On December 9, 2011, the Government Accountability Office Personnel Appeals Board (the Board or PAB) published an interim rule reflecting a change in law concerning grievance procedures and changing some specific terms in the regulations to ones more commonly used throughout the government. 76 FR 76873, December 9, 2011. The formal period for comments closed on February 7, 2012, and no comments were received. Accordingly, the interim rule amending 4 CFR part 28 which was published at 76 FR 76873 on December 9, 2011, is adopted as a final rule without substantial changes. Additionally, since the PAB is moving its offices as of March 19, 2012, title 4, part 28 of the Code of Federal Regulations is being amended to reflect the change in location and mailing address.

For the reasons set forth in the preamble, the interim rule amending title 4, part 28, Code of Federal Regulations, which was published at 76 FR 76873 on December 9, 2011, is adopted as final, with changes as follows:

Background Legal Authority

The Drug Enforcement Administration (DEA) is a component of the Department of Justice and is the primary agency responsible for coordinating the drug law enforcement activities of the United States. DEA also assists in the implementation of the President's National Drug Control Strategy. DEA's mission is to enforce U.S. controlled substances laws and regulations and bring to the criminal and civil justice system those organizations and individuals involved in the growing, manufacturing, or distribution of controlled substances and listed chemicals appearing in or destined for illicit traffic in the U.S., including organizations that use drug trafficking proceeds to finance terrorism. The diversion control program (DCP) is a strategic component of the DEA's law enforcement mission. The DCP implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 801-971), as amended (hereinafter, “CSA”). 1 DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1321. The CSA, together with these regulations, is designed to help prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring a sufficient supply of controlled substances and listed chemicals for legitimate medical, scientific, research, and industrial purposes.

Pursuant to the CSA, each controlled substance is classified in one of five schedules based upon its potential for abuse, currently accepted medical use, and the degree of dependence it may cause if abused. 21 U.S.C. 812. Likewise, under the CSA, listed chemicals are separately classified based on their use and importance to the manufacture of controlled substances (List I or List II chemicals). 21 U.S.C. 802(33)-(35). The CSA mandates that DEA register persons and entities who manufacture, distribute, import, or export controlled substances or List I chemicals, and those persons and entities who dispense or conduct research or chemical analysis with controlled substances. These registrants are permitted to handle controlled substances and List I chemicals as authorized by their registration and are required to comply with the applicable requirements associated with their registration. 21 U.S.C. 822, 958. The identification and registration of all individuals and entities authorized to handle controlled substances and List I chemicals establishes a closed system of distribution that DEA is charged to maintain.

Under the CSA, DEA is authorized to charge reasonable fees relating to the registration and control of the manufacture, distribution, dispensing, import, and export of controlled substances and listed chemicals. 21 U.S.C. 821 and 958(f). DEA must set fees at a level that ensures the recovery of the full costs of operating the various aspects of its DCP. 21 U.S.C. 886a. Each year, DEA is required by statute to transfer the first $15 million of fee revenues into the general fund of the Treasury, and the remainder of the fee revenues is deposited into a separate fund of the Treasury called the Diversion Control Fee Account (DCFA). 21 U.S.C. 886a(1). On at least a quarterly basis, the Secretary of the Treasury is required to reimburse DEA an amount from the DCFA “in accordance with estimates made in the budget request of the Attorney General for those fiscal years” for the operation of the DCP. 2 21 U.S.C. 886a(1)(B) and (D). A Notice of Proposed Rulemaking (NPRM) proposing an adjusted fee schedule for DEA registration and reregistration was published on July 6, 2011, at 76 FR 39318, with a 60 day comment period. The comment period closed on September 6, 2011.

In 1970, Congress consolidated more than 50 laws related to the control of narcotics and dangerous drugs into one statute—the CSA. The statute was “designed to improve the administration and regulation of the manufacturing, distribution, and dispensing of controlled substances by providing for a `closed' system of drug distribution for legitimate handlers of such drugs,” with criminal penalties for transactions outside the legitimate chain. 3 With the enactment of the CSA, the Bureau of Narcotics and Dangerous Drugs (BNDD) was granted the authority to charge reasonable fees relating to both registration and control  4 of persons and entities engaged in the manufacture, distribution, dispensing, export, and import of controlled substances. 5 To this end, BNDD established a three- tiered fee structure for companies and individuals wishing to participate in the U.S. controlled substance industry. 6

In 1973, BNDD was abolished, and all of its functions were transferred to the newly-created DEA, including the authority to charge registrants reasonable fees. 7 In 1982, the General Accounting Office (GAO)  8 advised that the 1971 fee schedule did not adequately recover the costs for the DCP administered by DEA. An increase in fees was proposed and finalized in 1983. 9 All fees collected through 1992 were deposited into the general fund of the United States Treasury.

In 1993, Congress determined that the DCP would be fully funded by fees rather than by appropriations, 10 and established the DCFA as a separate account of the Treasury to “[ensure] the recovery of the full costs of operating the various aspects of [the diversion control program]” from fees charged by DEA. 21 U.S.C. 886a(1)(C). Congress also specified the general operation of the DCFA. Each fiscal year, the first $15 million of collected fees are transferred to the general fund of the Treasury and are not directly available for use by the DCP. Fees collected in excess of $15 million are used to reimburse DEA for expenses incurred in the operation of the DCP, in accordance with estimates made in the budget request of the Attorney General. 21 U.S.C. 886a(1).

Shortly after enactment of the 1993 Appropriations Act, DEA published a NPRM proposing to increase the existing fee schedule to comply with Congress's direction to set fees at a level that ensures the recovery of the full costs of operating the DCP. 11 After a comment period, a final rule was published on March 22, 1993, implementing changes to the fee structure and excluding chemical control costs from the calculation of fees. 12 Several registrants impacted by the fee increase challenged it, first in federal district court, where it was upheld, and subsequently on appeal, where it was remanded for additional information to support the fees. 13

Upon remand, the March 1993 final fee rule was reopened for further comment in 1996. 14 DEA undertook studies and internal reorganizations to enable it to better identify DCP activities and costs, and, in 2002, DEA published for additional public comment more information on the components and activities of the fee-funded DCP. 15 After that publication, the Office of the Inspector General, Department of Justice (OIG) concluded its review of the DCP, and determined that DEA was not adequately supporting the DCP. 16

In February 2003, DEA published a proposed rule to raise registration and reregistration fees so as to comply with the statutory requirement to charge fees at a level ensuring the recovery of the full costs of operating the various aspects of the DCP. 17 Shortly thereafter, DEA created the Validation Unit to ensure that DCFA-funded expenditures support registration and diversion control-related activities. The Validation Unit reports to the DEA Deputy Administrator and independently reviews specified expenditures attributable to the DCFA. If an expense only partially supports the DCP, such as a field office's rent or utility cost, the Validation Unit determines the amount that may be properly apportioned to the DCFA. On October 10, 2003, a new fee was finalized by publication of a final rule. 18

Meanwhile, in December 1993, the Domestic Chemical Diversion Control Act of 1993 amended the CSA to require that manufacturers, distributors, importers, and exporters of List I chemicals obtain a registration from DEA. DEA was also authorized to charge “reasonable fees relating * * * to the registration and control of regulated persons and regulated transactions.”  19

In 2004, the CSA was amended to define the DCP as “the controlled substance and chemical diversion control activities of the Drug Enforcement Administration.” 21 U.S.C. 886a(2)(A). 20 Furthermore, “controlled substance and chemical diversion control activities” means “those activities related to the registration and control of the manufacture, distribution, dispensing, importation, and exportation of controlled substances and listed chemicals.” 21 U.S.C. 886a(2)(B). Congress further provided that reimbursements from the DCFA “shall be made without distinguishing between expenses related to controlled substance activities and expenses related to chemical activities” (21 U.S.C. 886a(1)(B)) and amended the language of 21 U.S.C. 821 and 958(f) to be consistent with the definition of the DCP articulated in 21 U.S.C. 886a(2). As a result, all fees collected in excess of $15 million are deposited into the DCFA, and reimbursements by the Secretary of the Treasury are made without distinction between controlled substance and List I chemical activities.

In 2005, based upon internal organizational changes and the 2005 Appropriations Act, DEA proposed an adjusted fee schedule to appropriately reflect all costs associated with the DCP. 21 In July 2006, the OIG reported on its Follow-up Review of DEA's Efforts to Control the Diversion of Controlled Pharmaceuticals and recommended that DEA apply more resources to diversion control, including more Special Agent support. 22 The OIG also recommended that DEA increase training for those individuals who support the DCP. The OIG also noted that the diversion of controlled substance pharmaceuticals had dramatically increased over recent years and that the increase coincided with the use of emerging technologies such as the Internet. Twelve comments were received and analyzed in response to DEA's proposed fee rule, and DEA published the final rule on August 29, 2006. 23 Collections associated with that fee adjustment did not begin until FY 2007, on November 1, 2006.

The OIG completed a Review of DEA's Use of the Diversion Control Fee Account in 2008 and did not find that any DCFA funds were misused for non-diversion control activities between FY 2004 and FY 2007. To the contrary, the OIG found that DEA did not fully fund all diversion control costs with the DCFA, as required by law. 24

It has been more than five years since the last fee adjustment. DEA proposed a new fee schedule by publication of a NPRM on July 6, 2011. 76 FR 39318-41. DEA outlined the scope of the DCP, the need for a new fee calculation, the four different methodologies or options considered for calculating the fee, the proposed weighted-ratio methodology, and the calculation resulting in the proposed fee increase of approximately 33 percent. The fee increase incorporates additional DCP costs identified in the above-mentioned OIG report, as well as an expanded diversion control program required by Congress, and it accounts for a number of current circumstances related to the diversion of controlled substance pharmaceuticals and listed chemicals.

Fees must be “set at a level that ensures the recovery of the full costs of operating the various aspects of [the DCP].” 21 U.S.C. 886a(1)(C). In addition, any methodology for calculating fees must result in fees that are reasonable. 21 U.S.C. 821 and 958(f). As outlined below in responses to comments, DEA must calculate and collect fees prior to actually expending the funds in order to have funds with which to operate the DCP. Moreover, each year DEA is required to transfer the first $15 million of fee revenues into the general fund of the Treasury, with the remainder deposited into a separate fund of the Treasury called the Diversion Control Fee Account or DCFA. 21 U.S.C. 886a(1). On at least a quarterly basis, the Secretary of the Treasury is required to reimburse DEA an amount from the DCFA “in accordance with estimates made in the budget request of the Attorney General for those fiscal years” for the operation of the DCP. 21 U.S.C. 886a(1)(B) and (D).

In the NPRM, DEA outlined four alternative methodologies to calculate the registration and reregistration fees. 76 FR 39329-32. These were the Past-Based Option, Future-Based Option, Flat Fee Option, and Weighted-Ratio Option. For each of the options considered, the calculated fees are analyzed for reasonableness by examining: (1) The absolute amount of the fee increase, (2) the change in fee as a percentage of registrant revenue from 2007 to 2012, and (3) the relative fee increase across registrant groups. Additionally, each calculation methodology is re-evaluated for its overall strengths and weaknesses in recovering the full costs of the DCP.

Based on the analysis provided in the NPRM, DEA did not adopt the “Past-Based Option.” There are two key reasons for rejecting this methodology. First, the fee increase would be disproportionately burdensome to a small number of registrants. Distributors' fees would increase by over three fold, while the fees for the remaining registrant groups would increase by 10 percent and 32 percent. DEA believes this is unreasonable. Second, the past-based option uses FY 2007-FY 2009 investigation work hour data to set the apportionment of cost to each registrant category. Pre-registration and scheduled investigation costs are assigned to registrant classes and all other costs are recovered on an equal, per-registrant basis. This method is retrospective and assumes that future investigations will be similar to the past. DEA cannot assume that past work hour data accurately reflects future workload because priorities change as the threats change. For example, in order to monitor registrant regulatory compliance and leverage the deterrent effect of scheduled investigations, DEA increased the frequency of all scheduled investigations beginning in 2008. In 2011, DEA began pre-registration investigations of all pharmacies located in the State of Florida in order to address the rampant diversion in south Florida. And in 2010, DEA began conducting nationwide take back events to provide a mechanism for the public to dispose of their unwanted, unused, and expired controlled substance pharmaceutical drugs. The past-based option is vulnerable to short-term fluctuations in priorities which can greatly affect fees among the different categories. As a result, DEA has concluded that past work hour data alone is not the best basis for the calculation of registration fees.

The second option analyzed in the NPRM is the “Future-Based Option” which is based on projected work hours for each registrant class using scheduled investigation work plan goals and anticipated/planned resources. Under this option, DEA based its calculations on projected work hour data by registrant group for FY 2012-2014. In other words, the future-based option is based on DEA's projection of work plan goals and the resources required for these years—specifically examining the direct cost of anticipated scheduled investigations.

DEA rejects this methodology because it would result in an unreasonable increase in fees for some registrants and a severe disparity of fees among the registrant groups. The large proportional increase in fees for two registrant categories may not pass the reasonable standard required by statute. The vast disparity in the increase, where fees for manufacturers increase by more than 700 percent while fees for dispensers increase by 26 percent, is unreasonable. This method is unfair to the registrant categories because a variety of factors other than scheduled investigations affect cost allocations. Actual operations typically differ from scheduled work plans due to shifting threats and other operational demands. The future-based option is based on projected work hour data of anticipated scheduled investigations, however, only 3.5% of the workload is directly attributable to scheduled investigations. The remaining 96.5% must be apportioned equally across all registrant categories.

The third option analyzed in the NPRM is called the “Flat Fee Option.” This methodology would result in equal fees across all registrant groups regardless of the proportion of DCP costs and resources the registrant group may require (e.g., oversight and investigation resources). The fee calculation is straightforward: The total amount needed to be collected over the three-year period is divided by the total number of registration fee transactions over the three-year period, adjusting for registrants on the three-year registration cycle.

DEA did not select this methodology because it would result in disparate changes in fees among registrant groups. Under this option, fees for manufacturers and distributors would decrease by 89 percent and 78 percent respectively, while fees for practitioners would increase by 34 percent. Thus, setting the fees at the same level across all registrant groups is not reasonable. DEA registrants include some of the largest corporations in the world although the vast majority of registrants are individual practitioners, such as physicians, physician assistants, dentists, and nurse practitioners. To satisfy the reasonable standard, registration fees should account for differences in regulatory investigations and other DCP costs that vary among the registrant categories.

The fourth methodology evaluated and ultimately selected in the NPRM is the “Weighted-Ratio Option.” This option distinguishes among the categories to establish a reasonable fee for each category. To determine the fee, a weighted ratio is assigned based on registrant group, and the amount needed to be collected over the FY 2012-FY 2014 period to cover the costs of the DCP is divided by the weighted number of estimated registrations.

Historically, costs vary and a fee must be set in advance. Since the inception of registration fees, even before DEA was required to recover the full costs of the DCP, DEA has utilized a weighted method of fee allocation. On April 24, 1971, DEA's precursor agency, the Bureau of Narcotics and Dangerous Drugs, published regulations implementing the Comprehensive Drug Abuse Prevention and Control Act of 1970. Those regulations required registration/reregistration fees in the following amounts: $50 for manufacturers; $25 for distributors; and $5 for dispensers and persons conducting research, instructional activities, or chemical analysis. In 1983, DEA published a NPRM which indicated that a 1982 GAO report found that DEA's previous fees did not adequately recover the costs incurred by the Government. The GAO recommended that DEA set a fee schedule of $250 for manufacturers, $125 for distributors, and $25 for practitioners. DEA, however, ultimately set the fee based on its own estimates as follows: $250 for manufacturers; $125 for distributors, importers, and exporters; and $20 for dispensers and persons conducting research, instructional activities, or chemical analysis. DEA indicated that these estimates were based on “an increase in the number of practitioner registrants since 1980 * * *.” 48 FR 14640.

The first known published discussion which attempted to capture the specific ratio of fees occurred in the Final Rule; Remanded for Further Notice and Comment, published by DEA in 1996. That Final Rule augmented DEA's first fee-setting rule initiated to recover the full costs of the DCP as defined by Congress. It was published in response to a decision by the United States Court of Appeals which required DEA to identify the components of the DCP and provide a brief explanation of why DEA deemed each component to be part of the program. In that Final Rule, DEA stated that the ratio of fees implemented with the CSA in 1971 was as follows: “A distributor's fee is 50% of the manufacturer's fee and a dispenser's fee is 16-20% of the distributor's fee. The fee ratios have remained consistent [since 1971] and have not been the subject of any substantive comment or objection by the regulated industry.” 61 FR 68632. A variation of this ratio has been applied in each fee structure since the implementation of the fee system, usually as expressed above.

The fee structure established by this rule is based on the same ratios that have been utilized since the first amendment to the fee structure, as follows: 1 for researchers, canine handlers, analytical labs, and narcotic treatment programs, who are on a one-year registration cycle; 3 for registrants on three-year registration cycles such as pharmacies, hospitals/clinics, practitioners, teaching institutions, and mid-level practitioners; 6.25 for distributors and importers/exporters; and 12.5 for manufacturers. The ratio of 1 represents a base annual fee by which each ratio is multiplied to determine the total fee per cycle, i.e., one year or three years.

The weighted-ratio methodology, much like the flat fee methodology, is straightforward and easy to understand. Unlike the flat fee, however, this method applies historic weighted ratios to differentiate fees among registrant groups. The fees calculated using this methodology are similar to fees calculated in the past-based option, which allocates three years of historical pre-registration and scheduled investigation costs to registrant groups. This method, however, does not create a disproportionate fee increase in any registrant group. The proposed fee published in the NPRM was calculated using this methodology and resulted in an increase of approximately 33 percent for all registrant groups.

DEA is finalizing the fee schedule using the weighted-ratio methodology as proposed. This approach has been used since Congress established registrant fees and continues to be a reasonable reflection of differing costs. The registration fees under the weighted-ratio option result in differentiated fees among registrant groups, where registrants with higher revenues and costs pay higher fees than registrants with lower revenues and costs. Furthermore, the weighted-ratio avoids the disparity that resulted from the past-based methodology. The weighted ratios used by DEA to calculate the fees have proven effective and reasonable over time. Additionally, the selected calculation methodology accurately reflects the differences in registration and other DCP activities by registrant category. For example, these costs are greater for manufacturers. The weighted-ratio methodology results in reasonable fees for all registrant groups at a level sufficient to ensure the recovery of the full costs of operating the DCP.

