, 2012 (77 FR 50942).

Comment 5: Two commenters discussed how emissions from the RGGS have impacted local vegetation and wildlife, making it difficult for the tribal community to exercise its cultural practices (e.g., herbal medicine).

Response 5: EPA understands that the health of local vegetation and wildlife are important issues to the Moapa community. In addition to ozone production, emissions of NO X also contribute to acid and nutrient deposition. These processes can affect the health of terrestrial and aquatic ecosystems through acidification or eutrophication. 9 Our final BART determination for RGGS is expected to significantly reduce emissions of NO X. In addition, EPA sets secondary standards to protect public welfare, including damage to animals and vegetation. In general, the secondary standards for the criteria pollutants are less stringent than, or equal to, the primary standards. Because RGGS is not located in an area that is designated nonattainment for any NAAQS, air quality in the area surrounding RGGS is meeting the NAAQS set by EPA to protect human health and public welfare, including animals and vegetation.

EPA is taking final action to extend the date by which Units 1, 2, and 3 at RGGS must comply with NO X emission limits under the BART requirement of the Regional Haze Rule, by 18 months, from January 1, 2015 to June 30, 2016.

This final action extends the compliance date for a single source to comply with the emission limits in an existing FIP. This type of action is exempt from review under Executive Orders (EO) 12866 (58 FR 51735, October 4, 1993) and EO 13563 (76 FR 3821, January 21, 2011).

This final action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b). Because the action merely extends a compliance date, it does not impose an information collection burden and the Paperwork Reduction Act does not apply.

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

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

After considering the economic impacts of this final action on small entities, I certify that this final action will not have a significant economic impact on a substantial number of small entities. The owner of the affected units at Reid Gardner Generating Station, Nevada Energy, also known as Nevada Power Company, is not a small entity and the final extended compliance date is supported by this entity. See Mid-Tex Electric Cooperative, Inc. v. FERC, 773 F.2d 327 (D.C. Cir. 1985).

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538, requires Federal agencies, unless otherwise prohibited by law, to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Federal agencies must also develop a plan to provide notice to small governments that might be significantly or uniquely affected by any regulatory requirements. The plan must enable officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates and must inform, educate, and advise small governments on compliance with the regulatory requirements.

This final rule does not contain a Federal mandate that may result in expenditures of $100 million or more for state, local, and tribal governments, in the aggregate, or the private sector in any one year. This action merely finalizes an 18-month extension of a compliance date. Thus, this rule is not subject to the requirements of sections 202 or 205 of UMRA.

This final rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This rule does not impose regulatory requirements on any government entity.

This final action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or in the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action finalizes an 18-month extension of a compliance date. Thus, Executive Order 13132 does not apply to this action. EPA further notes that we received a comment letter from the Nevada Division of Environmental Protection in support of the extended compliance date for RGGS.

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

EPA has concluded that this final rule may have tribal implications because the Reid Gardner Generating Station is located adjacent to reservation lands of the Moapa Band of Paiute Indians. However, it will neither impose substantial direct compliance costs on tribal governments, nor preempt tribal law.

During a telephone call on March 15, 2013, and in a letter of the same date, Regional Administrator Blumenfeld invited Chairman William Anderson of the Moapa Band of Paiute Indians to consult on our proposed action to extend the compliance date for Reid Gardner. On April 29, 2013, EPA held a public hearing in the Administration Building of the Moapa Band of Paiute Indians, in Moapa, Nevada, to accept comment on the proposed action. During the public hearing, EPA received comments from 12 individuals, including Chairman Anderson, several members of the Moapa Band, and the Sierra Club. A letter from the attorney jointly representing the Moapa Band of Paiute Indians, the Sierra Club, and the National Parks Conservation Association, expressed no position on our action to extend the compliance date for RGGS by 18 months. EPA did not receive a response regarding government-to-government consultation from Chairman Anderson.

Additionally, for prior actions related to regional haze and the Reid Gardner Generating Station, EPA consulted with Chairman Anderson and other tribal representatives early in the process to allow the Moapa Band of Piute Indians to have meaningful and timely input into its development. During the comment period for those prior actions, the Moapa Band raised concerns to EPA about the environmental impacts of this facility. For those previous rulemakings, EPA consulted the Moapa Band regarding these concerns and visited the reservation and the facility. Additional details of our consultation with the Moapa Band are provided in section IV.F of our final rulemaking published on August 23, 2012 (77 FR 50936).

EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because it does not establish an environmental standard intended to mitigate health or safety risks. This final action addresses regional haze and visibility protection.

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

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 12(10) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards (VCS) in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. VCS are technical standards (e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by the VCS bodies. The NTTAA directs EPA to provide Congress, through annual reports to OMB, with explanations when the Agency decides not to use available and applicable VCS.

This final rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any VCS.

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

EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because, while the final rule provides an 18-month extension in the compliance date, the facility will still achieve significant reductions in NO X emissions. The new compliance date for reducing emissions is less than five years from the effective date of the final BART determination, consistent with the BART provisions under the CAA.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 804 exempts from section 801 the following types of rules (1) rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's final action under section 801 because this is a rule of particular applicability and only applies to one facility, the Reid Gardner Generating Station.

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 28, 2013. Filing a petition for reconsideration by the administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2)).

For the reasons stated in the preamble, Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

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

On November 9, 2011 (76 FR 69896), we published a partial approval and partial disapproval of the San Joaquin Valley Unified Air Pollution Control District's (SJVUAPCD or District) 2008 PM 2.5 Plan and the California Air Resources Board's (CARB) 2007 State Strategy (collectively the “SJV PM 2.5 SIP”). As part of this action, EPA disapproved the contingency measure provisions in the SJV PM 2.5 SIP as failing to meet the requirements of Clean Air Act (CAA) section 172(c)(9) and 40 CFR 51.1012, which require that the SIP for each PM 2.5 nonattainment area contain contingency measures to be implemented if the area fails to make reasonable further progress or to attain the NAAQS by the applicable attainment date. See 76 FR 41338, 41357 to 41559 (July 13, 2011) and 76 FR 69896, 69924 (November 9, 2011). This disapproval action became effective on January 9, 2012 and started a sanctions clock for imposition of offset sanctions 18 months after January 9, 2012 and highway sanctions 6 months later, pursuant to CAA section 179 and our regulations at 40 CFR 52.31. As such, offset sanctions applied on July 9, 2013 and will continue to apply, and highway sanctions will apply on January 9, 2014, unless EPA determines that the deficiency forming the basis of the disapproval has been corrected.

On July 3, 2013, the State of California submitted as a SIP revision the SJVUAPCD's “Quantifying Contingencies for the 2008 PM 2.5 Plan ” (dated June 20, 2013) (“Contingency Measure SIP”). In the Proposed Rules section of today's Federal Register , we are proposing to approve this SIP revision because we believe that it corrects the deficiency identified in our November 9, 2011 partial disapproval action. Based on today's proposed approval, we are taking this final rulemaking action, effective on publication, to stay the imposition of the offset sanctions and to defer the imposition of the highway sanctions triggered by our November 9, 2011 partial disapproval.

EPA is providing the public with an opportunity to comment on this stay and deferral of sanctions. If comments are submitted that change our assessment described in this final determination and the proposed full approval of the Contingency Measure SIP, we intend to take subsequent final action to re-impose sanctions pursuant to 40 CFR 52.31(d). If no comments are submitted that change our assessment, then all sanctions and sanction clocks will be permanently terminated on the effective date of a final rule approval.

We are making an interim final determination to stay the imposition of the offset sanctions and to defer the imposition of the highway sanctions associated with our partial disapproval of the SJV PM 2.5 SIP, based on our concurrent proposal to approve the State's SIP revision as correcting the deficiency that initiated these sanctions.

Because EPA has preliminarily determined that the State has corrected the deficiency identified in EPA's partial disapproval action, relief from sanctions should be provided as quickly as possible. Therefore, EPA is invoking the good cause exception under the Administrative Procedure Act (APA) in not providing an opportunity for comment before this action takes effect (5 U.S.C. 553(b)(3)). However, by this action EPA is providing the public with a chance to comment on EPA's determination after the effective date, and EPA will consider any comments received in determining whether to reverse such action.

EPA believes that notice-and-comment rulemaking before the effective date of this action is impracticable and contrary to the public interest. EPA has reviewed the State's submittal and, through its proposed action, is indicating that it is more likely than not that the State has corrected the deficiency that started the sanctions clocks. Therefore, it is not in the public interest to initially impose sanctions or to keep applied sanctions in place when the State has most likely done all it can to correct the deficiency that triggered the sanctions clocks. Moreover, it would be impracticable to go through notice-and-comment rulemaking on a finding that the State has corrected the deficiency prior to the rulemaking approving the State's submittal. Therefore, EPA believes that it is necessary to use the interim final rulemaking process to stay and defer sanctions while EPA completes its rulemaking process on the approvability of the State's submittal. Moreover, with respect to the effective date of this action, EPA is invoking the good cause exception to the 30-day notice requirement of the APA because the purpose of this notice is to relieve a restriction (5 U.S.C. 553(d)(1)).

This action stays and defers federal sanctions and imposes no additional requirements.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget.

This action is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action.

The Administrator certifies that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

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

This rule does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action does not have federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This rule is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply to this rule because it imposes no standards.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to Congress and the Comptroller General. However, section 808 provides that any rule for which the issuing agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the agency promulgating the rule determines. 5 U.S.C. 808(2). EPA has made such a good cause finding, including the reasons therefore, and established an effective date of August 28, 2013. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 28, 2013 . Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purpose of judicial review nor does it extend the time within which petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2012-0549 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 October 28, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0549, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of January 16, 2013 (78 FR 3377) (FRL-9375-4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2E8069) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.582 be amended by establishing tolerances for residues of the fungicide pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester and its metabolite methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]otolyl] carbamate (BF 500-3), expressed as the parent compound, in or on artichoke, globe at 3.0 parts per million (ppm); endive, belgium at 3.0 ppm; and persimmon at 3.0 ppm. The petition additionally requested that EPA establish tolerances in or on vegetable, bulb, group 3-07 at 0.9 ppm; vegetable, fruiting, group 8-10 at 1.4 ppm; fruit, citrus, group 10-10 at 2.0 ppm; fruit, pome, group 11-10 at 1.5 ppm; oilseed, group 20 at 0.45 ppm; caneberry subgroup 13-07A at 4.0 ppm; bushberry subgroup 13-07B at 4.0 ppm; small fruit, vine climbing subgroup (except fuzzy kiwi) 13-07F at 2.0 ppm; and low growing berry subgroup 13-07G at 1.2 ppm. Further, upon approval of these subgroup/crop group tolerances the petition also requested that the following existing tolerances be removed for berry, group 13 at 4.0 ppm; fruit, citrus, group 10 at 2.0 ppm; fruit, pome, group 11 at 1.5 ppm; grape at 2.0 ppm; strawberry at 1.2 ppm; vegetable, bulb, group 3 at 0.9 ppm; vegetable, fruiting, group 8 at 1.4 ppm; borage, seed at 0.45 ppm; castor oil plant, seed at 0.45 ppm; chinese tallowtree, seed at 0.45 ppm; crambe, seed at 0.45 ppm; cuphea, seed at 0.45 ppm; echium, seed at 0.45 ppm; euphorbia, seed at 0.45 ppm; evening primrose, seed at 0.45 ppm; flax seed at 0.45 ppm; gold of pleasure, seed at 0.45 ppm; hare's ear mustard, seed at 0.45 ppm, jojoba, seed at 0.45 ppm; lesquerella, seed at 0.45 ppm, lunaria, seed at 0.45 ppm; meadowfoam, seed at 0.45 ppm; milkweed, seed at 0.45 ppm; mustard, seed at 0.45 ppm; niger seed, seed at 0.45 ppm; oil radish, seed at 0.45 ppm; poppy, seed at 0.45 ppm; rapeseed, seed at 0.45 ppm; rose hip, seed at 0.45 ppm; safflower, seed at 0.45 ppm; sesame, seed at 0.45 ppm; stokes aster, seed at 0.45 ppm; sunflower, seed at 0.45 ppm; sweet rocket, seed at 0.45 ppm; tallowwood, seed at 0.45 ppm; tea oil plant, seed at 0.45 ppm; and ternonia, seed at 0.45 ppm. That document referenced a summary of the petition prepared on behalf of IR-4 by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Additionally, in the Federal Register of August 22, 2012 (77 FR 50661) (FRL-9358-9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8038) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC, 27709-3528. The petition requested that 40 CFR 180.582 be amended by establishing tolerances for residues of the fungicide pyraclostrobin, carbamic acid, expressed as the parent compound, in or on sugarcane, cane at 0.2 ppm. No tolerances were proposed for the processed commodities refined sugar and molasses, as no concentration of pyraclostrobin residues are expected in these commodities. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the proposed tolerance level in or on endive, belgium. Further, the petitioner later requested to amend low growing berry subgroup 13-07G to exclude cranberry. The reasons for these changes are explained in Unit IV.C.

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 FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 pyraclostrobin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyraclostrobin 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.

There are no concerns for reproductive susceptibility, neurotoxicity, mutagenicity, genotoxicity, or immunotoxicity. The most consistently observed effects resulting from pyraclostrobin exposure across species, genders, and treatment durations were diarrhea and decreased body weight, body weight gain, and food consumption. Pyraclostrobin also causes intestinal disturbances, as indicated by increased incidence of diarrhea or duodenum mucosal thickening. These intestinal effects appeared to be related to the irritating action on the mucus membranes as demonstrated by irritation seen in the primary eye irritation study. In the rat acute and subchronic neurotoxicity studies, neuropathology and behavior changes were not observed.

In the rat developmental toxicity study, developmental toxicity including an increased incidence of dilated renal pelvis and cervical ribs occurred at a dose greater than the dose causing maternal toxicity (including decreased body weights and body weight gains and reduced food consumption and reduced food efficiency). The rabbit developmental toxicity study indicates qualitative evidence of increased developmental susceptibility based on increased resorptions per litter, increased post-implantation loss and dams with total resorptions, in the presence of maternal toxicity (reduced body weight gain, food consumption, and food efficiency). In a dose range-finding one-generation reproduction study, systemic toxicity was manifested as decreased body weight and body weight gain in both the parents and offspring. The effects occurred at the same dose levels for both parental and the offspring, but the decrease in pup weight was more than that in the parental animals. However, the body weight effect was not found in the guideline 2-generation reproduction study in either parental or offspring animals at similar dose level. No reproductive toxicity was seen.

Pyraclostrobin has been classified as not likely to be carcinogenic to humans based on the lack of treated related increase in tumor incidence in adequately conducted carcinogenicity studies in rats and mice. Pyraclostrobin did not cause mutagenicity or genotoxicity in the in vivo and in vitro assays, nor did it cause immunotoxicity in T-cell dependent antibody response assays in mice with preliminary review.

Specific information on the studies received and the nature of the adverse effects caused by pyraclostrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: “Pyraclostrobin—Human Health Risk Assessment for a Section 3 Registration of New Uses on Sugarcane, Globe Artichoke, Belgium Endive, Persimmon, Greenhouse Grown Tomato Transplants for Home Consumer Market, and Residential Ornamentals, Landscape Gardens, Fruit Trees, and Nut Trees; Plus Crop Group Expansions/Revisions for Bulb Vegetable Group 3-07, Fruiting Vegetable Group 8-10, Citrus Fruit Group 10-10, Pome Fruit Group 11-10, Berry Subgroups 13-07A, B, F, and G, and Oilseed Group 20” at pages 43-49 in docket ID number EPA-HQ-OPP-2012-0549.

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

A summary of the toxicological endpoints for pyraclostrobin used for human risk assessment is shown in Table 1. of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyraclostrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing pyraclostrobin tolerances in 40 CFR 180.582. EPA assessed dietary exposures from pyraclostrobin in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for pyraclostrobin.

In estimating acute dietary exposure, EPA used Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16, which uses food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003 through 2008. As to residue levels in food, EPA used tolerance-level residues or highest field trial residues and empirical or default processing factors. Experimentally-derived processing factors were used for fruit juices, tomato, sugarcane, and wheat commodities. For all other processed commodities, DEEM default processing factors were assumed.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA included tolerance-level or average field trial residues, average percent crop treated (PCT) estimates when available, and empirical processing factors. Experimentally-derived processing factors were used for fruit juices, tomato, sugar cane, and wheat commodities. For all other processed commodities, DEEM default processing factors were assumed.

