In the Federal Register of July 27, 1998 (63 FR 40025), FDA published a final rule classifying certain previously unclassified preamendments pedicle screw spinal systems and reclassifying certain postamendments pedicle screw spinal systems. Following publication of the rule, the agency discovered that the rule contained several errors.

FDA inadvertently omitted one intended use from the codified language in the rule. This use, for which the device was being classified into class II, is treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having the implants attached to the lumbar and sacral spine with removal of the implants after attainment of a solid fusion. This omission from the codification was a typographical error. As described in the preamble to the rule, the Orthopedics and Rehabilitation Devices Advisory Panel (the Panel) recommended classifying the device into class II when intended for this use, and the agency had determined that class II was the appropriate class. In fact, the summary of the final rule included this intended use in the list of intended uses for which the device was being classified into class II. The agency is correcting the rule, therefore, to include treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having the implants attached to the lumbar and sacral spine with removal of the implants after attainment of solid fusion in the list of class II intended uses for the device.

In the final rule, FDA described the intended uses listed above as postamendments intended uses. However, on March 20, 1998, prior to publication of the final rule, FDA cleared a premarket notification submission (510(k)) that included preamendments documentation showing that spondylolisthesis (all types and grades), spondylolysis, trauma, failed previous fusions (pseudarthrosis), degenerative disc disease, and degeneration of the facets accompanied by instability in the cervical, thoracic, lumbar and sacral spine (C2-S1) are preamendments intended uses (Ref. 1). The 510(k) submission included affidavits establishing preamendments use from the original device marketer, the device inventor, credible users, and the sponsor of the 510(k). CDRH’s Office of Compliance found these documents adequate to establish the preamendments status of this device as a pedicle screw spinal system for specific indications. Consequently, the rule should have stated that for these intended uses, the device was being classified, not reclassified.

FDA acknowledges that the additional preamendments intended uses should have been incorporated into the final rule prior to its publication. If this had been done, the codified language would be as it is below. The agency regrets any inconveniences that this delay in incorporating the additional preamendments intended uses may have caused.

FDA’s error in referring to the device when intended to treat degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, or failed previous fusion (pseudarthrosis), as a postamendments, rather than a preamendments, device did not affect the classification into class II under the final rule. The agency intended to classify the device when intended for these uses into class II. In addition, the requirement that the agency obtain a recommendation from an advisory panel regarding the classification of a preamendments device was met because the Panel considered these intended uses when making its recommendation (Ref. 2). The fact that these are preamendments devices, rather than postamendments devices, intended uses has no impact on either the classification of the device or the premarket submissions required for pedicle screw spinal systems intended for these uses. In addition, no change in the codified language of the rule is necessary to reflect this fact.

FDA also described the device when intended to treat degenerative disc disease and spondylolisthesis other than severe spondylolisthesis (grades 3 and 4) at L5-S1 as a postamendments, rather than as a preamendments, device. This error did not affect the classification of the device, when intended for these uses, into class III under the final rule. The agency intended to classify the device when intended for these uses into class III. In addition, the requirement that the agency obtain from an advisory panel a recommendation regarding the classification of a preamendments device was satisfied because the Panel considered these intended uses when making its recommendation (Ref. 2).

However, the agency’s error does affect the type of premarket submission required for the device when intended for these uses. Because these are preamendments intended uses, premarket approval applications are not required until the agency issues a final rule under section 515(b) of the act (21 U.S.C. 360e(b)) requiring submission of premarket approval applications. FDA intends to initiate the call for premarket approval applications for the device when intended for these uses in a future document in the Federal Register . Until that time, the devices may enter the market after clearance of a premarket notification (510(k)) submission. The agency is correcting the rule accordingly.

On January 20, 1995, the agency cleared a 510(k) that included documentation that use of pedicle screw spinal systems to treat severe spondylolisthesis (grades 3 and 4) at L5-S1 in patients receiving fusion by autogenous bone graft having the implants attached to the lumbar and sacral spine with removal of the implants after attainment of a solid fusion is a preamendments intended use. While the preamendments indication originally described by the agency in the final rule was limited to skeletally mature patients, the preamendments documentation also supports the use of this pedicle screw spinal system for the same intended use in patients who are not skeletally mature (Ref. 3).

In addition, the March 20, 1998, 510(k) clearance described above in section II.B of this document identified a number of intended uses that were not included as part of the final rule, specifically:

(1) Spondylolysis in the thoracic, lumbar and sacral spine;

(2) Degeneration of the facets accompanied by instability in the thoracic, lumbar and sacral spine;

(3) Cervical spondylolisthesis (all grades and types);

(4) Cervical spondylolysis;

(5) Cervical degenerative disc disease;

(6) Degeneration of the cervical facets accompanied by instability;

(7) Cervical trauma (fracture and dislocation); and

(8) Revision of failed previous fusion surgery (pseudarthrosis) of the cervical spine.

Neither the use in nonskeletally mature patients nor the eight intended uses listed above were discussed by the Panel at either its August 20, 1993, or July 23, 1994, meetings or as part of the information they subsequently reviewed. Because they are preamendments intended uses, a panel recommendation is required before they may be classified (21 U.S.C. 360c(c)). FDA intends to seek the recommendation of an advisory panel with respect to classification of the device when intended for these uses at a future Panel meeting. For these intended uses, the device currently is considered an unclassified preamendments device and may enter the market after clearance of a 510(k) submission.

In light of the above, FDA has made the following changes to § 888.3070:

(1) FDA has reorganized the section to simplify the presentation.

(2) FDA has added “severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra” to the intended uses for the class II pedicle screw spinal systems (§ 888.3070(b)(1)). FDA has also added this intended use to the labeling for the special controls.

(3) FDA has changed the intended uses for which pedicle screw spinal systems are in class III from “all other uses” to “when intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment” (§ 888.3070(b)(2)).

(4) FDA has amended § 888.3070(c) to state that, for the devices described in paragraph § 888.3070(b)(2), no effective date has been established for submission of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP). FDA will issue a rule to require PMA’s or PDP’s for these devices in the future. Until that time, pedicle screws for these intended uses may be marketed through the premarket notification process.

(5) At a future time, and after obtaining a Panel recommendation, FDA will propose a rule to classify the device for the unclassified uses described in section II.C of this document

The following references have been placed on display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. These references may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

The agency had determined under 21 CFR 25.30(i) that this final rule is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impact of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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, and other advantages; distributive impacts; and equity). The agency believes that this rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, this rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The only effect of this correction is to delay the requirement for manufacturers of pedicle screw spinal systems intended for certain uses to submit PMA’s for these devices until FDA issues a regulation requiring such submissions. Therefore, the agency certifies that this final rule will not have a significant economic impact on a substantial number of small entities. This rule also does not trigger the requirement for a written statement under section 202(a) of the Unfunded Mandates Reform Act because it does not impose a mandate that results in an expenditure of $100 million or more by State, local, or tribal governments in the aggregate, or by the private sector, in any one year.

Medical devices.

(a) Identification . Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.

(b) Classification . (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:

(i) Compliance with material standards;

(ii) Compliance with mechanical testing standards;

(iii) Compliance with biocompatibility standards; and

(iv) Labeling that contains these two statements in addition to other appropriate labeling information:

(2) Class III (premarket approval), when intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

(c) Date PMA or notice of completion of a PDP is required . No effective date has been established of the requirement for premarket approval for the devices described in paragraph (b)(2) of this section. See § 888.3.

The Office published a final rule in the Federal Register of March 22, 2001 (66 FR 16004), entitled “Revision of Patent Cooperation Treaty Application Procedure.” This document corrects errors in §§ 1.494(c)(2), 1.495(c)(2), and 1.497(a)(1).

Specifically, §§ 1.494(c)(2) and 1.495(c)(2) as revised in the above final rule inadvertently omitted the provisions that:

Section 1.497(a)(1) as revised in the above final rule inadvertently omitted the section symbols before the reference to §§ 1.66 or 1.68.

The information in this section is organized as follows:

EPA is approving a revision to the State of Maryland SIP which was submitted on January 4, 2001 by MDE. This revision repeals Regulation .04, Petroleum Refineries, under Maryland's Code of Maryland Administrative Regulations (COMAR) 26.11.11, Control of Petroleum Products Installations, including Asphalt Paving and Asphalt Concrete Plants. At one time there was the possibility of a petroleum refinery being constructed in the State of Maryland which would have required regulation under COMAR 26.11.11.04, and under Maryland's SIP. However, a facility was never constructed, and at the present time there are no petroleum refineries located in Maryland.

EPA is approving this SIP revision at the request of MDE. Since there are no petroleum refineries located in the State of Maryland, Maryland repealed its petroleum refinery regulation, COMAR 26.11.11.04, Petroleum Refineries, under COMAR 26.11.11, Control of Petroleum Products Installations, including Asphalt Paving and Asphalt Concrete Plants. Because there are no oil refineries in the State of Maryland, EPA is approving the SIP revision to amend COMAR 26.11.11 to repeal Regulation 26.11.11.04, Petroleum Refineries.

As stated previously, there are no petroleum refineries located in Maryland. Therefore, a regulation to control such sources is not necessary. If a new petroleum refinery were to move in to Maryland, it would be subject to New Source Performance Standards (NSPS), New Source Review (NSR), Prevention of Significant Deterioration requirements (PSD), Maximum Achievable Control Technology (MACT) standards, as well as Maryland's Toxic Air Pollutants (TAPs) regulations. Therefore, EPA finds the Maryland request approvable.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in a separate document in this Federal Register publication, EPA is proposing to approve the SIP revision should adverse written comments be filed. This rule will be effective on July 23, 2001 without further notice unless EPA receives adverse comment by June 21, 2001. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

EPA is approving the revision to the State of Maryland SIP which was submitted on January 4, 2001 by MDE. This revision amends COMAR 26.11.11, Control of Petroleum Products Installations, including Asphalt Paving and Asphalt Concrete Plants to repeal Regulation 26.11.11.04, Petroleum Refineries.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action 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 rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule 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 any unfunded mandate or 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 a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. 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 SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission 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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 23, 2001. Filing a petition for reconsideration by the Administrator of this final rule approving the repeal of Regulation 26.11.11.04, Petroleum Refineries under COMAR 26.11.11, Control of Petroleum Products Installations, including Asphalt Paving and Asphalt Concrete Plants 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).)

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

On January 10, 2001, 66 FR 1927, EPA proposed a limited approval and limited disapproval of the following rule that was submitted for incorporation into the California SIP.

We proposed a limited approval because we determined that this rule improves the SIP and is largely consistent with the relevant CAA requirements. We simultaneously proposed a limited disapproval because some rule provisions conflict with section 110 and part D of the Act. These provisions include the following:

Our proposed action contains more information on the basis for this rulemaking and on our evaluation of the submittal.

EPA provided for a 30-day public comment period on January 10, 2001 in 66 FR 1927. EPA received the following verbal comments on the proposed rulemaking during the comment period from Bernard Bigham of the Chesapeake Environmental Group.

Comment 1: VCAPCD 74.29 does little to reduce VOC emissions. Under the exemption in paragraph (C)(3)(f), it is estimated that 200,000 tons/year of contaminated soil is excavated and trucked to landfills, and VOCs volatilize during transport and when soil is used as landfill daily cover. There is currently no rule other than VCAPCD 74.17 that controls VOC loss in contaminated soil transport to landfills. VCAPCD should remove paragraph (C)(3)(f), or Rule 74.17 should be revised to establish soil handling procedures and specify test methods that adequately evaluate and control VOC loading of landfills. The commenter points, for example, to Bay Area Air Quality Management District Rule 8-40.

Response: We discussed this comment with VCAPCD staff, who explained that Alternate Daily Cover (ADC) soil is only exempt under (C)(3)(f) if it meets the test in Definition (G)(2), which states limits by weight ppm VOC as referenced in (F)(2) test methods. We agree that this does establish some control on emissions from ADC, but recommend that the rule be clarified by stating these requirements in paragraph (B) or (C)(3)(f), and by clearly referencing the appropriate test methods in this requirement.

We also recommend that the rule be revised to reference the other District protocols for safe handling and transport of contaminated soil to safe disposal.

Comment 2: Paragraph (F)(2) appropriately references Methods 8015B and 5035, but 74.29(F)(5) undermines (F)(2) by referencing (B)(1)(a), which specifies Method 21. Method 25D should be referenced in (B)(1)(a) instead in light of crust formation on piled soil.

Response: The District believes Definition (G)(2), Alternate Daily Cover, calls for the measurement of weight ppm VOC content of crusted soils, which requires the use of Method 25D for determining VOCs beneath the surface of excavated soil.

EPA concurs that an appropriate method is being required, but recommends for clarity that testing for weight ppm VOC, by methods in paragraph (F)(2), be a requirement for the “Alternate Daily Cover” exemption allowed in paragraph (C)(3)(f).

EPA has made several additional rule recommendations based on the submitted comments. No comments were submitted, however, that change our overall assessment of the rule or modify our action on the rule as described in our proposed action. Therefore, as authorized in sections 110(k)(3) and 301(a) of the Act, EPA is finalizing a limited approval of the submitted rule. This action incorporates the submitted rule into the California SIP, including those provisions identified as deficient. As authorized under section 110(k)(3), EPA is simultaneously finalizing a limited disapproval of the rule. As a result, sanctions will be imposed unless EPA approves subsequent SIP revisions that correct the rule deficiencies within 18 months of the effective date of this action. These sanctions will be imposed under section 179 of the Act according to 40 CFR 52.31. In addition, EPA must promulgate a federal implementation plan (FIP) under section 110(c) unless we approve subsequent SIP revisions that correct the rule deficiencies within 24 months. Note that the submitted rule has been adopted by the VCAPCD, and EPA's final limited disapproval does not prevent the local agency from enforcing them.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action 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 rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule 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 any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). For the same reason, this rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). 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), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. 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 SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission 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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. 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).

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 July 23, 2001. 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).)

On November 13, 2000, the State of Maryland submitted formal revisions to its State Implementation Plan (SIP). These SIP revisions, submitted by the Maryland Department of the Environment (MDE), consist of the control of volatile organic compound (VOC) emissions from distilled spirits facilties.

COMAR 26.11.19.29 applies to a person who owns or operates a distilled spirits facility that has a total potential to emit VOCs of 25 tons or more per year.

This section establishes definitions for the terms “aging warehouse,” “bottling operation,” “distilled spirits,” “distilled spirits facility,” and “vacuum filling system.”

This section requires the use of one of the following control methods at distilled spirits facilities subject to this regulation:

• Empty and fill barrels using a pump-operated, bayonet-type suction and filling device, or comparably effective device that minimizes VOC evaporative losses when emptying or filling barrels,

• Drain distilled spirits from filter plates that are located between the barrel unloading and storage tanks to either a recycling tank or to an enclosed collection system, and

• Use a gravity and vacuum or pressure filling system or comparably effective system to minimize fugitive emissions from the bottling operations.

This section also requires during the warmer weather, used barrels that are stored in the outdoors awaiting disposal shall be periodically (at least weekly) wetted down to reduce potential leakage and fugitive emissions.

This section requires a submittal to MDE for approval, a good operating practices manual to minimize fugitive VOC emissions from the aging warehouse, and shall be implemented not later than 60 days after approval by MDE. This section also requires a report to be submitted to MDE following implementation of the approved good operating practices.

Evaluation: This SIP revision, controlling VOC emissions from distilled spirits facilities, will result in significant enforceable VOC emission reductions. EPA has determined that COMAR 26.11.19.29 is approvable as a SIP revision.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipate no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on July 23, 2001 without further notice unless EPA receives adverse comment by June 21, 2001. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

EPA is approving the SIP revisions submitted by MDE on November 13, 2000 to control VOC emissions from distilled spirits facilities.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action 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 rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule 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 any unfunded mandate or 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 a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. 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 SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action, pertaining to revisions to the Maryland SIP establishing requirements for distilled spirits facilities, must be filed in the United States Court of Appeals for the appropriate circuit by July 23, 2001. 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).)

The Environmental Protection Agency (EPA) is approving the New York State Department of Environmental Conservation's (New York's) Nitrogen Oxides ( NO X ) SIP Call State Implementation Plan (SIP) revision. The following table of contents describes the format for this SUPPLEMENTARY INFORMATION section:

EPA is approving revisions to New York's ground level ozone SIP which New York submitted on April 3, 2000 and April 18, 2000. These SIP revisions include a new regulation, 6 NYCRR Part 204, “NO X Budget Trading Program,” adopted January 18, 2000, and a narrative entitled, “New York State Implementation Plan For Ozone; Meeting The Statewide Oxides of Nitrogen ( NO X ) Budget Requirements Contained In The NO X SIP Call (63 FR 57356, October 27, 1998),” dated April 18, 2000 and supplemented on May 16, 2000. New York submitted the regulation and narrative, including NO X reducing measures, in order to strengthen its one-hour ozone SIP and to comply with the NO X SIP Call during each ozone season, i.e. , May 1 through September 30, beginning in 2003. EPA has determined that New York's submittal is fully approvable as a SIP-strengthening measure for New York's one-hour ground level ozone SIP and as meeting the NO X SIP Call requirements.