DEA received 195 comments on the NPRM published on July 6, 2011, at 76 FR 39318. Of these comments, 121 were from mid-level practitioners (e.g. nurse practitioners, nurse mid-wives, nurse anesthetists, clinical nurse specialist, and physician assistants), 4 were from practitioners, 9 were from associations or corporations and 61 commenters did not identify their registration category.

Comments: The majority of commenters opposed the fee increase on principle or as coming at a bad time due to the economic climate. Some commenters believed it was a tax on practitioners and other registrants.

DEA Response: DEA outlined the legal authority, the history of the fees, the need for an increase in fees, the methodology, and the proposed fee calculation in the NPRM in an attempt to make it transparent why there is a fee, why there is a periodic recalculation, and how the proposed new fee schedule was calculated. Rather than a “tax,” the registration fee is a statutory requirement for those seeking to participate in the closed system of distribution by handling, or having access to, controlled substances or List I chemicals. The fee funds the DCP under the Controlled Substances Act which includes providing and maintaining services to DEA registrants.

One commenter suggested DEA postpone a fee increase until the economy improves and several suggested imposing incremental increases over a period of time. DEA is sensitive to the economic challenges facing many registrants and has endeavored to set the fee as low as possible consistent with its statutory mandates. DEA continually strives to be fiscally responsible. The last fee increase was set in FY 2006 and was designed to encompass only FYs 2006-2008. Through various efforts and cost-saving measures, the DCP has been able to operate under that fee structure through FY 2011. However, DEA cannot further postpone any increase because without an adjustment in the annual registration fees, the DCP will be unable to continue current operations and will be in violation of the statutory mandate that fees charged “shall be set at a level that ensures the recovery of the full costs of operating the various aspects of [the diversion control program.]” 21 U.S.C. 886a(1)(C). For example, collections under the current fee schedule would require the DCP to significantly cut existing and planned DCP operations vital to its mission. DEA relies on the DCP to maintain the integrity of the closed system of distribution, particularly at this time of increased abuse and diversion outlined in the proposed rule.

It is not feasible for DEA to implement an incremental increase while ensuring the recovery of the full costs of operating the various aspects of the DCP, as required by the CSA, and such an increase would not be fair or equitable to registrants. Under the current fee structure, the vast majority of registrants renew their registration once every three years. If DEA were to implement an incremental increase within the three-year cycle, registrants who must renew their registration in the third year of that cycle would pay a substantially higher amount than those registrants who must renew in the first year of the cycle. Additionally, DEA must have reliable collection estimates for budget formulation and execution activities throughout the three-year collection cycle.

Comments: A number of comments suggested that the calculation recognize that other non-federal licensure and registration fees are also increasing.

DEA Response: DEA recognizes there may be other fee increases by states. However, the CSA requires that DEA fees be based on the full costs of operating the various aspects of the DCP.

Comments: Mid-level practitioners expressed the belief that any fee increase is unfair to certain types of registrants, such as mid-level practitioners, who make less money than other types of practitioners.

DEA Response: The fees are on a graduated scale based on the three categories of registration established by statute. Under current authority, DEA has not created additional fee categories or differentiated within a fee category. As discussed, the fees are based on DCP program costs and individual practitioners, regardless of professional occupation, require similar DCP expenditures related to registration and oversight. Furthermore, as outlined in the economic analysis using estimated 2012 average income based on 2004-2009 data provided by the Bureau of Labor Statistics, the fee as a percentage of average income for physicians and dentists is 0.1% and it is 0.26% for physician assistants. These percentages are essentially the same as in 2006, the year of the previous fee adjustment, where the fee as a percentage of average income was 0.1% for physicians and dentists and 0.25% for physician assistants.

Comments: One comment suggested that the length of registration should be extended at the same time there is an increase in the fee.

DEA Response: The statute clearly sets forth the period of registration:

DEA currently allows for the maximum three-year registrations for dispensers of controlled substances, except certain practitioners who dispense narcotic drugs for narcotic treatment, who are statutorily required to obtain annual registrations. 21 U.S.C. 823(g)(1).

Comments: Some commenters indicated that DEA should not raise registration fees but instead decrease its spending, be more efficient with the fees it currently collects or find another source of funds. One commenter questioned whether increased funding would improve the effectiveness of the DCP.

DEA Response: By statute, DEA cannot use another source of funds for the DCP. By enacting 21 U.S.C. 886a, Congress mandated that the DCP be fully funded through the collection of fees rather than appropriated funds. The CSA specifically states that “[f]ees charged by the Drug Enforcement Administration under its diversion control program shall be set at a level that ensures the recovery of the full costs of operating the various aspects of that program.” 21 U.S.C. 886a(1)(C).

It has been more than five years since the last fee adjustment. DEA last adjusted the fee schedule in August 2006, and that fee schedule was intended to be sufficient to cover the “full costs” of the DCP for FY 2006 through FY 2008. The DCP has continued to operate under this fee schedule due to cost savings through reorganization, modernization efforts, and by delays in execution of planned programs. As indicated by the above-referenced 2008 OIG report, additional salary and other costs attributable to diversion control activities needed to be incorporated into the DCP as was done in this fee calculation. In addition, Congress has expanded the scope of the DCP through budgetary and legislative action in order to address an increase in the diversion of controlled substances and listed chemicals that seriously impact public health and safety.

DEA has been and will continue to be fiscally responsible and will remain vigilant towards identifying methods to improve efficiencies or identifying other cost saving measures. As discussed, the DCP has been evaluated by the OIG and it did not find that DCFA funds were misused. As noted earlier, the OIG found that DEA did not fully fund all diversion control costs with the DCFA as required. 25 The DCP plans to continue cost-saving technology improvements in doing business and to implement such improvements for those that do business with the DCP through its regulatory functions such as registration and reporting systems.

The DCP exercises a variety of management controls, including independent review of certain DCFA expenditures. This is accomplished by the Validation Unit which was established in 2003 to review DCFA expenditures of $500 or more to ensure that each expense is in support of diversion-related activities. DEA continues to evaluate the appropriate mix of management controls. The costs to the DCP associated with additional review of expenditures must be balanced against the risks of error. DEA may adjust the expenditure threshold level for review and validation up to $2,500 to adjust the review process and reduce the associated costs to the DCP. The DCP will continue to provide managerial oversight on expenditures involving DCFA funds to include oversight by agency managers and by the Validation Unit.

The DCP is expanding its use of Tactical Diversion Squads and is conducting more investigations, inspections, and scheduling actions now than ever before due to the increase in prescription drug abuse and the corresponding efforts to divert such substances to illicit use. Similarly, an ever expanding number of synthetic substances, such as synthetic cannabinoids (a large family of chemically unrelated structures functionally similar to [Delta]9-tetrahydrocannabinol (THC), the active principle of marijuana) and synthetic cathinones (drugs of the phenethylamine class which are structurally and pharmacologically similar to amphetamine and other related substances, and are commonly falsely marketed as bath salts or plant food) require the DCP to dedicate resources to analyze and respond to new and emerging threats more often now than at any time in the past to protect the public health and safety.

The DCP also establishes and maintains various IT systems for use by registrants. These systems result in cost savings and help both DEA and the registrants perform day-to-day functions more efficiently.

Comments: One commenter felt DEA appropriations and not DCP funds should be used to pursue illicit entities operating via the internet and “pill mills” since they are the major sources of controlled substance abuse and diversion.

DEA Response: DEA must set fees at a level that ensures the recovery of the full costs of operating the various aspects of the DCP. 21 U.S.C. 886a(1)(C). As discussed above under the History of Fees, the fees are for the “registration and control” of the manufacture, distribution, and dispensing as well as importing and exporting of controlled substances and listed chemicals. 21 U.S.C. 821 and 958(f). The “control” of controlled substances and listed chemicals includes enforcement costs where the DCP carries out the mandates of the Controlled Substances Act. In doing so, the DCP may investigate the diversion of controlled substances regardless of the method or source of diversion, including illicit operations involving the internet and “pill mills.”

Comments: Several commenters requested more specificity on what the fee increase will support.

DEA Response: A supplemental document titled the Proposed Fee Calculation, located with the NPRM on www.regulations.gov, and an updated version of this document titled New Registrant Fee Schedule Calculations, posted with this final rule, also on www.regulations.gov, outline specific costs of the DCP used in calculating the fee. As discussed in the NPRM and above, the DCP is defined as “the controlled substance and chemical diversion control activities of the Drug Enforcement Administration.” 21 U.S.C. 886a(2)(A). The term “controlled substance and chemical diversion control activities” is defined as “those activities related to the registration and control of the manufacture, distribution, dispensing, importation, and exportation of controlled substances and listed chemicals.” 21 U.S.C. 886a(2)(B). Additionally, detailed program costs may be found in the annual President's Budget, as well as supporting budget documents released on the Department of Justice's Web site at http://www.justice.gov/about/bpp.htm . See in particular pages 97-101 of the FY 2012 DEA budget.

Comments: One registrant recommended that DCP funds be better used to provide for adequate staffing for the DCP functions involving quota requests, scheduling determinations, and policy and regulatory interpretations in order to be more responsive to the regulated community.

DEA Response: DEA continuously monitors and adjusts the number of employees assigned to various DCP tasks, including those that respond to inquiries from the registrant community. The DCP maintains a robust public Web site that is continually updated with information on topics of interest to registrants such as administrative final orders, significant guidance documents, “questions and answers” on common topics, registration tools and resources, and registrant reporting requirements. The Web site is intended to alleviate the burden of responding to multiple inquiries regarding similar or common topics, and to communicate new policies and/or views to registrants. The DCP regulates a registrant population of approximately 1.4 million that continues to grow every year, and each written inquiry requires a thorough review of the pertinent facts in order to provide a fair, measured response. While awaiting a response from the DCP, registrants are encouraged to review the DCP Web site for information and guidance, and to seek assistance from their local DEA offices and state licensing bodies. The DCP also organizes regional conferences designed to provide information and resources to registrants. Finally, all quota requests are scrutinized in detail and the supplemental information provided by quota applicants is verified and cross-checked in order to ensure the DCP is fulfilling all of its statutory obligations. The volume of quota applications and the level of review required for an appropriate assessment is time consuming. Accordingly, DEA is undertaking a comprehensive review of its quota regulations pursuant to Executive Order 13563 with the goal of updating and streamlining the quota application process.

Comments: Several comments stated that any fee increase is unfair to persons who do not prescribe controlled substances but are required by an employer or an insurance company to maintain a DEA registration. Similarly, some allege that many registrants are not reimbursed for their payment of the registration fee by their employer or that fewer reimbursements occur than in the past.

DEA Response: DEA issues registrations to practitioners for the purpose of prescribing or dispensing controlled substances. DEA does not control or otherwise have authority over requirements by outside entities such as insurance companies or employers. Furthermore, DEA expends resources to review applications to determine qualifications, and it expends resources to maintain registrations once they are issued. As such, DEA cannot consider the underlying reasons registrants apply for a registration, other than those related to the handling of controlled substances, nor can DEA consider whether a particular registrant is reimbursed for the fee.

Comments: Other comments stated that any fee increase is detrimental to persons with registrations in multiple states. Another commenter suggested that a DEA number should be assigned to a provider throughout their career, regardless of their practice location.

DEA Response: By statute, “[a] separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or List I chemicals.” 21 U.S.C. 822(e). Thus, some registrants, based upon their particular circumstances and business decisions, may have more than one registration within the same state or in multiple states where more than one state has authorized the registrant to conduct the above described activities. Registration is an essential component of the closed system of distribution established under the CSA and is predicated on compliance with all applicable state and local laws, including state licensure in each state the registrant practices.

Comments: A number of commenters focused on situations where one person may be more impacted by the fee increase than another, such as persons working in low-income areas where there is little or no reimbursement for registration fees, persons working in rural areas, and persons in sole practice or in small practices. Several commenters expressed concern that fee increases will affect patient care as some registrants may not renew or seek to register because of the cost.

DEA Response: DEA may only operate within its statutory authority, which requires that the fees be set at a level that ensures the recovery of the full costs of operating the DCP. DEA notes that there are currently 1.4 million active registrants and, as such, even if business model or size of practice could be objectively measured and accounted for in individualized fee calculations, such individual calculations would be costly. It is likely that any cost savings would be offset by the increased need for personnel to perform the individual fee calculations. It should also be noted that historically, DCP costs are higher for rural areas because of the additional travel costs from DEA office locations. Each applicant for registration must evaluate their need to be able to handle controlled substances or listed chemicals.

Comments: One commenter suggested that those state, federal, and tribal organizations that are exempt from payment of the fee should be required to pay a fee before the current fee is increased.

DEA Response: Registration fee exemptions are set forth in the existing regulations. Generally, hospitals and other institutions operated by an agency of the United States or of any state or any political subdivision or agency thereof, as well as any individual required to obtain a registration in order to carry out his or her duties as an official of an agency of the United States or of any state or any political subdivision or agency thereof may be exempt from payment of a registration or reregistration fee. 21 CFR 1301.21. Such an individual is not exempt if his/her registration is used for appropriate private activities unrelated to the performance of his/her official duties. Tribal governments are also exempt pursuant to the Indian Health Care Improvement Act of 2010. 26 DEA is committed to carefully reviewing all applications for fee exempt status to ascertain that such exemptions are not inappropriately granted. Approximately 96,000 individual and institutional registrants, or 7% of all registrants, are exempt from registration fees.

Comments: Some commenters suggested that persons who over-prescribe or violate the law should be charged additional fees and penalties to help make up any shortfall in collections. Likewise, it was suggested that the end users of controlled substances be charged an additional fee. Others suggested that DEA legalize “agriculture-based controlled substance production” to either decrease costs or charge a fee to fund the DCP.

DEA Response: DEA has no authority to implement these suggestions. DEA's statutory authority is to charge reasonable registration fees set at a level that ensures the recovery of the full costs of operating the various aspects of the DCP. In addition, the CSA provides for mechanisms independent of the registration fee by which to exact financial remuneration from registrants who violate the law. Registrants who violate the law with regard to controlled substances may be subject to civil and criminal penalties, as well as forfeitures. 21 U.S.C. 841, 842, 843, 881.

Comments: Some commenters suggested that the fee should be based on the rate of prescribing of controlled substances or pro-rated to the salary of the prescriber or based on the registrant's number of Medicaid and Medicare patients.

DEA Response: DEA does not have access to the controlled substance prescribing rates of practitioners. In fact, many states with prescription drug monitoring programs prohibit law enforcement entities from using prescribing data without specific, independent legal authority to do so, e.g., a subpoena or warrant. Even so, DEA does not have the expertise or resources to calculate the rate of prescribing for each registrant in order to personalize each registrant's registration fee. Additionally, allowing individualized calculations based on prescribing rates, income, or type of patients served would introduce uncertainty and unpredictable fluctuations in the collection cycle, thereby jeopardizing the statutory mandate to recover the full costs of operating the DCP.

Comment: One association felt DEA fails to recognize the unfairness of the “Weighted-Ratio” methodology for fee calculation because dispensers or practitioners make no income from writing a prescription whereas manufacturers and distributors more directly benefit from their authorization by registration to handle controlled substances. This commenter believed the difference in annual revenue or income for a practitioner compared to a manufacturer or distributor was more than the 9 times ratio for distributors and the 12 times ratio for manufacturers.

DEA Response: It is important to emphasize that the focus of DEA's fee calculation methodology is to account for DCP program costs among the registrant categories and not to set fees according to a percentage of registrant revenue from use of a DEA registration. DEA provided an analysis of incomes to show the economic impact of the relatively minor proportion of that income that may be expended for payment of a registration fee. Additionally, the analysis showed that the fees as percentages of income/revenue are essentially the same as in 2006, the year of the last fee adjustment.

As discussed in the NPRM, DEA last adjusted the fee schedule in August 2006. This fee schedule was calculated to cover the “full costs” of the DCP for FY 2006 through FY 2008 or October 1, 2005 through September 30, 2008. However, collections did not begin until FY 2007. 27 The DCP program has continued to operate under this fee schedule due to cost savings through reorganization and modernization efforts and by inadvertently excluding certain costs from the DCP. As indicated by the above-referenced 2008 OIG report, additional salary and other costs attributable to diversion control activities need to be incorporated into the DCP. In addition, the scope of the DCP has been expanded by Congress and by the need to address the diversion of controlled substances and listed chemicals that seriously impact public health and safety.

The Office of Diversion Control at DEA is focused on the supply side of this serious threat to the public health and safety. At the end of FY 2008, a reorganization within DEA expanded the use of Tactical Diversion Squads across the country to allow Diversion Investigators to focus their expertise on regulatory oversight, thereby increasing the deterrent effect of increased regulatory investigations. Tactical Diversion Squads incorporate the criminal investigative skills and statutory authority of Special Agents as well as state and local Task Force Officers in an effort to stop those organizations and individuals who violate the CSA by diverting controlled substances and listed chemicals into the illicit market. Diversion Investigators are a key asset as they lend their keen knowledge of the closed system of distribution to the Tactical Diversion Squads. Diversion Investigators' familiarity and detailed understanding of the closed system of distribution require, however, that they continue to lead the regulatory oversight of DEA registrants. DCP costs increase with the need to expand the number and use of Tactical Diversion Squads.

Due to the rise in controlled substance diversion and abuse, as well as the recent emergence of designer drug abuse, the DCP has increased scheduled investigations of registrants and drug scheduling initiatives, as well as other modifications in its diversion control efforts. The DCP continues to draw technical expertise from Diversion Investigators, and the DCP has incorporated greater numbers of Special Agents, Chemists, Information Technology Specialists, Attorneys, Intelligence Research Specialists, and state and local personnel. It is essential to utilize a diverse skilled workforce and constantly review and modify all aspects of the DCP to help successfully execute the drug trafficking disruption goals of the National Drug Control Strategy and effectively prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring a sufficient supply of these substances for legitimate medical, scientific, research, and industrial purposes.