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

iv. Percent crop treated (PCT) information. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The following average PCT estimates were used in the chronic dietary risk assessments for the crops that are currently registered for pyraclostrobin: almonds 40%; apples 15%; apricots 25%; barley 10%; green beans 5%; blueberries 45%; broccoli 5%; cabbage 10%; caneberries 50%; cantaloupes 15%; carrots 35%; cauliflower 2.5%; celery 2.5%; cherries 50%; corn 10%; cotton 2.5%; cucumber 5%; dry beans/peas 10%; garlic 15%; grapefruit 25%; grapes 30%; hazelnuts (filberts) 15%; lemons 2.5%; lettuce 5%; nectarines 10%; onions 20%; oranges 5%; peaches 20%; peanuts 25%; pears 15%; green peas 5%; pecans 2.5%; peppers 10%; pistachios 30%; plums/prunes 5%; potatoes 15%; pumpkins 20%; soybeans 5%; spinach 5%; squash 15%; strawberries 65%; sugar beets 45%; sweet corn 5%; tangelos 15%; tangerines 10%; tomatoes 25%; walnuts 1%; watermelons 30%; wheat 5%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which pyraclostrobin may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for pyraclostrobin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pyraclostrobin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of pyraclostrobin for acute exposures are estimated to be 35.6 parts per billion (ppb) for surface water and 0.06 ppb for ground water. Chronic exposures for non-cancer assessments are estimated to be 2.3 ppb for surface water and 0.02 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 35.6 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 2.3 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Pyraclostrobin is currently registered for the following uses and additional proposed uses that could result in residential handler and postapplication exposures: Treated gardens, fruit or nut trees, tomato transplants, and turf. EPA assessed residential exposure using the following assumptions: Short-term adult handler exposures via the dermal and inhalation routes resulting from application of pyraclostrobin to gardens, trees, and turf. Short-term dermal postapplication exposures were assessed for adults, youth 11 to 16 years old, and children 6 to 11 years old. Short-term dermal and incidental oral exposures were assessed for children 1 to < 2 years old. Based on the registered uses of pyraclostrobin on residential and golf course turf, intermediate-term postapplication exposures are possible. However, since the short- and intermediate-term endpoints and PODs for dermal and oral routes are the same, the short-term exposure and risk estimates are considered to be protective of potential intermediate-term exposure and risk.

For the aggregate assessment, inhalation and dermal exposures were not aggregated together because the toxicity effect from the inhalation route of exposure was different than the effect from the dermal route of exposure. The scenarios with the highest residential exposures that were used in the short-term aggregate assessment for pyraclostrobin are as follows:

• Adult short-term aggregate assessment—Residential inhalation exposure from application pyraclostrobin to turf via manually pressurized hand wand or backpack sprayer; residential dermal postapplication exposure via activities on treated turf.

• Youth (11-16 years old) short-term aggregate assessment—Residential dermal exposure from postapplication golfing on treated turf.

• Children (6-11 years old) short-term aggregate assessment—Residential dermal exposures from postapplication activities in treated gardens.

• Children (1 < 2 years old) short-term aggregate assessment—Residential dermal and hand-to-mouth exposures from postapplication exposure to treated turf.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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

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

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

2. Prenatal and postnatal sensitivity. There is no evidence that pyraclostrobin results in increased susceptibility in rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. Although there is qualitative evidence of increased susceptibility in the prenatal development study in rabbits, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of pyraclostrobin. The degree of concern for prenatal and/or postnatal toxicity is low.

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

i. The toxicity database for pyraclostrobin is complete.

ii. There is no indication that pyraclostrobin is a neurotoxic chemical. Effects seen in the acute and subchronic neurotoxicity studies in rats are considered to reflect perturbations in mitochondrial respiration leading to effects on energy production rather than signs of neurotoxicity; therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity

iii. There is no evidence that pyraclostrobin results in increased susceptibility in rats in the prenatal developmental study or in young rats in the 2-generation reproduction study. The prenatal rabbit developmental toxicity study showed qualitative evidence of increased susceptibility to prenatal rabbits; however, this study was chosen for endpoint selection for the acute dietary (females 13-49) and short-term dermal exposure scenarios. This study has a clearly defined NOAEL of 5.0 mg/kg/day. EPA did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of pyraclostrobin. The degree of concern for prenatal and/or postnatal toxicity is low.

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary exposure assessments were performed assuming 100 PCT and tolerance-level or highest field trial residues. The chronic dietary exposure assessments were performed using average PCT estimates, when available, and tolerance-level or highest field trial residues. These data are reliable and are not expected to underestimate risks to adults or children. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to pyraclostrobin in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pyraclostrobin.

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

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to pyraclostrobin will occupy 87% of the aPAD for females 13-49 years old; and 2.8% for children 1-2 years old, the population group receiving the greatest exposure for the general U.S. population, including infants and children.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to pyraclostrobin from food and water will utilize 27% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of pyraclostrobin is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pyraclostrobin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pyraclostrobin.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 120 for children 1-2 years old, 360 for children 6-11 years old, 1,500 for youth 11-16 years old, 760 for adult handlers, and 230 for adults from postapplication exposures. Because EPA's level of concern for pyraclostrobin is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pyraclostrobin is currently registered for uses that could result in intermediate-term residential exposure; however, since the short- and intermediate-term endpoints and PODs for dermal and oral routes are the same, the short-term exposure and risk estimates are considered to be protective of potential intermediate-term exposure and risk and an intermediate-term aggregate assessment was not performed.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, pyraclostrobin is not expected to pose a cancer risk to humans.

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

Two adequate methods are available to enforce the tolerance expression for residues of pyraclostrobin and the metabolite BF 500-3 in or on plant commodities: A liquid chromatography with tandem mass spectrometry (LC/MS/MS) method, BASF Method D9908; and a high-performance LC with ultraviolet detection (HPLC/UV) method, Method D9904. The methods may be found in the Pesticide Analytical Manual, Volume I.

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 United Nations 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 pyraclostrobin in or on sugarcane, endive, belgium, and persimmon. A Codex MRL has been established for pyraclostrobin in or on globe artichoke at 2.0 ppm. EPA has determined that the U.S. tolerance should be set at 3.0 ppm. The field trials comprising the data set used by Codex are from Europe, and these trials were conducted under an application rate and preharvest interval different from that on the U.S. trials. The U.S. tolerance is based on application of the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures to the validated field trial data, which shows that the U.S. tolerance for globe artichoke must be at 3.0 ppm to avoid violations for crops treated in accordance with the EPA approved label. These different tolerance levels may be due, in part, to the different residue definitions for pyraclostrobin for the U.S. tolerances and the Codex MRLs. Codex established MRLs for residues of pyraclostrobin only, and in the U.S. tolerances, are currently established for parent and its desmethoxy metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] phenylcarbamate). Currently, pyraclostrobin has over 100 tolerances for multiple commodities and crop groups. When this chemical goes through registration review the U.S. EPA will determine if it is possible to change the existing residue definition to align with Codex which would potentially allow for harmonization of MRL and tolerance levels. However, given the number of existing tolerances it is not appropriate to consider such a change for this petition only. Therefore, because the residue definitions are currently different and pyraclostrobin field trials in the U.S. show higher residue levels than Codex MRL levels, it is not possible to harmonize the U.S. tolerance for globe artichoke with the Codex MRL. Additionally, the following U.S. crop group tolerances established in this action could not be harmonized because of the difference in residue definitions between U.S. tolerances for pyraclostrobin and Codex MRLs. The crop group tolerances which could not be harmonized with Codex MRLs for commodities in these crop group tolerances include: The bulb vegetable group 3-07; the fruiting vegetables group 8-10; the pome fruit group 11-10; the caneberry subgroup 13-07A; the bushberry subgroup 13-07B; the small fruit vine climbing subgroup 13-07F; and the low growing berry subgroup 13-07G. The Codex has established an MRL for the Codex equivalent of the U.S. citrus fruit group 10-10 and for the oilseed group 20, but although the numerical levels for the U.S. and Codex crop groups are the same, the numerical values refer to different residues.

Based on the data submitted with the petition, EPA is revising the proposed tolerance in or on endive, belgium from 3.0 ppm to 4.0 ppm. The Agency revised this tolerance level based on analysis of the residue field trial data using the OECD tolerance calculation procedures. EPA is additionally removing the time-limited tolerance in or on sugarcane, cane at 0.02 ppm as it will be superseded by the permanent tolerance at 0.2 ppm. Finally, EPA is removing the time-limited tolerance in or on sugarcane, molasses at 0.4 ppm, as the Agency has determined that no concentration of pyraclostrobin residues are expected in these commodities and the tolerance is therefore not necessary. The information regarding sugarcane, molasses was included in the August 22, 2012 (77 FR 50661) notice of filing for PP number 2F8038.

Therefore, tolerances are established for residues of pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1 H - pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl N -[[[1-(4-chlorophenyl)-1 H -pyrazol-3-yl]oxy]methyl]phenyl carbamate), calculated as the stoichiometric equivalent of pyraclostrobin in or on artichoke, globe at 3.0 ppm; endive, belgium at 4.0 ppm; persimmon at 3.0 ppm; sugarcane, cane at 0.20 ppm; vegetable, bulb, group 3-07 at 0.9 ppm; vegetable, fruiting, group 8-10 at 1.4 ppm; fruit, citrus, group 10-10 at 2.0 ppm; fruit, pome, group 11-10 at 1.5 ppm; oilseed group 20 at 0.45 ppm; caneberry subgroup 13-07A at 4.0 ppm; bushberry subgroup 13-07B at 4.0 ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; and berry, low growing, subgroup 13-07G, except cranberry at 1.2 ppm. This regulation additionally removes established tolerances in or on vegetable, bulb, group 3; vegetable, fruiting, group 8; fruit, citrus, group 10; fruit, pome, group 11; cotton, undelinted seed; borage, seed; castor oil plant, seed; Chinese tallowtree, seed; crambe, seed; cuphea, seed; echium, seed; euphorbia, seed; evening primrose, seed; flax, seed; gold of pleasure, seed; hare's ear mustard, seed; jojoba, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed; milkweed, seed; mustard, seed; niger seed, seed; oil radish, seed; poppy, seed; rapeseed, seed; rose hip, seed; safflower, seed; sesame, seed; stokes aster, seed; sunflower, seed; sweet rocket, seed; tallowwood, seed; tea oil plant, seed; vernonia, seed; berry, group 13; grape; and strawberry. This regulation finally removes the time-limited tolerances in or on sugarcane, cane and sugarcane, molasses.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq. ).

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) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined 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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2012-0586 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 October 28, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0586, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-9364-6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2E8050) by IR-4, IR-4 Project Headquarters, 500 College Rd. East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR 180.479 be amended by establishing tolerances for residues of the herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in or on artichoke and caneberry subgroup 13-07A at 0.05 parts per million (ppm). That document referenced a summary of the petition prepared by Gowan Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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 FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 halosulfuron-methyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with halosulfuron-methyl follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. With repeated dosing, halosulfuron-methyl produces non-specific effects, which are frequently characterized by reduced body weight/body weight gain in the test animals. In the prenatal developmental toxicity study in rats, increases in resorptions, soft tissue (dilation of the lateral ventricles) and skeletal variations, and decreases in body weights were seen in the fetuses compared to clinical signs and decreases in body weights and food consumption in the maternal animals at a similar dose level. In the rabbit developmental toxicity study, increases in resorptions and post-implantation losses and decrease in mean litter size were seen in the presence of decreases in body weight and food consumption in maternal animals were observed. However, a clear no observed adverse effect level (NOAEL) for these effects was established in both rat and rabbit developmental toxicity studies. Halosulfuron-methyl did not produce reproductive effects. No neurotoxic effects were observed in the acute or subchronic neurotoxicity studies.

Halosulfuron-methyl is classified as “not likely to be carcinogenic to humans.” It is negative for mutagenicity in a battery of genotoxicity studies.

Although there is no immunotoxicity study for halosulfuron-methyl, the available data indicate that halosulfuron-methyl is unlikely to be an immuno toxicant. EPA is currently reviewing a waiver request for these data.

Specific information on the studies received and the nature of the adverse effects caused by halosulfuron-methyl as well as the NOAEL and Lowest Observed-Adversed-Effective-Level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: “Halosulfuron-Methyl: Human Health Risk Assessment for Proposed New Uses on Artichoke and Caneberry (Crop subgroup 13-07A),” dated March 25, 2013, pp. 30-34, docket ID number EPA-HQ-OPP-2012-0586-0004.

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

A summary of the toxicological endpoints for halosulfuron-methyl used for human risk assessment is discussed in Unit III. of the final rule published in the Federal Register of December 3, 2012 (77 FR 71555) (FRL-9370-6).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to halosulfuron-methyl, EPA considered exposure under the petitioned-for tolerances as well as all existing halosulfuron-methyl tolerances in 40 CFR 180.479. EPA assessed dietary exposures from halosulfuron-methyl in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. There was no indication of an adverse effect attributable to a single dose for the general U.S. population including infants and children. Therefore, an acute dietary assessment was not conducted for the U.S. general population. However, such effects were identified for females 13-49 years old for halosulfuron-methyl. In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model—Food Consumption Intake Database (DEEM-FCID, ver. 3.16), which incorporates consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA); 2003-2008). As to residue levels in food, EPA conducted an unrefined assessment that assumed 100 percent crop treated (PCT), dietary exposure evaluation model (DEEM) 7.81 default processing factors, and tolerance-level residues for all existing and proposed uses.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID, ver. 3.16 which incorporates consumption information from the USDA NHANES/WWEIA; 2003-2008. As to residue levels in food, EPA conducted an unrefined assessment that assumed 100 PCT, DEEM 7.81 default processing factors, and tolerance-level residues for all existing and proposed uses.

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

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for halosulfuron-methyl. Tolerance level residues and100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for halosulfuron-methyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of halosulfuron-methyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Tier 1 Rice Model v.1.0 and Screening Concentration in Ground Water (SCI-GROW) models, respectively, the estimated drinking water concentrations (EDWCs) of halosulfuron-methyl for acute exposures are estimated to be 59.2 parts per billion (ppb) for surface water and 0.065 ppb for ground water.

For chronic exposures for non-cancer assessments EDWC's are estimated to be 59.2 ppb for surface water and 0.065 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both the acute and chronic dietary risk assessments, the water concentration value of 59.2 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Halosulfuron-methyl is currently registered for the following uses that could result in residential exposures: Residential turf use. EPA assessed residential exposure using the following assumptions: Residential handler short-term (1-30 days) dermal and inhalation exposures, and residential post-application short-term dermal and incidental oral (hand-to-mouth, object-to-mouth, and soil ingestion) exposures are expected from activities associated with the existing uses. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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

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

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

2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for halosulfuron-methyl includes rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. As discussed in Unit III.A., there was no quantitative evidence for increased susceptibility following prenatal and/or postnatal exposure. However, there was qualitative evidence for increased susceptibility of fetuses in the rat and rabbit developmental studies. In the rat study, increases in resorptions, soft tissue (dilation of the lateral ventricles) and skeletal variations, and decreases in body weights were seen in the fetuses compared to clinical signs and decreases in body weights and food consumption in the maternal animals. In the rabbit study, increases in resorptions and post-implantation losses and decrease in mean litter size was seen in the presence of decreases in body weight and food consumption in maternal animals. Thus, in both species, the developmental effect was considered to be qualitatively more severe than maternal effects (i.e., qualitative evidence for susceptibility). Nevertheless, the degree of concern for these effects is low, and there are no residual uncertainties for prenatal toxicity in both rats and rabbits for the following reasons:

i. In both studies, there are clear NOAELs/LOAELs for developmental and maternal toxicities.

ii. Developmental effects were seen in the presence of maternal toxicity.

iii. The effects were only seen at the high dose.

iv. In rats, developmental effects were seen at a dose which approached the limit-dose.

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

i. The toxicity database for halosulfuron-methyl is complete except for an immunotoxicity study. In the absence of specific immunotoxicity studies, EPA has evaluated the available halosulfuron-methyl toxicity data to determine whether an additional uncertainty factor is needed to account or potential immunotoxicity. The toxicology database for halosulfuron-methyl does not show any evidence of biologically relevant effects on the immune system following exposure to this chemical. The overall weight-of-evidence suggests that this chemical does not directly target the immune system. Based on these considerations, EPA does not believe that conducting immunotoxicity testing will result in a point of departure lower than those already selected for halosulfuron-methyl risk assessment, and an additional database uncertainty factor is not needed to account for the lack of this study.

ii. There is no indication that halosulfuron-methyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.

iii. Although there is qualitative evidence of increased susceptibility in the prenatal developmental studies in rats and rabbits, as discussed in Unit III.D.2., there are no residual uncertainties after establishing toxicity endpoints and the degree of concern for pre- and/or postnatal toxicity is low.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to halosulfuron-methyl in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by halosulfuron-methyl.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to halosulfuron-methyl will occupy <1% of the aPAD for females 13-49 years, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to halosulfuron-methyl from food and water will utilize 5.5% of the cPAD for all children 1-2 years old, the population group receiving the greatest exposure. Chronic residential exposure to residues of halosulfuron-methyl is not expected. Therefore, the chronic aggregate risk would be equivalent to the chronic dietary exposure estimate.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Halosulfuron-methyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to halosulfuron-methyl.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1,800 for adults and 840 for children. Residential exposure for use in the aggregate assessment of adults and children 1 to <2 years old reflects the combined post-application dermal plus hand-to-mouth exposures from turf treated with liquid applications of halosulfuron-methyl. Because EPA's level of concern for halosulfuron-methyl is a MOE of 100 or below, these estimates of aggregate risk do not exceed the Agency's level of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, halosulfuron-methyl is not registered for any use patterns that would result in intermediate-term residential exposure pathway. Because there is no intermediate-term residential exposure, the intermediate-term aggregate risk would be equivalent to the chronic dietary exposure estimate. Chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the equivalent POD value used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, halosulfuron-methyl is not expected to pose a cancer risk to humans.