Separately, EPA is also approving administrative revisions to the New York SIP.

Independent of New York's NO X SIP Call SIP revision, New York submitted various regulations as revisions to New York's SIP on August 10, 1979. The August 1979 submittal included, among other things, the repeal of part 204 “Hydrocarbon Emissions From Storage and Loading Facilities—New York City Metropolitan Area,” because part 204 was superceded by part 229. By Federal Register notice published on February 5, 1980 (45 FR 7803), one of the conditions EPA imposed was either to regulate the storage of petroleum liquids other than gasoline or provide acceptable justification for not regulating such storage. New York submitted adopted revisions to part 229 to address the inclusion of petroleum liquids. On July 1, 1980 (see 45 FR 44273), EPA took final rulemaking to remove this condition after New York revised part 229 to include petroleum liquids. Since part 229 regulated all the sources previously regulated in part 204 and in some cases was more stringent, EPA should have, but inadvertently failed to, remove part 204 from the SIP at that time.

As part of today's action, EPA is now revising Title 40, § 52.1679 “EPA-approved New York State regulations,” by removing the entry for old part 204, Hydrocarbon Emissions From Storage and Loading Facilities—New York City Metropolitan Area, and adding an entry for the new part 204, “NO X Budget Trading Program.”

In addition to part 204, New York made administrative amendments to regulations part 200 “General Provisions,” part 220 “Portland Cement Plants,” Subpart 227-1, “Stationary Combustion Installations,” subpart 227-2, “Reasonably Available Control Technology (RACT) for Oxides of Nitrogen (NO X ),” and subpart 227-3, “Pre-2003 Nitrogen Oxides Emissions Budget and Allowance Program.”

EPA is approving amendments to part 200, subpart 227-1, subpart 227-2, and subpart 227-3 for the purposes of enforcing the SIP, as well as for enforcing New York's NO X Budget Trading Program. Since New York's amendments to part 200, subpart 227-1, subpart 227-2, and subpart 227-3 were administrative, EPA is revising the SIP to include the amended regulations. With respect to the administrative amendments to part 220, “Portland Cement Plants,” EPA is currently reviewing other amendments to part 220 adopted on January 18, 2000. Therefore, EPA will address all part 220 amendments at the same time in a future rulemaking.

EPA is approving this action in order to:

• Approve New York's NO X Budget Trading Program (part 204) under the NO X SIP Call as a control program that reduces NO X emissions, a precursor of ozone, and which therefore helps to achieve the national ambient air quality standard for ozone in the New York City metropolitan nonattainment area,

• Fulfill New York's and EPA's requirements under the NO X SIP Call,

• Approve administrative changes to New York's regulations part 200, part 204, subpart 227-1, subpart 227-2 and subpart 227-3.

• Make New York's NO X allowance trading regulation federally enforceable and available for credit in the SIP, and

• Make New York's SIP narrative, including the ozone season NO X budget and State reporting requirements, federally enforceable as part of the New York SIP.

These actions have the effect of assuring that the section 126 requirements will no longer apply to New York sources.

On March 3, 2000, the Circuit Court of the District of Columbia handed down its decision in Michigan v. EPA , which largely upheld the NO X SIP Call but remanded a few minor issues to EPA. After this decision, EPA decided to separate the requirements of the regional strategy into two phases. The deadline for states to submit their plans to comply with Phase 1 of the strategy was October 30, 2000. Details of Phase 1 were outlined in April 11, 2000 letters to Governors in the affected states, including New York. New York met the Phase 1 SIP submittal requirements by its April 2000 SIP revision.

On January 5, 2001, the outgoing Administrator signed a notice of proposed rulemaking for Phase 2 of the NO X SIP Call. This notice was placed on EPA's website at http://www.epa.gov/ttn/rto/sip/related.html#prop but has not been published pending further EPA evaluation. Phase 2 is designed to respond to issues remanded by the court by addressing, among other things, whether, and if so, how, a small subclass of facilities that generate electricity—cogenerators—should be included in the rule, and what control levels should be assumed in reducing NO X from large, stationary internal combustion (IC) engines. The proposal would affect 22 jurisdictions, 1 including New York, and would identify a range of due dates for the affected states subject to Phase 2 to submit a SIP revision.

EPA fully expects that the Phase 2 rule would have no more than a slight effect on New York Statewide NO X emission budgets. In the January 5, 2001 version of EPA's notice of proposed rulemaking, New York's Phase 2 Statewide 2007 NO X emissions budget would be 240,285 tons or 240,322 tons based on IC engines with control efficiencies of 91% and 82%, respectively. The corresponding Phase 2 NO X emission reductions from the 2007 baseline emissions would be 15,368 tons and 15,331 tons, respectively. New York's April 2000 SIP revision, which EPA is approving today, includes a demonstration, including a detailed emission inventory, that the Statewide emissions would not exceed 239,549 tons in 2007, corresponding to NO X reductions of 16,103 tons (see 65 FR 76197). Therefore, EPA fully expects that New York's April 2000 SIP revision will meet the Phase 2 Statewide budgets when finalized by EPA.

Therefore, in today's action EPA is also approving New York's April 2000 SIP revision as fully meeting the NO X SIP Call requirements including the Phase 2 Statewide NO X emissions budget that will apply when the Phase 2 rulemaking is completed. EPA recognizes that its Phase 2 rulemaking has not been completed, but as noted above, fully expects that the final Statewide budget promulgated in that rulemaking will be no more stringent than New York's current budget. Once EPA finalizes the Phase 2 rule, should New York's adopted 2007 NO X emissions budget (as submitted in April 2000) exceed the final Phase 2 budget (so that additional NO X reductions are needed), EPA will take appropriate action.

As stated in the December 6, 2000 Proposed Rulemaking (see 65 FR 76197 at 76202), a SIP meeting the March 2, 2000 budgets and providing for reductions by May 1, 2003, should fully address the significant NO X transport from that state. Therefore, upon approval of such a SIP, § 52.34(i) of the section 126 rule would apply to automatically withdraw the section 126 requirements for sources in that state. As noted immediately above, EPA has no reason to expect that the Phase 2 budget for New York, when finalized, will mandate any additional NO X reductions. Thus, meeting the March 2, 2000 budget is adequate for New York's SIP to meet the NO X SIP Call requirements. Since the New York SIP revision meets the March 2, 2000 budgets, provides for reductions by May 1, 2003, and is fully approved today as proposed, the section 126 requirements are automatically withdrawn, as of the effective date of this final rule, for sources in the State of New York pursuant to 40 CFR 52.34(i).

On December 6, 2000, EPA published in the Federal Register (65 FR 76197) a Proposed Rulemaking to approve New York's regulation and SIP narrative as a SIP revision and providing for a 30-day public comment period, which ended on January 5, 2001.

EPA received no public comments regarding the Proposed Rulemaking.

A detailed discussion of this program is available in the December 6, 2000 Proposed Rulemaking (65 FR 76197). A Technical Support Document, prepared in support of the proposed rulemaking, contains the full description of New York's submittal and EPA's evaluation. A copy of the Technical Support Document is available upon request from the EPA Regional Office listed in the ADDRESSES section.

EPA is approving New York's April 3, 2000 and April 18, 2000 SIP submittals, as supplemented on May 16, 2000, that address EPA's NO X SIP Call. EPA has reviewed New York's control measures and projected reductions and finds them approvable. Therefore, EPA is approving Part 204 and the SIP narrative into the New York SIP at this time. In addition, as a result of today's action, the Clean Air Act section 126 rule requirements will no longer apply to sources in the State of New York.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action 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 rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule 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 any unfunded mandate or 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 a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000) nor will this rule have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. 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 SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission 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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. )

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major” rule as defined by 5 U.S.C. 804(2). This rule will be effective June 21, 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 July 23, 2001. 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).)

The Environmental Protection Agency (EPA) is approving the New Jersey Department of Environmental Protection's (New Jersey's) Nitrogen Oxides ( NO X ) SIP Call State Implementation Plan (SIP) revision. The following table of contents describes the format for this SUPPLEMENTARY INFORMATION section:

EPA is approving revisions to New Jersey's ground level ozone SIP which New Jersey submitted on December 10, 1999 and July 31, 2000. These SIP revisions include an amended regulation, N.J.A.C. 7:27-31 (Subchapter 31), “ NO X Budget Program,” adopted July 28, 2000, and a narrative entitled, “State Implementation Plan (SIP) Revision for the Attainment and Maintenance of the Ozone and Carbon Monoxide National Ambient Air Quality Standards-Meeting the Requirements of the Regional NO X Cap Program and Transportation Conformity Budgets Related to the Attainment of the Ozone and Carbon Monoxide National Ambient Air Quality Standards,” dated December 10, 1999 and supplemented on July 31, 2000. New Jersey submitted the regulation and narrative, including NO X reducing measures, in order to strengthen its one-hour ozone SIP and to comply with the NO X SIP Call during each ozone season, i.e., May 1 through September 30, beginning in 2003. EPA has determined that New Jersey's submittal is fully approvable as a SIP-strengthening measure for New Jersey's one-hour ground level ozone SIP and as meeting the NO X SIP Call requirements. On May 31, 2000, EPA found the mobile source emissions budgets to be adequate for transportation conformity purposes. (See 65 FR 36689, June 9, 2000).

EPA is approving this action in order to:

• Approve New Jersey's NO X Budget Trading Program (Subchapter 31) under the NO X SIP Call as a control program that reduces NO X emissions, a precursor of ozone, and which therefore helps to achieve the national ambient air quality standard for ozone in nonattainment areas in New Jersey,

• Fulfill New Jersey's and EPA's requirements under the NO X SIP Call,

• Make New Jersey's NO X allowance trading regulation federally enforceable and available for credit in the SIP, and

• Make New Jersey's SIP narrative, including the ozone season NO X budget and State reporting requirements, federally enforceable as part of the New Jersey SIP.

These actions have the effect of assuring that the section 126 requirements will no longer apply to New Jersey sources.

On March 3, 2001, the Circuit Court of the District of Columbia handed down its decision in Michigan v. EPA, which largely upheld the NO X SIP Call but remanded a few minor issues to EPA.

After this decision, EPA decided to separate the requirements of the regional strategy into two phases. The deadline for states to submit their plans to comply with Phase 1 of the strategy was October 30, 2000. Details of Phase 1 were outlined in April 11, 2000 letters to Governors in the affected states, including New Jersey. New Jersey met the Phase 1 SIP submittal requirements by its December 1999 and July 2000 SIP revisions.

On January 5, 2001, the outgoing Administrator signed a notice of proposed rulemaking for Phase 2 of the NO X SIP Call. This notice was placed on EPA's website at http://www.epa.gov/ttn/rto/sip/related.html#prop but has not been published pending further EPA evaluation. Phase 2 is designed to respond to issues remanded by the court by addressing, among other things, whether, and if so, how, a small subclass of facilities that generate electricity—cogenerators—should be included in the rule, and what control levels should be assumed in reducing NO X from large, stationary internal combustion (IC) engines. The proposal would affect 22 jurisdictions  1 , including New Jersey, and would identify a range of due dates for the affected states subject to Phase 2 to submit a SIP revision.

EPA fully expects that the Phase 2 proposed rule would have no more than a slight effect on New Jersey Statewide NO X emission budgets. In the January 5, 2001 version of EPA's notice of proposed rulemaking, New Jersey's Phase 2 Statewide 2007 NO X emissions budget would be 96,876 tons. The corresponding Phase 2 NO X emission reductions from the 2007 baseline emissions would be 8,613 tons. New Jersey's December 1999 and July 2000 SIP revisions, which EPA is approving today, includes a demonstration, including a detailed emission inventory, that the Statewide emissions would not exceed 96,275 tons in 2007 corresponding to NO X reductions of 9,214 tons (see 65 FR 71278 and 77695). Therefore, EPA fully expects that New Jersey's December 1999 and July 2000 SIP revisions will meet the Phase 2 Statewide budgets when finalized by EPA.

Therefore, in today's action EPA is also approving New Jersey's December 1999 and July 2000 SIP revisions as fully meeting the NO X SIP Call requirements including the Phase 2 Statewide NO X emissions budget that will apply when the Phase 2 rulemaking is completed. EPA recognizes that its Phase 2 rulemaking has not been completed, but as noted above, fully expects that the final Statewide budget promulgated in that rulemaking will be no more stringent than New Jersey's current budget. Once EPA finalizes the Phase 2 rule, should New Jersey's adopted 2007 NO X emissions budget (as submitted in December 1999 and July 2000) exceed the final Phase 2 budget (so that additional NO X reductions are needed), EPA will take appropriate action.

As stated in the November 30, 2000 Proposed Rulemaking (see 65 FR 71278 at 71282), a SIP meeting the March 2, 2000 budgets and providing for reductions by May 1, 2003, should fully address the significant NO X transport from that state. Therefore, upon approval of such a SIP, § 52.34(i) of the section 126 rule would apply to automatically withdraw the section 126 requirements for sources in that state. As noted immediately above, EPA has no reason to expect that the Phase 2 budget for New Jersey, when finalized, will mandate any additional NO X reductions. Thus, meeting the March 2, 2000 budget is adequate for New Jersey's SIP to meet the NO X SIP Call requirements. Since the New Jersey SIP revision meets the March 2, 2000 budgets, provides for reductions by May 1, 2003, and is fully approved today as proposed, the section 126 requirements are automatically withdrawn, as of the effective date of this final rule, for sources in the State of New Jersey pursuant to 40 CFR 52.34(i).

On November 30, 2000, as corrected on December 12, 2000, EPA published in the Federal Register (65 FR 71278 and corrected at 77695) a Proposed Rulemaking to approve New Jersey's regulation and SIP narrative as a SIP revision and providing for a 30-day public comment period, which ended on January 2, 2001.

EPA received no public comments regarding the Proposed Rulemaking.

A detailed discussion of this program is available in the November 30, 2000 Proposed Rulemaking (65 FR 71278), as corrected in the December 12, 2000 Federal Register (65 FR 77695). A Technical Support Document, prepared in support of the proposed rulemaking, contains the full description of New Jersey's submittal and EPA's evaluation. A copy of the Technical Support Document is available upon request from the EPA Regional Office listed in the ADDRESSES section.

EPA is approving New Jersey's December 10, 1999 and July 31, 2000 SIP submittals, including New Jersey's July 31, 2000 supplement, that address EPA's NO X SIP Call. EPA has reviewed New Jersey's control measures and projected reductions and finds them approvable. Therefore, EPA is approving Subchapter 31 and the SIP narrative into the New Jersey SIP at this time. In addition, as a result of today's action, the Clean Air Act section 126 rule requirements will no longer apply to sources in the State of New Jersey.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action 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 rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule 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 any unfunded mandate or 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 a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will this rule have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. 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 SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission 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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. )

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major” rule as defined by 5 U.S.C. 804(2). This rule will be effective June 21, 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 July 23, 2001. 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).)

On August 17, 2000, the Environmental Protection Agency (EPA) proposed a site-specific rule (65 FR 50283) that set forth the mechanisms through which USFRS and participating generators and transporters can test the effectiveness of an integrated, flexible, performance-based approach for managing ion exchange filter resins (“resins”) and associated wastes to determine whether this approach promotes an increase in the recovery and recycling of metals from electroplating operations, a reduction in the amount of hazardous chemicals which are discharged to the local publicly owned treatment works (POTWs) and the amount of water used in the manufacturing process. The development and implementation of the USFRS XL Project will be piloted at USFRS and at approved generators and transporters of USFRS resin wastes. The approved generators and transporters will handle, store and transport the resin wastes in accordance with specific standards contained in new part 266, subpart O of Title 40 of the Code of Federal Regulations (“subpart O”). These requirements would operate in lieu of the requirements imposed under parts 261-265, 268, 270, 273 and 279 of Title 40 of the Code of Federal Regulations. As a result, it is anticipated that there will be an increase in the recovery and recycling of metals from the electroplating waste waters and that the generators will reduce their discharge of process waste waters to local POTWs. USFRS will handle the resin wastes as hazardous waste and in accordance with subpart O and its RCRA hazardous waste permit. The rule imposes on USFRS additional reporting and handling requirements in exchange for the regulatory flexibility provided to the generators and transporters.