DEA has been and will continue to be fiscally responsible and will remain vigilant in identifying methods to improve efficiencies or identifying other cost saving measures. As discussed above, however, a new fee calculation is needed. Without an adjustment in the annual registration fees, DEA will be unable to continue current operations and will be in violation of the statutory mandate that fees charged “shall be set at a level that ensures the recovery of the full costs of operating the various aspects of [the diversion control program].” 21 U.S.C. 886a(1)(C). For example, in FY 2009, the DCP's regulatory activities included more outreach programs to help the registrant population better comply with the CSA. The DCP increased investigation cycles as well as depth of review. In FY 2009, there were 1,065 scheduled investigations; in FY 2012, DEA projected performance targets of 3,906 scheduled investigations—an increase of 2,841. Additionally, DEA coordinates National Prescription Drug Take-Back Day initiatives, providing an opportunity for the safe disposal of unwanted or unused prescription drugs. DEA also projects to increase the number of Diversion Priority Target Organizations not Linked to Consolidated Priority Organization Targets Disrupted or Dismantled to 85 (disrupted)/90 (dismantled), an increase of 32 (disrupted)/66 (dismantled) over FY 2007's 53 (disrupted)/24 (dismantled), and is authorized and plans to establish an additional 12 Tactical Diversion Squads, which conduct criminal enforcement activities, across the United States. The new fee schedule will allow DEA to sustain current, planned, and future operations and employ additional personnel in support of important program initiatives during Fiscal Years 2012-2014.

DEA must ensure the recovery of the full costs of operating the DCP while charging registrants reasonable fees relating to the registration and control of the manufacture, distribution, import, and export of controlled substances and listed chemicals, as well as the dispensing of controlled substances. For the DCP to have funds to function, DEA must determine, in advance of actual expenditures, a reasonable fee to be charged. As a result, historical data and projections must be used to project the annual costs of the DCP. Additionally, a reasonable fee must be calculated that will fully recover the costs of the DCP based on the variability over time of the number of registrants in the different categories of registration. The fees collected must be available to fully fund the DCFA and to reimburse DEA for expenses incurred in the operation of the DCP (21 U.S.C. 886a); therefore, there must always be more collected than is actually spent to avoid running a deficit in violation of federal fiscal law. 28 In operating the DCP, DEA must be prepared for changes in investigative priorities, diversion trends, and emerging drugs and chemicals posing new threats to the public health and safety.

Current options to calculate fees are also limited by the ability and practicability of tracking and allocating detailed costs, although the agency continues to improve its capabilities on this front. Part of the difficulty stems from the fact that the mission of DEA involves investigations and actions that often involve poly-drug organizations (drug trafficking organizations that traffic multiple drugs), various types of registrants, or investigations that may start out as one type of investigation and result in another, based upon the way the facts develop. It is apparent that Congress recognized that the costs of the registration and control of controlled substances and listed chemicals are not properly attributed on a per registrant basis when Congress differentiated among the categories of registrants for purposes of calculating a reasonable fee, i.e., manufacturers, distributors, importers, exporters, and dispensers. The weighted ratio of 12.5 for manufacturers, 6.25 for distributors (including importers and exporters), and 1 for dispensers is consistent with Congress's differentiation between the categories of registrants.

Because of the complexity of many diversion investigations, tracking costs within the DCP according to registrant categories or within a given registrant category has not been possible or cost-efficient. Such detailed cost attribution may or may not be feasible in the future. DEA is in the process of testing a system where personnel would account for their daily hours according to whether their time is spent on DCP or other DEA mission activities. DEA has also made progress through reorganization and there is recognition throughout the agency of the need to identify and separate DCP costs from other agency costs.

Thus, the fee is calculated by assigning registrants to a business activity or category ( e.g., researcher, practitioner, distributor, manufacturer) based on the statutory fee categories. Then a base fee rate is established according to the annual estimated costs of the DCP. A projected population is calculated for each business activity or category. That figure is then multiplied by a ratio of 1.0 for researchers, 3.0 for practitioners (for administrative convenience the fee is collected every three years for practitioners), 6.25 for distributors, and 12.5 for manufacturers. By utilizing these different ratios, the agency recognizes the statutory need to charge reasonable fees relating to the registration and control of the manufacture, distribution, dispensing, importation, and exportation of controlled substances and listed chemicals. Historically, registration and other DCP activities are greatest for manufacturers. This is because there is great risk and grave consequences associated with the quantity and purity of controlled substances and/or chemicals with each manufacturer at this point in the closed system. All of the individual business activity figures are then added together to form a weighted sum for one projected year. This process is performed for two more years using future projected registrant populations for those years multiplied by the ratio. The annual figures for these three years are then added together and divided into the total budget requirements for that three-year period to arrive at the base rate fee to be charged to each category of registrant.

In calculating fees to recover the full costs of operating the DCP, DEA estimates the costs of operating the DCP for the next three fiscal years. 29 To develop the DCFA budget estimates for Fiscal Year (FY) 2012, FY 2013 and FY 2014, DEA compiles: (1) The actual DCFA financial data for FY 2011; (2) the FY 2012 President's Budget Request; (3) the estimated budgets for FY 2013 and FY 2014; and (4) the required annual $15 million transfer to the United States Treasury as mandated by the CSA (21 U.S.C. 886a). The following paragraphs explain the annual revenue calculations and how the total amount to be collected for the FY 2012-2014 period was calculated. In developing this figure, DEA begins with annual projected DCP obligations, including payroll, operational expenses and necessary equipment. The DCP budget has increased due to inflationary adjustments for rent and payroll and to increase staffing resources that support the regulatory and law enforcement activities of the program. These additional costs have not been reflected in the fees until now because the fees were last adjusted for the time period of FY 2006-2008. Specific details on the DCP budget are available in the annual President's Budget Submission and supplemental budget justification documents provided to Congress. 30

Total obligations for the DCP have increased from FY 2007 to FY 2010 by approximately 49 percent. For the FY 2006-2008 period, payroll expenses (staff compensation and benefits) composed the largest component of DCP costs at 55.7 to 57.6 percent per year. Between the period of FY 2006 and FY 2010, payroll constituted an average of 56.7 percent of DCP expenses. Operating expenses and capital expenditures made up the remainder of DCP costs. Operating expenses (an average of 39.3 percent for the FY 2006-2010 period) include daily operation costs such as investigative costs, travel, and purchases of goods and services. Capital expenditures, including equipment and furniture purchases, capital leases, and land/structure improvements and purchases, averaged 4.0 percent during this same period.

For the FY 2012-2014 period covered by this rulemaking, the overall breakdown of DCP major cost categories does not depart significantly from previous years in terms of percentage of costs; however, totals for each of these major cost categories do increase to reflect additional costs in each of these categories.

In addition to the budget estimates for each of the fiscal years, the cost components outlined below are also considered in determining required registration fee collections.

At times, DEA enters into an obligation to purchase a product or service that is not delivered immediately, such as in a multi-year contract. Changes in obligations can occur for a variety of reasons, e.g., changes in planned operations, delays in staffing, implementation of cost savings, changes in vendor capabilities, etc. When DEA does not expend its obligation, the “deobligated” funds are “recovered” and the funds become available for DCP use. Based on historical trends and for purposes of calculating the fee levels, the recovery from deobligation of prior year obligations is estimated at $13.5 million per year.

As discussed, in 1993, Congress determined that the DCP would be fully funded by registration fees rather than by appropriations. 31 Congress established the DCFA as a separate account of the Treasury to “[ensure] the recovery of the full costs of operating the various aspects of [the diversion control program]” from fees charged by DEA. 21 U.S.C. 886a(1)(C). Collected fees are deposited into the DCFA. Each fiscal year, the first $15 million is transferred to the Treasury and is not available for use by the DCP. Therefore, DEA needs to collect an additional $15 million per year beyond estimated costs for transfer to the Treasury.

DEA maintains an operational continuity fund (OCF) based on the need to maintain DCP operations when monthly collections and obligations fluctuate. Historically, current obligations sometimes exceed current collections consecutively for several months. Therefore, an operational continuity fund is maintained in order to avoid operational disruptions due to these fluctuations and monthly differences in collections and obligations. Using statistical analysis of the historical fluctuations between amounts collected and amounts obligated, DEA has determined that seven percent of the projected obligations is adequate to avoid operational disruptions. The amount required to bring the operational continuity fund balance to the $15 million plus seven percent level is added to projected costs.

The FY 2012-FY 2014 OCF balance projections have been changed from those shown in the NPRM to reflect actual FY 2011 financial data. The FY 2012 beginning OCF balance of $41,726,554 is higher than the FY 2014 end of year target OCF balance of $40,943,670 by $782,884. The higher beginning OCF balance allows lower required collections from registration fees. The incremental changes in OCF balance for FY 2012, FY 2013, and FY 2014 are −$2,047,144, $863,240, and $401,020 respectively (or a cumulative decrease of $782,884). The cumulative decrease of $782,884 is a change from the cumulative increase of $8,320,115 estimated in the NPRM. The two main factors that contributed to the change from the NPRM calculation estimated in early 2011 to the final rule calculation performed after the end of FY 2011 (September 30, 2011) are: (1) Lower than estimated actual FY 2011 spending which led to a higher beginning FY 2012 OCF balance; and (2) lower estimated budgets for FY 2013 and FY 2014, which lowered the target OCF balance.

Under the CMEA, DEA collects a self-certification fee for regulated sellers of scheduled listed chemical products, which is included as part of the total collections. The fee is waived for any person in good standing and holding a current DEA registration to dispense controlled substances, such as a pharmacy. DEA has observed an approximately 26 percent decline in self-certifications from FY 2008 to FY 2011 and anticipates that the decline will stabilize at approximately 5,000 per year from FY 2012 to FY 2014. The self-certification fee is $21. CMEA self-certification fee collection estimates for FY 2012, FY 2013, and FY 2014 for purposes of calculating the fee levels are $105,000 annually.

DEA also derives revenue from the sale/salvage of official government vehicles dedicated to DCP use. DEA's estimate for all other collections is $533,766 per year. This is the actual amount for FY 2011.

Based on these figures, DEA calculated the total amount required to be collected for the FY 2012-2014 period for purposes of calculating the fee levels as follows:

Required registration fee collections for FY 2012 are $320,814,090. This figure includes the budget of $322,000,000, plus $15 million for transfer to the Treasury, minus $13.5 million in recoveries, $2,047,144 for the decrease in the OCF balance, $105,000 in CMEA self-certification collections, and $533,766 in other collections.

Required registration fee collections for FY 2013 are $354,287,474. This figure includes the estimated budget of $352,563,000, plus $15 million for transfer to the Treasury and $863,240 for the increase in the OCF balance, minus $13.5 million in recoveries, $105,000 in CMEA self-certification collections, and $533,766 in other collections.

Required registration fee collections for FY 2014 are $366,157,254. This figure includes the estimated budget of $364,895,000, plus $15 million for transfer to the Treasury and $401,020 for the increase in the OCF balance, minus $13.5 million in recoveries, $105,000 in CMEA self-certification collections, and $533,766 in other collections.

In total, DEA needs to collect $1,041,258,818 in registration fees over the three year period, FY 2012-FY 2014, to fully fund the DCP.

As in the past, DEA is calculating the fee for each registrant category for a three-year period (FY 2012-2014). The vast majority of registrants are practitioners who pay a three-year registration fee. These registrants are divided into three separate groups who pay their three-year registration fees on alternate year cycles. Because registration cycles may differ from year to year, the total amount collected through fees in a given year may not exactly match the projected amount. For purposes of calculating the new fee schedule, DEA used a new fee collection start date of March 1, 2012, and used the current fee schedule for calculating the first five months of FY 2012 registration fee collections.

In calculating the new fees through FY 2014 using the selected weighted-ratio methodology, DEA has updated the data used in the calculation set forth in the proposed rule. Instead of budget estimates for FY 2012, 2013, and 2014, the final fee calculation uses the actual FY 2012 budget, revised budget estimates for FY 2013 and FY 2014, and revised estimates for recoveries from deobligations and for the Operational Continuity Fund. These revisions are outlined in the overview of the Diversion Control Fee Account below:

Based upon careful consideration of all of the comments and applying the above, a new fee schedule is set forth below. This new fee schedule is slightly less than the fee schedule proposed in the NPRM on July 6, 2011, due to the completion of FY 2011 and the availability of actual financial data for the fiscal year as well as progression in the budget process due to the passage of time since the NPRM was prepared.

This fee schedule replaces the current fee schedule for controlled substance and chemical registrants in order to recover the full costs of the DCP so that it may continue to meet the programmatic responsibilities set forth by statute, Congress, and the President. As discussed, without an adjustment to fees, the DCP will be unable to continue current operations, necessitating dramatic program reductions, and possibly weakening the closed system of distribution. Particularly in light of increased needs for diversion control and demands upon the DCP outlined in the NPRM, the following fees for the FY 2012-2014 period will be effective April 16, 2012.

DEA continues to review possible methodologies as technology continues to afford increased tracking and allocation of specific costs. However, at this time, DEA has determined that it is both practicable and reasonable to continue to apply the weighted-ratio methodology. Consistent with the statutory direction to charge reasonable fees relating to the registration and control of the manufacture of controlled substances and listed chemicals, the 12.5 ratio is applied to the manufacturing registrant group. The 6.25 ratio applies to the “distribution” of controlled substances and listed chemicals, or the distributor registrant group. The “dispensing” registrant group has the largest number of registrants and each registrant has a relatively low registration and control cost, and a relatively smaller quantity and lower purity of controlled substances within their physical possession. Thus, the base fee, or the 1 ratio, is applied to the dispensing registrant group. The practitioner fee is the base fee on an annual basis but is collected every three years for administrative convenience.

Thus, the new fees, some of which are paid annually and some of which are paid every three years, range from $244 for ratio 1 to $3,047 for ratio 12.5, depending upon the particular registrant category. Specifically, the annual registration fee for practitioners, mid-level practitioners, dispensers, researchers, and narcotic treatment programs is $244. For administrative convenience for both the collection and the payment, practitioners will pay a combined registration fee of $731 every three years. The annual registration fee for distributors, importers, and exporters is $1,523, and for manufacturers the annual fee is $3,047. 21 CFR 1301.13 and 1309.11.

DEA continually reviews the DCP and its methods of operation to ensure that it is fiscally responsible. The DCP works diligently to provide the registrants with cost effective and state-of-the-art means for complying with laws and regulations related to manufacturing, distributing, dispensing, importing, and exporting controlled substances and listed chemicals. Some examples of this include online registration, the Controlled Substance Ordering System (CSOS) for electronic controlled substance ordering between registrants, and electronic reporting of thefts and significant losses of controlled substances.

DEA takes seriously its responsibilities to manage the DCP in an efficient and effective manner, particularly in light of the current economy. DEA cannot foresee Congressionally-mandated changes to the DCP, emerging trends, or how such trends may impact the DCP, but it is committed to managing in a fiscally responsible manner. The Office of Diversion Control is committed to reviewing the registration process to ensure efficiency and accountability as well as reviewing current regulations related to fee exempt registrants.

In updating the number of registrants since the NPRM and the proposed fee calculation, there is a slight increase, with a total of 1,407,119 controlled substances and listed chemical registrants as of August 2011 (1,406,021 controlled substances registrants and 1,098 chemical registrants), as shown in Table 10.

Not all registrants listed in Table 10 are subject to the fees. Publicly owned institutions, law enforcement agencies, the Indian Health Service, the Department of Veterans Affairs, Federal Bureau of Prisons, and military personnel are exempt from fees.

The number of registrations exceeds the number of individual registrants because some registrants are required to hold more than one registration. The CSA requires a separate registration for each location where controlled substances are handled and a separate registration for each business activity; that is, a registration for activities related to the handling of controlled substances and a registration for activities related to the handling of List I chemicals. Some registrants may conduct multiple activities under a single registration ( e.g., manufacturers may distribute substances they have manufactured without being registered as a distributor), but firms may hold multiple registrations for a single location. Individual practitioners who prescribe, but do not store controlled substances, may use a single registration at multiple locations within a state, but need separate registrations for each state in which they prescribe controlled substances.

This rule affects those manufacturers, distributors, dispensers, importers, and exporters of controlled substances and List I chemicals that are required to obtain and pay a registration fee with DEA pursuant to the CSA (21 U.S.C. 822 and 958(f)). As of August 2011, there was an increase of registrants from December 2010, with 1,407,119 controlled substances and List I chemical registrants (1,406,021 controlled substances registrants and 1,098 List I chemical registrants), as shown above in Table 10.

Pharmacies, hospitals/clinics, practitioners, teaching institutions, and mid-level practitioners comprise 98.9 percent of all registrants. These registrants register every three years. Other registrants maintain an annual registration. Registration and reregistration costs vary by registrant category as described in more detail in the sections below.

The fees affect a wide variety of entities. Table 11 indicates the sectors affected by this rule and their average annual revenue/income. Most DEA registrants are considered small entities under Small Business Administration (SBA) standards. There are 1,309,275 registered practitioners and mid-level practitioners as of August 2011, and almost all practitioners are considered small (annual revenues of less than $6 million to $8.5 million, depending on specialty).

Supermarkets, discount stores, warehouse clubs, and superstores handle controlled substances through their distribution centers and pharmacies. Drug products containing List I chemicals are primarily distributed as over-the-counter medicines. These are distributed by drug wholesalers who specialize in non-prescription drugs, wholesalers who supply convenience stores, and grocery, pharmacy, and discount stores that operate their own distribution centers.

This fee is expected to have two levels of impact. Initially, the fee adjustment will impact the registrants. Then the fee or portion of the fee increase may be passed on to the general public. The analysis below assumes that the impact of the fee adjustment is absorbed entirely by the registrants. Some commenters have confirmed this statement and have indicated some registrants may decide not to renew their registration as a result of the higher fees.

The registration fee may be a deductible business expense for some registrants. As a result, the increase in the fee may be dampened by reduced tax liability as a result of the increase in registration fee expense. For example, if a practitioner pays an additional $60 per year in registration fees and the combined federal and state income tax is 35 percent, the net cash impact is $39, not $60. The additional $60 causes income/profit to decrease by $60, decreasing the tax liability by $21. The net cash outlay is $39. 32

DEA examined the new fees as a percentage of income for physicians, dentists, and physician's assistants in the practitioner registrant group and as a percentage of revenue for pharmacies, manufacturers, and distributors. This analysis indicates the fee adjustment is expected to have the greatest effect on small businesses in the practitioner registrant group. The majority of practitioners work in small businesses. Physicians, dentists, and physician's assistants reflect a representative sub-group of the practitioner registrant group. The effect of the fee increase is diminished by any increase in registrant income.

