The regulations in 9 CFR parts 93, 94, 95, and 96 (referred to below as the regulations) govern the importation of certain animals, birds, poultry, meat, other animal products and byproducts, hay, and straw into the United States in order to prevent the introduction of various animal diseases, including bovine spongiform encephalopathy (BSE). BSE is a neurological disease of cattle and is not known to exist in the United States.

It appears that BSE is primarily spread through the use of ruminant feed containing protein and other products from ruminants infected with BSE. Therefore, BSE could become established in the United States if materials carrying the BSE agent, such as certain meat, animal products, and animal byproducts from ruminants, are imported into the United States and are fed to ruminants in the United States. BSE could also become established in the United States if ruminants with BSE are imported into the United States.

Sections 94.18, 95.4, and 96.2 of the regulations prohibit or restrict the importation of certain meat and other animal products and byproducts from ruminants that have been in regions in which BSE exists or in which there is an undue risk of introducing BSE into the United States. In § 94.18, paragraph (a)(1) lists the regions in which BSE exists. Paragraph (a)(2) lists the regions that present an undue risk of introducing BSE into the United States because their import requirements are less restrictive than those that would be acceptable for import into the United States and/or because the regions have inadequate surveillance. Paragraph (b) of § 94.18 prohibits the importation of fresh, frozen, and chilled meat, meat products, and most other edible products of ruminants that have been in any region listed in paragraph (a)(1) or (a)(2). Paragraph (c) of § 94.18 restricts the importation of gelatin derived from ruminants that have been in any of these regions. Section 95.4 prohibits or restricts the importation of certain byproducts from ruminants that have been in any of those regions, and § 96.2 prohibits the importation of casings, except stomach casings, from ruminants that have been in any of these regions. Additionally, the regulations in 9 CFR part 93 pertaining to the importation of live animals provide that the Animal and Plant Health Inspection Service may deny the importation of ruminants from regions where a communicable disease such as BSE exists and from regions that present risks of introducing communicable diseases into the United States (see § 93.404(a)(3)).

Currently, the Czech Republic is among the regions listed in § 94.18(a)(2), which are regions that present an undue risk of introducing BSE into the United States. However, on June 8, 2001, a case of BSE was confirmed in a native-born animal in the Czech Republic. Therefore, in order to update the disease status of this region regarding BSE, we are amending the regulations by removing the Czech Republic from the list in § 94.18(a)(2) of regions that present an undue risk of introducing BSE into the United States and adding the Czech Republic to the list in § 94.18(a)(1) of regions where BSE is known to exist. The effect of this action is a continued restriction on the importation of ruminants that have been in the Czech Republic and on the importation of meat, meat products, and certain other products and byproducts of ruminants that have been in the Czech Republic. We are making these amendments effective retroactively to June 8, 2001, which is the date that BSE was confirmed in a native-born animal in that region.

This rulemaking is necessary on an emergency basis to update the disease status of the Czech Republic regarding BSE. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register .

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register . The document will include a discussion of any comments we receive and any amendments we are making to the rule as a result of the comments.

This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review process required under Executive Order 12866.

We are amending the regulations by adding the Czech Republic to the list of regions where BSE exists because the disease has been detected in native-born animals in that region. The Czech Republic is currently listed among the regions that present an undue risk of introducing BSE into the United States. Regardless of which of the two lists a region is on, the same restrictions apply to the importation of ruminants and meat, meat products, and most other products and byproducts of ruminants that have been in the region. Therefore, this action, which is necessary in order to update the disease status of the Czech Republic regarding BSE, will not result in any change in the restrictions that apply to the importation of ruminants and meat, meat products, and certain other products and byproducts of ruminants that have been in the Czech Republic.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has retroactive effect to June 8, 2001; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

This interim rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

In rule FR Doc. 01-24005 published on September 26, 2001, (66 FR 49093) make the following corrections:

On October 3, 2001, the Federal Aviation Administration (FAA) issued Emergency Airworthiness Directive (AD) 2001-20-51, applicable to Rolls-Royce Corporation (formerly Allison Engine Company) models 250-C20, -C20B, -C20F, -C20R, -C20R/1, -C20R/2, -C20S, and -C20W turboshaft engines, and 250-B17, -B17C, -B17D, -B17E, -B17F, -B17F/1, and -B17F/2 turboprop engines, which requires replacement of any helical torquemeter gearshaft assembly with 100 hours or less time-since-new (TSN) with a serviceable helical torquemeter gearshaft assembly, before further flight. That action was prompted by a report of uncontained release of power turbine blades and disk fragments caused by engine overspeed, resulting in an uncommanded engine shutdown, engine fire, and damage to the aircraft. This condition, if not corrected, could result in uncontained release of power turbine blades and disk fragments caused by engine overspeed, resulting in an uncommanded engine shutdown, engine fire, and damage to the aircraft. Since that Emergency AD was issued, it has been found that engine model 250-C20J was inadvertantly omitted from emergency AD 2001-20-51, and is added to the applicability section of this AD.

Since the unsafe condition described is likely to exist or develop on other engines of the same type design, the FAA issued emergency AD 2001-20-51 to prevent uncontained release of power turbine blades and disk fragments caused by engine overspeed, resulting in an uncommanded engine shutdown, engine fire, and damage to the aircraft. This AD requires replacement of any helical torquemeter gearshaft assembly with 100 hours or less time-since-new (TSN) with a serviceable helical torquemeter gearshaft assembly, before further flight.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunuty for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2001-NE-38.” The postcard will be date stamped and returned to the commenter.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

(f) This amendment becomes effective December 19, 2001.

Schering-Plough Animal Health Corp., 1095 Morris Ave., P.O. Box 3182, Union, NJ 07083, filed a supplement to NADA 140-951 that provides for use of CLINACOX (0.2 percent diclazuril) Type A medicated article to make Type B and Type C medicated turkey feeds used for the prevention of coccidiosis caused by Eimeria adenoeides , E. gallopavonis , and E. meleagrimitis . The NADA is approved as of September 21, 2001, and the regulations are being amended in §§ 556.175 and 558.198 (21 CFR 556.175 and 558.198) to reflect the approval. In addition, § 556.175 is being redesignated as § 556.185 to place it in alphabetical order in 21 CFR part 556. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of each application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning September 21, 2001, because the application contains substantial evidence of the effectiveness of the drug involved, any studies of animal safety or, in the case of food-producing animals, human food safety studies (other than bioequivalence or residue studies) required for approval of the application and conducted or sponsored by the applicant.

The agency has carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, “ * * * a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * *; and rules and regulations consistent with regulations issued by the Secretary pursuant to the Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Utah program on January 21, 1981. You can find background information on the Utah program, including the Secretary's findings, the disposition of comments, and the conditions of approval of the Utah program in the January 21, 1981, Federal Register (46 FR 5899). You also can find later actions concerning Utah's program and program amendments 30 CFR 944.15 and 944.30.

By letter dated March 20, 1998 (administrative record number UT-1103), Utah sent to us an amendment to its program (SPATS No. UT-037-FOR, administrative record number 1105) under SMCRA (30 U.S.C. 1201 et seq. ). Utah sent the amendment in response to a June 5, 1996, letter (administrative record number UT-1083) that we sent to the State in accordance with 30 CFR 732.17(c).

Changes to the Utah Administrative Rules (Utah Admin. R.) that the State proposed included: Adding definitions for “material damage,” “non-commercial building,” “occupied residential dwelling and structures related thereto,” “replacement of water supply,” and “State-appropriated water supply” at Utah Admin R. 645-100-200; adding requirements at Utah Admin. R. 645-301-525.100 through -525.130 for pre-subsidence surveys; removing existing requirements for subsidence control plans at Utah Admin. R. 645-301-525 through -525.170; recodifying rules at Utah Admin. R. 645-301-525.200 through -525.240 pertaining to protected areas; removing existing requirements for subsidence control at Utah Admin. R. 645-301-525.200 through -525.232; adding requirements at Utah Admin. R. 645-301-525.300 through -525.490 for subsidence control and subsidence control plans; adding requirements for subsidence damage repair at Utah Admin. R. 645-301-525.500 through -525.530; adding a rebuttable presumption of causation by subsidence at Utah Admin. R. 645-301-525.540 through -525.545; adding provisions at Utah Admin. R. 645-301-525.550 for adjusting bond amounts for subsidence damage; recodifying rules at Utah Admin. R. 645-301-525.600 and 645-301-525.700 that require compliance with approved subsidence control plans and public notice of proposed mining, respectively; removing existing provisions for surveys of renewable resource lands at Utah Admin. R. 645-301-724.600; adding a provision at Utah Admin. R. 645-301-728.350 for finding whether underground coal mining and reclamation activities might contaminate, diminish or interrupt State-appropriated water; and adding a requirement at Utah Admin. R. 645-301-731.530 for replacing State-appropriated water supplies that are contaminated, diminished, or interrupted by underground coal mining activities.

We announced receipt of the proposed amendment in the April 8, 1998, Federal Register (63 FR 17138). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the amendment's adequacy (administrative record number UT-1108). We did not hold a public hearing or meeting because nobody requested one. The public comment period ended on May 8, 1998. We received comments from two law firms on behalf of a special service district, a water conservancy district, an irrigation company, and a water users association. We also received comments from a mining association, the State Historic Preservation Officer, and two Federal agencies.

During our review of the amendment, we identified a concern relating to Utah's use of the undefined term “underground mining activities” at proposed Utah Admin. R. 645-301-731.530, which is entitled “State-appropriated water supply.” We discussed our concern with Utah in telephone conversations on April 29 and May 11, 1998 (administrative record numbers UT-1111 and UT-1113, respectively).

Utah formally responded in a letter dated May 13, 1998, that its use of the undefined term was an oversight (administrative record number UT-1115). In the same letter, the State committed to replacing the undefined term “underground mining activities” with its defined term “underground coal mining and reclamation activities” in its rules, though its May 13 letter was sufficient to revise the proposed amendment. Based on Utah's response, we decided that reopening the comment period was not necessary and continued our review of the amendment. Utah promulgated a rule that includes the defined term on September 30, 1998 (Utah Division of Administrative Rules (DAR) file number 21334).

We completed our review of the amendment and the comments we received and identified five topics of concern. Two of those topics involved pre-subsidence surveys and contents of subsidence control plans. They appeared to require changes in Utah's proposed rules. The remaining three topics required additional clarification from Utah on the scope of the terms “State-appropriated water” and “State-appropriated water supply,” the scope of water replacement with respect to “developed” water supplies, and of the proposed definition of “replacement of water supply.” We notified Utah of our concerns in a letter dated October 1, 1998 (administrative record number UT-1125).

In a letter dated July 8, 1999 (administrative record number UT-1131), Utah notified us that the Huntington-Cleveland Irrigation Company filed a civil action in the State's Seventh Judicial District Court challenging the proposed water replacement rules included in this amendment. At Utah's request, we suspended our review of the amendment while the State addressed the legal and technical issues involved in that litigation.

On December 22, 1999, we suspended certain Federal regulations pertaining to subsidence in relation to underground mining as a result of the April 27, 1999, decision of the U.S. Court of Appeals for the District of Columbia in National Mining Association v. Babbitt , 173 F.3d 906 (1999). We suspended the part of 30 CFR 784.20(a)(3) that required a pre-subsidence survey of certain structures within an angle of draw unless the permit applicant was denied access to do such a survey by the structure owner(s). We also suspended 30 CFR 817.121(c)(4) (i) through (iv) in their entirety. Those regulations established an angle of draw and created a rebuttable presumption that subsidence damage to structures protected under section 2504 of the Energy Policy Act of 1992 (Pub.L. 102-486, 106 Stat. 2776; hereafter “EPAct”), and section 720 of SMCRA (as revised by EPAct) within an area defined by an angle of draw was caused by the underground mining operation. We notified Utah of the suspension by electronic mail on December 22, 1999, and included the December 22, 1999, Federal Register notice of that suspension with our message (64 FR 71652; administrative record number 1132).

In a letter dated September 1, 2000 (administrative record number UT-1144), Utah asked us to resume our review of the amendment, noting that litigation of the proposed water replacement rules would continue. The State also committed to respond to our October 1, 1998, issue letter.

Utah responded to our October 1, 1998, letter with a letter dated October 31, 2000 (administrative record number 1145). The State revised two proposed rules in its amendment and provided additional clarification on three topics. However, the State's response showed that it did not revise its proposed amendment in light of our December 22, 1999, suspension of 30 CFR 784.20(a)(3) and 817.121(c)(4) (i) through (iv). We discussed this with Utah in a telephone conversation on November 8, 2000 (administrative record number 1146), at which time the State agreed to consider whether it would revise its amendment in light of our suspension of those Federal regulations. A follow-up telephone conversation of November 21, 2000 (administrative record number UT-1148), confirmed that Utah wanted us to review the amendment as originally submitted on March 20, 1998, corrected on May 13, 1998, and addressed in its October 31, 2000, response to our issue letter without further revisions related to our suspension of the Federal regulations.

We announced receipt of revisions to the amendment in the February 20, 2001, Federal Register (66 FR 10866; administrative record number UT-1157). In the same document, we reopened the public comment period for 15 days to provide for review of the changes and additional information Utah included in its October 31, 2000, response letter. The extended comment period closed on March 7, 2001.

Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 731.17. We are approving the amendment as described below.

Utah proposed minor recodification changes to the following previously approved rules (with the counterpart Federal regulations shown in parentheses):

Utah Admin. R. 645-301-525.240 through -525.270, areas protected from underground mining and subsidence, recodified as 645-301-525.200 through -525.240 (30 CFR 817.121(d) through (g));

Utah Admin. R. 645-301-525.220, compliance with approved subsidence control plan, recodified as 645-301-525.600 (30 CFR 817.121(a)(3)(b)); and

Utah Admin. R. 645-301-525.300, public notice of proposed mining, recodified as 645-301-525.700 (30 CFR 817.122).

Because these changes are minor and non-substantive in nature, we find that they will not make Utah's rules less effective than the corresponding Federal regulations.

Utah proposed revisions to the following rules containing language that is the same as, or similar to, the corresponding Federal regulations (which are listed in parentheses):

Utah Admin. R. 645-100-200, addition of new definitions of “material damage” and “occupied residential dwelling and structures related thereto” (30 CFR 701.5);

Utah Admin. R. 645-301-525.300 through -525.313, addition of new subsidence control provisions for preventing or minimizing damage, replacing existing Utah Admin. R. 645-301-525.200 and -525.210, which are removed (30 CFR 817.121(a)(1) through (a)(3));

Utah Admin. R. 645-301-525.410, new requirement for a description in the subsidence control plan of the coal removal method, replacing the existing provision at Utah Admin. R. 645-301-525.110, which is removed (30 CFR 784.20(b)(1));

Utah Admin. R. 645-301-525.420, new requirement for a map to be in the subsidence control plan showing underground workings where planned subsidence is expected and identifying areas where subsidence will be minimized and where subsidence-related damage will be minimized and corrected (30 CFR 784.20(b)(2));

Utah Admin. R. 645-301-525.430, new requirement for a description to be in the subsidence control plan of physical conditions affecting subsidence, replacing existing Utah Admin. R. 645-301-525.120, which is removed (30 CFR 784.20(b)(3));

Utah Admin. R. 645-301-525.440, new requirement for a description to be in the subsidence control plan of subsidence monitoring to be done, replacing existing Utah Admin. R. 645-301-525.140, which is removed (30 CFR 784.20(b)(4));

Utah Admin. R. 645-301-525.450 through -525.460, new requirement for a description to be in the subsidence control plan of subsidence control measures, replacing existing Utah Admin. R. 645-301-525.130 through -525.134 and Utah Admin. R. 645-301-525.150, which are removed (30 CFR 784.29(b)(5) through (b)(6));

Utah Admin. R. 645-301-525.470, new requirement for a description to be in the subsidence control plan of methods to minimize damage from planned subsidence (30 CFR 784.20(b)(7));

Utah Admin. R. 645-301-525.500, new section heading added for repair of damage, replacing the existing introductory statement at Utah Admin. R. 645-301-525.230, which is removed (30 CFR 817.121(c));

Utah Admin. R. 645-301-525.510, new rule requiring repair of subsidence damage to surface lands, replacing existing Utah Admin. R. 645-301-525.231, which is removed (30 CFR 817.121(c)(1));

Utah Admin. R. 645-301-525.520, new rule requiring repair of, or compensation for, subsidence damage to non-commercial buildings and related structures, replacing, in part, existing Utah Admin. R. 645-301-525.232, which is removed (30 CFR 817.121(c)(2)); and

Utah Admin. R. 645-301-525.545, new provision added for information to be considered in determining the cause of damage (30 CFR 817.121(c)(4)(v)).

Because these rules contain language that has the same meaning as the corresponding Federal regulations, we find that they are no less effective than the Federal regulations. We also find that they satisfy item numbers B.2 and B.4 in their entirety, and C.3, D.2, and D.3 in part, of our June 5, 1996, 30 CFR part 732 letter.

Utah proposed to add the definition of “non-commercial building” at Utah Admin. R. 645-100-200 as follows:

Utah's proposed definition and the Federal definition of “non-commercial building” reference definitions of the terms “community or institutional building” and “public building.” The definition of “public building” at Utah Admin. R. 645-100-200 is virtually identical to the Federal definition of “public building” at 30 CFR 761.5. Utah's definition of “community or institutional building” at Utah Admin. R. 645-100-200 differs slightly from the Federal definition of that term. Utah's version includes the phrase “* * * functions including, but not limited to * * *” in the second clause of the sentence in which building functions are described. By including this phrase, Utah's definition includes community or institutional buildings within the scope of non-commercial buildings if they function as educational, cultural, historic, religious, scientific, correctional, mental-health or physical-health care facilities and those serving other unnamed functions as well. Structures included in the Federal definition of “community or institutional buildings” are limited to those serving the functions specifically listed.

The effect of this difference is to extend the protections against material damage caused by subsidence provided by Utah Admin. R. 645-301-525.100 through -525.700 to potentially more structures than encompassed by the Federal definition. Essentially, under Utah's proposed definition: More buildings may be subject to pre-subsidence surveys; permittees may be required to prevent or minimize subsidence-related damage to more buildings; subsidence control plans may have to describe methods to be used to minimize damage to more buildings from planned subsidence; and more buildings may be subject to provisions for repair or compensation for subsidence-related damage.

We note that part of the Federal regulation at 30 CFR 784.20(a)(3) concerning pre-subsidence surveys is suspended and that 30 CFR 817.121(c)(4)(i) through (iv) concerning the rebuttable presumption of causation by subsidence are suspended in their entirety. In part, Utah's proposed definition invokes subsidence protections in its rules the Federal counterparts to which are among the suspended regulations. That does not, however, make Utah's proposed definition inconsistent with SMCRA or less effective than the Federal regulations. Section 505(b) of SMCRA specifically states “Any provision of any State law or regulation in effect on the date of enactment of this Act, or which may become effective thereafter, which provides for the control and regulation of surface mining and reclamation operations for which no provision is contained in this Act shall not be construed to be inconsistent with this Act.” This final rule describes the details of the suspended Federal regulations and its effect on Utah's proposed rules in greater detail in our findings concerning the State's proposed pre-subsidence survey rules, subsidence control plan contents, and the rebuttable presumption at parts III.C.6, III.C. 7, and III.C.9, respectively.

Based on the reasoning we described above, Utah's proposed definition of “non-commercial building” is no less effective than the counterpart Federal definition and is not inconsistent with SMCRA. It also satisfies item B.3 of our June 5, 1996, 30 CFR part 732 letter.

Utah proposed the definition of “State-appropriated water supply” at Utah Admin. R. 645-100-200 as follows:

Utah's proposed definition of “State-appropriated water supply” is based on its use of the term “State-appropriated water” at Utah Code Annotated (UCA) 40-10-18(15)(c). As written in that section of the Code,

In a January 29, 1997, letter clarifying the proposed use of the term “State-appropriated water” at UCA 40-10-18(15)(c) in amendment UT-035-FOR (administrative record number UT-1094), the State noted that it conferred and agreed with Utah water users and coal operators on use of that term. Utah wrote:

The SMCRA counterpart to UCA 40-10-29(1) is found at section 717(a).

Utah further explained that existing statutes at Title 73 of the Utah Code Annotated govern all waters of the State. Utah wrote:

Utah asserted that use of “State-appropriated water” in its statute, therefore, provided broader water replacement protection than the Federal provision for underground mining activities which is limited to “drinking, domestic or residential water supply” from a well or spring. For example, Utah noted that State-appropriated agricultural irrigation and industrial water must be replaced under its provision. We agreed with Utah and approved the State's use of “State-appropriated water” at UCA 40-10-18(15)(c) as no less stringent than section 720(a)(2) of SMCRA (62 FR 41845, August 4, 1997; finding number 7).

We received public comments on amendment UT-037-FOR that questioned the scope of Utah's proposed water replacement provisions (administrative record number UT-1112). One commenter specifically wrote that

The comment raised a question concerning the State's January 29, 1997, clarification that “State-appropriated water” covers all legal uses of water in Utah. It also prompted the need for clarification of Utah's proposed definition of “State-appropriated water supply” in this amendment.

We have previously said that section 717(a) of SMCRA requires deference to State water law on questions of water allocation and use ( See 60 FR 16722, 16733; March 31, 1995). Utah's definition of “State-appropriated water supply” defers to existing State law in its recognition of State-created water rights. In its October 31, 2000, letter, Utah explained that, under UCA 73-3-5, the State can recognize water claims established by diversion (“diligence rights”) before statehood and before the State Engineer's office was established. As a result, the scope of “State-appropriated water” includes territorial water rights (Utah provided this explanation in response to a question we asked in our October 1, 1998, letter that was prompted by a public comment. See Part IV.1 of this final rule for that discussion of “pre-statehood” water rights). Utah asserts that “State-appropriated water supply” includes all legal water uses and that all legal uses of water in Utah must be appropriated by the State under provisions of the Utah Code. The term therefore includes water from wells and springs and any appurtenant delivery systems providing water for direct human consumption or household use as does the Federal definition of “drinking, domestic or residential water supply.” It also extends protection to other water uses not included in the Federal definition of the term “drinking, domestic or residential water supply,” such as water used only for agricultural or industrial needs.

Based on the State's explanation that the term “State-appropriated water supply” encompasses the “universe of legal water uses by the universe of legal water users” in Utah, we find Utah's proposed definition of “State-appropriated water supply” at Utah Admin. R. 645-100-200 to be no less effective than the Federal definition of “drinking, domestic or residential water supply” at 30 CFR 701.5. It also satisfies item B.1 of our June 5, 1996, 30 CFR part 732 letter.

Utah proposed the definition of “replacement of water supply” at Utah Admin. R. 645-100-200 as follows:

Under Utah's proposed definition, those water supplies subject to being replaced are State-appropriated water supplies contaminated, diminished, or interrupted by coal mining and reclamation operations. The Federal definition is similar but differs by extending replacement protection to “protected water supplies” that are adversely affected by “coal mining operations.”

As explained in the previous finding at Part III.C.2 of this final rule, the State's proposed definition of “State-appropriated water supply” at Utah Admin. R. 645-100-200 includes the same water supplies that are included under the Federal counterpart definition of “drinking, domestic or residential water supply” at 30 CFR 701.5. In addition, as Utah explained in its January 29, 1997, clarification (administrative record number UT-1094), the State's term includes other water supplies such as water for agricultural and industrial needs. The term “protected water supplies” used in the Federal definition of “replacement of water supply” is not defined. However, the performance standard for water replacement at 30 CFR 817.41(j) identifies water supplies to be replaced as “* * * any drinking, domestic or residential water supply that is contaminated, diminished, or interrupted by underground mining activities * * *.” Such water supplies are included in Utah's definition of “State-appropriated water supply” as supported by the underlying definition of “State-appropriated water” in UCA 40-10-18(15)(c). In its January 29, 1997, clarification, the State further explained that “State-appropriated water” includes all legal water uses in Utah.

Utah's proposed definition of “replacement of water supply” requires replacement of an adversely affected “State-appropriated water supply,” which, in turn, is based on the term “State-appropriated water” as used at UCA 40-10-18(15)(c). That statutory provision addresses replacement of water adversely affected by underground coal mining operations. Utah clarified the scope of the term “State-appropriated water” in its January 29, 1997, letter as covering all legitimate water uses, including State-appropriated agricultural irrigation and industrial water. However, defining “replacement of water supply” in terms of “State-appropriated water supply” appeared to establish the scope of “replacement of water supply” in terms of underground coal mining operations only. As we explained in the preamble to the final rule approving the Federal counterpart definition of “replacement of water supply” (60 FR 16722, 16726; March 31, 1995), the Federal definition applies to underground and surface coal mining operations that affect water supplies. Our explanation added that the final rule is intended to apply to replacement of water supply under sections 717(b) and 720(a)(2) of SMCRA, which are the Federal counterparts to UCA 40-10-29(2) and 40-10-18(15)(c), respectively. Reference to “protected water supplies” in the Federal definition of “replacement of water supply” is broad enough to include water adversely affected by surface and underground operations.

In our October 1, 1998, letter (administrative record number UT-1125), we asked Utah to clarify its proposed definition of “replacement of water supply.” We specifically asked Utah to clarify whether its term, as proposed to require replacement of adversely affected State-appropriated water supplies, requires replacement of water adversely affected by surface and underground coal mining operations under UCA 40-10-18(15)(c) and 40-10-29(2).

Utah responded to our request for clarification in its October 31, 2000, letter (administrative record number UT-1145). In its response, Utah wrote:

We received public comments concerning the scope of Utah's proposed water replacement rules in amendment UT-037-FOR (administrative record number UT-1112). Several comments suggested expanding Utah's water replacement provisions and are addressed under Part IV of this final rule.

In responses to comments the State received during its rulemaking process, Utah explained that it intends to require replacement of “developed” water supplies through its proposed water replacement rules (administrative record number UT-1119). That interpretation of the State's proposed rules does not appear to be consistent with its January 29, 1997, letter clarifying use of the underlying term “State-appropriated water” at UCA 40-10-18(15)(c). As asserted in that letter, any State-appropriated water covers the universe of legal Utah water uses by the universe of legal water users. Depending on what Utah considers “developed” water supplies to be, we believed some waters covered by the term “State-appropriated water” in the Utah Code might not be included in the proposed definition of “State-appropriated water supply” or covered by various rules incorporating that term throughout the proposed amendment.

In our October 1, 1998, letter, we asked Utah to describe what constitutes a “developed” water supply in its interpretation of its proposed rules. We also asked Utah to clarify how its interpretation is consistent with its interpretation of the term “State-appropriated water” at UCA 40-10-18(15)(c). Utah responded to our request for clarification in its October 31, 2000, letter by stating, “The Division interprets that a “State-Appropriated Water Supply” includes the drinking, domestic, and residential water supplies of a water user.”

As we explained above and in our finding for the proposed definition of “replacement of water supply,” the State's proposed definition of “State-appropriated water supply” at Utah Admin. R. 645-100-200 includes the same water supplies included under the Federal definition of “drinking, domestic or residential water supply” at 30 CFR 701.5. Utah also explained in its January 29, 1997, clarification that its term includes other water supplies such as those supplying water for agricultural or industrial needs. The scope of water supply replacement under Utah's proposed definition of “replacement of water supply” is potentially broader than that provided by the Federal definition of “replacement of water supply” by virtue of the State's use of the term “State-appropriated water supplies” to identify water supplies subject to being replaced if contaminated, diminished, or interrupted by “coal mining and reclamation operations.”

For these reasons, we find Utah's proposed definition of “replacement of water supply” is no less effective than the Federal definition. It also satisfies item B.5 of our June 5, 1996, 30 CFR part 732 letter.

Utah proposed to delete the introductory statement at Utah Admin. R. 645-301-525 as well as its existing survey provisions at Utah Admin. R. 645-301-525.100 and 645-301-724.600. The State proposes to replace those rules with new rules introducing the subsidence control plan provisions in general and the pre-subsidence survey provisions at Utah Admin. R. 645-301-525 through -525.130.

In proposed section R645-301-525.100, Utah introduces the subsections on subsidence control plans and pre-subsidence survey requirements as pertaining to “underground coal mining and reclamation activities.” Use of that term is consistent with Utah's definition of the same term at R645-100-200. Though the Federal regulation at 30 CFR 784.20 does not contain a similar qualifying statement, part 784 of the 30 CFR regulations is entitled, “UNDERGROUND MINING PERMIT APPLICATIONS—MINIMUM REQUIREMENTS FOR RECLAMATION AND OPERATION PLAN” and includes section 784.20.

Utah's proposed section R645-301-525.110 differs from the Federal counterpart regulation at 30 CFR 784.20(a)(1) in two ways. First, it refers to a larger map scale required, if necessary, by the “Division” as compared to “the regulatory authority” in the Federal regulations. Second, it requires such maps to show the location and type of “State-appropriated water” compared to the Federal term, “drinking, domestic, and residential water supplies.” The Division [of Oil, Gas and Mining] is the regulatory authority in Utah. As we explained in our finding for Utah's proposed definition of “State-appropriated water supply” at Part III.C.2 of this final rule, the State's use of this term is based its use of the term “State-appropriated water” in the statutory provision for water replacement at Utah Code Annotated 40-10-18(15)(c). We approved Utah's use of “State-appropriated water” in the Utah Code as no less stringent than the term “drinking, domestic, or residential water supply” at section 720(a)(2) of SMCRA in the August 4, 1997, final rule Federal Register (62 FR 4185).

The requirement at proposed Utah Admin. R. 645-301-525.120 for a narrative indicating if subsidence could materially damage or diminish the value or use of structures or renewable resource lands or adversely affect water supplies differs from the counterpart Federal regulation at 30 CFR 784.20(a)(2) only in Utah's use of the term “State-appropriated water supplies.” As explained above, we find this term to be no less effective than the counterpart Federal term “drinking, domestic or residential water supplies.”

Proposed Utah Admin. R. 645-301-525.130 requires a survey of the quantity and quality of all “State-appropriated water supplies” within the permit and adjacent areas that could be contaminated, diminished, or interrupted by subsidence. The counterpart Federal regulation also requires such a survey, but of the quantity and quality of “drinking, domestic, or residential water supplies.” As explained above, we find this term to be no less effective than the Federal term “drinking, domestic or residential water supplies.”

This same proposed rule also requires a permittee to give written notification to property owners who deny access to conduct surveys of buildings, dwellings, other structures, and water supplies of the effect denial will have as “described in R645-301-525.543.” Utah's original amendment contained a reference to Utah Admin. R. 645-301-525. In our October 1, 1998, letter (administrative record number UT-1125), we notified Utah of our concern that its reference should be more specific to ensure that applicants provide sufficient notice to owners that there will be no presumption of causation by subsidence if the owners deny applicants access to perform pre-subsidence surveys. Utah responded in its October 31, 2000, letter (administrative record number UT-1145) by changing the reference to cite Utah Admin. R. 645-301-525.543. The referenced rule provides that a rebuttable presumption does not exist if the permittee is denied access to conduct a pre-subsidence survey. Under proposed Utah Admin. R. 645-301-525.541, if material damage occurs to any noncommercial building, occupied residential dwelling, or related structure as a result of earth movement within the angle of draw from the outer boundary of underground mine workings to the land surface, a rebuttable presumption exists that the permittee caused the damage. Though the presumption can be rebutted, if it is not, the permittee must repair or compensate property owners for such damage under proposed Utah Admin. R. 645-301-525.520. Utah committed to promulgating the change proposed in its October 31, 2000, letter in its formal rulemaking process.

Proposed Utah Admin. R. 645-301-525.130 also requires permittees to give copies of the pre-subsidence survey and any technical assessment or engineering evaluation to the property owner and the “Division.” The Federal regulation at 30 CFR 784.20(a)(3) requires copies to be given to the property owner and the “regulatory authority,” which is the Division in Utah's case.

We note that the State based proposed Utah Admin. R. 6445-301-525.130 on the Federal regulation at 30 CFR 784.10(a)(3), part of which we suspended after our initial review of Utah's amendment. The last sentence of 30 CFR 784.20(a)(3) states “* * * the requirements to perform a survey of the condition of all noncommercial buildings or occupied residential dwellings and structures related thereto, that may be materially damaged or for which the reasonably foreseeable use may be diminished by subsidence, within the areas encompasses by the applicable angle of draw is suspended per court order.”

In its April 27, 1999, decision in National Mining Association v. Babbitt, 173 F.3d 906 (1999), the United States Court of Appeals for the District of Columbia vacated certain parts of the Federal subsidence regulations that were among those published on March 31, 1995, under SMCRA and section 2504 of the Energy Policy Act of 1992 (“EPAct;” Pub. L. 102-486, 106 Stat.2776 (1992)). EPAct added a new section 720 to SMCRA. Section 720 requires underground mine operators to repair or to compensate for material damage to residential structures and noncommercial buildings, and to replace drinking, domestic, or residential water supplies adversely affected by underground mining. The Federal regulation at 30 CFR 817.121(c)(4)(i) through (iv) provided that, if damage to any non-commercial building or occupied residential dwelling or related structures occurred as a result of earth movement in an area determined by projecting a specific angle of draw from the outer-most boundary of any underground mine workings to the surface of the land, a rebuttable presumption would exist that the permittee caused the damage. The presumption typically would have applied to a 30-degree angle of draw. The Court of Appeals vacated 30 CFR 817.121(c)(4)(i) through (iv) in their entirety. As we explained in the December 22, 1999, Federal Register (64 FR 71652), “* * * the Court rejected the Secretary's contention that the angle of draw concept was reasonably based on technical and scientific assessments and that it logically connected the surface area that could be damaged from earth movement to the underground mining operation. The angle of draw provided the basis for establishing the surface area within which the rebuttable presumption would apply * * *.” The Court held that the angle of draw was irrationally broad and that the scientific facts presented did not support the logical inference that damage to the surface area would be caused by earth movement from underground mining within the area.

Based on the conclusion that there was no scientific or technical basis provided for establishing a rational connection between the angle of draw and surface area damage, the Court further concluded that the rebuttable presumption failed. Essentially, the Court found that “* * * for the presumption to be permissible, the facts would have to demonstrate that the earth movement from the underground mining operation ‘more likely than not’ caused the damage at the surface * * *.” We suspended 30 CFR 817.121(c)(4)(i) through (iv) in the December 22, 1999, final rule to comply with the Court's decision.

The Court also vacated the part of 30 CFR 784.20(a)(3) that required a specific structural condition survey of all EPAct-protected structures located within an area defined by an angle of draw. As we explained in the December 22, 1999, final rule:

Utah declined to revise its amendment in light of the suspended Federal regulations (administrative record number UT-1148). The fact that we suspended the part of 30 CFR 784.20(a)(3) requiring a pre-subsidence structural condition survey of EPAct-protected structures within the area defined by an angle of draw does not preclude Utah from having that provision in its rules. In addition, Utah's proposal to include such a provision in its rules does not make Utah's proposed rule less effective than the Federal regulations or less stringent than SMCRA. Section 505(b) of SMCRA provides that “Any provision of any State law or regulation in effect on the date of enactment of this Act, or which may become effective thereafter, which provides for the control and regulation of surface mining and reclamation operations for which no provision is contained in this Act shall not be construed to be inconsistent with this Act.” The State promulgated proposed Utah Admin. R. 645-301-525.130 on March 15, 1998. In addition, this proposed rule provides for the control and regulation of surface mining and reclamation operations in accordance with section 505(b) of SMCRA. 0

Therefore, based on the reasoning presented above, we find proposed Utah Admin. R. 645-301-525 through -525.120 are no less effective than the counterpart Federal regulations, and proposed Utah Admin. R. 645-301-525.130 is not inconsistent with SMCRA or the Federal regulations. The State's proposal to remove existing provisions at Utah Admin. R. 645-301-525 through -525.100 and at 645-301-724.600 is appropriate in light of the new provisions it is adding.

Utah proposes to add new provisions at Utah Admin. R. 645-301-525.400 through -525.490 describing information that must be included in subsidence control plans. It also proposes to remove existing provisions for subsidence control plans at Utah Admin. R. 645-301-525.110 through -525.170.

Proposed R645-301-525.400, which describes the conditions under which a pre-subsidence survey is to be conducted and what it information it must contain, differs somewhat from the Federal counterpart regulation at 30 CFR 784.20(b). Utah's rule refers to surveys conducted under “R645-301-525.100” where the Federal regulation refers to surveys conducted “under paragraph (a) of this section.” The Federal reference is to 30 CFR 784.20(a), which introduces the pre-subsidence survey requirements of subsections (a)(1) through (a)(3). Referenced R645-301-525.100, as also proposed in this amendment, is Utah's counterpart to 30 CFR 784.20(a). Proposed R645-301-525.400 also refers to surveying for the existence of “State-appropriated water supplies” and the need for a permit application to include a subsidence control plan if a survey shows such water supplies exist or could be adversely affected by subsidence. As we explained previously in this final rule, we find the State's term “State-appropriated water supply” to be no less effective than the Federal term “drinking, domestic, or residential water supply.” Additionally, references in proposed R645-301-525.400 to the “Division” are analogous to the counterpart Federal regulation's references to the “regulatory authority” because the Division is the regulatory authority in Utah.

Proposed Utah Admin. R. 645-301-525.480 requires subsidence control plans to include a description of measures to be taken “in accordance with R645-301-731.530 and R645-301-525.500 to replace adversely affected State-appropriated water supplies or to mitigate or remedy any subsidence-related material damage to the land and protected structures * * *.” The counterpart Federal regulation at 30 CFR 784.20(b)(8) requires a description of measures taken to replace “protected water supplies” and to mitigate or remedy subsidence damage to land and protected structures in accordance with “ * * * §§ 817.41(j) and 817.121(c) of this chapter * * *.” Referenced Utah Admin. R. 645-301-731.530 and 645-301-525.500 in Utah's proposed rule are the State's counterparts to OSM's performance standards for water replacement and surface damage repair at 30 CFR 817.41(j) and 817.121(c), respectively. We explained previously in our finding at Part III.C.3 of this final rule that, while the Federal regulations do not define “protected water supplies,” 30 CFR 817.41(j) clearly identifies a protected water supply subject to replacement as a “drinking, domestic, or residential water supply.” We also previously found that the State's term “State-appropriated water supply” is no less effective than the Federal term “drinking, domestic, or residential water supply.”

Proposed Utah Admin. R. 645-301-525.490 requires subsidence control plans to include other information specified by the “Division” as needed to show the operation will be conducted according to R645-301-525.200, -525.300, -525.500, and -525.6500. In comparison, the counterpart Federal regulation at 30 CFR 784.20(b)(9) refers to the “regulatory authority” and to “ * * * § 817.121 of this chapter.” As we noted above, the Division is the regulatory authority in Utah.

In the original amendment, proposed Utah Admin. R. 645-301-525.490 only referred to Utah Admin. R. 645-301-525.300. That referenced rule includes the State's performance standards for preventing or minimizing subsidence-related damage under Utah Admin. R. 645-301-525.310 through -525.313. Referenced counterpart 30 CFR 817.121 includes a much wider range of provisions that an operation must be conducted under. Because the State's original reference was less inclusive than the referenced counterpart Federal regulation, we found originally proposed Utah Admin. R. 645-525-301.490 did not ensure that the Division will be provided with sufficient information to determine that an operation will be conducted in accordance with all applicable provisions for subsidence control. We notified Utah of our concern in our October 1, 1998, letter (administrative record number UT-1125), and advised the State that its proposed rule should include a more inclusive reference. In its October 31, 2000, response (administrative record number UT-1145), the State revised proposed Utah Admin. R. 645-301-525.490 to include references to Utah Admin. R. 645-301-525.200, -525.500, and -525.600 in addition to the original reference to -525.300. These referenced rules contain provisions analogous to those included under 30 CFR 817.121. Utah committed to promulgating this change in its formal rulemaking process.

We note that the State based proposed Utah Admin. R. 645-301-525.400, -525.480, and -525.490 on the need for a subsidence control plan when indicated by the pre-subsidence survey conducted under Utah Admin. R. 645-301-525.130. That latter rule, in turn, is based on the Federal counterpart regulation at 30 CFR 784.20(a)(3), which is suspended in part. The fact that we suspended the part of 30 CFR 784.20(a)(3) requiring a pre-subsidence structural condition survey of EPAct-protected structures within the area defined by an angle of draw does not preclude Utah from having that provision, and other provisions based on it, in its rules. As we explained previously, Utah's proposal to include provisions in its rules that are not found in SMCRA or the Federal regulations does not make Utah's proposed rules less effective than the Federal regulations or less stringent than SMCRA if those State provisions are in effect and control and regulate surface mining and reclamation operations in accordance with section 505(b) of SMCRA.

Based on these reasons, we find proposed Utah Admin. R. 645-301-525.400, -525.480, and -525.490 are no less effective than the counterpart Federal regulations and are not inconsistent with SMCRA. The State's proposal to remove existing provisions at Utah Admin. R. 645-301-525.110 through -525.170 is appropriate in light of the new provisions being added.

Proposed Utah Admin. R. 645-301-525.530 requires repair of, or compensation for, subsidence-caused damage to structures or facilities not protected by Utah Admin. R. 645-301-525.520. The Federal counterpart regulation at 30 CFR 817.121(c)(3) provides that the permittee “* * * must, to the extent required under applicable provisions of State law, * * *” correct material subsidence damage caused to any structures or facilities not protected “* * * by paragraph (c)(2) of this section * * *” by repairing damage or compensating owners for the decreased value resulting from subsidence. Utah's proposed rule does not require permittees to correct damage or compensate owners “to the extent required under applicable provisions of State law” but says they “* * * shall either correct material damage from subsidence caused to any structures or facilities not protected by paragraph 525.520 * * * ” by repairing such damage or by compensating owners for the resulting decreased value.