Today's final rule promulgates regulations that are identical to the proposed rule, except where otherwise noted below. Today's rule will facilitate implementation of the FPA that has been developed and signed by USFRS, EPA, the Minnesota Pollution Control Agency (MPCA), the counties of Anoka, Carver, Dakota, Hennepin, Ramsey, Scott and Washington in Minnesota, Pioneer Tank Lines. 1 As generators and transporters are approved for participation they too will sign the FPA. The FPA is available in the docket for today's action and on the world wide web at http://www.epa.gov/projectxl/. The FPA addresses the nine project XL criteria, and the expectation of EPA that this XL project will meet those criteria. Those criteria are: (1) Environmental results superior to what would be achieved through compliance with current and reasonably anticipated future regulations; (2) economic opportunity; (3) stakeholder involvement, support and capacity for community participation; (4) test of innovative, multi-media, pollution prevention strategies for achieving environmental results; (5) approaches that could be evaluated for future broader application (transferability); (6) technical and administrative feasibility; (7) mechanisms for monitoring, reporting and evaluation; (8) consistency with Executive Order 12898 on Environmental Justice (avoidance of shifting of risk burden); and (9) community planning. The FPA specifically addresses the manner in which the project is expected to produce superior environmental benefits.

Today's rule is one of the required legal mechanisms necessary to implement the provisions of the USFRS XL Project. However, Minnesota has an authorized hazardous waste program. Therefore, the requirements outlined in today's rule will not take effect until Minnesota either receives from EPA authorization for an equivalent legal mechanism to implement this rule or the State uses an existing authorized mechanism to implement this rule. EPA will not be the primary regulatory agency responsible for implementing the requirements of today's rule. The State of Minnesota and, in certain areas, the County Agencies will be the primary regulatory agency. For the sake of simplicity, however, the remainder of this preamble refers to the effects of this rule, although it will be the corresponding State and local law and permits by which it will be implemented.

The information presented in this preamble is organized as follows:

EPA is publishing this final regulation under the authority of sections 2002, 3001, 3002, 3003, 3006, 3010, and 7004 of the Solid Waste Disposal Act of 1970, as amended by the Resource Conservation and Recovery Act, as amended (42 U.S.C. 6912, 6921, 6922, 6923, 6926, 6930, and 6974).

The FPA sets forth the intentions of EPA, MPCA, Pioneer Tank Lines the counties of Anoka, Carver, Dakota, Hennepin, Ramsey, Scott and Washington, 2 Minnesota and USFRS with regard to the USFRS XL Project. Project XL is an EPA initiative to allow regulated entities an opportunity to achieve better environmental results at less cost.

EPA announced Project XL—“eXcellence and Leadership”— on March 16, 1995. It is a central part of the National Performance Review and the EPA's effort to reinvent environmental protection. See 60 FR 27282 (May 23, 1995). Under Project XL EPA provides a limited number of private and public regulated entities an opportunity to develop their own pilot projects to provide regulatory flexibility that will result in environmental protection that is superior to what would be achieved through compliance with current and reasonably anticipated future regulations. These efforts are crucial to EPA's ability to test new strategies that reduce regulatory burden and promote economic growth while achieving better environmental and public health protection. EPA intends to evaluate the results of this and other Project XL projects to determine which specific elements of the project(s), if any, should be more broadly applied to other regulated entities for the benefit of both the environment and the economy.

Under Project XL, participants in four categories—facilities, industry sectors, governmental agencies and communities—are offered the flexibility to develop common sense, cost-effective strategies that will replace or modify specific regulatory requirements, on the condition that they produce and demonstrate superior environmental performance.

The XL program is intended to allow EPA to experiment with potentially promising regulatory approaches, both to assess whether they provide benefits at the specific facility affected, and whether they should be considered for wider application. Such pilot projects allow EPA to proceed more quickly than would be possible when undertaking changes on a nationwide basis.

Adoption of such alternative approaches or interpretations in the context of a given XL project does not, however, signal EPA's willingness to adopt that interpretation as a general matter, or even in the context of other XL projects. It would be inconsistent with the forward-looking nature of these pilot projects to adopt such innovative approaches prematurely on a widespread basis without first determining whether or not they are viable in practice and successful in the particular projects that embody them. Furthermore, as EPA indicated in announcing the XL program, EPA expects to adopt only a limited number of carefully selected projects. These pilot projects are not intended to be a means for piecemeal revision of entire programs. Depending on the results in these projects, EPA may or may not be willing to consider adopting the alternative interpretation again, either generally or for other specific facilities.

EPA believes that adopting alternative policy approaches and interpretations, on a limited, site-specific basis and in connection with a carefully selected pilot project, is consistent with the expectations of Congress about EPA's role in implementing the environmental statutes (provided that the Agency acts within the discretion allowed by the statute). Congress' recognition that there is a need for experimentation and research, as well as ongoing re-evaluation of environmental programs, is reflected in a variety of statutory provisions, such as section 8001 of RCRA.

To participate in Project XL, applicants must develop alternative pollution reduction strategies pursuant to eight criteria: superior environmental performance; cost savings and paperwork reduction; local stakeholder involvement and support; test of an innovative strategy; transferability; feasibility; identification of monitoring, reporting and evaluation methods; and avoidance of shifting risk burden. They must have full support of affected federal, state and tribal agencies to be selected.

For more information about the XL criteria, readers should refer to the two descriptive documents published in the Federal Register (60 FR 27282, May 23, 1995 and 62 FR 19872, April 23, 1997), and the December 1, 1995 “Principles for Development of Project XL Final Project Agreements” document. For further discussion as to how the USFRS XL Project addresses the XL criteria, readers should refer to the USFRS FPA available from the EPA RCRA docket or Region 5 library for this action (see ADDRESSES section of today's preamble).

Development of a Project has four basic phases: the initial pre-proposal phase where the project sponsor comes up with an innovative concept that it would like EPA to consider as an XL pilot; the second phase where the project sponsor works with EPA and interested stakeholders in developing its XL proposal; the third phase where EPA, local regulatory agencies, and other interested stakeholders review the XL proposal; and the fourth phase where the project sponsor works with EPA, local regulatory agencies, and interested stakeholders in developing the FPA and legal mechanisms. The XL pilot proceeds into the implementation phase and evaluation phase after promulgation of the required federal, state and local legal mechanisms and after the designated participants sign the FPA.

The FPA is a written agreement between the project sponsor, participants and regulatory agencies. The FPA contains a detailed description of the proposed pilot project. It addresses the eight Project XL criteria, and the expectation of EPA that this XL Project will meet those criteria. The FPA identifies performance goals and indicators (monitoring schedules) which will enable USFRS to clearly illustrate the baseline quantities and compare them to quantities derived after implementation of the pilot. The FPA specifically addresses the manner in which the project is expected to produce superior environmental benefits. The FPA also discusses the administration of the agreement, including dispute resolution and termination. The FPA for the USFRS XL Project is available for review in the docket for today's action, and also is available on the world wide web at http://www.epa.gov/projectxl/.

Today's new rules will facilitate implementation of the FPA and the USFRS XL Project. The regulatory relief provided in the final rules promulgated today, however, will not be federally effective in Minnesota until the state has made similar changes to its hazardous waste management program and, as necessary, EPA has approved of those changes as part of the State's authorized hazardous waste program. See the preamble to the August 17, 2000, Federal Register for a more detailed discussion of the manner in which the state may make such changes and the consequences of such actions.

The USFRS XL Project is limited in scope to the USFRS facility located in Roseville, Minnesota and to approved generators and transporters located within the State of Minnesota. It is further limited to waste specifically defined as USFRS XL wastes from the approved generators.

This XL Project is limited to USFRS ion exchange resin canisters, the USFRS resin process filters used prior to and after waste water treatment in the resin canisters (“pre- and postfilters”) and the contents of the resin canisters and filter containers after use by an approved generator. The wastes include the resins, the wastes contained on or within the resins, the pre- and post-resin filters and any other wastes contained within the canisters or the filter containers. The wastes include only those wastes which are generated from processes subject to the RCRA F006 hazardous waste listing from approved generators.

EPA and MPCA must approve of each generator or transporter prior to it being added to this XL Project as a participant. If the generator's principal place of business is located within the counties of Anoka, Carver, Dakota, Hennepin, Ramsey, Scott or Washington, Minnesota then the environmental agencies located within these counties (“county environmental agencies” or “county agencies”) must also approve of the generator. EPA's review of a proposed participant will focus primarily on its compliance and enforcement history. Before USFRS proposes to EPA to add a company to this project USFRS will conduct a preliminary evaluation of the company to ensure that it qualifies.

USFRS' preliminary evaluation of a proposed generator will ensure that the proposed generator is within the electroplating, metal working and circuit board manufacturing industrial sectors, has a complete USFRS application form, and has a storage area which meets the standards specified in subpart O. Only generators who generate or may generate waste water treatment sludges from electroplating operations may participate in the USFRS XL Project since it is limited in scope to RCRA F006 hazardous waste.

USFRS' preliminary evaluation of a proposed transporter will consist of determining whether the transporter has a current satisfactory safety rating from the United States Department of Transportation (USDOT), an EPA hazardous waste identification number, and a Minnesota Uniform Hazardous Materials Registration (Minnesota registration). This USFRS XL Project is limited to transporters who have a current satisfactory rating from the USDOT. They do not need an EPA identification number or Minnesota registration to participate.

The federal procedures for approving a company as a participant in the USFRS XL Project as a generator or transporter are detailed in the final rule. In summary, if a company passes USFRS' preliminary evaluation, USFRS will notify EPA in writing of its desire to add the company to the USFRS XL Project. EPA will have twenty one days to veto such company's participation in the USFRS XL Project. If USFRS does not receive a written disapproval from EPA within the twenty one days, the company is deemed to have EPA approval. USFRS must also obtain the approval of the MPCA and appropriate county agency. After USFRS has received the approval of EPA, MPCA and the appropriate county agency it will notify the potential generator or transporter that it has received the required agency approvals. At that time, USFRS will obtain the company's signature to the FPA and a certification that it has received the appropriate training. Upon request, USFRS will forward a copy of the signed documents to EPA, MPCA and the appropriate county agency.

On the date USFRS receives the signed FPA and certification, the potential generator or transporter is considered part of this USFRS XL Project. This date may be referred to as the generator or transporter “effective date.” Only generators or transporters who signed the FPA and certification after receiving EPA's approval may participate in the USFRS XL Project. The generator or transporter must handle its USFRS XL waste generated on or after the effective date in accordance with the requirements of part 266, subpart O. The generator or transporter must handle USFRS XL waste generated prior to the effective date according to the RCRA regulations applicable at that time. New subpart O does not apply retroactively to these wastes.

The USFRS Roseville facility will handle the USFRS XL wastes as a hazardous waste and consistent with its hazardous waste permit. 3 USFRS' treatment of the wastes will consist of treatment to regenerate the resins and make them amenable for reuse in another canister. USFRS will handle any residual wastes from the resin regeneration process and the filters from the pre- and post-filtration process according to the RCRA hazardous waste code designation they would have had if they were not subject to the XL001 designation (i.e., F006 and any other appropriate waste codes). USFRS will ensure that this hazardous waste is legitimately recycled through metal recovery.

USFRS has stated that the present RCRA regulatory structure may act as a disincentive for certain manufacturers to use the ion exchange resin process. This in turn may act as a disincentive for them to reduce the amount of metals being discharged to a water body; to increase the recycling of metals from electroplating processes and reduce the consumption of potable water.

Electroplaters, metal finishers and other similar industries use large volumes of water to wash and rinse materials during the manufacturing process. In most manufacturing processes today, wash and rinse water is used once, then discarded. This “single-use” waste water is usually directed to an on-site waste water treatment plant where it is treated to levels required by the Clean Water Act prior to discharge to a POTW or surface waters. This single-use of water is very wasteful. A great amount of effort and cost is expended to produce potable water for this single use. Additional costs are incurred in treating these waste waters prior to discharge.

To minimize single water use and to encourage recycling of rinse waters, USFRS has developed an ion exchange resin treatment process (“resin process”). The resin process consists of three separate but integrally linked components—pre-filter, resin filter and post-filter components. The manufacturing waste waters are directed to the pre-filter components first. The pre-filter components consist of a polypropylene wound particle cartridge(s) contained in a plastic container. The pre-filters collect a certain size particulate from the waste water. They are essential to the proper operation of the resin filter since they collect particles which may plug or foul the resin filter. The pre-filters collect particles which contain metals such as copper, zinc, chrome and nickel from the manufacturing waste waters. The waste waters are directed from the pre-filters by hose to the resin filters. The resin filter consists of a cylindrical canister which contains the ion exchange resin. The waste waters are directed to the resins which further collect metals onto themselves. After treatment in the resin canisters the waste waters are directed to the post-filters via hose. The post-filters also consist of a polypropylene wound particle cartridge(s) contained within a plastic canister. The post-filters function as a final polishing step and fail-safe mechanism should the ion exchange resin leak from the resin canister. The waste waters entering the post-filter container(s) generally meet final discharge limits under the Clean Water Act. The water that exits the post-filters (“regenerated water”) can then be discharged to the local publicly owned treatment works (POTW) or directed back to the manufacturing process and reused. If the regenerated water is directed back to the manufacturing process this would reduce the amount of potable water that is needed in the manufacturing process.

The use of water reuse systems such as USFRS's ion exchange system by electroplaters, metal finishers and similar industries often results in the resins, filters, canisters and associated containers being considered a listed hazardous waste (F006) once the resins and filters have been spent at the manufacturing plant. However, these resins and the canisters can be regenerated at USFRS' Roseville, Minnesota facility. This regeneration process produces a regenerated resin and residual wastes containing metals, such as copper, nickel and zinc (“sludges”). The regenerated resin may be reused again in other water treatment systems. The residual wastes from USFRS's regeneration process along with the pre- and post-filters may be recycled to recover the metals contained within them. However, since the resins, filters, canisters and associated containers may be a RCRA hazardous waste, the manufacturer incurs additional obligations under RCRA that it would not necessarily incur if it had not implemented the water reuse system. The additional regulatory obligations may act as a disincentive to a company's use of a water reuse system and thus increases the use of potable water.

USFRS suggested that the use of its water reuse system would lower the amount of metals ultimately discharged to a local water body. Collecting and recycling of sludges and filters will result in less wastes being land filled. Furthermore, USFRS suggests that the metals that are recovered may reduce the energy and environmental impacts from mining and manufacturing of virgin ores.

To encourage water and waste reduction and increased recycling new subpart O will temporarily defer from the RCRA regulatory requirements contained in 40 CFR parts 261-265, 268, 270, 273 and 279 the resins, filters, resin canisters and filter containers used in the USFRS ion exchange resin treatment process. This temporary deferral will be implemented through a new waste code designation which will be used while the waste is at the approved generator and during its transport to USFRS. This deferral is premised on the fulfillment of five general requirements. First, the generator would handle the waste in accordance with specific standards required by the new rule. Second, the waste is transported only to USFRS' Roseville, Minnesota facility and only by approved transporters. Third, the generators and transporters are limited to companies located in Minnesota who pass a preliminary evaluation by USFRS and are approved by EPA, MPCA and the appropriate county agencies. Fourth, USFRS handles the waste according to the waste code designation it would have had but for the temporary deferral contained in the new rule (i.e., F006 and any other appropriate waste code). Finally, USFRS will recycle, through metals recovery, any metals contained in these wastes. Presented in Section IV below is a more detailed discussion of these elements of the new rule and final FPA.

Nine public meetings were held to inform the general public and environmental groups about the project and to invite their comments and participation. EPA solicited comments on the draft FPA and proposed rule on August 17, 2000 and made them both available on its web page and in dockets established in Washington, D.C. and Chicago, Illinois.

USFRS may hold additional public meetings during implementation of the FPA based on public interest or as decided by direct participants. Stakeholder input and community goals have been and will continue to be considered throughout project implementation. USFRS shall report on a quarterly basis efforts to maintain stakeholder involvement and public access to information in accordance with the requirements of the new subpart O.

EPA believes that this project has the potential for cost savings by making recycling of water and waste more cost competitive with traditional treatment/disposal options. Costs savings may include those associated with: purchase of additional potable water for single use; capital and operating costs to treat mildly contaminated waste waters so that they meet pretreatment standards prior to discharge; discharge fees associates with wastewater discharge (including permits, monitoring and sewer access charges); transport and disposal of hazardous waste sludges; and taxes paid to local authorities. 4 A cost comparison will be conducted during project implementation to evaluate the cost savings. EPA believes that the paperwork burden for the generator will be reduced as compared to current RCRA requirements. USFRS will be required to retain and submit certain reports which RCRA would normally require of its customers, and report ongoing environmental performance and success in meeting its targets. For further information about the impacts of this rule on paperwork reduction, please see section VI.E.