The table below describes the average income for physicians, dentists, and physician's assistants from 2004 to 2012, and reflects the impact of the fee as a percentage of average income. This analysis assumes that the fee is absorbed personally by each practitioner and is not passed on to customers in such forms as higher prices for medical services or products. The analysis also ignores the dampening effect of registration fees as a potentially deductible business expense.

In 2007, the current fee of $184 on an annual basis represents 0.119 percent, 0.125 percent, and 0.237 percent of annual income for physicians, dentists, and physician's assistants respectively. In 2012, the new fee of $244 (on an annual basis) would represent approximately 0.125 percent, 0.139 percent, and 0.258 percent of annual income for physicians, dentists, and physician's assistants respectively. While the new fee is approximately 33 percent above the current fees implemented at the end of 2006, average incomes for physicians, dentists, and physician's assistants have increased 26 percent, 19 percent, and 22 percent respectively over the same period. This estimated increase in average income dampens the effect of the fee increase as a percentage of average income. The diminishing effect is more apparent when comparing 2012 to 2006, the year for which the current fee was calculated and implemented. Additionally, as the average income grows in 2013 and 2014, the income adjusted fees are not any higher than in recent history.

Exempt from the payment of registration fees is any hospital or other institution that is operated by an agency of the United States, of any state, or of any political subdivision or agency thereof. Likewise, an individual who is required to obtain a registration in order to carry out his/her duties as an official of a federal or state agency is also exempt from registration fees. 34 Fee exempt registrants are not affected by the new fees.

DEA concludes that this new fee schedule is not an economically significant regulatory action because it does not result in a materially adverse effect on the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities. 35 The new fee will initially affect all fee paying registrants. The fees may eventually be passed on to the general public, diminishing the impact of the fee adjustment on individual registrants. The impact of the fee on registrants may also be diminished by a reduction in tax liabilities and an increase in average income. Additionally, hospitals and institutions operated by federal, state, or local governments, and their employees are exempt from registration fees. 36 Moreover, DEA believes that this final rule will enhance the public health and safety.

This final rule is necessary to ensure the full funding of the DCP through registrant fees as required by 21 U.S.C. 886a. It has been five years since the last fee change. As discussed above, statutory and operational changes to the DCP cannot be fully offset by improved operational efficiencies and require a recalculation of registrant fees. This rule does not change the requirement to register to handle controlled substances and/or List I chemicals but rather changes the annual fee associated with registration and reregistration that will allow DEA to meet its statutory obligations. DEA recognizes that the fee changes affect small businesses, but does not believe the relative individual impact is significant. The average annual increase in estimated registration fee collections is less than $100 million at an estimated annual increase of $76,226,568.

This rule will not impose additional information collection requirements on the public.

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) (RFA), federal agencies must evaluate the impact of rules on small entities and consider less burdensome alternatives. DEA has evaluated the impact of this final rule on small entities as summarized above and concluded that although the rule will affect a substantial number of small entities, it will not impose a significant economic impact on any regulated entities.

In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Deputy Assistant Administrator hereby certifies that this rulemaking has been drafted consistent with the Act and that a regulatory analysis on the effects or impact of this rulemaking on small entities has been done and summarized above. 37 While DEA recognizes that this increase in fees will have a financial effect on registrants, the change in fees will not have a significant economic impact. A change in fees is necessary to fully comply with 21 U.S.C. 886a and related statutes governing the DCP and the Diversion Control Fee Account by which DEA is legally mandated to collect fees to cover the full costs of the DCP as defined by all activities relating to the registration and control of the manufacture, distribution, import, export, and dispensing of controlled substances and listed chemicals.

This rule is not a discretionary action but implements statutory direction to charge reasonable fees to recover the full costs of activities constituting the DCP through registrant fees (21 U.S.C. 821, 886a, and 958(f)). As discussed above and in the Economic Impact Analysis of the Final Rule found in the rulemaking docket at www.regulations.gov, DEA analyzed four fee calculation methodologies—Past-Based, Future-Based, Flat Fee, and Weighted-Ratio. DEA selected the weighted-ratio methodology to calculate the new fee structure. This approach has been used since Congress established registrant fees and continues to be a reasonable reflection of differing costs. Furthermore, the weighted-ratio does not create a disparity in the relative increase in fees from the current to the new fees. The weighted-ratios used by DEA to calculate the fee have proven effective and reasonable over time. Additionally, the selected calculation methodology accurately reflects the differences in activity level, notably in pre-registration and scheduled investigations, by registrant category—for example, these costs are greatest for manufacturers. DEA selected this option because it is the only option that resulted in reasonable fees for all registrant groups.

Under the weighted-ratio methodology, the individual effect on small business registrants is minimal. Practitioners represent 93 percent of all registrants, and nearly all practitioners are employed by small businesses pursuant to SBA standards. Practitioners will pay a three-year registration fee of $731 or the equivalent of $244 per year.

For consideration of the impact of the fee on small businesses, DEA analyzed the new registration fee as a percentage of annual income for a representative practitioner group: physicians, dentists, and physician's assistants. While there are many specialists listed in the Bureau of Labor Statistics income data, incomes for physicians, dentists, and physician's assistants are representative of the practitioner registrant group. For practitioners, the new fee, on an annual basis, would be $244; the annual increase would be $60 from the current fee. From the calculation performed in the preceding section, Economic Impact Analysis of Final Rule, the impacts of the new fees, $60 per year increase from current fees, were found to be 0.007 percent, 0.014 percent, and 0.022 percent (rounded to the third decimal) of annual income for physicians, dentists, and physician's assistants respectively, when normalized for income increases. In consideration of the calculated impact and potentially further mitigating factors discussed in the Economic Impact Analysis of Final Rule, DEA concludes that the final rule will not have a significant economic impact on a substantial number of small entities.

This final rule increasing registrant fees has been developed in accordance with the principles of Executive Orders 13563 and 12866. Supporting information may be found at www.regulations.gov. The difference between the current fee and the new fee—the fee increase—is less than $100 million annually. Specifically, the difference in the fees projected to be collected under the current fee rates and in the fees projected to be collected under the new fee rates for the three years of FY 2012-FY 2014 is $228,679,704. Thus, the annual increase is $76,226,568. This rule has been reviewed by the Office of Management and Budget.

The primary cost of this final rule is the increase in the registration fees paid by registrants. Benefits of the rule are an extension of the benefits of the DCP. The DCP is a strategic component of United States law and policy aimed at preventing, detecting, and eliminating the diversion of controlled substances and listed chemicals into the illicit market while ensuring a sufficient supply of controlled substances and listed chemicals for legitimate medical, scientific, research, and industrial purposes. The absence of or significant reduction in this program would result in enormous costs for the citizens and residents of the United States due to the diversion of controlled substances and listed chemicals into the illicit market as outlined in the Economic Impact Assessment found in the rulemaking docket.

This final regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

This rulemaking does not preempt or modify any provision of state law, impose enforcement responsibilities on any state or diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

This rule does not contain a federal mandate and will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $136,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. DEA notes that many governmental entities operate DEA-registered facilities and that they are currently fee exempt. Moreover, the effect of this fee adjustment on individual entities and practitioners is minimal. The majority of the affected entities will pay a fee of $731 for a three year registration period ($244 per year or an increase of $60 per year). This rule is promulgated in compliance with 21 U.S.C. 886a that the full costs of operating the DCP be collected through registrant fees.

This rule is required by statute, will not have tribal implications and will not impose substantial direct compliance costs on Indian tribal governments.

This rule is not a major rule as defined by the Congressional Review Act (5 U.S.C. 804). This rule will not result in an annual effect on the economy of $100,000,000 or more, a major increase in costs or prices, or have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign based companies in domestic and export markets.

For the reasons set out above, 21 CFR parts 1301 and 1309 are amended as follows:

This document, the notice of proposed rulemaking (NPRM), and all comments received may be viewed online through the Federal eRulemaking portal at: http://www.regulations.gov . The Web site is available 24 hours each day, 365 days each year. Please follow the instructions. An electronic copy of this document may also be downloaded by accessing the Office of the Federal Register's home page at http://www.archives.gov or the Government Printing Office's Web page at http://www.gpo.gov/fdsys/ .

This rulemaking modifies existing regulations to make them consistent with several changes in applicable laws and regulations and to ensure compatibility with 23 U.S.C. 106 and the Office of Management and Budget (OMB) Circular A-131 on Value Engineering. These revisions also will address certain findings contained in a 2007 Office of Inspector General (OIG) report on value engineering in the Federal-aid highway program (FAHP) ( http://www.oig.dot.gov/sites/dot/files/pdfdocs/mh2007040.pdf ) in which the OIG recommended that the FHWA make certain changes to the VE policy.

The regulation is also being revised to enhance the consistency of VE analyses that are conducted and to improve FHWA's stewardship and oversight of these regulations. Additionally, these revisions will advance the integration of VE analysis into the planning and development of Federal-aid projects. Furthermore, these revisions will facilitate enhancements to the VE analyses agencies conduct and will foster the use of innovative technologies and methods while eliminating unnecessary and costly design elements, thereby improving the projects' performance, value, and quality. The proposed revisions are discussed in the section analysis below.

The VE analyses on Federal-aid highway projects were first established by Congress in the Federal-Aid Highway Act of 1970. The current requirement to conduct a VE analysis for certain Federal-aid highway projects is codified at 23 U.S.C. 106(e). The OMB Circular A-131 on Value Engineering, which was issued in May 1993 ( http://www.whitehouse.gov/omb/circulars_a131 ), requires all Federal agencies to establish and maintain a VE program to improve the quality of their programs and acquisition functions. Under the OMB Circular, Federal agencies are required to develop and maintain policies and procedures to ensure a VE analysis is conducted on appropriate projects and report annually on the results and accomplishments of the analyses conducted and the program's accomplishments. The FHWA annually collects and reports on VE accomplishments achieved within the Federal-aid and Federal Lands Highway Programs. For VE studies conducted during the planning and development phases of projects, the FHWA tracks the number of studies conducted, the number of proposed and implemented recommendations, the value of the implemented recommendations, information regarding the State transportation agency's (STA's) VE program (e.g., policies, procedures, training conducted), and FHWA's stewardship and oversight of the VE program. Conducting VE analyses continues to be an effective tool in improving the quality and cost effectiveness of the FAHP projects. Additional information on STA, local authority, and FHWA VE programs and practices is available at: http://www.fhwa.dot.gov/ve .

On June 22, 2011, the FHWA published a Notice of Proposed Rulemaking (NPRM) in the Federal Register at 76 FR 36410 soliciting public comments on its proposal to update the existing regulations. The following presents an overview of the comments received in response to the NPRM. Comments were submitted by STAs, industry organizations, and individuals. The docket contained comments from nine parties, including seven STAs, the American Association of State Highway and Transportation Officials (AASHTO), and one individual.

Overall, the commenters supported the proposed rule, namely to enhance the integration of VE analysis in the planning and development of highway improvement projects. The FHWA appreciates the feedback the commenters provided and has carefully reviewed and analyzed all the comments that were submitted.

The AASHTO and STAs support conducting a VE analysis to improve the quality, efficiency, and effectiveness of developing and implementing highway improvement projects. While there was support for revising the VE regulations to ensure consistency with prior changes in legislation and regulations, AASHTO and several STAs commented on issues they believe FHWA needs to consider related to the type of projects subject to a VE analysis, and when the VE analysis is required to be conducted on applicable projects. The AASHTO and STAs also commented on the need to clarify definitions, when and what type of projects require a VE analysis, how life-cycle costs should be considered and integrated in a VE analysis, the expectations of STAs to facilitate VE training, and STA VE Program requirements.

The NPRM stated that STAs and local authorities shall establish the policies, procedures, functions, and capacity to monitor, assess, and report on the performance of the VE program. The AASHTO commented that local authorities are obligated to meet all Federal requirements and that reference to local authorities is redundant. Local public agencies (as specified in 23 CFR 635.105) already are required to meet all Federal requirements, which includes the requirement to operate under approved VE policies and procedures, when Federal-aid highway program funding is utilized on projects. The FHWA agrees with these comments. However, there are instances within this regulation where additional emphasis is provided to identify specific VE requirements for which STAs must ensure that local public agencies meet when administering projects utilizing Federal-aid highway program funding. Most references to local public agencies have been removed from 23 CFR part 627. The term local public agency was used throughout 23 CFR part 627 for consistency with 23 CFR 635.105.

The AASHTO and Wyoming DOT suggested adding a definition for a bridge project. The FHWA agreed with this comment, and the definition of a bridge project was added to section 627.3.

The AASHTO and several STAs provided comments regarding how final design is referenced with regard to the need to conduct a VE analysis (as specified in section 627.5). The FHWA agreed with these comments, and a definition of final design was added to section 627.3 by referencing its current definition in 23 CFR 636.103.

The AASHTO and several STAs commented on the need to consistently use one term when referencing a VE study or analysis. Currently, several terms are used interchangeably in practice to describe the VE process and analysis that is conducted. The FHWA agreed that one term should be used in this regulation. Part 627 has been changed to use the term “VE analysis” for consistency with the provisions in 23 U.S.C. 106(e).

The AASHTO and several STAs expressed concern with the lowest overall life-cycle cost (LCCA) being the primary factor to consider when evaluating and selecting VE recommendations. Under 23 U.S.C. 106(e) and (f), LCCA is required to be conducted during a VE analysis. The FHWA agreed with this comment and has modified the definition of VE analysis in section 627.3(e), by eliminating the use of “lowest” when used with LCCA, and has clarified that LCCA should be a consideration along with other factors, such as quality, environment, safety, and operational efficiency, in determining whether a VE recommendation is viable. The FHWA has made similar changes in other sections of this regulation where LCCA is referenced.

The Washington State DOT recommended FHWA require STAs to follow the guidance developed by SAVE International for a VE Job Plan, which would better align with the State's practices. The SAVE International guidance fits, in principle, with the particular requirements applicable to the FAHP, but not in its entirety. Thus, FHWA agreed and changed the definition of a VE Job Plan to outline the intent without replicating the SAVE International guidance in Section 627.3(f).

The AASHTO and four STAs commented that the proposed step in the VE Job Plan to evaluate and track the implemented VE recommendations would be a burden. The intent of FHWA was to track VE recommendations to ensure they are either approved or rejected and incorporated into the design of the project(s). The intent was not to evaluate the implementation of these recommendations in the construction phase. The FHWA recognizes that tracking VE recommendations into the construction phase would be a burden for STAs and has clarified the definition of the VE Job Plan to require the implementation of approved recommendations during the design phase.

The AASHTO and several STAs stated that as proposed, the VE Job Plan was too burdensome and that all the steps should not be required for every VE analysis. Specifically, smaller projects should have the ability to eliminate some of the steps in the VE Job Plan. The VE Job Plan identifies the phases to be followed in conducting a VE analysis. The VE Job Plan does not specify the analysis that is to be performed, level of effort expended, or how the VE analysis should be conducted. Thus, the VE Job Plan and the analysis that is actually conducted are scalable to meet the needs of each project. The changes described above that FHWA has made to the definition of a VE Job Plan identified only the phases to be followed in conducting a VE analysis. The changes do not specify the level of effort and analysis to be conducted, which should be determined by the STAs based on the specific conditions of each project. Section 627.3(f) was modified to clarify the intent and purpose of the VE Job Plan.

The Montana DOT stated that it would be beneficial to define what is included in the determination of total project costs. The FHWA agreed with this comment and added a definition for total project costs, which specifies that it includes all the costs associated with the environmental, design, right-of-way, utilities, and construction phases of a project.

The AASHTO and several STAs stated that the requirements in sections 627.5(b)(4) were too restrictive because projects with completed designs should not require a VE analysis if their costs exceed the threshold due to construction cost escalation. Also, several STAs stated that after the final design of a project has been completed, a scope or design change should be the trigger to require a VE analysis, and not a 3 year delay. The FHWA agreed with these comments, and revisions were made to section 627.5 to clarify when a VE analysis is required.

The requirement to conduct VE analyses on projects that exceed the thresholds for applicable projects must be satisfied (as specified in 23 U.S.C. 106(e)), and FHWA does not have the authority to change these thresholds. A VE analysis is not required for projects with a total project cost that is under the thresholds established for applicable projects at the completion of final design if there is no scope or design change prior to the letting and the construction costs have escalated to where the project is over these thresholds. However, a VE analysis is required for a project that is under the thresholds established for applicable projects at the completion of final design, but a change made to the project's scope or design prior to the letting causes the total project cost to exceed these thresholds. By definition, if a scope or design change is made to a final set of plans, the project has gone back to the design phase where a VE analysis is required if these changes result in the project exceeding the thresholds established for applicable projects.

The AASHTO and the Kansas and Wyoming STAs recommended that FHWA reinsert the current provision (as specified in 23 CFR 627.5(d)) which states that VE analysis is an activity that is eligible for reimbursement from the Federal-aid highway program. This provision was removed since Federal eligibility for engineering services is defined in 23 CFR 1.11. Value engineering analysis is an engineering service and is therefore an expense that is eligible for reimbursement from the Federal-aid highway program funding. Accordingly, specifically identifying this cost as eligible in part 627 is redundant.

The AASHTO and several STAs commented that the proposed section 627.5 was confusing because it addressed two issues: FHWA-directed additional VE analysis, and the need for a STA's VE Policy to identify when it may be appropriate to conduct additional VE analyses. Some STAs stated that they should be solely responsible for identifying when additional studies are required while others felt that it should be a determination made in collaboration between the STA and FHWA. These two issues have been separated for clarification. Section 627.5(b)(5) specifies that FHWA may direct an additional VE analysis when appropriate, and section 627.5(d) was revised to address the single issue of the STA VE Policy identifying, on a programmatic basis, when any additional VE analysis should be considered or conducted in the planning and development of transportation projects. Additionally, this section was modified to clarify that when a VE analysis is required, it must be conducted prior to completing the final design of the project and prior to the release of the final request for proposals or other applicable VE solicitation documents for design-build projects or other alternative project delivery methods.

The AASHTO and several STAs stated that the thresholds for applicable projects should be increased since it has been a number of years since the thresholds were established. The FHWA does not have the authority to increase the thresholds, as they are specified in the enabling legislation and codified in Federal law at 23 U.S.C. 106(e).