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

An adequate analytical method is available for enforcement of tolerances for halosulfuron-methyl residues in plants. The gas chromatography (GC) method quantifies halosulfuron-methyl as its rearrangement ester (RRE; 1- H -pyrazole-4-carboxylic acid, 3-chloro-5-[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl, methyl ester) using thermionic-specific detection (TSD, nitrogen specific). For confirmation, the RRE can be determined by gas chromatography mass spectroscopic detection (GC/MS).

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations 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. There are no Codex MRLs established for residues of halosulfuron-methyl in/on any commodity.

Therefore, tolerances are established for residues of the herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino] carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in or on the commodities artichoke at 0.05 ppm and caneberry subgroup 13-07A at 0.05 ppm.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq. ).

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) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-1018 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 October 28, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-1018, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.

In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-9), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 1F7901) by Wagner Regulatory Associates, Inc. (the Petitioner), on behalf of Bedoukian Research, Inc., 21 Finance Drive, Danbury, CT 06810. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of ethyl-2E,4Z-decadienoate (pear ester). The notice referenced a summary of the petition prepared by the Petitioner, which is available in the docket, http://www.regulations.gov. No relevant comments were received on this notice of filing.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require 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 . . . . ” Additionally, FFDCA section 408(b)(2)(D) requires that 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 performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability, and the relationship of this information 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.

Ethyl-2E,4Z-decadienoate (pear ester) is a naturally occurring, volatile substance emitted from mature, ripening fruit, that is attractive to the codling moth (CM), Cydia pomonella, a major agricultural pest of pome fruit worldwide. Male and female moths are attracted to pear ester and fly to the ripening fruit, where they mate and lay their eggs. Synthetic pear ester is structurally and functionally identical to the natural compound, and its intended pesticidal use is to disrupt CM mating behavior by attracting the moths away from the fruit, reducing their chances of finding mates and laying eggs in fruit orchards.

All applicable mammalian toxicology data requirements supporting the petition to exempt residues of pear ester from the requirement of a tolerance in or on all food commodities have been fulfilled. No toxic endpoints were identified in studies conducted and data obtained from open technical literature. Moreover, pear ester is not likely a mutagen or developmental toxicant. There are no known effects on endocrine systems via oral, dermal, or inhalation routes of exposure. For a more in-depth synopses of the data upon which EPA relied and its human health risk assessment based on that data can be found in the document entitled, “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Ethyl-2E,4Z-decadienoate (Pear Ester),” available in the docket for this action as described under ADDRESSES .

In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

The proposed use patterns may result in dietary exposure to pear ester, although its residues are not expected to be any greater than that of current exposure due to use of pear ester as a flavoring agent. No significant exposure via drinking water is expected when pear ester is used according to the product label directions. The reason for this conclusion is that pear ester is applied at low rates, degrades rapidly, and is not directly applied to water. Should exposure occur, however, minimal to no risk is expected for the general population, including infants and children, due to the low toxicity of pear ester as demonstrated in the data submitted and evaluated by the Agency.

Non-occupational exposure is not expected because pear ester will be applied as a codling moth mating disruptor for agricultural purposes only.

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 determined pear ester to have a non-toxic mode of action, and does not appear to produce any toxic metabolites; therefore, 408(b)(2)(D)(v) does not apply. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) 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 that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. In applying this provision, EPA either retains the default value of 10X, or uses a different additional or no safety factor when reliable data are available to support a different additional or no safety factor. As part of its qualitative assessment, EPA evaluated the available toxicity and exposure data on pear ester and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA considers the toxicity database to be complete and has identified no residual uncertainty with regard to prenatal and postnatal toxicity or exposure. No hazard was identified based on the available studies. Based upon its evaluation, EPA concludes that there are no threshold effects of concern to infants, children, or adults when pear ester is applied as a mating disruptor of codling moth and used in accordance with label directions and good agricultural practices. As a result, EPA concludes that no additional margin of exposure (safety) is necessary.

An analytical method is not required for enforcement purposes because EPA 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 United Nations 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 ethyl-2E,4Z-decadienoate (pear ester).

EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of ethyl-2E,4Z-decadienoate (pear ester). EPA is therefore establishing an exemption from the requirement of a tolerance for residues of ethyl-2E,4Z-decadienoate (pear ester) in or on all food commodities when applied as a codling moth mating disruptor and used in accordance with good agricultural practices.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq. ).

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) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

This is a synopsis of the Commission's Memorandum Opinion and Order, MM Docket No. 02-266, adopted July 31, 2013, and released August 1, 2013. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or www.BCPIWEB.com.

In the Report and Order in this proceeding, the Bureau granted a Petition for Rulemaking filed by Clear Channel Communications for the reallotment, downgrade in class of channel, and change of community of license for its Station WCGX(FM) (formerly WMRN-FM) from Channel 295B at Marion, Ohio to Channel 294B1 at Dublin, Ohio, over the objection of the Committee. See 70 FR 19337 (April 13, 2005). The Committee had argued that the reallotment to Dublin could not be implemented because it would violate the local radio ownership rule. However, the Report and Order rejected this argument, explaining that multiple ownership issues are not considered in FM allotment proceedings. The Committee sought reconsideration on the same ground, and the Bureau denied the petition in the Memorandum Opinion and Order. See 71 FR 40927 (July 19, 2006).

On review, the Commission finds that, contrary to the Committee's contention, the Bureau did not err in deferring the issue of compliance with the multiple ownership rule until an implementing application was filed because such an approach is consistent with then-existing policy. Additionally, the Commission concludes that the Bureau did not err in referring to Station WCGX(FM) as formerly licensed to Marion because the Report and Order did modify the Station WCGX(FM) license to specify Dublin. However, that modification had no immediate impact on competition in the Columbus radio market as Clear Channel was required to file an implementing application and demonstrate compliance with the multiple ownership rule, which Clear Channel did. This document is not subject to the Congressional Review Act. (The Commission, is, therefore, not required to submit a copy of this Memorandum Opinion and Order to GAO, pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A) because the Application for Review was denied.)

The Board's regulations at 49 CFR 1002.3 provide for an annual update of the Board's entire user-fee schedule. Fees are generally revised based on the cost study formula set forth at 49 CFR 1002.3(d). The fee changes adopted here reflect a combination of the unchanged salary costs from the 2012 User Fee Update decision; no change in the publication cost levels of that decision; plus increase changes to two of the three Board overhead cost factors (the other overhead factor remains unchanged from its 2012 level), resulting from the mechanical application of the update formula in 49 CFR 1002.3(d). Results from the formula application indicate that justified fee amounts in this 2013 update decision either remain unchanged (50 fees) or increase (75 fees) from their respective 2012 update levels. No new fee items are proposed in this proceeding. Therefore, the Board finds that notice and comment are unnecessary for this proceeding. See Regulations Governing Fees For Services—1990 Update, 7 I.C.C.2d 3 (1990); Regulations Governing Fees For Services—1991 Update, 8 I.C.C.2d 13 (1991); and Regulations Governing Fees For Services—1993 Update, 9 I.C.C.2d 855 (1993).

Additional information is contained in the Board's decision. To obtain a free copy of the full decision, visit the Board's Web site at http://www.stb.dot.gov or call the Board's Information Officer at (202) 245-0245. [Assistance for the hearing impaired is available through Federal Information Relay Services (FIRS): (800) 877-8339.]

For the reasons set forth in the preamble, title 49, chapter X, part 1002, of the Code of Federal Regulations is amended as follows:

Why we need to publish a rule. On August 24, 2012, we published a proposed rule in the Federal Register to revise our regulations to provide the public earlier access to the draft economic analysis supporting critical habitat designations, as directed by the President's February 28, 2012, memorandum (Memorandum for the Secretary of the Interior, Proposed Revised Habitat for the Spotted Owl: Minimizing Regulatory Burdens, 77 FR 12985 (March 5, 2012)). 77 FR 51503 (Aug. 24, 2012). The President's February 28, 2012, memorandum directed the Secretary of the Interior to revise the regulations implementing the Endangered Species Act to provide that a draft economic analysis be completed and made available for public comment at the time of publication of a proposed rule to designate critical habitat. Both transparency and public comment will be improved if the public has access to both the scientific analysis and the draft economic analysis at the same time. We are now issuing a final rule to achieve these goals. Because the Act and its implementing regulations are jointly administered by the Departments of the Interior and Commerce, the rule has been developed jointly. This final rule also addresses several court decisions and is informed by conclusions from a 2008 legal opinion by the Solicitor of the Department of the Interior. Specifically, we revise 50 CFR 424.19 to clarify the instructions for making information available to the public, considering the impacts of critical habitat designations, and considering exclusions from critical habitat. Except for the revision to the timing of making draft economic analyses available to the public, these revisions will not change how we implement the Act; rather, the revisions serve to codify the current practices of the agencies. This final rule is consistent with Executive Order 13563, and in particular with the requirement of retrospective analysis of existing rules, designed “to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.”

This rule makes the following changes:

(1) We changed the title of section 424.19 from “Final Rules—impact analysis of critical habitat” to “Impact analysis and exclusions from critical habitat.” We removed the reference to “[f]inal rules” to allow this section to apply to both proposed and final critical habitat rules. We added the term “exclusions” in the title to more fully describe that this section addresses both impact analyses and how they inform the exclusion process under section 4(b)(2) of the Act for critical habitat.

(2) We divided section 424.19 into three paragraphs. The division into three paragraphs closely tracks the requirements of the Act under section 4(b)(2) and provides for a clearly defined process for consideration of exclusions as required under the Act.

(3) Paragraph (a) implements the direction of the President's February 28, 2012, memorandum by stating that, at the time of proposing a designation of critical habitat, the Secretary will make available for public comment the draft economic analysis of the designation. As it was proposed, paragraph (a) included a third sentence, relating to section 4(b)(8) of the Act, which would have been carried over from the existing regulations with modifications. This sentence is not being implemented in this final rule to sharpen this regulation's focus on implementing section 4(b)(2) of the Act and to ensure consistency with other sections of part 424. Please see the discussion in the “Rationale for Revised Paragraph (a),” below.

(4) Paragraph (b) implements the first sentence of section 4(b)(2) of the Act, which directs the Secretary to consider the economic impact, the impact on national security, and any other relevant impact of specifying any particular area as critical habitat. This paragraph states that the impact analysis should focus on the incremental effects resulting from the designation of critical habitat.

(5) Paragraph (c) implements the second sentence of section 4(b)(2) of the Act, which allows the Secretary to exclude areas from the final critical habitat designation under certain circumstances.

The purposes of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ) (Act), are to provide a means to conserve the ecosystems upon which listed species depend, to develop a program for the conservation of listed species, and to achieve the purposes of certain treaties and conventions. Moreover, the Act states that it is the policy of Congress that the Federal Government will seek to conserve threatened and endangered species, and use its authorities in furtherance of the purposes of the Act.

In passing the Act, Congress viewed habitat loss as a significant factor contributing to species endangerment. Habitat destruction and degradation have been a contributing factor causing the decline of a majority of species listed as threatened or endangered under the Act (Wilcove et al. 1998). The present or threatened destruction, modification, or curtailment of a species' habitat or range is included in the Act as one of the factors on which to base a determination that a species may be a threatened or an endangered species. One of the tools provided by the Act to conserve species is designation of critical habitat.

Critical habitat represents the habitat essential for the species' recovery. Once designated, critical habitat provides for the conservation of listed species in several ways. Specifying the geographic location of critical habitat facilitates implementation of section 7(a)(1) of the Act by identifying areas where Federal agencies can focus their conservation programs and use their authorities to further the purposes of the Act. Designating critical habitat also helps focus the efforts of other conservation partners, such as State and local governments, nongovernmental organizations, and individuals. Furthermore, when designation of critical habitat occurs near the time of listing, it provides early conservation planning guidance to bridge the gap until the Services can complete more thorough recovery planning.

In addition to serving as a notification tool, the designation of critical habitat also provides a significant regulatory protection—the requirement that Federal agencies consult with the Services under section 7(a)(2) of the Act to ensure that their actions are not likely to destroy or adversely modify critical habitat. The Federal Government, through its role in water management, flood control, regulation of resource-extraction and other industries, Federal land management, and funding, authorization, or conduct of myriad other activities, may propose actions that are likely to affect critical habitat. The designation of critical habitat ensures that the Federal Government considers the effects of its actions on habitat important to species' conservation and avoids or modifies those actions that are likely to destroy or adversely modify critical habitat. This benefit should be especially valuable when, for example, species presence or habitats are ephemeral in nature, species presence is difficult to establish through surveys (e.g., when a species such as a plant's “presence” may be limited to a seed bank), or protection of unoccupied habitat is essential for the conservation of the species.

The Secretaries of the Interior and Commerce (the “Secretaries”) share responsibilities for implementing most of the provisions of the Act. Generally, marine and anadromous species are under the jurisdiction of the Secretary of Commerce and all other species are under the jurisdiction of the Secretary of the Interior, though jurisdiction is shared between the two departments for some species, such as sea turtles and Atlantic salmon. Authority to administer the Act has been delegated by the Secretary of the Interior to the Director of the FWS and by the Secretary of Commerce to the Assistant Administrator for Fisheries of the National Oceanic and Atmospheric Administration.

This final rule addresses two developments related to 50 CFR 424.19. First, the Solicitor of the Department of the Interior issued a legal opinion on October 3, 2008, regarding the Secretary of the Interior's authority to exclude areas from critical habitat designation under section 4(b)(2) of the Act (M-37016, “The Secretary's Authority to Exclude Areas from a Critical Habitat Designation under Section 4(b)(2) of the Endangered Species Act” (Oct. 3, 2008)) (DOI 2008). The Solicitor concluded, among other things, that, while the Act requires the Secretary to consider the economic impact, the impact on national security, and any other relevant impact, the decision whether to make exclusions under section 4(b)(2) of the Act is at the discretion of the Secretary; that the Secretary has wide discretion when weighing the benefits of exclusion against the benefits of inclusion; and that it is appropriate for the Secretary to consider impacts of a critical habitat designation on an incremental basis. These conclusions have been confirmed by judicial decision. See Building Industry Ass'n of the Bay Area v. U.S. Dep't of Commerce, 2012 U.S. Dist. Lexis 170688 (N.D. Cal. Nov. 30, 2012).

Second, the President's February 28, 2012, memorandum directed the Secretary of the Interior to revise the implementing regulations of the Act to provide that an analysis of the economic impacts of a proposed critical habitat designation be completed by the Services and made available to the public at the time of publication of a proposed rule to designate critical habitat. The memo stated: “Uncertainty on the part of the public may be avoided, and public comment improved, by simultaneous presentation of the best scientific data available and the analysis of economic and other impacts.” The Services have based this final rule on the reasoning and conclusions of the Solicitor's opinion and the President's February 28, 2012, memorandum.

This final rule revises 50 CFR 424.19 to clarify the instructions for making information available to the public, considering the impacts of critical habitat designations, and considering exclusions from critical habitat.

In making the specific changes to the regulations that follow, and setting out the accompanying clarifying discussion in this preamble, the Services are establishing prospective standards only. Nothing in this final rule to revise the regulations is intended to require that any previously completed critical habitat designation be reevaluated on this basis. Furthermore, we will implement the requirements of this regulation following the effective date. For proposed critical habitat designations published prior to the effective date of this final regulation, the Services will continue to follow their current practices.