EPA will ensure the integrity of this project through the regulations that it is finalizing today, its prior approval of the generators and transporters, its normal enforcement and oversight authority and coordination and cooperation with the State of Minnesota and appropriate county agencies.

The final rules will be the primary vehicle EPA will use to ensure that USFRS and all generators or transporters of USFRS XL waste handle the USFRS XL wastes in a manner which is acceptable to EPA.

All XL projects must include a legally enforceable mechanism to ensure accountability and superior environmental performance. EPA retains its full range of enforcement options under the final rules. Thus, once there is a federally enforceable mechanism in place, if EPA determines that a company is not in compliance with it then EPA and, under certain conditions, private citizens may take enforcement action against that company and may terminate that person's continued participation in the project (section 3005(d), 3006(d) and 3008(a) of RCRA).

In addition to its enforcement options EPA retains its option to terminate a company's continued participation in this XL Project. In the event EPA terminates a person's continued participation in this XL Project, EPA will use the criteria and procedures identified in the final rules, not those contained in Minnesota's rules, statutes, permits or other implementing mechanisms. 5 (See proposed § 266.414-418).

The enforcement response on the part of EPA will depend upon the actual performance of each generator, transporter and USFRS, the mechanism the State uses to implement this XL Project and the severity of any violation.

EPA will enforce the existing Minnesota hazardous waste management regulations which are part of the Minnesota authorized hazardous waste program. The flexibility proposed in the final rule will not be available to USFRS, its generators and transporters until the State of Minnesota adopts equivalent flexibility which is federally applicable and enforceable. The instrument selected for the State's implementation of this XL Project must be one that is clearly federally enforceable.

Once all of the required federal and state legal authorities are in place, EPA will retain a role in evaluating this XL Project, USFRS and each generator and transporter. EPA will evaluate each generator and transporter prior to it being accepted into the program. Additionally, once this XL Project is effective EPA may routinely inspect any of the participants to determine their compliance. If EPA determines that a participant has violated a particular provision of the rules, then that participant may be subject to civil or criminal penalties pursuant to section 3008 of RCRA. Furthermore, EPA may terminate that company's continued participation in this XL Project.

In the event of a termination, the participant must remove the USFRS XL waste, take appropriate steps to decontaminate and return to compliance with RCRA. 6 The new rules specify a time period for accomplishing this. USFRS XL waste transporters will have 30 days after receipt of EPA's notice of termination to complete the termination procedures required by the new rules and return to compliance with RCRA. USFRS XL waste generators will have 60 days and USFRS will have 120 days. During the 30, 60 and 120 transition periods, the provisions of new subpart O would continue to apply in full. At the conclusion of the transition periods, the applicable RCRA regulations would again apply to the participant.

The rationale for the transition period is to allow sufficient time for the participant to reinstate the operational and administrative infrastructure necessary for proper RCRA compliance. EPA selected different time frames for the transporters, generators and USFRS based on the complexity of the activities they may have to engage in to return to compliance with RCRA. The preamble to the August 17, 2000 Federal Register explained the rationale for the various time frames.

As with all XL projects testing alternative environmental protection strategies, the term of this XL Project is one of limited duration. Today's rules would set the term of the XL Project at five years after the date that Minnesota modifies USFRS' RCRA permit to incorporate the requirements imposed on USFRS under new subpart O.

Because Project XL is a voluntary and experimental program, today's rule contains provisions that allow the project to conclude prior to the end of the five years in the event that it is desirable or necessary to do so. For example, an early conclusion would be warranted if the project's environmental benefits do not meet the Project XL requirement for the achievement of superior environmental results. In addition, new laws or regulations may become applicable to the wastes during the project term which might render the project impractical, or might contain regulatory requirements that supersede the superior environmental benefits that are being achieved under this XL Project. Similarly, the participants may also ask to discontinue participation in this XL Project prior to the five years if the experimental project does not provide sufficient benefits for them to justify continued participation.

A definition of “USFRS XL waste” is contained in new 40 CFR 266.401. Based on its review of the public comments EPA has modified the definition contained in the proposed rule in two ways. First, EPA has included within the definition of USFRS XL waste, and thus in this XL Project, the USFRS pre- and post-filters and their containers used as part of the ion exchange resin process. Second, EPA has eliminated the requirement that the treated waste waters must be reused in the manufacturing process. EPA discusses the rationale for these changes and their anticipated impact on the project's environmental performance in section V below.

“USFRS XL waste” will consist of the USFRS used water treatment resin canisters, the USFRS required pre- and post-resin filters and their containers and the contents of the canisters and filter containers. It is limited to approved USFRS generators located within the State of Minnesota. The USFRS XL wastes are limited to wastes which result from processes which would be subject to the RCRA F006 hazardous waste designation at the point of generation (i.e. waste water treatment sludges from specified electroplating operations). These wastes may also exhibit a characteristic of hazardous waste as a result of the operations of a particular company. Spills of USFRS XL wastes by the generator or transporter are considered USFRS XL waste provided the generator or transporter handles the spill in accordance with the spill requirements of proposed 40 CFR 266.408(e) and 266.411. This definition does not include wastes that were generated prior to the date a generator is added to this USFRS XL Project. The definition states that USFRS XL waste while at an approved generator and during transport will be identified by the waste code XL001. It further states that the XL001 waste designation applies only to USFRS XL wastes generated by approved USFRS XL waste generators.

Section 266.400 contains a definition for an “approved USFRS XL waste generator.” It is a company located in Minnesota who: has properly identified its wastes and processes; has passed a preliminary evaluation by USFRS; has not been excluded by EPA, MPCA and appropriate county agencies; has received notice of approval from USFRS; and has signed the FPA, and a certification that it has taken and understood the specific training required by subpart O.

Section 266.400 contains definitions for other terms used in subpart O, such as County Environmental Agencies, USFRS, USFRS XL waste application form, USFRS XL waste approved customer, USFRS waste approved transporter, USFRS XL waste facility, USFRS XL waste final project agreement, USFRS XL waste generator, USFRS XL waste project, USFRS XL waste training module, USFRS XL waste transportation tracking document and USFRS XL waste transporter. Except as noted in section V below, EPA has not changed these definitions from those it proposed on August 17, 2000.

Pursuant to § 266.406, prior to being accepted into this XL Project, the customer/potential generator company will properly identify its processes and chemicals contributing to the water proposed for treatment in the USFRS ion exchange resin treatment process. It may only identify those waste streams which meet the F006 listing. The company will complete and submit the USFRS XL waste application form to USFRS. After being accepted into this XL Project, the company shall provide USFRS with prior notification of any changes in its processes.

USFRS will perform a chemical profile analysis, of the company's waste stream(s) and processes contributing to the water treated within the ion exchange resin treatment process. USFRS will conduct this analysis in accordance with the test methods identified in its waste analysis plan contained in its RCRA hazardous waste permit. This waste stream analysis will substitute for an analysis of the resins and filters after use in their canisters and containers. The analysis will also ensure that the waste waters are compatible with the ion exchange resin process and that the wastes are compatible with maintaining the integrity of the canisters and containers. USFRS will conduct the waste stream analysis once for each company prior to accepting it into this XL Project. Once a company is accepted into the USFRS XL Project, USFRS will repeat the analysis whenever a company provides it with notice that it has changed its processes contributing to the USFRS XL waste.

The USFRS XL waste designation will only apply to those water treatment resin canisters, the pre- and post-resin filter containers and their contents for processes identified by the customer, evaluated by USFRS and approved by EPA, MPCA and appropriate county agencies.

The new rules relieve the approved generators and transporters from the RCRA requirements of submitting an EPA hazardous waste notification form and obtaining an EPA identification number. In lieu of these RCRA requirements USFRS and its generators and transporters will follow the notification requirements and processes contained new §§ 266.402, 403 and 406. The procedures for adding generators and transporters to this XL Project are contained in new §§ 266.402 and 266.403. Section 266.406 requires the generators to use and complete the USFRS XL waste application form. Additionally, it requires USFRS to assign a unique customer and process waste stream number to each approved generator and waste stream. The USFRS XL waste application form will contain information similar to that required on the EPA Hazardous Waste Notification Form, except that it will identify the wastes by the “XL001” designation in addition to the EPA waste codes.

Section 266.406 requires USFRS to assign to each approved generator a unique client number. The generator will use this number whenever it generates and transports off-site USFRS XL waste. USFRS will also assign to each approved waste stream from the generator a unique number known as a waste profile number.

Pursuant to new proposed § 266.419(c), USFRS will maintain a list of the approved customers and generators. 7 USFRS will include on that list the customer name, the USFRS client and waste profile numbers, a summary of the results of the USFRS profile analysis and the process waste streams approved for participation in the XL Project. USFRS will have that list available at its Roseville, Minnesota facility and will provide that list to EPA and MPCA on a quarterly basis. 8 If any of the customer information is claimed as confidential business information or trade secrets USFRS will indicate that fact and notify EPA and MPCA. EPA will treat such material in accordance with 40 CFR part 2.

The new rules ensure that USFRS XL waste reaches its destination by applying strict transportation routing and tracking requirements on the transportation of USFRS XL waste from the time it leaves the generator to the time it is received by USFRS. Subpart O accomplishes this by directly imposing these requirements on USFRS and its generators and transporters (proposed § 266.410). The requirements are summarized below.

USFRS will control the transportation and routing of the USFRS XL wastes from a generator and its transporters. All USFRS XL waste generators must use a USFRS XL waste approved transporter to transport the USFRS XL waste. The USFRS XL waste must be sent to USFRS' Roseville, Minnesota facility. The generator must contact USFRS when it wants to transport its USFRS XL waste. USFRS' Roseville facility has a dedicated shipping department. That department will arrange with a USFRS XL waste approved transporter to pick-up the generator's USFRS XL waste within the 90 days the generator is allowed to store the waste on site. 9 USFRS' shipping department will complete the USFRS Transportation Tracking Document and provide it to the generator with a copy to USFRS' lab analysis. USFRS will include on the Transportation Tracking Document information required by these new rules. USFRS will provide the generator with the Transportation Tracking Document by the time the transporter arrives at the generator's site to pick up the waste. 10

USFRS's transporters must pick-up the USFRS XL waste at the generator within the 90 days the generator is allowed to store the waste on-site. The transporters are required to transport the USFRS XL waste to USFRS' Roseville, Minnesota facility within 30 days of picking up the waste at the generator. A USFRS transporter may store or arrange to store a shipment of USFRS XL waste during that 30 day period, provided however, it may only do so for a 10 day or less period without triggering the facility requirements in sections 264, 265, 268 and 270 of RCRA. This 10 day limitation on the storage of USFRS XL waste by the transporter mirrors the limitations on storage by transfer facilities contained in section 263.12.

If the shipment is not received by USFRS within 30 days of the USFRS transporter picking it up at the USFRS generator, USFRS will contact the transporter to determine the disposition of the load. If USFRS does not receive the shipment within 5 days of its scheduled arrival date, it will notify EPA, MPCA and appropriate county agencies. USFRS will send a copy of the Transportation Tracking Document to the USFRS generator within 10 days of USFRS' receipt of the XL001 waste from the transporter. 11

USFRS will use its own trucks or those of approved transporters to transport USFRS XL waste to USFRS's Roseville facility. USFRS may use any transporter provided it conducts a preliminary evaluation of the transporter; the transporter has a current satisfactory safety rating from USDOT; the transporter has been approved by EPA, MPCA, and, as appropriate the County Agencies; it has completed the USFRS XL waste training; and it has signed the FPA. New § 266.403 requires USFRS to include in its preliminary evaluation information on the current USDOT safety rating for the transporter, its EPA identification number and the status of its Minnesota registration to transport hazardous waste. USFRS will assign to each approved transporter a unique USFRS client identification number. This number will be used on the Transportation Tracking Document.

In lieu of the manifest, the new rules require USFRS, its transporters and generators to use the USFRS Transportation Tracking Document when transporting the USFRS XL waste from the generator to USFRS's Roseville facility. New rule § 266.410 and the definition of the USFRS XL Waste Transportation Tracking Document contained in proposed § 266.401 requires that USFRS obtain EPA approval of the Transportation Tracking Document prior to using the Transportation Tracking Document and whenever it proposes to revise it. With this rule EPA approves of the Transportation Tracking Document provided by USFRS and included in the docket for this rule. Pursuant to proposed §§ 266.419(d), 420 and 421 USFRS, the transporter and the generator(s) will retain a copy of the Transportation Tracking Document for three years for each shipment of XL wastes that is shipped off-site to the Roseville, Minnesota facility.

Section 266.410(a), requires USFRS, not the generator, to complete and submit any exception reports. USFRS will use a shorter time period—five days—to gauge whether it is necessary to take further steps to locate a shipment. If USFRS is unable to locate the shipment within five days it will then notify EPA, MPCA and appropriate county agencies of that fact.

The new rules specify that only USFRS or an approved USFRS transporter will transport the USFRS XL wastes from the generator to the USFRS Roseville, Minnesota facility. 12 USFRS has an EPA identification number and a hazardous waste permit. USFRS approved transporters will have a current satisfactory safety rating from USDOT and a unique USFRS customer identification. All transporters will use the USFRS Transportation Tracking Document when transporting USFRS XL waste. Pursuant to §§ 266.408(c) and 409 the transporters and generators will ensure the USFRS XL wastes have affixed to the ion exchange resin canisters and the filter containers the following warning statement which will be provided by USFRS:

The accumulation and storage requirements are contained in § 266.408. The new rule requires the generator to store its USFRS XL waste on an impervious surface. Pursuant to § 266.402(c), prior to accepting a customer into this XL Project, USFRS will obtain from its customers the waste application form. This form will provide information on the location and condition of the proposed storage area. This information will be supplied on a site engineering form which USFRS developed and submitted as part of the waste application form. The generator will indicate on the site engineering form the location and construction of the storage area for the USFRS XL waste. Prior to accepting a generator into this XL Project, USFRS will review the site engineering form and inspect the company's storage area to determine if it is impervious. USFRS will only propose to EPA for this XL Project persons who, among other things, have an impervious storage area. Upon request, USFRS will provide a copy of the customer's site engineering form and the results of USFRS' evaluation of the customer to EPA, MPCA and appropriate county agencies.

The rule limits the generator to 90 days for the on-site storage of its USFRS XL waste. The generator must store the USFRS XL wastes in the water treatment resin canisters and filter containers and must store them separately from its other wastes or materials, including explosive or ignitable wastes or materials. The generator will ensure that the canisters and containers are closed and disconnected from the manufacturing process(es). It will place on the resin canisters and filter containers a label which indicates the company's name, location, contents of the resin canister and filter container and the date they were placed in storage. The generator will ensure that there is adequate aisle space to determine the condition of the canisters and containers and to respond to any leaks from them during their storage. The generator will inspect the condition of the canisters or containers weekly while they are stored on-site. The generator will maintain a log of these inspections. The log will indicate the date the canister and containers were placed in storage, the condition of the canisters and containers, the date of the inspection, the person conducting the inspection and the condition of the canisters and containers and the storage area at the time of the inspection.

Pursuant to § 266.413, the generator will retain the ability to legally treat or dispose of its wastes contributing to its USFRS XL waste stream in the event that it is no longer a participant in this XL Project. In most cases this will mean that the generator would have to make arrangements with its local POTW whereby the POTW would agree to take the generators' wastewater on 60 days notice. The POTW serving the Counties of Anoka, Hennepin, Ramsey, Washington, Dakota, Carver and Scott, known as the Metropolitan Council of Environmental Services (MCES) has advised EPA that it will be able to accept the wastewater of those generators who participate in this XL Project in its district on 60 days notice.

Generators will comply with tailored closure requirements contained in § 266.412. If and when a generator's participation is terminated in this XL Project, USFRS will pick up all of the generator's canisters and containers. Generally, § 266.415 provides USFRS and the generator sixty days to complete the closure activities required by proposed § 266.412. USFRS will collect the generator's USFRS XL waste within thirty days of notice of the company's termination in the program. The generator will remove from the storage area any USFRS XL wastes and clean any related contamination. The generator will retain records of all activities it has undertaken to decontaminate its storage area and equipment.

Within the same sixty days, the generator will provide USFRS with access to visit the generator. The purpose of this access is to allow USFRS to determine if all of the USFRS XL waste has been removed. USFRS has developed a systems discontinuation form that it will use to document its visual observations during this visit. Pursuant to § 266.412(b) USFRS will provide a summary of its observations at the generator of the condition of the storage area and the removal of all USFRS XL Waste. USFRS may use its systems discontinuation form. USFRS will provide the summary to the customer to EPA, MPCA and appropriate county agencies. Pursuant to §§ 266.419(d) and 266.420 USFRS and the USFRS XL waste generator will maintain records of their compliance with the requirements of § 266.412, including a copy of the systems discontinuation form or its EPA approved equivalent summary.