The AASHTO and several STAs stated that the requirement to conduct the VE analysis prior to initiating final design will limit the ability of STAs to effectively manage their VE program. The FHWA agreed with these comments. This section was modified to clarify that when a VE analysis is required, it must be conducted prior to completing the final design of a project. For design-build projects, the VE analysis must be completed prior to the release of the final request for proposals or other applicable solicitation documents for alternative project delivery methods.

The AASHTO and several STAs stated that the term “capacity building initiative” needed more clarification. The FHWA agreed with these comments. This section was modified to clarify the need for STAs' VE programs to facilitate training in place of the originally proposed capacity building initiative.

The AASHTO and Wyoming STA commented that the statement “a consideration of combining or eliminating inefficient use of the existing facility” in section 627.9(b) was unclear as written. The FHWA agreed with these comments. This sentence has been deleted from this section.

The AASHTO and several STAs stated that a VE analysis is only required on substructures and expressed concern over the inclusion of superstructure in the required VE analysis to be conducted on bridges. The STAs are required to consider the substructure requirements of a bridge (as specified in 23 U.S.C. 106(e)(4)(A)); however, this provision does not limit the VE analysis to only the substructure. The VE analysis conducted for bridges must “be evaluated on engineering and economic basis, taking into consideration acceptable designs for bridges” (as specified in 23 U.S.C. 106(e)(4)(B)). This consideration would include all bridge elements, substructure, superstructure, approaches, and any other design elements in the contract. Therefore, the FHWA determined that this section did not require any revisions.

The AASHTO and several STAs stated that the reference to conflict of interest in section 627.9(f) was unclear. The FHWA agrees with this comment and this section was modified to include a reference to FHWA's existing provisions at 23 CFR 1.33.

The FHWA has determined that this rule is not an economically significant rulemaking action within the meaning of Executive Order 12866 and is not a significant rulemaking action within the meaning of the U.S. Department of Transportation regulatory policies and procedures. Additionally, this action complies with the principles of Executive Order 13563 by fostering the use of innovative technologies and methods while eliminating unnecessary and costly design elements. This rule establishes revised requirements for conducting VE analyses and it is anticipated that the economic impact of this rulemaking will be minimal. In addition, these changes will not interfere with any action taken or planned by another agency and will not materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs.

In compliance with the Regulatory Flexibility Act (RFA) (Pub. L. 96-354, 5 U.S.C. 60l-612), the FHWA has evaluated the effects of this rule on small entities. The FHWA has determined that this action does not have a significant economic impact on a substantial number of small entities. The proposed amendment addresses VE studies performed by STAs on certain projects using Federal-aid highway funds. As such, it affects only States, and States are not included in the definition of small entity set forth in 5 U.S.C. 601. Therefore, the RFA does not apply, and the FHWA certifies that this action will not have a significant economic impact on a substantial number of small entities.

This final rule does not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995, 109 Stat. 48). Furthermore, in compliance with the Unfunded Mandates Reform Act of 1995, FHWA evaluated this rule to assess the effects on State, local, and Tribal governments and the private sector. This rule does not result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $140.8 million or more in any one year (2 U.S.C. 1532). Additionally, the definition of “Federal Mandate” in the Unfunded Mandates Reform Act excludes financial assistance of the type in which State, local, or Tribal governments have authority to adjust their participation in the program in accordance with changes made in the program by the Federal Government. The Federal-aid highway program permits this type of flexibility.

This rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, dated August 4, 1999, and the FHWA has determined that this rule will not have a substantial direct effect or sufficient federalism implications to warrant preparation of a federalism assessment. The FHWA has also determined that this rule does not preempt any State law or regulation or affect the States' ability to discharge traditional State governmental functions.

Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et. seq. ), Federal agencies must obtain approval from the OMB for each collection of information they conduct, sponsor, or require through regulations.

The FHWA has determined that this rule contains a requirement for data and information to be collected and maintained in support of compiling the results of the VE analyses that are conducted annually. The FHWA received no comments to this information collection.

It will take approximately 200 burden hours to compile the results of the VE analyses annually (400 analyses at 30 minutes each). It will take approximately 156 burden hours to compile the results of all of the VE analyses that are conducted annually in each State DOT, the District of Columbia, and Puerto Rico and to submit these results to FHWA (52 analyses at 3 hours each). The estimated total burden to provide the additional information to attain full compliance with the final rule is 356 hours.

The FHWA has analyzed this rule for the purpose of the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and has determined it will not have any effect on the quality of the human and natural environment, because this rule merely establishes the requirements that apply to VE analyses whenever an applicable Federal-aid highway project is to be constructed. The promulgation of this regulation has been determined to be a categorical exclusion under 23 CFR 771.117(c)(20).

The FHWA has analyzed this action under Executive Order 13175, dated November 6, 2000, and believes that this rule does not have substantial direct effects on one or more Indian Tribes; does not impose substantial direct compliance costs on Indian Tribal governments; and does not preempt Tribal law. This rule establishes the requirements that apply to VE analyses whenever an applicable Federal-aid highway project is to be constructed and does not impose any direct compliance requirements on Indian Tribal governments, nor does it have any economic or other impacts on the viability of Indian Tribes. Therefore, a Tribal summary impact statement is not required.

The FHWA has analyzed this rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution or Use. We have determined that this rule does not constitute a significant energy action under that order since it will not have a significant adverse effect on the supply, distribution, or use of energy. Therefore, the FHWA certifies that a Statement of Energy Effects under Executive Order 13211 is not required.

The FHWA has analyzed this rule under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. The FHWA has determined that this rule does not effect a taking of private property or otherwise have taking implications under Executive Order 12630.

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

The FHWA has analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. The FHWA certifies that this rule does not cause an environmental risk to health or safety that may disproportionately affect children.

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

In consideration of the foregoing, the FHWA amends title 23 of the Code of Federal Regulations by revising part 627 to read as follows:

PBGC's regulations on Allocation of Assets in Single-Employer Plans (29 CFR Part 4044) and Benefits Payable in Terminated Single-Employer Plans (29 CFR Part 4022) prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulations are also published on PBGC's Web site ( http://www.pbgc.gov ).

The interest assumptions in Appendix B to Part 4044 are used to value benefits for allocation purposes under ERISA section 4044. PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the asset allocation regulation are updated quarterly; assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for April 2012 and updates the asset allocation interest assumptions for the second quarter (April through June) of 2012.

The second quarter 2012 interest assumptions under the allocation regulation will be 3.11 percent for the first 20 years following the valuation date and 3.36 percent thereafter. In comparison with the interest assumptions in effect for the first quarter of 2012, these interest assumptions represent no change in the select period (the period during which the select rate (the initial rate) applies), a decrease of 0.63 percent in the select rate, and a decrease of 0.34 percent in the ultimate rate (the final rate).

The April 2012 interest assumptions under the benefit payments regulation will be 1.25 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for March 2011, these interest assumptions are unchanged.

PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the valuation and payment of benefits under plans with valuation dates during April 2012, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

In consideration of the foregoing, 29 CFR parts 4022 and 4044 are amended as follows:

Regulatory Information

On December 22, 2011, we published a notice of proposed rulemaking (NPRM) entitled Special Local Regulations; Patriot Challenge Kayak Race, Ashley River, Charleston, SC in the Federal Register (76 FR 79571). We received no comments on the proposed rule. No public meeting was requested, and none was held.

The legal basis for the rule is the Coast Guard's authority to establish special local regulations: 33 U.S.C. 1233. The purpose of the rule is to insure safety of life on navigable waters of the United States during the Patriot Challenge Kayak Race.

On Saturday, April 28, 2012, the Patriot Challenge Kayak Race is scheduled to take place on the waters of the Ashley River in Charleston, South Carolina. The race will begin at Brittlebank Park, transit southeast on the Ashley River, head north between Shutes Folly Island and the Charleston peninsula, and then turn around in Tidewater Reach. The race will return to Brittlebank Park by the same route. Approximately 150 paddle boats are anticipated to participate in the Patriot Challenge Kayak Race. Participant paddle boats will include kayaks, canoes, and paddleboards.

This rule establishes special local regulations on the Ashley River in Charleston, South Carolina consisting of a series of buffer zones around vessels participating in the Patriot Challenge Kayak Race. These buffer zones are as follows: (1) All waters within 75 yards of the lead safety vessel; (2) all waters within 75 yards of the last safety vessel; and (3) all waters within 100 yards of all other participating vessels, including kayaks, canoes, and paddleboards. Notice of the special local regulations, including the identities of the lead safety vessel and the last safety vessel, will be provided prior to the marine parade by Local Notice to Mariners and Broadcast Notice to Mariners. The special local regulations will be enforced from 12:30 p.m. until 3:30 p.m. on April 28, 2012. Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the buffer zones unless authorized by the Captain of the Port Charleston or a designated representative. Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the buffer zones by contacting the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16. If authorization to enter, transit through, anchor in, or remain within any of the buffer zones is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization are required to comply with the instructions of the Captain of the Port Charleston or a designated representative.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

Executive Orders 13563, Improving Regulation and Regulatory Review, and 12866, Regulatory Planning and Review, direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget has not reviewed this rule under Executive Order 12866.

The economic impact of this rule is not significant for the following reasons: (1) The special local regulations will be enforced for only three hours; (2) although persons and vessels will not be able to enter, transit through, anchor in, or remain within the buffer zones without authorization from the Captain of the Port Charleston or a designated representative, they may operate in the surrounding area during the enforcement period; (3) persons and vessels may still enter, transit through, anchor in, or remain within the buffer zones if authorized by the Captain of the Port Charleston or a designated representative; and (4) the Coast Guard will provide advance notification of the special local regulations to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of the Ashley River encompassed within the special local regulations from 12:30 p.m. until 3:30 p.m. on April 28, 2012. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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

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

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

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

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

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

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

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

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction. This rule involves special local regulations issued in conjunction with a regatta or marine parade. Under figure 2-1, paragraph (34)(h), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

The Coast Guard will enforce a 100 foot safety zone around the fireworks barge off of Pier 50 in position 37°46′28″ N, 122°23′06″ W (NAD 83) from 11 a.m. until 8:30 p.m. on April 14, 2012. From 8:30 p.m. to 8:40 p.m. on April 14, 2012 the loaded barge will transit from Pier 50 to the launch site near Pier 48 in position 37°46′39.9″ N, 122°23′06.78″ W (NAD83). The 100 foot safety zone applies to the navigable waters around and under the fireworks barge within a radius of 100 feet during the loading, transit, and arrival of the fireworks barge to the display location and until the start of the fireworks display. Upon the commencement of the fireworks display, scheduled to take place from 9:30 p.m. to 9:45 p.m. on April 14, 2012, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius 1,000 feet around the launch site near Pier 48 in position 37°46′39.9″ N, 122°23′06.78″ W (NAD83) for the San Francisco Giants Fireworks Display in 33 CFR 165.1191. This safety zone will be in effect from 11 a.m. to 10:10 p.m. on April 14, 2012.

Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.

This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notice in the Federal Register , the Coast Guard will provide the maritime community with extensive advance notification of the safety zone and its enforcement period via the Local Notice to Mariners.

If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard did not have necessary information regarding the training course until February 22, 2012. As a result, the Coast Guard did not have sufficient time to publish an NPRM and to receive public comments prior to the training course. Any delay in the effective date of this rule would be contrary to the public interest because immediate action is needed to minimize potential danger to the public during the small boat tactical training and maneuvering.

For the same reason discussed above, under 5 U.S.C. 553(d)(3) the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

The legal basis for the rule is the Coast Guard's authority to establish regulated navigation areas and other limited access areas: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.

The purpose of the rule is to protect the public from hazards associated with executing small boat law enforcement tactics and high speed maneuvers during the training course.

From Monday, March 19, 2012 through Friday, March 23, 2012, the Maritime Law Enforcement Academy will conduct tactical training and high speed maneuvering with Coast Guard small boats. This tactical training and high speed maneuvering will include application of various law enforcement tactics, high speed turns, and outside loop maneuvers.

The temporary safety zone encompasses certain waters of the Wando River in Charleston, South Carolina. This safety zone will be enforced from: (1) 7 a.m. until 11:30 a.m. and 12:30 p.m. until 4:30 p.m. on March 19 and 20, 2012; (2) 7 a.m. until 11:30 a.m., 12:30 p.m. until 4:30 p.m., and 8 p.m. until 10 p.m. on March 21 and 22, 2012; and (3) 7 a.m. until 11:30 a.m. and 12:30 p.m. until 3 p.m. on March 23, 2012. Persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Charleston or a designated representative. Persons and vessels desiring to enter, transit through, anchor in, or remain within the safety zone may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the safety zone is granted by the Captain of the Port Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the safety zone by Broadcast Notice to Mariners and Marine Safety Information Bulletins. The Coast Guard will also provide notice of the safety zone by on-scene designated representatives.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

Executive Orders 13563, Improving Regulation and Regulatory Review, and 12866, Regulatory Planning and Review, direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget has not reviewed this regulation under Executive Order 12866.

The economic impact of this rule is not significant for the following reasons: (1) The safety zone will be enforced for a total of 45 hours; (2) although persons and vessels will not be able to enter, transit through, anchor in, or remain within the safety zone without authorization from the Captain of the Port Charleston or a designated representative, they may operate in the surrounding area during the enforcement period; (3) persons and vessels may still enter, transit through, anchor in, or remain within the safety zone if authorized by the Captain of the Port Charleston or a designated representative; and (4)advance notification of the safety zone will be made to the local maritime community by Broadcast Notice to Mariners and Marine Safety Information Bulletins.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of the Wando River encompassed within the temporary safety zone from 7 a.m. on March 19, 2012 through 3 p.m. on March 23, 2012. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

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

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

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

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph 34(g), of the Instruction. This rule involves establishing a temporary safety zone that will be enforced for a total of 45 hours. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard will enforce the security zone for the Portland Rose Festival detailed in 33 CFR 165.1312 for all vessels operating in the Columbia River Captain of the Port Zone from 11 a.m. on June 6, 2012 until 11 a.m. on June 11, 2012.

Under the provisions of 33 CFR 165.1312 and 33 CFR part 165, subpart D, no person or vessel may enter or remain in the security zone without permission of the Captain of the Port, Columbia River. Persons or vessels wishing to enter the security zone may request permission to do so from the on scene Captain of the Port representative via VHF Channel 16 or 13. The Coast Guard may be assisted by other Federal, State, or local enforcement agencies in enforcing this regulation.

This notice is issued under authority of 33 CFR 165.1312 and 5 U.S.C. 552(a). In addition to this notice in the Federal Register , the Coast Guard will provide the maritime community with notification of this enforcement period via the Local Notice to Mariners.

EPA is approving a revision, submitted by New Jersey on December 15, 2009, and a supplemental revision, submitted by New Jersey on October 12, 2010, to the New Jersey State Implementation Plan (SIP) pertaining to New Jersey's motor vehicle enhanced inspection and maintenance (I/M) program. New Jersey provided EPA with documentation on the emission impacts that will result from proposed changes to New Jersey's enhanced I/M program including a comparison to the EPA I/M performance standard. The revisions submitted by New Jersey include a new exhaust emission test for gasoline fueled vehicles; the extension of the new vehicle inspection exemption from 4 years to 5 years; the elimination of repair cost waivers; the increase in the inspection frequency (to annual) for certain classes of commercial vehicles such as limousines, taxis and jitneys; and the subjecting of light duty diesel vehicles to emissions testing.

On December 15, 2009, New Jersey submitted a revision to the State of New Jersey's I/M program SIP. The submittal consists of new rules and rule amendments to the New Jersey Department of Environmental Protection's rules at New Jersey Administrative Code (N.J.A.C.) 7:27-15, 7:27B-5 and the Motor Vehicle Commission rules at N.J.A.C. 13:20-7, 13:20-24, 13:20-26, 13:20-28, 13:20-29, 13:20-32, 13:20-33, 13:20-43, 13:20-44, 13:20-45, and N.J.A.C. 13:21-15.8 and 13:21-15.12.

The proposed changes to New Jersey's I/M program include the establishment of a new exhaust emission test for gasoline fueled vehicles. The Two Speed Idle (TSI) test will replace both the Acceleration Simulation Mode (ASM5015) and 2500 Revolutions per Minute (RPM) tests. The TSI test is a tailpipe test which checks the vehicle's hydrocarbons, carbon monoxide, oxygen and carbon dioxide (HC, CO, O 2 and CO 2 , respectively) exhaust emissions concentration levels at two different engine speeds, the regular idle and a fast idle around 2500 RPM. The ASM5015 test measures the concentrations of HC, CO and oxides of nitrogen (NO X ), in a vehicle's tailpipe emissions when a vehicle is running under marginal load and at a steady rate or RPM. The 2500 RPM test is a tailpipe test that checks the vehicle's HC, CO, O 2 and CO 2 exhaust emissions concentration levels at 2500 RPM.

The proposed changes to New Jersey's I/M program also include: the elimination of repair cost waivers, the increase in the inspection frequency (to annual) for certain classes of commercial vehicles such as limousines, taxis and jitneys, and the subjecting of light duty diesel vehicles to emissions testing. New Jersey provided documentation on the emission impacts that will result from proposed changes to New Jersey's I/M program including a comparison to the EPA I/M performance standard.

On October 12, 2010, New Jersey submitted a supplemental I/M program SIP revision which consisted of amendments to chapter 8 of Title 39 of the Revised Statutes of the state of New Jersey at R.S. 39:8-1, 39:8-2, and 39:8-3. The submittal includes an extension of the new vehicle inspection exemption from 4 years to 5 years and an acknowledgement with supporting justification that New Jersey's decentralized I/M network (the private inspection facilities, or PIFs) is currently 96 percent as effective as New Jersey's centralized I/M network (the centralized inspection facilities, or CIFs). PIFs were previously assumed to be 80 percent as effective as CIFs, which New Jersey considered to likely be very conservative in light of the program and technology changes that were implemented in the years following the 80 percent effectiveness assumption. In May 2010, New Jersey authorized MACTEC Engineering and Consulting, Inc. to assess improvements in effectiveness of the decentralized program and to determine a reasonable effectiveness fraction that may be supported by data and technical reasoning. MACTEC analyzed the effectiveness of the decentralized PIF network relative to the CIF (centralized) network. The relative effectiveness of PIFs was based on data collected from PIFs and CIFs in 2009. As a result of the analysis, MACTEC determined that New Jersey should increase the effectiveness factor for PIFs and provided the following justifications:

• Fail rates for OBD inspections in PIFs were found to be nearly identical to those in CIFs;

• An analysis of triggers for OBD tests performed in 2009 showed that over 99% of inspections in PIFs have no indications of fraud;

• New Jersey has implemented several additional OBD triggers in the new program, which will further reduce the incidence of fraud.