Utah's proposed rule extends replacement or compensation protection to structures and facilities not provided such protections under Utah Admin. R. 645-301-525.520, which is based on UCA 40-10-18(15)(b)(i). Those sections of Utah's rules and its Code, respectively, provide for repair of damage to occupied residential dwellings and related structures or noncommercial buildings caused by underground coal mining after October 24, 1992. However, they do not extend such protections to other structures damaged by subsidence as provided in proposed Utah Admin. R. 645-301-525.530. By not including a phrase corresponding to the phrase “to the extent required under applicable provisions of State law” in the counterpart Federal regulation, proposed Utah Admin. R. 645-301-525.530 is Utah's legal requirement that a permittee repair or compensate for subsidence-caused material damage to structures not protected by UCA 40-10-18(15)(b)(i) or Utah Admin. R. 645-301-525.520. As a result, there is no need to qualify the remedies available to owners of structures or facilities by the extent to which they are otherwise required under applicable provisions of State law.

Other differences between the wording in the proposed State rule and the counterpart Federal regulation do not make Utah's proposed rule less effective. Further, the State's reference to “525.520” in its proposed rule refers to Utah Admin. R. 645-301-525.520, which is Utah's counterpart to referenced “paragraph (c)(2) of this section,” or 30 CFR 817.121(c)(2), in the corresponding Federal regulation.

For these reasons, we find proposed Utah Admin. R. 645-301-525.530 is no less effective than the counterpart Federal regulation. It also satisfies item D.3 of our June 5, 1996, 30 CFR Part 732 letter.

Proposed Utah Admin. R. 645-301-525.540 through -525.544 introduce and establish a rebuttable presumption that damage sustained by certain structures was caused by mining. Proposed Utah Admin. R. 645-301-525.541 provides that, if damage occurs to any non-commercial building or occupied residential dwelling or structure related thereto as a result of subsidence in an area determined by an angle of draw from the outermost boundary of any underground workings to the land surface, there is a rebuttable presumption that the permittee caused the damage. The angle of draw normally is 30 degrees from the vertical but may be different if amended by the Division on a mine-specific basis under proposed Utah Admin. R. 645-301-525.542. Proposed Utah Admin. R. 645-301-525.543 provides for no presumption where a landowner denies a permittee access to perform a pre-subsidence survey. Finally, proposed Utah Admin. R. 645-301-525.544 provides that the presumption will be rebutted if damage predated mining, was caused by something other than subsidence, or occurred outside the surface area in which mining actually caused subsidence.

The State based its proposed rules at Utah Admin. R. 645-301-525.540 through -525.544 on the counterpart Federal regulations at 30 CFR 817.121(c)(4)(i) through (iv), which are suspended in their entirety. The fact that we suspended the Federal provisions for a rebuttable presumption of causation by subsidence at 30 CFR 817.121(c)(4)(i) through (iv) does not preclude Utah from having those provisions in its rules. In addition, Utah's proposal to include such provisions in its rules does not make Utah's proposed rules less effective than the Federal regulations or less stringent than SMCRA. Again, Utah's proposal to include provisions in its rules that are not found in SMCRA or the Federal regulations does not make Utah's proposed rules less effective than the Federal regulations or less stringent than SMCRA if those State provisions are in effect and control and regulate surface mining and reclamation operations in accordance with section 505(b) of SMCRA.

Based on this reasoning, we find proposed Utah Admin. R. 645-301-525.540, -525.541, -525.542, -525.543, and -525.544 are no less effective than the counterpart Federal regulations and are not inconsistent with SMCRA.

Proposed Utah Admin. R. 645-301-525.550 adds provisions for adjusting bond amounts when protected land, structures, or facilities are materially damaged by subsidence or when protected water supplies are contaminated, diminished, or interrupted. Utah's proposed rule references land, structures, or facilities protected under Utah Admin. R. 645-301-525.500 through -525.530. Those referenced proposed rules address protected surface lands, non-commercial buildings, dwellings, and related structures, and other structures or facilities. Parts III.B and III.C.6 of this final rule contain our findings that those rules are no less effective than the Federal regulations. The Federal counterpart to Utah Admin. R. 645-301-525.550 is 30 CFR 817.121(c)(5). It provides for adjusting bond amounts as a result of subsidence damage to the same buildings, dwellings, structures and facilities but refers to lands, buildings, structures and facilities protected under “* * * paragraphs (c)(1) through (c)(3) of this section * * *.” Those referenced paragraphs are found at 30 CFR 817.121(c)(1) through (c)(3), which correspond to referenced Utah Admin. R. 645-301-525.500 through -525.530.

Utah's proposed rule also provides for adjusting bond amounts when subsidence contaminates, diminishes, or interrupts water supplies protected under proposed Utah Admin. R. 645-301-731.530. As noted in previous findings in this final rule, Utah identifies protected water supplies as “State-appropriated water supplies.” The Federal regulation at 30 CFR 817.121(c)(5) similarly provides for bond adjustments when “* * * water supplies protected under §§ 817.41(j) * * *” are adversely affected by subsidence. Section 817.41(j) is the Federal counterpart to Utah Admin. R. 645-301-731.530 and identifies a protected water supply as a “drinking, domestic, or residential water supply.” As we explained previously, Utah's term “State-appropriated water supply” is no less effective than the Federal term “drinking, domestic, or residential water supply.”

References to the “Division” in Utah's proposed rule are analogous to the Federal regulation's reference to the “regulatory authority” because the Division is the regulatory authority in Utah.

For the reasons explained above, we find proposed Utah Admin. R. 645-301-525.550 is no less effective than the Federal regulation at 30 CFR 817.121(c)(5). The State's proposed rule also satisfies item D.5 of our June 5, 1996, 30 CFR Part 732 letter.

Proposed Utah Admin. R. 645-301-728.350 requires probable hydrologic consequences determinations to find whether underground coal mining and reclamation activities conducted after October 24, 1992, will adversely affect State-appropriated water that exists in the proposed permit or adjacent areas at the time a permit application is submitted, and that is used for legitimate purposes in those areas.

The proposed rule differs from the Federal counterpart regulation at 30 CFR 784.14(e)(3)(iv) in Utah's use of the term “State-appropriated water,” reference to use of that water for “legitimate purposes,” and reference to “underground coal mining and reclamation activities.” Utah hydrology rules at Utah Admin. R. 645-301-700 establish requirements for information that must be included in applications for surface and underground coal mining. Because proposed Utah Admin. R. 645-301-728.350 pertains to a finding that must be included in PHC determinations specific to underground mines, the reference to “underground coal mining and reclamation activities” clearly identifies it as such. Similarly, adding a semi-colon at the end of the preceding subsection at Utah Admin. R. 645-301-728.340 and the word “OR” following it distinguishes proposed Utah Admin. R. 645-301-728.350 from subsection -728.340 as a finding that must be made for underground coal mining and reclamation activities as opposed to surface coal mining and reclamation activities. Utah's term “underground coal mining and reclamation activities” includes a reference to “coal mining and reclamation activities” as both are defined at Utah Admin. R. 645-100-200. The former term is the State's counterpart to the “underground mining activities” referred to in the counterpart Federal regulations at 30 CFR 784.14(e)(3)(iv), which are defined at 30 CFR 701.5.

The term “State-appropriated water” and reference to use of that water for “legitimate purposes” in proposed Utah Admin. R. 645-301-728.350 are not inconsistent with the Federal regulations. As noted in previous findings for this amendment, Utah's statutory provision for water replacement at Utah Code Annotated (UCA) 40-10-18(15)(c) is based on the term “State-appropriated water.” As used in this proposed rule and UCA 40-10-18(15)(c) and clarified by Utah in its January 29, 1997, letter (administrative record number UT-1094), “State-appropriated water” provides broader water replacement protection than is provided under the corresponding term “drinking, domestic, or residential water supply” used in the Federal regulation for PHC findings at § 784.14(e)(3)(iv) and protected under section 720(a)(2) of SMCRA. Utah's proposed qualification that the water in existence at the time a permit application is submitted be used for “legitimate purposes” refers back to its term “State-appropriated water.” To paraphrase Utah's clarification about the term “State-appropriated water” in its January 29, 1997, letter, the only legitimate use of water in Utah is the use of water appropriated by the State. Moreover, the criterion for legitimate water use proposed at Utah Admin. R. 645-301-728.350 for underground mining is consistent with the requirement that PHC determinations include findings on the impacts of surface coal mining and reclamation activities on the source(s) of water used for domestic, agricultural, industrial, or other legitimate purpose at Utah Admin. R. 645-301-728-340 and counterpart 30 CFR 780.21(f)(3)(iii) (emphasis added).

Based on the reasons explained above, proposed Utah Admin. R. 645-301-728.350 and the proposed revision to Utah Admin. R. 645-301-728.340 are not inconsistent with, and are no less effective than, the Federal regulation at 30 CFR 784.14(e)(3)(iv). The proposed rules also satisfy item C.1 of our June 5, 1996, 30 CFR part 732 letter.

Proposed Utah Admin. R. 645-301-731.530 requires a permittee to replace any State-appropriated water supply that is contaminated, diminished, or interrupted by underground coal mining and reclamation activities conducted after October 24, 1992, if the affected water supply existed before the Division received the permit application for the activities causing the adverse effects. It also requires use of baseline hydrologic and geologic information required in Utah Admin. R. 645-301-700 to determine mining impacts on the water supply. Utah's proposed rule differs from the counterpart Federal regulation at 30 CFR 817.41(j) in its use of the terms “State-appropriated water supply,” “underground coal mining and reclamation activities,” and “Division” and by referring to Utah Admin. R. 645-301-700. The corresponding terms in the Federal regulation are “drinking, domestic or residential water supply,” “underground mining activities,” and “regulatory authority.” Also, the Federal regulation refers to baseline hydrologic information required in 30 CFR 780.21 and 784.14 and geologic information required in sections 780.21 and 784.22.

In Part IV.A of this final rule, we describe in detail commenters' concern for the scope of Utah's proposed water replacement rules and their suggestion for expanding the State's water replacement provisions (administrative record number UT-1112). As we explained above and in previous findings in this final rule, the State's proposed definition of “State-appropriated water supply” at Utah Admin. R. 645-100-200 includes those water supplies included under the Federal definition of “drinking, domestic or residential water supply” at 30 CFR 701.5. Utah explained in its January 29, 1997, clarification that its term includes other water supplies such as wells and springs that supply water for agricultural, commercial or industrial needs. Therefore, the scope of water supply replacement under Utah's proposed rule is potentially broader than that provided under the Federal definition of “replacement of water supply” by virtue of the State's use of its defined terms “State-appropriated water supplies” and “replacement of water supply” in describing those water supplies subject to replacement if contaminated, diminished, or interrupted by underground coal mining and reclamation activities.

Utah's original (March 20, 1998) submittal of this amendment required prompt replacement of water adversely affected by “underground mining activities.” While that term appears to be identical to that in the counterpart Federal regulation, it is undefined in Utah's rules and statute. In telephone conversations on April 29 and May 11, 1998, we advised Utah that use of its defined term “underground coal mining and reclamation activities” would be more appropriate (administrative record numbers UT-1111 and UT-1113, respectively). The State responded with a letter dated May 13, 1998 (administrative record number UT-1115), in which it agreed to change “underground mining activities” to “underground coal mining and reclamation activities” through formal rulemaking. Utah promulgated the corrected rule that includes the term “underground coal mining and reclamation activities” on September 30, 1998 (DAR file number 21334), which is among those we are approving in this final rule. As defined at Utah Admin. R. 645-100-200, “underground coal mining and reclamation activities” is the State's counterpart to the Federal term “underground mining activities” as defined at 30 CFR 701.5.

As noted previously, the Division is the regulatory authority in Utah.

Based on the reasons explained above, we find proposed Utah Admin. R. 645-301-731.530 is no less effective than the counterpart Federal regulation. It also satisfies item D.1 of our June 5, 1996, 30 CFR part 732 letter.

Following are summaries of all written comments on the proposed amendment that we received and our responses to those comments.

We asked for public comments on the proposed amendment as originally submitted (administrative record number UT-1106) and as revised in Utah's October 31, 2000, letter (administrative record number UT-1156). We received six comment letters, two of which attached comments from four water user groups.

The Utah Mining Association (UMA) responded in a May 5, 1998, letter, by expressing its support for the proposed amendment and urging us to approve it (administrative record number UT-1114). UMA noted that it was actively involved in developing the State legislation that enabled the rule changes. It explained how it worked with the State Engineer to ensure protection of water rights throughout the legislative process and with water users in Utah's coal regions to develop legislative language.

We also received comments submitted by two law firms on behalf of a special service district, a water conservancy district, an irrigation company, and a water users association (hereafter, collectively the “water users”) (administrative record number UT-1112). These commenters represent water users in a predominant coal mining region of Utah. The remaining discussions under Part IV.A of this final rule describe the water users' comments and our responses.

A number of water user comments proposed changes to rules that are not the subject of amendment UT-037-FOR. Those comments addressed alternative water source information for surface coal mining and reclamation activities, PHC findings and requirements concerning acid- or toxic-forming materials, discharges into underground mines, and gravity discharges. While these comments pertain to water-related issues, we find that the rules and changes they suggested do not apply to this rulemaking. However, we forwarded these comments to the State for its consideration.

One comment described Utah's proposed definition of “replacement of water supply” at Utah Admin. R. 645-100-200 as applicable only to surface mining operations. The comment based this conclusion on Utah's reference to State-appropriated water supplies adversely affected by “coal mining and reclamation operations.” It assumed that this term in Utah Admin. R. 645-100-200 is less inclusive than the term “coal mining operations” in the Federal definition of “replacement of water supply” at 30 CFR 701.5.

As defined at Utah Admin. R. 645-100-200, “coal mining and reclamation operations” includes activities conducted on the surface of lands in connection with a surface coal mine and surface coal mining and reclamation operations, as well as surface impacts incident to an underground coal mine. The phrase “surface impacts incident to an underground coal mine,” also is defined at Utah Admin. R. 645-100-200 and means all operations involved in or related to underground coal mining and reclamation activities. It includes activities conducted on the land surface, that alter or disturb the land surface, or that disturb the surface, air, or water resources of the area.

The Federal counterpart to Utah's term “coal mining and reclamation operations” is “surface coal mining operations” and is defined at section 701(28) of SMCRA. “Surface coal mining operations” includes the scope of activities included in the term “coal mining operations” as defined at 30 CFR 705.5 and 706.3, and included in the Federal definition of “replacement of water supply.” It also includes activities conducted on the surface of lands in connection with a surface coal mine as well as to surface operations and surface impacts incident to an underground coal mine. Also, as we explained in our finding at Part III.C.3. of this final rule, Utah clarified in its October 31, 2000, letter (administrative record number UT-1145) that its proposed definition of “replacement of water supply” provides for the replacement of water supplies adversely affected by “coal mining and reclamation operations.” The latter term is defined in Utah's rules to include surface and underground mining. For these reasons, we found Utah's definition of “replacement of water supply” to be no less effective than the Federal counterpart definition at 30 CFR 701.5.

Other comments suggested removing the word “supply” from Utah's definitions of “replacement of water supply” and “State-appropriated water supply,” and from references to water supply throughout Utah's proposed amendment. In some cases, comments suggested replacing the word “supply” or “supplies” with “source” or “sources” or to add the term “water sources.” While the preamble to the final rule approving the Federal definition of “replacement of water supply” indicates that circumstances could require replacement of a water source ( See 60 FR 16722, 16733, March 31, 1995), sections 717(b) and 720(a)(2) of SMCRA and the Federal regulations use the terms “supply” and “supplies.” The standard we use for review of Utah's program is that it must be no less effective than the Federal regulations and no less stringent than SMCRA. We cannot require Utah's provisions to be more stringent than SMCRA or more effective than the Federal regulations. Utah's use of the terms “supply” and “supplies” in its proposed rules is consistent with use of those terms in SMCRA and the Federal regulations. We therefore find the State's proposed rules are no less stringent than SMCRA and no less effective than the counterpart Federal regulations without the suggested changes.

Another comment suggested replacing the term “water supply owner” in Utah's proposed definition of “replacement of water supply” with “water rights holder.”

One comment also maintained that UCA 40-10-18 is not limited to water “supply” but pertains to all State-appropriated water. It also stressed that many water rights in Utah pre-date statehood and thus are not State-created, but are recognized by Utah law. Sections of the State's rules to which this comment applied include: Utah Admin. R. 645-100-200, definitions; 645-301-525.120 and 525.130, pre-subsidence survey; 645-301-525.400 and 525.480, subsidence control plan contents; 645-301-525.550, adjustment of bond amount for subsidence damage; 645-301-728.350, PHC determinations for underground coal mining and reclamation activities; and 645-301-731.530, replacement of State-appropriated water supply.

In our October 1, 1998, letter to Utah (administrative record number UT-1125), we asked the State to further clarify its interpretation of the term “State-appropriated water” to address the question of whether there are legal uses of water in Utah that fall outside the scope of “State-appropriated water.” We also asked Utah to clarify its interpretation of the proposed definition of “State-appropriated water supply” to address the assertion that legal water rights exist in the State that are recognized by Utah law but are not created by the State.

Utah responded to our request for clarification in a letter dated October 31, 2000 (administrative record number UT-1145). In its response, Utah said it has a process under Utah Code Annotated Section 73-5-13 [which it included in its letter] to recognize water claims established by diversion (“diligence rights”) before the State Engineer's office was established and before Utah became a State. Utah's response concluded that “State-appropriated water” therefore includes territorial water rights. UCA 73-5-13 is entitled, “Claim to surface or underground water not otherwise represented—Information required—Corrections—Filing—Investigation—Publication—Judicial action to determine validity—Rules.” Subsection (1)(a) provides that:

Our finding at Part III.C.2. of this final rule describes Utah's clarification of its term “State-appropriated water” at UCA 40-10-18(15)(c). We found the definition of this term to be no less effective than the counterpart Federal term “drinking, domestic, or residential water supply.” That Federal term is based on the wording of section 720(a)(2) of SMCRA as amended by EPAct and requires replacement of water supplies adversely affected by underground mining coal mining operations. Our findings at Parts III.C.2, 3, 4, 5, 9 and 10 of this final rule also explain why we find Utah's definitions and rules as proposed with the terms water “supply” or “supplies” to be no less effective than the Federal regulations. As we further explained at Part III.C.2 of this final rule, and is found at UCA 40-10-29(1), this provision supplements, but does not otherwise affect in any way, anyone's right to protect or enforce his or her interest in water resources affected by a coal mining operation.

In addition, Utah's rules contain other provisions to ensure protection of surface and ground water beyond the protections afforded by this amendment. Utah Admin. R. 645-301-728 addresses determinations of the probable hydrologic consequences of mining on surface and groundwater in proposed permit and adjacent areas. As required by Utah Admin. R. 645-301-729, for each permit application, the State develops a cumulative hydrologic impact assessment (CHIAs) of probable impacts of mining and reclamation on surface and ground water systems in the cumulative impact area. A CHIA also determines if proposed mining and reclamation is designed to prevent material damage to the hydrologic balance outside the permit area. Performance standards at Utah Admin. R. 645-301-750 et seq. require all coal mining and reclamation operations to be conducted to minimize disturbance to the hydrologic balance in the permit and adjacent areas. They also require those operations to prevent material damage to the hydrologic balance outside the permit area and to support approved postmining land uses.

One comment suggested rewording Utah's definition of “replacement of water supply” to require payment of actual delivery costs instead of costs in excess of customary and reasonable delivery costs for premining water supplies. As proposed in Utah's definition, such payment pertains to operation and maintenance costs in excess of customary and reasonable costs of premining water supply delivery. We considered payment of costs in the preamble to the final rule approving the Federal definition of “replacement of water supply” at 30 CFR 701.5 (60 FR 16722, 16726, March 31, 1995). In that discussion, we noted that payment of costs for replacement water supply operation and maintenance in excess of premining costs would ensure a water supply user or owner is made whole upon installation of the replacement supply by not passing-on to the user any additional costs beyond those that were customary and reasonable for the premining supply. The final Federal definition provides for payment of costs in excess of customary and reasonable delivery costs for premining supplies. Utah's proposed definition is no less effective than the Federal definition because it contains the same provision for payment of costs without the change suggested in the comment. As explained previously, the standard we use for review of Utah's program is that it must be no less effective than the Federal regulations and no less stringent than SMCRA. We cannot require Utah's provisions to be more stringent than SMCRA or more effective than the Federal regulations.

In another comment, water users suggested removing paragraph (b) from Utah's proposed definition of “replacement of water supply” at Utah Admin. R. 645-100-200. Paragraph (b) provides that demonstrating that a suitable alternative water source is available and could feasibly be developed will satisfy replacement requirements if the affected supply was not needed for the existing land use when it was lost, contaminated, or diminished, and if it is not needed to achieve the post mine land use. If this approach is selected, written concurrence from the supply owner must be obtained. The commenter maintained that no statutory provision excuses a permittee from the requirement to replace adversely affected State-appropriated water.

We considered similar comments in our preamble discussion of the Federal definition of “replacement of water supply” in the March 31, 1995, final rule ( Id ., at 16727). We adopted the Federal definition, including the alternative water source demonstration, to give the water supply owner the option of foregoing installation of a delivery system in circumstances in which the system was not wanted or needed. We reasoned that the provision still would require all coal mining operations to be conducted to ensure water sources remain to support existing and proposed land use by requiring the permittee to demonstrate water availability equal to premining quality and quantity. Only a water delivery system that would not be used for the postmining land use, and that was not needed for the premining land use, may be waived. We concluded that this provision ensures compliance with EPAct and section 717 of SMCRA in all essential respects, while avoiding unneeded expense. The same reasoning applies to Utah's proposed definition of “replacement of water supply.” Based on this reasoning, we believe Utah's proposed definition is no less effective than the counterpart Federal definition at 30 CFR 701.5 without the suggested change. Further, we cannot require Utah's provisions to be more stringent than SMCRA or more effective than the Federal regulations.

Four comments submitted by water users suggested that Utah should define a number of terms and create additional rebuttable presumptions to provide more protection to water rights holders. The terms included: “Promptly,” as used to describe replacement of State-appropriated water at UCA 40-10-18(15)(c) and proposed Utah Admin. R. 645-301-731.530; and “contamination of water,” “diminution of water,” and “interruption of water” as used to describe water subject to replacement at UCA 40-10-18(15)(c) and included in several rules in this amendment. The comments also suggested that these additional definitions should include rebuttable presumptions of contamination, diminution, and interruption, respectively.

The Federal counterpart to UCA 40-10-18(15(c) is section 720(a)(2) of SMCRA, as amended by EPAct. SMCRA does not define the terms “promptly,” “contamination of water,” “diminution of water,” or “interruption of water” as used in that section. We previously found UCA 40-10-18(15)(c) to be no less stringent than 720(a)(2) of SMCRA and approved it on that basis (62 FR 41845, August 4, 1997). In our discussion of comments in the preamble to the March 31, 1995, final rule, however, we decided that providing guidance on the issue of timing water supply replacement would promote consistent implementation of replacement requirements ( Id., at 16727). Guidance on “prompt” replacement, in particular, is provided in that discussion, and we intend it to help regulatory authorities decide if water supplies have been “promptly” replaced. We explained in our finding at Part III.C.3 of this final rule that we found Utah's definition of “replacement of water supply” to be no less effective than the counterpart Federal definition at 30 CFR 701.5 as proposed by the State.

SMCRA and the Federal regulations do not require presumptions of water contamination, diminution, or interruption. In the preamble to the final rule approving the Federal regulation at 30 CFR 817.121(c)(4) that established the rebuttable presumption that subsidence damaged noncommercial buildings, dwellings, and related structures, we considered comments suggesting a presumption of subsidence causation for damage to water supplies ( Id ., at 16741; Note: This pre-dated our suspension of 30 CFR 817.121(c)(4)(i) through (iv) on December 22, 1999). We did not establish a presumption for water supply damage because we believe determining the cause(s) of water supply damage does not lend itself to such a presumption. We based our conclusion, in part, on our belief that determining the cause of damage to a water supply from springs and wells can be much more complex than determining the cause of damage to surface lands and structures because the cause(s) of water supply damage can involve a potentially greater variety of geological and hydrological formations and dynamics. At the same time, we also concluded that a water supply owner's ability to have an adversely affected water supply replaced will not be inhibited by the absence of a presumption that subsidence damaged the supply. In Utah's case, if the Division ultimately proves that a water supply has been adversely affected by an underground mining operation, the permittee must promptly replace the affected supply. Consequently, we believe Utah's definition of “replacement of water supply” is no less effective than the counterpart Federal definition without the suggested presumptions.

In another comment, water users suggested adding a sentence concerning map requirements in pre-subsidence surveys to the end of the proposed paragraph at Utah Admin. R. 645-301-525.110. The suggestion would require permittees to file such maps with the State Engineer, the local conservancy district, the largest water right holder in the drainage, and the County office(s) where the permit area is located in addition to including it in the permit application. In Part III.C.4 of this final rule, we found Utah Admin. R. 645-301-525.110 is no less effective than the counterpart Federal regulation at 30 CFR 784.20(a)(1) without the provision for map submittal with a permit application as suggested by the comment. This comment would add requirements to Utah's proposed rule that go beyond the scope of the counterpart Federal regulation. As explained previously, we cannot require Utah's rules to be more effective than the Federal regulations.

In addition, however, existing State rules already require maps to be available to the public in their requirements for public participation and notice. Utah Admin. R. 645-300-121 provides for public notice of the Division's receipt of an application (including maps) in local newspapers, for making the application available for public inspection and copying at county courthouses, and notifying local governmental agencies, including planning agencies, water treatment authorities and water companies where they can inspect the complete application. Utah Admin. R. 645-300-122 provides for public comments and objections related to a permit application. Utah Admin. R. 645-300-123 provides for informal public conferences about permit applications. All permit applications (including maps) on file with the Division will be made available for public inspection and copying at reasonable times as provided by Utah Admin. R. 645-300-124.

Another comment suggested adding a statement to proposed Utah Admin. R. 645-301-525.130 requiring the [permit] applicant to consult water rights holder(s), land owner(s), and the State Engineer to determine that all springs and water sources have been properly identified, monitored, and addressed in the pre-subsidence survey. Utah's approved regulatory requirements for public participation and notice are described in the preceding paragraph's response to a similar comment. Further, the State's rules at Utah Admin. R. 645-301-700 et seq. require permit applications to include descriptions of existing hydrologic resources, including baseline information about surface and groundwater. We believe Utah Admin. R. 645-301-525.130 is not inconsistent with SMCRA and the Federal regulations as the State proposed it without the suggested additional statement.

Two water user comments suggested removing the phrase “and economically” from Utah Admin. R. 645-301-525.311 and -525.312, which require measures to respectively prevent and minimize material damage to protected structures caused by subsidence to the extent technologically and economically feasible. We considered economic feasibility in our discussion of comments in the March 31, 1995, final rule adopting the Federal subsidence control regulations ( Id., at 16734). Recognizing that some material damage to protected structures from subsidence is possible, we required that such damage must be repaired. At the same time, we did not intend to discourage use of planned and controlled subsidence mining methods or to require underground mining methods not normally associated with such operations. We did, however, intend to require reasonable measures to be taken on the surface to protect occupied residential dwellings and related structures and non-commercial buildings from material damage. In that context, we reasoned that, by requiring measures to minimize subsidence damage to non-commercial buildings and occupied residential dwellings and related structures only when technologically and economically feasible, we mitigated any potential for unreasonably expensive minimization measures by providing that the requirement does not apply if the permittee demonstrates that minimization would cost more than repair. The same rationale applies to Utah Admin. R. 645-301-525.300 through -525.313. We believe the proposed rule is no less effective than the counterpart Federal regulations without the suggested change.

One water user comment suggested adding a new provision at Utah Admin. R. 645-301-525.312.3. The suggested provision would require written consent of all holders of State-appropriated water with a source in, adjacent to, or down drainage from the permit area as a second prerequisite for waiving measures to minimize material damage to protected structures to the extent technologically and economically feasible. We cannot require Utah to make this suggested change because it goes beyond the scope of the State's proposed rules and the Federal regulations by requiring water holders' consent in connection with the potentially unrelated issue of structural damage.

One comment suggested changes to proposed Utah Admin. R. 645-301-525.400 that would add requirements for concurrence by the State Engineer on the results of pre-subsidence surveys and with determinations by the Division that structures, renewable resource lands, or water supplies will be adversely affected by subsidence. The same comment suggested replacing references to water “supplies” with water “sources.” We previously explained in this final rule that Utah's use of the terms water “supply” or “supplies” is consistent with use of the same terms in the Federal regulations and SMCRA. We also previously explained that we cannot require Utah to include provisions in its rules that are more stringent than SMCRA or more effective than the counterpart Federal regulations. Additionally, in its January 29, 1997, clarification for statutory amendment UT-035-FOR (administrative record number UT-1094) Utah recognized the State Engineer's existing authority under State water law. For these reasons, we believe Utah Admin. R. 645-301-525.400 is no less effective than the Federal counterpart regulation at 30 CFR 784.20(b) without the suggested change.

One water user comment suggested adding a statement at the end of proposed Utah Admin. R. 645-301-525.420 that would require a separate plan, as part of the subsidence control plan, to replace any State-appropriated water that could be adversely affected by subsidence. Neither SMCRA nor the Federal regulations require a separate plan for this purpose so we cannot require Utah's rules to do so. Moreover, upon approval of this amendment, Utah will have measures in place to begin corrective action when water is adversely affected. They include: the second part of Utah Admin. R. 645-301-525.420, which refers to measures described in Utah Admin. R. 645-301-525.440, -525.450, and -525.470 that will be taken, when applicable, to correct subsidence-related material damage; and Utah Admin. R. 645-301-731.530, which requires replacement of certain adversely affected water supplies, using the baseline hydrologic and geologic information required in Utah Admin. R. 645-301-700 to determine the impact(s) of mining on water supplies. We believe Utah Admin. R. 645-301-525.420 is no less effective than counterpart 30 CFR 784.20(b)(2) without requiring a “plan within a plan” to replace water adversely affected by subsidence.

In another comment, water users suggested removing the phrase “technologically and economically feasible” from proposed Utah Admin. R. 645-301-525.510, which concerns repair of damage to surface lands. The same reasoning we described in our response to water users' comments under the Subsidence Control topic in Part IV.A.4 above applies to this comment as well. We believe Utah's proposed rule has the same meaning as the counterpart Federal regulation without the suggested change.

In one comment, water users suggested changes to Utah Admin. R. 645-301-525.550, which provides for adjusting bond amounts for subsidence damage. The suggested changes would replace the term water “supply” with water “source,” remove the reference to Utah Admin. R. 645-301-731.530, and require the permittee to pay the water right holder for all damages caused by adverse effects on water or a water source if replacement does not occur within 30 days after the water or source is materially damaged. Our responses to other comments above concerning the term “water supply” explained that Utah's use of that term in its rules is consistent with the wording of the Federal regulations and SMCRA.

With respect to removing the reference to Utah Admin. R. 645-301-731.530, that rule is Utah's performance standard for water replacement. As referenced, it identifies those protected water supplies subject to replacement if adversely affected by subsidence. Such adverse effects invoke the requirement in proposed Utah Admin. R. 645-301-525.550 to adjust bond amounts sufficient to ensure replacement of water supplies if, and until, they are to be replaced. Removing the reference would render Utah Admin. R. 645-301-525.550 less effective than the counterpart Federal regulation at 30 CFR 817.121(c)(5), which similarly references the Federal performance standard for water replacement at 30 CFR 817.41(j).

The comment's suggestion to require payment of damages if replacement does not occur within 30 days after water is adversely affected is beyond the scope of payment of operation and maintenance costs provided under the State and Federal definitions of “replacement of water supply.” At the same time, however, we note that the citizen suit provisions of section 520(e) of SMCRA provide that nothing (in that section) shall restrict any right which any person may have under any statute or common law to seek enforcement of any of the provisions of SMCRA and the regulations or to seek any other relief. Utah's counterpart to section 520 of SMCRA is found at UCA 40-10-21(5).

Based on the explanations given above, we believe proposed Utah Admin. R. 645-301-525.550 is no less effective than counterpart 30 CFR 817.121(c)(5) without the suggested changes.

Two water user comments suggested significant changes to two sections of Utah's rules that the State made only minor changes to in this amendment. One comment suggested changing Utah Admin. R. 645-301-525.700, which provides for public notice of proposed mining. This amendment only proposes to recodify Utah Admin. R. 645-301-525.700 in view of the new rules being added to the same subsection. The comment's suggested change would require a mine operator to mail written notification of proposed mining to all holders of State-appropriated water rights in or adjacent to the permit area at least one year prior to mining. That notification would identify where the operator's subsidence control and water replacement plans may be examined. This suggested change is beyond the scope of Utah's proposed rulemaking because it does not address Utah's proposed change. In addition, we explained previously in Part IV.A.3 of this final rule that Utah's rules already provide for public notice and review of permit applications. Those applications would include plans for subsidence control and water replacement. Utah Admin. R. 645-300-121 provides for public notice of the Division's receipt of an application in local newspapers, for making the application available for public inspection and copying at county courthouses, and notifying local governmental agencies, including planning agencies, water treatment authorities and water companies where they can inspect the complete application. Further, all permit applications on file with the Division will be made available for public inspection and copying at reasonable times as provided by Utah Admin. R. 645-300-124.

The other comment suggested changing Utah Admin. R. 645-301-728.340, which addresses findings to be included in PHC determinations for surface coal mining and reclamation activities. Utah Admin. R. 645-301-728.340 is revised in this amendment only by the addition of a semi-colon and the word “OR” at the end of the paragraph to distinguish it from the new PHC findings requirement being added for underground mining at Utah Admin. R. 645-301-728.350. The comment's suggested change would require PHC findings to determine whether surface mining and reclamation activities conducted after October 24, 1992, would contaminate, diminish, or interrupt and underground or surface source of State-appropriated water (emphasis added). Also, it would delete the qualifying statement that such water be located within the permit or adjacent areas and be used for domestic, agricultural, industrial or other legitimate purpose. This comment does not address Utah's proposed change and is beyond the scope of the State's amendment. Nevertheless, we note that the suggested change to Utah Admin. R. 645-301-728.340 strives for consistency between that provision and the provision that follows at proposed Utah Admin. R. 645-301-728.350 for underground coal mining and reclamation activities. It is important to note that the underlying authority for proposed Utah Admin. R. 645-301-728.350 is UCA 40-10-18(15)(c), which in turn is based on section 720(a)(2) of SMCRA. Those statutory provisions require replacement of water supplies adversely affected by underground coal mining operations and do not affect existing water replacement requirements applicable to surface mining in the Federal regulations or in Utah's rules.

Though both comments are beyond the scope of this amendment, we forwarded them to the State for its consideration.

One comment suggested rewording Utah Admin. R. 645-301-728.350, which addresses findings to be included in PHC determinations for underground coal mining and reclamation activities. The comment would change the phrase “* * * may result in contamination, diminution, and interruption * * *,” which describes adverse effects of underground mining, to read, “may contaminate, diminish, and interrupt.” It also suggested adding the term “water sources” after the term “State-appropriated water” and removing the qualifying statement that water be used for legitimate purposes within the permit or adjacent areas.

As proposed with the phrase “* * * may result in contamination, diminution, or interruption * * *,” Utah Admin. R. 645-301-728.350 provides for PHC findings as to whether underground coal mining and reclamation activities may adversely affect State-appropriated water supplies directly or indirectly. The water users' suggested language potentially could limit PHC findings to findings only of direct adverse effects of underground mining and reclamation activities. That, in turn, would render Utah Admin. R. 645-301-728.350 potentially less effective than the counterpart Federal regulation at 30 CFR 784.14(e)(3)(iv).

Utah's qualifying statement “* * * and used for legitimate purposes” * * *“ at Utah Admin. R. 645-301-728.350 describing existing water use is supported by a clarification the State provided for Utah Code amendment UT-035-FOR in its January 29, 1997, letter (administrative record number UT-1094). We discussed Utah's characterization of legitimate water use in the context of PHC findings at Utah Admin. R. 645-301-728.350 in our finding at Part III.C.9 of this final rule. Further, in the same finding, we explained how Utah's qualifying statement for legitimate use is consistent with the similar provision at Utah Admin. R. 645-301-728.340 for surface coal mining and reclamation activities. Additionally, our finding at Part III.C.2 of this final rule discusses Utah's clarification of the term “State-appropriated water,” including its reference to legitimate water use. Our previous responses to other comments concerning the term “water source” in Part IV.A of this final rule explain that Utah's use of “State-appropriated water” in its rules is no less effective than the Federal regulations and is no less stringent than SMCRA.

In the same comment, water users also maintained that there is no basis for Utah Admin. R. 645-301-728.350 to qualify that water subject to the PHC finding must have been used in the permit or adjacent areas. We considered the scope of “the permit and adjacent areas” in our discussion of comments in the March 31, 1995, final rule adopting the counterpart Federal regulation at 30 CFR 784.14(e)(3)(iv) ( Id., at 16729). In that discussion, we explained that “adjacent area” includes all areas outside the permit area where resources, including wells or springs, could reasonably be expected to be adversely impacted by the proposed mining operation, including probable impacts from underground workings. The same rationale applies to the provisions of Utah Admin. R. 645-301-728.350.

We therefore conclude that Utah Admin. R. 645-301-728.350 is no less effective than the counterpart Federal regulation at 30 CFR 784.14(e)(3)(iv) as proposed with its reference to State-appropriated water, its description of PHC findings of adverse effects, and its inclusion of the provision that existing water be used for legitimate purposes.

Under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the proposed amendment from various Federal agencies with an actual or potential interest in the Utah program. We asked for comments on the amendment as Utah originally submitted it and as revised in the State's October 31, 2000, letter (administrative record numbers UT-1106 and UT-1156, respectively).

The Utah Field Office of USFWS responded to our request for comments on the original amendment in a letter dated April 21, 1998 (administrative record number UT-1110). USFWS supported the proposed amendment, noting how subsidence and water loss can impact hydrologic systems and wildlife that depend on them. Additionally, USFWS observed that the amendment appears to strengthen requirements for controlling and mitigating subsidence damage and determining and correcting water supply losses.

An office of the Manti-LaSal National Forest submitted comments on the original amendment on behalf of the USFS after the close of the first comment period (administrative record number UT-1116). Discussion of those comments and our responses follow.

One USFS comment proposed changes to Utah's definition of “replacement of water supply” at Utah Admin. R. 645-100-200. It suggested changing the last sentence of paragraph (a) of the definition to require agreement to a one-time payment of increased operation and maintenance costs by the landowner or surface management agency in addition to the permittee and the water supply owner. The comment also suggested adding another part to the definition to read:

With respect to the suggested additional part of the definition, we cannot require Utah's rules to be more effective than the Federal regulations or more stringent than SMCRA. Utah's proposed definition already provides that water replacement support existing land uses and postmining land use, as demonstrated by its provision of waivers only for replacement of adversely affected supplies not needed for the existing or postmining land uses. Further, as noted above in our response to the first part of this comment, requiring landowner or surface management agency consent could create conflict if not required by other provisions of State law. We believe Utah's definition is no less effective than the counterpart Federal definition at 30 CFR 701.5 without the suggested additional language.

Another USFS comment suggested that the part of Utah Admin. R. 645-301-525 which addresses subsidence control plans require pre-subsidence surveys of all renewable resource lands, structures, and water sources within a subsidence area whether or not the permittee determines they will be adversely affected by subsidence. The comment also asserted that limiting surveys to State-appropriated waters will generate insufficient baseline data to determine the causes and effects of subsidence because they will overlook other protected water resources.

We believe Utah's proposed rules adequately provide for pre-subsidence surveys of structures, renewable resource lands and water supplies. Proposed Utah Admin. R. 645-301-525.100 specifically requires pre-subsidence surveys in each application for underground coal mining and reclamation activities. Whether adverse effects on structures, renewable resources or State-appropriated water resulting from subsidence are expected to occur or not is the basis for determining if the subsidence control plan must include the additional information described in Utah Admin. R. 645-301-525.410 through -525.490. As provided in Utah Admin. R. 645-301-525.400, that additional information will not be required in the subsidence control plan if the survey conducted under R645-301-525.100 shows, and the Division agrees, that: No structures, State-appropriated water supplies, or renewable resource lands exist; or, that no material damage to lands or structures, or no reduction in their value or use, and no adverse effects on water supplies, would occur as a result of subsidence. Proposed Utah Admin. R. 645-301-525 through -525.120 provide the same scope of pre-subsidence surveys as required by the counterpart Federal regulations at 30 CFR 784.20(a)(1) through (a)(2). Further, proposed Utah Admin. R. 645-301-525.130 provides for pre-subsidence structural surveys within an applicable angle of draw when that part of the corresponding Federal regulation at 30 CFR 784.20(a)(3) is suspended. We explained in our findings in Parts III.C.4 and III.C.5 of this final rule that partial suspension of 30 CFR 784.20(a)(3) does not make Utah's proposed provisions for pre-subsidence surveys of EPAct protected structures and subsidence control plan content inconsistent with SMCRA.

We also believe Utah's proposed rules adequately cover protected water supplies. As explained in our findings at Part III.C.3 and III.C.10 of this final rule and in our responses to other public comments in Part IV.A, Utah's water replacement provisions are based on its use of the term “State-appropriated water” at UCA 40-10-18(15)(c). Based on clarification provided by the State, that term expands Utah's protection and replacement provisions beyond the drinking, domestic, and residential water supplies from wells or springs included under the Federal regulations and SMCRA. Further, Utah's rules require baseline hydrologic data in addition to the pre-subsidence survey requirements proposed in this amendment. Provisions at Utah Admin. R. 645-301-700 et seq. list information required in permit applications to characterize hydrologic resources, identify potential impacts of mining on those resources, and to minimize disturbance of such resources located in proposed permit and adjacent areas.