The regulatory changes described below derive from sections 4(b)(2) of the Act. For the convenience of the reader, we are reprinting section 4(b)(2) of the Act here:

Under the first sentence of section 4(b)(2) of the Act, the Services are required to take “into consideration the economic impact, the impact on national security, and any other relevant impact, of specifying any particular area as critical habitat.” This evaluation is referred to as the “impact analysis.” Under the second sentence of section 4(b)(2) of the Act, the Secretary (via delegated authority to the Services) proceeds to a process of considering whether to exclude an area from critical habitat after identifying and weighing the benefits of inclusion and exclusion. This process is referred to as the “discretionary 4(b)(2) exclusion analysis.”

Based on public comment and for clarity, in this final rule, we have changed the reference to the analysis under the second sentence of 4(b)(2) of the Act from “optional weighing of benefits” to “discretionary 4(b)(2) exclusion analysis.”

An economic analysis is a tool that informs both the required impact analysis and the discretionary 4(b)(2) exclusion analysis. Additionally, the draft economic analysis informs the determinations established under other statutes, regulations, Executive Orders, or directives that apply to rulemakings generally, including critical habitat designations. However, the draft economic analysis addresses only the consideration of the potential economic impact of the designation of critical habitat.

An “incremental analysis” is a method of determining the probable impacts of the designation; it seeks to identify and focus solely on the impacts over and above those resulting from existing protections. This method applies to the impact analysis, discretionary 4(b)(2) exclusion analysis, and economic analysis.

The purpose of the impact analysis is to inform the Secretaries' decision about whether to engage in the discretionary exclusion analysis under the second sentence of section 4(b)(2) of the Act. Information that is used in the impact analysis can come from a variety of sources, one of which is the draft economic analysis of the proposed designation of critical habitat. The Secretaries must consider the probable economic, national security, and other relevant impacts of the designation of critical habitat. This comparison is done through the method of an incremental analysis of economic, national security, and other relevant impacts. The incremental-analysis methodology compares conditions with and without the designation of critical habitat.

We changed the title of this section from that of the previous regulation, which read, “Final rules—impact analysis of critical habitat” to “Impact analysis and exclusions from critical habitat.” The reference to “[f]inal rules” was deleted to allow for the application of this section to both proposed and final critical habitat rules. We added the term “exclusions” to the title to more fully describe that this section addresses both impact analyses and how they inform the exclusion process under section 4(b)(2) of the Act for critical habitat.

In the following text, we frequently refer to the previous regulatory language at 50 CFR 424.19 and then give detailed information about how we revised that language. For your convenience, we set out the previous text of section 424.19 here:

We divided the previous section 424.19 into three paragraphs. The two sentences of paragraph (a) are new and have been added to comply with the Presidential memorandum. They read:

The President's February 28, 2012 memorandum directed the Secretary of the Interior to take `prompt steps' to revise the regulations. The first sentence of the revised regulations will comply with the President's direction. The second sentence specifies that a summary of the draft economic analysis is to be published in the Federal Register notice of the proposed designation of critical habitat. The draft economic analysis itself is to be made available on http://www.regulations.gov along with the proposed designation of critical habitat or on other Web sites as deemed appropriate by the Services. It is this summary of the draft economic analysis that will constitute the Services' consideration of the economic impact, as required under the first sentence of section 4(b)(2) of the Act, of the proposed designation of critical habitat for a species.

As set out in the proposed rule, paragraph (a) included a third sentence which would have carried over the first half of the first sentence of the previous section 424.19, with modifications. As a result of public comment and review of the provisions for proposed and final rules at 50 CFR 424.16(b) (Proposed rules) and 424.18(a)(2) (Final rules—general), respectively, we have removed the proposed third sentence from this final regulation.

Sections 424.16(b) and 424.18(a)(2) govern the contents of Federal Register notices for proposed and final rules, respectively. Each states that the rule will, to the maximum extent practicable, “include a brief description and evaluation of those activities (whether public or private) that . . . may adversely modify such habitat or [may] be affected by such designation.” (The edited language varies slightly between the two provisions.) This language implements section 4(b)(8) of the Act. The third sentence of the proposed rule was similar. In this final rule, we are deleting that sentence because it is redundant with the language in sections 424.16(b) and 424.18(a)(2). Compliance with section 4(b)(8) of the Act fits more logically in those provisions, as they address the contents of Federal Register notices, which is the subject of section 4(b)(8) of the Act. This change also has the benefit of simplifying section 424.19 so that it addresses only one statutory provision (section 4(b)(2) of the Act), rather than two different provisions.

Although the language in sections 424.16(b) and 424.18(a)(2) repeats the statutory language, we note that the “may adversely modify” language could be misinterpreted to suggest that certain activities necessarily must undergo section 7 consultation, or that the Services must predetermine the result of any future section 7 consultation. Properly interpreted, this language reflects Congress's intent that the Services alert the public to the general relationship between the designation of critical habitat and types of activities that may occur on the landscape, without definitively asserting that consultations are required for such activities, or what the results of any consultations might be. Congress's use of the word “may” in this phrase supports our interpretation. Thus, notwithstanding any statement in the proposed or final critical habitat designation about the relationship between the designation and particular types of activities, Federal agencies must determine whether their individual proposed actions trigger the requirement for section 7 consultations. And if an agency does consult on an action, the Services will make an adverse modification determination by applying the standards of section 7 to the facts of the action at issue, rather than by looking to the general statements made in compliance with section 4(b)(8) of the Act in the preamble to the critical habitat designation.

Paragraph (b) implements the first sentence of section 4(b)(2) of the Act (“The Secretary shall designate critical habitat . . . after taking into consideration the economic impact, the impact on national security, and any other relevant impact, of specifying any particular area as critical habitat.”). The first sentence of new section 424.19(b) carries over the second half of the first sentence of the previous section 424.19, with modifications, and thus repeats the basic statutory requirement. We replaced “after proposing designation of such an area” with “[p]rior to finalizing the designation of critical habitat” to expressly provide for more flexibility in the timing of the consideration. Thus the first sentence of paragraph (b) reads:

The statute itself requires only that the consideration occur—it does not specify when in the rulemaking process it must occur. Furthermore, the Presidential memorandum only required the Services to change the timing of the availability of the economic analysis of designations of critical habitat and did not speak to the timing of the mandatory considerations specified in the Act. That being said, we stress that the Act's legislative history is clear that Congress intended consideration of economic impacts to neither affect nor delay the listing of species. Therefore, regardless of the point in the rulemaking process at which consideration of economic impacts of a designation of critical habitat begins, that consideration must be kept analytically distinct from, and have no effect on the outcome or timing of, listing determinations. We also note that a draft economic analysis of a critical habitat designation is only one of many pieces of information the Secretaries use in determining whether to exclude areas under section 4(b)(2) of the Act, if the Secretary decides to engage in that discretionary analysis.

Also in paragraph (b), we retained from previous section 424.19 the phrases “probable” and “upon proposed or ongoing activities.” These phrases provide guidance that the Services should not consider improbable or speculative impacts. However, the Services do not intend that the term “probable” requires a showing of statistical probability or any specific numeric likelihood. Moreover, the “activities” at issue are only those that would require consultation under section 7 of the Act. See DOI 2008 at 10-12. Although impact analyses are based on the best scientific data available, any predictions of future impacts are inherently uncertain and subject to change. Thus, the Services should consider the likely general impact of the designation and not make specific predictions of the outcome of particular section 7 consultations that have not in fact been completed.

We added the phrase “national security” to reflect statutory amendments to section 4(b)(2) of the Act (National Defense Authorization Act for Fiscal Year 2004, Pub. L. 108-136). Also, we added the word “relevant” to the other impacts that the Services must consider to more closely track the statutory language.

The first sentence of paragraph (b) uses the term “consider,” which reflects the statutory term “consideration” in section 4(b)(2) of the Act. This final regulation does not further define this term. However, we agree with the Solicitor's 2008 Opinion that, in the context of section 4(b)(2) of the Act, to “consider” impacts the Services must gather available information about the impacts on proposed or ongoing activities that would be subject to section 7 consultation, and then must give careful thought to the relevant information in the context of deciding whether to proceed with the discretionary 4(b)(2) exclusion analysis. See DOI 2008 at 14-16.

The second and third sentences of paragraph (b) are additions that provide further guidance on how the Services will consider impacts of critical habitat designation. They read:

The first phrase of the second sentence, “[t]he Secretary will consider impacts at a scale that the Secretary determines to be appropriate,” clarifies that the Secretary has the discretion to determine the scale at which impacts are considered. The Secretary would determine the appropriate scale based on what would most meaningfully or sufficiently inform the decision in a particular context. For example, for a wide-ranging species covering a large area of potential habitat across several States, a relatively coarse-scale analysis would be sufficiently informative, while for a narrow endemic species, with specialized habitat requirements and relatively few discrete occurrences, it might be appropriate to engage in a relatively fine-scale analysis for the designation of critical habitat. The Secretary may also use this discretion to focus the analysis on areas where impacts are more likely. See DOI 2008 at 17.

The second phrase of the second sentence, “and will compare the impacts with and without designation,” clarifies that impact analyses evaluate the incremental impacts of the designation. This evaluation is sometimes referred to as an “incremental analysis” or “baseline approach.” For the purpose of the impacts analysis required by the first sentence of section 4(b)(2) of the Act, the incremental impacts are those probable economic, national security, and other relevant impacts of the proposed critical habitat designation on ongoing or potential Federal actions that would not otherwise occur without the designation. Put another way, the incremental impacts are the probable impacts on Federal actions for which the designation is the “but for” cause.

To determine the incremental impacts of designating critical habitat, the Services compare the protections provided by the critical habitat designation (the world with the particular designation) to the combined effects of all conservation-related protections for the species and its habitat in the absence of the designation of critical habitat (the world without designation, i.e., the baseline condition including listing). Thus, determining the incremental impacts requires identifying at a general level the additional protections that a critical habitat designation would provide for the species. This determination does not require prejudging the precise outcomes of hypothetical section 7 consultations. Finally, the Services determine the probable impacts of those incremental protections on Federal actions, in terms of economic, national security, or other relevant impacts (the incremental impacts). See DOI 2008 at 11. Probable impacts to Federal actions could occur on private as well as public lands.

In addition to using an incremental analysis in the impacts analysis, the Secretary will use an incremental analysis in the discretionary analysis under the second sentence of section 4(b)(2), if the Secretary decides to undertake that discretionary analysis. In that context, the Secretary will use an incremental analysis to identify the benefits (economic and otherwise) of excluding an area from critical habitat, and will likewise use an incremental analysis to identify the benefits of specifying an area as critical habitat.

Benefits that may be addressed in the discretionary 4(b)(2) exclusion analysis can result from additional protections, in the form of project modifications or conservation measures due to consultation under section 7 of the Act; conversely, a benefit of exclusion can be avoiding costs associated with those protections. In addition, benefits (and associated costs) can result if the designation triggers compliance with separate authorities that are exercised in part as a result of the Federal critical habitat designation (e.g., additional reviews, procedures, or protections under legal authorities of States or local jurisdictions). See DOI 2008 at 22-23.

Finally, because the primary purpose of an economic analysis is to facilitate the mandatory consideration of the economic impact of a designation of critical habitat, to inform the discretionary 4(b)(2) exclusion analysis, and to determine compliance with relevant statutes and Executive Orders, the economic analysis should focus on the incremental impact of the designation.

Use of an incremental analysis in each of these contexts is the only logical way to implement the Act. The purpose of the impact analysis is to inform the Secretary's decision about whether to engage in the discretionary exclusion analysis under the second sentence of section 4(b)(2) of the Act (addressed in paragraph (c)). To understand the difference that designation of an area as critical habitat makes and, therefore, the benefits of including an area in the designation or excluding an area from the designation, one must compare the hypothetical world with the designation to the hypothetical world without the designation. For this reason, the Services compare the protections provided by the designation to the protections without the designation. This methodology is consistent with the general guidance given by the Office of Management and Budget to executive branch agencies as to how to conduct cost-benefit analyses. See Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf ).

Nonetheless, between 2002 and 2007, the Services generally did not conduct an incremental analysis; instead, they conducted a broader analysis of impacts pursuant to the guidance from the United States Court of Appeals for the Tenth Circuit in New Mexico Cattlegrowers Ass'n v. FWS, 248 F.3d 1277 (10th Cir. 2001). The genesis of the court's conclusion in that case was the definitions of “jeopardize the continued existence of” and “destruction or adverse modification,” which are the standards for section 7 consultations in the Services' 1986 joint regulations. See 50 CFR 402.02. Both phrases were defined in a similar manner in that each looked to impacts on both survival and recovery of the species.

The court in New Mexico Cattle Growers noted the similarity of the definitions, concluding that they were “virtually identical” and that the definition of “destruction or adverse modification” was in effect subsumed into the jeopardy standard. 248 F.3d at 1283. According to the court, these definitions thus led FWS to conclude that designation of critical habitat usually had no incremental impact beyond the impacts of the listing itself. Thus, given these definitions, the court concluded that doing only an incremental analysis rendered meaningless the requirement of considering the impacts of the designation, as there were no incremental impacts to consider. Although the court noted that the regulatory definitions had previously been called into question, id. at 1283 n.2 (citing Sierra Club v. U.S. Fish & Wildlife Serv., 245 F.3d 434 (5th Cir. 2001)), the validity of the regulations had not been challenged in the case before it. Instead, to cure this apparent problem, the court held that the FWS must analyze “all of the impacts of a critical habitat designation, regardless of whether those impacts are attributable co-extensively to other causes.” Id. at 1285.

In 2004, the Ninth Circuit ( Gifford Pinchot Task Force v. USFWS, 378 F.3d 1059 (9th Cir. 2004)) invalidated the prior regulatory definition of “destruction or adverse modification.” The court held that the definition gave too little protection to critical habitat by not giving weight to Congress's intent that designated critical habitat support the recovery of listed species. Since then, the Services have been applying “destruction or adverse modification” in a way that allows the Services to define an incremental effect of designation. This process eliminated the predicate for the Tenth Circuit's analysis. Therefore, the Services have concluded that it is appropriate to consider the impacts of designation on an incremental basis.

Indeed, no court outside of the Tenth Circuit has followed New Mexico Cattle Growers after the Ninth Circuit issued Gifford Pinchot Task Force . In particular, the Ninth Circuit recently concluded that the “faulty premise” that led to the invalidation of the incremental analysis approach in 2001 no longer applies. Arizona Cattle Growers Ass'n v. Salazar, 606 F.3d 1160, 1173 (9th Cir. 2010). The court held, in light of this change in circumstances, that “the FWS may employ the baseline approach in analyzing a critical habitat designation.” Id. In so holding, the court noted that the baseline approach is “more logical than” the coextensive approach. Id.; see also:

• Maddalena v. FWS, No. 08-CV-02292-H (AJB) (S.D. Cal. Aug. 5, 2010);

• Otay Mesa Property L.P. v. DOI, 714 F. Supp. 2d 73 (D.D.C. 2010), reversed on other grounds, 646 F.3d 914 (D.C. Cir. 2011).

• Fisher v. Salazar, 656 F. Supp. 2d 1357 (N.D. Fla. 2009);

• Home Builders Ass'n of No. Cal. v. USFWS, 2006 U.S. Dist. Lexis 80255 (E.D. Cal. Nov. 2, 2006), reconsideration granted in part, 2007 U.S. Dist. Lexis 5208 (Jan. 24, 2007), aff'd, 616 F.3d 983 (9th Cir. 2010);

• CBD v. BLM, 422 F. Supp. 2d 1115 (N.D. Cal. 2006);

• Cape Hatteras Access Preservation Alliance v. DOI, 344 F. Supp. 2d 108 (D.D.C. 2004).

The Services may still, in appropriate circumstances, also analyze the broader impacts of conserving the species at issue to put the incremental impacts of the designation in context, or for complying with the requirements of other statutes or policies. See:

• Arizona Cattle Growers' Ass'n v. Kempthorne, 534 F. Supp. 2d 1013 (D. Ariz. 2008), aff'd, 606 F.3d 1160 (9th Cir. 2010);

• Home Builders Ass'n of No. Cal. v. USFWS, 2007 U.S. Dist. Lexis 5208 (E.D. Cal. Jan. 24, 2007), aff'd, 616 F.3d 983 (9th Cir. 2010);

• DOI 2008 at 21.

The third sentence of paragraph (b) clarifies that impacts may be qualitatively or quantitatively described. In other words, there is no absolute requirement that impacts of any kind be expressed numerically. See Cape Hatteras Access Preservation Alliance v. DOI, 731 F. Supp. 2d 15 (D.D.C. Aug. 17, 2010).