On July 8, 2010, New Jersey submitted to EPA the final report prepared by MACTEC, dated June 23, 2010 entitled “New Jersey Motor Vehicle Inspection Program PIF Effectiveness Study.”

On September 16, 2011 (76 FR 57691), EPA proposed to approve New Jersey's revised I/M program. For a detailed discussion on the content and requirements of the revisions to New Jersey's regulations, the reader is referred to EPA's proposed rulemaking action.

In response to EPA's September 16, 2011 proposed rulemaking action, EPA received no comments.

EPA's review of the materials submitted indicates that New Jersey has revised its I/M program in accordance with the requirements of the Clean Air Act, 40 CFR part 51 and all of EPA's technical requirements for an approvable Enhanced I/M program. EPA is approving the rules and rule amendments to the New Jersey Department of Environmental Protection's rules at N.J.A.C. 7:27-15, 7:27B-5 (replaces B-4), effective November 16, 2009, the Motor Vehicle Commission rules at N.J.A.C. 13:20-7, 13:20-24, 13:20-26, 13:20-28, 13:20-29, 13:20-32, 13:20-33, 13:20-43, 13:20-44, 13:20-45, and N.J.A.C. 13:21-15.8 (replaces 15.7), 13:21-15.12, all effective October 19, 2009 and the amendments to chapter 8 of Title 39 of the Revised Statutes of the state of New Jersey at R.S. 39:8-1, 39:8-2, and 39:8-3, effective July 1, 2010, which incorporate New Jersey's motor vehicle inspection program requirements. The Clean Air Act gives states the discretion in program planning to implement programs of the state's choosing as long as necessary emission reductions are met.

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 14, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

For the purpose of this document, we are giving meaning to certain words or initials as follows:

(i) The word Act or initials CAA mean or refer to the Clean Air Act, unless the context indicates otherwise.

(ii) The word Commission means the joint Southern Ute Indian Tribe/State of Colorado Environmental Commission.

(iii) The words EPA, we, us or our mean or refer to the United States Environmental Protection Agency.

(iv) the word Title V Program means the Tribe's Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated January 14, 2009, the subsequent Supplement to Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated September 28, 2010 and the Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012.

(v) The word Tribe means the Southern Ute Indian Tribe, unless the context indicates otherwise.

Under Title V of the Clean Air Act (the Act or CAA) as amended (1990), EPA has promulgated rules that define the minimum elements of a full approval of a Title V operating permits program for state and tribal permitting authorities. The corresponding standards and procedures by which the EPA will approve, oversee, and withdraw approval of state and tribal title V operating permits programs can be found at 57 FR 32250 (July 21, 1992) and 63 FR 1322 (January 10, 2000) and are codified at 40 CFR part 70.

In addition, as part of the 1990 Amendments to the CAA, Congress enacted Section 301(d) authorizing EPA to “treat Indian tribes as states” under the Act so that tribes may develop and implement CAA programs in a similar manner as states within tribal reservations or in other areas subject to tribal jurisdiction. Section 301(d)(2) of the Act authorizes EPA to promulgate regulations specifying those provisions of the CAA “for which it is appropriate to treat Indian tribes as States.” 42 U.S.C. 7601(d)(2).

On February 12, 1998, EPA issued a final rule specifying those provisions of the CAA for which it is appropriate to treat eligible Indian tribes in a similar manner as states, known as the Tribal Authority Rule (TAR). 63 FR 7254, codified at 40 CFR part 49. As a general matter, the regulations authorize eligible Indian tribes to have the same rights and responsibilities as States under the CAA; however, EPA also determined in the TAR that it is not appropriate to treat Indian tribes in a similar manner as states for purposes of specific CAA program submittal and implementation deadlines. This is because, among other reasons (discussed at 59 FR at 43,964-65), although the CAA contains many provisions mandating the submittal of state plans, programs, or other requirements by certain dates, the Act does not similarly require Indian tribes to develop and seek approval of CAA programs.

Thus, Indian tribes are generally not subject to CAA provisions that specify a deadline by which something must be accomplished, e.g., provisions mandating the submission of state title V operating permits programs under sections 502(d)(1), 502(d)(2)(B), and 502(d)(3)of the Act. 40 CFR 49.4.

A tribe that meets the eligibility criteria for treatment in a similar manner as a state (TAS) may, however, choose to implement a CAA program. A tribe may also submit reasonably severable portions of a CAA program, if it can demonstrate that its proposed air program is not integrally related to program elements not included in the plan submittal and is consistent with applicable statutory and regulatory requirements. 40 CFR 49.7(c); see also CAA § 110(o). This modular approach is intended to give Indian tribes the flexibility to address their most pressing air quality issues and acknowledges that Indian tribes often have limited resources with which to address their environmental concerns. Consistent with the exceptions listed in 40 CFR 49.4, once submitted, an Indian tribe's proposed air program will be evaluated in accordance with applicable statutory and regulatory criteria in a manner similar to the way EPA would review a similar state submittal. 40 CFR 49.9(h).

EPA expects Indian tribes to fully implement and enforce their approved CAA programs and, as with states, EPA retains its authority to impose sanctions for failure to implement an approved air program. See 59 FR 43,956 at 43,965 (Aug. 25, 1994).

The CAA allows Indian tribes to develop and submit title V operating permit programs to EPA at their own discretion. The EPA's title V operating permit program review occurs pursuant to section 502 of the Act and the part 70 regulations, which together outline criteria for interim approval, full approval or disapproval. The Tribe has requested operating permit program approval and this action is in response to that request.

EPA did not receive any comments on our March 9, 2011 Federal Register notice proposing interim approval of the Tribe's Title V Program.

The EPA completed a review of the Tribe's authority to regulate air pollution sources located within the exterior boundaries of the Reservation. Under section 301(d) of the CAA and the TAR, EPA may treat a tribe in a similar manner as a state for purposes of administering certain CAA programs or grants if the tribe demonstrates that: (1) It is a federally-recognized tribe; (2) it has a governing body carrying out substantial governmental duties and powers; (3) the functions to be exercised by the tribe pertain to the management and protection of air resources within the exterior boundaries of the reservation (or in other areas under the tribe's jurisdiction); and (4) it can reasonably be expected to be capable, in EPA's judgment, of carrying out the functions for which it seeks approval, consistent with the CAA and applicable regulations. 40 CFR 49.6. The sections below outline the details of EPA's review of the Tribe's authorities.

In July 1998 the Southern Ute Indian Tribe applied for TAS seeking approval to administer a CAA title V air quality operating permit program throughout the Reservation. The State of Colorado challenged the Tribe's CAA TAS application, asserting that the Act of May 21, 1984, Public Law 98-290, 25 U.S.C. 668, which defined the boundaries of the Reservation, established the State's jurisdiction to regulate non-Indian-owned air pollution sources located on fee lands within the Reservation. The Tribe and the State, while continuing to disagree over who has jurisdiction over these sources, formed the Southern Ute Indian Tribe/State of Colorado Environmental Commission (Commission), and executed an intergovernmental agreement (IGA) on December 13, 1999, to establish a single air quality program applicable to all lands within the exterior boundaries of the Reservation.

In general, the IGA allows for the Tribe to implement and administer CAA programs, on a Reservation-wide basis, through the joint Commission. It also provides that the State will support the Tribe's CAA TAS application as long as it is consistent with the IGA. Congress then passed the Southern Ute and Colorado Intergovernmental Agreement Implementation Act of 2004, Public Law 108-336 on October 18, 2004, which codifies the basic framework of the IGA, and authorizes EPA to grant TAS authority to the Tribe for air programs submitted under CAA section 301(d). The Tribe has previously received TAS approval on April 26, 2000, for the purposes of grant funding under CAA Section 105.

On January 20, 2009, the Tribe submitted its CAA TAS application together with the Tribe's initial Title V Program. On July 14, 2009, EPA found the Tribe's CAA program TAS application to be administratively complete. This means the Tribe's CAA program TAS application contains the basic information needed for EPA to make a TAS eligibility determination.

On March 2, 2012, EPA issued its determination finding that the Tribe is eligible for TAS for the purposes of approval of the title V program.

As previously discussed in Section I above, the TAR allows for Indian tribes to seek approval of partial elements of CAA programs as long as those portions are determined to be reasonably severable elements, that is, not integrally related to program elements that are not included in the plan submittal, and are consistent with applicable statutory and regulatory requirements. 40 CFR 49.7(c). Each submittal is evaluated for adequacy by EPA on a case-by-case basis.

In the March 9, 2011 proposed interim approval, we stated that the underlying Federal regulations at CAA sections 111 (Standards of Performance for New Stationary Sources), 112 (National Emissions Standards for Hazardous Air Pollutants) and the Acid Rain Program at title IV of the CAA were reasonably severable elements of a title V program. At that time, the Region's view was that the authority to implement and enforce these regulations independent of title V, as contrasted with the authority to include the requirements that apply to a particular source in that source's title V permit and to enforce those requirements, is a necessary part of an approvable title V program.

After careful consideration, we find that, where, as is the case here, the title V permitting authority has the ability to include all applicable requirements in a title V permit and to enforce all requirements of a permit, the authority to implement CAA sections 111 and 112 as well as the Acid Rain Program directly (i.e., independently of title V) is not a necessary element of an approvable title V program and therefore does not require severing pursuant to 40 CFR 49.7(c). While we believe that it is convenient in a number of respects for a permitting authority to have the authority to implement and enforce the Acid Rain Program and other underlying regulations outside of the context of an approved title V program, we are not, at this juncture, concluding that such authority is a necessary element of an approvable title V program.

Thus, it is not necessary to sever these CAA requirements in the context of approving the Tribe's Title V Program. 1 Nevertheless, we note that the Tribe has submitted a letter to EPA expressing its intent to incorporate CAA section 111 and 112 requirements into the Reservation Air Code and pursue authorization from EPA to implement and enforce those CAA programs.

The TAR provides for a Federal role in criminal enforcement of a program when the CAA or its implementing regulations mandate criminal enforcement authority and the applicant tribe is precluded from exercising such authority. 40 CFR 49.7(a)(6) and 49.8. In these circumstances, the TAR allows EPA to approve a tribal application if the tribe enters into a Memorandum of Agreement (MOA) with EPA that provides for the Federal government to exercise primary criminal enforcement responsibility. Id. These provisions of the TAR recognize that Federal law places certain limitations on tribal criminal jurisdiction and sanctions. In this instance, the IGA reached between the Tribe and the State of Colorado contemplates that EPA will exercise criminal enforcement within the Reservation boundary for air pollution violations.

On this basis, on February 10, 2009, the Tribe and EPA entered into a MOA which provides a procedure by which the Tribe will supply potential investigative leads to the Federal government in an appropriate and timely manner when the Tribe is precluded from asserting criminal enforcement authority.

EPA conducted a thorough review of the Tribe's Title V Program original and subsequent supplemental applications ( Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated January 14, 2009; Supplement to Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated September 28, 2010; Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012) according to 40 CFR 70.4(b) Elements of the initial program submission. Upon review of those applications, EPA concluded that the 16 elements found at 40 CFR 70.4(b) were adequately addressed by the Tribe's Title V Program.

The Southern Ute Indian Tribe submitted an initial and a supplemental Title V Program to EPA on January 20, 2009 and September 28, 2010 respectively. The Title V Program submittals include a legal opinion from the Tribe's legal counsel stating that the laws of the Tribe and Southern Ute Indian Tribe/State of Colorado Environmental Commission provide adequate legal authority to carry out all aspects of the Title V Program, and a description of how the Tribe intends to implement the Title V Program.

EPA comments noting deficiencies in the Tribe's initial January 20, 2009 Title V Program submittal were sent to the Tribe in a letter dated December 23, 2009. The deficiencies were segregated into those that require corrective action prior to Title V Program approval, and those that, if addressed, would serve to strengthen the Title V Program, but were not necessary for approval.

In the September 28, 2010 supplemental Title V Program application, the Tribe addressed the deficiencies that required corrective action prior to Title V Program approval as well as those that served to strengthen the Title V Program. EPA reviewed these changes and determined that they were adequate to allow for Title V Program interim approval pursuant to 40 CFR 70.4(a).

The EPA's March 9, 2011 proposed interim approval Federal Register notice outlined two changes to the Tribe's Program to be made in order for a final full approval to be granted. Those two changes were:

○ Modify the “emission unit” definition to include pollutants listed under 112(b) of the Act; and

○ Modify the “major source” definition to include the updated definition for purposes of regulating greenhouses gases as part of the Prevention of Significant Deterioration/Title V Greenhouse Gas Tailoring Rule (GHG Tailoring Rule). See 75 FR 106 at 31514-31608 (June 3, 2010).

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(1). The Tribe submitted a complete program description ( Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated January 14, 2009, Tab 1, Program Description) which describes how the Tribe intends to carry out its responsibilities under part 70.

The Tribe's Title V Program, with the operating permit regulations ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 6, Reservation Air Code, Articles I and II), meets the requirements of 40 CFR 70.4(b)(2) including evidence of procedurally correct adoption of the Tribe's Reservation Air Code as well as public notice and comments on its adoption. The Tribe's Title V Program satisfies the requirements outlined in 40 CFR 70.4 and all other relevant sections of part 70.

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(3). The Tribe's independent legal counsel, Maynes, Bradford, Shipps & Sheftel, LLP Attorneys at Law, submitted an initial and a supplemental legal opinion in both the initial and supplemental Title V Program applications ( Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated January 14, 2009 and Supplement to Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated September 28, 2010). The signatory of the legal opinion, the Tribe's legal counsel, Sam Maynes of Maynes, Bradford, Shipps & Sheftel, LLP Attorneys at Law, has full authority to independently represent the Tribe in court on all matters pertaining to the Tribe's Title V Program. The legal opinion includes a demonstration of adequate legal authority to carry out the requirements of part 70, including authority to carry out those activities listed at 40 CFR 70.4(b)(3)(i) through (xiii).

EPA notes that the Tribe's program provides for appropriate review of final permit actions, consistent with 40 CFR § 70.4(b)(3)(x), by providing that final permit actions of the Commission are reviewable in the United States Court of Appeals for the Tenth Circuit. See Pub. L. 108-336; Resolution No. 2008-01 dated January 31, 2008, Procedural Rules of the Southern Ute Indian Tribe/State of Colorado Environmental Commission, Section V. C.; see also 63 FR at 7261-62.

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(4). The Tribe submitted extensive application forms ( Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated January 14, 2009, Tab 4, Program Forms) for review as well as comprehensive instructions for each form.

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(5). The Tribe submitted multiple compliance assurance procedures and guidelines ( Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated January 14, 2009, Tab 5, Compliance Tracking).

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(6). The Tribe's Reservation Air Code ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 6, Reservation Air Code) Article II, Sections 2-106(3) and 2-107(1)(a) demonstrates adequate authority and procedures to determine within 60 days of receipt whether applications (including renewal applications) are complete, to request such other information as needed to process the application, and to take final action on complete applications within 18 months of the date of its submittal, except for initial permit applications, for which the part 70 permitting authority may take up to 3 years from the effective date of the Title V Program to take final action on the application, consistent with 40 CFR 70.4(b)(11)(ii).

The Tribe's Title V Program includes a fee accounting, which includes projected fee collection and programmatic costs ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 10 Revised Fee Demonstration Figure 1 page 6 and Table 2 page 7) that set fees above the presumptive minimum set forth in section 70.9.

The Tribe's Title V Program requires that part 70 sources pay $50 per ton of fee pollutant (not including greenhouse gases (GHGs)) for the first year of permit issuance and then $50 per ton plus any percentage increase necessary to reflect any increase in the Consumer Price Index (CPI) each year thereafter. The Tribe has adequately shown in the Fee Demonstration, that $50 per ton is sufficient to cover the permit program costs and that any fees generated will be used exclusively for permit program costs. The $50 per ton is a slight increase from the current annual part 71 fees, $47.11 per ton. EPA notes that although the Tribe's Title V Program does not assess fees for GHGs, the fee structure is expected to be adequate to cover all program costs, provided that GHG sources below the threshold of 40 CFR part 70 are not subject to the program. The Tribe will review resource needs for GHG-emitting sources in its fee structure if necessary and EPA will work with the Tribe if it requests assistance in establishing title V fees related to GHG emissions.

The Tribe submitted a statement that adequate personnel and funding have been made available to develop, administer, and enforce the Title V Program ( Supplement to Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated September 28, 2010, Tab 10, 40 CFR 70.4(b)(8)). This demonstration, however, does not include permit issuance to GHG sources at 100 tpy. In addition, the Tribe has provided a supplemental staffing plan (January 4, 2011 email from Brenda Jarrell) that outlines a staff of six individuals. Those staff resumes can be found in Tab 11 of the Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program.

EPA has reviewed the Tribe's statement and staffing plan and concludes they are adequate. EPA notes that the Tribe's Title V Program does not cover sources below the threshold of 40 CFR part 70 (i.e., only those sources that emit at least 100 tpy on a mass basis and 100,000 tpy on a Carbon Dioxide equivalent (CO 2 e)  2 basis will be treated as a major source subject to title V permitting as a result of GHG emissions). Accordingly, applicability of the Tribe's Title V Program is consistent with GHG permitting requirements. See 75 FR 82254 (December 30, 2010) (Title V GHG Narrowing Rule). We conclude that the Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(8).

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(9). The Tribe submitted a commitment ( Application for Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permit Program dated January 14, 2009, Tab 9, 40 CFR 70.4(b)(9)) to submit, at least annually to the Administrator, information regarding the Tribe's enforcement activities including, but not limited to, the number of civil, judicial and administrative enforcement actions either commenced or concluded; the penalties, fines, and sentences obtained in those actions; and the number of administrative orders issued.