Another USFS comment suggested that Utah Admin. R. 645-301-724.600 should not be removed as proposed in this amendment. This existing rule requires a survey to determine if aquifers and recharge areas would be materially damaged or diminished by subsidence, if it occurred, from underground mining. The comment stressed the importance of aquifers and recharge areas to surface water. It also stressed the need to inventory water resources other than those appropriated by the State and to address them in the subsidence control plan to ensure protection of hydrologic systems. Proposed Utah Admin. R. 645-301-525.110, which replaces Utah Admin. R. 645-301-724.600, provides for pre-subsidence surveys to determine whether subsidence, if it occurred, would adversely affect structures, renewable resource lands and State-appropriated water. As defined at Utah Admin. R. 645-100-200, “renewable resource lands” includes aquifers, aquifer recharge areas, and other underground waters. SMCRA (as amended by EPAct) and the implementing Federal regulations extend replacement protection to drinking, domestic and residential water supplies from wells or springs. We explained previously in this final rule that Utah's protection of “State-appropriated water supplies” is no less effective than the Federal regulation and no less stringent than SMCRA because it extends protection to a wider range of water supplies. Utah clarified in its October 31, 2000, letter (administrative record number UT-1145) that, because it has a process under UCA 73-5-13 to recognize water claims established by diversion (“diligence rights”) before the State Engineer's office was established and before Utah became a State, “State-appropriated water” also includes territorial water rights. Our response to the preceding comment also showed that Utah requires baseline data for other water resources under Utah Admin. R. 645-301-700 et seq. As a result, we believe the State's proposed removal of existing Utah Admin. R. 645-301-724.600 is appropriate in light of the rules it proposed to add at Utah Admin. R. 645-301-525 through -525.130.

Under 30 CFR 732.17(h)(11)(ii), we are required to get a written agreement from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the changes Utah proposed in amendment UT-037-FOR pertain to air or water quality standards. As a result, we did not request EPA's concurrence.

Nevertheless, we provided copies of the original and revised amendments to EPA for review under 30 CFR 732.17(h)(11)(i) and asked if it had any comments (administrative record numbers UT-1106 and UT-1156). We did not receive any comments from EPA.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. In letters dated March 25, 1998, and April 6, 1998, we requested comments from the SHPO and the ACHP, respectively, on the original amendment (administrative record number UT-1106). We asked for comments on the revised amendment from the SHPO and the ACHP in letters dated January 11, 2001, (administrative record number UT-1156). We received one response from the SHPO in a letter dated April 7, 1998 (administrative record number UT-1109). In that letter, the SHPO concurred with the determination we made under the 36 CFR 800 regulations that the proposed amendment will have no effect on properties listed, or eligible for listing, on the National Register of Historic Places. We did not receive comments from the ACHP.

Based on the above findings, we approve Utah's proposed amendment as submitted on March 20, 1998, corrected on May 13, 1998, and revised on October 31, 2000.

We approve, as discussed in Part III.A: Utah Admin. R. 645-301-525.200 through 525.240, recodified rules pertaining to protected areas; Utah Admin. R. 645-301-525.600, recodified rule pertaining to compliance with the approved subsidence control plan; and Utah Admin. R. 645-301-525.700, recodified rule pertaining to public notice of proposed mining; in Part III.B: Utah Admin. R. 645-100-200, definitions of “material damage” and “occupied residential dwelling and structures related thereto;” Utah Admin. R. 645-301-525.300 through -525.313, subsidence control measures to prevent or minimize damage, replacing existing Utah Admin. R. 645-301-525.200 and -525.210, which are removed; Utah Admin. R. 645-301-525.410, description in the subsidence control plan of coal removal method(s), replacing existing Utah Admin. R. 645-301-525.110, which is removed; Utah Admin. R. 645-301-525.420, requirement for a map to be in the subsidence control plan showing underground workings where planned subsidence is suspected, areas where subsidence will be minimized, and areas where subsidence-related damage will be minimized and corrected; Utah Admin. R. 645-301-525.430, description in the subsidence control plan of physical conditions affecting subsidence, replacing existing Utah Admin. R. 645-301-525.120, which is removed; Utah Admin. R. 645-301-525.440, requirement for a description in the subsidence control plan of subsidence monitoring to be done, replacing existing Utah Admin. R. 645-301-525.140, which is removed; Utah Admin. R. 645-301-525.450 through -525.460, description in the subsidence control plan of subsidence control measures, replacing existing Utah Admin. R. 645-301-525.130 through -525.134 and Utah Admin. R. 645-301-525.150, which are removed; Utah Admin. R. 645-301-525.470, description in the subsidence control plan of methods to minimize damage from planned subsidence; Utah Admin. R. 645-301-525.500, heading “Repair of damage,” replacing existing introductory statement at Utah Admin. R. 645-301-525.230, which is removed; Utah Admin. R. 645-301-525.510, requirement to repair damage to surface lands, replacing existing Utah Admin. R. 645-301-525.231, which is removed; Utah Admin. R. 645-301-525.520, requirement to repair, or compensate for, damage to non-commercial buildings and dwellings and related structures, replacing, in part, existing Utah Admin. R. 645-301-525.232, which is removed; and Utah Admin. R. 645-301-525.545, information to be considered in determination the cause of damage; in Part III.C.1: Utah Admin. R. 645-100-200, definition of “non-commercial building;” in Part III.C.2: Utah Admin. R. 645-100-200, definition of “State-appropriated water supply;” in Part III.C.3: Utah Admin. R. 645-100-200, definition of “replacement of water supply;” in Part III.C.4: Utah Admin. R. 645-301-525 through 645-301-525.130, subsidence control plans, pre-subsidence surveys, replacing existing Utah Admin. R. 645-301-724.600, which is removed; in Part III.C.5: Utah Admin. R. 645-300-525.400, -525.480, and -525.490, subsidence control plan contents, replacing existing Utah Admin. R. 645-301-525 through -525.170, which are removed; in Part III.C.6: Utah Admin. R. 645-301-525.530, repair or compensation for damage to other structures; in Part III.C.7: Utah Admin. R. 645-301-525.540, rebuttable presumption of causation by subsidence; Utah Admin. R. 645-301-525.541, rebuttable presumption of causation for damage within angle of draw; and Utah Admin. R. 645-301- 525.542, approval of site-specific angle of draw; in Part III.C.8: Utah Admin. R. 645-301-525.550, adjustment of bond amount for subsidence damage; in Part III.C.9: Utah Admin. R. 645-301-728.340 and 728.350, probable hydrologic consequences determination for underground mining effects; and in Part III.C.10: Utah Admin. R. 645-301-731.530, replacement of State-appropriated water supply.

We approve these rules as Utah proposed them with the provision that the State fully promulgate them in a form identical to the rules submitted to, and reviewed by, OSM and the public. To implement this decision, we are amending the Federal regulations at 30 CFR part 944, which codify decisions concerning the Utah program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 405(d) of SMCRA requires that the State have a program that is in compliance with the procedures, guidelines, and requirements established under the Act. Making this regulation effectively will expedite that process. Further, SMCRA requires consistency of State and Federal standards.

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

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

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

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

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

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

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

The Department of the Interior has determined that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal that is the subject of this rule is based on counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect on a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the State. The Department relied on the data and assumptions for the counterpart Federal regulations in making the determination as to whether this rule would have a significant economic impact.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

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

OSM has determined and certifies under the Unfunded Mandates Reform Act (2 U.S.C. 1502 et seq. ) that this rule will not impose a cost of $100 million or more in any given year on any local, State, or Tribal governments or private entities.

On September 13, 2001, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations; Harlem River, New York, in the Federal Register (66 FR 47601). We received no comment letters in response to the notice of proposed rulemaking. No public hearing was requested and none was held.

The Metro North (Park Avenue) Bridge, at mile 2.1, across the Harlem River, has a vertical clearance of 25 feet at mean high water and 30 feet at mean low water. The existing drawbridge operation regulations listed at 33 CFR 117.789(e) require the bridge to open on signal, from 10 a.m. to 5 p.m., except as provided in paragraph (b).

The owner of the bridge, Metro North, requested a change to the operating regulations to allow the bridge to open on signal, from 10 a.m. to 5 p.m., after a four-hour advance notice is given.

Metro North advised the Coast Guard that all the bridge openings during the last five years were for either vessel traffic employed in the construction of the Oak Point Link railroad Bridge located upstream or Metro North test openings at the bridge. The large construction barges, with equipment such as cranes on board, generally require a bridge opening.

The vessels that frequently use this waterway on a regular basis fit under the bridges without requiring bridge openings, with the exception of the Spuyten Duyvil railroad bridge, which has only 5 feet of vertical clearance at mean high water. All the upstream bridges, with the exception of the Spuyten Duyvil railroad bridge, presently require a four-hour advance notice for bridge openings, from 10 a.m. to 5 p.m., daily.

The existing drawbridge operation regulations are consistent with regard to the four-hour advance notice requirement, from 10 a.m. to 5 p.m., daily.

In addition, all the bridges, except Spuyten Duyvil, have similar or greater vertical clearances at mean high water (MHW) and at mean low water (MLW). The clearances for the bridges on the Harlem River are as follows.

As a result of all the above information the Coast Guard believes that it is reasonable to allow the Metro North (Park Avenue) railroad bridge to open on signal, from 10 a.m. to 5 p.m., after a four-hour advance notice is given, except as provided in paragraph (b).

The Coast Guard received no comment letters. No changes will be made to this final rule.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). This conclusion is based on the fact that the bridge will continue to open for vessel traffic after the advance notice is given.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612) we considered whether this rule would have a significant economic impact on a substantial number of small entities. “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 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 conclusion is based on the fact that the bridge will open on signal after the advance notice is given.

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

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those unfunded mandate costs. This rule will not impose an unfunded mandate.

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

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

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

The Coast Guard considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (32)(e) of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation because promulgation of changes to drawbridge regulations have been found to not have a significant effect on the environment. A written “Categorical Exclusion Determination” is not required for this final rule.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have 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. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

On August 28, 1998, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations for the Missouri River in the Federal Register (63 FR 45980). No negative comments were received on the proposed rulemaking. No public hearing was requested and none was held.

In order to accommodate vessels during the winter season's low-water period, the Missouri River drawbridge operation regulations contained in 33 CFR 117.411(a) and 117.687(a) require that drawbridges on this waterway shall open on signal; except that from 16 December through the last day of February, the draws shall open on signal if at least 24 hours notice is given. Additionally, 33 CFR 117.691 requires that the draw of the Illinois Central Gulf Railroad Bridge located on the Missouri River shall open on signal; except that, from 1 December through the last day of February, the draw shall open on signal if at least 24 hours notice is given. These regulations reflect the actual dates that the ACOE had manipulated the water level on the Missouri River; however, during the past ten years, the ACOE has adopted a more flexible water-management regime. The change implemented by this final rule will bring the drawbridge operating regulations in synch with the commercial navigation season. This will be accomplished by tying the drawbridge on-demand-opening requirement to the ACOE's closure and opening of the commercial navigation season on the Missouri River.

No negative comments were received during the comment period for the Notice of Proposed Rulemaking. The rule will align the drawbridge regulations with the commercial navigation season and allow bridge owners to more efficiently manage their operations at the beginning and end of the commercial navigation season.

This rule is not a “significant regulatory action” under section 3(f) of the Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). The Coast Guard expects the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary.

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. There are no small entities involved in this rulemaking.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), 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. Any individual that qualifies, or believes he or she qualifies, as a small entity, and requires assistance with the provisions of this rule, may contact Mr. Roger K. Wiebusch, Bridge Administrator, Eighth Coast Guard District Bridge Branch, (314) 539-3900, extension 378.

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

A final 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 final rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. This rule will not impose an unfunded mandate.

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. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have considered the environmental impact of this rule and concluded that under Figure 2-1, paragraph 32(e) of Commandant Instruction M16475.1 (series), this rule is categorically excluded from further environmental documentation because promulgation of changes to drawbridge regulations have been found not to have significant effect on the human environment. This rule merely alters the time frame when the drawbridges on the Missouri River are required to open on demand. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES .

On September 11, 2001, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations; Back River, Maine, in the Federal Register (66 FR 47121). We received no comment letters in response to the notice of proposed rulemaking. No public hearing was requested and none was held. Pursuant to 5 U.S.C. 553, good cause exists for making this regulation effective in less than 30 days after publication in the Federal Register . The local fishermen haul their equipment in November and do not transit this bridge during the winter months. The bridge has not had any requests to open during the last three years December through April. Any delay encountered in this regulation's effective date would be unnecessary and contrary to the public interest since immediate action is needed to perform this necessary bridge maintenance during the winter months when the bridge normally does not receive requests to open.

The MDOT, highway bridge, at mile 4.6, across the Back River has a vertical clearance of 6 feet at mean high water and 15 feet at mean low water. The existing regulations are listed at 33 CFR 117.523.

The bridge owner, MDOT, asked the Coast Guard to temporarily change the drawbridge operation regulations to facilitate structural repairs at the bridge. This temporary rule will allow the bridge owner to keep the bridge in the closed position from December 15, 2001 through April 15, 2002. The bridge operates on a twenty-four hours advance notice from November 1 through May 31, normally. The local fishermen haul out their equipment during the month of November, after which, the bridge historically receives few requests to open. The number of bridge openings from December through April in past years have been relatively low. The bridge opening log data for December through April for the past three years is as follows:

The Coast Guard believes this rulemaking is reasonable based upon the relatively low number of bridge opening requests during past years December through April and the fact that this work is necessary maintenance required to assure continued uninterrupted operation of the bridge.

The Coast Guard received no comment letters. No changes will be made to this final rule.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). This conclusion is based on the fact that there have been few requests to open the bridge historically, during the time period that the bridge will be closed.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612) we considered whether this rule would have a significant economic impact on a substantial number of small entities. “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 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 conclusion is based on the fact that there have been few requests to open the bridge during the time period the bridge will be closed.

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

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those unfunded mandate costs. This rule will not impose an unfunded mandate.

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

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

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

The Coast Guard considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (32)(e) of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation because promulgation of changes to drawbridge regulations have been found to not have a significant effect on the environment. A written “Categorical Exclusion Determination” is not required for this final rule.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have 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. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The Witt-Penn (Route 7) Bridge has a vertical clearance in the closed position of 35 feet at mean high water and 40 feet at mean low water. The existing regulations require the draw to open on signal at all times.

The bridge owner, New Jersey Department of Transportation, has requested a temporary deviation from the drawbridge operating regulations to facilitate scheduled maintenance, the replacement of the bridge power and communications cable at the bridge. The nature of the required maintenance repairs will require the bridge to be closed to navigation during the implementation of this work.

This deviation to the operating regulations will allow the bridge to remain in the closed position from 9 a.m. on December 4, 2001 through 6 a.m. on December 7, 2001.

This deviation from the operating regulations is authorized under 33 CFR 117.35, and will be performed with all due speed in order to return the bridge to normal operation as soon as possible.

The Metro North Bridge has a vertical clearance in the closed position of 20 feet at mean high water and 27 feet at mean low water. The existing regulations are listed at 33 CFR 117.209.

The bridge owner, Metro North Railroad, has requested a temporary deviation from the drawbridge operating regulations to facilitate necessary structural maintenance at the bridge. The nature of the required structural repairs will require the bridge to be closed to navigation during the implementation of this work.

This deviation to the operating regulations will allow the bridge to remain in the closed position from 6 a.m. on November 26, 2001 through 7 p.m. on December 6, 2001; from 6 a.m. on December 10, 2001 through 7 p.m. on December 21, 2001; and from 6 a.m. on January 7, 2002 through 7 p.m. on January 16, 2002.

This deviation from the operating regulations is authorized under 33 CFR 117.35, and will be performed with all due speed in order to return the bridge to normal operation as soon as possible.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. Publishing a NPRM and delaying the rule's effective date would be contrary to the public interest since immediate action is needed to protect the public, ports and waterways of the United States. The Coast Guard will issue a broadcast notice to mariners announcing the creation of this rule and place Coast Guard or other law enforcement vessels in the vicinity of these zones to advise mariners of the restriction.

For the same reasons, 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 .

Based on the September 11, 2001, terrorist attacks on the World Trade Center buildings in New York City and the Pentagon in Arlington, Virginia, there is an increased risk that subversive activity could be launched by vessels or persons in close proximity to the Florida Power Crystal River power plant. This power plant provides critical energy to the Tampa area and contains extremely hazardous materials. The security zone for the Florida Power Corporation Channel encompasses the waters within the following points: 28° 56.87′ N, 082° 45.17′ W (Northwest corner), 28° 57.37′ N, 082° 41.92′ W (Northeast corner), 28° 56.81′ N, 082° 45.17′ W (Southwest corner), and 28° 57.32′ N, 082° 41.92′ W (Southeast corner). The security zone for the Demory Gap Channel encompasses the waters within the following points: 28° 57.61′ N, 082° 43.42′ W (Northwest corner), 28° 57.53′ N, 082° 41.88′ W (Northeast corner), 28° 57.60′ N, 082° 43.42′ W (Southwest corner), 28° 57.51′ N, 082° 41.88′ W (Southeast corner). Entry into these security zones is prohibited, unless specifically authorized by the Captain of the Port, Tampa, Florida or his designated representative.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979) because we have determined that only a small number of recreational fishermen will be affected by this regulation and there are ample areas nearby to fish that are not covered by this regulation. Moreover, vessels may be allowed to enter the zones on a case-by-case basis with the authorization of the Captain of the Port.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), the Coast Guard considered whether this rule would have a significant economic effect upon a substantial number of small entities. “Small entities” include 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 because we have determined that only a small number of recreational fishermen will be affected by this regulation and there are ample areas nearby to fish that are not covered by this regulation. Moreover, small entities may be allowed to enter these zones on a case by case basis with the authorization of the Captain of the Port.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 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. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding this rule.

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).

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

A rule has implication 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 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.

The Coast Guard considered the environmental impact of this rule and concluded under Figure 2-1, paragraph 34(g) of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation.

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 relationships 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 Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

Section 709 of title 17, United States Code provides that:

In cases of disruptions or suspensions of postal, transportation or communications services, section 709 permits the Register to assign, as the date of receipt for deposits, applications, fees and other materials submitted to the Office, the date on which the materials would have been received but for the disruption or suspension, so long as the Office has actually received the material within one month after the disruption or suspension has ended.

The Office has not promulgated any regulations relating to determination of the appropriate date of receipt of materials when a general disruption or suspension of postal or other transportation or communications services has taken place. Until now, the Office has perceived no need for such regulations. However, recent events have, unfortunately, demonstrated that such regulations are necessary. Concerns about anthrax in United States Postal Service facilities in the District of Columbia have caused severe disruptions of postal service to the Office since October 17.

Today the Register of Copyrights is publishing a separate notice declaring that commencing on October 18, there has been a general disruption of postal services to the Library of Congress. The Library continues to experience disruptions in its postal service. The Register shall publish another notice when she determines that the disruption of services has ceased.

The Office has already received one request to assign a date of receipt for a copyright registration application that was delayed due to the disruption of postal services, and it is anticipated that additional requests will be made. In order expeditiously to permit the application of section 709 to materials submitted during the current period of disruption of services, the Office is announcing interim regulations to govern such requests and the Office's determination of the date of receipt.

Assigning a date of receipt based on the date materials would have been received but for the disruption is important in a number of contexts. The effective date of registration of a copyright is the date the application, fees and deposit are received by the Copyright Office. 17 U.S.C. 410(d). That date can affect the copyright owner's rights and remedies, such as eligibility for statutory damages and attorney's fees. See 17 U.S.C. 412 (statutory damages and attorney's fees available only for works with effective date of registration prior to commencement of infringement or, for published works, within three months of first publication of the work). The date of recordation of a document can be crucial in determining priorities among conflicting transfers. See 17 U.S.C. 205, 37 CFR 201.9(c) (date of recordation is the date when all elements required for recordation, including the prescribed fee, have been received in the Copyright Office). The date of recordation of a notice of termination of a grant of a transfer or license can be crucial in determining whether the termination is effective. See 17 U.S.C. 304(c)(4)(b) (notice of termination must be recorded in the Copyright Office before the effective date of termination), 37 CFR 201.10((f)(3) (date of recordation of notice of termination is the date when all of the elements required for recordation have been received in the Copyright Office).

Under section 201.8(a) of the interim regulations, when the Register determines that there has been a general disruption or suspension of postal or other transportation or communications services that has delayed the receipt by the Copyright Office of deposits, applications, fees, or any other materials, the Register shall publish an announcement to that effect. When the state of disruption or suspension of such services has ceased, the Register shall publish an announcement to that effect.

Section 201.8(b) provides that persons who have submitted material to the Office, the receipt of which has been delayed due to the suspension or disruption of services, may request that the Register assign, as the date of receipt of the material, the date on which the Register determines the material would have been received but for the disruption or suspension of services. Section 201.8(f) states where such requests should be sent.

Section 201.8(c) sets forth when a request may be submitted. Requests pertaining to applications for copyright registration must be made no later than one year after the claimant has received a certificate of registration. Such requests ordinarily will not be permitted until after the claimant has received a certificate of registration. Exceptions are made for cases in which the Office is communicating with a claimant about the application for other reasons, or other cases in which the Register finds there is good cause to consider a request prior to issuance of the certificate. In general, permitting the submission of requests prior to issuance of the certificate would impose unacceptable burdens on the Office due to difficulties in locating the particular pending applications to which the requests pertain. But when the Office has already communicated with the claimant in connection with an application, and the claimant is responding to the communication from the Office, the claimant may submit the request because there should be no difficulty in locating the application which is the subject of the communication.

Requests relating to transfers of copyright or other documents submitted for recordation must also be made no later than one year after the person seeking recordation has received a certificate of recordation, but there is no requirement to wait until after the certificate has issued. In fact, because it is easier for the Documents Recordation Section of the Cataloging Division to correct the date of recordation prior to recording the document, persons seeking adjustment of the date of receipt of a document submitted for recordation are encouraged to submit requests as soon as possible.

Requests pertaining to any other material submitted to the Copyright Office must be made no later than one year after the date the material is received by the Office.

Section 201.8(d) provides that when a certificate of registration or a certificate of recordation has already been issued, the original certificate must be returned to the Office along with the request. If the request is granted, the Office will issue a new certificate with the revised effective date of registration or date of recordation. If the request is not granted, the original certificate will be returned.

Section 201.8(e) provides that as evidence that the material would have been received on that date, the person making the request must submit a receipt from the United States Postal Service or a delivery service such as, or comparable to, United Parcel Service, Federal Express, or Airborne Express, indicating how and when the material was received by the Postal Service or delivery service, and indicating sufficient information to determine when the Postal Service or delivery service would have delivered the material to the Copyright Office but for the disruption or suspension of services. The Office will also accept other documentary evidence that it considers equivalent to such receipts, and it will accept sworn statements from persons with personal knowledge of the facts relating to the attempt to deliver the material to the Office.

Section 201.8(f) provides for certain presumptions as to when material deposited with the United States Postal Service or a delivery service would have been received but for the disruption or suspension of services.

Because of the unanticipated nature of the recent disruption in services and the necessity of providing a mechanism that will immediately permit the Copyright Office to adjust the date of receipt of materials in appropriate circumstances due to that disruption, the Register finds that there is good cause for the interim regulations to take effect immediately.

The Office solicits comments from the public on these interim regulations. Comments are due 30 days from the date these regulations are published. The Office will consider these comments in preparing final regulations.

The Office also solicits comments concerning a related issue. The Office was closed for business from October 18 through October 24, 2001, because of concerns about possible anthrax contamination in the Library of Congress. During this period, the Office could not receive any applications, fees, deposits or other materials, whether by mail, courier or any other means of delivery. Because the Office's inability to receive materials during this time period was due to the closure of the Library of Congress, and not due to a general disruption or suspension of postal or other transportation or communications services, it does not appear that section 709 provides any authority for the Register to assign a date of receipt during that period for any materials that would have been received by the Office on a day during that period but for the closure of the Library. Thus, a person who attempted to deliver an application for copyright registration to the Office in person on October 22 would not be able to seek an effective date of registration of October 22, because the Office was not open on that date.

Section 410(c) of 17 U.S.C. provides that “[t]he effective date of a copyright registration is the day on which an application, deposit, and fee, which are later determined by the Register of Copyrights or by a court of competent jurisdiction to be acceptable for registration, have all been received in the Copyright Office.” (Emphasis added). The only exception to the requirement that the effective date of registration be the date of actual receipt is set forth in section 709, which does not address the unanticipated closure of the Office.

Moreover, a person who deposited an application addressed to the Office with an overnight delivery service on October 17, with an expected date of receipt in the Office of October 18, would not be able to seek an effective date of registration on October 18 because section 709 only permits the Register to assign as a date of receipt the date on which the material “would have been received in the Copyright Office in due time except for a general disruption or suspension of postal or other transportation or communications services.” (Emphasis added.) In this case, the reason the Office did not receive the application on October 18 was not a general disruption or suspension of postal or other transportation or communications services; it was the closure of the building that houses the Office. Thus, the earliest date of receipt that the Office could assign to the application would be October 25, the next date on which the Office was open.

The Office would like to be able to offer relief to persons who were unable to deliver materials to the Office due to unanticipated closure of the Office during normal business hours, but we are aware of no authority that permits us to grant such relief. We welcome any comments providing citations to and analysis of authority that would permit the Office to issue regulations governing such a situation notwithstanding the express language of 17 U.S.C. 410(c).

This section contains additional information about our final rulemaking, organized as follows:

The Clean Air Act (CAA) Amendments of 1990 required all state and local permitting authorities to develop operating permits programs that meet certain federal criteria. The State of Hawaii's operating permits program was submitted in response to this directive. Because the State's program substantially, but not fully, met the requirements of part 70, EPA granted interim approval to the program in a rulemaking published on December 1, 1994 (59 FR 61549). The interim approval notice described the conditions that had to be met in order for the State program to receive full approval.

After Hawaii revised its program to address the conditions of the interim approval, EPA promulgated a proposal to approve Hawaii's Title V operating permits program on October 15, 2001 (66 FR 52368).

EPA did not receive any comments on the proposed action, so this action promulgates final full approval of the State of Hawaii's operating permits program.

EPA is granting full approval to the operating permits program submitted by the State of Hawaii based on the revisions submitted on September 21, 2001, which satisfactorily address the program deficiencies identified in EPA's July 26, 1994 interim approval (see 59 FR 37957). In addition, the State has made other changes to its operating permit program that are unrelated to the changes made to correct interim approval deficiencies. EPA is not taking any action on these additional program changes in this notice. EPA will evaluate the additional program changes and will take appropriate action at a later date.

EPA is using the good cause exception under the Administrative Procedure Act (APA) to make the full approval of the State's program effective on November 30, 2001. In relevant part, section 553(d) provides that publication of “a substantive rule shall be made not less than 30 days before its effective date, except— * * * (3) as otherwise provided by the agency for good cause found and published with the rule. Good cause may be supported by an agency determination that a delay in the effective date is “impracticable, unnecessary, or contrary to the public interest.” EPA believes that it is necessary and in the public interest to make this action effective sooner than 30 days following publication. In this case, EPA believes that it is in the public interest for the program to take effect before December 1, 2001. The interim approved program expires on December 1, 2001. In the absence of this approved program taking effect on November 30, the federal program would automatically take effect and would remain in place until the effective date of the fully-approved state/district program. EPA believes it is in the public interest for sources, the public and the State to avoid any gap in coverage of the State program, as such a gap could cause confusion regarding permitting obligations. Furthermore, a delay in the effective date is unnecessary because the State of Hawaii has been administering the Title V permit program for seven years under an interim approval. Through this action, EPA is approving a few revisions to the existing and currently operational program. The change from the interim approved program which substantially but did not fully meet the part 70 requirements, to the fully approved program is relatively minor, in particular if compared to the changes between a state approved program and the federal program. Finally, sources are already complying with all of the newly approved requirements as a matter of state law. Thus, there is little or no additional burden with complying with these requirements under the federally approved program.

Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this final approval is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) the Administrator certifies that this final approval will not have a significant economic impact on a substantial number of small entities because it merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. This rule does not contain any unfunded mandates and does not significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) because it approves pre-existing requirements under state law and does not impose any additional enforceable duties beyond that required by state law. This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). This rule also does not have Federalism implications because 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, “Federalism” (64 FR 43255, August 10, 1999). This rule merely approves existing requirements under state law, and does not alter the relationship or the distribution of power and responsibilities between the State and the Federal government established in the Clean Air Act. This final approval also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) or 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. This action will not impose any collection of information subject to the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , other than those previously approved and assigned OMB control number 2060-0243. For additional information concerning these requirements, see 40 CFR part 70. 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.

In reviewing State operating permit programs submitted pursuant to Title V of the Clean Air Act, EPA will approve State programs provided that they meet the requirements of the Clean Air Act and EPA's regulations codified at 40 CFR Part 70. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a State operating permit program for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews an operating permit program, to use VCS in place of a State program that otherwise satisfies the provisions of the Clean Air Act. 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.

The Congressional Review Act, 5 U.S.C. Section 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. section 804(2). This rule will be effective on November 30, 2001.

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 February 4, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 70, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

This section provides additional information by addressing the following questions:

As required under Subchapter V, generally known as title V, of the Clean Air Act (“the Act”), as amended (1990), EPA has promulgated regulations which define the minimum elements of an approvable state operating permits program and the corresponding standards and procedures by which the EPA will approve, oversee, or withdraw approval of the state programs (see 57 FR 32250 (July 21, 1992)). These regulations are codified at 40 Code of Federal Regulations (CFR) part 70. Pursuant to title V, and EPA's implementing regulations, states developed and submitted to EPA programs for issuing operating permits to all major stationary sources and to certain other sources. Where a program substantially, but not fully, met the requirements of part 70, EPA granted the program interim approval. If EPA has not fully approved a state's operating permit program by the expiration of its interim approval period, a federal program under 40 CFR part 71 will automatically take effect in that state.

EPA promulgated final interim approval of the Illinois title V program on March 7, 1995 (60 FR 12478), and the program became effective on that date.

Illinois submitted amendments to its title V program for approval on May 31, 2001. Illinois intended the amendments to correct the four interim approval issues identified in the March 7, 1995 interim approval action. EPA proposed full approval of the Illinois title V program on October 22, 2001 (66 FR 53370), based on the resolution of the four identified interim approval issues.

In the October 22, 2001 notice, the EPA stated that Illinois needed to make two form clarifications as well as send a letter regarding its understanding of its ability to use the State's enhanced NSR provision at 415 ILCS 5/39.5(13)(c)(v). Illinois sent a letter dated November 9, 2001, to address the clarifications and changes requested in the proposed full approval.

The first form change dealt with identifying specific requirements applicable to insignificant emission units (IEUs). EPA stated that, prior to receiving full approval, Illinois must clarify that applicants must include in their applications all information on IEUs necessary to determine applicability of and compliance with specific requirements. Illinois has added text to the instructions of its application form 297-CAAPP to clarify that sources must provide information regarding specific applicable requirements which apply to IEUs, and compliance of the IEUs with those specific applicable requirements.

The second form change and additional statements dealt with Illinois' enhanced NSR provision at 415 ILCS 5/39.5(13)(c)(v). The EPA stated that, to assure that Illinois will not use this provision, Illinois will amend the State's administrative amendment application form, 273-CAAPP, to delete the category that enables a source to take advantage of incorporation of a construction permit through administrative amendment procedures. Illinois has deleted from application form 273-CAAPP the statement regarding the ability to incorporate a construction permit into the title V permit through the administrative amendment procedures. Additionally, in the November 9 letter submitted by Illinois, the State expressed that it would not use this option until the proper procedures are in place. Specifically, Illinois stated, “the Illinois EPA understands that in order to use the enhanced NSR process, as described in 40 CFR 70.7(d)(1)(v), we must develop and obtain USEPA approval for program regulations which are substantially equivalent to the procedural requirements of 40 CFR 70.7 and 70.8 and compliance requirements substantially equivalent to those contained in 40 CFR 70.6.” These form changes and clarifications provide adequate responses to the issues raised in the October 22, 2001 proposed full approval.

The EPA is granting full approval of the Illinois title V operating permits program based on the revisions submitted on May 31, 2001 and the previously mentioned November 9, 2001 letter. These revisions and clarifications satisfactorily address the four program deficiencies identified in EPA's March 7, 1995, interim approval rulemaking and the clarifications required in the proposed full approval.

In its program submission, Illinois did not assert jurisdiction over Indian country. To date, no tribal government in Illinois has applied to EPA for approval to administer a title V program in Indian country within the state. EPA regulations at 40 CFR part 49 govern how eligible Indian tribes may be approved by EPA to implement a title V program on Indian reservations and in non-reservation areas over which the tribe has jurisdiction. EPA's part 71 regulations govern the issuance of federal operating permits in Indian country. EPA's authority to issue permits in Indian country was challenged in Michigan v. EPA, (D.C. Cir. No. 99-1151). On October 30, 2001, the court issued its decision in the case, vacating a provision that would have allowed EPA to treat areas over which EPA determines there is a question regarding the area's status as if it is Indian country, and remanding to EPA for further proceedings. EPA will respond to the court's remand and explain EPA's approach for further implementation of part 71 in Indian country in a future action.

On May 22, 2000, EPA promulgated a rulemaking that extended the interim approval period of 86 operating permits programs until December 1, 2001. (65 FR 32035) The action was subsequently challenged by the Sierra Club and the New York Public Interest Research Group (NYPIRG). In settling the litigation, EPA agreed to publish a notice in the Federal Register that would alert the public that they may identify and bring to EPA's attention alleged programmatic and/or implementation deficiencies in title V programs and that EPA would respond to their allegations within specified time periods if the comments were made within 90 days of publication of the Federal Register notice.

One citizen group commented on what it believes to be deficiencies with respect to the Illinois title V program. As stated in the Federal Register notice published on October 22, 2001 (66 FR 53370), proposing to fully approve Illinois' operating permit program, EPA takes no action on those comments in today's action. Rather, EPA expects to respond by December 1, 2001 to timely public comments on programs that have obtained interim approval, and by April 1, 2002 to timely comments on fully approved programs. We will publish a notice of deficiency (NOD) when we determine that a deficiency exists, or we will notify the commenter in writing to explain our reasons for not making a finding of deficiency. In addition, we will publish a notice of availability in the Federal Register notifying the public that we have responded in writing to these comments and how the public may obtain a copy of our response. EPA Region 5 will also post its response letters on the Internet at http://yosemite.epa.gov/r5/ardcorre.nsf/Title+V+Program+Comments. EPA Region 5 includes the states of Michigan, Minnesota, Illinois, Indiana, Ohio, and Wisconsin. An NOD will not necessarily be limited to deficiencies identified by citizens and may include any deficiencies that we have identified through our program oversight. Furthermore, in the future, EPA may issue an additional NOD if EPA or a citizen identifies other deficiencies.

Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this final approval is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this final approval will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain an unfunded mandate nor does it significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified by Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). This rule also does not have federalism implications because 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, “Federalism” (64 FR 43255, August 10, 1999). This rule merely approves existing requirements under state law, and does not alter the relationship or the distribution of power and responsibilities between the state and the federal government established in the Act.

This final approval is also not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not a significant regulatory action under Executive Order 12866. This action will not impose any collection of information subject to the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., other than those previously approved and assigned OMB control number 2060-0243. For additional information concerning these requirements, see 40 CFR part 70. 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.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTA), 15 U.S.C. 272 note, requires federal agencies to use technical standards that are developed or adopted by voluntary consensus to carry out policy objectives, so long as such standards are not inconsistent with applicable law or otherwise impracticable. In reviewing state operating permit programs submitted pursuant to title V of the Act, EPA will approve state programs provided that they meet the requirements of the Act and EPA's regulations codified at 40 CFR part 70. Absent a prior existing requirement for the state to use voluntary consensus standards, EPA has no authority to disapprove a state operating permit program for failure to use such standards, and it would thus be inconsistent with applicable law for EPA to use voluntary consensus standards in place of a state program that otherwise satisfies the provisions of the Act. Therefore, the requirements of section 12(d) of the NTTA do not apply.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective November 30, 2001.

Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2) of the Act.)

EPA's approval of Illinois' title V program is effective on November 30, 2001. Pursuant to section 502(h) of the Act, the effective date of a permitting program approved under title V is the date of approval by the Administrator or her delegatee. Furthermore, the good cause exception under the Administrative Procedure Act (APA) allows EPA to make the full approval of the state's program immediately effective. In relevant part, the APA provides that publication of “a substantive rule shall be made not less than 30 days before its effective date, except— * * * (3) as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. § 553(d)(3). Section 553(b)(3)(B) of the APA provides that good cause may be supported by an agency determination that a delay in the effective date is impracticable, unnecessary, or contrary to the public interest. The EPA finds that it is necessary and in the public interest to make this action effective sooner than 30 days following publication. In this case, EPA believes that it is in the public interest for the program to take effect before December 1, 2001. The EPA's interim approval of Illinois' program expires on December 1, 2001. In the absence of this full approval of Illinois' amended program taking effect on November 30, the federal program under 40 CFR part 71 would automatically take effect in Illinois and would remain in place until the effective date of the fully-approved state program. The EPA believes it is in the public interest for sources, the public and Illinois to avoid any gap in coverage of the state program, as such a gap could cause confusion regarding permitting obligations. Furthermore, a delay in the effective date is unnecessary because Illinois has been administering the title V permit program under an interim approval. Through this action, EPA is approving a few revisions to the existing and currently operational program. The change from the interim approved program which substantially met the part 70 requirements, to the fully approved program is relatively minor, in particular if compared to the changes between a state-established and administered program and the federal program.

In its program submission, Illinois did not assert jurisdiction over Indian country. To date, no tribal government in Illinois has applied to EPA for approval to administer a title V program in Indian country within the state. The EPA regulations at 40 CFR part 49 govern how eligible Indian tribes may seek approval from EPA to implement a title V program on Indian reservations and in non-reservation areas over which the tribe has jurisdiction. The EPA's part 71 regulations govern the issuance of federal operating permits in Indian country. The EPA's authority to issue permits in Indian country was challenged in Michigan v. EPA, (D.C. Cir. No. 99-1151). On October 30, 2001, the court issued its decision in the case, vacating a provision that would have allowed EPA to treat areas over which EPA determines there is a question regarding the area's status as if it is Indian country, and remanding to EPA for further proceedings. The EPA will respond to the court's remand and explain EPA's approach for further implementation of part 71 in Indian country in a future action.

40 CFR part 70 is amended as follows:

This section provides additional information by addressing the following questions:

As required under Subchapter V of the Act, EPA has promulgated regulations that define the minimum elements of an approvable state operating permit program and the corresponding standards and procedures by which EPA will approve, oversee, or withdraw approval of state operating permit programs (see 57 FR 32250 (July 21, 1992)). These regulations are codified at 40 Code of Federal Regulations (CFR) part 70. Pursuant to Subchapter V, generally known as title V, states and local permitting authorities developed, and submitted to EPA, programs for issuing operating permits to all major stationary sources and to certain other sources.

The EPA's program review occurs under section 502 of the Act and the part 70 regulations, which together outline criteria for approval or disapproval. Where a program substantially, but not fully, meets the requirements of part 70, EPA granted the program interim approval. If EPA has not fully approved a state operating permit program by the expiration of its interim approval period, EPA must establish and implement a federal operating permit program under 40 CFR part 71.

The Michigan Department of Environmental Quality (MDEQ) submitted the state's title V operating permit program for approval on May 16, 1995, with supplements submitted on July 20, 1995, October 6, 1995, November 7, 1995, and January 8, 1996. The EPA promulgated interim approval of the Michigan title V program on January 10, 1997 (62 FR 1387), finding that Michigan's program substantially, but not fully, met the requirements of title V and part 70 and identifying certain deficiencies that Michigan would need to correct. The interim approved program became effective on February 10, 1997. Subsequently, EPA extended Michigan's title V interim approval period on several occasions, most recently to December 1, 2001 (65 FR 32036). On June 18, 1997, EPA granted Michigan source category limited interim approval, approving Michigan's 4-year initial permit issuance schedule (62 FR 34010). Source category limited interim approval allows EPA to approve an initial state permit issuance schedule up to 2 years past the 3-year phase in period required by 40 CFR 70.4(b)(11)(ii).

The MDEQ submitted revisions to its title V program for EPA approval on June 1, 2001, and submitted a supplemental package on September 20, 2001. The submittals included corrections to the deficiencies identified in the January 10, 1997 interim approval action, and also included additional program revisions and updates. Based on the interim approval corrections contained in the submittals, EPA proposed full approval for the Michigan title V program on October 30, 2001 (66 FR 54737). The EPA did not receive any public comments on the proposal. The EPA is taking final action to grant full approval to the Michigan title V program.

The EPA is granting full approval of the operating permit program submitted by Michigan based on the interim approval corrections submitted on June 1, 2001, and the supplemental package submitted on September 20, 2001. These revisions satisfactorily address the program deficiencies identified in EPA's January 10, 1997 interim approval rulemaking.

On May 22, 2000, EPA promulgated a rulemaking that extended the interim approval period of 86 operating permits programs until December 1, 2001 (65 FR 32035). The action was subsequently challenged by the Sierra Club and the New York Public Interest Research Group. In settling the litigation, EPA agreed to publish a notice in the Federal Register that would alert the public that they may identify and bring to EPA's attention alleged programmatic and/or implementation deficiencies in title V programs. In turn, EPA would respond to the public's allegations within specified time periods, if the comments were made within 90 days of publication of the Federal Register notice.