Abbreviated closure requirements are specified in § 266.414 for those companies who have not generated USFRS XL wastes at the time their participation is terminated. All that is required of these companies is that notice of their termination is provided and that they implement the alternative treatment or disposal required by § 266.413. This truncated closure is appropriate for these companies (i.e., USFRS XL waste approved customers) because at the time of their termination they will not have generated any USFRS XL waste. Consequently, the requirements related to decontamination and off-site shipment contained in § 266.412 are not appropriate.

Section 266.408(e) specifies the generator's responsibilities for spilled or leaked USFRS XL waste on-site. If there is a leak or spill of USFRS XL waste in the generator's storage area, then the generator will immediately contain and collect the wastes. It is anticipated that the spilled or leaked materials may consist of water and/or resins. The generator will place spilled or leaked resins in a polycontainer of sufficient size to contain the spilled or leaked resins. 14 When allowed by the local POTW, the generator will direct water spilled from the canisters or filters to its drainage system for permitted discharge to the local POTW, and notify the POTW. Otherwise, the generator will place the spilled or leaked water and resin from the canister(s) in a polycontainer of sufficient size to contain the spilled or leaked water and resin. The generator will store and label the spilled or leaked USFRS XL wastes in accordance with the requirements for USFRS XL wastes. The generator will notify USFRS and MPCA of the spill or leak and arrange with USFRS for the transport of any such spilled or leaked USFRS XL wastes with the next scheduled shipment of USFRS XL wastes.

This XL Project and the new rule do not impose on the generator a requirement for an internal communication device. It eliminates the need for fire extinguishers, water or foam. It also eliminates the need for a written contingency plan and an emergency coordinator at the generator. Instead, § 266.408(i) requires the generator to have an external communication device, such as a telephone. It also requires in §§ 266.408(a) and (b) that the generator store the wastes in a manner which should all but eliminate the potential for a release to the environment or an emergency. In particular, it requires the generator to segregate the USFRS XL wastes from other wastes and to store it on an impervious surface. Section 266.408(d) and (e) require the generator to inspect the storage area on a weekly basis and to immediately respond to spills or leaks of the USFRS XL waste.

Prior to generating any USFRS XL waste, pursuant to § 266.408(h), the generator must designate a contact person responsible for handling the USFRS XL wastes and responding to any releases of the wastes. It also requires USFRS to provide that person with adequate training on how to handle the USFRS XL waste and any releases. USFRS is required to provide each company (generators and transporters) with adequate training through the use of a training module (“USFRS training module”). USFRS may use any recorded communication media that it believes is appropriate for the training module (e.g., printed brochures, videos, etc.) Pursuant to proposed § 266.404 USFRS will submit this training module to EPA, MPCA and the appropriate county agency early enough such that it may obtain the necessary approvals prior to accepting the first shipment of USFRS XL waste. Further, pursuant to the new rule, the USFRS training module will, at a minimum, identify the hazards presented by the USFRS XL waste, the steps needed to install and replace the ion exchange resin canisters and filter containers, the requirements imposed by these rules, the procedures to follow in the event of a release of the USFRS XL wastes and the proper procedures to decontaminate equipment, structures and material in the event that the generator no longer participates in the XL Project. Prior to approving a person as a participant into the USFRS XL Project, USFRS will obtain a signed certification from that person. The certification will state that the person has reviewed, viewed or read the training materials and agrees to follow it. As part of this certification the potential generator will identify the individual responsible for its compliance with the conditions of these rules, the individual's job title and a description of his or her duties.

Pursuant to new § 266.405, USFRS will provide every potential generator with a material safety data sheet (“USFRS XL waste MSDS”) for the USFRS XL waste. USFRS will provide this at the time the company applies to USFRS for participation in this XL Project. The USFRS XL waste MSDS will provide sufficient information for a person to respond safely to a spill or release of USFRS XL waste. 15 Pursuant to § 266.408(h) the generator will maintain and exhibit in a prominent location a copy of the USFRS XL waste MSDS on its property and will provide a copy of it to local police and fire departments and to the local hospital. USFRS will ensure that the USFRS XL waste MSDS prominently instructs individuals in the proper emergency response procedures for handling spills or leaks of the USFRS XL wastes at the generator or while in transit to USFRS. The USFRS XL waste MSDS will also accompany each shipment of USFRS XL wastes.

If an imminent or actual emergency occurs which threatens the release of USFRS XL waste at the generator site, then the generator will notify the EPA, MPCA, USFRS and the appropriate local emergency responders and county agencies. The generator will take actions to ensure the releases do not occur, recur or spread; contact USFRS to arrange for the transport and disposal of the USFRS XL wastes; and make a written recording of the event and its actions in response to such event.

Sections 266.419, 420 and 421 present the recordkeeping and reporting requirements for USFRS, the generators and transporters. Pursuant to these rules, the generator will not be required to retain copies of the waste analysis or annual reports. Instead the burden will shift to USFRS to retain equivalent information to that contained within these reports. In particular, USFRS will retain for three years a copy of all approval letters to its approved customers and generators of USFRS XL wastes; any correspondence with its approved customers or generators relevant to their participation in this XL Project; a copy of the approved customer's and generator's XL Waste application form, site engineering form, summary of its generator closure review pursuant to § 266.412; waste analysis; its analyses of the approved customer's or generator's storage area; and the Transportation Tracking Document for each shipment of USFRS XL waste.

Each generator will be required to retain for three years records of any spill or emergency notifications and other duties imposed pursuant to § 266.408(e); the signed FPA and its certification; its weekly inspection log required by § 266.408(d); its compliance with the training requirements of § 266.408(h); a copy of the signed Transportation Tracking Document for USFRS XL wastes it generated; and its records of compliance with the decontamination requirements of § 266.412.

Each transporter will retain for three years a copy of the USFRS XL Waste FPA and its certification; a copy of the signed Transportation Tracking Document for USFRS XL waste it transported; and its record of any notification of spills or leaks of USFRS XL wastes required by § 266.411.

In addition to the records listed above, USFRS will develop and submit certain additional reports, lists and documents. Many of these reports and documents are in lieu of requiring the same or similar information from its generators (e.g., annual reports or contingency plan). The reporting requirements are presented in § 266.419 according to their frequency: annual reports (§ 266.419(a)), semi-annual reports (§ 266.419(b)) and quarterly reports (§ 266.419(c)). A summary of each report is presented below.

Quarterly reports are presented in § 266.419(c) and consist of status reports on generator and transporter participation in the XL Project. Separate lists, with similar information, will be reported for each. The generator list is summarized in this paragraph. USFRS will identify on the XL participant list information on its preliminary evaluation of the transporters and generators, the dates of EPA, MPCA and appropriate county approvals, the effective date of a company being added to the USFRS XL Project and any termination date. For the generators, USFRS will also include a summary of USFRS's profile analysis, the generator's process waste streams approved for participation in the XL Project and the condition of the customer's storage area at the time of its application to USFRS. For generators who discontinue participation in this XL Project, USFRS will include on the XL generator list the date of the notice of termination of its participation, the date USFRS removed the last ion exchange canister and filter container, and the date of the USFRS review of the generator's decontamination efforts. USFRS will update the XL participant list as persons are added to or eliminated from this XL Project. USFRS will have the XL generator list available for review by EPA or MPCA at its Roseville, Minnesota facility. USFRS will send a copy of the XL generator list to EPA, MPCA and appropriate county agencies on a quarterly basis.

The annual report requirements are presented in § 266.419(a) and are intended to provide a substitute for the hazardous waste biennial report. USFRS will provide an annual report on all USFRS XL wastes. USFRS will include in the annual report, at a minimum, each USFRS XL waste generator, the quantity of USFRS XL waste that USFRS received from each generator during the calendar year and a certification by USFRS that those wastes were treated at USFRS in accordance with the requirements imposed by new part 266, subpart O. USFRS will include information on the amount of metals it reclaimed and recycled from the resins.

USFRS will develop and track certain information that will be used to determine the environmental benefits derived from the USFRS XL Project. From the generators USFRS will report on an annual basis the following information: the amount of water recycled by the generators, the pretreatment chemicals and energy the generators did not use as a result of participating in this USFRS XL Project, the amount of water discharged to the local POTW before and during this project, the amount of sludge recovered by USFRS before and during this project, the amount of sludge recovered instead of being disposed by a generator (if the generator disposed of the sludge prior to participating in this project), the quantity of material (ion exchange resins, filters, other wastewater treatment sludge, residues) collected from each facility (monthly), the frequency of canister and container replacement in terms of process volume, the constituents in the material (ion exchange resins, filters, wastewater treatment sludge, residues) collected at each facility (e.g., recoverable metals, contaminants/non-recoverable materials), and constituents in the material (ion exchange resins, filters, wastewater treatment sludge, residues) disposed by each facility (e.g., contaminants/non-recoverable material).

USFRS will report on an annual basis the following information from its facility: quantity of material (ion exchange resins, filter media, wastewater treatment sludge, residues) to be processed, quantity of metals recovered, the constituents of the recovered material (ion exchange resins, filter media, wastewater treatment sludge, residues), quantity and constituents of the non-recoverable material (ion exchange resins, filter media, wastewater treatment sludge, residues) and how it was disposed.

USFRS shall report on an annual basis the following information from the metal reclamation facility it uses to recycle sludges: the quantity of each metal recovered.

Pursuant to § 266.419(b), USFRS will collect and report on a semi-annual basis financial information related to the costs and savings realized as a result of implementation of this project and sufficient information for EPA to determine the amount of superior environmental benefit resulting from this project. Pursuant to § 266.419(b)(1), the report will contain information which includes, but is not limited to: 1. The volume of waste collected and recycled, 2. The amount of metals recycled, 3. The volume of recycled material sold to others, 4. Data regarding the management of the ion exchange canisters and filter containers, 5. The constituents of the sludge and 6. Information regarding how the sludge and residues are managed.

Additionally, § 266.419(b)(2) requires USFRS to report certain financial information related to implementation of this XL Project. It specifies that USFRS will collect baseline and XL costs. The baseline costs shall be calculated using two scenarios: (1) Typical charges (prior to the XL Project) for pretreating and disposing effluent wastewater under the applicable Clean Water Act requirements and the costs for manifesting, transporting and disposing of F006 sludges; and (2) typical charges that would be incurred if wastes were recycled in compliance with RCRA and requirements for manifesting and transporting those hazardous wastes (including tax obligations under both scenarios). The XL costs will include the current costs to the generator for completing transportation tracking documents, the current transportation costs for XL wastes, the generator's cost to install the ion exchange resin process, and the cost to USFRS of metals reclamation off-site (including costs associated with transportation and disposal). USFRS will compare the baseline costs to the XL costs and provide an analysis of whether the project is resulting in cost savings for the generators and which aspects of the XL Project produce these savings.

USFRS has a RCRA permit which allows it to receive the USFRS XL wastes. Pursuant to § 266.407 once USFRS receives the USFRS XL waste at its Roseville, Minnesota facility, the waste will lose its USFRS XL waste designation (XL001) and must be handled as a fully regulated hazardous waste (i.e, as F006 and any other applicable hazardous waste code designation). USFRS will determine the appropriate designation of the waste based on its waste profile analysis and knowledge of the waste stream. USFRS will comply with all terms and conditions of its RCRA permit for handling these hazardous wastes. USFRS will also be responsible for the conditions and terms identified in items A-F above as applicable to USFRS—e.g., waste profiling, use of the Transportation Tracking Document, generator annual report, training module, MSDS, discontinuation review of the customer, and transportation of waste to the Roseville, Minnesota facility. USFRS will arrange for the recycling through metals recovery of the metals which are contained in the generator's USFRS XL wastes. Pursuant to § 266.407(b) USFRS may not accept any customers into this Project unless and until it has arranged for recycling of the metals contained in the XL001 wastes it receives. This rule further requires USFRS to recycle the metals contained in the XL001 waste it receives throughout the duration of the XL Project.

To ensure proper coordination of responses to spills, leaks or emergencies of USFRS XL waste at the generator or while in transit, § 266.407(c) requires USFRS to have a spill response coordinator. This person will receive all calls from generators and transporters regarding spills, leaks or emergencies related to the USFRS XL wastes. This person shall also be responsible for coordinating the proper response to such spills, leaks or emergencies.

During the comment period provided for the proposed rule EPA received comments from USFRS, the State of Minnesota and a citizen representing an unidentified third party. A summary of the comments, EPA's responses and any changes from the proposed rule is contained within this section.

Comment. USFRS requested EPA to include “pre” and “post” filters as part of the XL project. USFRS pointed out that the pre and post filters are an integral part of the ion exchange filter process which is the subject of the USFRS XL project. USFRS will handle these filters in the same manner that it does the ion exchange resin canisters. Namely, it will collect them from the generators and send them to a third party for recovery of the metals along with the sludges in the resin canisters. If the pre and post filters, however, are not included as part of the USFRS XL project they would be considered F006 hazardous waste. A project participant thus would be subject to the USFRS XL project requirement for the ion exchange resin canisters and the RCRA hazardous waste requirements for the pre and post filters. This dual system would discourage generators from participating and thus would reduce the environmental benefits anticipated from this project.

Response. EPA agrees that the pre and post filters should be included as part of this XL project and subject to the same management standards as the ion exchange resin canisters. Consequently, EPA will modify the definition of USFRS XL waste contained in § 266.401.

According to USFRS the ion exchange treatment system consists of three components: (1) filtration of the waste water prior to ion exchange resin treatment (“pre-filter” phase); (2) the ion exchange resin treatment; and (3) filtration of the waste water after it exits the ion exchange resin treatment (“post-filter” phase). The pre and post filters consist of polypropylene wound particle cartridges contained in plastic canisters. The canisters are connected directly by hose to the ion exchange resin canisters. The pre-filters collect a certain size particulate in the waste water prior to it being introduced to the ion exchange resin canister for treatment. The pre-filters are essential to ensuring that the ion exchange resin canister are not plugged or fouled. According to USFRS, without the pre-filter the ion exchange resin canisters will not work as effectively. The post-filters receive the waste waters after they have been treated by the ion exchange resin canisters and prior to discharge or re-use of the treated waste water. According to USFRS, the post-filters will not usually receive as much or as large a particulate size as the pre-filters. They are used for final polishing and as a fail-safe mechanism should there be a leak of the treatment resins from the ion exchange resin canisters. The pre-filters will usually collect metals such as copper, nickel, zinc and chrome. The post-filters may collect some of these same metals but after the waste water has been treated to levels which would meet the water treatment discharge levels for these contaminants. Both filters would be considered F006 hazardous waste by operation of the RCRA derived from rule, regardless of the concentration of the metals, since the waste waters are electroplating waste waters.

Neither the proposed rule nor the preamble to it mentions the pre and post filters. EPA was not aware of their existence and function in the ion exchange treatment system until USFRS raised the issue in its comments. Including these filters within the scope of this project is consistent with the goals of the USFRS XL Project. The preamble to the proposed rule stated that the primary purpose of the USFRS XL Project was to encourage the use of the ion exchange resin treatment system. USFRS suggested that if more companies used this system then there would be an increase in the recycling of the sludges which resulted from the process; a reduction in the use of potable water; and a reduction in the energy associated with the use of potable water in the production process. USFRS stated that generators were reluctant to use the ion exchange resin process because of the stigma and costs associated with the resins being identified as a RCRA hazardous waste. The resins would be considered an F006 hazardous waste by virtue of the electroplating process waste waters which came in contact with them. To reduce the stigma and the costs EPA proposed to identify the ion exchange resin canisters with a unique hazardous waste code (XL001) and to subject them to special management standards contained in new subpart O to part 266.