Paragraph (c) implements the second sentence of section 4(b)(2) of the Act, which allows the Secretary to exclude areas from the final critical habitat designation under certain circumstances. Paragraph (c) reads:

The first sentence of paragraph (c) carries over the second sentence of the existing section, with modifications. The phrase “the Secretary has discretion” has been added to emphasize that the exclusion of particular areas under section 4(b)(2) of the Act is always discretionary. See DOI 2008 at 6-9, 17. For example, the Secretary may choose not to exclude an area even if the impact analysis and subsequent discretionary 4(b)(2) exclusion analysis indicate that the benefits of exclusion exceed the benefits of inclusion, and even if such exclusion would not result in the extinction of the species.

Additional minor changes to the first sentence make it more closely track the statutory language.

The second sentence of paragraph (c) is new. It codifies aspects of the legislative history, the case law, and the Services' practices with respect to exclusions. The second sentence clarifies the breadth of the Secretary's discretion with respect to the types of benefits to consider. See:

• CBD v. Norton, 240 F. Supp. 2d 1090 (D. Ariz. 2003);

• Home Builders Ass'n of No. Cal. v. USFWS, 2006 U.S. Dist. Lexis 80255 (E.D. Cal. Nov. 2, 2006), reconsideration granted in part 2007 U.S. Dist. Lexis 5208 (Jan. 24, 2007), aff'd, 616 F.3d 983 (9th Cir. 2010);

• DOI 2008 at 25-28.

For example, the Secretary may consider effects on tribal sovereignty and the conservation efforts of non-Federal partners when considering excluding specific areas from a designation of critical habitat. Similarly, the House Committee report that accompanied the 1978 amendments that added section 4(b)(2) to the Act stated that “[t]he consideration and weight given to any particular impact is completely within the Secretary's discretion.” H.R. Rep. No. 95-1625, at 17. Subsequent case law and the Solicitor's Opinion have reflected that view, as does this final rule. See:

• CBD v. Salazar, 2011 U.S. Dist. Lexis 26967 (D.D.C. Mar. 16, 2011);

• Wyoming State Snowmobile Ass'n v. USFWS, 741 F. Supp. 2d 1245 (D. Wyo. 2010);

• DOI 2008 at 24.

The third sentence of paragraph (c) essentially repeats the third sentence of the previous § 424.19. This sentence incorporates the limitation in the last clause of section 4(b)(2) of the Act. See DOI 2008 at 25.

On August 24, 2012, we published a proposed rule (77 FR 51503) that requested written comments and information from the public on the proposed revisions to the regulations pertaining to impact analyses conducted for designations of critical habitat under the Act. The first comment period opened on August 24, 2012, and closed on October 23, 2012. In response to that proposed rule, we received numerous requests for an extension of the first comment period, and we subsequently published a notice (77 FR 66946) that reopened the comment period from November 8, 2012, through February 6, 2013. Comments received from both comment periods are grouped into general categories specifically relating to the proposed regulation revisions.

Comment (1): Many commenters, including federally-elected officials, requested an extension of the public comment period announced in the proposed regulation revision.

Response: On November 8, 2012 (77 FR 66946), we reopened the public comment period for an additional 90 days to accommodate this request and allow for additional review and public comment.

Comment (2): The Services should set out the clear expectations and consequences for publishing and implementing the final regulation.

Response: We agree with the commenter, and have further clarified to the extent possible within this final rule our expectations of the implications of this final rule, most specifically in our responses to comments. We have specifically provided clarifications on: paragraph (a) of the regulation, regarding the shift in timing of the economic analysis to comply with the intent of the Presidential memorandum of February 28, 2012; paragraph (b), concerning the incremental approach to impact analysis, the use of either a quantitative or qualitative analysis of economic impacts as permissible under the Office of Management and Budget (OMB) Circular A-4, and the scale of the impact analysis; and paragraph (c), the codification of Secretarial discretion as defined by the Act and case law. The desired consequences of this revision to the regulation are to further provide clarity, promote predictability and reduce uncertainty, and to codify established interpretation, practices, and prevailing case law.

Comment (3): One commenter disagrees that the proposed rule would not have significant takings implications because the Services should apply the Penn Central three-prong test for a taking. Also, the commenter states that the “legitimate governmental interest” test has been invalidated by the U.S. Supreme Court, and the Services erred in relying on this test.

Response: To clarify any confusion in our required determination related to these comments, we have amended the language in the takings assessment. Again, we reiterate that these revisions to section 50 CFR 424.19 do not affect private property. They only govern the process by which the Services will consider the impacts of designation of critical habitat and possible exclusions from those designations, and codify the Services' current practices. Therefore, these revisions cannot affect areas that have already been designated as critical habitat nor change the outcome with respect to future designations, and therefore will not affect private property. Contrary to the assertion of the commenter, in Penn Central Transportation Co. v. City of New York, 438 U.S. 104 (1978), the Supreme Court did not set forth a discrete test for determining whether a constitutional taking has occurred. Rather, the court noted that there was no set formula for what were “essentially ad hoc, factual inquiries,” although it did identify three factors of particular significance: economic impact, reasonable investment-backed expectations, and the character of the government action. For a government action whose character and effect are limited to improving the efficiency and transparency of government procedures and that has no on-the-ground impact, there would not be any economic impact or interference with reasonable investment-backed expectations.

Comment (4): One commenter believes that because Federal critical habitat triggers additional state or local regulations, this rule should perform a takings assessment because “a landowner is denied economically beneficial or productive use of its land” from the designation. The commenter gives an example of Washington's state environmental policy act (SEPA) that Federal critical habitat triggers Class IV special forest practice restrictions.

Response: We reiterate that these regulations are procedural or administrative in nature, and will have no effect on the environment or on private property. These regulations do not designate critical habitat themselves, nor will they result in any change to the outcome of, public involvement in, or standards used for making any critical habitat determination. Therefore, the commenter's example of a state statute in which additional protections are triggered when critical habitat is designated, would not be affected by these regulatory revisions. We have revised the required determination for takings to make this more clear.

Comment (5): Several commenters commented on the rationale for our certifications and statements regarding the statutes and executive orders in the Required Determinations.

Response: We have incorporated responses to these comments under the appropriate statutes or executive orders in the appropriate Required Determinations section, below.

Comment (6): The Services should recognize the central purpose of impact analyses, namely improving the information available to those potentially affected by critical habitat designations, and explain how this regulation will further that purpose.

Response: The Services recognize the importance of this regulation in providing information to the public and those entities potentially affected by the designation of critical habitat. The President's February 28, 2012, memorandum directed the Services to promulgate this rule “in order to provide more complete information in the future regarding potential economic impacts when critical habitat proposals are first offered to the public.” Another important purpose of the impact analysis is to provide information to the Secretaries in order for them to consider economic impacts, the impacts to national security, and any other relevant impacts under section 4(b)(2) of the Act. Additionally, the Secretaries may exclude particular areas from a designation of critical habitat based on a discretionary 4(b)(2) exclusion analysis using this information.

Comment (7): Several commenters suggested specific line edits or word usage.

Response: We addressed these comments as appropriate in this document.

Comment (8): Several commenters suggested a change in the title of the regulation to “Analysis of Economic and Other Impacts and Exclusions from Critical Habitat.”

Response: The revised title identified in the proposed and this final rule gives equal weight and consideration to all factors under section 4(b)(2) of the Act. Changing the title to that suggested by the commenter could imply greater consideration of economics, above that of national security and other relevant impacts. The Services do not agree that economics should be given greater consideration than other impacts. Therefore, we rejected this suggested edit.

Comment (9): The same commenters suggested substantial revisions to paragraphs (b) and (c) of the proposed regulation revision, and the addition of several paragraphs, and provided specific language edits. One commenter stated that the Services should amend paragraph (b) to add language directing that analyses are to be consistent with the Data Quality Act (i.e., best available data standard), to ensure the scale of impact analysis is sufficient to evaluate particular areas for exclusion under section 4(b)(2), and to indicate that quantitative assessments will be done to the maximum extent practicable. The commenter's suggested paragraph (c) would cover data disclosure requirements, and the suggested new paragraph (d) would detail the use of coextensive and incremental analyses to more fully analyze what the commenter viewed as the economic impacts. Finally, the suggested new paragraph (e) would state that the Secretaries will use the best available scientific and commercial data with respect to quantitative and qualitative analyses of the economic impacts of a proposed critical habitat designation.

Response: We disagree with the commenter's suggested edits for both procedural and substantive reasons. First, to adopt the changes suggested by the commenter would be a significant deviation from the previous and proposed text of the regulation and go well beyond the Services' intent in undertaking this regulation. Furthermore, because they would raise new substantive issues not discussed in the proposed rule, any such changes likely would need to be proposed as a new regulation, and go through a new rulemaking procedure, which would take a significant amount of time. To adopt these changes and go through a new rulemaking would be counter to the intent of the Presidential memorandum, which was to promptly revise our regulations. Moreover, the Services do not find that there is a good basis for the substantive suggestions advanced by the commenter. Accordingly, the Services decline to expand the scope of the rule to address such issues.

In conducting impact analyses, of which an economic analysis is part, the Services use the best available scientific and commercial data available. However, the further analysis and interpretation of those data are subject to persons seeking correction to the resulting disseminated information. As a result of this final regulation, the draft economic analysis of the proposed critical habitat designation will be available concurrently with the proposed critical habitat designation and the Services will seek public comment on both. Any concerns identified by the public in analysis or data could be identified and considered in the final rule. If someone requests a correction under the Information Quality Act (also known as the Data Quality Act), the Services will consider the original source of the information used (best available scientific and commercial data) will be considered against the correction suggested by the complainant. Therefore, this recommendation need not be adopted. Further, the recommendation for disclosure of data is addressed by the requirements for Federal electronic rulemaking as part of the e-Government Act, the Administrative Procedure Act (APA), and the Freedom of Information Act and would be redundant. We address the commenter's remaining specific suggested changes below in our responses grouped by subject matter.

Comment (10): The majority of commenters supported the shift in timing of the draft economic analysis, and stated that this approach will improve the regulatory process. Several commenters expressed concern that the shift in timing of the draft economic analysis would lead to a reduction in regulatory efficiency. They suggested that the Services need to clarify what measures will be taken to ensure that the proposed revisions to the economic analysis process will not introduce additional delays in the designation of critical habitat.

Response: We appreciate the concerns expressed by commenters on the shift in timing of the draft economic analysis, and we do not anticipate a reduction in regulatory efficiencies as a result. The Services are committed to doing an analysis sufficient, given the shift in timing and process, to provide the information needed by the Secretaries to make informed decisions on a factual basis. We do not anticipate that the shift in timing of the analysis will introduce delays in the designation process, as a summary of the draft economic analysis will be made available concurrently with the publication of the proposed rule.

Comment (11): Many commenters stated that shifting the timing of the draft economic analysis to be earlier in the rulemaking process will provide for earlier, more meaningful participation by the public. However, other commenters were concerned that this approach would limit public participation by interested and affected stakeholders in the decision-making process. They believe it may reduce the time the public has to comment on the proposed rule. Further, they stated this approach will lead to an overly narrow consideration of economic impacts, or might allow economic analyses to be ignored. Several commenters stated that, by changing the timing of the economic analysis to be earlier in the rulemaking process, the Services may fail to identify and adequately analyze impacts.

Response: Upon publication of the proposed designation of critical habitat, which will include a summary of the draft economic analysis, we will solicit information from the public through at least a 60-day comment period in accordance with our regulations, 50 CFR 424.16(c)(2), and the APA. During this comment period, the public will have opportunity to review the proposed designation and the supporting draft economic analysis, and provide information and comments on both the proposed rule and the draft economic analysis simultaneously. The Act requires the Secretaries to consider economic impacts of a designation of critical habitat, and the Services are committed to conducting an economic analysis, based on the best data available, given the shift in timing and process, sufficient to provide the information needed by the Secretaries to make informed decisions on a factual basis. The economic analysis is the vehicle by which we take economic impacts into consideration. We do not anticipate that the shift in timing of the analysis will result in a failure of the Services to consider probable economic impacts.

Comment (12): The Services should publish an initial notice of impact analysis calling for submission of information to be evaluated prior to proposing a critical habitat designation. Only following the notice of the impact evaluation should the Services publish the proposed critical habitat.

Response: In general, the Services do not anticipate publishing an advanced notice of proposed rulemaking (ANPR) for our critical habitat actions prior to publication of a proposed designation. However, the Services are committed to providing the public with notice and materials related to planned actions for each upcoming year. The notice and materials will be made available on the Services' Web sites, and will include appropriate contact information, which will allow the public to provide information to the Services in advance of particular rulemakings. Further, the Services will be coordinating with potentially affected Federal agencies during the development of the critical habitat designation to assess the probable impacts of critical habitat designation. Information obtained from this coordination or otherwise provided by the public will be used to inform our proposed designation and economic analysis. Further, we will request public comment and any additional information available on the proposed designation and our draft economic analysis at the time the proposed rule publishes.

Comment (13): Several commenters expressed concern over the shift in timing of the economic analysis, as the proposed revision would allow for the draft economic analysis to take place at the same time that critical habitat designation is proposed, creating the potential for the analysis of economic impacts to inappropriately interfere with the designation process. The economic analysis should not influence the identification of critical habitat, which should be based solely on the best scientific data available. Any exclusion of critical habitat must be supported by the record and be made only at the final rulemaking stage.

Response: We appreciate and are cognizant of this concern. We base our identification of critical habitat solely on the best scientific data available. Although the relevant Service will have an economic analysis at the time it proposes to designate critical habitat, that analysis will not influence the biological determination of which areas meet the definition of critical habitat. The economic information, along with information related to national security and other relevant impacts, may be used in the discretionary analysis under the second sentence of section 4(b)(2) of the Act. A final decision on exclusions from critical habitat will be made at the final rulemaking stage and will be supported by information in the supporting record for the rulemaking.

Comment (14): Some commenters expressed concern that when the Services propose listing and critical habitat simultaneously, having available a draft economic analysis of the proposed critical habitat designation might result in that analysis influencing the determination of whether a species warrants listing as a threatened or endangered species.

Response: Section 4(b)(1)(A) of the Act states that determinations required by section 4(a)(1) of the Act (i.e., determinations regarding the listing status of a species) be made solely on the basis of the best scientific and commercial data available. While having the draft economic analysis for a proposed critical habitat designation completed and available concurrent with the proposed listing determination may provide the opportunity for a real or perceived influence on the listing status ultimately given the species, the Services will ensure a separation of the two analyses and determinations. For example, one step that FWS has taken to ameliorate this concern is to develop listing determinations and critical habitat designation (if prudent and determinable) concurrently, but in separate rulemakings. Furthermore, the House of Representatives conference report (97-835) for the 1982 amendments to the Act specifically states that economic considerations have no relevance to determinations of species status under the Act.

Comment (15): Requiring the draft economic analysis to be completed at time of critical habitat proposal could result in more findings by the Services that critical habitat is not determinable.

Response: The regulations at 50 CFR 424.12 (a)(2) state that “critical habitat is not determinable when one or both of the following situations exist: (i) Information sufficient to perform required analyses of the impacts of the designation is lacking, or (ii) The biological needs of the species are not sufficiently well known to permit identification of an area as critical habitat.” Thus, the Services may invoke subparagraph (i) of this provision to find that the designation of critical habitat is not determinable if the information to perform the economic analysis is lacking. However, it has generally not been our practice to find that a designation of critical habitat is not determinable on this basis. We do not anticipate using this provision with greater frequency in the future as a result of this rulemaking.

Comment (16): Several commenters were concerned that only a draft of the economic analysis, and not a final analysis, will be available at proposal.

Response: As a result of this final rule, the Services will be providing a summary of our economic analyses within our proposed designations of critical habitat. Furthermore, we will make available the economic analysis on http://www.regulations.gov in the docket of the proposed rulemaking. However, it is the draft economic analysis that should be available for the public to review and comment on concurrent with the proposed rule. Further, the Services have generally found in their experience that most economic analyses do not substantively change following public review and comment, so most draft analyses can be viewed as approximating the final analysis. However, we will incorporate comments and information received on the draft analysis as appropriate into the text of our final rule.

Comment (17): A commenter requested that, in addition to the analysis of economic impacts being made available prior to the proposal, the regulation be amended to include the analysis of all other impacts specified in the statute, and the balancing of all relevant benefits be done prior to publication of a proposed rule as well.

Response: While we appreciate the commenter's position, we do not agree that it is wise to mandate that these additional analyses and the discretionary 4(b)(2) exclusion analysis be available at that stage of the designation process in all circumstances. The statute does not specify when these additional analyses should be undertaken, and the Services find that the purposes of the statute are best served by retaining flexibility on this point to respond to the degree of available data and agency priorities in a particular circumstance. As a matter of practice, NMFS's current procedure is consistent with the commenter's request. FWS, as a matter of practice, prefers to retain a greater degree of discretion as to the timing of making these analyses available, although in cases where specific data on other impacts is available at the proposed rule stage, FWS may set forth the evaluation of these data and, if applicable, its provisional 4(b)(2) exclusion analysis in the proposed rule.