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(10). The relevant provisions of the Tribe's Reservation Air Code ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 6, Reservation Air Code) Article II, Sections 2-106 and 2-107 are consistent with requirements outlined in 40 CFR 70.5(a)(2) and 70.6(f).

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(11). The Tribe's comprehensive Revised Transition Plan ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 9, Revised Transition Plan) outlines a plan and schedule for submittal and final action on initial permit applications for all part 70 (previously part 71) sources within the exterior boundaries of the Reservation.

Currently, EPA Region 8 has issued 44 part 71 permits on the Southern Ute Indian Reservation. Transfer of primary responsibility for permits is outlined in the Tribe's Revised Transition Plan. According to the Tribe's Code, this Title V Program “shall become effective upon the date of the approval by the Administrator of the Tribe's application for treatment as a state and part 70 program approval.” ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 6, Reservation Air Code, Article II, Part I, 2-102).

Thus, upon signature of this Federal Register notice and the separate TAS application, the Tribe will begin the process of contacting all part 71 sources and informing them of when each source is expected to submit a part 70 permit application per the Tribe's transition plan ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 9, Revised Transition Plan).

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(12). The Tribe's Reservation Air Code ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 6, Reservation Air Code) contains provisions, Article II, Sections 2-110, 2-111 and 2-116, allowing for changes within a permitted facility without requiring a permit revision, if the changes are not modifications under any provision of title I of the Act and the changes do not exceed the emissions allowable under the part 70 permit, provided the facility provides written notification as required in section 70.4(b)(12) consistent with 40 CFR 70.4(b)(12)(i) through (iii).

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(13). The Tribe's Reservation Air Code ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 6, Reservation Air Code) Article II, Section 2-111 provides for adequate, streamlined and reasonable procedures for expedited review of permit revisions or modifications.

The Tribe's Title V Program does not allow changes that are not addressed or that are prohibited as described in 40 CFR 70.4(b)(14). Thus, this section does not apply to the Tribe's Title V Program.

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(15). The Tribe's Reservation Air Code ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 6, Reservation Air Code) Article II, Section 2-116(2) prohibits sources from making, without a permit revision, changes that are not addressed or that are prohibited by the part 70 permit, if such changes are subject to any requirements under title IV of the Act or are modifications under any provision of title I of the Act.

The Tribe's Title V Program meets the requirements of 40 CFR 70.4(b)(16). The Tribe's Reservation Air Code ( Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program dated January 30, 2012, Tab 6, Reservation Air Code) Article II, Sections 2-107, 2-110 and 2-112 requires the Tribe's Title V Program to implement the requirements of 40 CFR 70.6 and 70.7.

EPA is promulgating a full approval rather than a full interim approval because the issues identified in the proposed interim approval have been addressed. Thus, the EPA is moving to a full approval in today's action.

The Title V Program issues identified in the EPA's March 9, 2011 proposed interim approval were addressed. The Tribe's updated RAC became effective on August 8, 2011. An Application for Full Approval of the Southern Ute Indian Tribe's 40 CFR Part 70 Operating Permits Program was submitted to the EPA on January 30, 2012 for final action. The following changes were made to the Tribe's Title V Program, effective August 8, 2011:

(1) The “emission unit” definition in the RAC (found at RAC Section 1-103(26)) was modified to include pollutants listed under section 112(b) of the CAA (42 U.S.C. 7412(b));

(2) The “major source” definition in the RAC (found at RAC Section 1-103(38)) was modified to include the code of Federal regulations' updated definitions of “major source” and “subject to regulation” (found at RAC Section 1-103(65)) for purposes of addressing greenhouse gases as part of EPA's Prevention of Signification Deterioration/Title V Greenhouse Gas Tailoring Rule (GHG Tailoring Rule). See 75 FR 106 at 31514-31608 (June 3, 2010).

The change to the “emission unit” definition clarified and made the Tribe's Title V Program consistent with 40 CFR part 70. Although the Tribe has the authority to regulate pollutants listed under 112(b) of the Act through its “major source” and “regulated air pollutant” definitions, to be consistent, the “emission unit” definition should include 112(b) pollutants as well.

The change to the “major source” definition narrowed the number of sources requiring Title V review for greenhouse gases (GHGs) after July 1, 2011, by raising the major source threshold from 100 tons per year (tpy) to 100,000 tpy for GHGs. With this modification, the Tribe will be issuing Title V operating permits to sources with GHG emissions in a manner consistent with the Federal regulations as set out in the GHG Tailoring Rule.

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 any new information collection burden. The information collection requirements in the Title V Program are all mandated by 40 CFR part 70. The Office of Management and Budget (OMB) previously approved the information collection requirements specified in 40 CFR part 70 under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-0243. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The 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 impact of this final rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's 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 rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities.

EPA's action in approving the Tribe's Title V Program does not contain a Federal mandate that may result in expenditures of $100 million or more for state, local and tribal governments, in the aggregate, or the private sector in any one year. Thus, this action is not subject to the requirements of sections 202 or 205 of 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 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. The Title V Program primarily affects private industry and does not impose significant economic costs on state or local governments. Thus, Executive Order 13132 does not apply to this action.

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

EPA has concluded that this action will have tribal implications in that it will result in responsibility for issuing title V permits being transferred from EPA to the Tribe in that it will result in responsibility for issuing title V permits being transferred from EPA to the Tribe. However, it will neither impose substantial direct compliance costs on tribal governments, nor preempt Tribal law. EPA's action in approving the Title V Program will make the requirements of the Title V Program enforceable under Federal law.

EPA consulted with tribal officials early in the process of developing this action to permit them to have meaningful and timely input into its development. Government to Government consultation occurred on November 3, 2010 between Region 8 Administrator, James B. Martin and then Chairman Matthew Box. Additionally, routine staff level conference calls and meetings have been held consistently throughout the review process.

EPA interprets E.O. 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 E.O. has the potential to influence the regulation. This action is not subject to E.O. 13045 because it approves the Title V Program submitted by the Southern Ute Indian Tribe and thus does not concern health or safety risks.

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, 12(d) (15 U.S.C. 272 note) directs 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. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order (E.O.) 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.

EPA has determined that this final action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This final action approves the Title V Program submitted by the Southern Ute Indian Tribe and thus transfers responsibility for issuing title V permits from EPA to the Tribe.

The CRA, 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 final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to publication of the final 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). The final rule will be effective upon approval by the Region 8 Administrator.

40 CFR part 70 is amended as follows:

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

We conclude that Oklahoma's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we grant Oklahoma Final authorization to operate its hazardous waste program with the changes described in the authorization application. Oklahoma has responsibility for permitting treatment, storage, and disposal facilities within its borders. Also section 10211(a) of the Safe, Accountable, Flexible, Efficient Transportation Equity Act of 2005 (“SAFETEA”), Public Law 109-59, 119 Statute 1144 (August 10, 2005) provides the State of Oklahoma opportunity to request approval from EPA to administer RCRA subtitle C in Indian Country and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that the EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, the EPA will implement those requirements and prohibitions in Oklahoma including issuing permits, until the State is granted authorization to do so.

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

• Do inspections, and require monitoring, tests, analyses, or reports;

• Enforce RCRA requirements and suspend or revoke permits; and

• Take enforcement actions after notice to and consultation with the State.

This action does not impose additional requirements on the regulated community because the regulations for which Oklahoma is being authorized by today's action is already effective under State law, and are not changed by today's action.

The EPA did not publish a proposal before today's rule because we view this as a routine program change and do not expect comments that oppose this approval. We are providing an opportunity for public comment now. In addition to this rule, in the proposed rules section of today's Federal Register we are publishing a separate document that proposes to authorize the State program changes.

If the EPA receives comments that oppose this authorization, we will withdraw this rule by publishing a document in the Federal Register before the rule becomes effective. The EPA will base any further decision on the authorization of the State program changes on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time. If we receive comments that oppose only the authorization of a particular change to the State hazardous waste program, we will withdraw only that part of this rule, but the authorization of the program changes that the comments do not oppose will become effective on the date specified in this document. The Federal Register withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn.

Oklahoma initially received final Authorization on January 10, 1985, (49 FR 50362-50363) published December 27, 1984 to implement its base hazardous waste management program. We authorized the following revisions: Oklahoma received authorization for revisions to its program with publication dates: April 17, 1990 (55 FR 14280-14282), effective June 18, 1990; September 26, 1990 (55 FR 39274) effective November 27, 1990; April 2, 1991 (56 FR 13411-13413) effective June 3, 1991; September 20, 1991 (56 FR 47675-47677) effective November 19, 1991; September 29, 1993 (58 FR 50854-50856) effective November 29, 1993; October 12, 1993 (58 FR 52679-52682) effective December 13, 1993; October 7, 1994 (59 FR 51116-51122) effective December 21, 1994; January 11, 1995 (60 FR 2699-2702) effective April 27, 1995; October 9, 1996 (61 FR 52884-52886) effective December 23, 1996; Technical Correction March 14, 1997 (62 FR 12100-12101) effective March 14, 1997; September 22, 1998 (63 FR 50528-50531) effective November 23, 1998; March 29, 2000 (65 FR 16528-16532) effective May 30, 2000; May 10, 2000 (65 FR 29981-29985) effective June 10, 2000; January 2, 2001 (66 FR 28-33) effective March 5, 2001; April 9, 2003 (68 FR 17308-17311) effective June 9, 2003 and February 4, 2009 (74 FR 5994-6001). The authorized Oklahoma RCRA program was incorporated by reference into the CFR published on December 9, 1998 (63 FR 67800-67834) effective February 8, 1999, August 26, 1999 (64 FR 46567-46571) effective October 25, 1999, August 27, 2003 (68 FR 51488-51492) effective October 27, 2003, August 27, 2010 (75 FR 36546) June 28, 2010 and (66 FR 18927-18930) effective June 6, 2011. On December 20, 2011, Oklahoma submitted a final complete program revision application seeking authorization of its program revision in accordance with 40 CFR 271.21.

The Oklahoma Hazardous Waste Management Act (“OHWMA”) provides the ODEQ with the authority to administer the State Program, including the statutory and regulatory provisions necessary to administer the provisions of RCRA Cluster XX, and designates the ODEQ as the State agency to cooperate and share information with EPA for the purpose of hazardous waste regulation. The Oklahoma Environmental Quality Code (“Code”), at 27 A O.S. Section 2-7101 et seq. establishes the statutory authority to administer the Hazardous waste management program and subtitle C. The State regulations to manage the Hazardous waste management program are at Oklahoma Administrative Code (OAC) Title 252 Chapter 205.

The DEQ adopted applicable Federal hazardous waste regulations as amended through July 1, 2011. The provisions for which the State of Oklahoma is seeking authorization are documented in the Regulatory Documentation For Federal Provisions For Which The State Of Oklahoma Is Seeking Authorization, Federal Final Rules Published Between July 1, 2009 Through June 30, 2010 RCRA Cluster XX, prepared on April 22, 2011.

The DEQ incorporates the Federal regulations by reference and there have been no changes in State or Federal laws or regulations that have diminished the DEQ's ability to adopt the Federal regulations by reference as set forth in the authorizations at 75 FR 1236-1262, 75 FR 12989-13009, 75 FR 31716-31717 and 75 FR 33712-33724 for RCRA Cluster XX. The Federal Hazardous waste regulations are adopted by reference by the DEQ at OAC 252:205, Subchapter 3. The DEQ does not adopt Federal regulations prospectively.

The State Hazardous waste management program (“State Program”) now has in place the statutory authority and regulations for all required components of Checklists 222, 223, and 224 in Cluster XX. These statutory and regulatory provisions were developed to ensure the State program is equivalent to, consistent with and no less stringent than the Federal Hazardous waste management program.

The Environmental Quality Act, at 27A O.S. Section 1-3-101(E), grants the Oklahoma Corporation Commission (“OCC”) authority to regulate certain aspects of the oil and gas production and transportation industry in Oklahoma, including certain wastes generated by pipelines, bulk fuel sales terminals and certain tank farms, as well as underground storage tanks. To clarify areas of environmental jurisdiction, the ODEQ and OCC developed an ODEQ/OCC Jurisdictional Guidance Document to identify respective areas of jurisdiction. The current ODEQ/OCC jurisdictional Guidance Document was amended and signed on January 27, 1999. The revisions to the State Program necessary to administer Cluster XX will not affect the jurisdictional authorities of the ODEQ or OCC.

The Board adopted RCRA Cluster XX amendments on November 16, 2010 and became effective on July 1, 2011. The rules were also codified at OAC 252:205 et seq., Subchapter 3.

Pursuant to OAC 252:205-3-2, the State's incorporation of Federal regulations does not incorporate prospectively future changes to the incorporated sections of the 40 CFR, and no other Oklahoma law or regulation reduces the scope of coverage or otherwise affects the authority provided by these incorporated-by-reference provisions. Further, Oklahoma interprets these incorporated provisions to provide identical authority to the Federal provisions. Thus, OAC Title 252, Chapter 205 provides equivalent and no less stringent authority than the Federal Subtitle C program in effect July 1, 2011. The State of Oklahoma incorporate by reference the provisions of 40 Code of Federal Regulations (CFR) parts 124 of 40 CFR that are required by 40 CFR 271.14 (with the addition of 40 CFR 124.19(a) through (c), 124.19(e), 124.31, 124.32, 124.33 and Subpart G); 40 CFR parts 260-268 [with the exception of 260.21, 262 Subparts E and H, 264.1(f), 264.1(g)(12), 264.149, 264.150, 264.301(1), 264.1030(d), 264.1050(g), 264.1080(e), 264.1080(f), 264.1080(g), 265.1(c)(4), 265.1(g)(12), 265.149, 265.150, 265.1030(c), 265.1050(f) 265.1080(e), 265.1080(f), 265.1080(g), 268.5, 268.6, 268.13, 268.42(b), and 268.44(a) through (g)]; 40 CFR part 270 [with the exception of 270.1(c)(2) (ix and 270.14(b)(18)]; 40 CFR part 273; and 40 CFR part 279.

The DEQ is the lead Department to cooperate and share information with the EPA for purpose of hazardous waste regulation.

Pursuant to 27A O.S. Section 2-7-104, the Executive Director has created the Land Protection Division (LPD) to be responsible for implementing the State Program. The LPD is staffed with personnel that have the technical background and expertise to effectively implement the provisions of the State program subtitle C Hazardous waste management program.

On December 20, 2011, the State of Oklahoma submitted final complete program applications, seeking authorization of their changes in accordance with 40 CFR 271.21. We now make an immediate final decision, subject to receipt of written comments that oppose this action that the State of Oklahoma's hazardous waste program revision satisfies all of the requirements necessary to qualify for final authorization. The State of Oklahoma revisions consist of regulations which specifically govern Federal Hazardous waste revisions promulgated from July 1, 2009 through June 31, 2010 (RCRA Cluster XX). Oklahoma requirements are included in a chart with this document.

There are no State requirements that are more stringent or broader in scope than the Federal requirements.

Oklahoma will issue permits for all the provisions for which it is authorized and will administer the permits it issues. The EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization. We will not issue any more new permits or new portions of permits for the provisions listed in the Table in this document after the effective date of this authorization. The EPA will continue to implement and issue permits for HSWA requirements for which Oklahoma is not yet authorized.

Section 8 U.S.C. 1151 does not affect the State of Oklahoma because under section 10211(a) of the Safe, Accountable, Flexible, Efficient Transportation Equity Act of 2005 (“SAFETEA”), Public Law 109-59, 119 Statute 1144 (August 10, 2005) provides the State of Oklahoma opportunity to request approval from EPA to administer RCRA subtitle C in Indian Country and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA).

Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the CFR. We do this by referencing the authorized State rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272, subpart LL for this authorization of Oklahoma's program changes until a later date. In this authorization application the EPA is not codifying the rules documented in this Federal Register notice.

The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. The reference to Executive Order 13563 (76 FR 3821, January 21, 2011) is also exempt from review under Executive orders 12866 (56 FR 51735, October 4, 1993). This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify 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. ). Because this action authorizes preexisting requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action 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 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule 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 under Executive Order 12866.

Under RCRA 3006(b), the EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a State authorization application to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. 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, 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 document 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 in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective May 14, 2012.

In 1980, Congress enacted the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601-9675 (“CERCLA” or “the Act”), in response to the dangers of uncontrolled releases or threatened releases of hazardous substances, and releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. CERCLA was amended on October 17, 1986, by the Superfund Amendments and Reauthorization Act (“SARA”), Public Law 99-499, 100 Stat. 1613 et seq.

To implement CERCLA, the EPA promulgated the revised National Oil and Hazardous Substances Pollution Contingency Plan (“NCP”), 40 CFR part 300, on July 16, 1982 (47 FR 31180), pursuant to CERCLA section 105 and Executive Order 12316 (46 FR 42237, August 20, 1981). The NCP sets guidelines and procedures for responding to releases and threatened releases of hazardous substances, or releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. The EPA has revised the NCP on several occasions. The most recent comprehensive revision was on March 8, 1990 (55 FR 8666).

As required under section 105(a)(8)(A) of CERCLA, the NCP also includes “criteria for determining priorities among releases or threatened releases throughout the United States for the purpose of taking remedial action and, to the extent practicable, taking into account the potential urgency of such action, for the purpose of taking removal action.” “Removal” actions are defined broadly and include a wide range of actions taken to study, clean up, prevent or otherwise address releases and threatened releases of hazardous substances, pollutants or contaminants (42 U.S.C. 9601(23)).

The NPL is a list of national priorities among the known or threatened releases of hazardous substances, pollutants, or contaminants throughout the United States. The list, which is appendix B of the NCP (40 CFR part 300), was required under section 105(a)(8)(B) of CERCLA, as amended. Section 105(a)(8)(B) defines the NPL as a list of “releases” and the highest priority “facilities” and requires that the NPL be revised at least annually. The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is of only limited significance, however, as it does not assign liability to any party or to the owner of any specific property. Also, placing a site on the NPL does not mean that any remedial or removal action necessarily need be taken.

For purposes of listing, the NPL includes two sections, one of sites that are generally evaluated and cleaned up by the EPA (the “General Superfund Section”) and one of sites that are owned or operated by other Federal agencies (the “Federal Facilities Section”). With respect to sites in the Federal Facilities Section, these sites are generally being addressed by other Federal agencies. Under Executive Order 12580 (52 FR 2923, January 29, 1987) and CERCLA section 120, each Federal agency is responsible for carrying out most response actions at facilities under its own jurisdiction, custody or control, although the EPA is responsible for preparing a Hazard Ranking System (“HRS”) score and determining whether the facility is placed on the NPL.