The EPA received two timely comment letters pertaining to the Michigan title V program. As stated in the Federal Register notice published on October 30, 2001 proposing to fully approve Michigan's operating permit program, EPA takes no action on those comments in today's action. Rather, EPA expects to respond by December 1, 2001 to timely public comments on Michigan's program and other programs that have obtained interim approval, and by April 1, 2002 to timely comments on fully approved programs. Consistent with these time frames, EPA also will publish a notice of deficiency (NOD) if EPA determines that a deficiency exists, or will notify the commenter in writing to explain the reasons for not making a finding of deficiency. An NOD will not necessarily be limited to deficiencies identified by citizens and may include any deficiencies that EPA has identified through its program oversight. Furthermore, in the future, EPA may issue an additional NOD if EPA or a citizen identifies other deficiencies. EPA Region 5 will post its response letters on the Internet at http://yosemite.epa.gov/r5/ardcorre.nsf/Title+V+Program+Comments. EPA Region 5 includes the states of Michigan, Minnesota, Illinois, Indiana, Ohio, and Wisconsin. EPA will also publish a national notice of availability in the Federal Register notifying the public that EPA has responded in writing to the commenters and explaining how the public may obtain a copy of EPA's responses.

Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this final approval is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this final approval will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain an unfunded mandate nor does it significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified by Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). This rule also does not have federalism implications because 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, “Federalism” (64 FR 43255, August 10, 1999). This rule merely approves existing requirements under state law, and does not alter the relationship or the distribution of power and responsibilities between the state and the federal government established in the Act.

This final approval is also not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not a significant regulatory action under Executive Order 12866. This action will not impose any collection of information subject to the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , other than those previously approved and assigned OMB control number 2060-0243. For additional information concerning these requirements, see 40 CFR part 70. 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.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTA), 15 U.S.C. 272 note, requires federal agencies to use technical standards that are developed or adopted by voluntary consensus to carry out policy objectives, so long as such standards are not inconsistent with applicable law or otherwise impracticable. In reviewing state operating permit programs submitted pursuant to title V of the Act, EPA will approve state programs provided that they meet the requirements of the Act and EPA's regulations codified at 40 CFR part 70. Absent a prior existing requirement for the state to use voluntary consensus standards, EPA has no authority to disapprove a state operating permit program for failure to use such standards, and it would thus be inconsistent with applicable law for EPA to use voluntary consensus standards in place of a state program that otherwise satisfies the provisions of the Act. Therefore, the requirements of section 12(d) of the NTTA do not apply.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective November 30, 2001.

Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2) of the Act.)

The EPA's approval of Michigan's title V program is effective on November 30, 2001. Pursuant to section 502(h) of the Act, the effective date of a permitting program approved under title V is the date of approval by the Administrator or her delegatee. Furthermore, the good cause exception under the Administrative Procedure Act (APA) allows EPA to make the full approval of the state's program immediately effective. In relevant part, the APA provides that publication of “a substantive rule shall be made not less than 30 days before its effective date, except—* * * (3) as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(3). Section 553(b)(3)(B) of the APA provides that good cause may be supported by an agency determination that a delay in the effective date is impracticable, unnecessary, or contrary to the public interest. The EPA finds that it is necessary and in the public interest to make this action effective sooner than 30 days following publication. In this case, EPA believes that it is in the public interest for the program to take effect before December 1, 2001. The EPA's interim approval of Michigan's prior program expires on December 1, 2001. In the absence of this full approval of Michigan's amended program taking effect on November 30, the federal program under 40 CFR part 71 would automatically take effect in Michigan and would remain in place until the effective date of the fully-approved state program. The EPA believes it is in the public interest for sources, the public and Michigan to avoid any gap in coverage of the state program, as such a gap could cause confusion regarding permitting obligations. Furthermore, a delay in the effective date is unnecessary because MDEQ has been administering the title V permit program for nearly five years under an interim approval. Through this action, EPA is approving a few revisions to the existing and currently operational program. The change from the interim approved program which substantially met the part 70 requirements, to the fully approved program is relatively minor, in particular if compared to the changes between a state-established and administered program and the federal program.

In Michigan's final interim approval (62 FR 1387, January 10, 1997), EPA did not approve the state's program in Indian country. Similarly, this final full approval, which only addresses the state's interim approval corrections, also does not approve Michigan's operating permit program in Indian country. To date, no tribal government in Michigan has applied to EPA for approval to administer a title V program in Indian country within the state. The EPA regulations at 40 CFR part 49 govern how eligible Indian tribes may seek approval from EPA to implement a title V program on Indian reservations and in non-reservation areas over which the tribe has jurisdiction. The EPA's part 71 regulations govern the issuance of federal operating permits in Indian country. The EPA's authority to issue permits in Indian country was challenged in Michigan v. EPA , (D.C. Cir. No. 99-1151). On October 30, 2001, the court issued its decision in the case, vacating a provision that would have allowed EPA to treat areas over which EPA determines there is a question regarding the area's status as if it is Indian country, and remanding to EPA for further proceedings. The EPA will respond to the court's remand and explain EPA's approach for further implementation of part 71 in Indian country in a future action.

This section provides additional information by addressing the following questions:

As required under Subchapter V of the Act, EPA has promulgated regulations that define the minimum elements of an approvable state operating permit program and the corresponding standards and procedures by which the EPA will approve, oversee, and withdraw approval of state operating permit programs (see 57 FR 32250 (July 21, 1992)). These regulations are codified at 40 Code of Federal Regulations (CFR) part 70. Pursuant to Subchapter V, generally known as title V, states and local permitting authorities developed, and submitted to EPA, programs for issuing operating permits to all major stationary sources and to certain other sources.

The EPA's program review occurs under section 502 of the Act and the part 70 regulations, which together outline criteria for approval or disapproval. Where a program substantially, but not fully, met the requirements of part 70, EPA granted the program interim approval. If EPA has not fully approved a program by the expiration of its interim approval period, EPA must establish and implement a federal Operating permit program under 40 CFR part 71.

The state of Wisconsin submitted its title V operating permits program for approval on January 27, 1994. The EPA promulgated interim approval of the Wisconsin title V program on March 6, 1995 (60 FR 12128), finding that Wisconsin's program substantially, but not fully, met the requirements of title V and part 70 and identifying certain deficiencies that Wisconsin would need to correct. The interim approved program became effective on April 5, 1995. Subsequently, EPA extended Wisconsin's title V interim approval period on several occasions, most recently to December 1, 2001 (65 FR 32036).

Wisconsin submitted revisions to its title V program for EPA approval on March 28, 2001, and submitted supplemental packages on September 5, 2001 and September 17, 2001. The submittals included corrections to the deficiencies identified in the March 6, 1995 interim approval action and also included additional program revisions and updates. Based on the interim approval corrections contained in the submittals, EPA proposed full approval for the Wisconsin title V program on October 30, 2001 (66 FR 54734). The EPA received no public comments on the proposal. The EPA is taking final action to grant full approval to the Wisconsin title V program.

The EPA is granting full approval of the operating permit program submitted by Wisconsin based on the interim approval corrections submitted on March 28, 2001, and supplemental packages submitted September 5, 2001 and September 17, 2001. These revisions satisfactorily address the program deficiencies identified in EPA's March 6, 1995 interim approval rulemaking.

On May 22, 2000, EPA promulgated a rulemaking that extended the interim approval period of 86 operating permit programs until December 1, 2001 (65 FR 32035). The action was subsequently challenged by the Sierra Club and the New York Public Interest Research Group. In settling the litigation, EPA agreed to publish a notice in the Federal Register that would alert the public that they may identify and bring to EPA's attention alleged programmatic and/or implementation deficiencies in title V programs. In turn, EPA would respond to the public's allegations within specified time periods, if the comments were made within 90 days of publication of the Federal Register notice.

The EPA received one timely comment letter pertaining to the Wisconsin title V program. As stated in the Federal Register notice published on October 30, 2001 proposing to fully approve Wisconsin's operating permit program, EPA takes no action on those comments in today's action. Rather, EPA expects to respond by December 1, 2001 to timely public comments on Wisconsin's program and other programs that have obtained interim approval, and by April 1, 2002 to timely comments on fully approved programs. Consistent with these time frames, EPA also will publish a notice of deficiency (NOD) if EPA determines that a deficiency exists, or will notify the commenter in writing to explain the reasons for not making a finding of deficiency. An NOD will not necessarily be limited to deficiencies identified by citizens and may include any deficiencies that EPA has identified through its program oversight. Furthermore, in the future, EPA may issue an additional NOD if EPA or a citizen identifies other deficiencies. EPA Region 5 will post its response letters on the Internet at http://yosemite.epa.gov/r5/ardcorre.nsf/Title+V+Program+Comments. EPA Region 5 includes the states of Michigan, Minnesota, Illinois, Indiana, Ohio, and Wisconsin. EPA will also publish a national notice of availability in the Federal Register notifying the public that EPA has responded in writing to the commenters and explaining how the public may obtain a copy of EPA's responses.

Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this final approval is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this final approval will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain an unfunded mandate nor does it significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified by Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). This rule also does not have federalism implications because 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, “Federalism” (64 FR 43255, August 10, 1999). This rule merely approves existing requirements under state law, and does not alter the relationship or the distribution of power and responsibilities between the state and the federal government established in the Act.

This final approval also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not a significant regulatory action under Executive Order 12866. This action will not impose any collection of information subject to the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., other than those previously approved and assigned OMB control number 2060-0243. For additional information concerning these requirements, see 40 CFR part 70. 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.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTA), 15 U.S.C. 272 note, requires federal agencies to use technical standards that are developed or adopted by voluntary consensus to carry out policy objectives, so long as such standards are not inconsistent with applicable law or otherwise impracticable. In reviewing state operating permit programs submitted pursuant to title V of the Act, EPA will approve state programs provided that they meet the requirements of the Act and EPA's regulations codified at 40 CFR part 70. Absent a prior existing requirement for the state to use voluntary consensus standards, EPA has no authority to disapprove a state operating permit program for failure to use such standards, and it would thus be inconsistent with applicable law for EPA to use voluntary consensus standards in place of a state program that otherwise satisfies the provisions of the Act. Therefore, the requirements of section 12(d) of the NTTA do not apply.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective November 30, 2001.

Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2) of the Act.)

The EPA's approval of Wisconsin's title V program is effective on November 30, 2001. Pursuant to section 502(h) of the Act, the effective date of a permitting program approved under title V is the date of approval by the Administrator or her delegatee. Furthermore, the good cause exception under the Administrative Procedure Act (APA) allows EPA to make the full approval of the state's program immediately effective. In relevant part, the APA provides that publication of “a substantive rule shall be made not less than 30 days before its effective date, except— * * * (3) as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. § 553(d)(3). Section 553(b)(3)(B) of the APA provides that good cause may be supported by an agency determination that a delay in the effective date is impracticable, unnecessary, or contrary to the public interest. The EPA finds that it is necessary and in the public interest to make this action effective sooner than 30 days following publication. In this case, EPA believes that it is in the public interest for the program to take effect before December 1, 2001. The EPA's interim approval of Wisconsin's prior program expires on December 1, 2001. In the absence of this full approval of Wisconsin's amended program taking effect on November 30, the federal program under 40 CFR part 71 would automatically take effect in Wisconsin and would remain in place until the effective date of the fully-approved state program. The EPA believes it is in the public interest for sources, the public and Wisconsin to avoid any gap in coverage of the state program, as such a gap could cause confusion regarding permitting obligations. Furthermore, a delay in the effective date is unnecessary because WDNR has been administering the title V permit program for over five years under an interim approval. Through this action, EPA is approving a few revisions to the existing and currently operational program. The change from the interim approved program which substantially met the part 70 requirements, to the fully approved program is relatively minor, in particular if compared to the changes between a state-established and administered program and the federal program.

In Wisconsin's final interim approval (60 FR 12128, March 6, 1995), EPA did not approve the state's program in Indian country. Similarly, this final full approval, which only addresses the state's interim approval corrections, also does not approve Wisconsin's operating permit program in Indian country. To date, no tribal government in Wisconsin has applied to EPA for approval to administer a title V program in Indian country within the state. The EPA regulations at 40 CFR part 49 govern how eligible Indian tribes may seek approval from EPA to implement a title V program on Indian reservations and in non-reservation areas over which the tribe has jurisdiction. The EPA's part 71 regulations govern the issuance of federal operating permits in Indian country. The EPA's authority to issue permits in Indian country was challenged in Michigan v. EPA , (D.C. Cir. No. 99-1151). On October 30, 2001, the court issued its decision in the case, vacating a provision that would have allowed EPA to treat areas over which EPA determines there is a question regarding the area's status as if it is Indian country, and remanding to EPA for further proceedings. The EPA will respond to the court's remand and explain EPA's approach for further implementation of part 71 in Indian country in a future action.

On May 21, 2001, August 30, 2001, and September 26, 2001, the District of Columbia submitted amendments to its operating permit program. These amendments are the subject of this document and this section provides additional information on the amendments by addressing the following questions:

The Clean Air Act (CAA or the Act) Amendments of 1990 required all States (including the District) to develop operating permit programs that meet certain federal criteria. When implementing the operating permit programs, the States require certain sources of air pollution to obtain permits that contain all of their applicable requirements under the CAA. The focus of the operating permit program is to improve enforcement by issuing each source a permit that consolidates all of its applicable CAA requirements into a Federally enforceable document. By consolidating all of the applicable requirements for a given air pollution source into an operating permit, the source, the public, and the State environmental agency can more easily understand what CAA requirements apply and how compliance with those requirements is determined.

Sources required to obtain an operating permit under this program include “major” sources of air pollution and certain other sources specified in the CAA or in the EPA's implementing regulations. For example, all sources regulated under the acid rain program, regardless of size, must obtain operating permits. Examples of “major” sources include those that have the potential to emit 100 tons per year or more of volatile organic compounds, carbon monoxide, lead, sulfur dioxide, nitrogen oxides, or particulate matter (PM10); those that emit 10 tons per year of any single hazardous air pollutant (HAP) specifically listed under the CAA; or those that emit 25 tons per year or more of a combination of HAPs. In areas that are not meeting the national ambient air quality standards (NAAQS) for ozone, carbon monoxide, or particulate matter, major sources are defined by the gravity of the nonattainment classification.

Where a title V operating permit program substantially, but not fully, met the criteria outlined in the implementing regulations codified at 40 CFR part 70, EPA granted interim approval contingent upon the State revising its program to correct the deficiencies. Because the District's operating permit program substantially, but not fully, met the requirements of part 70, EPA granted interim approval of the District's program in a rulemaking published on August 7, 1995 (60 FR 40101). The interim approval notice described the conditions that had to be met in order for the District's operating permit program to receive full approval. On May 21, 2001,August 30, 2001, and September 26, 2001, the District of Columbia submitted amendments to its operating permit program to EPA to address its outstanding interim approval deficiencies.

The District fulfilled the conditions of the interim approval and EPA published a direct final rule on October 16, 2001 (66 FR 52538) granting full approval of the District of Columbia's operating permit program. However, in a letter dated November 15, 2001, EarthJustice submitted adverse comments on behalf of the District of Columbia Chapter of the Sierra Club in response to the companion proposal notice that was also published on October 16, 2001 (66 FR 52561). The October 16, 2001 direct final rule has, therefore, been withdrawn.

On May 22, 2000, EPA promulgated a rulemaking that extended the interim approval period of 86 operating permits programs until December 1, 2001 (65 FR 32035). The action was subsequently challenged by the Sierra Club and the New York Public Interest Research Group (NYPIRG). In settling the litigation, EPA agreed to publish a notice in the Federal Register that would alert the public that they may identify and bring to EPA's attention alleged programmatic and/or implementation deficiencies in title V programs and that EPA would respond to their allegations within specified time periods if the comments were made within 90 days of publication of the Federal Register notice. That notice was published in the Federal Register on December 11, 2000 (65 FR 77376).

The EarthJustice Legal Defense Fund commented on what they believe to be deficiencies with respect to the District of Columbia's title V program. As stated in the Federal Register notice published on October 16, 2001 (66 FR 52538) proposing to fully approve the District of Columbia's operating permit program, EPA takes no action on those comments in this final rule. Rather, EPA expects to respond by December 14, 2001 to timely public comments on programs that have obtained interim approval. We will publish a notice of deficiency (NOD) when we determine that a deficiency exists, or we will notify the commenter, in writing, to explain our reasons for not making a finding of deficiency. In addition, we will publish a notice of availability in the Federal Register notifying the public that we have responded, in writing, to these comments and how the public may obtain a copy of our response. A NOD will not necessarily be limited to deficiencies identified by citizens and may include any deficiencies that we have identified through our program oversight. Furthermore, in the future, EPA may issue an additional NOD if we or a citizen identifies other deficiencies.

As previously stated, EPA received one comment letter during the public comment period. EarthJustice provided comments on behalf of the District of Columbia Chapter of the Sierra Club in a letter dated November 15, 2001. In its November 15, 2001 letter, EarthJustice incorporated, by reference, prior comments it had provided to EPA pursuant to other actions taken by the Agency regarding the District of Columbia's operating permit program. Those comments incorporated a letter dated March 12, 2001commenting in response to the Federal Register notice published by EPA on December 11, 2000 (65 FR 77376). A copy of this letter is included in the docket of this final rulemaking maintained at the EPA Region III office. The following summarizes the comments raised in EarthJustice's November 15, 2001 letter and provides EPA's responses.

Comment: The commenter indicates that EPA cannot grant full approval of the District of Columbia title V operating permit program unless the program fully complies with all requirements of title V and EPA's implementing rules, and without first requiring the District to address all alleged deficiencies identified by EarthJustice in its prior comment letters.

Response: EPA is aware that comments have been made regarding alleged deficiencies other than those listed in the District of Columbia's August 7, 1995 final interim approval (60 FR 40101) and March 21, 1995 proposed interim approval (60 FR 14921). EPA agrees that these allegations must be addressed through appropriate actions by both the District and EPA. For the reasons discussed below, however, we disagree that newly alleged or other identified deficiencies prohibit EPA from granting full approval of the District of Columbia's operating permit program at this time.

In 1990, Congress amended the Act, 42 U.S.C. subsections 7401 to 7671q, by adding title V, 42 U.S.C. subsections 7661 to 7661f, which requires certain air pollutant emitting facilities, including “major source[s]” and “affected source[s],” to obtain and comply with operating permits. See 42 U.S.C. subsection 7661a(a). Title V is intended to be administered by local, state or interstate air pollution control agencies, through permitting programs that have been approved by EPA. See 42 U.S.C. subsection 7661a(a). EPA is charged with overseeing the State's efforts to implement an approved program, including reviewing proposed permits and objecting to improper permits. See 42 U.S.C. subsections 7661a(i) and 7661d(b). Accordingly, title V of the CAA provides a framework for the development, submission and approval of State operating permit programs. Following the development and submission of a State program, the Act provides two different approval options that EPA may utilize in acting on State submittals. See 42 U.S.C. subsection 7661a(d) and (g). Pursuant to section 502(d), EPA “may approve a program to the extent that the program meets the requirements of the Act * * *” EPA may act on such program submittals by approving or disapproving, in whole or in part, the State program. An alternative option for acting on State programs is provided by the interim approval provision of section 502(g). This section states: “If a program * * * substantially meets the requirements of this title, but is not fully approvable, the Administrator may by rule grant the program interim approval.” This provision provides EPA with the authority to act on State programs that substantially, but do not fully, meet the requirements of title V and part 70. Only those program submittals that meet the requirements of eleven key program areas are eligible to receive interim approval. See 40 CFR subsection 70.4(d)(3)(i)-(xi). Finally, section 502(g) directs EPA to “specify the changes that must be made before the program can receive full approval.” 42 U.S.C. subsection 7661a(g); 40 CFR subsection 70.4(e)(3). This explicit directive encompasses another, implicit one: Once a State corrects the specified deficiencies then it will be eligible for full program approval. EPA believes this is so even if deficiencies have been identified sometime after final interim approval, either because the deficiencies arose after EPA granted interim approval or, if the deficiencies existed at that time, EPA failed to identify them as such in proposing to grant interim approval.

Thus, an apparent tension exists between these two statutory provisions. Standing alone, section 502(d) appears to prevent EPA from granting a State operating permit program full approval until the State has corrected all deficiencies in its program no matter how insignificant, and without consideration as to when such deficiency was identified. Alternatively, section 502(g) appears to require that EPA grant a State program full approval if the State has corrected those issues that the EPA identified in the final interim approval. The central question, therefore, is whether the District of Columbia, by virtue of correcting the deficiencies identified in the final interim approval, is eligible at this time for full approval, or whether the District must also correct any newly alleged or recently identified deficiencies as a prerequisite to receiving full program approval.

According to settled principles of statutory construction, statutory provisions should be interpreted so that they are consistent with one another. See Citizens to Save Spencer County v. EPA , 600 F.2d 844, 870 (D.C. Cir. 1979). Where an agency encounters inconsistent statutory provisions, it must give maximum possible effect to all of the provisions, while remaining within the bounds of its statutory authority. Id. at 870-71. Whenever possible, the agency's interpretation should not render any of the provisions null or void. Id. Courts have recognized that agencies are often delegated the responsibility to interpret ambiguous statutory terms in such a fashion. See Chevron U.S.A, Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 845 (1984). Harmonious construction is not always possible, however, and furthermore should not be sought if it requires distorting the language in a fashion never envisioned by Congress. Citizens to Save Spencer County , 600 F.2d at 870.

In this situation, in order to give effect to the principles embodied in title V of the CAA that major stationary sources of air pollution be required to have an operating permit that conforms to certain statutory and regulatory requirements, and that operating permit programs be administered and enforced by State permitting authorities, the appropriate and more cohesive reading of the statute recognizes EPA's authority to grant the District full approval in this situation while working simultaneously with the District, in its oversight capacity, on any additional problems that have been or may be identified. To conclude otherwise would disrupt the current administration of the State program and cause further delay in the District of Columbia's ability to issue operating permits to major stationary sources. A smooth transition from interim approval to full approval is in the best interest of the public and the regulated community and best reconciles the statutory directives of title V of the CAA.

Furthermore, requiring the District to fix all of the deficiencies that have been alleged or formally identified in the past year in order to receive full approval runs counter to the established regulatory process that is already in place to deal with newly identified program deficiencies. Section 502(i)(4) of the Act and 40 CFR subsections 70.4(i) and 70.10 provides EPA with the authority to issue NODs whenever EPA makes a determination that a permitting authority is not adequately administering or enforcing an approved part 70 program, or that the State's permit program is inadequate in any other way. Consistent with these provisions, any NOD issued by EPA will specify a reasonable time-frame for the permitting authority to correct the identified deficiency. The interim approval status of the District of Columbia's title V operating permit program expires on December 1, 2001. This deadline would not provide adequate time for the District to correct any newly identified issues prior to the expiration of interim approval. Allowing the District of Columbia's program to expire because of issues alleged as recently as March 2001 and November 2001 will cause disruption and further delay in the issuance of permits to major stationary sources in the District. As explained previously, we do not believe that title V of the Act requires such a result. Rather, the appropriate mechanism for dealing with additional deficiencies that are identified sometime after a program received interim approval but prior to being granted full approval is the notice of program deficiency or administration deficiency as discussed herein. It should be noted that notices of deficiency (NODs) may also be issued by EPA after a program has been granted full approval. Following the defined process for the identification of deficiencies and the issuance of NODs will provide the District of Columbia an adequate amount of time after such findings to implement any necessary changes without unduly disrupting the entire State operating permit program. As a result, addressing any newly identified problems separately from the full approval process will not cause these issues to go unaddressed. To the contrary, if EPA determines that any of the alleged deficiencies in the District of Columbia's program are well-founded, it will issue a NOD and place the District on notice that it must promptly correct the non-interim approval deficiencies within a specified time period or face CAA sanctions and withdrawal of program approval. At this time, EPA is still evaluating some of the deficiencies alleged by the commenter and others and will, in the very near future, respond to those allegations in a separate action. The comments EPA received from EarthJustice on March 12, 2001 will be considered when taking that separate action. EPA may issue NODs for any other deficiencies identified through EPA's oversight of the District's operating permits program at any time.

Therefore, EPA disagrees with the commenter that EPA must consider all alleged deficiencies prior to granting full approval of the District of Columbia's operating permit program. The proper administrative procedures have been followed to allow interested parties an opportunity to identify any concerns they may have with the various aspects of the District's title V operating permit program. EPA will address those concerns in the context of the relevant rulemaking or administrative actions, including this final rule granting full approval of the District of Columbia's operating permit program; the proposed rulemaking action approving any revisions to the District of Columbia's program; and as part of the process of responding to public comments pursuant to the December 11, 2000 notice (65 FR 77376).

Comment: The commenter indicates that EPA cannot grant full approval of the District of Columbia's title V operating permit program because the program excludes changes reviewed under minor new source review from the definition of Title I modifications.

Response: EPA, in its proposed interim approval, indicated that a revision of the 20 DCMR 399.1 Definition of Title I Modification or modification under any provision of Title I of the Act to include changes reviewed under minor new source review would be required only if EPA established such a change in definition through rulemaking. Because EPA has yet to revise the definition of a “Title I modification” to include changes subject to minor new source review, the District's current regulations remain consistent with 40 CFR part 70. Although EPA believes that the better interpretation of “Title I modifications” is to include changes reviewed under a minor source preconstruction review program, EPA does not believe it is appropriate to require the District to change the definition until EPA completes its rulemaking on this provision.

Should EPA revise this definition in the future, the District will be required to revise its regulations as appropriate. As stated in EPA's proposed interim approval (March 21, 1995, 60 FR 14921), EPA did not identify the District's definition of “Title I modification or modification under any provision of Title I of the Act” as necessary grounds for either interim approval or disapproval. Accordingly, EPA has not identified the District's definition of this term to be a program deficiency.

Comment: The commenter stated that the District of Columbia's regulation 20 DCMR 302.4(e)(1) only required that a request for coverage under a general permit “provide any additional information the general permit specifies.”

Response: The quoted provision is only a portion of 20 DCMR 302.4(e)(1). Section 302.4(e)(1) also provides, among other things, that “a request for coverage under a general permit shall provide information sufficient to demonstrate that the source is in compliance with the general permit.” Title 20 DCMR 302.4(e), read in its entirety, satisfies 40 CFR 70.6(d)(2) requiring that the request for coverage under a general permit include all information necessary to assure compliance with the general permit. 20 DCMR 302.4(e) therefore corrects the interim approval deficiency.

Comment: The commenter asserts that although the District revised 20 DCMR 303.3(a) regarding the applicability of public participation and EPA review to the entire draft renewal permit (including those portions which are incorporated by reference), the revised provision does not require that public participation and EPA and affected state review will extend to anything other than the provisions being revised.

Response: 20 DCMR 303.3(a) clearly states that “applications for permit renewal shall be subject to the same procedural requirements , including those for public participation, affected State comment, and Administrator's review, that apply to initial permit issuance under section 303.1.” Section 303.3(a) further provides that an application for permit renewal may address only those portions of the permit that require revision, supplementing, or deletion, incorporating the remaining permit terms by reference from the previous permit. Because the “remaining permit terms” are to be incorporated by reference, they become a part of the permit renewal which is subject to the same procedural requirements that apply to initial permit issuance. Therefore, public participation and EPA and affected State review will apply to the entire renewal permit, including those portions which are incorporated by reference. This is consistent with 40 CFR 70.7(c)(1)(i).

Comment: The commenter indicates that the District's addition of 20 DCMR 303.5(d)(1)(E) is inadequate to correct the significant permit modification interim approval deficiency. 20 DCMR 303.5(d)(1)(E) requires that significant modification procedures shall be used for applications requesting permit modifications that do not qualify as administrative permit amendments under 303.4(a) or minor permit modifications under 303.5(b). The commenter states that 303.5(d)(1)(A), (B), (C), (D) and (E) are not listed in the alternative, and therefore permittees may argue that significant modification procedures are required only where all of the conditions in 303.5(d)(1)(A) through (E) are met.

Response: EPA interprets 20 DCMR 303.5(d)(1)(A), (B), (C), (D) and (E) as independent provisions such that if any one of the requirements in those provisions are met, the significant permit modification procedures would have to be followed. EPA similarly interprets the minor permit modification procedures provisions in the Federal regulation at 40 CFR 70.7(e)(2)(i)(A). EPA reads 40 CFR 70.7(e)(2)(i)(A)(1), (2), (3), (4), (5) and (6) as independent provisions even though the word “and” appears between 70.7(e)(2)(i)(A)(5) and (6). Therefore, EPA believes that the District of Columbia has corrected the interim approval issue relating to significant permit modification procedures.

Comment: The commenter indicates that the District's changes to its public notice requirements are deficient as the District had already issued all 35 title V permits within its jurisdiction. The commenter also asserts that the District's revised public notice rule is still deficient because it does not require notice “by other means if necessary to assure adequate notice to the affected public.”

Response: During the permit issuance process, adequate procedures for public notice were followed by the District, including offering an opportunity for public comment and a hearing on the draft permits. Notice was given in the District of Columbia Register, and public hearings were held on each draft title V permit. There is no outstanding action on any of the issued title V permits. Although the District did not have the requirement to provide for sending notice to persons on a mailing list (including those people who request in writing to be on the list), this has been corrected with the revision of the public participation procedures of 20 DCMR subsection 303.10(a). During the process of issuing the 35 title V permits within the District, no one from the public requested to be on a mailing list. The revisions to 20 DCMR subsection 303.10(a) require notice of all future title V permit renewals and significant permit modifications to be sent to those individuals who are now on the District's mailing list. Moreover, the District has added information to its website, located at www.environ.state.dc.us which provides members of the public with an opportunity to have their name added to the District's title V permitting mailing list. Through these actions, the District has adequately addressed the deficiency identified in EPA's proposed interim approval.

With regard to the comment that the District's revised public notice rule is still deficient because it does not require notice “by other means if necessary to assure adequate notice to the affected public”, the District, in fact, does provide notice by other means as it has established online information on dates of public hearings, title V permits, contact phone numbers, etc. Furthermore, the District of Columbia made amendments to its regulations to address interim approval issues identified by EPA. In the proposed and final actions granting interim approval of the District of Columbia's program (March 21, 1995, 60 FR 14921 and August 7, 1995, 60 FR 40101, respectively), EPA fulfilled its obligation under section 502(g) of the CAA by specifying the changes the District of Columbia must make to its program in order to receive full approval. 42 U.S.C. subsection 7661a(g); 40 CFR subsection 70.4(e)(3). EPA directed the District to amend 20 DCMR 303.10(a) to require that notice be sent to persons on a mailing list (including those people who request in writing to be on the list). As instructed by EPA, the District amended 20 DCMR 303.10(a) to include this requirement. Therefore, the District has met its statutory obligation under section 502(g) of the CAA to make changes to its operating permit program as specified by EPA and, consequently, its program may now receive full approval.

EPA did not identify any concerns with respect to requiring that the District also modify 20 DCMR 303.10(a) to include a requirement for notice “by other means if necessary to assure adequate notice to the affected public”. Therefore, in its November 15, 2001 comment letter, EarthJustice is expressing a concern with the District's public notice rule that was not identified by EPA or any other interested party prior to EPA's interim approval in 1995. As discussed previously, the District's receipt of full approval of its operating permit program is contingent upon it successfully correcting its regulations as directed by EPA in the March 21, 1995 and August 7, 1995 notices granting interim approval and not the correction of all deficiencies alleged or identified after interim approval was granted. Because the scope of today's action is limited to the District's correction of its interim approval deficiencies, this comment is not germane and EPA does not address it here.

EPA, however, will carefully consider EarthJustice's concerns regarding the impact of 20 DCMR 303.10(a) on the District's operating permit program and determine whether or not a NOD is warranted. Any such NOD will be issued in an action separate from this full approval.

Comment: The commenter indicates that the District's regulations provide for use of the incorrect value for the Consumer Price Index (CPI) in 20 DCMR 305.2(b) to calculate annual permit fees.

Response: In fact, this is not the case. As stated in 20 DCMR 305.2(a) “The Consumer Price Index for any calendar year is the average of the Consumer Price Index for all urban consumers published by the Department of Labor, as of the close of the twelve (12) month period ending on August 31st of each calendar year.” Then 20 DCMR 305.2(b) goes on to say “The revision of the Consumer Price Index which is most consistent with the Consumer Price Index for the calendar year 1989 shall be used. The Consumer Price Index for all urban consumers for the month of August 1989 is one hundred twenty-four and six tenths (124.6).” The statements made in these regulations are correct. The commenter's assertion that “Section 305.2(b) continues to show 124.6 as the base year index for calculating fee increases' is incorrect. Although, 305.2(b) states that the August 1989 CPI is 124.6, this provision requires that the calendar year 1989 CPI shall be used as the base year index. As required by 20 DCMR 305.2(a), the District adjusts the annual fee based on the CPI-Urban Index that represents the 12-month average from September through August of the previous year. The District uses the same presumptive minimum fee that is computed by EPA each year. The commenter's remarks may have been relevant several years ago, however, it is highly improbable that a permittee would go back 12 years to adjust the CPI, when in practice, each title V source in the District is provided the updated adjusted annual fee calculation each year by the District's Air Quality Division. With this clarification, the District of Columbia's program is consistent with 40 CFR 70.9(b)(2)(iv).

Comment: The commenter states that the District of Columbia's Corporation Counsel did not cite to legislative authority that the Mayor can create a right of action in court and that the power to confer judicial jurisdiction and create judicial causes of action is traditionally reserved to the legislature (here either the Counsel or Congress).

Response: In the interim approval, EPA had requested that Corporation Counsel revise its opinion to reference existing provisions in District of Columbia law which satisfy the requirements of 40 CFR 70.11(a)(1) and (2), or establish authorities to restrain or enjoin immediately permit violators presenting substantial endangerment, and to seek injunctive relief for program and permit violations without the need for prior revocation of the permit. The District satisfied this requirement by citing to numerous provisions to establish such authority under its regulations. The District's legislative authority for these actions already existed in section 4(b) of the District of Columbia's Air Pollution Control Act enacted by Congress on July 30, 1968 (P.L. 90-440) which provides that “[f]or the purpose of carrying out his duties under this act, the Commissioner [now the Mayor] may * * * (2) issue such orders as may be necessary to enforce the regulations prescribed by the Counsel under this Act and enforce such orders by all appropriate administrative and judicial proceedings, including injunctive relief; (3) hold hearings relating to the administration of this Act;* * * and (6) take any other actions which may be necessary to carry out his duties under this Act”. After Congress granted the District limited home rule by enacting the District of Columbia Home Rule Act on December 24, 1973 (Pub. L. 93-198), the enactments of Congress remained in force until amended by the Council. The Council of the District of Columbia subsequently re-enacted the same provision in D.C. Law 5-165, effective March 15, 1985, among other things, to amend it to reflect that the Mayor now serves as the chief executive officer. This authority is sufficient to meet the requirements of 70.11(a)(1) and (2).

Comment: The commenter states that criminal offenses and fines can only be set by the legislature and that Corporation Counsel has not cited any legislative authority for seeking criminal fines for violations of the District's operating permit program. The commenter also references Corporation Counsel's statement that 20 DCMR section 105.2 does not provide the Mayor with authority for criminal enforcement of the Air Pollution Control Act to support a proposition that the District lacks the criminal authority.

Response: The District, in Corporation Counsel's amended opinion, cited numerous provisions to establish such authority under the District's regulations. In addition, the authority to seek criminal fines already existed in D.C. Law 5-165, section 3, which enacted the first 9 chapters of Title 20 of the District of Columbia Municipal Regulations as the Air Quality subtitle. The provisions in sections 105.1 and 105.2 (subsequently renumbered 105.5) establish criminal penalties for air quality violations. Section 105.1 of D.C. Law 5-165 provides, in pertinent part, that each person who fails to comply with any of the provisions of this subtitle shall be punished by a fine not to exceed ten thousand dollars or imprisonment not to exceed ninety days, or both. Section 105.5 of D.C. Law 5-165 provides, in pertinent part, that each day of violation shall constitute a separate offence and the penalties described shall be applicable to each separate offense.

EPA believes that the commenter incorrectly concludes that Corporation Counsel's statement that 20 DCMR Section 105.2 does not provide the Mayor with authority for criminal enforcement of the Air Pollution Control Act is supportive of its (the commenter's) proposition that the District lacks the criminal authority. Corporation Counsel was noting that 105.2 is the incorrect provision to reference for the criminal authority and that Sections 105.1 and 105.5 are the correct provisions that established such authority. The District of Columbia has resolved the interim approval issue regarding criminal enforcement.

Comment: The commenter states that the District has not:

(a) Demonstrated that title V fees are adequate to cover compliance and enforcement activities;

(b) Shown how they will monitor and track source compliance;

(c) Committed to submission of annual enforcement reports;

(d) Reviewed self-monitoring reports; and

(e) Shown how it will follow up on violations.

Response: With regard to (a), the District has documented to EPA that time spent on title V activities by clerical staff, engineers and supervisors (in both the Engineering & Planning Branch (EPB) and the Compliance & Enforcement Branch (CEB)) are being tracked and accounted for appropriately as title V fees. In addition, the District's title V account shows a surplus, which demonstrates that title V fees are more than adequate to cover compliance and enforcement activities. Section IV of the District's original title V program submittal (dated January 13, 1994), states that “District law provides authority for the Administrator of the Environmental Regulation Administration to assess and collect annual permit fees (or the equivalent amount of fees over some other period of time) from sources within the District which are subject to the requirements of title V of the CAA and 40 CFR part 70, in an amount sufficient to cover all reasonable direct and indirect costs required to develop, administer, and enforce the District's title V program.” The District authority's is provided in 20 DCMR Sections 302.1(h) and 305.

With regard to (b), the District has committed to monitor and track source compliance through the “Air Quality Inspection/Compliance Monitoring Plan” which it has submitted to EPA. The most recent plan submitted to EPA is dated October 1, 2001. The plan identifies inspection objectives and targets title V air pollution sources for inspection, and sets out criteria for determining which minor sources within the District will be inspected.

With regard to (c), the submission of annual enforcement reports, the commenter asserts that the requirement is not satisfied merely by submission of information to the Aerometric Information Retrieval System/AIRS Facility Subsystem (AIRS/AFS). In addition to AIRS/AFS, the District submits enforcement reports to EPA on a semi-annual and annual basis. These reports were submitted in April 2001 and October 2001. The report entitled, “Compliance and Enforcement Activities and Accomplishments—Year End 2001 Report” contains information on High Priority Violators, as well as the dates that inspections were conducted at all title V sources in the District. In addition, the District participates in quarterly enforcement program reviews with EPA.

With regard to (d), the review of self-monitoring reports, in the “Air Quality Inspection/Compliance Monitoring Plan”, the District has committed to review title V self certifications, semi-annual monitoring and periodic monitoring reports, and any other reports required by the permit.

In response to item (e), in a section of the “Air Quality Inspection/Compliance Monitoring Plan” entitled “Compliance Monitoring Evaluation—Section 5.3,” the District demonstrates how it will follow-up on violations. That section of the plan describes three compliance categories used by the District. This is taken from EPA's Clean Air Act Stationary Source Compliance Monitoring Strategy. In addition, another report entitled “Compliance and Enforcement Activities and Accomplishments—Year End 2001 Report” contains information on new “High Priority Violators”.

The commenter's statement that the “above-referenced requirements are not satisfied merely by citing existing EPA/DC agreements under other programs.” is incorrect. Title 40 CFR 70.4(b)(5) provides that the submission should contain “a complete description of the State's compliance tracking and enforcement program or reference to any agreement the State has with EPA that provides this information.” Therefore, the above plans and reports are sufficient to demonstrate that compliance and enforcement activities are being properly tracked and reported to EPA.

Based upon our analysis of the comments received, EPA has determined that the concerns raised regarding the interim approval deficiencies do not constitute deficiencies in the District of Columbia's operating permit program. The District has satisfactorily addressed the 29 program deficiencies identified by EPA in its final interim approval of the District's operating permit program on August 7, 1995. The operating permit program amendments submitted by the District of Columbia on May 21, 2001, August 30, 2001, and September 26, 2001, considered together with that portion of the District of Columbia's operating permit program that was earlier approved on an interim basis, fully satisfies the minimum requirements of 40 CFR part 70 and the Clean Air Act.

Therefore, EPA is granting final full approval of the District of Columbia's title V operating permit program.

EPA is using the good cause exception under the Administrative Procedure Act (APA) to make the full approval of the District of Columbia's program effective on November 30, 2001. In relevant part, the APA provides that publication of “a substantive rule shall be made not less than 30 days before its effective date, except—* * * (3) as otherwise provided by the agency for good cause found and published with the rule” (5 U.S.C. 553(d)(3)). Section 553(b)(3)(B) of the APA provides that good cause may be supported by an agency determination that a delay in the effective date is impracticable, unnecessary, or contrary to the public interest. EPA finds that it is necessary and in the public interest to make this action effective sooner than 30 days following publication. In this case, EPA believes that it is in the public interest for the program to take effect before December 1, 2001. EPA's interim approval of the District of Columbia's prior program expires on December 1, 2001. In the absence of this full approval of the District of Columbia's amended program taking effect on November 30, 2001, the Federal program under 40 CFR part 71 would automatically take effect in the District of Columbia and would remain in place until the effective date of the fully-approved state program. EPA believes it is in the public interest for sources, the public and the District of Columbia to avoid any gap in coverage of the State program, as such a gap could cause confusion regarding permitting obligations. Furthermore, a delay in the effective date is unnecessary because the District of Columbia has been administering the title V permit program for six years under an interim approval.

In its program submission, the District of Columbia did not assert jurisdiction over Indian country. To date, no tribal government in the District of Columbia has applied to EPA for approval to administer a title V program in Indian country within the District of Columbia. EPA regulations at 40 CFR part 49 govern how eligible Indian tribes may be approved by EPA to implement a title V program on Indian reservations and in non-reservation areas over which the tribe has jurisdiction. EPA's part 71 regulations govern the issuance of Federal operating permits in Indian country. EPA's authority to issue permits in Indian country was challenged in Michigan v. EPA , (D.C. Cir. No. 99-1151). On October 30, 2001, the court issued its decision in the case, vacating a provision that would have allowed EPA to treat areas over which EPA determines there is a question regarding the area's status as if it is Indian country, and remanding to EPA for further proceedings. EPA will respond to the court's remand and explain EPA's approach for further implementation of part 71 in Indian country in a future action.

Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this final approval is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) the Administrator certifies that this final approval will not have a significant economic impact on a substantial number of small entities because it merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. This rule does not contain any unfunded mandates and does not significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) because it approves pre-existing requirements under state law and does not impose any additional enforceable duties beyond that required by state law. This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). This rule also does not have Federalism implications because 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, “Federalism” (64 FR 43255, August 10, 1999). This rule merely approves existing requirements under state law, and does not alter the relationship or the distribution of power and responsibilities between the State and the Federal government established in the Clean Air Act. This final approval also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) or 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. This action will not impose any collection of information subject to the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , other than those previously approved and assigned OMB control number 2060-0243. For additional information concerning these requirements, see 40 CFR part 70. 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.

In reviewing State operating permit programs submitted pursuant to title V of the Clean Air Act, EPA will approve State programs provided that they meet the requirements of the Clean Air Act and EPA's regulations codified at 40 CFR part 70. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a State operating permit program for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews an operating permit program, to use VCS in place of a State program that otherwise satisfies the provisions of the Clean Air Act. 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.

The Congressional Review Act, 5 U.S.C. section 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. section 804(2). This rule will be effective on November 30, 2001.

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 February 4, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action granting final full approval of the District of Columbia's title V operating permit program may not be challenged later in proceedings to enforce its requirements. ( See Section 307(b)(2).)

On November 20, 2000, the Commonwealth of Virginia submitted amendments to its State operating permit program. These amendments are the subject of this document, and this section provides additional information on the amendments by addressing the following questions:

The Clean Air Act (CAA) Amendments of 1990 required all States to develop operating permit programs that meet certain federal criteria. When implementing the operating permit programs, the States require certain sources of air pollution to obtain permits that contain all of their applicable requirements under the CAA. The focus of the operating permit program is to improve enforcement by issuing each source a permit that consolidates all of its applicable CAA requirements into a federally enforceable document. By consolidating all of the applicable requirements for a given air pollution source into an operating permit, the source, the public, and the State environmental agency can more easily understand what CAA requirements apply and how compliance with those requirements is determined.

Sources required to obtain an operating permit under this program include “major” sources of air pollution and certain other sources specified in the CAA or in the EPA's implementing regulations. For example, all sources regulated under the acid rain program, regardless of size, must obtain operating permits. Examples of “major” sources include those that have the potential to emit 100 tons per year or more of volatile organic compounds, carbon monoxide, lead, sulfur dioxide, nitrogen oxides, or particulate matter (PM10); those that emit 10 tons per year of any single hazardous air pollutant (HAP) specifically listed under the CAA; or those that emit or have the potential to emit 25 tons per year or more of a combination of HAPs. In areas that are not meeting the national ambient air quality standards (NAAQS) for ozone, carbon monoxide, or particulate matter, major sources are defined by the gravity of the nonattainment classification. For example, in the counties and cities in northern Virginia that are part of the Metropolitan Washington, DC serious ozone nonattainment area, major sources include those with the potential of emitting 50 tons per year or more of volatile organic compounds or nitrogen oxides.

Where a title V operating permit program substantially, but not fully, met the criteria outlined in the implementing regulations codified at 40 CFR part 70, EPA granted interim approval contingent upon the State revising its program to correct the deficiencies. Because the Virginia operating permit program substantially, but not fully, met the requirements of part 70, EPA granted interim approval of Virginia's program in a rulemaking published on June 10, 1997, as corrected on March 19, 1998 (62 FR 31516 and 63 FR 13346, respectively). The interim approval notice described the conditions that had to be met in order for the Virginia operating permit program to receive full approval. Interim approval of Virginia's operating permit program expires on December 1, 2001.

EPA tentatively concluded that the Commonwealth of Virginia fulfilled the conditions of the interim approval. Consequently, EPA published a direct final rule on October 10, 2001 (66 FR 51581) granting full approval of Virginia's operating permit program. However, adverse comments were received in response to the companion proposal notice that was also published on October 10, 2001 (66 FR 51620). The direct final rule was withdrawn on November 21, 2001 (66 FR 58400). In today's notice, EPA is responding to comments and taking final action on the companion proposal.

On May 22, 2000, EPA promulgated a rulemaking that extended the interim approval period of 86 operating permits programs until December 1, 2001 (65 FR 32035). The action was subsequently challenged by the Sierra Club and the New York Public Interest Research Group (NYPIRG). In settling the litigation, EPA agreed to publish a notice in the Federal Register that would alert the public that they may identify and bring to EPA's attention alleged programmatic and/or implementation deficiencies in title V programs and that EPA would respond to their allegations within specified time periods if the comments were made within 90 days of publication of the Federal Register notice. That notice was published on December 11, 2000 (65 FR 77376).

In response to the December 11, 2000 notice, several citizens commented on what they believe to be deficiencies with respect to the Virginia title V program. As stated in the Federal Register notice published on October 10, 2001 (66 FR 51620) proposing to fully approve Virginia's operating permit program, EPA takes no action on those comments in this final rulemaking action. Rather, EPA expects to respond by December 14, 2001 to timely public comments on programs that have obtained interim approval. We will publish a notice of deficiency (NOD) when we determine that a deficiency exists, or we will notify the commenter, in writing, to explain our reasons for not making a finding of deficiency. In addition, we will publish a notice of availability in the Federal Register notifying the public that we have responded, in writing, to these comments and how the public may obtain a copy of our response. A NOD will not necessarily be limited to deficiencies identified by citizens, and may include any deficiencies that we have identified through our program oversight. Furthermore, in the future, EPA may issue an additional NOD if EPA or a citizen identifies other deficiencies. The process for issuance of NODs is discussed in greater detail below.

EPA received two comment letters during the public comment period. The Virginia Manufacturers Association provided a letter dated November 9, 2001 stating its support of EPA's action to grant full approval of Virginia's operating permit program. Since this letter did not raise any concerns with the proposed action, no response is necessary. EarthJustice provided comments on behalf of the Virginia Chapter of the Sierra Club dated November 9, 2001. In its November 9, 2001 letter, EarthJustice incorporated, by reference, its prior comments submitted to EPA pursuant to other actions taken by the Agency regarding Virginia's operating permit program. Those comments were submitted in letters as follows: (a) Letter of March 12, 2001 commenting in response to EPA's December 11, 2000 Federal Register notice (65 FR 77376) which announced a 90-day comment period for the public to identify deficiencies in State and Local agency operating permits programs; and (b) Letter of November 2, 2001 regarding EPA's October 3, 2001 notice of proposed rulemaking approving revisions to the Virginia title V program (66 FR 50375).

Copies of each of these letters are included in the docket file maintained at the EPA Region III office. The following is a discussion of the issues raised in EarthJustice's November 9, 2001 letter and EPA's responses.

Comment: The commenter indicates that EPA cannot grant full approval of the Virginia title V operating permit program without first addressing all alleged deficiencies identified by EarthJustice in its prior comment letters.

Response: EPA is aware that comments have been made regarding alleged deficiencies other than those listed in Virginia's June 10, 1997 interim approval. EPA agrees that these allegations must be addressed through appropriate actions by EPA and/or the Commonwealth of Virginia. For the reasons discussed below, however, we disagree that newly alleged or formally identified deficiencies prohibit EPA from granting full approval of Virginia's operating permit program at this time.

In 1990, Congress amended the Clean Air Act, 42 U.S.C. 7401 to 7671q, by adding title V, 42 U.S.C. subsections 7661 to 7661f, which requires certain air pollutant emitting facilities, including “major source[s]” and “affected source[s],” to obtain and comply with operating permits. See 42 U.S.C. subsection 7661a(a). Title V is intended to be administered by local, state or interstate air pollution control agencies, through permitting programs that have been approved by EPA. See 42 U.S.C. subsection 7661a(a). EPA is charged with overseeing the State's efforts to implement an approved program, including reviewing proposed permits and objecting to improper permits. See 42 U.S.C. subsections 7661a(i) and 7661d(b). Accordingly, title V of the CAA provides a framework for the development, submission and approval of State operating permit programs. Following the development and submission of a State program, the Act provides two different approval options that EPA may utilize in acting on State submittals. See 42 U.S.C. subsection 7661a(d) and (g). Pursuant to section 502(d), EPA “may approve a program to the extent that the program meets the requirements of the Act * * * ” EPA may act on such program submittals by approving or disapproving, in whole or in part, the State program. An alternative option for acting on State programs is provided by the interim approval provision of section 502(g). This section states: “If a program * * * substantially meets the requirements of this title, but is not fully approvable, the Administrator may by rule grant the program interim approval.” This provision provides EPA with the authority to act on State programs that substantially, but do not fully, meet the requirements of title V and part 70. Only those program submittals that meet the requirements of eleven key program areas are eligible to receive interim approval. See 40 CFR subsection 70.4(d)(3)(i)-(xi). Finally, section 502(g) directs EPA to “specify the changes that must be made before the program can receive full approval.” 42 U.S.C. subsection 7661a(g); 40 CFR subsection 70.4(e)(3). This explicit directive encompasses another, implicit one: Once a State corrects the specified deficiencies then it will be eligible for full program approval. EPA believes this is so even if deficiencies have been identified sometime after final interim approval, either because the deficiencies arose after EPA granted interim approval or, if the deficiencies existed at that time, EPA failed to identify them as such in proposing to grant interim approval.

Thus, an apparent tension exists between these two statutory provisions. Standing alone, section 502(d) appears to prevent EPA from granting a State operating permit program full approval until the State has corrected all deficiencies in its program no matter how insignificant, and without consideration as to when such deficiency was identified. Alternatively, section 502(g) appears to require that EPA grant a State program full approval if the State has corrected those issues that the EPA identified in the final interim approval. The central question, therefore, is whether Virginia, by virtue of correcting the deficiencies identified in the final interim approval, is eligible at this time for full approval, or whether Virginia must also addresses any newly alleged or recently identified deficiencies as a prerequisite to receiving full program approval.

According to settled principles of statutory construction, statutory provisions should be interpreted so that they are consistent with one another. See Citizens to Save Spencer County v. EPA , 600 F.2d 844, 870 (D.C. Cir. 1979). Where an agency encounters inconsistent statutory provisions, it must give maximum possible effect to all of the provisions, while remaining within the bounds of its statutory authority. Id. at 870-71. Whenever possible, the agency's interpretation should not render any of the provisions null or void. Id. Courts have recognized that agencies are often delegated the responsibility to interpret ambiguous statutory terms in such a fashion. See Chevron U.S.A, Inc. v. Natural Resources Defense Council, Inc. , 467 U.S. 837, 845 (1984). Harmonious construction is not always possible, however, and furthermore should not be sought if it requires distorting the language in a fashion never imagined by Congress. Citizens to Save Spencer County , 600 F.2d at 870.

In this situation, in order to give effect to the principles embodied in title V of the CAA that major stationary sources of air pollution be required to have an operating permit that conforms to certain statutory and regulatory requirements, and that operating permit programs be administered and enforced by State permitting authorities, the appropriate and more cohesive reading of the statute recognizes EPA's authority to grant Virginia full approval in this situation while working simultaneously with the State, in its oversight capacity, on any additional problems that have been or may be identified. To conclude otherwise would disrupt the current administration of the State program and cause further delay in Virginia's ability to issue operating permits to major stationary sources. A smooth transition from interim approval to full approval is in the best interest of the public and the regulated community and best reconciles the statutory directives of title V of the CAA.

Furthermore, requiring the Commonwealth of Virginia to fix all of the deficiencies that have been alleged or formally identified in the past year in order to receive full approval runs counter to the established regulatory process that is already in place to deal with newly identified program deficiencies. Section 502(i)(4) of the Act and 40 CFR subsections 70.4(i) and 70.10 provides EPA with the authority to issue NODs whenever EPA makes a determination that a permitting authority is not adequately administering or enforcing an approved part 70 program, or that the State's permit program is inadequate in any other way. Consistent with these provisions, any NOD issued by EPA will specify a reasonable time-frame for the permitting authority to correct the identified deficiency. The interim approval status of Virginia's title V operating permit program expires on December 1, 2001. This deadline would not provide adequate time for the Commonwealth to correct any newly identified issues prior to the expiration of interim approval. Allowing the Commonwealth's program to expire because of issues alleged as recently as March 2001 and November 2001 will cause disruption and further delay in the issuance of permits to major stationary sources in Virginia. As explained above, we do not believe that title V of the CAA requires such a result. Rather, the appropriate mechanism for dealing with additional deficiencies that are identified sometime after a program received interim approval but prior to being granted full approval is the notice of program deficiency or administration deficiency as discussed herein. It should be noted that NODs may also be issued by EPA after a program has been granted full approval. Following the defined process for the identification of program issues and the issuance of NODs will provide the Commonwealth an adequate amount of time after such findings to implement any necessary changes without unduly disrupting the entire State operating permit program. As a result, addressing any newly identified problems separately from the full approval process will not cause these issues to go unaddressed. To the contrary, if EPA determines that any of the alleged deficiencies in Virginia's program are well-founded, it will issue a NOD and place Virginia on notice that it must promptly correct the non-interim approval deficiencies within a specified time period or face CAA sanctions and withdrawal of program approval. At this time, EPA is still evaluating the deficiencies alleged by the commenter and others and will, in the very near future, respond to those allegations in a separate action. The comments EPA received from EarthJustice on March 12, 2001 mentioned above will be considered as part of that separate action.

Virginia also made revisions to its operating permit program since its program received interim approval in 1997. The revisions were not intended to address any of the identified interim approval deficiencies. Rather, the intent of these discretionary program changes was to improve implementation of the existing program. In a rulemaking action separate from this action granting full approval, EPA, in accordance with 40 CFR subsection 70.4(i), proposed approval of those revisions on October 3, 2001 (66 FR 50375). The EPA disagrees with the commenter's assertion that the amendments Virginia made to its program to address the identified interim approval deficiencies are inextricable from the program revisions that are the subject of the October 3, 2001 notice. The approval of the discretionary program revisions is not necessary in order for Virginia to adequately address its interim approval deficiencies, nor must they be approved prior to Virginia receiving full approval. The EPA will proceed with the appropriate administrative process to respond to any comments received pursuant to the October 3, 2001 proposed rulemaking action on the discretionary program revisions. The comments received from EarthJustice on November 2, 2001 will be considered as when taking that separate action.

Therefore, EPA disagrees with the commenter that EPA must consider all program revisions and alleged deficiencies prior to granting full approval of Virginia's operating permit program. The proper administrative procedures have been followed to allow interested parties an opportunity to identify any concerns they may have with the various aspects of Virginia's title V operating permit program. The EPA will address those concerns in the context of the relevant rulemaking or administrative actions, including this final rule granting full approval of Virginia operating permit program; the proposed rulemaking action approving revisions to Virginia's program; and, the process of responding to public comments pursuant to the December 11, 2000 notice (65 FR 77376).

Comment: EarthJustice believes Virginia's insignificant activity provisions for emergency generators are not consistent with title V of the CAA. Specifically, the commenter believes that the potential emissions generated by the types of internal combustion powered generators as defined under 9 VAC 5-80-720 C 4 should not be eligible to be classified as insignificant activities. Further, the commenter contends that Virginia's regulations would allow these types of units to emit pollutants at levels that would trigger title V requirements and still be classified as insignificant activities because there are no explicit restrictions on hours of operation or emissions for these units.

Response: With regard to the emergency generators that are central to EarthJustice's comment, EPA disagrees that emergency generators of the size and fuel-use capability as specified by 9 VAC 5-80-720 C 4 have the potential for significant emissions. First, the regulations specify that in order to be eligible for classification as insignificant activities these types of emergency generators may only be used when power is unavailable from the utility. If the facility in question is not served by a utility, the generators would not qualify as “emergency” generators because they would be the principal means by which the facility generated electricity. The EPA interprets 9 VAC 5-80-720 C 4 as excluding generators at facilities not served by a utility. Further, EPA is unaware of any facility in Virginia that is currently required to obtain a title V operating permit that is not served by a utility and the likelihood of such a title V source in the future is negligible. Second, it is unlikely for facilities that are provided power from a utility to need to use their emergency generators in excess of 500 hours in any given year. In support of its guidance document entitled, “Calculating Potential to Emit (PTE) for Emergency Generators” (September 6, 1995 memorandum from John S. Seitz, Director, EPA Office of Air Quality Standards and Planning to Directors, EPA Regional Air Divisions), EPA determined that an emergency generator would likely operate 500 hours per year or less under worst case conditions. Therefore, the emergency generators specified by Virginia's regulations would only be in operation for a short time each year and the real potential for significant emissions is minimal. Finally, an analysis of the potential emissions from emergency generators of the size and fuel-type defined by 9 VAC 5080-720 C 4 indicates that if any of these generators were to operate 500 hours in a particular year, the worst case potential emissions from any of the classes of emergency generators would be six tons of nitrogen oxides per year. For these reasons, EPA believes the classification of emergency generators as defined in 9 VAC 5-80-720 C 4 as insignificant activities is appropriate and consistent with title V and part 70. As will be discussed in greater detail, the construction of Virginia's insignificant activities regulations provides additional assurances that emergency generators will not be incorrectly classified as insignificant activities and that all necessary and relevant operational and emissions data will be provided by applicants in order to determine if these types of sources have any title V requirements.

The purpose of insignificant activities lists and designation of units as insignificant activities is to enable permit applicants to streamline their applications by allowing them to exclude certain information and emissions data for individual emission units when such information or data is not needed to determine whether applicable requirements may apply to that unit or whether the source is a “major source” according to title V and part 70. The identification of a particular unit as an insignificant activity in no way relieves any applicable requirement that may apply to that unit. The EPA disagrees with the commenter's assertion that Virginia's permit program would allow certain insignificant activities to operate in excess of levels that would trigger title V requirements or “major source” requirements. While Virginia's operating permit program allows certain activities to be classified as insignificant, it does not allow these emission units to circumvent any applicable requirements of title V. Virginia's program also provides safeguards to prevent the mis-classification of units as insignificant and the omission of relevant emission data from title V permit applications.

Virginia's operating permit program regulations address insignificant activities in three ways. Virginia's regulations, at 9 VAC 5-80-720 A, provide a specific list of activities for which the permit applicant does not have to include information regarding these emission units in its title V permit application, including emission levels. Virginia's program, at 9 VAC 5-80-720 B, also allows permit applicants to identify emission units which fall below certain emission thresholds as insignificant activities, but does not require specific emission data for each of these units in the application. Finally, under 9 VAC 5-80-720 C, emission units may be listed in the application as insignificant activities if they fall below certain size or production rates for specific categories of units. Pursuant to 9 VAC 5-80-90 D and 9 VAC 5-80-440 D, the permit application must indicate the size or production rate of each unit that is being classified as an insignificant activity. The emergency generators that are the subject of the commenter's concern fall into this last general category.

Virginia's operating permit program regulations at 9 VAC 5-80-90 D and 9 VAC 5-80-440 D require that applicants must include any emissions data or other relevant information that is necessary to determine applicability of title V or of any other applicable requirements. As part of this full approval action, EPA is approving amendments to Virginia's regulations that clarify that permit applicants are obligated to provide this type of information for all emission units, including those that may be classified as insignificant activities. Therefore, even if a specific unit may be classified as an insignificant activity pursuant to 9 VAC 5-80-720, the applicant must provide emissions data or other information if the omission of such information would interfere with determining whether that unit has applicable requirements that must be reflected in a title V permit. Virginia also amended its regulations to require explicitly that all applicable requirements for all emission units, including those for insignificant activities must be contained in the title V permit. These amendments were made to address interim approval issues and are more fully discussed in the October 10, 2001 (66 FR 51581) direct final rulemaking notice.

Virginia's insignificant activity regulations significantly minimize the potential for inappropriate use of the insignificant activities list and the other mechanisms for identifying insignificant activities as provided in 9 VAC 5-80-720, including those for emergency generators. The purpose of the title V permit application is to provide all of the information necessary to develop a title V permit that contains all of a given source's applicable requirements. Virginia's regulations with regard to insignificant activities provide that all information necessary to determine applicable requirements for inclusion in title V permits must be provided by the applicant even if a given unit can be identified as an insignificant activity. Therefore, the various mechanisms to identify insignificant activities may be used by the applicant at their discretion with assumed liability for failure to provide complete and accurate information to Virginia. Pursuant to 9 VAC 5-80-80 G and 9 VAC 5-20-230, all applicants must certify, subject to civil and criminal penalty, that all information contained in its application is complete, accurate and true.

Comment: EarthJustice asserts that the identified interim approval issue regarding malfunction as an affirmative defense in Virginia's title V operating permit program has not been fully corrected. The commenter also believes Virginia's malfunction provisions at 9 VAC 5-20-180 are not consistent with title V of the CAA. Specifically, EarthJustice contends that title V sources may claim an affirmative defense for malfunctions to a degree far broader than provided under title V and 40 CFR subsection 70.6(g).

Response: Virginia's title V operating permit program regulations establish the permissible scope of claims for affirmative defense for noncompliance with title V permits due to emergencies at 9 VAC 5-80-250 and 9 VAC 5-80-650. (Virginia uses the term “malfunction” instead of “emergency”, however, the term as defined at 9 VAC 5-80-60 C and 5-80-370 is consistent with EPA's definition of “emergency'.) The commenter has not asserted that the provisions of 9 VAC 5-80-250 and 5-80-650 are inconsistent with title V or 40 CFR subsection 70.6(g). Virginia made amendments to these sections of its regulations to address interim approval issues. In the proposed and final actions granting interim approval of Virginia's program (March 18, 1997, 62 FR 12778 and June 10, 1997, 62 FR 31516, respectively), EPA fulfilled its obligation under section 502(g) of the CAA by specifying the changes Virginia must make to its program in order to receive full approval. 42 U.S.C. subsection 7661a(g); 40 CFR subsection 70.4(e)(3). EPA directed Virginia to amend 9 VAC 5-80-250 B 4 and 9 VAC 5-80 650 to require permittees to properly report malfunctions of any duration in order for those malfunctions to be eligible for consideration as an affirmative defense. Previously, these regulations did not require permittees to report malfunctions of less than one hour, yet allowed for an affirmative defense for these unreported malfunctions. As instructed by EPA, Virginia amended 9 VAC 5-80-250 B 4 and 9 VAC 5-80-650 to require the reporting of malfunctions of any duration. These amendments are more fully discussed in the October 10, 2001 (66 FR 51581) direct final rulemaking notice granting full approval of Virginia's program. Therefore, Virginia has met its statutory obligation under section 502(g) of the CAA to make changes to its operating permit program as specified by EPA and, consequently, its program may now receive full approval.

EarthJustice's main concern regards Virginia's malfunction provisions as they exist outside of the operating permit program regulations. The malfunction defenses provided by 9 VAC 5-20-180 are codified as part of the general provisions of Virginia's air pollution control regulations. In its proposed and final rulemaking granting interim approval of Virginia's program, EPA did not identify any concerns with these provisions of Virginia's regulations, nor did it instruct Virginia to make any corrections to 9 VAC 5-20-180. Likewise, the malfunction provisions of 9 VAC 5-20-180 were not discussed in the October 10, 2001 proposed rulemaking action regarding full approval of Virginia's operating permit program. Therefore, in its November 9, 2001 comment letter, EarthJustice is expressing a concern with Virginia's operating permit program that has heretofore not been identified by EPA or any other interested party. As discussed more fully above, Virginia's receipt of full approval of its operating permit program is contingent upon it successfully correcting its regulations as directed by EPA in the March 18, 1997 and June 10, 1997 notices granting interim approval and not the correction of all deficiencies alleged or identified after interim approval was granted.

The EPA will carefully consider EarthJustice's concerns regarding the impact of 9 VAC 5-20-180 on Virginia's operating permit program and determine whether a notice of deficiency is warranted. Any such notice of deficiency will be issued in an action separate from this full approval.

Comment: EarthJustice has expressed concern with the discussion of Virginia's Voluntary Environmental Assessment Privilege Law (“Privilege Law”), Va. Code Sec. 10.1-1198, and Immunity Against Administrative or Civil Penalties for Voluntarily Disclosed Violation Law (“Immunity Law”), Va. Code Sec. 10.1-1199 as contained in the October 10, 2001 notice. The commenter is not satisfied with EPA's conclusion that these laws do not preclude Virginia from enforcing its operating permit program in a manner consistent with the CAA. EarthJustice further argues that the Virginia Attorney General's interpretation of these laws that supports EPA's conclusion are not binding on the courts of Virginia. EarthJustice suggests that the most appropriate remedies are for Virginia to either repeal the laws in their entirety or amend them to expressly exclude the title V program from their scope.

The EPA disagrees with the commenter's assertion that the Agency's and Virginia Office of Attorney General's interpretation of the existing Privilege and Immunity Laws may apply to Virginia's operating permit program. To the contrary, the commenter has not demonstrated that these laws pose any threat to the enforcement of title V operating permits in Virginia. EarthJustice has not identified a single instance where any source has successfully asserted protection under these laws from the enforcement of their title V operating permits by EPA, the Commonwealth of Virginia, or the public, in manner that is inconsistent with the CAA. As to the relevance of the Virginia Office of Attorney General's opinion on this matter, section 502(d) of the CAA requires as part of any approvable title V operating permit program a legal opinion from the State Attorney General, or equivalent, indicating that the State can enforce its operating permit program in a manner consistent with federal law. 42 U.S.C. subsection 7661a(d); 40 CFR subsection 70.4(b)(3). The EPA relies on the Attorney General's interpretation of the law, although the Agency recognizes it is always theoretically possible for developing case law to eventually overrule certain, or even all, of the opinions expressed by the Attorney General.

In this instance, the Virginia Office of Attorney General provided EPA legal opinions on December 29, 1997 and January 12, 1998 that state that the Commonwealth's Privilege Law does not extend to information required by federal law and that the Immunity Law does not apply to federally authorized programs such as the title V operating permit program. In absence of any rulings by the Virginia courts that further illuminate the application of these laws, EPA maintains its conclusion that the Commonwealth of Virginia's Privilege and Immunity Laws do not apply to enforcement of Virginia's operating permit program, and any permits issued pursuant to that program. Should the Virginia courts come to interpret these laws in the future in a manner that conflicts with the CAA, EPA will consider the full effect of those rulings and determine the most appropriate response, including the possible issuance of a NOD. Any such NOD will be issued in an action separate from this full approval.

Based on analysis of the comments received, EPA has determined that the concerns raised do not constitute deficiencies in the Virginia operating permit program. The Commonwealth of Virginia has satisfactorily addressed the six program deficiencies identified when EPA granted final interim approval of its operating permit program on June 10, 1997, as corrected on March 19, 1998. The operating permit program amendments submitted by Virginia on November 20, 2000 considered together with that portion of Virginia's operating permit program that was earlier approved on an interim basis fully satisfy the minimum requirements of 40 CFR part 70 and the Clean Air Act. Therefore, EPA is granting final full approval of the Commonwealth of Virginia's title V operating permit program.

EPA is using the good cause exception under the Administrative Procedure Act (APA) to make the full approval of the Virginia's program effective on November 30, 2001. In relevant part, the APA provides that publication of “a substantive rule shall be made not less than 30 days before its effective date, except—* * * (3) as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. § 553(d)(3). Section 553(b)(3)(B) of the APA provides that good cause may be supported by an agency determination that a delay in the effective date is impracticable, unnecessary, or contrary to the public interest. EPA finds that it is necessary and in the public interest to make this action effective sooner than 30 days following publication. In this case, EPA believes that it is in the public interest for the program to take effect before December 1, 2001. EPA's interim approval of Virginia's prior program expires on December 1, 2001. In the absence of this full approval of Virginia's amended program taking effect on November 30, the federal program under 40 CFR part 71 would automatically take effect in Virginia and would remain in place until the effective date of the fully approved state program. EPA believes it is in the public interest for sources, the public and the Commonwealth of Virginia to avoid any gap in coverage of the State program, as such a gap could cause confusion regarding permitting obligations. Furthermore, a delay in the effective date is unnecessary because Virginia has been administering the title V permit program for four years under an interim approval. Through this action, EPA is approving a few revisions to the existing and currently operational program. The change from the interim approved program which substantially met the part 70 requirements, to the fully approved program is relatively minor, in particular if compared to the changes between a state-established and administered program and the federal program.

In its program submission, Virginia did not assert jurisdiction over Indian country. To date, no tribal government in Virginia has applied to EPA for approval to administer a title V program in Indian country within the Commonwealth. EPA regulations at 40 CFR part 49 govern how eligible Indian tribes may be approved by EPA to implement a title V program on Indian reservations and in non-reservation areas over which the tribe has jurisdiction. EPA's part 71 regulations govern the issuance of federal operating permits in Indian country. EPA's authority to issue permits in Indian country was challenged in Michigan v. EPA , (D.C. Cir. No. 99-1151). On October 30, 2001, the court issued its decision in the case, vacating a provision that would have allowed EPA to treat areas over which EPA determines there is a question regarding the area's status as if it is Indian country, and remanding to EPA for further proceedings. EPA will respond to the court's remand and explain EPA's approach for further implementation of part 71 in Indian country in a future action.

Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this final approval is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) the Administrator certifies that this final approval will not have a significant economic impact on a substantial number of small entities because it merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. This rule does not contain any unfunded mandates and does not significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) because it approves pre-existing requirements under state law and does not impose any additional enforceable duties beyond that required by state law. This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). This rule also does not have Federalism implications because 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, “Federalism” (64 FR 43255, August 10, 1999). This rule merely approves existing requirements under state law, and does not alter the relationship or the distribution of power and responsibilities between the State and the Federal government established in the Clean Air Act. This final approval also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) or 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. This action will not impose any collection of information subject to the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , other than those previously approved and assigned OMB control number 2060-0243. For additional information concerning these requirements, see 40 CFR part 70. 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.

In reviewing State operating permit programs submitted pursuant to title V of the Clean Air Act, EPA will approve State programs provided that they meet the requirements of the Clean Air Act and EPA's regulations codified at 40 CFR part 70. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a State operating permit program for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews an operating permit program, to use VCS in place of a State program that otherwise satisfies the provisions of the Clean Air Act. 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.

The Congressional Review Act, 5 U.S.C. section 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. section 804(2). This rule will be effective on November 30, 2001.

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 February 4, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action granting final full approval of Virginia's title V operating permit program may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

This section provides additional information by addressing the following questions:

As required under Subchapter V of the Clean Air Act (“the Act”), EPA has promulgated regulations which define the minimum elements of an approvable state operating permits program and the corresponding standards and procedures by which the EPA will approve, oversee, and withdraw approval of state operating permits programs (see 57 FR 32250 (July 21, 1992)). These regulations are codified at 40 Code of Federal Regulations (CFR) part 70. Pursuant to Subchapter V, generally known as title V, states developed, and submitted to EPA, programs for issuing these operating permits to all major stationary sources and to certain other sources.

The EPA's program review occurs under section 502 of the Act and the part 70 regulations, which together outline criteria for approval or disapproval. Where a program substantially, but not fully, met the requirements of part 70, EPA granted the program interim approval. If EPA has not fully approved a program by the expiration of an interim program, it must establish and implement a federal program.

The Minnesota Pollution Control Agency (MPCA) submitted its title V operating permits program (title V program) for approval on November 15, 1993. EPA promulgated interim approval of the Minnesota title V program on June 16, 1995 (60 FR 31637), and the program became effective on July 16, 1995. Subsequently, EPA extended Minnesota's title V interim approval period on several occasions, most recently to December 1, 2001 (65 FR 32036).

MPCA submitted amendments to its title V program for our approval on June 9, 2000, July 21, 2000, and June 12, 2001. Minnesota intended these amendments to correct interim approval issues identified in the June 16, 1995, action. Based on this submittal, EPA proposed full approval for the Minnesota title V program on October 30, 2001 (66 FR 54739). EPA did not receive any adverse public comment(s) on the proposal; therefore, EPA is taking final action to give full approval to the Minnesota title V program.

The EPA is granting full approval of the operating permits program submitted by MPCA based on the interim approval corrections submitted on June 9, 2000, July 21, 2000, and June 12, 2001. These revisions satisfactorily address the program deficiencies identified in EPA's June 16, 1995, interim approval rulemaking.

On May 22, 2000, EPA promulgated a rulemaking that extended the interim approval period of 86 operating permits programs until December 1, 2001 (65 FR 32035). The action was subsequently challenged by the Sierra Club and the New York Public Interest Research Group. In settling the litigation, EPA agreed to publish a notice in the Federal Register , so that the public would have the opportunity to identify and bring to EPA's attention alleged programmatic and/or implementation deficiencies in title V programs. In turn, EPA would respond to the public's allegations within specified time periods, if the comments were made within 90 days of publication of the Federal Register notice.

The EPA received one timely comment letter pertaining to the Minnesota title V program. As stated in the Federal Register notice published on October 30, 2001 proposing to fully approve Minnesota's operating permit program, EPA takes no action on those comments in today's action. Rather, EPA expects to respond by December 1, 2001 to timely public comments on programs that have obtained interim approval, and by April 1, 2002 to timely comments on fully approved programs. The EPA will publish a notice of deficiency (NOD) if EPA determines that a deficiency exists, or will notify the commenter in writing to explain the reasons for not making a finding of deficiency. EPA Region 5 will also post its response letters on the Internet at http://yosemite.epa.gov/r5/ardcorre.nsf/title+V+Program+Comments. EPA Region 5 includes the states of Michigan, Minnesota, Illinois, Indiana, Ohio, and Wisconsin. The EPA will also be posting all response letters on the national EPA website, and the Agency will publish a Federal Register notice of the availability of those response letters.

Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this final approval is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this final approval will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain an unfunded mandate nor does it significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified by Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). This rule also does not have federalism implications because 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, “Federalism” (64 FR 43255, August 10, 1999). This rule merely approves existing requirements under state law, and does not alter the relationship or the distribution of power and responsibilities between the state and the federal government established in the Act.

This final approval is also not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not a significant regulatory action under Executive Order 12866. This action will not impose any collection of information subject to the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , other than those previously approved and assigned OMB control number 2060-0243. For additional information concerning these requirements, see 40 CFR part 70. 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.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTA), 15 U.S.C. 272 note, requires federal agencies to use technical standards that are developed or adopted by voluntary consensus to carry out policy objectives, so long as such standards are not inconsistent with applicable law or otherwise impracticable. In reviewing state operating permit programs submitted pursuant to title V of the Act, EPA will approve state programs provided that they meet the requirements of the Act and EPA's regulations codified at 40 CFR part 70. Absent a prior existing requirement for the state to use voluntary consensus standards, EPA has no authority to disapprove a state operating permit program for failure to use such standards, and it would thus be inconsistent with applicable law for EPA to use voluntary consensus standards in place of a state program that otherwise satisfies the provisions of the Act. Therefore, the requirements of section 12(d) of the NTTA do not apply.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective November 30, 2001.

Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2) of the Act.)

EPA's approval of Minnesota's title V program is effective on November 30, 2001. Pursuant to section 502(h) of the Act, the effective date of a permitting program approved under title V is the date of approval by the Administrator or her delegatee. Furthermore, the good cause exception under the Administrative Procedure Act (APA) allows EPA to make the full approval of the state's program immediately effective. In relevant part, the APA provides that publication of “a substantive rule shall be made not less than 30 days before its effective date, except—* * * (3) as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. § 553(d)(3). Section 553(b)(3)(B) of the APA provides that good cause may be supported by an agency determination that a delay in the effective date is impracticable, unnecessary, or contrary to the public interest. The EPA finds that it is necessary and in the public interest to make this action effective sooner than 30 days following publication. In this case, EPA believes that it is in the public interest for the program to take effect before December 1, 2001. The EPA's interim approval of Minnesota's prior program expires on December 1, 2001. In the absence of this full approval of Minnesota's amended program taking effect on November 30, the federal program under 40 CFR part 71 would automatically take effect in Minnesota and would remain in place until the effective date of the fully-approved state program. The EPA believes it is in the public interest for sources, the public and Minnesota to avoid any gap in coverage of the state program, as such a gap could cause confusion regarding permitting obligations. Furthermore, a delay in the effective date is unnecessary because MPCA has been administering the title V permit program for more than six years under an interim approval. Through this action, EPA is approving a few revisions to the existing and currently operational program. The change from the interim approved program which substantially met the part 70 requirements, to the fully approved program is relatively minor, in particular if compared to the changes between a state-established and administered program and the federal program.

In its program submission, Minnesota did not assert jurisdiction over Indian country. To date, no tribal government in Minnesota has applied to EPA for approval to administer a title V program in Indian country within the state. EPA regulations at 40 CFR part 49 govern how eligible Indian tribes may be approved by EPA to implement a title V program on Indian reservations and in non-reservation areas over which the tribe has jurisdiction. EPA's part 71 regulations govern the issuance of federal operating permits in Indian country. EPA's authority to issue permits in Indian country was challenged in Michigan v. EPA, (D.C. Cir. No. 99-1151). On October 30, 2001, the court issued its decision in the case, vacating a provision that would have allowed EPA to treat areas over which EPA determines there is a question regarding the area's status as if it is Indian country, and remanding to EPA for further proceedings. EPA will respond to the court's remand and explain EPA's approach for further implementation of part 71 in Indian country in a future action.

This section provides additional information by addressing the following questions:

As required under Subchapter V of the Clean Air Act (“the Act”), as amended (1990), EPA has promulgated regulations which define the minimum elements of an approvable state operating permits program and the corresponding standards and procedures by which the EPA will approve, oversee, and withdraw approval of state operating permits programs (see 57 FR 32250 (July 21, 1992)). These regulations are codified at 40 Code of Federal Regulations (CFR) part 70. Pursuant to Subchapter V, generally known as title V, states developed, and submitted to EPA, programs for issuing these operating permits to all major stationary sources and to certain other sources.

The EPA's program review occurs under section 502 of the Act and the part 70 regulations, which together outline criteria for approval or disapproval. Where a program substantially, but not fully, meets the requirements of part 70, EPA granted the program interim approval. If EPA has not fully approved a program by the expiration of an interim program, it must establish and implement a federal program.

The Indiana Department of Environmental Management (IDEM) submitted its title V operating permits program (title V program) for approval on August 10, 1994. EPA promulgated interim approval of the Indiana title V program on November 14, 1995 (60 FR 57188), and the program became effective on December 14, 1995. Subsequently, EPA extended Indiana's title V interim approval period on several occasions, most recently to December 1, 2001 (65 FR 32036).

IDEM submitted amendments to its title V program for our approval on May 22, 1996. Indiana intended these amendments to correct interim approval issues identified in the November 14, 1995, action. Based on this submittal, EPA proposed full approval for the Indiana title V program on July 30, 2001 (66 FR 39293). EPA received one adverse public comment on the proposal. After carefully reviewing and considering the issues raised by the commenter, EPA is taking final action to give full approval to the Indiana title V program.

The comment that EPA received in response to our July 30, 2001, proposal objects to granting full approval to the Indiana title V program. The commenter states that public comments on deficiencies in the Indiana title V program remain unaddressed. In addition, he notes that changes to the Indiana program adopted since the November 14, 1995, interim approval also remain unaddressed. He believes that these issues result in a program that is insufficient and demonstrate that Indiana is “unwilling or unable to produce a minimally acceptable 40 CFR part 70 Operating Permits Program that meets the standard of full approval.”

EPA is aware that issues other than those listed in the November 14, 1995, interim approval exist in the Indiana program and that the Indiana regulations have undergone changes since 1995 that have not been submitted to EPA for approval. EPA agrees that these issues must be addressed and that the state must submit all changes made since 1995 for EPA review and approval. For the reasons discussed below, however, we disagree that newly identified deficiencies prohibit us from granting Indiana full program approval at this time.

In 1990, Congress amended the Act, 42 U.S.C. 7401 to 7671q, by adding title V, 42 U.S.C. 7661 to 7661f, which requires certain air pollutant emitting facilities, including “major source[s]” and “affected source[s],” to obtain and comply with operating permits. See 42 U.S.C. 7661a(a). Title V is intended to be administered by local, state or interstate air pollution control agencies, through permitting programs that have been approved by EPA. See 42 U.S.C. 7661a(a). EPA is charged with overseeing the state's efforts to implement an approved program, including reviewing proposed permits and vetoing improper permits. See 42 U.S.C. 7661a(i) and 7661d(b). Accordingly, title V of the Act provides a framework for the development, submission and approval of state operating permit programs. Following the development and submission of a state program, the Act provides two different approval options that EPA may use in acting on state submittals. See 42 U.S.C. 7661a(d) and (g). Pursuant to section 502(d), EPA “may approve a program to the extent that the program meets the requirements of the Act * * *” EPA may act on such program submittals by approving or disapproving, in whole or in part, the state program. An alternative option for acting on state programs is provided by the interim approval provision of section 502(g). This section states: “If a program * * * substantially meets the requirements of this title, but is not fully approval, the Administrator may by rule grant the program interim approval.” This provision provides EPA with the authority to act on state programs that substantially, but do not fully, meet the requirements of title V and part 70. Only those program submittals that meet the requirements of eleven key program areas are eligible to receive interim approval. See 40 CFR 70.4(d)(3)(i)-(xi). Finally, section 502(g) directs EPA to “specify the changes that must be made before the program can receive full approval.” 42 U.S.C. 7661a(g); 40 CFR 70.4(e)(3). This explicit directive encompasses another, implicit one: Once a state corrects the specified deficiencies then it will be eligible for full program approval. EPA believes this is so even if deficiencies have been identified sometime after final interim approval, either because the deficiencies arose after EPA granted interim approval or, if the deficiencies existed at that time, EPA failed to identify them as such in proposing to grant interim approval.