EPA agrees that if the pre and post filters were not included as part of this XL Project then they would be properly characterized as F006 hazardous waste by virtue of the “derived from rule.” The major contaminants on the filters and resin canisters are essentially the same—metals from electroplating waste waters. Regardless of whether they are identified as F006 or XL001 wastes the ion exchange resin canisters and pre and post filters would be subject to the same final disposition—metals recovery—under the USFRS XL Project. However, without making the change requested this would not occur. Additionally, there would be two separate management systems with some incompatibility between them. For example, if the pre and post filters are treated as F006 waste the generator will have to use the uniform hazardous waste manifest; can use any transporter; can arrange for the disposal of the filters at any hazardous waste facility and depending on the volume of wastes it generates can store the filters up to 270 days. The same generator, however, under new subpart O would not be required to use the manifest for the ion exchange resin canisters but would have to use an approved transporter; would have to send the resin canisters to USFRS where USFRS would arrange for metals recovery; and would be limited to a 90 day storage time limit, regardless of the volume of wastes generated by the generator. Such a dual management system can work. However, if USFRS is correct (i.e., that it will act as a disincentive to certain generators) it may be counterproductive to the purpose and goal of this XL project. Conversely, it may be better to subject the filters to the special management standards of new subpart O because it requires metals recovery and for some generators, may place a shorter time period for the on-site storage of the filters. To the extent that it is administratively easier for a generator to have the same management system and requirements for essentially the same wastes it may result in more participants in this XL project. With more participants EPA would expect greater metal recovery amounts and greater reductions in the use of potable water and energy. For all of these reasons EPA believes that it is appropriate and may enhance the success of the USFRS XL project to include the pre and post filters in this XL Project. EPA believes it can do this by revising the definition of USFRS XL001 waste to include the pre-and post-filters and their containers. EPA will revise this definition accordingly and will make conforming changes in other parts of the rules where necessary. For example the MSDS required by § 266.405, the spill response requirements of §§ 266.408 and 411, the closure requirements of § 266.412 and the recycling requirements of § 266.407 will be revised to reflect this change.

Comment. USFRS requested EPA to clarify the definition of USFRS XL waste. USFRS questioned whether the requirement in the definition of “USFRS XL waste” that limited participation to generators who would reuse “substantially all of the treated waste waters” would include processes where up to 50% of the process waters require use of new water in order for the customer to operate its processes effectively. USFRS pointed out that in any water reuse system there is a percent of water that is discharged rather than being returned to the original process (referred to as “bleed off”). Related to this issue USFRS suggested that the USFRS XL project be expanded to generators who use the ion exchange resin system regardless of whether they discharged the treated waste waters or reused them in their production process. USFRS felt that as long as the generators were required to send their resins to USFRS for metals recovery—a primary benefit of this project—there would be recovery of metals and a reduction in the disposal of these metals.

Response. USFRS projected that this project would benefit the environment by reducing the use of potable water in the manufacturing process and increasing the recycling of metals contained in the manufacturing waste waters. In the preamble to the proposed rule, EPA solicited comment on two related topics. First, EPA asked for data or comments on what would be an acceptable percent of “bleed off.” USFRS' proposal at that time was limited to those generators who reused their treated waste waters. EPA recognized that some bleed off would occur. However, without data it could not establish a numeric bench mark for water reuse. At that time EPA believed that a numeric benchmark would be useful to ensure that one of the goals of the project was obtained—i.e., reduction in the use of potable water. Second, EPA asked for comments on whether the reduction in the use of potable water was sufficient environmental benefit by itself to warrant proceeding with the USFRS XL project. EPA explained that although it proposed to require the recycling and recovery of the metals in the sludges  16 it was not confident that there were facilities available to complete this task. EPA was concerned that if USFRS was not able to find a recycler of this waste the project would not proceed. Consequently, there would not be any environmental benefit from the Project.

The USFRS XL project is a RCRA regulatory reform initiative. One of the major environmental benefit expected from the USFRS XL project is a reduction in the disposal of the electroplating waste water treatment sludges and an increase in the recovery of metals from the ion exchange resin and filters. An increase the recycling and recovery of metals from the resins and filters would increase the waste disposal environmental benefits derived from this project. During the comment period EPA did not receive any comment suggesting that it should eliminate the recycling requirement. On the contrary, the private citizen strongly encouraged EPA to retain this requirement. Consequently, if USFRS is correct, allowing generators who discharge their treated waters to participate in this project would satisfy this commenter and might enhance this project's ability to recover metals and reduce their disposal. One method of accomplishing this would be to revise the definition of USFRS XL waste to eliminate from the proposed rule the treated water reuse requirement—specifically, eliminate the phrase “ion exchange resin canisters which result in reuse of substantially all of the treated waste waters.” By doing this EPA, would also eliminate the need to identify a benchmark amount for bleed off and the requirement for any water re-use.

EPA recognizes that eliminating the water re-use requirement may have an impact on the amount of potable water used in the manufacturing process. This in turn may be less of an environmental benefit than EPA originally anticipated in the August 17, 2000 Federal Register . However, it is unclear, at this point, that such a negative impact will occur. It is possible that other factors, such as reduced local taxes for reduced water use or discharge, may work in concert with the rule and result in a net reduction in the use of potable water. To obtain an accurate assessment of the impact of this project on water use and re-use EPA will retain in the final rule the reporting requirements related to water reuse contained in the proposed rule. U.S. EPA believes that such information will be useful and valuable for it to more completely assess the overall environmental impact of this USFRS XL project.

Comment. USFRS wanted EPA to clarify that although its training manual will instruct participants on how to handle spills of USFRS XL waste it will not relieve them of the responsibility, if any, to have their own spill response plans and satisfy all federal, state and local requirements regarding training and how to handle spills.

Response. EPA agrees with USFRS. The applicability section of subpart O, § 266.400 clearly states that a participant in this XL project is relieved from compliance with specific RCRA requirements. All other federal, state and local requirements are applicable to the participants, including spill response and training requirements.

Comment. USFRS questioned the manner in which it will calculate the quantity of metals it recovers from its generators as required in new §§ 266.419(a)(2) and (3). USFRS stated that it will calculate the metals collected/recovered for each generator based on the initial chemical profile analysis it performed on the generator's waste and the volume of resin received for regeneration during the relevant reporting period.

Response. EPA agrees with the method USFRS proposes and does not believe that a change in the rule is needed. The rule presently states that USFRS will report the quantity of metals it recovers at its facility. It does not specify a method for calculating that quantity. EPA recognizes that the method proposed by USFRS will provide it with an estimate of the actual amount of metals recovered not the actual amount recovered that it recovers. EPA believes that such an estimate is sufficient given the other data USFRS will report—amount of ion exchange resins, other wastewater treatment sludges and residues it recovers from each of its generators; the amount of water recycled by the generators and associated treatment costs saved by the generators; the amount of metals it recovers at its facility and the amount of metals actually recovered at off-site metals recovery facilities (see § 266.419(a)(4)). 17

Comment. USFRS suggested that the rules be revised to allow for continued participation by a participant after it has changed ownership. USFRS stated that it was inappropriate to automatically terminate a participant given the efforts it has expended to enroll transporters and generators and the time it has taken to develop this Project. USFRS suggested that instead of an automatic termination there should be a review of the participant when there is a change in ownership.

Response. EPA agrees that new owners of generators or transporters may participate in this XL Project. EPA, however, does not believe it is appropriate or necessary to allow for a new owner of a generator or transporter to automatically continue participating in this Project pending a review and approval by EPA. EPA does believe that the new rules should be modified to allow for the substitution of a new owner of USFRS and to allow EPA to approve of a modified closure when there is new owner generator.

The August 17, 2000 Federal Register proposed that a company's continued participation in this XL Project would terminate when it changed owners. It did not require prior notice of the change in ownership. 18 The rules provided the prior owners with time to close and return to compliance with RCRA (see §§ 266.414-418)  19 . The time periods varied depending on whether the company was a generator, transporter or USFRS. If a generator changed owners the prior owner would have to discontinue generation of USFRS XL waste and complete the closure requirements contained in § 266.412. The prior owner would have 60 days from date of the change in ownership to disconnect its processes from the water treatment resin process, implement alternative treatment and disposal, remove all USFRS XL waste from its property and decontaminate the any contaminated areas.

The August 17, 2000, Federal Register proposed that generators and transporters may be added to this XL project at any time. Consequently, a new owner could be added before or after the change in ownership provided it met the criteria for such approval and the appropriate processes were completed. (See §§ 266.402 and 266.403). One of the criteria is prior approval of EPA. EPA's prior approval of XL participants is important to the success of EPA's XL projects and this XL Project in particular. A company must be knowledgeable of and committed to the XL project and the regulations promulgated thereunder. Additionally, it must have an exemplary environmental compliance history.

EPA believes that USFRS suggestion of allowing a new owner to continue without prior EPA approval may allow for a company which does not meet these criteria and does not qualify to participate. When a company changes ownership it is unknown whether the new owners meet these criteria. Additionally, a number of practical problems are presented. The new owners may decide not to participate in the XL project; they may decide to change personnel, operations or generate waste streams different from their predecessor; or they may have to clean-up wastes that the prior owner left. EPA believes that these issues should be resolved before a new owner is added to this XL project and generates USFRS XL waste. In instances where these issues are quickly resolved—e.g., everything stays the same but for the name of the owner—USFRS should be able to expedite the addition of the new owner to this XL project. Since the rules allow for the addition of a new generator or transporter at any time, a new owner could apply to participate prior to the change in ownership. This would minimize the disruption in any continuing operations. The advantage of terminating the prior owner's participation is that it clearly delineates the responsibility for any previously generated USFRS XL waste. The prior owner is responsible for closure.

EPA believes, however, that the termination procedures should be modified in one instance. 20 According to § 266.415(d) once there has been a change in ownership of a generator the prior generator has 60 days to complete the closure requirements of § 266.412. EPA is concerned that the rule as proposed would not allow a new owner to assume the prior generator's closure responsibilities or continue the pre-existing ion exchange resin process. This may be appropriate in certain instances—e.g., where the new owner is not approved or does not want to assume those responsibilities. However, there are other instances where it may be environmentally better to allow the new owner to continue the previous process without disruption or to assume the clean up responsibilities of the prior owner. To strike the proper balance between these two interests and to provide some flexibility EPA will change section 266.415(d) to require the prior owner to complete closure within 60 days of the change in ownership unless, within that time period, EPA has approved of the new owner and EPA has approved of any modifications the new owner proposes to the prior owner's closure responsibilities. If these approvals are not received within this time period the prior owner is still responsible for completing the closure within the 60 days.

The change in ownership of USFRS presents a problem not previously contemplated by EPA when it developed the proposed rule. The rules do not provide a mechanism or procedure to add the new owner of USFRS. Instead, they required USFRS to notify EPA of the change in ownership within 30 days of it happening and then within 90 days to arrange for the transition of all the USFRS XL waste project participants to return to compliance with RCRA. (See § 266.418(b)). Consequently, if USFRS were to change ownership then this XL Project would automatically terminate. This would set into motion the termination of the continued participation of all of the generator and transporters approved for participation in this project. The automatic termination of USFRS could potentially have a significant economic and environmental impact as a large number of companies attempt to switch from the ion exchange resin filter system to some other system within the same time. Such a consequence may be unavoidable where there are substantive reasons for terminating USFRS continued participation or this XL project—e.g. USFRS continuously violates its permit or the project does not demonstrate any environmental benefit. However, in the case of a change in ownership this is not necessarily true. Consequently, EPA believes that some procedure should be established to allow for the new owner of USFRS to continue operating this XL Project. This would be consistent with the RCRA permit rules which allow for the continued operation of a permitted facility after a change in ownership, provided the Agency has approved of the change in ownership. Consequently, EPA has modified § 266.418(b) to require USFRS to provide EPA with 90 days advance notice of any change in ownership and to provide EPA with its proposed revisions to the FPA if the new owner wishes to continue this XL Project. If EPA and the new owner are able to agree upon and sign the proposed revisions to the FPA within that 90 day time frame then the new owner may continue this XL Project. If an agreement and signature is not obtained within that time frame then procedures presently in the rules for automatic termination apply.

Comment. USFRS and MPCA requested that EPA extend the duration of the project to account for the time that it will take to obtain the necessary State, county and federal approvals. Both entities were concerned that it may take up to a year to obtain all of the necessary governmental approvals. This time will erode the five years that were given for the duration of the project.

Response. EPA agrees that sufficient time should be allowed for the project. Proposed § 266.422 stated that the new federal rules would be effective for five years from the effective date of the final rules. However, the preamble to the proposed rules clearly stated that USFRS may not implement the program outlined in the rules until the State of Minnesota either: (1) Receives federal authorization for similar state rules, (2) issues variances under its existing federally authorized hazardous waste program or (3) receives federal authorization for permits it issues to participating generators, transporters and USFRS pursuant to the Minnesota XL statute. Each of these options can easily take six months, at a minimum, to complete.

Minnesota has indicated a preference for the latter option-using its XL statute to develop general permits for the generators and transporters and modifying the existing hazardous waste permit for USFRS. Minnesota most likely will work on the XL permits in a sequential manner. It will develop the generator and transporter general permits first and then make the changes needed to USFRS RCRA hazardous waste permit. It will not issue the modifications to the USFRS RCRA hazardous waste permit until the generator and transporter general permits are completed and Minnesota has received authorization for these permits. 21 In this process the modified USFRS RCRA hazardous waste permit is the last element needed to make this XL project effective in the State.

EPA anticipates that Minnesota will need up to year to complete all the steps needed to implement its preferred option. Consequently, without providing an extension to the effective date of the proposed rule the project will last for only four years, at most, not the five years proposed.

Providing more time may also act as an incentive for more generators to participate in the USFRS XL project. This in turn may provide USFRS and EPA with more reliable information on the environmental benefits derived from the project. It may also provide EPA with additional time to evaluate whether the project can and should be expanded. Consequently, EPA has modified § 266.422 in the following two ways to provide the full five years for the duration of the project. EPA has changed the effective date of subpart O to six months after publication of the final rule in conformance with section 6930(b) of RCRA. Second, EPA has changed § 266.422 to indicate that the project will run for five years from the date that Minnesota issues a modification to the USFRS RCRA permit to implement this XL project. Since the modified RCRA permit is the last step anticipated in Minnesota's implementation process for this project it is reasonable that the duration of the project be measured from that date.

Comment. USFRS requested EPA to amend the rules to allow it more than 30 days to pick up a generator's XL waste. USFRS indicated that this requirement would effectively reduce the 90 day storage allowed for generators of the USFRS XL waste to 30 days. This in turn would have the greatest impact on USFRS being able to attract new customers located outside the Minneapolis-St. Paul area. Generators outside of the metropolitan area would be most sensitive to transportation costs. The 30 day time limit would increase those transportation costs since USFRS expected that there would be more frequent pick-ups with smaller loads. If the time period were extended USFRS felt that some of the expenses could be reduced. USFRS suggested that the rule allow it to pick-up the XL waste within the 90 days allowed for the generator to store the XL waste. USFRS further suggested that it would agree that the rule state that at no time would the XL wastes be allowed to remain on-site for greater than 90 days.

Response. EPA agrees with USFRS' request and will revise § 266.410(a) and (c) to allow it and its transporter to pick up a generator's USFRS XL waste within the 90 days allowed the generator to store the waste. The changes suggested by USFRS are consistent with the goal of the project and the rule and may result in a rule which works better than the proposed rule.

One of the goals of this project is to increase the recycling of F006 waste. It is reasonable to expect that the more participants in this project the greater the chance that this goal will be met. Consequently, if USFRS is correct, then USFRS may be able to maximize the number of participants with EPA providing a longer time period for USFRS to pick up the wastes. EPA selected the 30 day time period in the proposed rule because it appeared that USFRS could meet this time period. The ultimate goal of the rule was to ensure that there was adequate cooperation between the project participants to accomplish the same goal—i.e., remove the XL waste from the generator's storage area prior to the expiration of the 90 day storage limit. This goal can be met by revising § 266.410(a) and (c) to specify that USFRS and its transporters will pick up a generator's XL waste before the 90 day storage time limit expires on the waste. 22

Comment. USFRS requested EPA to change § 266.410(a) to allow it more time to send a copy of the Transportation Tracking document it received with the shipment of XL waste to the generator. USFRS stated that 5 days was inconsistent with its present practice approved by the State. Namely, USFRS mails copies of the hazardous waste manifests to the state and the generators once per week.

Response. EPA agrees to extend the time from 5 days to 10 days. This is more stringent than the 30 days allowed under RCRA but should allow USFRS to continue its existing practice which the State has approved for other hazardous waste shipments. It will also provide the generator and USFRS sufficient time to track any missing shipments.

Comment. USFRS requested EPA to modify § 266.410(a) to allow it to provide the generator's with the Transportation Tracking Document and warning statement at the time the transporter arrives at the generator to pick-up the USFRS XL waste. USFRS indicated that such a modification to the rule will make the rule harmonious with its existing system for all wastes. This would allow it to maintain the 48 hour response time for pick-up of its customer's wastes in the local area.

Response. EPA agrees to make the change requested by USFRS in § 266.410(a). The proposed rule stated that USFRS was to provide the Transportation Tracking Document and warning statement to the generator prior to the transporter arriving at the generator. The purpose of the timing requirement was to provide the generator with time to review the document and make any changes that might be necessary. This can be accomplished if the document arrives with the transporter. Additionally, since the generator and the transporter are still responsible for verifying the accuracy of the document under § 266.410(b) and (c) the ultimate goal of the rule is still achieved—i.e., accurate transportation tracking documents.