Comment (18): Providing a summary of the findings of the draft economic analysis in the proposed rule as published in the Federal Register is redundant if the draft economic analysis is otherwise available on the internet.

Response: This final regulation will require the Services to provide a summary of our draft economic analyses within our proposed designations of critical habitat. Additional supporting documents will be available in the supporting record and http://www.regulations.gov . The Services conclude that we will further the purposes of the Act and the APA by including the summary of the draft economic analysis in the body of the proposed rule, as doing so will facilitate public review by having the key information available in one place. Further, that summary will provide the supporting information and factual basis for the certification of specific required determinations.

Comment (19): The proposed regulation would require description of any significant activities that are known to have the “potential to affect” an area considered for designation as critical habitat. But this language introduces a new standard not in the Act (potential to affect). Potential to affect is a broader standard; the standard “may adversely modify” from the statute should be used. Further, by using a new standard, critical habitat proposals would have to segregate activities that have the potential to affect from those that may adversely modify.

Response: We have removed the language containing this phrase from this final regulation. See the preamble discussion for further information.

Comment (20): The Services should add to paragraph (a), “To the maximum extent practicable” to lead off. And they should qualify that the economic analysis will be released at the same time as the proposed rule “or as soon thereafter as it is available.”

Response: We have removed the language containing this phrase from this final regulation. However, to use this phrase to preface the requirements of paragraph (a) would indicate that the Services would provide a draft economic analysis to the maximum extent practicable, implying that the Services might elect not to release the draft economic analysis at the time of the proposed rule if inconvenient, which is contrary to the Presidential memorandum of February 29, 2012. The Presidential memorandum directs the Services to make available the draft economic analysis at the time of publication of the proposed critical habitat rule, and the Services intend to fulfill the President's direction because it is consistent with the purposes of both the Act and the APA.

Comment (21): Absent a clear regulatory definition of adverse modification, the Service cannot reasonably assess the economic impact of any critical habitat designation.

Response: Courts invalidated the previous regulatory definition of destruction or adverse modification because they found it to be contrary to the language of the Act. However, at this time the Services are operating under a 2004 Director's memorandum and a 2005 Assistant Administrator's memorandum, which confirm that the Services use the statutory conservation standard in implementing the prohibition on destruction or adverse modification of critical habitat under section 7 of the Act. These memoranda provide a clear and reasonable basis for the Services to evaluate incremental impacts due to the designation of critical habitat in a manner consistent with the purposes and text of the Act. Further, the Services plan to propose a new regulatory definition for destruction or adverse modification of critical habitat in the near future.

Comment (22): Many commenters oppose the incremental approach to conducting economic analyses, arguing that this approach does not capture the full impact of a critical habitat designation and that it would be less transparent than a coextensive approach. Other commenters were supportive of the incremental-analysis approach.

Response: As we discussed above in the preamble and in the proposed rule, we have concluded that an incremental analysis is consistent with the Act and general OMB guidance, and is the most logical way of analyzing impacts. The Services have consistently been evaluating the incremental impacts of a designation in the section 4(b)(2) evaluation process. FWS has been using the incremental analysis approach for economic analyses since 2007 in areas outside the jurisdiction of the Tenth Circuit Court. The Services have not found that there is a diminishment or lack of transparency in the process relative to the coextensive evaluation.

Comment (23): The incremental approach is contrary to the Services' prior practice and the Presidential memorandum.

Response: The incremental approach is not contrary to the Services' prior practices, nor is it contrary to the Presidential memorandum. The Presidential memorandum does not specify the type of analysis to use for consideration of impacts. The Services have consistently been evaluating the incremental impacts of a designation in the section 4(b)(2) evaluation process for some time, and this approach has been judicially recognized as more logical and appropriate. FWS has been using the incremental analysis approach for economic analyses since 2007 in areas outside the jurisdiction of the Tenth Circuit Court. The OMB Circular A-4 supports the use of the incremental approach of evaluating the effects of Federal rulemakings, including the evaluation of probable economic impacts.

Comment (24): The incremental approach is not consistent with Congressional intent in the Act and legislative history as it relates to section 4(b)(2) of the Act. To be more consistent with the Act, the Services should conduct an analysis that sums both a baseline and an incremental analysis (i.e., coextensive analysis). The Act does not qualify the mandatory consideration of economics and other relevant factors and, therefore, all impacts should be considered. Another commenter stated that the significant lag time between listing and critical habitat often done by the Services should not be used to hide the costs of the Act as “listing costs.”

Response: Congressional intent is reflected in the language of the Act. The purpose of consideration of impacts is to inform decisions on possible exclusions from critical habitat; in turn, the purpose of exclusions is to avoid the probable negative impacts of designating particular areas as critical habitat. Fundamentally, it is not an “impact” of a designation if an impact will happen with or without the designation--those impacts will not be avoided by exclusion. For example, the impacts due to the listing of a species will occur regardless of designation of critical habitat or exclusion of areas from critical habitat. Exclusion of a particular area because of an impact that will occur regardless of the exclusion will be completely ineffective at avoiding the impact and is illogical. We conclude that Congress did not intend to mandate consideration of impacts that cannot be avoided by exclusion from critical habitat, and therefore that Congress did not intend to mandate a coextensive analysis.

With respect to the commenter's assertion that a delay of the critical habitat designation may hide the costs of the designation as listing costs, we disagree. As discussed above, the incremental-analysis approach is the correct approach regardless of whether the designation occurs at the time of listing, and that approach does not serve to “hide” the costs of the Act. Under the Act, the costs that stem from listing are simply not relevant, except as setting the baseline against which to measure the incremental impacts of designation. Moreover, as a factual matter, in the vast majority of cases, there is no longer a significant time lag between listing and critical habitat designation.

Comment (25): The total economic impact that should be considered is the impacts both before and after critical habitat is designated; in other words, both the baseline and the incremental together. This approach does not contradict the prohibition on consideration of economic impacts due to the original listing of a species, but it does allow consideration of the full magnitude of all economic pressures on a particular community, industry, or activity when considering imposing the additional economic cost associated with a critical habitat designation, or granting exclusion (i.e., cumulative regulatory and economic impact).

Response: An economic analysis serves to inform the relevant Service's consideration of the economic impact of a critical habitat designation. That consideration is mandatory under the first sentence of section 4(b)(2) of the Act. That consideration, in turn, informs the Service's decision as to whether to undertake the discretionary exclusion analysis under the second sentence of section 4(b)(2) of the Act, and, if the Service chooses to do so, the ultimate outcome of that exclusion analysis. As discussed above, only incremental impacts of designation can be relevant to this analysis, because those impacts are the only ones that can be avoided by excluding a particular area from the designation. In other words, it would be illogical to exclude an area based on benefits of exclusion that will not in fact follow from the exclusion. Because implementation of the exclusions process of section 4(b)(2) of the Act necessarily depends on a weighing of the incremental benefits of exclusion and inclusion, and because there is an implied consistency between the two sentences of 4(b)(2) given that the process of the first sentence informs the process of the second, we conclude that the consideration of impacts required under the first sentence of section 4(b)(2) of the Act is likewise limited to incremental impacts.

The OMB Circular A-4 supports the use of the incremental approach of evaluating the effects of Federal rulemakings, including the evaluation of probable economic impacts, in complying with other statutes and Executive Orders (which the economic analysis also informs). Further, as discussed in the preamble of our proposal, use of an incremental analysis is supported by relevant case law and the Solicitor's M-Opinion. It has also been the general practice of the Services (outside the jurisdiction of the 10th Circuit Court). Moreover, even if there was some nonstatutory policy benefit to doing a broader analysis of the economic impacts of species conservation, in most circumstances it is not practical to conduct a robust evaluation of baseline effects due to data limitations and resource and time constraints.

Comment (26): The incremental approach is overly narrow and allows the Services to easily discount the economic impacts of critical habitat designations or only consider those immediately visible. The Services currently narrowly interpret economic impact as the administrative costs incurred by the section 7 consultation process and discounts to zero virtually all other economic impacts because they are too speculative or are unquantifiable.

Response: The incremental approach is not overly narrow, as it properly focuses on the probable costs resulting from the designation of critical habitat. When the Services develop a draft economic analysis to consider the economic impacts of designating critical habitat, we include reasonably known or probable impacts reasonably likely to occur. Using the incremental approach, we often identify administrative costs that will result from section 7 consultation in critical habitat units that are occupied by the species. Substantive changes in the form of project modifications are less likely to be attributable solely to critical habitat, as they may also be required to avoid jeopardy to the species, which is prohibited regardless of the designation of critical habitat. With respect to designation of critical habitat units that are unoccupied by the species, the Services may more frequently identify higher probable impacts. In that circumstance, any project modifications stemming from the consultation process would be due solely to the designation of critical habitat and the requirement of avoiding its adverse modification, because the species is not present in the area. By contrast, certain conservation measures that are attributable to the species' listed status, such as project modifications undertaken to avoid jeopardy to a species, fall under the baseline costs, and are not part of the incremental cost of a critical habitat designation.

Comment (27): Some commenters suggested that the Services use the incremental approach on all Federal lands and the coextensive approach on all State and private lands. They assert that this dual approach would fully analyze any economic impacts and would meet the intent of the President in considering maximum exclusion of the final revised critical habitat on private and State lands.

Response: For consistency, the incremental approach should be used for the entire designation, and not for specific land ownership. Further, based on OMB guidance in Circular A-4, as well as supportive case law, the Services' interpretation is that the incremental approach is the correct approach for impact analyses (see Comment (19) above for further elaboration on use of the incremental approach). Critical habitat receives regulatory protection under section 7 of the Act where there is a Federal nexus, regardless of land ownership. Even if the Services were to use the approach suggested by the commenter, any potential exclusion analysis under section 4(b)(2) of the Act would be difficult, as two different standards would be applied based on landownership, thereby increasing complexity and decreasing transparency and credibility of such balancing.

The last part of the comment, regarding maximizing exclusions from critical habitat, is specifically in reference to the directives in the Presidential memorandum regarding revision of critical habitat for the northern spotted owl. We note that those directives in the Presidential memorandum do not apply to all critical habitat rulemaking. However, the Services do consider other relevant impacts of a designation of critical habitat, including probable impacts to private and State lands, in all critical habitat rulemakings. Designation of critical habitat on Federal lands provides clear conservation benefits because Federal land managers have an obligation under section 7(a)(1) of the Act to carry out programs to conserve listed species. A designation of critical habitat helps focus such programs. As a result of these considerations, the Secretaries may enter into the discretionary 4(b)(2) exclusion analysis to consider exclusion of non-Federal lands, and may exclude particular areas from a designation of critical habitat if the benefits of exclusion outweigh the benefits of inclusion.

Comment (28): Since the Act requires critical habitat to be designated concurrent with listing to the maximum extent prudent and determinable, if the Services follow the incremental approach, there is no regulatory baseline against which the impacts of critical habitat may be compared.

Response: While we agree that in some cases regulatory baseline information may be limited at the time of listing, the Services will use the best data available in considering the impacts of designating critical habitat. Thus, when developing a critical habitat designation for a species not yet listed, the Services will use their experience and the data that is available, including the regulatory baseline condition of comparable surrogate listed species, to establish a probable baseline condition, as well as to determine the probable incremental impacts. The Services conclude that the use of information derived from an evaluation of comparable surrogate species or conditions is reasonable and consistent with standard economic methodology.

Comment (29): The incremental approach erroneously assumes that occupied critical habitat will forever remain occupied. As a result, areas considered occupied critical habitat within the impact analysis will have little or no incremental impacts over baseline.

Response: Neither coextensive nor incremental approaches to evaluating impacts are dependent upon the occupancy of a particular area in a designation. While we acknowledge that the occupancy of a particular area may change over time regardless of designation of critical habitat or listing, the Act directs us to designate critical habitat at the time a species is listed, to the maximum extent prudent and determinable, based on best scientific data available at the time of the designation.

Should an occupied portion of a critical habitat unit become unoccupied over time, and a future project is initiated in that area, the probable incremental costs associated with any project modifications needed to avoid adverse modification generally may be higher as they are no longer considered to be part of the baseline. However, as impact analyses are done at the time of critical habitat designation, it may not be possible to reliably predict when or where a range contraction may occur and whether this scenario would occur. In any event, the effects of an action on a designation would be evaluated in a section 7 consultation within the scope of that consultation and will be addressed on a case-by-case basis, and changes in occupancy that may result in range contraction as compared to the original designation, will be evaluated within the scope of future consultations. In some cases, the Services may elect to revise a critical habitat designation in the event of a serious or unanticipated range contraction to reflect a change in a species' range. In a revised rulemaking, the Services could reconsider prior exclusions from critical habitat or consider new exclusions from critical habitat.

Comment (30): One commenter cited a 2012 study of 4,000 biological opinions conducted under section 7 of the Act that identified no instances where a consultation concluded that the action resulted in an adverse modification of critical habitat, absent a comparable determination that the action would also jeopardize the continued existence of the species. As a consequence, the incremental approach for evaluating the impacts of critical habitat is of little value.

Response: Frequently, conservation measures and project modifications are negotiated with the Federal action agency during the informal and formal consultation processes, which can have the effect of precluding an adverse modification determination. The cost of these conservation measures and project modifications, if resulting solely from the designation, and the cost of the consultation itself constitute the incremental impacts of the designation, which must be evaluated under section 4(b)(2) of the Act. Thus, the lack of a determination of adverse modification in a section 7 consultation does not mean there is no incremental impact resulting from the designation.

Comment (31): The Services have a burden to clearly delineate the difference between jeopardy and adverse modification when using the incremental approach.

Response: As part of our evaluation of the probable incremental effects, the Services make a reasonable effort to explain the distinction between the results of application of the jeopardy and destruction or adverse modification standards to the facts of each species within the limits of what can be predicted from the best available information. In the evaluation of incremental impacts, we acknowledge the distinction between jeopardy and adverse modification is often most difficult to determine and articulate.

Comment (32): The Tenth Circuit found that the incremental approach is meaningless. Through the use of this approach, the Service has found that critical habitat designations covering vast expanses of private and public lands have no economic impacts other than incremental administrative costs associated with future section 7 consultations. The incremental approach does not require the Services to consider all economic impacts of a critical habitat designation and is, therefore, contrary to the Act and unlawful.

Response: In the preamble of our proposal and this final rule, the Services set forth in detail the rationale as to why the incremental approach is permissible and supported by the Act, relevant case law, and OMB Circular A-4. In particular, as the Ninth Circuit has noted, the Tenth Circuit's conclusion in New Mexico Cattle Growers was based on a faulty premise. We also note that there has been confusion as to what constitutes “all” economic impacts of a designation. OMB Circular A-4 states that agencies should evaluate the specific cost and benefit of the subject regulation relative to a baseline, which is “the way the world would look absent the proposed action. It may be reasonable to forecast that the world absent the regulation will resemble the present.” This approach captures all of the impacts that are actually relevant to the decision to be made. As applied to the decision of whether to exclude an area from a critical habitat designation, an incremental approach evaluates the cost solely resulting from a specific designation, which equates to the incremental difference between the world with and without the designation in place. Thus, in determining the incremental impacts of a designation, the Services do consider “all” of the reasonably likely or probable economic impacts of a designation.

Comment (33): Federal agencies have no authorities to resolve circuit court splits involving matters of statutory interpretation. The proposed rule is, therefore, unlawful because it represents an improper attempt by the Services to resolve a circuit split involving a matter of statutory interpretation. Rulemaking is not the way to resolve the judicial split between 10th and 9th circuit decisions. Congress or the Supreme Court should decide this issue. How would this rule, if finalized, apply in the 10th circuit?

Response: Federal agencies are empowered by Congress to interpret the laws that they implement. Courts also interpret the laws, and give varying degrees of deference to preexisting agency interpretations. Agencies may promulgate a rule that interprets a law differently than does a prior judicial opinion. See Nat'l Cable & Telecomms. Ass'n v. Brand X Internet Servs., 545 U.S. 967, 982-85 (2005). This is precisely what we are doing here. In other words, it is completely appropriate for an agency to issue a rule that has the effect of resolving a split in the circuit courts, so long as the agency's interpretation of the statute is permissible. And once it becomes effective, this regulation will apply to all subsequent critical habitat designations, whether or not that designation includes area within the geographic scope covered by the Tenth Circuit. Further, as we have explained, the more recent Ninth Circuit case law examined the predicate for the Tenth Circuit decision and found it no longer applied.

Comment (34): The incremental approach is not consistent with the “best scientific data” requirement.