There are three mechanisms for placing sites on the NPL for possible remedial action (see 40 CFR 300.425(c) of the NCP): (1) A site may be included on the NPL if it scores sufficiently high on the HRS, which the EPA promulgated as appendix A of the NCP (40 CFR part 300). The HRS serves as a screening tool to evaluate the relative potential of uncontrolled hazardous substances, pollutants or contaminants to pose a threat to human health or the environment. On December 14, 1990 (55 FR 51532), the EPA promulgated revisions to the HRS partly in response to CERCLA section 105(c), added by SARA. The revised HRS evaluates four pathways: ground water, surface water, soil exposure and air. As a matter of agency policy, those sites that score 28.50 or greater on the HRS are eligible for the NPL. (2) Pursuant to 42 U.S.C. 9605(a)(8)(B), each state may designate a single site as its top priority to be listed on the NPL, without any HRS score. This provision of CERCLA requires that, to the extent practicable, the NPL include one facility designated by each state as the greatest danger to public health, welfare or the environment among known facilities in the state. This mechanism for listing is set out in the NCP at 40 CFR 300.425(c)(2). (3) The third mechanism for listing, included in the NCP at 40 CFR 300.425(c)(3), allows certain sites to be listed without any HRS score, if all of the following conditions are met:

• The Agency for Toxic Substances and Disease Registry (ATSDR) of the U.S. Public Health Service has issued a health advisory that recommends dissociation of individuals from the release.

• The EPA determines that the release poses a significant threat to public health.

• The EPA anticipates that it will be more cost-effective to use its remedial authority than to use its removal authority to respond to the release.

The EPA promulgated an original NPL of 406 sites on September 8, 1983 (48 FR 40658) and generally has updated it at least annually.

A site may undergo remedial action financed by the Trust Fund established under CERCLA (commonly referred to as the “Superfund”) only after it is placed on the NPL, as provided in the NCP at 40 CFR 300.425(b)(1). (“Remedial actions” are those “consistent with a permanent remedy, taken instead of or in addition to removal actions. * * *” 42 U.S.C. 9601(24).) However, under 40 CFR 300.425(b)(2), placing a site on the NPL “does not imply that monies will be expended.” The EPA may pursue other appropriate authorities to respond to the releases, including enforcement action under CERCLA and other laws.

The NPL does not describe releases in precise geographical terms; it would be neither feasible nor consistent with the limited purpose of the NPL (to identify releases that are priorities for further evaluation), for it to do so. Indeed, the precise nature and extent of the site are typically not known at the time of listing.

Although a CERCLA “facility” is broadly defined to include any area where a hazardous substance has “come to be located” (CERCLA section 101(9)), the listing process itself is not intended to define or reflect the boundaries of such facilities or releases. Of course, HRS data (if the HRS is used to list a site) upon which the NPL placement was based will, to some extent, describe the release(s) at issue. That is, the NPL site would include all releases evaluated as part of that HRS analysis.

When a site is listed, the approach generally used to describe the relevant release(s) is to delineate a geographical area (usually the area within an installation or plant boundaries) and identify the site by reference to that area. However, the NPL site is not necessarily coextensive with the boundaries of the installation or plant, and the boundaries of the installation or plant are not necessarily the “boundaries” of the site. Rather, the site consists of all contaminated areas within the area used to identify the site, as well as any other location where that contamination has come to be located, or from where that contamination came.

In other words, while geographic terms are often used to designate the site (e.g., the “Jones Co. plant site”) in terms of the property owned by a particular party, the site, properly understood, is not limited to that property (e.g., it may extend beyond the property due to contaminant migration), and conversely may not occupy the full extent of the property (e.g., where there are uncontaminated parts of the identified property, they may not be, strictly speaking, part of the “site”). The “site” is thus neither equal to, nor confined by, the boundaries of any specific property that may give the site its name, and the name itself should not be read to imply that this site is coextensive with the entire area within the property boundary of the installation or plant. In addition, the site name is merely used to help identify the geographic location of the contamination, and is not meant to constitute any determination of liability at a site. For example, the name “Jones Co. plant site,” does not imply that the Jones company is responsible for the contamination located on the plant site.

EPA regulations provide that the Remedial Investigation (“RI”) “is a process undertaken * * * to determine the nature and extent of the problem presented by the release” as more information is developed on site contamination, and which is generally performed in an interactive fashion with the Feasibility Study (“FS”) (40 CFR 300.5). During the RI/FS process, the release may be found to be larger or smaller than was originally thought, as more is learned about the source(s) and the migration of the contamination. However, the HRS inquiry focuses on an evaluation of the threat posed and therefore the boundaries of the release need not be exactly defined. Moreover, it generally is impossible to discover the full extent of where the contamination “has come to be located” before all necessary studies and remedial work are completed at a site. Indeed, the known boundaries of the contamination can be expected to change over time. Thus, in most cases, it may be impossible to describe the boundaries of a release with absolute certainty.

Further, as noted above, NPL listing does not assign liability to any party or to the owner of any specific property. Thus, if a party does not believe it is liable for releases on discrete parcels of property, it can submit supporting information to the agency at any time after it receives notice it is a potentially responsible party.

For these reasons, the NPL need not be amended as further research reveals more information about the location of the contamination or release.

The EPA may delete sites from the NPL where no further response is appropriate under Superfund, as explained in the NCP at 40 CFR 300.425(e). This section also provides that the EPA shall consult with states on proposed deletions and shall consider whether any of the following criteria have been met:

(i) Responsible parties or other persons have implemented all appropriate response actions required;

(ii) All appropriate Superfund-financed response has been implemented and no further response action is required; or

(iii) The remedial investigation has shown the release poses no significant threat to public health or the environment, and taking of remedial measures is not appropriate.

In November 1995, the EPA initiated a policy to delete portions of NPL sites where cleanup is complete (60 FR 55465, November 1, 1995). Total site cleanup may take many years, while portions of the site may have been cleaned up and made available for productive use.

The EPA also has developed an NPL construction completion list (“CCL”) to simplify its system of categorizing sites and to better communicate the successful completion of cleanup activities (58 FR 12142, March 2, 1993). Inclusion of a site on the CCL has no legal significance.

Sites qualify for the CCL when: (1) Any necessary physical construction is complete, whether or not final cleanup levels or other requirements have been achieved; (2) the EPA has determined that the response action should be limited to measures that do not involve construction (e.g., institutional controls); or (3) the site qualifies for deletion from the NPL. For the most up-to-date information on the CCL, see the EPA's Internet site at http://www.epa.gov/superfund /cleanup/ccl.htm

The Sitewide Ready for Anticipated Use measure represents important Superfund accomplishments and the measure reflects the high priority the EPA places on considering anticipated future land use as part of our remedy selection process. See Guidance for Implementing the Sitewide Ready-for-Reuse Measure, May 24, 2006, OSWER 9365.0-36. This measure applies to final and deleted sites where construction is complete, all cleanup goals have been achieved, and all institutional or other controls are in place. The EPA has been successful on many occasions in carrying out remedial actions that ensure protectiveness of human health and the environment for current and future land uses, in a manner that allows contaminated properties to be restored to environmental and economic vitality. For further information, please go to http://www.epa.gov/superfund/programs/recycle/tools/index.html.

Yes, documents relating to the evaluation and scoring of the sites in this final rule are contained in dockets located both at the EPA Headquarters and in the Regional offices.

An electronic version of the public docket is available through www.regulations.gov (see table below for Docket Identification numbers). Although not all Docket materials may be available electronically, you may still access any of the publicly available Docket materials through the Docket facilities identified below in section II D.

The Headquarters Docket for this rule contains, for each site, the HRS score sheets, the Documentation Record describing the information used to compute the score, pertinent information regarding statutory requirements or the EPA listing policies that affect the site and a list of documents referenced in the Documentation Record. For sites that received comments during the comment period, the Headquarters Docket also contains a Support Document that includes the EPA's responses to comments.

The Regional Dockets contain all the information in the Headquarters Docket, plus the actual reference documents containing the data principally relied upon by the EPA in calculating or evaluating the HRS score for the sites located in their Region. These reference documents are available only in the Regional Dockets. For sites that received comments during the comment period, the Regional Docket also contains a Support Document that includes the EPA's responses to comments.

You may view the documents, by appointment only, after the publication of this rule. The hours of operation for the Headquarters Docket are from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. Please contact the Regional Dockets for hours.

Following is the contact information for the EPA Headquarters: Docket Coordinator, Headquarters; U.S. Environmental Protection Agency; CERCLA Docket Office; 1301 Constitution Avenue NW.; EPA West, Room 3334, Washington, DC 20004, 202/566-0276.

The contact information for the Regional Dockets is as follows:

You may obtain a current list of NPL sites via the Internet at http://www.epa.gov/superfund/sites/npl/index.htm or by contacting the Superfund Docket (see contact information above).

This final rule adds the following nine sites to the NPL, all to the General Superfund Section. All of the sites included in this final rulemaking are being added to the NPL based on HRS scores of 28.50 or above. The sites are presented in the table below:

The EPA reviewed all comments received on the sites in this rule and responded to all relevant comments. This rule adds nine sites to the NPL.

Five sites received no comments: Corozal Well (PR); Metro Container Corporation (PA); Continental Cleaners (FL); Southeastern Wood Preserving (MS); and Compass Plaza Well TCE (MO).

Four sites being placed on the NPL received comments specifically related to the HRS score and these are being addressed in response to comment support documents available concurrent with this final rule: Eighteenmile Creek (NY); Sauer Dump (MD); Chemfax, Inc. (MS); and CTS of Asheville, Inc. (NC).

Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the agency must determine whether a regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities or the principles set forth in the Executive Order.

No. The listing of sites on the NPL does not impose any obligations on any entities. The listing does not set standards or a regulatory regime and imposes no liability or costs. Any liability under CERCLA exists irrespective of whether a site is listed. It has been determined that this action is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to OMB review.

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations, after initial display in the preamble of the final rules, are listed in 40 CFR part 9.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. the EPA has determined that the PRA does not apply because this rule does not contain any information collection requirements that require approval of the OMB.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purposes of collecting, validating and verifying information, processing and maintaining information and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

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. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996) whenever an 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 governmental jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies 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.

This rule listing sites on the NPL does not impose any obligations on any group, including small entities. This rule also does not establish standards or requirements that any small entity must meet, and imposes no direct costs on any small entity. Whether an entity, small or otherwise, is liable for response costs for a release of hazardous substances depends on whether that entity is liable under CERCLA 107(a). Any such liability exists regardless of whether the site is listed on the NPL through this rulemaking. Thus, this rule does not impose any requirements on any small entities. For the foregoing reasons, I certify that this rule will not have a significant economic impact on a substantial number of small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on state, local and tribal governments and the private sector. Under section 202 of the UMRA, the EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “federal mandates” that may result in expenditures by state, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. Before the EPA promulgates a rule where a written statement is needed, section 205 of the UMRA generally requires the EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows the EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before the EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of the EPA regulatory proposals with significant Federal intergovernmental mandates and informing, educating and advising 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. Listing a site on the NPL does not itself impose any costs. Listing does not mean that the EPA necessarily will undertake remedial action. Nor does listing require any action by a private party or determine liability for response costs. Costs that arise out of site responses result from site-specific decisions regarding what actions to take, not directly from the act of placing a site on the NPL. Thus, this rule is not subject to the requirements of section 202 and 205 of UMRA.

This 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. As is mentioned above, site listing does not impose any costs and would not require any action of a small government.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires the EPA to develop an accountable process to ensure “meaningful and timely input by state and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” are defined in the Executive Order to include regulations that have “substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.”

This final rule does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it does not contain any requirements applicable to states or other levels of government. Thus, the requirements of the Executive Order do not apply to this final rule.

The EPA believes, however, that this final rule may be of significant interest to state governments. In the spirit of Executive Order 13132, and consistent with the EPA policy to promote communications between the EPA and state and local governments, the EPA therefore consulted with state officials and/or representatives of state governments early in the process of developing the rule to permit them to have meaningful and timely input into its development. All sites included in this final rule were referred to the EPA by states for listing. For all sites in this rule, the EPA received letters of support either from the Governor or a state official who was delegated the authority by the Governor to speak on their behalf regarding NPL listing decisions.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), requires the EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” are defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”

This final rule does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). Listing a site on the NPL does not impose any costs on a tribe or require a tribe to take remedial action. Thus, Executive Order 13175 does not apply to this final rule.

Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that the EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency.

This rule is not subject to Executive Order 13045 because it is not an economically significant rule as defined by Executive Order 12866, and because the agency does not have reason to believe the environmental health or safety risks addressed by this section present a disproportionate risk to children.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use” (66 FR 28355 (May 22, 2001)), requires Federal agencies to prepare a “Statement of Energy Effects” when undertaking certain regulatory actions. A Statement of Energy Effects describes the adverse effects of a “significant energy action” on energy supply, distribution and use, reasonable alternatives to the action and the expected effects of the alternatives on energy supply, distribution and use.

This action is not a “significant energy action” as defined in Executive Order 13211, because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. Further, the agency has concluded that this final rule is not likely to have any adverse energy impacts because adding a site to the NPL does not require an entity to conduct any action that would require energy use, let alone that which would significantly affect energy supply, distribution, or usage. Thus, Executive Order 13175 does not apply to this action.

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.

No. This rulemaking does not involve technical standards. Therefore, the EPA did not consider 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 does not affect the level of protection provided to human health or the environment. As this rule does not impose any enforceable duty upon state, tribal or local governments, this rule will neither increase nor decrease environmental protection.

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 has submitted 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).

Provisions of the Congressional Review Act (CRA) or section 305 of CERCLA may alter the effective date of this regulation.

Under the CRA, 5 U.S.C. 801(a), before a rule can take effect, the Federal agency promulgating the rule must submit a report to each House of the Congress and to the Comptroller General. This report must contain a copy of the rule, a concise general statement relating to the rule (including whether it is a major rule), a copy of the cost-benefit analysis of the rule (if any), the agency's actions relevant to provisions of the Regulatory Flexibility Act (affecting small businesses) and the Unfunded Mandates Reform Act of 1995 (describing unfunded Federal requirements imposed on state and local governments and the private sector) and any other relevant information or requirements and any relevant Executive Orders.

The EPA has submitted a report under the CRA for this rule. The rule will take effect, as provided by law, within 30 days of publication of this document, since it is not a major rule. Section 804(2) defines a major rule as any rule that the Administrator of the Office of Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB) finds has resulted in or is likely to result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, state or local government agencies or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. NPL listing is not a major rule because, as explained above, the listing, itself, imposes no monetary costs on any person. It establishes no enforceable duties, does not establish that the EPA necessarily will undertake remedial action, nor does it require any action by any party or determine liability for site response costs. Costs that arise out of site responses result from site-by-site decisions about what actions to take, not directly from the act of listing itself. Section 801(a)(3) provides for a delay in the effective date of major rules after this report is submitted.

Under 5 U.S.C. 801(b)(1), a rule shall not take effect, or continue in effect, if Congress enacts (and the President signs) a joint resolution of disapproval, described under section 802.

Another statutory provision that may affect this rule is CERCLA section 305, which provides for a legislative veto of regulations promulgated under CERCLA. Although INS v. Chadha, 462 U.S. 919,103 S. Ct. 2764 (1983), and Bd. of Regents of the University of Washington v. EPA, 86 F.3d 1214,1222 (DC Cir. 1996), cast the validity of the legislative veto into question, the EPA has transmitted a copy of this regulation to the Secretary of the Senate and the Clerk of the House of Representatives.

If action by Congress under either the CRA or CERCLA section 305 calls the effective date of this regulation into question, the EPA will publish a document of clarification in the Federal Register .

40 CFR part 300 is amended as follows:

The fishery for coastal migratory pelagic fish (king mackerel, Spanish mackerel, and cobia) is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils (Councils) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

Based on the Councils' recommended total allowable catch and the allocation ratios in the FMP, on April 30, 2001 (66 FR 17368, March 30, 2001) NMFS implemented a commercial quota of 2.25 million lb (1.02 million kg) for the eastern zone (Florida) of the Gulf migratory group of king mackerel. That quota is further divided into separate quotas for the Florida east coast subzone and the northern and southern Florida west coast subzones. The quota implemented for the Florida east coast subzone is 1,040,625 lb (472,020 kg)(50 CFR 622.42(c)(1)(i)(A)( 1 )).

Under 50 CFR 622.43(a), NMFS is required to close any segment of the king mackerel commercial sector when its quota has been reached, or is projected to be reached, by filing a notification at the Office of the Federal Register. NMFS has determined the commercial quota for Gulf group king mackerel in the Florida east coast subzone will be reached by March 14, 2012. Accordingly, the commercial sector for Gulf group king mackerel in the east coast subzone is closed effective 12:01 a.m., local time, March 14, 2012, through March 31, 2012, the end of the fishing year.

From November 1 through March 31 the Florida east coast subzone of the Gulf group king mackerel is that part of the eastern zone north of 25°20.4′ N. lat. (a line directly east from the Miami-Dade/Monroe County, FL, boundary) to 29°25′ N. lat. (a line directly east from the Flagler/Volusia County, FL, boundary). Beginning April 1, the boundary between Atlantic and Gulf groups of king mackerel shifts south and west to the Monroe/Collier County boundary on the west coast of Florida. From April 1 through October 31, king mackerel harvested along the east coast of Florida, including all of Monroe County, are considered to be Atlantic group king mackerel.

During the closure period, no person aboard a vessel for which a commercial permit for king mackerel has been issued may fish for or retain Gulf group king mackerel in Federal waters of the closed subzone. There is one exception, however, for a person aboard a charter vessel or headboat. A person aboard a vessel that has a valid charter/headboat permit and also has a commercial king mackerel permit for coastal migratory pelagic fish may continue to retain king mackerel in or from the closed subzone under the 2-fish daily bag limit, provided the vessel is operating as a charter vessel or headboat. Charter vessels or headboats that hold a commercial king mackerel permit are considered to be operating as a charter vessel or headboat when they carry a passenger who pays a fee or when more than three persons are aboard, including operator and crew.

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

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

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

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