Comment. USFRS was concerned that it could not meet the MSDS requirements in §§ 266.405, 266.408(g), 266.410(c) and 266.411 because its MSDS covered the ion exchange resins prior to use (i.e., “fresh resins”) whereas these rules contemplated an MSDS which covered the resins after use (i.e., with contamination on them). It proposed using another document—the Treatment and Storage form—which identifies the hazards associated with the wastes and emergency response protocols.

Response. EPA will revise § 266.405 to allow USFRS to use the MSDS or an equivalent form which identifies the hazards associated with the resins and filters after use and the emergency response protocols. This change should allow USFRS to use its Treatment and Storage form if it contained the requisite information.

Comment. USFRS stated that in certain instances the subpart O rules are more stringent than RCRA or its routine practices and should be revised to be the same as RCRA (e.g.., generator storage of USFRS XL waste limited to 90 days, regardless of the amount; storage of the USFRS XL waste on an impervious surface; time limits for exiting the XL project which are inconsistent with RCRA and notice to more entities of a spill than just MPCA). USFRS felt that these provisions would make it difficult to convince potential customers who are knowledgeable about RCRA to participate in this program.

Response. An XL project must be environmentally superior to the existing regulatory program. Consequently, EPA would anticipate that certain elements of this XL project would be more stringent than the RCRA regulatory program. In developing the subpart O rules, EPA attempted to balance the desire to maximize the number of participants with the need to ensure that the project would result in superior environmental benefits. EPA believes that it has done that by replacing the manifest and reporting requirements for the generators, expanding the scope of the program to include pre and post filters and eliminating the treated water re-use requirement. In exchange for these provisions EPA believes that the requirements identified as more stringent are a reasonable trade off.

Comment. USFRS suggested that § 266.412 was incorrect based on their understanding that it referred to discontinuation of business not the generator closure identified on page 50307 of the August 17, 2000 Federal Register .

Response. EPA disagrees with USFRS. § 266.412 requires the generators to complete closure at the time of termination of the generator's participation in the USFRS XL project. § 266.415 specifies the manner in which a generator may terminate its participation—either voluntarily, as a result of action EPA, MPCA or the County Agencies, as a result of action by USFRS or after a change in ownership. The rule also specifies the time period for completing closure under each of these scenarios—it is 60 days.

Comment. USFRS and MPCA requested EPA to commit to assisting it in expanding this project beyond the State of Minnesota.

Response. As a general goal EPA agrees that expanding an XL Project to other States and other companies may be a desired outcome of its XL program, if the pilot shows promise. EPA, however, believes that it is premature for it to make the commitment USFRS and MPCA seek. XL Projects are participant driven pilot projects. The time and resources necessary to develop a project is significant and is the responsibility of the project sponsor. USFRS did a good job of developing this XL Project with the State of Minnesota and tailoring it to the rules of that State and its local governments. However, in order to expand this project beyond the State of Minnesota USFRS will need to involve other State, local, environmental and industry groups. Additionally, it will need to modify the proposal in a manner which is consistent with each State's authorized hazardous waste program. For example, USFRS' transportation tracking document may present certain States with administrative issues.

To the extent this project is amenable to expansion EPA believes that it can make such a determination after USFRS has implemented this project for one or two years. After that time USFRS will have obtained actual data on the environmental benefits derived from this XL project. USFRS will also have had the opportunity to identify improvements to the Project and to convene the necessary stakeholder meetings. At that time EPA will be in a position to ascertain if this project is capable of being expanded on a national basis and the appropriate manner in which to make such a change.

Comment. USFRS stated that the use of 55 gallon steel drums to collect and contain spills of ion exchange resins would be inappropriate. The steel can corrode when in contact with certain resins  23 or can irreversibly foul them. Additionally, the amount spilled may be significantly less than 55 gallons. As an alternative USFRS suggested that the drum be a polycontainer compatible with the wastes and of sufficient size to contain the amount spilled.

Response. EPA will revise §§ 266.408(e) and 266.411 as suggested by USFRS.

Comment. USFRS was concerned that § 266.408(b) would require the generators to store the USFRS XL wastes in separate areas from their storage of other wastes. USFRS believed that simple segregation of the USFRS XL wastes would be sufficient.

Response. EPA agrees that simple segregation of the USFRS XL wastes from the other wastes is sufficient. It disagrees that § 266.408(b) requires storage in a separate area. Storage in a separate area within a storage area for other wastes would be acceptable.

Comment. One individual felt that the public participation was inadequate. He suggested that there was not enough “non-governmental” stakeholders. He said that the FPA should not be signed until there were additional public meetings and his client had an opportunity to become one of the stakeholders.

Response. Stakeholder involvement and representation is an important element for every XL project. It is the responsibility of the project sponsor and continues throughout the project—even during implementation. EPA regrets when any stakeholder is not able to participate as early in the process and as often as it would like. EPA certainly would expect that USFRS would include any stakeholder who wishes to be added to this stakeholder's group.

EPA disagrees, however, that there was inadequate public participation and that the FPA and rule should not be signed. USFRS had 9 separate stakeholder meetings. They invited and had in attendance representatives from industry, the environmental community, private citizens and the State and local governments. All of this was done prior to EPA public noticing the draft FPA and proposed rules on August 17, 2000. With the August 17, 2000 Federal Register EPA invited the public to submit comments and request a public meeting. Requests for a public meeting were to be made by August 24, 2000. EPA did not receive any such requests until it received this request on September 7, 2000. Even though this is a late request for a public meeting EPA has evaluated the merits of the request and believes that an additional public comment period or a public meeting are unnecessary. This commenter submitted two pages of substantive comments on the proposed rule and draft FPA. (EPA presents a more detailed summary and response to these comments below). The commenter was primarily concerned with EPA retaining the recycling requirement. EPA has done that. Additionally, this commenter will continue to have meaningful opportunities to comment on this project after the FPA and rule are signed. As stated earlier, stakeholder involvement continues after the FPA is signed and this rule is promulgated. That involvement will be meaningful. Major implementation issues and decisions still have to be completed. Signing the FPA and new rule is just the first step in the process. For example, the State will have to develop the legal mechanisms which it will use to implement this project. Public involvement may be useful in completing this. Additionally, some of the legal mechanisms the State may use may require public participation prior to completion of them. To the extent the commenter is concerned that it is precluded from participating in the project that is not correct. The project is structured in a manner which allows any person who qualifies to be added to the project as a generator or a transporter. To the extent the commenter is concerned that the environmental benefits of the project may be insufficient, any person—not just stakeholders—may advise EPA, USFRS, MPCA or the County Agencies of project problems at any time. If the problems are major and not capable of being fixed, EPA has retained the ability in both the FPA and rules to terminate this project at an earlier time.

Comment. One commenter responded to EPA's request for comments on whether this project should be conditioned on USFRS' ability to recycle the USFRS XL wastes. The commenter stated that the recycling requirement must be retained. He stated that before EPA eliminated that requirement it needed to conduct further studies. Those studies would provide data on the impact of the increased metal disposal against the environmental benefit of a reduction in the use of potable water. The commenter also wanted EPA to ensure that generators who are currently reclaiming metals from F006 wastes continue to do so.

Response. EPA agrees that the recycling aspect of this Project is a major part of it and has the potential to yield a significant environmental benefit. Furthermore, it appears that there is a market for this service and that USFRS will be able to obtain such services. EPA has, therefore, retained the recycling requirement. Consequently, USFRS and participating generators, through USFRS, will be recycling the USFRS XL wastes.

If the project operates as USFRS projects the amount of metals recycled and the number of generators who recycle metals may increase. USFRS anticipates this would happen, in part, as a result of its resin process collecting more metals prior to waste water discharge to a POTW and in part due to companies doing waste water treatment when they did not previously do it.

EPA disagrees with the commenter's suggestion that certain studies are needed prior to EPA approving of this project. XL projects are intended to pilot new approaches. By their nature, some projects will not have the data on the actual environmental benefits a priori. They may be used to collect the data to substantiate the benefits anticipated. Such projects may be used to assist EPA in obtaining the data and experience, on a small scale, it needs to determine whether larger, national changes should be made. This XL project does that. It requires USFRS to collect and analyze data which will allow EPA to assess the comparative environmental benefits derived from the use of its resin regeneration process and the alternative management standards imposed on F006 wastes which are recycled. (See § 266.419).

Comment. The State submitted written comments indicating that it was uncertain of the legal mechanisms it could use to implement the XL project. In its written comments, due to resource constraints and other uncertainties, it generally disagreed with certain options EPA outlined in the preamble to the proposed rule. It suggested that EPA use the FPA to incorporate their understandings and agreement on the implementation options to be used for this project.

Response. EPA shares the State's concerns about the length of time and resources it will need to finish the State and, in two instances, federal authorization proceedings to implement the new subpart O rules. EPA also agrees that the FPA can be used to identify the legal options and mechanisms the EPA and the State may use to implement this XL Project. EPA has revised the FPA to do that.

The FPA allows the State to chose any of the three options EPA identified in the preamble to the August 17, 2000, Federal Register . In summary those options are: (1) Revise its existing hazardous waste rules to mirror new subpart O; (2) issue permits which mirror the new subpart O to the project participants using the State's XL statute; or (3) issue variance(s) which mirror the new subpart O to the project participants using the variance authority in its existing RCRA authorized hazardous waste program or. The first two options require the State to submit them to EPA for federal authorization after they are adopted by the State. 24 The State has indicated its preference for option 2 (issuing permit(s) and submitting an authorization application). To expedite matters, EPA has provided the State with guidance on the elements of an authorization application for option 2. EPA has also committed in the FPA to expedite its review of its request for authorization of option 2. Finally, EPA has delayed the start of the subpart O rules, and thus this project, in a manner which will allow USFRS to implement this XL project for the full five years, regardless of any delays the State or EPA may incur in putting in place the required legal mechanisms.

In addition to the changes already discussed EPA modified §§ 266.401, 266.403(c), 266.414, 266.415 and 266.416. EPA made these changes on its own initiative.

Sections 266.414-418 present the federal procedures for termination of an entities continued participation in this XL Project. EPA added in §§ 266.314, 266.315 and 266.316 that the State and County may have different procedures. Furthermore, EPA added that it is not bound by nor will it follow the State or local procedures. This is true regardless of the enforceable mechanisms the State uses to implement this XL Project. EPA explained this position in the preamble to the August 17, 2000 Federal Register and had stated it in proposed §§ 266.417 and 266.418. EPA inadvertently excluded this language in the proposed version of §§ 266.414, 266.415 and 266.416 and is correcting the final version of these sections with this final promulgation.

EPA is revising § 266.401 (definition of USFRS XL waste final project agreement) and § 266.403(c) to change the name Pioneer Transport to Pioneer Tank Lines. USFRS proposed Pioneer Tank Lines as one of the approved transporters for the USFRS XL waste. EPA mistakenly identified this company as Pioneer Transport in the proposed rules. EPA is correcting these rules to (§§ 266.401 and 266.403(c)) to reflect the correct name—Pioneer Tank Lines.

The designation for the regulatory text has been changed from subpart N, §§ 266.300-266.322 in the proposed rule to subpart O, §§ 266.400-266.422 in final rule. This is due to a numbering conflict with a simultaneously proposed rule.

With the promulgation of this new rule no further federal regulatory changes will be needed. However, since the state of Minnesota is authorized under section 3006 of RCRA to implement the federal RCRA program it will have to complete certain steps to provide USFRS, its generators and transporters with the regulatory flexibility needed to implement the USFRS XL project. The preamble to the proposed rule provides a detailed discussion of the steps Minnesota can take to implement this USFRS XL project. The approved generators, transporters and USFRS are subject to the present state regulations, which do not provide this flexibility, until such time as new regulations are adopted by the state of Minnesota or an equivalent state legal mechanism is used and authorized as part of the approved federal hazardous waste program for Minnesota. Therefore, conforming state regulatory changes or legal mechanisms must be implemented in addition to the proposed federal changes for companies to enter into this XL Project. Additionally, depending on the mechanism selected by the State of Minnesota, EPA may have to review and approve of the mechanism as part of the State's authorized hazardous waste program.

EPA is supporting this new approach because it believes that it will provide superior environmental performance by promoting recycling of water and recovery and reuse of metals that would otherwise be land disposed. USFRS and its customers will be complying with requirements that are as protective of public health and the environment as the RCRA requirements that would otherwise be applicable. EPA also believes that implementation of this project will result in a significant cost savings to the participating customers. The success of this project will be evaluated on an ongoing basis and will determine whether this new approach to waste management should be extended to other areas of the country.

Because this rules affects only U.S. Filter, its transporters and its customers, it is not a rule of general applicability. It is therefore, not subject to OMB review and Executive Order 12866. In addition, OMB has agreed that review of site-specific rules under Project XL is not necessary. Further, under Executive Order 12866, the Agency first must determine whether the regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety in State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlement, grants, user fees, or loan programs of the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Because the annualized cost of this proposed rule would be significantly less than $100 million and would not meet any of the other criteria specified in the Executive Order and because this proposed rule affects only USFRS and its transporters and generators, it is not a rule of general applicability or a “significant regulatory action” and therefore not subject to OMB review. Further today's proposed rule does not apply to any entity unless they choose on a voluntary basis to participate in this XL Project. Finally, OMB has agreed that review of site specific rules under Project XL is not necessary.

Executive Order 12866 also encourages agencies to provide a meaningful public comment period, and suggests that in most cases the comment period should be 60 days. However, in consideration of the very limited scope of today's rulemaking and the considerable public involvement in the development of the draft FPA, the EPA considers 30 days to be sufficient in providing a meaningful public comment period for today's action.

The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Under section 605(b) of the RFA, however, if the head of an agency certifies that a rule will not have a significant economic impact on a substantial number of small entities, the statute does not require the agency to prepare a regulatory flexibility analysis. Pursuant to section 605(b), the Administrator certifies that this proposal, if promulgated, will not have a significant economic impact on a substantial number of small entities for the reasons explained below. Consequently, EPA has not prepared a regulatory flexibility analysis.

Small entities include small businesses, small organizations and small governmental jurisdictions. For purposes of assessing the impacts of today's proposed rule on small entities, small entity is defined as : (1) A small business according to RFA default definitions for small business (based on SBA size standards); (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

Today's rule amends EPA's RCRA Regulations to modify the handling and reporting requirements for certain hazardous waste generators and transporters, as well as for USFRS. USFRS is not a small entity. The modifications authorized by the rule would reduce costs to the generators to whom it applies and those modifications should have no impact on costs to the transporters. EPA has concluded, therefore, that the rule will not have a significant economic impact on a substantial number of small entities.

The Office of Management and Budget (OMB) has approved the information collection requirements contained in this rule under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) and has assigned OMB control number 2010-0026.

EPA is requiring that information be collected regarding which generators and transporters are eligible for regulatory flexibility under the USFRS XL Project. Information is also needed in order to keep generators, transporters, USFRS, and emergency response teams abreast of XL 001 waste, its contents, and when it is shipped and received. Finally information is needed to determine whether the project produces superior economic and environmental benefits. The success of the project will help determine whether it should be extended to other areas of the country. Participation in the project is voluntary; however, if a generator or transporter decides to participate, EPA requires the filing of this information. Quarterly reports will be publicly available. The estimated total cost burden of collecting the information is $240,670/year and the estimated total length of time to collect it is 4205 hours/year. The estimated total number of respondents is 91. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15. EPA is amending the 40 CFR part 9 table of currently approved ICR control numbers issued by OMB for various regulations to list the information requirements contained in this final rule. The table lists the CFR citations for EPA's reporting and recordkeeping requirements, and the current OMB control numbers. This listing of OMB control numbers and their subsequent codification in the CFR satisfy the requirements of the Paperwork Reduction Act and OMB's implementing regulations at 5 CFR part 1320.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why the alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

As noted above, this proposed rule is limited to USFRS and certain of its customers and transporters. This proposed rule would create no federal mandate because it is a voluntary program proposed by USFRS. Further, EPA is imposing no enforceable duties that are anticipated to be more expensive or more onerous for the parties that would exist without this proposed rule. The rule does not change the authorization status of the State. Since the proposed rule is a relaxation of the federal regulatory program, it will not take effect until the State adopts the rule. The State is under no federal obligation to adopt less stringent requirements. EPA has also determined that this proposed rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. Thus, today's proposed rule is not subject to the requirements of sections 202 and 205 of the UMRA. EPA has also determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Nevertheless, in developing this proposed rule, EPA worked closely with MPCA, Ramsey, Hennepin, Anoka, Dakota, Carver, Scott and Washington Counties and received meaningful and timely input in the development of this proposed rule.