Response: The Act specifies that we are to designate critical habitat based on the best scientific data available. The incremental approach broadly applies to analysis of probable impacts stemming from the designation of critical habitat. As stated above, when evaluating probable impacts of a critical habitat designation, the Services' practice is to consider only those impacts resulting from the critical habitat (i.e., incremental approach), and not those impacts associated with a species' listed status or other conservation measures undertaken for that species. Furthermore, the purpose of the impact analysis is to inform decisions regarding exclusions from critical habitat. If the Secretaries exercise their discretion to exclude particular areas, the incremental impacts will be avoided. Data used to inform the impact analysis that are based on probable incremental impacts are the most useful in this evaluation. Therefore, the Services do use the best scientific information available to evaluate the incremental impacts of a critical habitat designation.

Comment (35): Commenters requested that the Services provide clarification of baseline and explain what is meant by “existing protections”?

Response: “Existing protections” make up the “baseline.” As discussed in the preamble of our proposed regulation revision, the baseline condition for impact analyses is the evaluation of the combined effects of all conservation-related protections for a species (including listing) and its habitat, in the absence of the designation of critical habitat. The baseline includes the effects of all conservation measures and regulations that are in place as a result of the species being listed under the Act (i.e., the world without critical habitat for the subject species). An analysis of incremental impacts identifies and evaluates those impacts due solely to the designation of critical habitat, above and beyond those already in place (i.e., baseline condition).

Examples of existing protections may include: (1) Conservation measures such as Service-approved habitat conservation plans (HCPs) and safe harbor agreements (SHAs); (2) tribal and Federal wildlife-management and wildlife-conservation plans; (3) State endangered species act regulations; (4) other conservation measures at the State and local levels; and (5) project modifications resulting from section 7 consultations to avoid jeopardy to listed species.

Comment (36): Several commenters opposed the use of qualitative analyses in estimating potential economic impacts, and stated that all analyses should be quantitative in nature. Others suggested that consistency with the Act, the President's March 9, 2010, Scientific Integrity memorandum, and the Data Quality Act require the Secretary to use, to the maximum extent practicable, a quantitative assessment method, and only use qualitative assessments if data required to conduct the analysis are not available. Further, if the Services adopt the incremental approach, the need for robust, quantitative economic impact assessments is even greater. The Services should closely examine the existing economic conditions and quantitatively compare the impacts of any critical habitat designation to ensure they obtain a complete picture of the consequences of the regulatory action.

Response: As described in OMB Circular A-4, “Sound quantitative estimates of benefits and costs, where feasible, are preferable to qualitative descriptions of benefits and costs because they help decisionmakers understand the magnitudes of the effects of alternative actions. However, some important benefits and costs (e.g., privacy protection) may be inherently too difficult to quantify or monetize given current data and methods.” Based on our years of designating critical habitat and evaluating resulting impacts, the Services have found that, in most instances, the data available to provide quantified estimates of specific impacts are limited, and as a result, the Services have relied on a combination of quantitative and qualitative approaches in performing our impact analyses. This approach is consistent with Circular A-4, which states “If you are not able to quantify the effects, you should present any relevant quantitative information along with a description of the unquantified effects, such as ecological gains, improvements in quality of life, and aesthetic beauty.” Our practice is also consistent with the President's March 9, 2010, Scientific Integrity memorandum, and the Data Quality Act.

Comment (37): The qualitative approach makes sense under environmental law, but could be seen as subjective. However, quantitative analysis could be just as subjective based on how the numbers are assembled.

Response: We appreciate the observation. The Services are committed to using the best scientific information available in evaluating reasonably probable incremental impacts of a critical habitat designation in our impact analyses. We use these data, whether quantitative or qualitative, to make objective, substantiated conclusions.

Comment (38): The Services should establish guidelines for determining appropriate and meaningful scale of analyses. Another commenter noted that paragraph (b) gives the Secretaries additional flexibility to determine the scale of the analysis.

Response: Setting out defined guidelines for the scale of an analysis in regulations would not be practical. Each critical habitat designation is different in terms of area proposed, the scope of the applicable Federal actions, economic activity, and the scales for which data are available. Additionally, the scale of the analysis is very fact specific. Therefore, the Services must have flexibility to evaluate these different areas in whatever way is most meaningful. For example, for a narrow-endemic species, a critical habitat proposal may cover a small area; in contrast, for a wide-ranging species, a critical habitat proposal may cover an area that is orders of magnitude greater. The appropriate scale of the impact analysis for these two species may not be the same. For the narrow-endemic species, an impact analysis may look at a very fine scale with a great level of detail. In contrast, the impact analysis for the wide-ranging species, which may cover wide expanses of land or water, may use a coarser scale of analysis, due to the sheer size of the proposed designation. Each critical habitat proposal includes a description of the scope of the area being proposed, and uses the scale of analysis appropriate to that situation.

Comment (39): Commenters requested that the Services define “proposed and ongoing” activities and “other relevant impacts,” to promote consistent consideration of impacts of critical habitat designations.

Response: The Services interpret the Act as requiring us to consider and evaluate only activities that are proposed or ongoing. We note that the regulation sets out the minimum that is required to comply with the mandate of the first sentence of section 4(b)(2) of the Act. The Services may in appropriate circumstances choose to consider other reasonably probable impacts, especially in the discretionary exclusion analysis under the second sentence of section 4(b)(2) of the Act. The Services cannot speculate about what projects may occur in the future, but must rely on information available regarding reasonably foreseeable or probable projects as indicated in the original text of this revised regulation. To do otherwise would not provide for a reasonable or credible impact analysis. Proposed and ongoing also captures those section 7 consultations that have already occurred or are in progress, so that the possible effects of critical habitat may already be known, which allows for a more accurate and credible impact assessment.

Comment (40): The Services should add the phrase “domestic energy security” following the term “national security,” as it is a critical component of national security.

Response: The current language in section 4(b)(2) of the Act includes the phrase “and any other relevant impact.” The legislative history indicates that Congress intended to give the Secretaries broad discretion as to what impacts to consider and what weight to give particular impacts. H.R. Rep. 95-1625, at 17 ; see, e.g., Cape Hatteras Access Preservation Alliance v. DOI, 731 F. Supp. 2d 15 (D.D.C. 2010) (“the Service has considerable discretion as to what it defines to be “other relevant impacts” under the ESA”). Therefore, if the relevant Service determines in a particular designation that domestic energy security is a relevant impact of that designation, that Service will consider the impacts of designation on domestic energy security.

Comment (41): The change in the proposed revision of the standard of “potential” to “probable” would place a burden on landowners and users that is not authorized by the Act. This change is inconsistent with the statute because there are no such limitations on impacts considered by the Secretaries.

Response: The word “potential” was not in the previous language of this regulation. However, the word “probable” was in the original language of this regulation. As discussed in the preamble of our proposal, we are not changing the term “probable.” The use of this word reflects a reasonable interpretation of the statute. Realistically, the Services can only consider activities reasonably likely to occur, which we interpret for purposes of this rule to mean the same thing as the term “probable.”

Comment (42): The proposed regulation change would give too much latitude to the Services to make inconsistent and arbitrary decisions when designating critical habitat, including the discretion to assign weights to the benefits of critical habitat designations. The proposed rule lacks criteria or guidance, which deprives the public of the opportunity to comment on how the rule will be implemented. Although the Act affords the Secretaries significant discretion in making these determinations, the Secretaries should articulate how they will exercise this discretion by regulation. The criteria and guidelines should be set forth in the final rule. The final regulation should outline how the Secretaries will exercise discretion with requirements and guidance to provide public understanding in the analysis of designation of critical habitat.

Response: One purpose of this paragraph of the revised regulations is to clarify the relationship between the mandatory consideration of impacts under the first sentence of section 4(b)(2) of the Act and the discretionary exclusion authority under the second sentence of section 4(b)(2) of the Act. This distinction has been recognized by courts. Building Industry Ass'n of the Bay Area v. U.S. Dep't of Commerce, 2012 U.S. Dist. Lexis 170688 (N.D. Cal. Nov. 30, 2012). We disagree that it would be helpful to include specific guidance as to how this authority will be applied in binding regulations. However, the Solicitor's Section 4(b)(2) memorandum (M-37016, “The Secretary's Authority to Exclude Areas from a Critical Habitat Designation under Section 4(b)(2) of the Endangered Species Act” (Oct. 3, 2008)) (DOI 2008) provides general guidance on how to implement section 4(b)(2) of the Act, and we are developing additional guidance in a forthcoming joint agency policy on section 4(b)(2) exclusions. Ultimately, the weight given to any impact or benefit and the decision to exercise discretion to exclude a particular area is fact specific and will continue to be addressed in each individual rulemaking. As a matter of practice, the Services set forth the 4(b)(2) exclusion analysis in the final rule or supporting record for any area that the Secretaries exercise their discretion to exclude.

Comment (43): The preamble of the proposed regulation states that the weighing of benefits (exclusion analysis) under section 4(b)(2) is “optional,” which raises serious concerns. Section 4(b)(2) requires that economic and other impacts be considered in designating critical habitat. This step is mandatory. The revisions to section 424.19 should make clear that the requirement to consider economic and other impacts when designating critical habitat is an integral part of the designation process and will be utilized to reduce adverse impacts on land and resource users, as Congress intended. With this new approach, the Services may consider the economic analysis to be discretionary. The Secretary's discretion to exclude or not exclude arises only after the Secretary has first engaged in a mandatory consideration of economic impacts, followed by a nondiscretionary weighing of benefits. The third and final step is a discretionary decision whether to exclude or not.

Response: There are two distinct processes under section 4(b)(2) of the Act—one mandatory and one discretionary—and this interpretation has been confirmed by the courts ( Building Industry Ass'n of the Bay Area v. U.S. Dep't of Commerce, 2012 U.S. Dist. Lexis 170688 (N.D. Cal. Nov. 30, 2012)). The first sentence of section 4(b)(2) of the Act sets out a mandatory requirement that the Services consider the economic impact, impact on national security, and any other relevant impacts prior to designating an area as part of a critical habitat designation. The Services will always consider such impacts as required under this sentence for each and every designation of critical habitat. The economic analysis is the vehicle by which we consider the probable economic impacts of a critical habitat designation. Thus, contrary to the suggestion in the comment, we do not consider the consideration of the probable economic impacts of a critical habitat designation to be discretionary.

The second sentence of section 4(b)(2) of the Act outlines a separate discretionary exclusion-analysis process that the Services may elect to conduct depending on the specific facts of the designation. The Services are particularly likely to conduct this discretionary analysis if the consideration of impacts mandated under the first sentence suggests that the designation will have significant incremental impacts. In this exclusion analysis the Services analyze whether the benefits of excluding a particular area outweigh the benefits of including the area and determine whether to exclude such an area from the designation if the exclusion will not result in the extinction of the species.

The exclusion analysis outlined in the second sentence of section 4(b)(2) of the Act is not required under the statute, and for some designations the Services may choose not to engage in such an analysis. Thus, for the reasons discussed above and in the Solicitor's M-Opinion, we disagree with the commenter that the exclusion analysis is nondiscretionary.

However, separate and different from the 4(b)(2) exclusion analysis discussed above, agencies are required under E.O. 12866 to assess both the costs and the benefits of the intended regulation and, recognizing that some costs and benefits are difficult to quantify, propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. The requirement of E.O. 12866 is applicable to the process of designating critical habitat.

To minimize confusion between the two analyses, we have changed the reference to the analysis under the second sentence of 4(b)(2) of the Act in this final rule from “optional weighing of benefits” to “discretionary 4(b)(2) exclusion analysis.”

Comment (44): Some commenters were concerned that the Secretaries might not exclude areas even if the benefits of exclusion outweigh those of inclusion. They argued that this approach would conflict with the general principles of E.O. 13563 and the intent of the 2012 Presidential memorandum. The Secretaries do not have discretion to ignore economic or other impacts in designating critical habitat, as implied by the Services' claim in having broad discretion in development of an economic impact analysis. If agency discretion is absolute, then this situation renders criteria set forth in section 4(b)(2) as serving no purpose. We understand the commenters to mean that this would render the Act's requirement that the Services consider the impacts of a designation of critical habitat illusory.

Response: We agree that the requirement of E.O. 12866 (and incorporated by E.O. 13563) to assess the costs and benefits of a rule, and, to the extent permitted by law, to propose or adopt the rule only upon a reasoned determination that the benefits of the intended regulation justify the costs is applicable to the process of designating critical habitat. However, as discussed above, the authority for the assessment of costs and benefits to satisfy the provisions of E.O. 12866 and E.O. 13563 is separate and different from the authority for the discretionary exclusion analysis conducted under the second sentence of section 4(b)(2) of the Act. Because the discretionary 4(b)(2) exclusion analysis and the assessment under the Executive Orders serve different purposes, we do not find that the discretionary 4(b)(2) exclusion analysis conflicts with the general principles of the Executive Orders. In fact, we believe that, in general, excluding an area because the benefits of exclusion outweigh the benefits of inclusion, and not excluding an area because the benefits of exclusion do not outweigh the benefits of inclusion, is fully consistent with the E.O. requirements discussed above.

In this final rule, we acknowledge that the first sentence of section 4(b)(2) of the Act sets forth a mandatory consideration of the economic, national security, or other relevant impacts of designating critical habitat. So we agree with the commenter that there is a mandatory consideration of economics and other impacts of designating critical habitat. However, we also acknowledge that the second sentence of section 4(b)(2) of the Act outlines a separate discretionary exclusion-analysis process that the Services may elect to conduct depending on the specific facts of the designation. The discretionary nature of this process has most recently been upheld in Building Industry Ass'n of the Bay Area v. U.S. Dep't of Commerce, 2012 U.S. Dist. Lexis 170688 (N.D. Cal. Nov. 30, 2012). We note that the Services are particularly likely to conduct this discretionary analysis if the consideration of impacts mandated under the first sentence suggests that the designation will have significant incremental impacts, and, generally, the Services' practice is to exclude an area from a designation when the benefits of exclusion outweigh the benefits of inclusion, provided that the exclusion will not result in the extinction of the species.

There is no single approach for evaluating and weighing incremental impacts resulting from a designation of critical habitat against the conservation needs of a species. Thus, the Secretaries must retain discretion in choosing the methods of evaluating these issues in the context of a particular designation. The Secretaries have broad discretion whether to exclude or not ( Building Industry Ass'n of the Bay Area v. U.S. Dep't of Commerce, 2012 U.S. Dist. Lexis 170688 (N.D. Cal. Nov. 30, 2012)); the only conditions are that we must consider economic impacts, impacts to national security, and other relevant impacts; and we may not exclude an area when such exclusion will result in the extinction of the species. As discussed above, The Services' ability to apply this discretion is fully consistent with E.O. 12866, E.O. 13563, or the Presidential memorandum. The existence of the agencies' broad discretion does not mean that section 4(b)(2) of the Act serves no purpose. Section 4(b)(2) of the Act gives the agencies authority to exclude, absent which exclusions from critical habitat would not be possible. This authority serves an important purpose (although not the purpose of allowing others to force the agencies to exercise that authority).

Comment (45): The Act requires that, when the economic costs outweigh the benefits of designating critical habitat in a certain area, the Secretaries must exert their discretion to exclude that area from the designation.

Response: We disagree. The Act is quite clear and specifically states that the Secretaries “may exclude”--we interpret this to mean exclusions are always discretionary and never mandatory. This interpretation has been upheld by the courts ( Building Industry Ass'n of the Bay Area v. U.S. Dep't of Commerce, 2012 U.S. Dist. Lexis 170688 (N.D. Cal. Nov. 30, 2012)). Therefore, exclusion of a particular area is never mandatory.

Comment (46): The Services' section 4(b)(2) impact analyses should be reviewable. The proposed regulation would establish that the Secretaries' decision not to exclude an area from critical habitat regardless of the result of the economic impact analyses would not be reviewable. Under the APA, agencies must respond to “significant comments.” The failure of the Services to provide a meaningful response to a request made by the public or other entity, such as by providing findings regarding relative costs and benefits of designating a particular area, would be arbitrary, capricious, and in violation of the law. Further, if the Secretaries reject a request to exclude an area from critical habitat, and provide an explanation for that decision, that decision would be subject to APA review.

Response: Recent case law supports our conclusion that exclusions are discretionary and the discretion not to exclude an area is judicially unreviewable ( Building Industry Ass'n of the Bay Area v. U.S. Dep't of Commerce, 2012 U.S. Dist. Lexis 170688 (N.D. Cal. Nov. 30, 2012)). While the Services will consider all significant comments, this process does not alter the fact that the Secretary has discretion as to whether to enter into the exclusion analysis under section 4(b)(2) of the Act and whether to exclude any particular areas. For example, an appropriate response to a comment seeking to force an exclusion analysis and subsequent exclusion would be that the Secretary has considered the relevant impacts under the first sentence of section 4(b)(2) of the Act but declines to exercise the Secretary's discretion to make an exclusion.