Thus, an apparent tension exists between these two statutory provisions. Standing alone, section 502(d) appears to prevent EPA from granting a state operating permit program full approval until the state has corrected all deficiencies in its program no matter how insignificant, and without consideration as to when such deficiency was identified. Alternatively, section 502(g) appears to require that EPA grant a state program full approval if the state has corrected those issues that the EPA identified in the final interim approval. The central question, therefore, is whether Indiana by virtue of correcting the deficiencies identified in the final interim approval is eligible at this time for full approval, or whether Indiana must also correct any new or recently identified deficiencies as a prerequisite to receiving full program approval.

According to settled principles of statutory construction, statutory provisions should be interpreted so that they are consistent with one another. See Citizens to Save Spencer County v. EPA, 600 F.2d 844, 870 (D.C. Cir. 1979). Where an agency encounters inconsistent statutory provisions, it must give maximum possible effect to all of the provisions, while remaining within the bounds of its statutory authority. Id. at 870-71. Whenever possible, the agency's interpretation should not render any of the provisions null or void. Id. Courts have recognized that agencies are often delegated the responsibility to interpret ambiguous statutory terms in such a fashion. See Chevron U.S.A, Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 845 (1984). Harmonious construction is not always possible, however, and furthermore should not be sought if it requires distorting the language in a fashion never imagined by Congress. Citizens to Save Spencer County, 600 F.2d at 870. Furthermore, as discussed more fully below, section 502 of the Act and 40 CFR 70.10 provide a mechanism for identifying problems in programs which states must correct to retain operating permit programs.

In this situation, in order to give effect to the principles embodied in title V that major stationary sources of air pollution must have an operating permit that conforms to certain statutory and regulatory requirements, and that state permitting authorities administer and enforce the operating permit programs, the appropriate and more cohesive reading of the statute recognizes EPA's authority to grant Indiana full approval in this situation while working simultaneously with the state, in EPA's oversight capacity, on any additional problems that were recently identified. To conclude otherwise would disrupt the current administration of the state program and cause further delay in Indiana's ability to issue operating permits to major stationary sources. A smooth transition from interim approval to full approval is in the best interest of the public and the regulated community and best reconciles the statutory directives of title V.

Furthermore, requiring the state to fix all of the deficiencies that have been identified in the past year to receive full approval runs counter to the established regulatory process, mentioned above, that is already in place to deal with newly identified program deficiencies. Section 502(i)(4) of the Act and 40 CFR 70.4(i) and 70.10 provide EPA with the authority to issue notices of deficiency (“NOD”) whenever EPA makes a determination that a permitting authority is not adequately administering or enforcing a part 70 program, or that the state's permit program is inadequate in any other way. Consistent with these provisions, EPA will specify in a NOD a reasonable time frame for the permitting authority to correct the identified deficiency.

The Indiana title V interim approval expires on December 1, 2001. This deadline does not provide adequate time for the state to correct newly identified issues prior to the expiration of interim approval. Allowing the state's program to expire because of issues identified as recently as March 2001 will cause disruption and further delay in the issuance of permits to major stationary sources in Indiana. As explained above, we do not believe that title V requires such a result. Rather, the appropriate mechanism for dealing with additional deficiencies that are identified sometime after a program received interim approval but prior to being granted full approval is the notice of program deficiency or administration deficiency as discussed herein. This process provides the state an adequate amount of time after such findings to implement any necessary changes without unduly disrupting the entire state operating permit program. As a result, addressing newly identified problems separately from the full approval process will not cause these issues to go unaddressed. To the contrary, EPA has notified Indiana that it must promptly correct the non-interim approval deficiencies within a specified time period or face sanctions and disapproval of its program. EPA identified non-interim approval deficiencies to Indiana in 2000. In response, Indiana began the process of revising its administrative code. Indiana worked with EPA throughout this rule adoption process to assure that all program deficiencies identified by EPA and by citizen groups are addressed by the revisions. Indiana's Air Pollution Control Board adopted the necessary title V rule revisions on October 3, 2001. These regulatory revisions still must undergo administrative review, and will not become effective until early 2002.

Because the regulatory revisions will not become effective by December 1, 2001, EPA will issue a NOD for these regulatory deficiencies in the Indiana program on that date. EPA recognizes that Indiana has almost completed the regulatory process to make the necessary revisions, and expects that the state will satisfy the conditions of the NOD by the end of February 2002. Furthermore, at the time that Indiana submits regulatory revisions to correct this NOD, the state must also submit for review and approval all changes that it has made to its title V program since we granted interim approval. Under that review, EPA will disapprove and issue NODs for any program revisions that are inconsistent with part 70.

The EPA is granting full approval of the operating permits program submitted by IDEM based on the interim approval corrections submitted on May 22, 1996. These revisions satisfactorily address the program deficiencies identified in EPA's November 14, 1995, interim approval rulemaking.

To date, no tribal government in Indiana has applied to EPA for approval to administer a title V program in Indian country within the state. The EPA regulations at 40 CFR part 49 govern how eligible Indian tribes may seek approval from EPA to implement a title V program on Indian reservations and in non-reservation areas over which the tribe has jurisdiction. The EPA's part 71 regulations govern the issuance of federal operating permits in Indian country. The EPA's authority to issue permits in Indian country was challenged in Michigan v. EPA, (D.C. Cir. No. 99-1151). On October 30, 2001, the court issued its decision in the case, vacating a provision that would have allowed EPA to treat areas over which EPA determines there is a question regarding the area's status as if it is Indian country, and remanding to EPA for further proceedings. The EPA will respond to the court's remand and explain EPA's approach for further implementation of part 71 in Indian country in a future action.

On May 22, 2000, EPA promulgated a rulemaking that extended the interim approval period of 86 operating permits programs until December 1, 2001. (65 FR 32035) The action was subsequently challenged by the Sierra Club and the New York Public Interest Research Group (NYPIRG). In settling the litigation, EPA agreed to publish a notice in the Federal Register that would alert the public that they may identify and bring to EPA's attention alleged programmatic and/or implementation deficiencies in title V programs and that EPA would respond to their allegations within specified time periods if the comments were made within 90 days of publication of the Federal Register notice.

Two citizens groups commented on what they believe to be deficiencies with respect to the Indiana title V program. As stated in the Federal Register notice published on July 30, 2001 proposing to fully approve Indiana's operating permit program, EPA takes no action on those comments in today's action. Rather, EPA expects to respond by December 1, 2001 to timely public comments on Indiana's program and other programs that have obtained interim approval, and by April 1, 2002 to timely comments on fully approved programs. Consistent with these time frames, EPA also will publish a notice of deficiency (NOD) if EPA determines that a deficiency exists, or will notify the commenter in writing to explain the reasons for not making a finding of deficiency. EPA Region 5 will also post its response letters on the Internet at http://yosemite.epa.gov/r5/ardcorre.nsf/Title+V+Program+Comments. EPA Region 5 includes the states of Michigan, Minnesota, Illinois, Indiana, Ohio, and Wisconsin. The EPA will also be posting all response letters on the national EPA website, and the Agency will publish a Federal Register notice of the availability of those response letters. An NOD will not necessarily be limited to deficiencies identified by citizens and may include any deficiencies that we have identified through our program oversight. Furthermore, in the future, EPA may issue an additional NOD if EPA or a citizen identifies other deficiencies.

Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this final approval is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this final approval will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain an unfunded mandate nor does it significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified by Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). This rule also does not have federalism implications because 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, “Federalism” (64 FR 43255, August 10, 1999). This rule merely approves existing requirements under state law, and does not alter the relationship or the distribution of power and responsibilities between the state and the federal government established in the Act.

This final approval is also not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not a significant regulatory action under Executive Order 12866. This action will not impose any collection of information subject to the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , other than those previously approved and assigned OMB control number 2060-0243. For additional information concerning these requirements, see 40 CFR part 70. 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.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTA), 15 U.S.C. 272 note, requires federal agencies to use technical standards that are developed or adopted by voluntary consensus to carry out policy objectives, so long as such standards are not inconsistent with applicable law or otherwise impracticable. In reviewing state operating permit programs submitted pursuant to title V of the Act, EPA will approve state programs provided that they meet the requirements of the Act and EPA's regulations codified at 40 CFR part 70. Absent a prior existing requirement for the state to use voluntary consensus standards, EPA has no authority to disapprove a state operating permit program for failure to use such standards, and it would thus be inconsistent with applicable law for EPA to use voluntary consensus standards in place of a state program that otherwise satisfies the provisions of the Act. Therefore, the requirements of section 12(d) of the NTTA do not apply.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective November 30, 2001.

Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2) of the Act.)

EPA's approval of Indiana's Title V program is effective on November 30, 2001. Pursuant to section 502(h) of the Act, the effective date of a permitting program approved under Title V is the date of approval by the Administrator or her delegatee. Furthermore, the good cause exception under the Administrative Procedure Act (APA) allows EPA to make the full approval of the state's program immediately effective. In relevant part, the APA provides that publication of “a substantive rule shall be made not less than 30 days before its effective date, except—* * * (3) as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(3). Section 553(b)(3)(B) of the APA provides that good cause may be supported by an agency determination that a delay in the effective date is impracticable, unnecessary, or contrary to the public interest. The EPA finds that it is necessary and in the public interest to make this action effective sooner than 30 days following publication. In this case, EPA believes that it is in the public interest for the program to take effect before December 1, 2001. The EPA's interim approval of Indiana's prior program expires on December 1, 2001. In the absence of this full approval of Indiana's amended program taking effect on November 30, the federal program under 40 CFR part 71 would automatically take effect in Indiana and would remain in place until the effective date of the fully-approved state program. The EPA believes it is in the public interest for sources, the public and Indiana to avoid any gap in coverage of the state program, as such a gap could cause confusion regarding permitting obligations. Furthermore, a delay in the effective date is unnecessary because IDEM has been administering the title V permit program for six years under an interim approval. Through this action, EPA is approving a few revisions to the existing and currently operational program. The change from the interim approved program which substantially met the part 70 requirements, to the fully approved program is relatively minor, in particular if compared to the changes between a state-established and administered program and the federal program.

The information in this section is organized as follows:

After evaluating GROWS' petition, we proposed to amend the current GROWS' delisting to increase the maximum annual waste volume covered by its exclusion from 1000 cubic yards to 2000 cubic yards. See 66 FR 38969, July 26, 2001. EPA is finalizing:

(1) The decision to grant GROWS' petition to increase the maximum annual waste volume covered by its exclusion from 1000 cubic yards to 2000 cubic yards, subject to certain conditions; and

(2) The decision to use the Delisting Risk Assessment Software, which includes the EPACMPT fate and transport model, to evaluate the potential impact of the petitioned waste on human health and the environment. We used this model to predict the concentration of hazardous constituents released from the petitioned waste, once it is disposed of in a Subtitle D landfill.

GROWS petitioned EPA to exclude the increased volume of its wastewater treatment sludge filter cake because it does not believe, even at the increased volume, that the petitioned waste meets the criteria for which it was listed.

GROWS also believes that the waste does not contain any other constituents that would render it hazardous. Review of this petition included consideration of the original listing criteria, as well as factors (including additional constituents) other than those for which the waste was listed, as required by the Hazardous and Solid Waste Amendments (HSWA) of 1984. See , section 222 of HSWA, 42 U.S.C. 6921(f), and 40 CFR 260.22(a)(1) and (2).

For reasons stated in both the proposed amendment and this document, we believe that GROWS’ wastewater treatment sludge filter cake should continue to be excluded from hazardous waste control at the increased volume. Therefore, we are granting the final amendment to GROWS, located in Morrisville, Pennsylvania, for its wastewater treatment sludge filter cake, generated at a maximum annual volume of 2000 cubic yards.

This amended exclusion applies to the waste described in the petition only if the requirements described in Table 1 of Appendix IX to part 261 of Title 40 of the Code of Federal Regulations are satisfied. The maximum annual volume of the wastewater treatment sludge filter cake is 2000 cubic yards.

The wastewater treatment sludge filter cake is currently being disposed of in a Subtitle D landfill under the provisions of the existing exclusion. This final amendment will allow GROWS to dispose of the specified increased volume of waste in a similar manner.

This rule is effective December 4, 2001. HSWA amended section 3010 of RCRA to allow rules to become effective in less than six months when the regulated community does not need the six-month period to come into compliance. That is the case here because this rule reduces, rather than increases, the existing requirements for persons generating hazardous wastes. For these same reasons, this rule can become effective immediately (that is, upon publication in the Federal Register ) under the Administrative Procedure Act, pursuant to 5 U.S.C. 553(d).

Because EPA is issuing today's exclusion under the Federal RCRA delisting program, only States subject to Federal RCRA delisting provisions would be directly affected. This would exclude two categories of States: States having a dual system that includes Federal RCRA requirements and their own requirements, and States who have received EPA's authorization to make their own delisting decisions. We describe these two situations below.

We allow states to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, under Section 3009 of RCRA. These more stringent requirements may include a provision that prohibits a Federally issued exclusion from taking effect in the State, or that prohibits a Federally issued exclusion from taking effect in the State until the State approves the exclusion through a separate State administrative action. Because a dual system (that is, both Federal and State programs) may regulate a petitioner's waste, we urge petitioners to contact the applicable State regulatory authorities or agencies to establish the status of their waste under that State's program.

We have also authorized some States (for example, Delaware and Pennsylvania) to administer a delisting program in place of the Federal program; that is, to make State delisting decisions. Therefore, this exclusion does not necessarily apply within those authorized States. If GROWS transports the petitioned waste to, or manages the waste in, any State with delisting authorization, GROWS must obtain delisting approval from that State before it can manage the waste as nonhazardous in that State.

Today, we are finalizing GROWS’ petition for amendment, even though the GROWS’ facility is located in a State which has recently been granted authorization for the delisting program, and with the knowledge that the amended exclusion is not automatically effective in a State authorized by EPA to make delisting decisions. Nevertheless, we take this action for the following reasons.

GROWS was granted its current Federal delisting exclusion on August 20, 1991 (56 FR 41286). For reasons described elsewhere in this preamble, on June 12, 2000, GROWS petitioned EPA for an amendment to this exclusion. This petition was received prior to November 27, 2000, the effective date of Pennsylvania's delisting authorization. Upon receiving the GROWS’ petition, we began our evaluation of it in consultation with the Pennsylvania Department of Environmental Protection.

The evaluation of this petition was performed using a significant improvement to the methodology previously used by EPA to evaluate risk, as described in detail in the July 26, 2001 proposed amendment (66 FR 38969). The process of amendment also provides an opportunity to update other conditions of the current exclusion.

In order for this amendment to be effective in an authorized State, that State must adopt this amendment through its State administrative process.

A delisting petition is a formal request from a generator to EPA or another agency with jurisdiction to exclude from the lists of hazardous waste regulated by RCRA, a waste that the generator believes should not be considered hazardous.

Under 40 CFR 260.20 and 260.22, a generator may petition EPA to remove its waste from hazardous waste control by excluding it from the lists of hazardous wastes contained in 40 CFR 261.31, 261.32 and 261.33. Specifically, 40 CFR 260.20 allows any person to petition the Administrator to modify or revoke any provision of parts 260 through 266, 268 and 273 of Title 40 of the Code of Federal Regulations. 40 CFR 260.22 provides generators the opportunity to petition the Administrator to exclude a waste on a “generator-specific” basis from the hazardous waste lists. A generator can petition EPA for an amendment to an existing exclusion under these same provisions of the Code of Federal Regulations.

A petitioner must provide sufficient information to allow EPA to determine that the waste to be excluded does not meet any of the criteria under which the waste was listed as a hazardous waste. In addition, the Administrator must determine that the waste is not hazardous for any other reason.

GROWS operates a commercial landfill and wastewater treatment plant in Morrisville, Pennsylvania. On November 13, 1986, GROWS petitioned EPA under the provisions in 40 CFR 260.20 and 260.22 to exclude from hazardous waste regulation a wastewater treatment sludge filter cake derived from the treatment of landfill leachate. This leachate originates, in part, from its closed landfill containing a mixture of solid wastes and hazardous wastes. The wastewater treatment plant also treats non-hazardous leachate from non-hazardous waste landfills.

A full description of these wastes and the Agency's evaluation of the 1986 GROWS' petition are contained in the “Proposed Rule and Request for Comments” published in the Federal Register on September 17, 1990 (55 FR 38090).

After evaluating public comment on the proposed rule, we published a final decision in the Federal Register on August 20, 1991 (56 FR 41286), to exclude GROWS’ wastewater treatment sludge filter cake derived from the treatment of EPA Hazardous Waste No. F039 (multi-source leachate) from the list of hazardous wastes found in 40 CFR 261.31.

EPA's final decision in 1991 was conditioned on the volume of waste identified in the 1986 GROWS’ petition. Specifically, the exclusion granted by EPA is limited to a maximum annual volume of 1000 cubic yards. Any additional waste volume in excess of this limit generated by GROWS in a calendar year had to be managed as hazardous waste.

As a result of an increase in wastewater treatment sludge filter cake production associated with an increase in the efficiency of the wastewater treatment operation, GROWS petitioned EPA on June 12, 2000, for an amendment to its August 20, 1991 final exclusion. In its petition, GROWS requested an increase in the maximum annual waste volume that is covered by its exclusion from 1000 cubic yards to 2000 cubic yards.

The exclusion which we granted to GROWS on August 20, 1991, is a conditional exclusion. In order for its exclusion to remain effective, GROWS must verify that its waste meets prescribed delisting levels.

To support its petition for amendment, GROWS submitted its verification testing results from the past two years to EPA. This submission consisted of the results of twenty-seven (27) analyses conducted on samples collected for the time period from December 15, 1997, until December 10, 1999.

The verification testing program prescribed by EPA in the August 20, 1991 exclusion requires GROWS to analyze metal constituents using the Toxicity Characteristic Leaching Procedure (TCLP), cyanide using a distilled water leaching procedure, and organics using total constituent analysis.

In addition to the two most recent years of verification testing results mentioned above, we also requested that GROWS submit the results of total constituent analyses for a minimum of four samples for the inorganic constituents. This was necessary because both total constituent analysis data and leachate data are now used in assessing the potential risk from disposal of a petitioned waste, and there is no reliable way to estimate actual total constituent concentrations of the inorganic constituents from leachate data.

Because the verification testing program specified by the current exclusion for GROWS does not require TCLP testing for organic constituents, we evaluated this request for an amendment by calculating theoretical maximum leachate concentrations for the organic constituents by applying the most conservative assumption. The procedure for determining the theoretical maximum leachate concentrations from total constituent analysis concentrations is described in the proposed amendment. See 66 FR 38969, July 26, 2001.

We received no public comments on the GROWS’ proposed amendment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a rule of general applicability and therefore is not a “regulatory action” subject to review by the Office of Management and Budget. Because this action is a rule of particular applicability relating to a particular facility, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), or to sections 202, 203, and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Because the rule will affect only one facility, it will not significantly or uniquely affect small governments, as specified in section 203 of UMRA, or communities of Indian tribal governments, as specified in Executive Order 13175 (65 FR 67249, November 6, 2000). For the same reason, this rule 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). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

This rule does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply. 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. Section 804 exempts from section 801 the following types of rules (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties (5 U.S.C. 804(3)). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability.

This final regulation establishes safe harbor protection for ambulance restocking arrangements. 1 Ambulance restocking is the practice, commonplace in many parts of the country, of hospitals or other receiving facilities restocking ambulance providers  2 with drugs or supplies used during the transport of a patient to the hospital or receiving facility. (For simplicity, we sometimes use the shorthand “hospital” or “receiving hospital” in this preamble; such terminology is intended to include other types of receiving facilities, such as urgent care or community health care clinics that provide emergency care services). Restocking enables the ambulance to depart the hospital ready for the next emergency call, fully stocked with current medications, sanitary linens, and a full complement of appropriate medications and supplies, and helps ensure that supplies, such as intravenous tubing and catheters, are compatible with equipment used in local emergency rooms so as to expedite the transfer of critically ill or injured patients to emergency room systems. Bona fide restocking arrangements serve a significant public interest and are consistent with Federal policy established over the past 25 years. 3

Set forth below is a brief background discussion addressing the anti-kickback statute and the proposed safe harbor for ambulance restocking; a summary of the provisions being adopted into the final regulations; and a review of the public comments received and our responses to those concerns.

Section 1128B(b) of the Social Security Act (the Act) (42 U.S.C. 1320a-7b(b)) provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive remuneration (i.e., anything of value, in cash or in kind) in order to induce the referral of business reimbursable by a Federal health care program. Violations of the statute may also result in civil money penalties under section 1128A(a)(7) of the Act or program exclusion under section 1128(a)(7) of the Act. The statute has been in existence since 1977 and applies broadly to all kinds of health care providers and suppliers. Payments tied to referrals corrupt the health care system, increasing the risks of overutilization of items and services, increased costs to the Federal health care programs, inappropriate steering of patients, and unfair competition. Ambulance restocking arrangements technically implicate the anti-kickback statute because the receiving hospital gives something of value (e.g., drugs or medical supplies) to a potential source of Federal health care program business, i.e., ambulance providers who deliver patients.

Notwithstanding the potential for a violation, the OIG believes that the vast majority of ambulance restocking arrangements are lawful under the anti-kickback statute. We fully recognize the importance of ambulances being restocked and ready for emergency use at all times. Properly structured restocking arrangements contribute to this laudable goal without significant risk of fraud or abuse.

The OIG was first asked to address an ambulance restocking arrangement in 1997 when two hospitals submitted a request for an advisory opinion under section 1128D of the Act. As required by the statute, the OIG responded to the request, even though the subject matter was not of significant concern to the OIG. As with all determinations under the anti-kickback statute, our review turned on the specific facts and circumstances of the arrangement as presented by the requesting hospitals. The request presented an unusual set of facts under which an unscrupulous party could potentially use an ambulance restocking arrangement for an unlawful purpose, namely the steering of patients to a particular hospital in exchange for remuneration. The OIG opined that the facts of the particular arrangement—as presented by the hospitals—would be likely to involve prohibited remuneration. 4 By law, the opinion applied only to the hospitals that requested it.

Subsequently, the OIG issued several favorable advisory opinions approving restocking arrangements that it believed to be much more representative of typical restocking arrangements. 5 Most recently, in December 2000, the OIG issued a favorable advisory opinion approving a hospital's proposal to restock only volunteer ambulance companies that do not charge anyone for their services.

On May 22, 2000, we published a notice of proposed rulemaking to promulgate safe harbor regulations for ambulance restocking arrangements (65 FR 32060). In the notice of proposed rulemaking, we proposed protecting two categories of ambulance restocking arrangements: (1) Arrangements under which the ambulance provider pays a receiving facility fair market value for restocked drugs or supplies; and (2) arrangements under which the ambulance service provider receives contemporaneous restocking of drugs or medical supplies used during emergency transport of a patient to the receiving facility, even if the restocking is without charge or at reduced prices. The proposed rule was designed to protect restocking for emergency transports only.

Proposed § 1001.952(v)(2), the fair market value category, was designed to protect restocking arrangements where an ambulance provider pays the receiving facility fair market value, based on an arms-length transaction, for restocked drugs or supplies (including linens) used in connection with the transport of an emergency patient. Under the proposal, payment need not be made at the same time as the restocking, provided commercially reasonable and appropriate payment arrangements are made in advance.

Proposed § 1001.952(v)(3) was designed to protect remuneration in the form of restocking of drugs or medical supplies (including linens) used during an emergency transport of a patient to the receiving facility, even if the restocking is for free or reduced prices. Under the proposed rule, the restocking arrangements would have to be implemented on a community-wide basis with some involvement of an oversight entity. The proposed safe harbor would not protect unilateral referral arrangements that were not open to all hospitals and ambulance companies in the service area.

Most commenters supported a new safe harbor, but many objected to certain aspects of the proposed rule. Some found the rule too narrow or burdensome, while others found the provisions of the proposed regulations ambiguous or impracticable. Of particular concern to many commenters were the proposed safe harbor conditions relating to monitoring by an oversight entity, written memorialization of the arrangement, and billing for restocked drugs and supplies. We have eliminated or substantially revised these conditions, as described in greater detail in section II. below.

As with the proposed rule, the goal of this final rule is safe harbor protection for the vast majority of ambulance restocking arrangements that further the important mission of insuring that pre-hospital emergency medical services (EMS) are timely, effective and efficient.

We have modified the proposed rule in a number of areas in response to public comments. Among the substantial changes and clarifications being made in the final regulations are:

• Eliminating the oversight entity condition in favor of a public operation and disclosure condition;

• Clarifying that no complicated written contracts or agreements are required and providing a short sample disclosure notice;

• Conforming the billing conditions to existing Federal health care program payment and coverage rules and regulations;

• Expanding the safe harbor to include restocking for non-emergency runs so long as the ambulance is also used for emergency runs;

• Allowing hospitals to limit the scope of protected restocking to all non-profit ambulance providers or all ambulance providers that do not charge for their services;

• Simplifying the documentation conditions so that only one party to the restocking arrangement is required to document the restocking;

• Adding specific safe harbor protection for Government-mandated ambulance restocking; and

• Including restocking of drugs or supplies initially administered to the patient by a first responder at the scene of the illness or injury.

The final safe harbor regulations establish broad protection for most existing ambulance restocking arrangements, while precluding protection for any abusive arrangements that use targeted or selective restocking for the purpose of inducing or rewarding referrals. The final regulations address three categories of restocking: (1) General restocking (whether for free or for a charge), (2) fair market value restocking, and (3) Government-mandated restocking. Parties need only satisfy the conditions applicable to any one of these categories. Parties who are unsure whether their restocking is at fair market value or is mandated by a Government authority may look to the general restocking category.

The final regulations provide that “remuneration” under the anti-kickback statute does not include any gift or transfer of drugs or medical supplies (including linens) by a hospital or other receiving facility to an ambulance provider for the purpose of replenishing comparable drugs or medical supplies (including linens) used by the ambulance provider (or a first responder) in connection with the transport of a patient by ambulance to the hospital or receiving facility if all applicable safe harbor conditions are satisfied.

The regulations are divided into two parts. First, there are four conditions, codified at § 1001.952(v)(2), that apply to all three of the restocking categories being protected by the safe harbor. Second, there are specific conditions codified at § 1001.952(v)(3) for each of the three categories being set forth (general restocking, fair market value restocking, and Government mandated restocking). To qualify for safe harbor protection, a restocking arrangement must meet all of the conditions in the first part and all of the conditions relevant to one category in the second part.

The four conditions applicable to all safe harbor restocking arrangements are:

(a) Appropriate billing of Federal health care programs. The final rule conditions safe harbor protection on Federal health care program billing for restocked drugs and medical supplies that is consistent with all applicable program payment and coverage rules and regulations. The ambulance provider and the hospital may not both bill for the same restocked drug or supply. For purposes of this safe harbor, billing includes submitting claims for bad debt. Compliance with the requirement that billing be appropriate will be determined separately for receiving facilities and ambulance providers. For example, if a hospital improperly bills for restocked supplies, the ambulance provider who received the supplies may still be protected, so long as the provider has not done anything to impede the hospital's compliance with the billing rules.

(b) Documentation requirements. We have simplified the documentation requirements. Under the final rule, either the hospital or the ambulance provider may generate the necessary documentation, so long as the other party receives and maintains a copy of it for 5 years. This 5-year period is consistent with the recordkeeping requirements of the Centers for Medicare and Medicaid Services' (CMS)  6 hospital conditions of participation. The pre-hospital care report typically prepared by the ambulance service provider (sometimes called the trip sheet, patient care report or patient encounter report) will be sufficient to satisfy this requirement if (i) the report identifies the drugs and supplies used on the patient and subsequently restocked and (ii) a copy of the report is filed with the receiving facility within a reasonable amount of time. For arrangements that include restocking of linens, an exchange of linens will be presumed to occur with each run, absent documentation to the contrary. The pre-hospital care report or other documentation may be prepared and filed with the other party in hard copy or electronically.

(c) No ties to referrals. In the light of the easing of the billing conditions, we are adding a safeguard similar to one found in other safe harbors that prohibits any restocking arrangement that is conditioned on, or otherwise takes into account, the volume or value of any referrals or other business generated between the parties for which payment may be made in whole or in part by a Federal health care program (other than the delivery to the receiving facility of the particular patient for whom the drugs and medical supplies are restocked).

(d) Compliance with all other applicable laws. We have retained the proposed condition that the receiving facility and the ambulance provider must comply with all Federal, State and local laws regulating ambulance services, including, but not limited to, emergency services, and the provision of drugs and medical supplies, including, but not limited to, laws relating to the handling of controlled substances.

The safe harbor conditions applicable to the three specific categories of safe harbor protection are summarized as follows:

(a) General restocking. This safe harbor for general restocking is available for free restocking arrangements, as well as arrangements under which the ambulance provider pays some amount for the restocked drugs and supplies (whether or not the amount is fair market value). (Any payment for drugs must comply with applicable Federal, State and local laws.) Two specific conditions apply to the general restocking category. First, the receiving facility must restock medical supplies or drugs on an equal basis for ambulance providers in one or more of three categories: (i) All ambulance providers; (ii) all non-profit and governmental providers; or (iii) all non-charging providers (typically volunteers and municipal providers). A receiving facility can offer restocking to more than one category, and can offer a different restocking program to each category that it restocks, so long as the restocking is uniform within each category. The final regulations make clear that safe harbor protection does not require each hospital and receiving facility in the service area to offer restocking, nor all ambulance providers to accept it.

Second, the restocking must be conducted publicly. As detailed in the regulations text, a restocking arrangement will be considered to be conducted publicly if: (i) The arrangement is memorialized in a conspicuously posted writing that outlines the terms of the restocking program and copies are available publicly (a sample disclosure form is included in the regulations); or (ii) The restocking program operates in accordance with a plan or protocol of general application promulgated by an EMS council or comparable organization. For purposes of safe harbor compliance, the writing need not disclose confidential proprietary or financial information.

(b) Fair market value restocking. This category protects restocking arrangements where an ambulance provider pays the receiving facility fair market value, based on an arms-length transaction, for restocked medical supplies (including linens). For consistency with the Prescription Drug Marketing Act, 7 and some State laws, the final regulations do not include the resale of drugs in this category. (Restocking of drugs may be covered under other safe harbor categories.) This safe harbor category has two conditions: (i) The restocking must be at fair market value, and (ii) payment arrangements must be commercially reasonable and made in advance. For reasons discussed in greater detail in the responses to comments in section III. of this preamble, we are not including any special accommodation related to the Non-Profit Institutions Act, 15 U.S.C. 13(c), exception to the Robinson-Patman Act. 8

(c) Government-mandated restocking. This final safe harbor protects restocking of drugs and supplies undertaken in accordance with a State or local statute, ordinance, regulations or binding protocol that requires hospitals or receiving facilities in the area subject to such requirement to restock ambulances that deliver patients to the hospital with drugs or medical supplies that are used during the transport of that patient.

As with all safe harbors, compliance with these new safe harbors is voluntary . While the vast majority of ambulance restocking arrangements should fit in this new safe harbor, failure to fit does not mean that an arrangement is illegal under the anti-kickback statute. Rather, it simply means that the legality of the arrangement must be evaluated on a case-by-case basis. If no purpose of the arrangement is to induce or reward the generation of Federal health care program business, there would be no violation of the statute. The obligation of parties to comply with the anti-kickback statute pre-dates this safe harbor rulemaking, and arrangements that were lawful before the rulemaking will continue to be lawful, whether or not they meet the safe harbor requirements. The safe harbor does not require the restructuring of any arrangements, although parties may choose to restructure to take advantage of the safe harbor protection. Parties who are unsure whether their existing or proposed arrangements fit in a safe harbor or would be subject to OIG sanctions may apply for an advisory opinion under section 1128D of the Act. The procedures for applying for an advisory opinion are set forth at 42 CFR part 1008 and on the OIG Web site at http://www.dhhs.gov/progorg/oig/advopn/index.htm .

In response to our proposed rulemaking, the OIG received a total of 46 timely-filed comments from a cross-section of ambulance providers, hospitals, local and regional emergency medical boards, professional associations and other interested parties. Set forth below is a summary of the issues raised by the commenters and our responses to those specific concerns.

The vast majority of the public comments supported promulgation of a safe harbor for ambulance restocking, although many commenters took issue with one or more specific aspects of the proposal.

Comment: Several commenters believed that the OIG advisory opinions on ambulance restocking under the anti-kickback statute, especially the first one issued in 1997, have had a chilling effect on ambulance restocking arrangements.

Response: While this comment reflects a common perception in the industry, we have learned that a major source of the reluctance of many hospitals to enter into, or continue, restocking programs is financial. In other words, their willingness to participate in restocking arrangements is directly related to their ability to be reimbursed by Medicare or other insurers for costly supplies and drugs provided without charge to local ambulance services. Many of these drugs and supplies are increasingly becoming the standard of care for pre-hospital services. In many cases, financially strapped hospitals are unwilling to continue to subsidize the emergency medical system in the absence of definitive assurance that they will be adequately reimbursed for drugs and supplies used during ambulance transports. Some hospitals have used the unfavorable 1997 advisory opinion as a pretext for justifying decisions to terminate, or decline to participate in, restocking arrangements in order to blunt negative publicity and adverse local community reaction.

Comment: A number of commenters misread the proposed regulations as an effort by the OIG to dictate Medicare payment policy.

Response: The OIG does not set Medicare payment and coverage policy. As stated in the proposed rule, we express no view in these regulations as to the appropriate Federal health care program payment or coverage policy for drugs and supplies used during ambulance transports. Those determinations are properly made by the relevant Federal program. In crafting safeguards to include in safe harbor regulations, we considered the ways in which a particular payment policy or practice may affect the risk of patient or program abuse.

Comment: An ambulance provider with a limited budget, and in an area with a low call volume, explained that it could not maintain an Advanced Life Support level of service, because it was unable to restock drugs from a local hospital. According to the commenter, their costs of purchasing expensive drugs in small quantities makes such drugs prohibitively expensive. In addition, the commenter observed that many small providers do not have the facilities to maintain proper environmental conditions for larger supplies of these types of drugs.

Response: Nothing in these regulations prohibits hospitals from restocking ambulances with drugs or prohibits ambulance providers from taking advantage of (i) volume discounts obtained by hospitals (to the extent otherwise permitted under Federal, State and local law) or (ii) any hospital facility for storing such drugs.

Comment: Several commenters indicated that in some parts of the country, local and State governments have imposed mandatory requirements relating to the restocking of ambulances that deliver patients to hospitals. These commenters requested an additional category of safe harbor protection to address arrangements controlled by State or local government requirements.

Response: Nothing in the safe harbor regulations precludes State and local governments from regulating ambulance restocking. If the State or local law or regulation is duly promulgated, and the restocking arrangement is conducted in accordance with its mandate, the OIG sees little risk under the anti-kickback statute, which requires a showing of unlawful intent. Accordingly, we are including an additional safe harbor category for Government-mandated restocking, and have adapted language suggested by a major trade association. We note that nothing in State or local government laws or regulations mandating ambulance restocking affects the reimbursement rules under Medicare or other Federal health care programs.

Comment: Some commenters questioned whether ambulance restocking arrangements raise kickback concerns at all. Specifically, with respect to patient steering risks, one commenter explained that conscious patients select their own destination, and unconscious or unstable patients are taken to the nearest facility. Other commenters expressed the view that instances of fraud in ambulance restocking arrangements would be isolated.

Response: We agree that fraud and abuse are likely to be uncommon in bona fide ambulance restocking arrangements. Nonetheless, in crafting safe harbors, we must be mindful not only of the benefits of the practices we seek to protect, but also the potential abuses. With ambulance restocking, the risks are low but not absent.

Comment: Several commenters requested clarification of the term “emergency patient” as used in the proposed safe harbor. These commenters inquired whether this term referred to the patient's actual condition or to the manner by which the ambulance is summoned. One commenter suggested that an emergency patient be defined as a patient delivered to a bona fide emergency department for medical or traumatic care.

Response: Because we are expanding the safe harbor to cover non-emergency transports, we do not believe any regulatory definition of the term “emergency patient “ is required. However, we are adding a definition of “emergency ambulance service” for purposes of identifying those ambulances and ambulance providers that provide emergency transports and are thus eligible for safe harbor-protected restocking. For purposes of these final regulations, we are defining an “emergency ambulance service” as one that results from a call through 9-1-1 or other emergency access number or a call from another acute care facility unable to provide the higher level care required by the patient and available at the receiving facility.

Comment: Paragraph (v)(1) of the proposed regulations indicated that remuneration “* * * does not include any gift or transfer of drugs or medical supplies (including linens) * * *” A commenter found the use of the word “gift” in this phrase confusing, since the safe harbor protects what is essentially an equal or equivalent exchange (i.e., what was used is restocked) and not the gifting of additional goods.

Response: The commenter is correct that the safe harbor is not designed to protect remuneration in the form of additional goods or services beyond the restocking of drugs or medical supplies (including linens) used on particular patients transported to the receiving facility. It does, however, protect restocking in the form of a gift, i.e., restocking bestowed voluntarily and without compensation.

Comment: A large self-insured manufacturing company that maintains its own private ambulance service to transport ill or injured employees to its preferred provider hospitals expressed concern about the impact of the proposed rule on its restocking arrangement. According to the commenter, the company negotiates preferred provider plans with hospitals in accordance with which the hospitals restock the ambulances at the hospitals' expense. No employees transported by the company's ambulance service are covered by Medicare or Medicaid, but the company is concerned that the safe harbor would affect restocking practices at the hospital.

Response: Because the company's ambulance service transports only private pay patients, nothing in this rule will directly affect the commenter's restocking arrangements. Short of making clear in this preamble discussion that the arrangement described in the comment need not be modified to comply with these rules, we know of no way of preventing the collateral impact anticipated by the company in particular cases.

Comment: A number of commenters urged the OIG to expand the proposed safe harbor to cover the restocking of drugs and medical supplies for non-emergency transports. Given that ambulances that provide non-emergency transports are frequently on call for emergencies, commenters noted that it would be contrary to the public health and safety goals of restocking to bar restocking of an ambulance that arrives at a hospital with a non-emergency patient. One commenter recommended that we expand the safe harbor to apply to all patients brought to the hospital or, in the alternative, to all patients brought to the emergency room.

Response: In general, the scope of replenishing needed after a non-emergency transport is likely to be minimal, since relatively few drugs or supplies are typically administered to non-emergency patients during a transport. Nevertheless, to further the goal of protecting restocking arrangements that ensure that ambulances are stocked and ready to respond to emergencies at all times, we are expanding the safe harbor to cover the restocking of drugs and supplies used on both emergency and non-emergency transports, provided that the ambulance that is restocked is used with some degree of regularity to respond to emergency calls (i.e., calls from 9-1-1 or another emergency access number). We do not intend to protect restocking of ambulances that are not used with some degree of regularity for emergencies. The fact that such restocking is outside the scope of this rulemaking does not mean that such restocking is illegal. Whether arrangements for restocking of non-emergency ambulances violate the anti-kickback statute must be determined on a case-by-case basis. Parties to such arrangements may request an OIG advisory opinion.

In order to create a bright line rule that is simple to apply, this expansion requires a measure for determining when an ambulance is used for emergency calls with sufficient regularity to qualify for replenishing under the safe harbor. The new regulations provide that an ambulance will satisfy this standard if the ambulance is used to respond to emergencies an average of three times per week measured over any reasonable time period. This test does not mean that the ambulance must actually make three emergency runs every week. Rather, over a reasonable period of time, the ambulance must be used an average of three times per week. Thus, for example, if an ambulance is used 12 times during a month, the test will be met. Similarly, the test will be met if the ambulance is used for emergency runs 156 times in a year, even if there are some weeks in which the ambulance receives no emergency calls. In essence, the three runs test is designed to differentiate between ambulances that are reasonably likely to be called out for an emergency transport, and thus have a compelling need to be restocked by a receiving facility after a non-emergency run, and those that are not.

Restocking arrangements for ambulances or ambulance providers that only provide routine, non-emergency services, or that do not meet the three runs test described above, must be evaluated under the anti-kickback statute on a case-by-case basis. Finally, nothing in these regulations will require restocking of non-emergency transports or the expansion of existing restocking programs to cover non-emergency transports.

Comment: The proposed rule conditioned safe harbor protection on a receiving hospital's provision of restocked drugs and supplies on an equal basis to all ambulance providers that deliver patients to the hospital. This condition was intended to insure that the safe harbor did not protect selective or targeted arrangements that are not bona fide restocking for the purpose of enhancing the delivery of EMS. Commenters argued that the safe harbor should protect receiving facilities that opt to restock only certain categories of ambulance providers. For example, some wanted to restock only volunteer ambulance providers or only ambulance providers that do not charge patients or insurers. Tax-exempt hospitals commented that requiring them to restock for-profit ambulance providers could jeopardize their tax-exempt status. Other commenters wanted to offer different restocking programs to different types of ambulance providers, such as offering full restocking to non-charging volunteer companies and more limited restocking to companies that charge for services.

Response: Having reviewed the comments, we have concluded that an appropriate safe harbor can be structured that would afford hospitals greater flexibility in crafting restocking programs, while preserving the principle that protected restocking programs should not be unilateral arrangements for the benefit of selected providers. (Of course, unilateral arrangements in remote service areas where there is only one receiving facility or one ambulance service provider are protected if they meet all the safe harbor conditions.) The final regulations protect restocking of: (i) All ambulance providers; (ii) all non-profit and governmental ambulance providers; or (iii) all ambulance providers that do not charge patients or insurers (typically volunteers and municipal providers). A hospital can offer restocking to more than one category and can offer a different restocking program to each category that it restocks, so long as the restocking is uniform within each category (i.e., non-charging providers may be offered a larger scope of restocked items than charging providers). Limiting the scope of free restocking to providers within these categories represents a reasonable distinction that will ensure that arrangements qualifying for safe harbor protection will not be related to the volume or value of referrals or other business generated for the hospitals. This modification accommodates hospitals' legitimate interests in containing the cost of their restocking programs. (The issue of the effect, if any, of a restocking arrangement on a hospital's tax exempt status would be a matter for the Internal Revenue Service.)

Comment: A commenter expressed concern that the “all ambulances” condition in the proposed rule would not permit facilities to restock only small, low volume volunteer companies without charge or at below cost. The commenter explained that, in their region, hospitals could not afford to restock large, high volume commercial ambulance companies for free.

Response: We have revised the safe harbor to permit hospitals to restock volunteer companies only. To qualify for safe harbor protection, the hospital must restock all volunteer companies uniformly. The safe harbor does not protect differential restocking based on the volume of transports, although offering free or discounted restocking only to low volume companies would not necessarily violate the anti-kickback statute.

Comment: Several commenters requested clarification as to whether all ambulance providers and receiving facilities in a service area would be required to participate in a restocking arrangement in order for the arrangement to qualify for safe harbor protection.

Response: All ambulance providers in a service area are not required to participate in order for an arrangement to fit in the safe harbor. Under the proposed rule, we did not intend to require all ambulance providers and receiving facilities in a service area actually to participate in a restocking arrangement in order for the arrangement to qualify for safe harbor protection. We did intend to require that a protected restocking arrangement be open to the voluntary participation of all ambulance providers and receiving facilities in a service area. The final regulations—including the new public operation and disclosure condition—generally reflect this intent. We have made exceptions for arrangements that limit the scope of restocking to the particular subcategories of ambulance providers described in the preceding response or that limit the scope to emergency transports. These limitations are a reasonable means of constraining the costs of restocking and are not related to the actual or potential volume or value of referrals or other business generated between the parties that is payable by a Federal health care program.

Comment: Some commenters objected to the proposed billing conditions. While designed to limit safe harbor protection to those arrangements that posed no risk of double payments or “double dipping,” the conditions were misconstrued by many commenters as prohibiting legitimate billing practices under Medicare payment rules, or as barring all billing by both the hospitals and the ambulance providers for the restocked drugs and supplies. Some commenters wondered why a safe harbor under the anti-kickback statute would need to take into account the question of billing at all. Commenters recommended that the conditions on billing in the proposed safe harbor be removed or altered to provide only that any billing for restocked items must be consistent with applicable Federal reimbursement provisions.

A commenter explained that ambulance providers in its State are not allowed to purchase or bill for drugs. The drugs used in the field are purchased and owned by the hospitals and restocked locally through a system of State-approved protocols. The commenter believed the following language would better accomplish the safe harbor objectives, while still allowing one party to bill for drugs: “Under no circumstances may the ambulance provider and the receiving facility both bill for the actual drug or supply. Restocked drugs or supplies may only be billed to any Federal health care program by either the ambulance provider or the receiving facility.” Several other commenters suggested similar language.

Response: We agree with the commenters that a safe harbor regulation is not a tool for setting program payment and coverage policy and doing so was not our intent. The billing conditions we proposed were designed to ensure that the safe harbor would not protect arrangements that could result in Medicare paying twice for the same drugs and supplies (i.e., situations in which both the ambulance company and the hospital bill for the same drug or supply), or in the ambulance services provider receiving a double benefit by billing Medicare for drugs and supplies for which it obtained free replacements (double-dipping). In both circumstances, ambulance restocking arrangements have the potential to increase costs to Medicare and other Federal health care programs. In the interest of simplification, we are adopting the commenters' suggestion and modifying the billing conditions to require that any billing of the Federal health care programs comport with applicable payment and coverage rules and regulations. Under applicable Medicare rules, a particular drug or supply administered to a patient in a pre-hospital setting will be covered under either the ambulance or the outpatient hospital benefit, depending on the circumstances (e.g., whether the ambulance transport is provided “under arrangements” with the hospital); thus, the ambulance provider and the hospital may not both bill for the same drug or supply. 9

Comment: Commenters raised a number of issues related to reimbursement for restocked drugs or supplies in particular circumstances. For example, a commenter explained that several volunteer rescue squads in its region do not bill any Federal health care programs. The commenter believes the proposed rule, as written, did not consider how a hospital would be reimbursed for drugs and supplies used by a volunteer service when an emergency patient is not admitted to the hospital. Some commenters questioned how ambulance providers would be reimbursed for new lifesaving drugs that could not have been included in the base rate payable to ambulance providers because the drugs did not exist, or were not used in a pre-hospital setting, when the base rates were set. Several commenters asked that we create a separate safe harbor to cover restocking arrangements that deal with specific drugs or devices that are administered at the order of a physician at the receiving hospital or centralized medical control. A commenter observed that unless private ambulance companies recover costs for expensive new medications, they will likely cease providing emergency services, thus shifting the entire responsibility onto the local governments to provide emergency medical care.

Response: The question of reimbursement in the circumstances described by the commenters is outside the scope of the OIG's regulatory authority and should be directed to CMS or the relevant fiscal intermediary or carrier. We included a condition in the proposed safe harbor that would have denied safe harbor protection for arrangements under which ambulance providers billed separately (i.e., in addition to the base rate payment) for restocked drugs and supplies. The condition would not have barred the restocking of any particular drugs or supplies. However, we have removed the former billing condition and replaced it in the final regulations with one that requires appropriate billing of the Federal health care programs, as determined by CMS or other relevant payment agency. Restocking of lifesaving drugs will be protected so long as the safe harbor conditions are met. None of the safe harbor conditions strikes us as imposing any particular burden on restocking of lifesaving drugs. Given this, we see no need for the additional safe harbor suggested by the commenters.

Comment: Several commenters observed that hospitals are unwilling to absorb the cost of emergency medications and supplies provided for free or below fair market values.

Response: Nothing in these regulations requires hospitals to provide ambulances with free or below cost medications or supplies for emergency services. Our interest in developing the safe harbor provisions is in insuring that the anti-kickback statute does not chill bona fide hospital restocking arrangements by hospitals that wish to provide them. To the extent that reimbursement policies may adversely impact the delivery of EMS, those concerns should be addressed to CMS.

Comment: A commenter asked about the intended impact of these safe harbor regulations on current and future arrangements involving hospitals that have negotiated prospective payment arrangements that may incorporate medication charges or EMS providers that have negotiated fee structures that bundle such charges in one overall set of base-rate and mileage charges. The commenter pointed out that CMS's negotiated rulemaking process for EMS rate setting may alter these arrangements as new rates, including bundled charges, are phased in.

Response: These rules should have no impact on the arrangements described by the commenter. Nothing in these rules alters or changes any billing practice or arrangement.

Comment: Several commenters raised concerns about the documentation requirement in the proposed safe harbor. Commenters believed that requiring both the hospital and the ambulance provider to document the restocking was unnecessary and duplicative. The commenters generally suggested that existing patient care reports (sometimes known as trip sheets or patient encounter reports) already maintained for other purposes, such as ensuring continuity of care and billing, should be sufficient. Commenters explained that in a busy emergency room, it would be difficult to maintain multiple logs for multiple ambulance providers for both supplies and medications. Several commenters noted that maintaining a record of every restocked item in a large urban EMS system with a large volume of patients would create large amounts of paperwork, consume limited resources, and slow down the response time of ambulances. Alternatively, some commenters suggested that parties could agree that either the hospital or the ambulance provider, but not both, should bear the responsibility for record keeping.

Response: We have modified the documentation requirement to permit either party to maintain records of the restocked drugs and medical supplies, so long as the other party receives and maintains a copy of the records. (In the alternative, both the hospital and the ambulance provider can maintain separate records of the restocking, in which case they need not file copies of their respective documentation with the other party.) Patient care reports, trip sheets, patient encounter reports, and the like (collectively being referred to as pre-hospital care reports in the final regulations) are sufficient to meet this requirement if they document the restocked drugs and medical supplies and are filed with the receiving facility within a reasonable time, in hard copy or electronically. It is our understanding that the preparation of a pre-hospital care report is the standard of care for transferring a patient to a receiving facility and is required by law in many States. However, parties may decide individually or between themselves to document the restocking using other kinds of paper or electronic records. In the case of first responder restocking, we are requiring that the restocked drugs and medical supplies be documented in the pre-hospital care report prepared by the transporting ambulance provider or in records maintained by the hospital and shared with the transporting provider.

Comment: One commenter favored the proposed documentation requirement in most situations, but suggested that this requirement might be rethought for linen exchanges and other routinely used items. In the commenter's view, the requirement that hospitals and ambulance providers keep records pertaining to routine items, like linens, is unduly burdensome. The commenter argued that there is little risk to the programs from a one-for-one exchange of soiled linen for clean linen, and that these exchanges are so prevalent throughout the industry that record keeping would be required on virtually every transport for many ambulance providers.

Response: We agree that providers need not document the exchange of linens. If they are part of a restocking arrangement, linens will be presumed to have been exchanged on a one-for-one basis. The commenter did not identify, and it would not be feasible to enumerate in these regulations, other supplies that may be so routinely used as to warrant a comparable presumption. We think parties will be able to devise simple means of documenting such routine restocking.

Comment: One commenter requested guidance on the length of time providers need to maintain records of restocked drugs and supplies.

Response: As indicated above, we have simplified the documentation requirements. Under the final regulations, either the hospital or the ambulance provider may generate the necessary documentation, so long as the other party receives and maintains a copy of it for 5 years, a period consistent with the CMS's hospital conditions of participation recordkeeping requirements.

Comment: Some commenters objected to the proposed condition requiring the restocking arrangement to be memorialized in writing. The proposed rule required that the ambulance restocking arrangement be memorialized in writing, either (i) in a plan or protocol of general application or (ii) in a written contract between the parties. Some commenters misread this condition as requiring providers to enter into written contracts or agreements. In addition, we have heard, anecdotally, that some industry consultants and counselors have been advising ambulance providers and hospitals that the proposed rule required the creation of lengthy and detailed contracts.

Response: As is typical of most safe harbor regulations, the proposed rule required that the protected ambulance restocking arrangement be memorialized in writing. Under the proposal, the writing could be either a plan or protocol of general application or a written contract or agreement between the parties. Under the final rule, no particular form of writing is mandated. Indeed, the writing can take the form of a simple disclosure statement. A sample disclosure statement is being included as an appendix to part 1001, subpart C of the regulations. This sample is intended for guidance purposes only. Parties are free to use other formats or to substitute written contracts or protocols. No public disclosure of confidential proprietary or financial information is required.

We believe that virtually all existing restocking arrangements are already being conducted in accordance with some form of written description of the arrangement. So long as the written description is conspicuously posted and publicly available and describes (i) The category, or categories, of ambulance provider that qualifies for restocking; (ii) the drugs or medical supplies included in the restocking program for each category; and (iii) the procedures for documenting the restocking, no new paperwork is required to qualify for safe harbor protection.

Comment: Many commenters objected to the “oversight entity” condition included in the proposed rule. Among other things, commenters argued that mandating a regional oversight body would unduly burden local communities by requiring the creation of a significant infrastructure and layers of bureaucracy. Some commenters expressed concern that the proposed rule was unclear as to the scope of the oversight entities' responsibilities and that such a requirement could lead to logistical problems for entities that would have to develop, review and monitor contracts for all regional providers. In some places, this would entail oversight of more than 80 receiving facilities. A hospital association expressed concern that the term “oversight” could imply a regulatory, rather than strictly an oversight, role. Some commenters thought the proposed rule tasked oversight entities with responsibility for monitoring contractual arrangements over which they might have little control. Some commenters noted that coordinated EMS councils do not exist in all parts of the country, and, where they do operate, it would often not be realistic to expect them to oversee the restocking programs of many different hospitals and ambulance providers. Other commenters found the language regarding the composition of the oversight entity confusing and questioned whether particular parties, such as labor unions, could be participants in the oversight entities.

Response: We originally proposed protecting ambulance restocking arrangements that were part of a comprehensive and coordinated EMS delivery system to ensure that the safe harbor would protect bona fide restocking arrangements and not selective arrangements used to attract or reward referrals. To effectuate this requirement, we proposed that restocking arrangements be implemented with the participation of, and monitored by, a regional EMS council or comparable entity.

While we had intended the oversight entity condition to be broad and flexible in accordance with local conditions, encompassing a broad array of entities of various composition that were representative of their service areas, the comments made clear that many in the industry found the requirement burdensome. Accordingly, we have eliminated the oversight entity condition, and in its place we have substituted three flexible safe harbor conditions that we believe will provide sufficiently comparable protection from a safe harbor perspective. These include conditions that: (i) Require a publicly conducted restocking arrangement, (ii) require uniformity in the restocking arrangement, and (iii) prohibit restocking that takes into account the volume or value of referrals (other than the referral of the particular patient to whom the restocked drugs and medical supplies were furnished). These new requirements should effectively exclude improperly selective or preferential arrangements from safe harbor protection, while protecting those arrangements that are truly intended to promote the safe, efficient and effective delivery of pre-hospital EMS.

Comment: One commenter noted that requiring restocking arrangements to be part of a comprehensive regional EMS delivery plan was an important way to guarantee compliance on the part of providers.

Response: Participation in a comprehensive regional EMS delivery system is an effective means of ensuring that ambulance restocking arrangements further the public interest in timely, effective and efficient EMS and are not improperly targeted at high referrers. Under the final rule, restocking arrangements that are conducted in accordance with a protocol or plan established by an EMS council or comparable body will satisfy the public operation and disclosure requirements of the safe harbor and will likely satisfy the other safe harbor requirements as well.

Comment: One commenter suggested that, as an alternative to the oversight entity condition, the OIG require hospitals (i) to have written policies, approved by the governing board, stating that their restocking program is open to all emergency ambulance providers; and (ii) to develop an internal system to confirm and verify this arrangement.

Response: We have essentially adopted this commenter's views in the final rule, although hospitals may limit the scope of their restocking programs to certain subcategories of ambulance providers. We are not requiring governing board approval or the development of internal compliance systems as part of this safe harbor regulation, but note that such practices may be prudent as part of the hospital's overall anti-fraud and abuse compliance program and necessary to ensure proper billing of the Federal health care programs.

Comment: One commenter urged that the proposed safe harbor conditions, especially the oversight entity condition, be eased for restocking arrangements in rural or isolated areas since ambulance providers in these areas have, in effect, no choice of where to deliver a patient.

Response: We believe the final rule, as modified, accommodates the special circumstances of rural and isolated areas. As stated above, we are no longer requiring establishment of an oversight entity. We believe the remaining safe harbor conditions are reasonable and impose few, if any, additional burdens on providers.

Comment: A commenter requested safe harbor protection for restocking for first responders. The commenter described the following situation:

Response: The final regulations protect hospital restocking of first responders as described by the commenter, provided the safe harbor conditions are satisfied. Specifically, the safe harbor accommodates those arrangements in which a 9-1-1 (or comparable emergency access number) first responder—including, but not limited to, a fire department, paramedic service or search and rescue squad—administers drugs or supplies to the patient, but does not transport the patient to the receiving facility. In these circumstances, the transporting ambulance provider may restock the first responder and then, in turn, be restocked by the hospital. Any billing by the hospital, the ambulance provider, or the first responder would be subject to the applicable Federal health care program payment and coverage rules and regulations. This safe harbor only addresses restocking by hospitals. Restocking of first responders by ambulance transport providers (independent of any hospital restocking) was outside the scope of the proposed rulemaking and is not addressed in these final regulations. Such arrangements must be analyzed on a case-by-case basis for compliance with the anti-kickback statute. Parties may seek an OIG advisory opinion about such arrangements. 10

Comment: Several commenters raised concerns about the fair market value safe harbor's application to the transfer of drugs. As these commenters explained, many hospitals participating in EMS systems historically have “owned” the medication and supplies used by the ambulances on emergency transports without passing title to the ambulance provider. In many cases, the drugs are controlled substances under State laws and cannot be the property of a fire department or ambulance company. The commenters asserted that if title does not pass to the ambulance provider, then the hospital does not provide anything of value when it replaces the drugs on the ambulance. In addition, several commenters questioned how prescription drugs could be sold to ambulance providers by hospitals. One commenter stated that the Prescription Drug Marketing Act of 1987 (21 U.S.C. 353(c)) specifically forbids hospitals from re-selling prescription drugs, except under narrow circumstances.

Response: We agree that the fair market value safe harbor category should be restricted to the resale of supplies and non-prescription drugs (which are included as “supplies” under Medicare's ambulance payment system). Nothing in these regulations should be construed as permitting any action in contravention of applicable Federal, State, or local laws governing the purchase and administration of controlled substances and prescription medications. Whether the transfer of drugs that cannot be owned by an ambulance provider, and that remain the property of the hospital when placed on an ambulance in accordance with State or local law, is remuneration to the ambulance provider that administers the drugs in the field turns, in the first instance, on whether the drugs are covered under Medicare's ambulance benefit or under the outpatient hospital benefit in the particular circumstances. As noted above, questions regarding appropriate coverage and payment under Medicare should be directed to CMS.

Comment: A commenter expressed concern that the fair market value safe harbor would make it impossible for a hospital to provide the goods on a pro bono basis to a small volunteer ambulance service. The commenter believed the proposed safe harbor required facilities either to charge volunteer companies the same rates they charge commercial or municipal services or to charge no one.

Response: The commenter misread the proposed safe harbor. Nothing in these regulations precludes bona fide charitable contributions by hospitals to volunteer ambulance services. The fair market value safe harbor at § 1001.952(v)(3)(ii) does not require that a receiving facility charge all ambulance providers the same prices. Rather, the safe harbor protects those arrangements that are at fair market value. Arrangements that are not at fair market value, such as free or deeply discounted restocking to volunteer companies or others, may be protected instead under the general restocking safe harbor at § 1001.952(v)(3)(i).

Comment: One commenter was concerned that market power disparity among receiving facilities could affect the fair market value prices ambulance companies pay, in turn creating an incentive for ambulance providers to take patients to larger hospital systems in a position to negotiate volume discounts for their drugs and supplies and pass those discounts on to ambulance companies. The commenter suggested that the OIG add provisions to guard against this risk.

Response: In applying the fair market value condition, fair market value should be measured in terms of prices the ambulance provider would pay for like supplies if it purchased them in an arms-length transaction from a seller (other than a receiving facility) for whom the ambulance provider is not a potential referral source. In many situations, fair market value will be a range of prices, not a single price. (Restocking at prices that are below fair market value is not protected by this safe harbor category, although the restocking may be protected by one of the other restocking safe harbor categories.) We recognize that there may be a potential inducement when the fair market value charged is at the low end of the range of fair market value prices. However, nothing in the anti-kickback statute prohibits legitimate price competition.

Comment: Some commenters questioned the reference in the proposed fair market value safe harbor to the Non-Profit Institutions Act (NPIA), 15 U.S.C. 13(c). The proposed safe harbor would have protected certain sales of supplies at cost by non-profit hospitals to non-profit ambulance providers if the sales were designed to take advantage of the NPIA exception to the Robinson-Patman Act. 11 One commenter indicated that the proposed language did not appear to address the situation of a non-profit hospital reselling supplies to a “for profit” ambulance provider. Another commenter asserted that absent definitive guidance from the Federal Trade Commission (FTC) that reselling supplies to an ambulance provider would fit within 15 U.S.C. 13(c), hospitals would be wary about complying with the safe harbor condition.

Response: We have reconsidered the need for the language referencing the NPIA in the fair market value safe harbor. Given the substantial easing of the conditions applicable to the general restocking safe harbor category, we believe that the final regulations provide adequate and easily achievable protection for all legitimate restocking, whether at fair market value prices, below fair market value prices or without charge. To the extent it may be unclear whether a particular resale of supplies is at fair market value, we do not believe it will pose any undue burden on non-profit hospitals to seek shelter under the general restocking safe harbor category, which offers protection to restocking without regard to what price, if any, the hospital charges for the restocked drugs or supplies. The question whether particular restocking arrangements undertaken by non-profit hospitals run afoul of the Robinson-Patman Act or qualify for the NPIA exception is an FTC concern outside the scope of our regulatory authority.

Section 205 of the Health Insurance Portability and Accountability Act, Public Law 104-191, established certain criteria that the Secretary may consider when modifying or establishing safe harbors to the anti-kickback statute. We have considered the criteria establishing in our notice of intent to develop regulations (61 FR 69061; December 31, 1996) in developing this final rule, and we believe, for the reasons described above, that these final safe harbor regulations for certain ambulance restocking arrangements is likely to: (1) Increase, or have no effect on, access for needy patients to health care services; (2) increase the quality of health care services for needy patients; (3) have little, or no effect on, the cost of Federal health care programs; (4) have little, or no effect on, competition; and (5) increase, or have no effect on, the quantity of services provided in underserved areas. We further believe that this safe harbor contains safeguards that limit the potential for overutilization and assure that patients retain their freedom of choice of service providers.

We have examined the impacts of this rule as required by Executive Order 12866, the Unfunded Mandates Act of 1995, and the Regulatory Flexibility Act (RFA) (Public Law 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any given year). Since this regulation will not have a significant effect on program expenditures and as there is no additional substantive costs to implement the resulting provision, we do not consider this to be a major rule. The provisions in this rule are designed to permit individuals and entities to engage freely in competitive business practices and arrangements; health care providers and others may voluntarily seek to comply with these safe harbor provisions so that they have the assurance that their that business practices are not subject to any enforcement actions under the anti-kickback statute.

Additionally, in accordance with the Unfunded Mandates Reform Act of 1995, we believe that there are no significant costs associated with these safe harbor guidelines that would impose any mandates on State, local or tribal governments, or the private sector that will result in an expenditure of $110 million or more, adjusted for inflation, in any given year. Further, in reviewing this rule under the threshold criteria of Executive Order 13132, Federalism, we have determined that this rule will not significantly affect the rights, roles and responsibilities of States, and that a full analysis under these Acts are not necessary.

Further, in accordance with the Regulatory Flexibility Act (RFA) of 1980, and SBREFA of 1996, which amended the RFA, we are required to determine if this rule will have a significant economic effect on a substantial number of small entities and, if so, to identify regulatory options that could lessen the impact. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and Government agencies. Most hospitals (and most other providers) are small entities, either by nonprofit status or by having revenues of $5 million to $25 million or less annually. For purposes of the RFA, most ambulance companies are considered to be small entities. Individuals and States are not included in the definition of a small entity. In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural providers. This analysis must conform to the provisions of section 603 of the RFA.

While these safe harbor provisions may have an impact on small entities and rural providers, we believe that the aggregate economic impact of this rulemaking will be minimal, since it is the nature of the conduct and not the size of the entity that will result in a violation of the anti-kickback statute. Since the vast majority of individuals and entities potentially affected by these regulations do not engage in prohibited arrangements, schemes or practices in violation of the law, we are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined, and we certify, that this rule does not have a significant impact on a substantial number of small entities, or a significant impact on the operations of a substantial number of small rural providers.

The Office of Management and Budget has reviewed this rule in accordance with Executive Order 12866.

In accordance with section 3506(c)(2)(A) of the Paperwork Reduction Act (PRA) of 1995, we are required to solicit public comments, and receive final OMB approval, on any information collection requirements set forth in rulemaking. While compliance with the provisions in this safe harbor rule would be voluntary, §§ 1001.952(v)(2) and (v)(3) include information collection activities that would require approval by OMB. As such, we are required to solicit public comments under section 3506(c)(2)(A) of the PRA on these information collection activities.

Title: Ambulance Replenishing Safe Harbor Under the Anti-Kickback Statute.

Summary of the collection of information: While complying with safe harbor provisions under the anti-kickback statute is voluntary, to qualify an ambulance restocking arrangement for safe harbor protection, parties must satisfy the following recordkeeping and disclosure requirements set forth in the regulations:

• The ambulance provider or the receiving facility must maintain for five years records documenting the replenished drugs and medical supplies, provide copies of such records to the other party within a reasonable period of time (unless the other party is separately maintaining records), and make the records available to the Secretary promptly upon request. These records may be in the form of pre-hospital patient care reports already in use for other purposes. See § 1001.952(v)(2)(ii)(A).

• Except for government-mandated or fair market value restocking, protected restocking arrangements must be conducted in an open and public manner. This condition may be achieved by posting a written disclosure notice at the receiving facility (with copies available to the public upon request) or by operating in accordance with a plan or protocol of general application promulgated by an EMS Council or comparable entity (with copies available to the public upon request). See § 1001.952(v)(3)(i)(B).

We have attempted to reduce any paperwork burden associated with compliance with these safe harbor regulations by permitting parties to utilize documentation produced or developed for other business purposes wherever possible, and we believe that most, if not all, of these recordkeeping requirements will be satisfied using such documentation. With respect to keeping and maintaining documentation of the restocking, most pre-hospital care reports (sometimes known as trip sheets or patient encounter reports) already maintained for other purposes, such as ensuring continuity of care and billing, will suffice. It is our understanding that the preparation of a pre-hospital care reports is the standard of care for transferring a patient to a receiving facility and is required by law in many States. However, parties may decide individually or between themselves to document restocking using other kinds of paper or electronic records. The five year record retention period is consistent with CMS's hospital conditions of participation.

With respect to the disclosure requirement, a written disclosure notice can take any reasonable form, and we anticipate that most parties engaged in ambulance restocking arrangements will have pre-existing materials that can be used for this purpose. For those who need or choose to produce a written disclosure notice, we have provided a short, sample disclosure form in these regulations. EMS Council plans and protocols are likely to be existing documents used to promote comprehensive and coordinated emergency medical services in local communities. These regulations do not require any drafting of new plans or protocols. Nothing in these regulations requires parties to draft or enter into contracts or written agreements. We expect that these regulations will result in few public requests for copies of disclosure notices or plans or protocols.

Brief description of the need for, and proposed use of, the information. The documentation and disclosure requirements set forth in these safe harbor regulations are necessary (i) to ensure that protected ambulance restocking arrangements pose a minimal risk of fraud or abuse and (ii) to enable parties to demonstrate—and the Government to verify where necessary—whether all safe harbor conditions are met.

Description of likely respondents and proposed frequency of response to the information collection request. The respondents for the collection of information described in these regulations are hospitals, other receiving facilities, and ambulance providers that participate in ambulance restocking arrangements and that want safe harbor protection under the anti-kickback statute. We believe that a significant number of hospitals, receiving facilities, and ambulance providers are engaged in, or desire to engage in, ambulance restocking arrangements and that many will want safe harbor protection. We do not anticipate any response that exceeds routine business practice.

Estimated burden that shall result from the collection of information. We are assigning only one burden hour to this collection, because we believe that compliance can be achieved with existing documents produced in the course of routine business practice.

In accordance with the PRA requirements, we are inviting comments on (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the estimate of the burden of the collection of information; (3) ways to enhance the quality, utility and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on parties, including through the use of automated collection techniques or other forms of information technology. As part of the OMB approval for the collection of information contained in this rule, we are soliciting public comments, thereby initiating the normal PRA clearance.

Comments on these information collection activities should be sent to the following address within 60 days following the Federal Register publication of this final rule:

OIG Desk Officer, Office of Management and Budget, Room 10235, New Executive Office Building, 725 17th Street NW., Washington, DC 20053, FAX: (202) 395-6974.

This Order, adopted November 21, 2001, and released November 29, 2001, will be available for public inspection during regular business hours at the FCC Reference Information Center, Room CY-A257, at the Federal Communications Commission, 445 12th St., SW., Washington, DC 20554. The complete text is available through the Commission's duplicating contractor: Qualex International, Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 202-863-2893, facsimile 202-863-2898, or via e-mail at qualexint@aol.com.

1. Effective upon publication of this Order in the Federal Register and until further notice, the following types of pleadings shall be filed with the Commission electronically, by overnight delivery service, or by hand delivery: (i) petitions to deny filed pursuant to section 309 of the Communications Act of 1934, as amended (Act); (ii) petitions for reconsideration filed pursuant to section 405 of the Act; (iii) applications for review filed pursuant to section 5(c)(4) of the Act; (iv) informal requests for Commission action involving pending applications filed pursuant to § 1.41 of the Commission's rules; (v) petitions to amend the TV and FM Broadcast Table of Allotments and responsive pleadings; and, (vi) comments or oppositions to open video system certification made pursuant to § 76.1502 (e)(1) of the Commission's rules. The types of pleadings described in (i) through (vi) are referred to in this document as “Covered Pleadings.” The filing requirement described in this paragraph shall not apply to requests for review of decisions issued by the Universal Service Administrative Company (USAC) filed pursuant to §§ 54.719-54.725 of the Commission's rules, or any petitions for reconsideration or applications for review arising from such proceedings. As noted, these emergency procedures are adopted on a temporary basis only, and will be discontinued when normal U.S. Mail delivery resumes.

2. In order to assist the Commission in determining whether Covered Pleadings were filed during the period of interrupted processing, parties that have filed or will file Covered Pleadings from October 1, 2001 through and including the effective date of this Order are required to resubmit such pleadings electronically prior to 12:00 midnight Eastern Time on the seventh calendar day following the effective date of this Order, by hand delivery at the Capitol Heights, Maryland location, prior to 9:00 PM Eastern Time on the seventh calendar day following the effective date of this Order, or by overnight delivery service other than U.S. Postal Service Express and Priority Mail to the Commission's headquarters, prior to 5:30 PM Eastern Time on the seventh calendar day following the effective date of this Order. Three exceptions to these requirements are specified in paragraph 4. All refilings pursuant to this paragraph shall be accompanied by a signed affidavit or a declaration pursuant to Commission rule § 1.16 stating that the previously filed pleading was timely filed in accordance with Commission rules, the date the pleading was originally sent to the Commission, and by what means. Covered Pleadings submitted up to 7 calendar days following the effective date of this Order in a manner not consistent with its terms must be refiled in the same manner as Covered Pleadings filed before the effective date. Covered Pleadings filed in accordance with this paragraph will be treated as timely filed as of the date the pleading was originally sent to the Commission, but the time for any responsive pleading will be tied to the time of resubmission to the extent Commission rules set response periods based on the date of filing.

3. There are three exceptions to the filing requirements stated in paragraph 3. The first exception to the refiling requirement is for Covered Pleadings that were previously filed electronically in accordance with our rules. The second exception is for Covered Pleadings that were hand delivered to the Commission's headquarters at 445 12th Street, SW., Washington, DC, between October 1 and October 19, 2001, or to our Capitol Heights location in accordance with the public notices issued on October 17 and October 18, 2001. See Public Notice, “FCC Announces Change in Filing Location for Paper Documents,” DA 01-2436 (October 17, 2001); Public Notice, “FCC Announces Changes In Filing Procedures,” DA 01-2430 (October 17, 2001; Public Notice, “Clarification on FCC's Announced Changes in Filing Procedures,” DA 01-2451 (October 18, 2001). The third exception is for Covered Pleadings delivered to the Commission by overnight delivery services other than U.S. Postal Service Express and Priority Mail. Covered Pleadings falling within one of the three exceptions specified in this paragraph and pleadings not falling in the categories specified in paragraph 2 need not be resubmitted.

4. If filed electronically by e-mail, pleadings shall be filed at the following e-mail addresses depending on the Bureau or Office handling the matter:

For security purposes, we recommend that documents filed via electronic mail be converted to PDF format. The Commission will automatically reply to all incoming e-mails to confirm receipt. If filed by facsimile, pleadings shall be faxed to 202-418-0187. The fax transmission should include a cover sheet listing contact name, phone number, and, if available, an e-mail address.

5. If filed by hand delivery, documents shall be delivered to 9300 East Hampton Drive, Capitol Heights, Maryland 20743 pursuant to the terms of our earlier October 17 and October 18, 2001 public notices. As stated in those public notices, all hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building.

6. If filed by overnight delivery service other than U.S. Postal Service Express and Priority Mail, filings must be received at the Commission's headquarters at 445 12th Street, SW., Washington, DC 20024. As noted in the October 17 and October 18, 2001 public notices, the Commission will divert those deliveries to the Capitol Heights facility. Documents filed under seal pursuant to § 0.457 or § 0.459 of the Commission's rules should be submitted by hand delivery or overnight delivery service to ensure confidential treatment under those rules.

7. Until further notice, parties filing Covered Pleadings electronically (either via electronic mail or facsimile) in accordance with the procedures set forth herein will not be required to file a paper original with the Office of the Secretary or the Capitol Heights, Maryland facility as described in our earlier October 17 and October 18, 2001 public notices.

8. Copies of all filings made pursuant to this Order should be provided to the Commission's duplicating contractor, Qualex International via e-mail at qualexint@aol.com. Copies of all filings and resubmitted filings must be served on parties to the extent service of such pleadings is required by Commission rules.

9. Failure to submit or resubmit pleadings in the manner set out by this Order will result in the waiver of any rights to have such pleading considered by the Commission if the Commission's decisional staff does not have the relevant pleadings before it at the time of its decision. Parties may file petitions for reconsideration regarding any decision made.

10. Accordingly, It Is Ordered that, pursuant to the authority of section 4(i) of the Communications Act of 1934, as amended, 47 U.S.C. 154 (i), the Commission ADOPTS the procedural requirements set forth in this Order and SUSPENDS any contrary requirements.

11. It Is Further Ordered that the Secretary is delegated authority to rule on requests for extensions of time based on operational problems associated with the Commission's electronic filing equipment.

The gopher frog ( Rana capito ) is a member of the large cosmopolitan family, Ranidae (“true frogs”). The genus Rana is the only North American representative of this family. We define the Mississippi gopher frog distinct population segment as those populations of gopher frogs in the lower coastal plain ranging from the Mississippi River in Louisiana to the Mobile River delta of Alabama. Goin and Netting (1940) originally described frogs from this geographic range as a distinct species of gopher frog, Rana sevosa . The taxonomic history of gopher frogs is complex (summary in Altig and Lohoefener 1983). Subsequent to the original description by Goin and Netting, frogs of this population segment were considered subspecies of Rana capito (gopher frog) ( R. c. sevosa , common name dusky gopher frog) (Wright and Wright 1942) and later subspecies of R. areolata (crayfish frog) ( R. a. sevosa ) (Viosca 1949, Neill 1957). In 1991, Collins challenged the taxonomic arrangement that lumped crayfish frogs and gopher frogs together as one species and recommended their separation based on biogeographical grounds. This arrangement was followed by Conant and Collins (1991), who again recognized the name R. c. sevosa .

Young and Crother (2001) conducted the first comprehensive biochemical analysis of the relationships between gopher frogs and crayfish frogs and among subspecies of gopher frogs. They used allozyme electrophoresis (an assay (examination) of gene products) to examine allelic (genetic) differences between and among populations. Allozyme data have been used extensively to investigate the evolution of genetic relationships among related species. Young and Crother (2001) analyzed tissue from gopher frogs across the range of the species including populations in Mississippi, Alabama, Georgia, Florida, and North Carolina, and from crayfish frogs from Arkansas, Kansas, and Missouri. They found strong support for the species designations R. areolata (crayfish frogs) and R. capito (gopher frogs). In addition, they found that the population of gopher frogs from Harrison County, Mississippi, showed a fixed difference at a single locus (site for a specific gene on a chromosome) from all other gopher frogs east of the Mobile River drainage in Alabama. This difference is considered by many taxonomists that support the phylogenetic (evolutionary) species concept to be significant enough to warrant elevation of the frog to its own species (Young and Crother 2001). No other specific taxonomic divisions were determined among the remaining populations of gopher frogs sampled. Since Harrison County is within the range of the original specimens used to describe R. sevosa , Young and Crother recommended the resurrection of R. sevosa as a distinct species.

Young and Crother's recommendation and their supporting data were published relatively recently (May 2001). Given the varied and confusing history surrounding sevosa, it is unclear if the suggested taxonomy will be accepted by the herpetological scientific community. Young and Crother (2001) alluded to potential debates about this designation in their paper when they stated: “It might be suggested that we have comfortably separated R. areolata from R. capito with three mutually exclusive differences but have not demonstrated the same for R. capito and R. sevosa with one fixed difference.” In any case, our analysis of the five listing factors would be the same whether the Mississippi gopher frog is considered a distinct population segment or a unique species. We will continue to use the common name “Mississippi gopher frog” to avoid confusion with other populations of gopher frogs further east. The Mississippi gopher frog distinct population segment will be defined as all gopher frogs west of Mobile Bay, following the range description of Goin and Netting (1940). The scientific name, Rana capito sevosa , will be used to represent this distribution of frogs. If the name Rana sevosa is ultimately accepted by the herpetological scientific community, we will revise our List of Endangered and Threatened Wildlife and Plants to reflect this change in nomenclature (scientific name).

The Mississippi gopher frog has a stubby appearance due to its short, plump body, comparatively large head, and relatively short legs (Conant and Collins 1991). The coloration of its back is dark and varies in individual frogs. It ranges from an almost uniform black to a pattern of reddish brown or dark brown spots on a ground color of gray or brown (Goin and Netting 1940). Warts densely cover the back. The belly is thickly covered with dark spots and dusky markings from chin to mid-body (Goin and Netting 1940, Conant and Collins 1991). Males are distinguished from females by their smaller size, enlarged thumbs, and paired vocal sacs on either side of the throat (Godley 1992). Richter (1998) reported mean snout-vent lengths from three years of data. They ranged from 63.2 to 70.2 millimeters (mm) (2.5 to 2.8 inches (in)) for males and 78.0 to 82.7 mm (3.1 to 3.3 in) for females in the extant population. Mississippi gopher frog tadpoles are presently indistinguishable in the field from those of leopard frogs and other gopher frogs (Altig et al. 2001).

Mississippi gopher frog habitat includes both upland sandy habitats historically forested with longleaf pine and isolated temporary wetland breeding sites embedded within the forested landscape. Frequent fires are necessary to maintain the open canopy and ground cover vegetation of their aquatic and terrestrial habitat.

Adult and subadult Mississippi gopher frogs spend the majority of their lives underground. They use active and abandoned gopher tortoise ( Gopherus polyphemus ) burrows, abandoned mammal burrows, and holes in and under old stumps as refugia (Allen 1932; LaClaire, pers. obs. 1996; Richter et al . 2001). Gopher tortoise burrows likely represented preferred underground habitats. In Florida, Godley (1992) reported that the closely related Florida gopher frog was known only from sites that supported gopher tortoises. The remaining Mississippi gopher frog population occurs in an area presently lacking gopher tortoises, most likely as a result of habitat degradation. An abandoned tortoise burrow occurs approximately 0.8 kilometers (km) (0.5 miles (mi)) from the breeding pond, and an active burrow was found within 1.6 km (1 mi) of the site in 1992 (T. Mann, Mississippi Department of Wildlife, Fisheries and Parks, pers. comm. 1999).

The Mississippi gopher frog breeding site is an isolated pond (not connected to any other water body) that dries completely on a cyclic basis. Faulkner (unpub. data 2000) recently conducted hydrologic research at the site. He described the pond as a depressional feature on a topographic high. The dominant source of water to the pond is rainfall within a small, localized watershed that extends 61 to 122 meters (m) (200 to 400 feet (ft)) from the pond's center. Substantial winter rains are needed to ensure that the pond fills sufficiently to allow hatching, development, and metamorphosis (change to adults) of larvae. The timing and frequency of rainfall are critical to the successful reproduction and recruitment of Mississippi gopher frogs.

The single remaining breeding pond known for the Mississippi gopher frog is located in Harrison County, Mississippi. Adult frogs move to this wetland breeding site during heavy rain events, usually from January to late March (Richter and Seigel 1998b). The breeding pond is approximately 1.5 hectares (3.8 acres) when filled. It attains a maximum depth of 1.1 m (3.6 ft). The pond is hard-bottomed, has an open canopy, and contains emergent and submergent vegetation. Female Mississippi gopher frogs attach their eggs to the rigid vertical stems of emergent vegetation (Young 1997, Richter and Seigel 1998a, 1998b). The pond typically dries in early to mid-summer, but on occasion has remained wet until early fall (G. Johnson, U.S. Forest Service, pers. comm. 1993; Young 1997; Richter and Seigel 1998b). As many as 21 amphibian species (17 frogs and 4 salamanders) are known to utilize the site (R. Seigel, unpub. data 2001). Bailey (1990), Palis (1998), and Greenberg (2001) found similar habitat attributes in breeding ponds of the closely related gopher frogs in Alabama and Florida.

Adult Mississippi gopher frogs leave the pond site after breeding during major rainfall events. Adults of both sexes use specific migratory corridors when exiting the breeding pond (Richter and Seigel 1998b). Movements away from the pond are slightly east of due north. Richter et al . (2001) tracked a total of 13 frogs using radio transmitters. The farthest movement recorded was 268 m (879 ft) by a frog tracked for 88 days from its exit of the breeding site. In Florida, gopher frogs have been found 2 km (1.2 mi) from their breeding sites (Carr 1940, Franz et al. 1988). It is unclear if the distances recorded for the Mississippi gopher frogs were typical as the tracking periods represented only a fraction of their yearly life cycle. Movements corresponded with major rain events. However, dry conditions prevailed during most of the two study periods. In fact, the frogs in Richter and Seigel's study moved during only one 24-hour period, which was associated with a rain event.

Amphibians need to maintain moist skin for respiration (breathing) and osmoregulation (controlling the amounts of water and salts in their bodies) (Duellman and Trueb 1986). Since they disperse from their aquatic breeding sites to the uplands where they live as adults, desiccation (drying out) can be a limiting factor in their movements. Thus, it is important that areas connecting their wetland and terrestrial habitats are protected in order to provide cover and appropriate moisture regimes during their migration. This may be especially important for juveniles as they move out of the breeding pond for the first time (A. Braswell, North Carolina State Museum of Natural Sciences, pers. comm. 2000).

It is likely that, given appropriate habitat, Mississippi gopher frogs are long-lived. The longevity record for a captive close relative, the Carolina gopher frog ( R. capito capito ), is 9 years, 1 month (Snider and Bowler 1992). However, overall low rates of recapture at the extant breeding pond suggest low adult survival in the Mississippi gopher frog population (Richter 1998).