Comment (47): The public should be able to review and comment on the Secretary's rationale for an exclusion.

Response: In some cases, the Services are able to provide the public with opportunity to review and comment on particular areas considered for, or proposed for, exclusion from a designation of critical habitat. In other instances, the Services may not know which areas will be considered or ultimately excluded from the final designation of critical habitat until after receiving public comment. If the Secretary chooses to exercise his or her discretion to exclude a particular area, the discretionary 4(b)(2) exclusion analysis will be presented in the final rule designating critical habitat and supporting information will be contained in the administrative record for the action. The rationale supporting the exclusion is then available for review. This procedure is consistent with the APA. See Home Builders Ass'n of No. Cal. v. USFWS, 2006 U.S. Dist. Lexis 80255 (E.D. Cal. Nov. 2, 2006), reconsideration granted in part 2007 U.S. Dist. Lexis 5208 (Jan. 24, 2007), aff'd, 616 F.3d 983 (9th Cir. 2010) (specific exclusion from critical habitat in final rule was a logical outgrowth of the proposed rule because the proposed rule had sought comment on whether any areas should be excluded).

Comment (48): The second sentence indicates that “the Secretary may consider and assign the weight to any benefits relevant to the designation of critical habitat.” This language is an attempt to authorize the Secretary to consider factors beyond those specified in the Act, which are those directly related to the conservation of the species that is the subject of the designation.

Response: We disagree. The first sentence of section 4(b)(2) of the Act requires consideration of “any” relevant impacts of designation, and the second sentence of section 4(b)(2) of the Act places no limitations as to the nature of the benefits that may be weighed in the discretionary process of considering exclusions. Nothing in the Act suggests that only factors directly related to conservation of the species can be considered in implementing section 4(b)(2) of the Act. Section 4(b)(2) of the Act is inherently broad, and the regulation reflects the manner in which the Secretary should use that authority.

Comment (49): Paragraph (c) should be revised to specifically acknowledge and analyze the combined State, local, and volunteer conservation-related protections for a species, and the Services should compare these protections to the benefits of a critical habitat designation. Paragraph (c) should be revised to include language defining benefits as including, but not limited to, local and regional economic development and sustainability, energy development and security, American job security, and volunteer conservation mitigation measures.

Response: While items such as those enumerated in the comment may well be relevant in a particular designation and may be considered if there is available information, the Services' intent in promulgating this revised regulation is to preserve the discretion and flexibility to shape the analysis as appropriate for each situation rather than to prescribe certain criteria for the discretionary analysis under the second sentence of section 4(b)(2) of the Act. Our intent in setting forth paragraph (c) is only to restate Secretarial discretion as provided by the Act and Congressional intent, and confirmed in relevant case law.

Comment (50): One commenter suggested that we revise paragraph (c) to clarify that any exclusion is not set forth until the rule is finalized; the commenter suggested the language “exclude any particular area from the [final] critical habitat.”

Response: While we appreciate the comment, we find that the edit is not necessary, because anything set forth in a proposed regulation does not have the force of law until the rule is finalized and effective.

Comment (51): Add language to paragraph (c) to clarify that the Secretary has discretion to exclude areas from the “final” critical habitat “designation” upon a determination “supported by the record.”

Response: We agree that decisions set forth in each rulemaking must be supported by the record. In fact, rational decisionmaking supported by the administrative record is a bedrock principle of the APA that applies to all final agency actions, and as such, does not need to be codified within this regulation.

Comment (52): The discretionary 4(b)(2) exclusion analysis must occur prior to including any specific area as critical habitat or excluding any specific area from critical habitat in the proposed rule.

Response: Initially, to the maximum extent prudent and determinable, the Services are required to identify those specific areas that meet the definition of critical habitat (in 16 U.S.C. 1532(5)), based on the best scientific data available. Subsequently, the Secretaries must consider the economic impact, the impact to national security, and any other relevant impact of designating any particular area as critical habitat. See 16 U.S.C. 1533(b)(2). We agree with the commenter that the Secretaries may exclude a particular area from critical habitat only after conducting a discretionary 4(b)(2) exclusion analysis (though such weighing and development of a 4(b)(2) report could be undertaken prior to release of the proposed rule). However, we note that the determination of areas meeting the definition of critical habitat is a biological determination and not done via a discretionary 4(b)(2) exclusion analysis.

Comment (53): The proposed rule does not meet the Executive Order 13563 (January 18, 2011) objectives of promoting predictability and reducing uncertainty in regulatory processes. The Services should implement the Presidential memorandum of February 28, 2012, in a way that is consistent with the entire suite of regulation reform directives. The proposed regulation revision is inconsistent with the intent of the Presidential memorandum in that it does not promote “economic growth, innovation, competitiveness, and job creation,” nor does it avoid the imposition of unnecessary costs and burdens to enhance regulatory flexibility. The Services go beyond the Presidential memorandum to advance vague standards that can further weaken economic impact analysis.

Response: Many commenters misinterpreted the scope of the Presidential memorandum. The Presidential memorandum was issued in response to the proposed revised critical habitat designation for the northern spotted owl, and focused specifically on the rulemaking process for that regulation, as evidenced in the title, Presidential Memorandum—Proposed Revised Habitat for the Spotted Owl: Minimizing Regulatory Burdens. Due to: (1) Concern for not having the economic analysis available with the proposed revised critical habitat for the northern spotted owl that would allow for the evaluation of effects, and (2) FWS' interpretation that the existing regulations limited the ability to provide the economic analysis concurrent with proposal, the memorandum further directed the Secretary to revise the relevant regulation to shift the timing of the economic analysis such that all subsequent critical habitat proposals would be published with a concurrent economic analysis. As a result, the core of the memorandum speaks to the designation process of the rulemaking for the northern spotted owl. This regulation addresses only that portion of the memorandum that requires a shift in the timing of the economic analysis. Further, the Services chose to revise the regulation to codify established interpretation, practices, and prevailing case law. We conclude that doing so will in fact provide clarity, promote predictability, and reduce uncertainty, consistent with Executive Order 13563.

Comment (54): One commenter asked the Services to explain how the proposed regulation change will decrease uncertainty and improve public participation, as directed by the Presidential memorandum.

Response: The revisions set forth in this regulation will provide clarity, promote predictability, and reduce uncertainty by making the economic analyses available concurrently with proposals to designate critical habitat so that the public has both the impact analysis and the proposal available for comment concurrently earlier in the process. The Presidential memorandum states “Uncertainty on the part of the public may be avoided, and public comment improved, by simultaneous presentation of the best scientific data available and the analysis of economic and other impacts.” We conclude that this regulation will achieve that goal. Further, the Services chose to address other relevant points within the revised regulation to codify established interpretation, practices, and prevailing case law, which also should decrease uncertainty and improve public participation.

Comment (55): Several commenters interpreted the Presidential memorandum to broadly instruct the Services to consider lessening the regulatory impacts on private and State land owners, and consider impacts to jobs.

Response: Please refer to our response under Comment 53, above.

Comment (56): The Services assert that they will use their current regulation until the new regulation is finalized, yet it used the proposed process in the recent rulemaking for the northern spotted owl. This appears to be a predecisional process approach for the final northern spotted owl regulation and for this proposed regulation.

Response: For the rulemaking for the northern spotted owl proposed revised critical habitat, the FWS followed the existing regulatory procedure set forth in 50 CFR 424.19 regarding the timing of the draft economic analysis, because it was made available following the publication of the proposed designation. The draft analysis used the incremental approach to evaluating impacts, which is consistent with agency practice since 2007, the Solicitor's memorandum (M-37016, “The Secretary's Authority to Exclude Areas from a Critical Habitat Designation under Section 4(b)(2) of the Endangered Species Act” (Oct. 3, 2008)) (DOI 2008) and case law in the Ninth Circuit. Thus we did not use a predecisional approach for the northern spotted owl revised critical habitat, but followed our normal practice.

Comment (57): The Services are improperly interpreting the February 28, 2012, Presidential memorandum, in which the Secretary of the Interior was simply directed to provide a draft economic analysis at the time of publication of the proposed northern spotted owl critical habitat rule. The Presidential memorandum did not require the Service to proceed with national rulemaking nor provide direction to utilize the incremental analysis in future critical habitat rulemaking.

Response: The Presidential memorandum specifically directs the Secretary of the Interior to “take prompt steps to propose revisions to the current rule (which, as noted, was promulgated in 1984 and requires that an economic analysis be completed after critical habitat has been proposed) to provide that the economic analysis be completed and made available for public comment at the time of publication of a proposed rule to designate critical habitat.” While the Presidential memorandum directed the Secretary of the Interior to revise the regulations to shift the timing of the economic impact analysis for critical habitat designation, it did not limit the scope of the revision to the regulations. To further provide clarity, promote predictability, and reduce uncertainty, the Services chose to address other relevant points within the revised regulation to codify established interpretation, practices, and prevailing case law.

Comment (58): We received numerous specific comments in several categories which were not directly relevant to the regulation and are, therefore, not addressed in this section. Below, we provide a summary of the topic areas that these comments encompass. While not directly relevant to this regulation, we may address some of these issues in future rulemaking and policy development by the Services.

(1) Providing guidance for the methodology for conducting economic analyses including data collection from and coordinating with potentially affected parties;

(2) Specific methodology for evaluation of direct and indirect economic effects;

(3) The relationship between critical habitat and recovery;

(4) The detrimental effect critical habitat may have on partnerships; and

(5) Tribal sovereignty and coordination.

Executive Order 12866 provides that the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is significant.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements. This final rule is consistent with Executive Order 13563 because it is designed “to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.”

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601 et seq. ), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency, or his designee, certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We certified at the proposed rule stage that this action would not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

This final rule revises and clarifies the regulations governing how the Services analyze and communicate the impacts of a possible designation of critical habitat, and how the Services may exercise the Secretary's discretion to exclude areas from designations. The final revisions to the regulations apply solely to the Services' procedures for the timing, scale, and scope of impact analyses and considering exclusions from critical habitat. The revisions discussed in this final regulatory revision serve to clarify, and do not expand the reach of, potential designations of critical habitat.

NMFS and FWS are the only entities that are directly regulated by this rule because we are the only entities that can designate critical habitat. No external entities, including any small businesses, small organizations, or small governments, will experience any economic impacts from this rule. Therefore, the only effect on any external entities large or small would likely be positive through reducing any uncertainty on the part of the public by simultaneous presentation of the best scientific data available and the economic analysis of the designation of critical habitat.

We received no comments on the economic impact of this rule or the certification. A final regulatory flexibility analysis is not required, and one was not prepared.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ):

(a) On the basis of information contained in the “Regulatory Flexibility Act” section above, these final regulations would not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, that these regulations would not impose a cost of $100 million or more in any given year on local or State governments or private entities. A Small Government Agency Plan is not required. As explained above, small governments would not be affected because the final regulations would not place additional requirements on any city, county, or other local municipalities.

(b) These final regulations would not produce a Federal mandate on State, local, or tribal governments or the private sector of $100 million or greater in any year; that is, this final rule is not a “significant regulatory action”' under the Unfunded Mandates Reform Act. These final regulations would impose no obligations on State, local, or tribal governments.

In accordance with Executive Order 12630, these final regulations would not have significant takings implications. These final regulations would not have any actual impacts to the environment or to private property interests, because they will not result in changes to applicable standards for identifying and designating critical habitat, the level of opportunity for public comment on critical habitat designations, or the outcome of critical habitat determinations. Because these final regulations affect only procedural or administrative matters, such as the timing of when the draft economic analysis will be prepared, they would not have the effect of compelling a property owner to suffer any physical invasion of their property; and would not deny any use of the land or aquatic resources. Moreover, there would be neither any burden to public property from the regulations nor any barrier to reasonable and expected beneficial use of private property.

In accordance with Executive Order 13132, we have considered whether these final regulations would have significant Federalism effects and have determined that a Federalism assessment is not required. These final regulations pertain only to determinations to designate critical habitat under section 4 of the Act, and would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government.

These final regulations do not unduly burden the judicial system and they meet the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988. These final regulations would clarify how the Services will make designations of critical habitat under section 4 of the Act.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In our final regulations, we explain that the Secretaries have discretion to exclude any particular area from the critical habitat upon a determination that the benefits of exclusion outweigh the benefits of specifying the particular area as part of the critical habitat. In identifying those benefits, the Secretaries may consider effects on tribal sovereignty.

This final rule does not contain any new collections of information that require approval by the OMB under the Paperwork Reduction Act. This final rule would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We have analyzed this rule in accordance with the criteria of the National Environmental Policy Act (NEPA) (42 U.S.C. 4332(c)), the Council on Environmental Quality's Regulations for Implementing the Procedural Provisions of NEPA (40 CFR parts 1500-1508), the Department of the Interior's NEPA procedures (516 DM 2 and 8; 43 CFR part 46), and NOAA's Administrative Order regarding NEPA compliance (NAO 216-6 (May 20, 1999)).

We have determined that this rule is categorically excluded from NEPA documentation requirements consistent with 40 CFR 1508.4 and 43 CFR 46.210(i). This categorical exclusion applies to policies, directives, regulations, and guidelines that are “of an administrative, financial, legal, technical, or procedural nature.” This action does not trigger an extraordinary circumstance, as outlined in 43 CFR 46.215, applicable to the categorical exclusion. Therefore, this rule does not constitute a major Federal action significantly affecting the quality of the human environment.

We have also determined that this action satisfies the standards for reliance upon a categorical exclusion under NOAA Administrative Order (NAO) 216-6. Specifically, this action fits within the categorical exclusion for “policy directives, regulations and guidelines of an administrative, financial, legal, technical or procedural nature.” NAO 216-6, section 6.03c.3(i). This action would not trigger an exception precluding reliance on the categorical exclusion because it does not involve a geographic area with unique characteristics, is not the subject of public controversy based on potential environmental consequences, will not result in uncertain environmental impacts or unique or unknown risks, does not establish a precedent or decision in principle about future proposals, will not have significant cumulative impacts, and will not have any adverse effects upon endangered or threatened species or their habitats. Id. section 5.05c. As such, it is categorically excluded from the need to prepare an Environmental Assessment. In addition, NMFS finds that because this rule will not result in any effects to the physical environment, much less any adverse effects, there would be no need to prepare an Environmental Assessment even aside from consideration of the categorical exclusion. See Oceana, Inc. v. Bryson, No. C-11-6257-EMC, 2013 WL 1563675, *24-25,—F. Supp. 2d—(N. D. Cal. April 12, 2013). Issuance of this rule does not alter the legal and regulatory status quo in such a way as to create any environmental effects. See Humane Soc. of U.S. v. Johanns, 520 F. Supp. 2d. 8, 12 (D.D.C. 2007).

Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. These final regulations are not expected to affect energy supplies, distribution, and use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

A complete list of all references cited in this document is available on the Internet at http://www.regulations.gov at Docket No. FWS-R9-ES-2011-0073 or upon request from the U.S. Fish and Wildlife Service (see FOR FURTHER INFORMATION CONTACT ).

We are taking this action under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2013 Pacific cod total allowable catch (TAC) specified for vessels using jig gear in the BSAI is 3,251 metric tons (mt) as established by the final 2013 and 2014 harvest specifications for groundfish in the BSAI (78 FR 13813, March 1, 2013). The Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that jig vessels will not be able to harvest 2,500 mt of the remaining 2013 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)( 1 ). Therefore, in accordance with § 679.20(a)(7)(iii)(A), NMFS apportions 2,500 mt of Pacific cod to catcher vessels less than 60 feet (18.3 meters(m)) LOA using hook-and-line or pot gear.

The 2013 Pacific cod TAC specified for catcher vessels greater than or equal to 60 feet LOA using hook-and-line gear in the BSAI is 463 mt as established by the final 2013 and 2014 harvest specifications for groundfish in the BSAI (78 FR 13813, March 1, 2013). The Regional Administrator has determined that catcher vessels greater than or equal to 60 feet LOA using hook-and-line gear will not be able to harvest 450 mt of the remaining 2013 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)( 3 ). Therefore, in accordance with § 679.20(a)(7)(iii)(A), NMFS apportions 450 mt of Pacific cod to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear.

The harvest specifications for Pacific cod included in the final 2013 harvest specifications for groundfish in the BSAI (78 FR 13813, March 1, 2013) are revised as follows: 751 mt for vessels using jig gear, 13 mt for catcher vessels greater than or equal to 60 feet (18.3 m) LOA using hook-and-line gear, and 7,577 mt to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of Pacific cod specified from other sectors to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear. Since the fishery is currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 21, 2013.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.