Historical records for the Mississippi gopher frog exist for two or possibly three parishes in Louisiana, six counties in Mississippi, and one county in Alabama. Researchers conducting numerous surveys have been unable to document the continuing existence of the Mississippi gopher frog in Louisiana (Seigel and Doody 1992, Thomas 1996) or in Alabama (Bailey 1992, 1994). The last observation of a gopher frog in Louisiana was in 1967 (G. Lester, Louisiana Natural Heritage Program, pers. comm. 1991). In Alabama, it was last seen in 1922 (Bailey 1994).

Historical records for the Mississippi gopher frog are limited. We have compiled 35 historical records—1 in Alabama, 14 in Louisiana, and 20 in Mississippi. Historical records are defined as those localities where gopher frogs were found prior to 1990. No new localities for the frog have been found since 1988. Localities are sites identified from specimens captured or heard calling during sampling of potential breeding sites or by surveying highway crossings when individuals were on their way to or from breeding sites. Of the 35 historical records, 24 provided data that were used to approximate the location of the original site.

Habitat degradation is the primary factor in the loss of gopher frog populations in Alabama, Louisiana, and Mississippi. Bailey (1994) visited the historical Alabama locality in 1993. The habitat had been developed as a residential area, and was no longer suitable for the gopher frog. Seigel and Doody (1992) and Thomas (1996) surveyed historical sites in Louisiana and searched for other potential sites that might be occupied by gopher frogs. They also found that longleaf pine forests in Louisiana had been severely degraded. The historical breeding and upland habitats had changed as a result of urbanization and conversion of forest to pine plantation. For example, they found three historical breeding sites that had been extensively altered. One had been converted into a permanent pond in a residential backyard. Two other ponds had been extensively altered by bedding, clearing, and nutrient loading during conversion of the surrounding habitat to pine plantation. Both survey efforts by Seigel and Doody (1992) and Thomas (1996) were unsuccessful to find any Mississippi gopher frogs in Louisiana.

Crawford (1988) surveyed 42 ponds in 6 Mississippi counties in 1987 and 1988. He attempted to relocate all of the State's historical localities for the gopher frog. He found that habitat in the vicinity of historical localities had been altered by conversion of natural forest to agriculture and pine plantations. Urbanization was a factor in the loss of at least three breeding ponds. The character of relocated historical breeding ponds had been changed from open-canopy, temporary ponds with clear water and hard bottoms to muddy, more permanent ponds with a closed canopy (G. Johnson, pers. comm. 1999). No appropriate habitat for the Mississippi gopher frog could be found near any of the localities (G. Johnson, pers. comm. 1999). Crawford (1988) also used aerial maps to identify potential breeding sites. In many cases, ponds identified on these maps no longer existed due to land use changes. However, he was able to verify the presence of the species at four new sites in Harrison County, Mississippi. At three of these four sites, only one individual was observed. Kuss (1988) surveyed 60 ponds in southern Mississippi for the flatwoods salamander ( Ambystoma cingulatum ). He did not encounter any gopher frogs during the surveys. Subsequent to these studies, surveys have documented the continued existence of only one population in Mississippi. This population breeds at a pond located in the DeSoto National Forest in Harrison County. Surveyors working in Mississippi during the 1990s have been unable to find the species at any other sites (R. Jones, Mississippi Department of Wildlife, Fisheries and Parks, pers. comm. 1998; G. Johnson, pers. comm. 1999). Although Allen (1932) found gopher frogs to be common in the coastal counties of Mississippi earlier in the century, today R. Seigel (Southeastern Louisiana University, pers. comm. 2001) estimates the extant Mississippi gopher frog population to be only 100 adult frogs at a single site.

The extensive habitat alteration found during surveys of historical gopher frog localities in Alabama, Louisiana, and Mississippi resulted from the loss of virtually all of the natural longleaf pine forest in these States. Presettlement longleaf pine forests were the dominant forest type of the southeastern coastal plain. Today, less than 2 percent of these forests remain (Ware et al. 1993). Second growth longleaf pine forests in the vicinity of historical Mississippi gopher frog breeding sites were clearcut extensively in the mid-1950s and then again in the 1980s and 1990s. Longleaf pine forest habitat was replaced with dense pine plantations, agriculture, and urban areas. Habitat degradation has occurred as a result of alterations in the soil horizon (layering of different soil types), forest litter, herbaceous community, and occurrence of downed trees and stumps that Mississippi gopher frogs use as refugia. Fire suppression has further degraded the habitat. The hydrology of many isolated temporary wetlands, required as breeding sites for the Mississippi gopher frog, has been altered. In addition, these same factors have resulted in the decline of the gopher tortoise, whose burrows are most likely the preferred habitat for adult gopher frogs. As a result of these habitat changes, both the uplands and the pond basins previously occupied by the Mississippi gopher frog have become unsuitable.

The biological evidence supports recognition of the Mississippi gopher frog as a distinct vertebrate population segment for purposes of listing, as defined in our February 7, 1996, Policy Regarding the Recognition of Distinct Vertebrate Population Segments (61 FR 4722). The definition of “species” in section 3(16) of the Act includes “any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature.” For a population to be listed under the Act as a distinct vertebrate population segment, three elements are considered—(1) The discreteness of the population segment in relation to the remainder of the species to which it belongs; (2) the significance of the population segment to the species to which it belongs; and (3) the population segment's conservation status in relation to the Act's standards for listing (i.e., is the population segment endangered or threatened?).

Habitat of the lower Gulf Coastal Plain from the Mississippi River to the Mobile River delta contains the westernmost population of gopher frogs. This population segment is discrete because it is geographically segregated from other gopher frogs by a large gap (approximately 200 km (125 mi)) of unoccupied habitat and the Mobile River delta. Consequently, this population does not mix with other gopher frogs.

Young and Crother (2001) presented data that the Mississippi gopher frog distinct population segment is biologically and ecologically significant due to genetic characteristics different from the species as a whole (see discussion in “Background” section). They analyzed tissue from gopher frogs across the range of the species, including populations in Mississippi, Alabama, Georgia, Florida, and North Carolina, and found that the population of gopher frogs from Harrison County, Mississippi, showed a fixed difference at a single locus (site for a specific gene on a chromosome) from all other gopher frogs east of the Mobile River drainage in Alabama. This difference is considered by many taxonomists to be significant enough to warrant elevation of the frog to its own species (Young and Crother 2001).

In our December 30, 1982, Notice of Review, we designated the dusky gopher frog (designation Rana areolata sevosa ) as a category 2 candidate and solicited status information (47 FR 58454). Category 2 candidates were those taxa for which we had information indicating that proposing to list as endangered or threatened was possibly appropriate, but for which sufficient data on biological vulnerability and threats were not currently available to support a proposed rule. In our September 18, 1985 (50 FR 37958), and January 6, 1989 (54 FR 554), Notices of Review, we retained the dusky gopher frog in category 2. We identified the dusky gopher frog as a category 1 candidate species in our November 21, 1991 (56 FR 58804), and November 15, 1994 (59 FR 58982), Notices of Review. Category 1 taxa were those taxa for which we had sufficient information on biological vulnerability and threats on file to support issuance of proposed listing rules. Beginning with our February 28, 1996, Notice of Review (61 FR 7596), we discontinued the designation of multiple categories of candidates, and we now consider only taxa that meet the definition of former category 1 taxa as candidates for listing. At that time, we removed Rana areolata sevosa from candidate status based on the need for additional information to support a listing proposal. We then completed an analysis of newly available information from recent studies and determined that listing the Mississippi gopher frog distinct population segment was warranted. We elevated the Mississippi gopher frog to candidate status in our October 25, 1999, Notice of Review (64 FR 57534).

We published the proposed rule to list the Mississippi gopher frog in the Federal Register on May 23, 2000 (65 FR 33283). This final rule is made in accordance with a judicially approved settlement agreement, which requires us to submit a final listing decision to the Federal Register by November 28, 2001.

We have been coordinating with our partners, the U.S. Forest Service, Mississippi Department of Wildlife, Fisheries and Parks, and Dr. Rich Seigel of Southeastern Louisiana University, on Mississippi gopher frog surveys and monitoring for the past 10 years. During the past 2 years, we and our partners have increased conservation efforts at the remaining breeding pond and adjacent areas on the DeSoto National Forest. These efforts have included attempting to alter two existing ponds to create potential breeding sites for the Mississippi gopher frog; developing a strategy to construct new breeding ponds; and responding to the ongoing drought by transporting water overland to the known breeding pond (with the assistance of the Mississippi National Guard) and digging two wells adjacent to the pond. A Memorandum of Understanding has been drafted between the partners for conservation of this species and is currently under review by the parties.

In the May 23, 2000, proposed rule and associated notifications, we requested that all interested parties submit factual reports or information that might contribute to the development of this final rule. The comment period for the proposed rule was open from May 23 through July 24, 2000. We contacted appropriate Federal and State agencies, county governments, scientific organizations, and other interested parties and requested that they comment. We published a legal notice in the Clarion Ledger on June 2, 2000, and another in the Sun Herald on June 3, 2000, announcing the proposal and inviting comment. We received 18 comment letters. Twelve of these supported, 3 opposed, and 3 were neutral on the proposed listing action. The breakdown of the comments included 2 from Federal agencies, 2 from State agencies, and 14 from individuals or groups. The Mississippi Department of Wildlife, Fisheries and Parks and the Louisiana Department of Wildlife and Fisheries supported the protection of the Mississippi gopher frog distinct population segment under the Act. One request was made for a public hearing, however the request was later withdrawn.

We updated the final rule to reflect comments and information we received during the comment period. We address opposing comments and other substantive comments concerning the rule below. Comments of a similar nature or point are grouped together (referred to as “Issues” for the purpose of this summary) below, along with our response to each.

Issue 1: The proposed listing rule was not based on the best scientific and commercial data available, as required by section 4(b)(1) of the Act. The Service used too many documents that were not published papers in peer-reviewed journals in writing the rule.

Response: We thoroughly reviewed all available scientific and commercial data in preparing the proposed rule. We sought and reviewed historic and recent publications and unpublished reports concerning the Mississippi gopher frog and other gopher frog species, as well as literature documenting the decline of the longleaf pine ecosystem in general. We considered all types of available information in making a listing determination. This included reliable unpublished reports, non-literature documentation, and personal communications with experts. The public reviewed the proposed rule, which also was peer reviewed according to our policy (see “Peer Review” section). In the process of updating the proposed rule, some citations have changed due to the publication in peer-reviewed journals of some data originally cited as personal communications, unpublished manuscripts, or theses. We used our best professional judgment and based our decision on the best scientific and commercial data available, as required by section 4(b)(1) of the Act.

Issue 2: The Service does not have sufficient scientific information to conclude that the Mississippi gopher frog is a distinct species or a distinct population segment. As a result, the evaluation of the five factors is insufficient to support the listing of the frog.

Response: We analyzed the Mississippi gopher frog in relation to the three elements necessary for a population to be listed under the Act as a distinct vertebrate population segment—discreteness, significance, and population segment conservation status (see “Distinct Vertebrate Population Segment” section). The commenters did not provide any data to support their assertions. The best available scientific evidence supports the designation of the Mississippi gopher frog as a distinct vertebrate population segment.

Issue 3: The scientific data may provide support that the Mississippi gopher frog is a distinct population segment. However, since there is only one extant population, this population cannot be considered the same as populations, now extinct, which once occurred within the described range of Rana sevosa (west of Mobile Bay).

Response: In the original description of Rana sevosa , Goin and Netting (1940) restricted this species to the area of the Gulf coast from Louisiana to west of Mobile Bay, Alabama. They considered Mobile Bay a biogeographic barrier. At that time, gopher frogs were not known from other areas of eastern Alabama or the Florida panhandle. Gopher frogs were later discovered in these areas and subsequent authors extended the range of what was then described as the subspecies R. capito sevosa into eastern Alabama and the panhandle of Florida. The range extension was based on similarities in size and coloration of frogs across this area. However, no empirical data exist to support this designation (P. Moler, Florida Fish and Wildlife Conservation Commission, pers. comm. 2000). Young and Crother (2001) recently completed genetic analyses of gopher frogs from Mississippi, eastern Alabama, and the panhandle of Florida. Their results, showing differences between Alabama and Florida panhandle populations and the Mississippi gopher frog, provide evidence that gopher frogs differ on either side of Mobile Bay. Since the Mississippi gopher frog occurs within the original geographic area described by Goin and Netting for Rana sevosa , we will regard all populations historically distributed within that original area as part of the Mississippi gopher frog distinct population segment until such time as data dictate otherwise.

Issue 4: The Service should conduct more research before a listing decision is made.

Response: We have conducted and supported research on the Mississippi gopher frog for the past 10 years. We have learned much about the species during this period. Although there are still aspects of this species' life history which are not known, the information standard in section 4(b)(1) of the Act does not require us to possess detailed or extensive information about the general biology of the species or to make an actual determination of the causes for the species' status to make a listing determination. We have made the decision that the Mississippi gopher frog is in danger of extinction using the best available scientific and commercial information as required by the Act's information standard. We evaluated all information with regard to its applicability to determination of species status using the five factors described under section 4(a)(1).

Issue 5: The Service should conduct more surveys before a listing decision is made. The Service may have missed populations of the Mississippi gopher frog due to the ongoing drought.

Response: Surveys for Mississippi gopher frogs have been ongoing since the late 1980s (see “Background” section). Most of the available habitat has been degraded or destroyed at historical sites. The drought has made sampling difficult; however, at most sites surveyed, poor habitat quality was the limiting factor, not lack of water. We used our best professional judgement and based our determination on the best scientific and commercial data available, as required by section 4(b)(1) of the Act.

Issue 6: Service suggestions that forest management activities have caused population declines in the Mississippi gopher frog are inappropriate.

Response: The best available information on the effects of timber management on the Mississippi gopher frog, cited in the “Background” and “Summary of Factors Affecting the Species” sections, indicates that habitat alteration, including loss of ground cover vegetation, destruction of subterranean refugia and alteration of hydrology at previously occupied sites, has been a causative factor in the decline of gopher frogs throughout the range of Rana capito sevosa . The manner, timing, and extent of silvicultural activities all dictate what effects they may have on the Mississippi gopher frog and its habitat. Timber management that avoids adverse effects to important habitat characteristics is compatible with maintenance of the Mississippi gopher frog, as evidenced by its continued occurrence on the DeSoto National Forest.

In accordance with our July 1, 1994 (59 FR 34270), Interagency Cooperative Policy on Peer Review, we requested the expert opinions of three independent specialists regarding pertinent scientific or commercial data and assumptions relating to supportive biological and ecological information in the proposed rule. The purpose of such review is to ensure that the listing decision is based on scientifically sound data, assumptions, and analyses, including input of appropriate experts and specialists.

We requested three individuals who possess expertise on gopher frog natural history and ecology to review the proposed rule and provide any relevant scientific data relating to taxonomy, distribution, or to the supporting biological data used in our analyses of the listing factors. All expressed their belief that the data supported protection of the Mississippi gopher frog distinct population segment under the Act. We have incorporated their comments into the final rule, as appropriate, and briefly summarized their observations below.

All three reviewers strongly supported the listing of the Mississippi gopher frog as endangered. One reviewer provided his assessment of the available taxonomic data for the Mississippi gopher frog. He agreed with our determination of the geographic range of the Mississippi gopher frog distinct population segment. The second reviewer provided comments on our analysis of Mississippi gopher frog telemetry data. He believed that the cessation of movement in frogs followed to the proximity of the clearcut could have been explained by several factors other than the habitat changes on the site. He suggested that the location where they stopped could have been the burrow where they normally resided; that the lack of rainfall may have affected their movements; and that the timeframe the frogs were tracked was too short to accurately determine the length of their movements. The third reviewer commented that emigrating juveniles are more subject to predation or dessication than adults as they move out of the pond. As a result, he believed that good quality terrestrial habitat close to the breeding pond, including cover objects, may be especially important for metamorphs.

After a thorough review and consideration of all information available, we have determined that the Mississippi gopher frog distinct population segment should be classified as an endangered species. We followed the procedures found at section 4(a)(1) of the Act (16 U.S.C. 1531 et seq. ) and regulations (50 CFR part 424) issued to implement the listing provisions of the Act. We may determine a species to be endangered or threatened due to one or more of the five factors described in section 4(a)(1). These factors and their application to the Mississippi gopher frog distinct population segment ( Rana capito sevosa Goin and Netting 1940) are as follows:

The range of the Mississippi gopher frog has been reduced as a result of habitat destruction and modification (see “Background” section). Longleaf pine forested habitat has been reduced to less than 2 percent of its original distribution. Historically, the Mississippi gopher frog distinct population segment occurred in at least nine counties or parishes in the States of Alabama, Mississippi, and Louisiana. Today, it is known from only one site in Harrison County, Mississippi. Potentially available habitat continues to be degraded due to the accelerated rate of residential and commercial development in Harrison County.

The private property 200 m (656 ft) immediately north of the only known Mississippi gopher frog breeding site is slated for residential and commercial development, including a 20,000-unit retirement community (L. Lewis, Brown and Mitchell, Inc., pers. comm. 1999). This site was clearcut and prepared in 1994 prior to acquisition by the development company. Potential habitat for the Mississippi gopher frog was considerably degraded as a result. Richter (1998) reported that the majority of gopher frogs leaving the breeding pond moved in a northerly direction towards this private property. Three frogs, tracked using transmitters, were observed at the fence line delineating the DeSoto National Forest property boundary from the property (Richter et al . 2001). It seems likely that Mississippi gopher frogs may have occurred on this site in the very recent past. We are currently working with the developers of the site on a plan to restore and protect habitat in a “no development zone” on the property. Nevertheless, the large scale of development in the vicinity of the remaining habitat for the Mississippi gopher frog, including both ongoing and planned highway expansion, will fragment the remaining longleaf pine habitat (see “Factor E”). Urbanization will expand along these highway corridors and further reduce available habitat for the frog.

The remaining breeding pond for the Mississippi gopher frog is located in the DeSoto National Forest. Silviculture, including timber sales with associated clearcutting and replanting, is currently the primary activity in this area. Incompatible timber management could alter the suitability of the Mississippi gopher frog's remaining habitat (see “Background” section). The private property north of the breeding pond (described above) was previously owned by a timber company. The negative effects of the clearcutting and site-preparation activities included the destruction of all burrows and stump holes that could have been used by migrating or resident frogs. During bedding, the soil structure and below-ground structure (burrows, stump holes) were destroyed as hummocks with deep furrows on either side were created on which to replant trees. In addition, all overstory was removed from the site. The immediate result of this activity was creation of an area that would represent a desert to moisture-requiring frogs. Although at least three frogs moved to the vicinity of this site, it is not known what effect the altered landscape may have had on their movements. The effects of the timber harvest and replanting on the Mississippi gopher frog population are unknown. The frogs may or may not have used the site prior to the timbering activities. However, the resultant changes in habitat have made the site currently unsuitable for them.

Several recent studies (National Council on Air and Stream Improvement, Inc. (NCASI), unpub. data 1999, Baughman 2000, Russell 2000) have demonstrated that management of industrial forest lands can be compatible with maintaining a diverse amphibian community. However, rare amphibians which are endemic to the longleaf pine ecosystem, such as gopher frogs (LaClaire 1997), are not a typical component of this amphibian community on industrial forest lands. For example, a recent survey of ephemeral ponds on intensively managed forest lands found gopher frogs in only 17 of 444 ponds (4 percent) surveyed in Alabama, Florida, and Georgia (NCASI, unpub. data 1999). The loss of essential upland and wetland habitat features is most likely responsible for the absence of these species. Habitat alterations resulting from historical land use practices, including fire suppression (see “Factor E”), removal of downed logs and other coarse woody debris, and short rotation times, may offer a partial explanation for the loss of these habitat features (Baughman 2000, Russell 2000).

Historical gopher frog breeding sites have been degraded and destroyed by roads that pass through or are adjacent to ponds. Erosion of unpaved roads adjacent to breeding sites may result in an influx of sediment from surrounding uplands during rainstorms. Runoff from paved roads may include petrochemicals or other substances toxic to frogs. The hydroperiod (period during which a wetland holds water) of the ponds can be negatively affected by increased input of water to the sites or by the road acting as a dam, both of which would create a more permanent pond. In addition, heavily traveled roads pose a threat to migrating frogs.

The open canopy and flat, unforested bottom of the Mississippi gopher frog breeding pond represent an alluring site for dumping unwanted trash and riding off-road vehicles (ORV). Many temporary ponds throughout the southeast have been degraded as a result of garbage dumping (LaClaire, pers. obs. 1994). ORVs can cause direct mortality of gopher frog tadpoles and adults (J. Jensen, Georgia Department of Natural Resources, pers. comm. 1996) as well as alter the quality of a breeding site. ORVs alter the contours of the pond floor, eliminate herbaceous vegetation, and can alter the hydrology of the site (LaClaire, pers. obs. 1995). Loss of herbaceous vegetation caused by ORVs could also discourage gopher frog reproduction, since egg masses are attached to stems of herbaceous vegetation (Young 1997; Richter and Seigel 1998a, 1998b). ORV tracks have been documented within the Mississippi gopher frog breeding site (G. Johnson, pers. comm. 1994). In 1994, an area of the DeSoto National Forest within 2.4 km (1.5 mi) of the existing breeding pond was temporarily closed due to accumulation of trash, soil erosion, and water quality degradation caused by ORVs, damage to endangered and sensitive plants and animals, and other vandalism (K. Godwin, U.S. Forest Service, pers. comm. 1994). ORV use on the DeSoto National Forest will likely increase in the vicinity of the pond when the proposed housing development is completed adjacent to the site.

Direct take of Mississippi gopher frogs for commercial, recreational, scientific, or educational purposes is not currently a threat. However, large numbers of other species of frogs are nationally and internationally traded for resale in pet stores and for food. Listing the Mississippi gopher frog may make it more attractive to collectors through recognition of its rarity. In addition, the life history and ecology of Mississippi gopher frogs make them vulnerable to collecting, as well as vandalism. Only one breeding pond remains for this frog. At predictable times of the year, all breeding adults congregate at this site to breed. A single act of collecting or vandalism could destroy the population.

Disease is not known to be a factor in the decline of the Mississippi gopher frog. However, during monitoring of our efforts to alter a nearby pond and create a new gopher frog breeding site, a fungal disease was observed in leopard frog tadpoles. Subsequent to this discovery, tadpole populations were monitored more closely and 100 percent mortality of these leopard frog tadpoles was observed. A sample of diseased tadpoles was sent to the U.S. Geological Survey's National Fish Wildlife Health Center in Madison, Wisconsin. The fungus has not yet been identified and the mode of transmission is unknown. However, this yeast-like fungus has been implicated in five die-offs at sites nationwide and has affected six species of ranid (frogs of the genus Rana ) tadpoles (D. Green, National Wildlife Health Center, Madison, Wisconsin, pers. comm. 2001). Biosecurity measures, such as sterilizing boots and equipment, have been implemented at the existing Mississippi gopher frog breeding pond as a precaution against disease transmission. An unrelated chytrid fungus has been implicated in the decline of amphibians in the western United States, including the endangered Wyoming toad (M. Jennings, U.S. Fish and Wildlife Service, pers. comm. 2001).

Predation may be a threat. Survivorship from the egg stage to metamorphosis is typically low for ranid frogs and was estimated by Richter (1998) to be 4.91 percent for Mississippi gopher frogs. Additional predation, beyond the norm, could result in complete reproductive failure. Richter and Seigel (1998a) reported that approximately 44 percent of all eggs at the existing breeding site were lost in 1997 prior to hatching. An undetermined amount of the egg mortality was due to predation by caddisfly larvae (Order Trichoptera, Family Phryganeidae) on the egg masses. Richter (2000) observed no larval caddisflies at the Mississippi gopher frog breeding site in 1996, but caddisflies infested 100 percent of Mississippi gopher frog egg masses in 1997 and 1998. He found that two larval caddisflies in laboratory test chambers could consume between 11 and 24 developing embryos of leopard frogs (another ranid species; gopher frog embryos were not used due to their rarity). The effect of caddisfly predation on the Mississippi gopher frog population is unknown. However, any increases in mortality resulting from predation are a cause for concern in such an extremely small and isolated population.

Predation from fish probably contributed to the loss of historic populations. Temporary ponds altered to form more permanent bodies of water and stocked with fish are no longer suitable breeding sites. Fish may have also entered breeding sites through the connection of drainage ditches and firebreaks to pond basins. The Mississippi gopher frog is adapted to temporary wetlands, and its larvae cannot survive the heavy predation of bass and sunfish commonly used to stock ponds. One historical location in Louisiana was destroyed in part because it has become a permanent pond inhabited by fish (Thomas 1996). In Mississippi, a calling male was discovered in 1987 at a site that has since been converted to a fish pond (T. Mann, pers. comm. 1998). No gopher frogs have been reported subsequently at this site, which is no longer considered suitable breeding habitat.

Louisiana has no protective legislation for the Mississippi gopher frog. Alabama protects all gopher frogs as nongame species (J. Woehr, Alabama Department of Conservation and Natural Resources, pers. comm. 1994). The Mississippi gopher frog is listed as endangered in Mississippi (Mississippi Department of Wildlife, Fisheries and Parks 1992), and both Mississippi and Alabama provide protection against collecting of the species. However, this legislation does nothing to alleviate the habitat loss that has caused the decline of the species. The only known breeding site for the Mississippi gopher frog is on U.S. Forest Service land in Mississippi. As a result, there has been a concerted effort to encourage the U.S. Forest Service to manage the site for the frog. Although the U.S. Forest Service has an obligation under the National Forest Managment Act, to ensure their land management activities protect fish and wildlife, forest management is often limited by existing funding. Other avenues of funding become available to the U.S. Forest Service once a species is federally listed.

Fire is needed to maintain the natural longleaf pine community. Ecologists consider fire suppression a primary reason for the degradation of the remaining longleaf pine acreage in the southeast (Noss 1988, Ware et al. 1993). Fire suppression has reduced the quality of terrestrial and aquatic habitat for the Mississippi gopher frog. Canopy closure from fire suppression alters the forest floor vegetation and threatens the open, herbaceous character typical of gopher frog breeding ponds (Kirkman 1995, LaClaire 1995). In addition, fire causes the release of nutrients bound in plant material. This release of nutrients results in a flush of primary productivity that is important to the herbivorous gopher frog tadpoles. Fire suppression has probably negatively impacted all of the historical Mississippi gopher frog sites. At this time, fire is the only known management tool that will maintain the existing breeding pond as suitable habitat.

Between 1991 and 2001, the U.S. Forest Service has conducted periodic growing-season burns of the forest compartment surrounding the Mississippi gopher frog breeding pond and of the pond basin itself. These burns improved habitat conditions, but the frequency and extent of burning needs to be improved. Appropriate burning regimes must be maintained to prevent woody encroachment and to enhance herbaceous growth. Residential and commercial development and road construction in the vicinity of the breeding pond will create increased concerns about, and likely reduce the use of, fire as a management tool. The fire management officer on the DeSoto National Forest estimates that, due primarily to smoke management concerns, that development in the area will cause a 20 percent reduction in the amount of days that the U.S. Forest Service will have the opportunity to burn Mississippi gopher frog habitat (J. Boykin, U.S. Forest Service, pers. comm. 2001).

Habitat fragmentation of the longleaf pine ecosystem, resulting from habitat conversion, threatens the survival of the single remaining Mississippi gopher frog population. Studies have shown that the loss of small, fragmented populations is common, and recolonization is critical for their regional survival (Fahrig and Merriam 1994, Burkey 1995). As patches of available habitat become separated beyond the dispersal range of a species, populations are more sensitive to genetic, demographic, and environmental variability and may be unable to recover (Gilpin 1987, Sjogren 1991, Blaustein et al. 1994). This scenario describes threats to the Mississippi gopher frog. Five historical Mississippi gopher frog localities exist within a 19.2 km (12 mi) radius of the remaining site. Highways have fragmented this area and contributed to habitat degradation. The most recent records of frogs at these locales was in the late 1980s. The planned construction of highways within 5 km (3.1 mi) both to the north and east of the existing Mississippi gopher frog pond will further isolate the remaining population from other potentially restorable habitat in the DeSoto National Forest. The Biloxi River and additional residential development bound the habitat to the west and south.

Low reproductive potential may also present a threat to the Mississippi gopher frog's continued existence. Studies at the Mississippi breeding site suggest that female Mississippi gopher frogs may not breed until 2 to 3 years of age and may breed only in alternate years and/or have only a single lifetime breeding event (Richter and Seigel 1998b). In addition, survival of juvenile frogs is thought to be extremely low (Richter and Seigel 1998b).

Annual variability in rainfall influences how frequently and how long a pond is appropriate breeding habitat. Reliance on specific weather conditions results in unpredictable breeding events and reduces the likelihood that recruitment will occur every year. No larvae survived to metamorphosis in 3 out of 6 years of the reproductive study of the extant Mississippi gopher frog population (summarized in Richter and Seigel 1998b). In addition, study results indicate that only 1 year out of 6 resulted in the explosive numbers (2,488) of juveniles typical of temporary pond breeding amphibians.

The Mississippi gopher frog population is highly susceptible to genetic isolation, inbreeding, and random demographic events as a result of having only one known breeding site. Long-lasting droughts or frequent floods may negatively affect the population. Although these are natural processes, other threats, such as habitat fragmentation, habitat degradation, and low reproductive potential, may cause the population to decline to the point that it cannot recover.

Pesticides and herbicides pose a threat to amphibians such as the Mississippi gopher frog, because their permeable eggs and skin readily absorb substances from the surrounding aquatic or terrestrial environment (Duellman and Trueb 1986). Aquatic frog larvae are likely more vulnerable than adults to chemical changes in their environment. Negative effects of commonly used pesticides and herbicides on amphibian larvae include delayed metamorphosis, paralysis, reduced growth rates, and mortality (Bishop 1992, Berrill et al. 1997, Bridges 1999). Sublethal levels of chemical contamination can alter juvenile recruitment in amphibian populations (Bridges and Semlitsch 2000). Adult gopher frogs are predaceous and could be affected by pesticides accumulated in their invertebrate prey. Herbicides may alter the density and species composition of vegetation surrounding a breeding site and reduce the number of potential sites for egg deposition, larval development, or shelter for migrating frogs.

We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats faced by this species in determining to make this rule final. Based on this evaluation, the preferred action is to list the Mississippi gopher frog distinct population segment as endangered. The Act defines an endangered species as one that is in danger of extinction throughout all or a significant portion of its range. A threatened species is one that is likely to become an endangered species in the foreseeable future throughout all or a significant portion of its range. As discussed under Factor A, in spite of extensive surveys throughout the known range of the Mississippi gopher frog, only one population of approximately 100 adult frogs is known to exist. Natural processes, such as genetic isolation, inbreeding, droughts, and floods, pose ongoing threats to this population. Further, residential and commercial development in conjunction with new and expanding highways will increase habitat fragmentation and the likelihood of fire suppression. Both habitat fragmentation and fire suppression pose threats to the frog's remaining habitat. For these reasons, we find that the Mississippi gopher frog distinct population segment is in danger of extinction throughout all or a significant portion of its range and, therefore, endangered status is appropriate.

Critical habitat is defined in section 3, paragraph 5(A), of the Act as: (i) the specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features (I) essential to the conservation of the species and (II) that may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. “Conservation” means the use of all methods and procedures needed to bring the species to the point at which listing under the Act is no longer necessary.

Section 4(a)(3) of the Act, and implementing regulations (50 CFR 424.12) require that, to the maximum extent prudent and determinable, we designate critical habitat at the time the species is determined to be endangered or threatened. In the proposed rule, we indicated we would make a final critical habitat determination with the final listing determination for the Mississippi gopher frog. However, our budget for listing and critical habitat activities is currently insufficient to allow us to immediately complete all of the listing actions required by the Act. Listing the Mississippi gopher frog without designation of critical habitat will allow us to concentrate our limited resources on other listing actions that must be addressed, while allowing us to invoke the protections needed for the conservation of this species without further delay. This is consistent with section 4(b)(6)(C)(i) of the Act, which states that final listing decisions may be issued without critical habitat designation when it is essential that such determinations be promptly published. We will prepare a critical habitat determination for the Mississippi gopher frog in the future at such time as our available resources and priorities allow.

Conservation measures provided to species listed as endangered or threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain activities. Recognition through listing results in public awareness and conservation actions by Federal, State, and local agencies, private organizations, and individuals. The Act provides for possible land acquisition and cooperation with the States and requires that recovery actions be carried out for all listed species. The protection required of Federal agencies and the prohibitions against taking and harm are discussed, in part, below.

Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as endangered or threatened and with respect to its critical habitat, if designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) requires Federal agencies to confer informally with us on any action that is likely to jeopardize the continued existence of a proposed species or result in destruction or adverse modification of proposed critical habitat. If a species is subsequently listed, section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of such a species or to destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into formal consultation with us.

The Mississippi gopher frog occurs in the DeSoto National Forest, Federal land administered by the U.S. Forest Service. The U.S. Forest Service will be required to evaluate whether their activities have the potential to adversely affect the Mississippi gopher frog. Their activities that could adversely affect the frog include, but are not limited to, forest management and road construction. Other Federal agencies that may be involved in authorizing, funding, or carrying out activities that may affect the Mississippi gopher frog include the U.S. Army Corps of Engineers, due to their regulation of discharges of dredged or fill material into wetlands under section 404 of the Clean Water Act; the Federal Energy Regulatory Commission, due to their oversight of gas pipeline and powerline rights-of-way; and the Federal Highway Administration, if Federal funds are involved in road construction. However, we have resolved nearly all section 7 consultations so that species are protected and project objectives are met.

We have been working with the U.S. Forest Service since 1988 to protect the last remaining population of the Mississippi gopher frog. We have advised the U.S. Forest Service on protection and management needs for this species. We have supported research on the ecology and life history of this population by projects funded through our cooperative agreement with the State of Mississippi under section 6 of the Act. In addition, we have collaborated with the U.S. Forest Service and the Mississippi Department of Wildlife, Fisheries and Parks on the plans to move gopher tortoises to the existing breeding site to provide additional subterranean refugia via the tortoise's burrows and to create new breeding ponds for the frog. We have drafted a Memorandum of Understanding with our partners and this document is currently under review by all the parties.

Section 9 of the Act and its implementing regulations found at 50 CFR 17.21 set forth a series of general prohibitions and exceptions that apply to all endangered wildlife. These prohibitions, in part, make it illegal for any person subject to the jurisdiction of the United States to take (includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these), import, export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any endangered wildlife species. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to our agents and agents of State conservation agencies.

It is our policy, published in the Federal Register on July 1, 1994 (59 FR 34272), to identify, to the maximum extent practicable at the time a species is listed, those activities that are or are not likely to constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effects of the listing on proposed and ongoing activities within a species' range.

We believe, based on the best available information, that the following activities are unlikely to result in a violation of section 9 for the Mississippi gopher frog:

(1) Possession of legally acquired Mississippi gopher frogs;

(2) Lawful hunting activities;

(3) Lawful burning of habitat where the Mississippi gopher frog is known to occur, including winter burning;

(4) Federally approved projects that involve activities such as discharge of fill material, draining, ditching, bedding, diversion or alteration of surface or ground water flow into or out of a wetland (i.e., due to roads, impoundments, discharge pipes, etc.), when the activity is conducted in accordance with any reasonable and prudent measures given by us in accordance with section 7 of the Act; and,

(5) Conversion of longleaf pine habitat where the Mississippi gopher frog does not occur.

We believe the following activities could potentially result in a violation of section 9; however, possible violations are not limited to these actions alone:

(1) Unauthorized killing, collecting, handling, or harassing of individual Mississippi gopher frogs, including unauthorized use of off-road vehicles in the wetland basins of known breeding sites of the species.

(2) Possessing, selling, transporting, or shipping illegally taken Mississippi gopher frogs;

(3) Unauthorized destruction or alteration of the hydrology of the frog's wetland breeding sites. These actions would include activities that alter the localized watershed that supplies water to the ponds or alter the water-holding capacity at existing breeding sites. Unauthorized actions that could alter the hydrology of breeding sites would include discharge of fill material, draining, ditching, bedding, clear-cutting within the wetland, diversion or alteration of surface or ground water flow into or out of a wetland (i.e., due to roads, impoundments, discharge pipes, etc.), and unauthorized use of vehicles within the wetland; and,

(4) Discharge or dumping of toxic chemicals, silt, or other pollutants (i.e., sewage, oil, pesticides, and gasoline) into isolated wetlands or upland habitats supporting the species. This includes any application of terrestrial or aquatic pesticide that results in the mortality of adult frogs or tadpoles, regardless if the pesticide was applied in accordance with the labeling instructions. This includes drift from aerial applications and runoff from surface applications.

We will review other activities not identified above on a case-by-case basis to determine whether they may be likely to result in a violation of section 9 of the Act. We do not consider these lists to be exhaustive and provide them as information to the public. You should direct questions regarding whether specific activities may constitute a violation of section 9 to the Field Supervisor of our Mississippi Field Office (see ADDRESSES section).

We may issue permits to carry out otherwise prohibited activities involving endangered wildlife species under certain circumstances. Regulations governing permits are at 50 CFR 17.22. For endangered species, you may obtain permits for scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. You may request copies of the regulations regarding listed wildlife from, and address questions about prohibitions and permits to, the U.S. Fish and Wildlife Service, 1875 Century Blvd., Suite 200, Atlanta, Georgia 30345, or telephone 404/679-4176; facsimile 404/679-7081.

We have determined that we do not need to prepare an environmental assessment, as defined under the authority of the National Environmental Policy Act of 1969, in connection with regulations adopted pursuant to section 4(a) of the Endangered Species Act, as amended. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

This rule does not contain any new collections of information other than those already approved under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , and assigned Office of Management and Budget clearance 1018-0094. 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 control number. For additional information concerning permit and associated requirements for endangered species, see 50 CFR 17.22.

You may request a list of all references cited in this document, as well as others, from the Mississippi Field Office (see ADDRESSES section).

The primary author of this proposed rule is Linda V. LaClaire, Mississippi Field Office ( see ADDRESSES section) (601/321-1126).

Regulations implemented under the authority of the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq .) and the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq .) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas among the various domestic fishing categories. The General category landings quota, including time-period subquotas and the New York Bight set-aside, are specified annually as required under § 635.27 (a)(1). The 2001 fishing year General category quota and effort control specifications were issued on July 13, 2001 (66 FR 37421, July 18, 2001).

NMFS is required, under § 635.28 (a)(1), to file with the Office of the Federal Register for publication notification of closure when a BFT quota is reached, or is projected to be reached. On and after the effective date and time of such closure notification, for the remainder of the fishing year or for a specified period as indicated in the notification, fishing for, retaining, possessing, or landing BFT under that quota category is prohibited until the opening of the subsequent quota period or until such date as specified in the notification.

The adjusted 2001 fishing year BFT quota specifications issued pursuant to § 635.27 set a total adjusted General category quota of 919.7 mt, including the New York bight set-aside, of large medium and giant BFT to be harvested from the regulatory area during the 2001 fishing year. Based on reported landings and effort, NMFS projects that this quota will be reached by November 30, 2001. Therefore, fishing for, retaining, possessing, or landing large medium or giant BFT intended for sale by persons aboard vessels in the General or Charter/Headboat categories must cease at 11:30 p.m. local time November 30, 2001. The intent of this closure is to prevent overharvest of the quota established for the General category.

General category permit holders may tag and release BFT while the General category is closed, subject to the requirements of the tag-and-release program at § 635.26. Vessels permitted in the Charter/Headboat category may continue to fish for and retain BFT under the Angling category regulations. The current Angling category daily retention limit, effective from November 1, 2001 through May 31, 2002 is one large school or small medium BFT (measuring from 47 to less than 73 inches (from 69 to less than 119 cm) curved fork length) (66 FR 31844, June 13, 2001). In addition, Angling and Charter/Headboat category vessels may retain one large medium or giant “trophy” BFT, measuring 73 inches (185 cm) or greater, per fishing year (June 1 through May 31).

This action is taken under § 635.28 (a) and is exempt from review under Executive Order 12866.

Regulations governing the Atlantic bluefish fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is apportioned on a percentage basis among the coastal states from North Carolina through Maine. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.160.

The initial total commercial quota for Atlantic bluefish for the 2001 calendar year was set equal to 9,583,010 lb (4,348,008 kg)(66 FR 23625, May 9, 2001). The percent allocated to vessels landing Atlantic bluefish in New York is 10.3851 percent, or 995,204 lb (451,544 kg). This quota was subsequently increased on November 15, 2001, (66 FR 57398) to 1,095,204 lb (496,784 kg) as the result of a 100,000 lb (45,360 kg) transfer of bluefish quota from the Commonwealth of Virginia.

Section 648.161 (b) requires the Administrator, Northeast Region, NMFS (Regional Administrator) to monitor state commercial quotas and to determine when a state’s commercial quota is harvested. The Regional Administrator is further required to publish a notification in the Federal Register advising a state and notifying Federal vessel and dealer permit holders that, effective upon a specific date, the state’s commercial quota has been harvested and no commercial quota is available for landing Atlantic bluefish in that state. The Regional Administrator has determined, based upon dealer reports and other available information, that the State of New York has attained its quota for 2001.

The regulations at § 648.4 (b) provide that Federal permit holders agree as a condition of the permit not to land Atlantic bluefish in any state that the Regional Administrator has determined no longer has commercial quota available. Therefore, effective 0001 hours, December 3, 2001, further landings of Atlantic bluefish in New York by vessels holding Atlantic bluefish commercial Federal fisheries permits are prohibited for the remainder of the 2001 calendar year, unless additional quota becomes available through a transfer and is announced in the Federal Register . Effective 0001 hours, December 3, 2001, federally permitted dealers are also advised that they may not purchase Atlantic bluefish from federally permitted vessels that land in New York for the remainder of the calendar year, or until additional quota becomes available through a transfer.

This action is required by 50 CFR part 648 and is exempt from review under E.O. 12866.