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

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This proposed rule is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866 and because the Agency does not have reason to believe the environmental, health or safety risks addressed by this action present a disproportionate risk to children. The proposed rule has no identifiable direct impact upon the health and/or safety risks to children and adoption of the proposed regulatory changes would not disproportionately affect children. Finally, all XL projects must demonstrate superior environmental performance. Therefore, EPA anticipates that the proposed rulemaking will benefit all people, including children. The proposed rulemaking is thus in compliance with the intent and requirements of the Executive Order.

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

Under section 6 of Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation.

This proposed rule does not have federalism implications. It will not have 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, as specified in Executive Order 13132. The requirements outlined in today's proposed rule would apply only to the USFRS facility and generators and transporters of USFRS XL waste and will not take effect unless Minnesota chooses to adopt equivalent legal mechanisms or requirements under state law. Thus, the requirements of Section 6 of the Executive Order do not apply to this rule. Although Section 6 of Executive Order 13132 does not apply to this rule, EPA did fully coordinate and consult with State and local officials in developing this rule.

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

This final rule does not have tribal implications. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

In the spirit of Executive Order 13175, and consistent with EPA policy to promote communications between EPA and tribal governments, EPA specifically solicits additional comment on this proposed rule from tribal officials.

Section 12(d) of NTTAA, Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary standards. This proposed rulemaking sets alternative handling and paperwork requirements for certain hazardous wastes; it does not set technical standards. EPA is not considering the use of any voluntary consensus standards.

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 rule is of particular applicability.

EPA Region 6 is publishing this Direct Final Notice of Deletion of the Gulf Coast Vacuum Services Superfund Site from the NPL.

The EPA identifies sites that appear to present a significant risk to public health or the environment and maintains the NPL as the list of those sites. As described in § 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for remedial actions, if conditions at a deleted site warrant such action.

Because the EPA considers this action to be noncontroversial and routine, the EPA is taking it without prior publication of a notice of intent to delete. This action will be effective July 23, 2001 unless the EPA receives adverse comments by June 21, 2001 on this rule. If adverse comments are received within the 30-day public comment period on this rule, the EPA will publish a timely Withdrawal of this Direct Final Rule of Deletion before the effective date of the deletion, and said deletion will not take effect. The EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the proposed Notice of Intent to Delete and the comments already received. There will be no additional opportunity to comment.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that the EPA is using for this action. Section IV discusses the Gulf Coast Vacuum Services Superfund Site and demonstrates how it meets the deletion criteria. Section V discusses the EPA's action to delete the Site from the NPL unless adverse comments are received during the public comment period.

Section 300.425(e) of the NCP provides that releases may be deleted from the NPL where no further response is appropriate. In making a determination to delete a release from the NPL, the EPA shall consider, in consultation with the State, whether any of the following criteria have been met:

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

ii. All appropriate Fund-financed (Hazardous Substance Superfund Response Trust Fund) response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

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

Even if a site is deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the deleted site above levels that allow for unlimited use and unrestricted exposure, CERCLA section 121(c), 42 U.S.C. 9621(c) requires that a subsequent review of the site be conducted at least every five years after the initiation of the remedial action at the deleted site to ensure that the action remains protective of public health and the environment. If new information becomes available which indicates a need for further action, the EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to deletion of the Site:

(1) The EPA consulted with the State of Louisiana on the deletion of the Site from the NPL prior to developing this Direct Final Rule of Deletion.

(2) The State of Louisiana concurred with deletion of the Site from the NPL.

(3) Concurrently with the publication of this Direct Final rule of Deletion, a parallel proposed Notice of Intent to Delete published today in the “Proposed Rules” section of the Federal Register is being published in a major local newspaper of general circulation at or near the Site and is being distributed to appropriate federal, state, and local government officials and other interested parties; the newspaper notice announces the 30-day public comment period concerning this action.

(4) The EPA placed copies of documents supporting the deletion in the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period, the EPA will publish a timely notice of Withdrawal of this Direct Final rule of Deletion, before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the proposed Notice of Intent to Delete and the comments already received.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter the EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist the EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.

The following information provides the EPA's rationale for deleting the Site from the NPL:

The Site is located 3.5 miles southwest of the town of Abbeville in Vermilion Parish, Louisiana, on Parish Road P-7-31, also called Junuis Road. The Site occupies approximately 12.8 acres, and is bounded to the north and west by pasture land and to the east and south by the D.L. Mud Superfund Site and the LeBoeuf Canal. Areas adjacent to the Site are used as pasture land for grazing cattle and for other agricultural uses, predominantly rice, sugar-cane, and soybean crop raising. Ten residences are located within 1/2 mile of the Site on Parish Road P-7-31 and Route 335, the nearest being on the southeast site boundary. Because these homes are outside the corporate limits of Abbeville, residents in the area rely on ground water for their drinking water and for irrigation.

The Site was a vacuum truck and oilfield drilling mud plant operation from approximately 1969 to 1980. During the period that the facility was in operation, unpermitted disposal of contaminated organic and inorganic materials, primarily oil industry-related waste, occurred in several open pits. Gulf Coast Vacuum Services and its predecessors used the property as a trucking terminal and disposal facility for materials and wastes generated from oil and gas exploration and production. Vacuum trucks were rinsed out in several on-site pits, while unpermitted disposal of contaminated material and waste also occurred. Primary hazardous substances at the Site were organic compounds such as benzene, carcinogenic polyaromatic hydrocarbons (PAHs), and metals such as arsenic and barium.

The EPA performed three Removal Actions at the Site prior to the initiation of a Remedial Action (RA). The purpose of these Removal Actions was to prevent contaminated rainwater, which accumulated on top of the sludge pits, from overflowing onto adjacent agricultural fields. These removals were conducted in March through April 1990, February through March 1991, and in April 1992. During each Removal Action, approximately 800,000 gallons of water were pumped, treated, and discharged. In addition, during the 1990 and 1992 removal actions, fencing around the pit areas was installed.

The EPA performed the Remedial Investigation (RI) of the Site from November 1990 through March 1992. Various heavy metal and PAH contaminants were detected at levels on-site that measured above health-based standards.

In July 1992, the EPA released the RI Report and the Feasibility Study (FS). The RI Report included all RI sampling results. The FS provided an in-depth analysis of remedial alternatives, which included on-site and off-site treatment alternatives such as incineration, on-site and off-site containment alternatives such as disposal and capping, and a “no action” alternative. The FS concluded that a “no action” alternative at the Site could result in a potential health threat to the public, through dermal contact with contaminated soils and sludges, and a potential health threat to nearby residents, who rely on ground water for their drinking water.

The EPA, in consultation with the LDEQ, signed two Records of Decision (ROD) on September 30, 1992. The Operable Unit 2 (OU2), Interim Source Control ROD, designed to address the short-term, immediate exposure risks associated with rainwater overflow from the pits, called for treatment of contaminated rainwater to LDEQ surface discharge standards, the consolidation of the Washout Pit into the West Pit, and the covering of the West Pit.

The September 1992 Operable Unit 1 (OU1), Final Source Action ROD, selected on-site incineration to address the long-term environmental and human health risks associated with the organic contaminants on-site. The OU1 ROD also selected stabilization and solidification of inorganic-contaminated soils and residuals of the organic treatment, and monitoring of the ground water. The OU1 ROD was amended in May 1995 (“the Amended ROD”) to change the way in which the organic-contaminated material was handled. Based on the OU1 ROD and the Amended ROD, the Final Source Control remedy for the Site included: on-site biological treatment of organic-contaminated pit sludges (surface and buried), associated soils and tank contents; stabilization and on-site disposal of the treated residuals from the bio-treatment as required to meet performance standards for inorganic compounds, and capping with a two (2) foot compacted clay cover; on-site stabilization and disposal of the Site soils contaminated with metals (inorganics), and capping with a two (2) foot compacted clay cover; and institutional controls, such as deed notices and long-term monitoring of the ground water.

One additional performance standard was that the stabilized material would have to pass Toxicity Characteristic Leaching Procedure (TCLP) requirements using a modified TCLP test (distilled water was substituted for the specified acid) and that the leachate from the TCLP test would also have to meet Clean Water Act Maximum Contaminant Levels.

The OU2 RD Work Plan submitted by the PRP Group was approved by the EPA on September 13, 1993. The OU1 RD Work Plan was approved by the EPA on June 2, 1997. These Work Plans detailed the design criteria and the steps that would be undertaken to achieve the goals of the Site RODs.

The OU2 ROD was implemented by a PRP group, consisting of 13 PRPs who were directed to do the action through a December 11, 1992, Unilateral Administrative Order (UAO). Implementation of the OU2 Remedial Action (RA) began on September 29, 1993. The OU2 RA work, performed in accordance with the UAO Statement of Work and the OU2 RD Work Plan, was completed on September 30, 1994. During the OU2 Interim Action, approximately 2 million gallons of water were treated and discharged, approximately 2,100 cubic yards of contaminated soil were moved from the Washout Pit to the West Pit, and the West Pit was covered with a synthetic cover. The OU2 remedial action was completed on September 30, 1994, the date the EPA approved the OU2 Remedial Action Certification Report.

On June 5, 1995, a Consent Decree (CD) between the EPA and a fourteen-member PRP group was entered in Federal District Court. The PRP group performed the OU1 activities under this CD and its accompanying Statement of Work and the OU1 RD Work Plan. OU1 remedy construction began on June 2, 1997. The PRPs conducted the following remedial activities: on-site biological treatment of 31,617 cubic yards of organic-contaminated pit sludges (surface and buried) and associated soils and tank contents; stabilization and on-site disposal (in the excavated West Pit and Washout Pit) of 21,347 cubic yards of Site soils contaminated with metals (inorganics) and approximately 20,000 cubic yards of biological treatment residuals; capping of the stabilized material with a two (2) foot compacted clay cover and seeding of the cover; fencing of the Site; implementation of deed notices; and ground water monitoring.

Confirmatory samples were taken of all excavated areas of the Site to ensure that all materials with concentrations of contaminants higher than the health-based Remedial Action Goals (RAGs) had been removed. In addition, performance samples were taken to ensure that the bio-treatment residuals met the RAGs, to show that the stabilized Site materials met the TCLP standard, and to show that the stabilized material had the physical properties (such as strength) specified in the RD work plan.

A pre-final inspection was conducted on February 19, 1999, and a final inspection was conducted on March 11, 1999. The EPA determined that the RA was complete during the final inspection, except for the submittal of the RA report and the filing of deed notices. The PRP group submitted the RA Report for OU1 to EPA on June 11, 1999. This report was reviewed by the LDEQ and a representative of the Technical Assistance Grant (TAG) group for the Site, and minor adjustments were made. Institutional controls, in the form of restrictive covenants were filed on September 29, 1999. The EPA approved the RA Report on October 4, 1999, and issued a Final Close Out Report on March 24, 2000.

The following contaminants were detected in the various Site media above health-based standards: Surface Soils—arsenic (2.3-56.7 mg/kg) and barium (480-21,400 mg/kg); Sludges—carcinogenic PAHs (.09-7.5 mg/kg), benzene (7-529 mg/kg); and Ground Water-barium (Non-detect (ND)—5550 μg/L), cadmium (ND-210 μg/L), chromium (ND—2580 μg/L), mercury (ND—4.6 μg/L), and lead (ND—2580 μg/L).

The RAGs specified in the OU1 ROD and the Amended ROD are: arsenic, 16 mg/kg; barium, 5,400 mg/kg, total carcinogenic PAHs, 3 mg/kg; total non-carcinogenic PAHs, Hazard Index < 1; previously unidentified carcinogenic compounds of concern (COCs), residual risk < 10-4—10-6 cumulative risk prior to stabilization and capping; and previously unidentified non-carcinogenic compounds of concern, HI < 1.

Site Operation & Maintenance (O&M) activities which will be performed by the PRP Group include routine Site inspections to ensure that the cap on the disposal cells remains intact and maintenance of perimeter fencing. These activities are sufficient to maintain the protectiveness of the remedy. The PRP group, as agreed upon in the CD and accompanying Statement of Work and as detailed in the RA Work Plan and the O&M Plan, has assumed all responsibility for O&M at the Site. In addition, under the CD, the PRP Group shall perform ground water monitoring during the O&M period. Plans for O&M are in place and are sufficient to maintain the protectiveness of the remedy. The PRP Group is fulfilling its obligation to perform the O&M. All institutional controls are also in place, as the Site is fenced and a declaration of restrictions was filed with Vermilion Parish on September 29, 1999, restricting use of the Site ground water and limiting activities in the capped disposal cells.

Because the implementation of the Site remedies resulted in hazardous substances remaining on-site at concentration levels above levels that allow for unlimited use and unrestricted exposure (see CERCLA section 121(c), 42 U.S.C. 9621(c), and 40 CFR 300.430(f)(4)(ii)), a review will be conducted at least every five years after commencement of the Remedial Action to assure that human health and the environment are being protected by the response action. The five-year reviews will be conducted pursuant to “Comprehensive Five-Year Review Guidance,” OSWER Directive 9355.7-03B-P, Draft October 1999, or whatever EPA guidance is current at the time of the review. All response activities have been completed at the Site other than O&M and five-year reviews.

Public participation activities have been satisfied as required in CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. Documents in the deletion docket which the EPA relied on for recommendation of the deletion from the NPL are available to the public in the information repositories.

The EPA, with concurrence of the State of Louisiana, has determined that all appropriate responses under CERCLA have been completed, and that no further response actions, under CERCLA, other than O&M and five-year reviews, are necessary. Therefore, the EPA is deleting the Site from the NPL.

Because the EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effective July 23, 2001 unless EPA receives adverse comments by June 21, 2001. If adverse comments are received within the 30-day public comment period on the proposal, the EPA will publish a timely Withdrawal of this Direct Final rule of Deletion before the effective date of the deletion, and it will not take effect, and the EPA will prepare a response to comments and continue with the deletion process on the basis of the proposed Notice of Intent to Delete and the comments already received. There will be no additional opportunity to comment.

EPA Region 6 is publishing this direct final notice of deletion of the Cleveland Mill Superfund Site from the NPL.

The EPA identifies sites that appear to present a significant risk to public health or the environment and maintains the NPL as the list of those sites. As described in the NCP at 40 CFR 300.425(e)(3), sites deleted from the NPL remain eligible for remedial actions if conditions at a deleted site warrant such action.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effective July 23, 2001 unless EPA receives adverse comments by June 21, 2001 on this document. If adverse comments are received within the 30-day public comment period on this deletion, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Cleveland Mill Superfund Site and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete the Site from the NPL unless adverse comments are received during the public comment period.

Section 300.425(e) of the NCP provides that releases may be deleted from the NPL where no further response is appropriate. In making a determination to delete a release from the NPL, EPA shall consider, in consultation with the State, whether any of the following criteria have been met:

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

ii. All appropriate Fund-financed (Hazardous Substance Superfund Response Trust Fund) response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

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

Even if a site is deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the deleted site above levels that allow for unlimited use and unrestricted exposure, CERCLA section 121(c), 42 U.S.C. 9621(c), requires that a subsequent review of the site be conducted at least every five years after the initiation of the remedial action at the deleted site to ensure that the action remains protective of public health and the environment. If new information becomes available which indicates a need for further action, EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to deletion of the Site:

(1) The EPA consulted with NMED on the deletion of the Site from the NPL prior to developing this direct final deletion.

(2) The NMED concurred with deletion of the Site from the NPL.

(3) Concurrently with the publication of this direct final deletion, a notice of the availability of the parallel notice of intent to delete published today in the “Proposed Rules” section of the Federal Register is being published in a major local newspaper of general circulation at or near the Site and is being distributed to appropriate federal, state, and local government officials and other interested parties; the newspaper notice announces the 30-day public comment period concerning the notice of intent to delete the Site from the NPL.

(4) The EPA placed copies of documents supporting the deletion in the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely notice of withdrawal of this direct final deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.

The following information provides EPA's rationale for deleting the Site from the NPL:

The Site is located in Grant County, in southwestern New Mexico, approximately 5.5 miles northeast of Silver City, New Mexico. The Site includes approximately 4 acres in mountainous terrain and 14 acres which extend down a drainage area into the streambed of Little Walnut Creek. The surrounding property is located in a rapidly developing residential area that is adjacent to the Gila National Forest and private lands. The population within a 3-mile radius of the Site is estimated to be 1,200.

The Site is a former ore processing mill area adjacent to the Cleveland Mine. The Cleveland Mine, located approximately 0.5 mile northeast of the mill area, is one of the Cleveland Group of Mines located in the West Pinos Altos Mining District. The first of the Cleveland Mining claims was staked in the early 1900s and included a milling operation at the Site. The milling operation employed a gravity separator until 1916, and a flotation process from 1916 until at least 1919. Approximately 125,000 tons of lead, zinc, and copper ore were produced from the Cleveland Mine during the period from about 1900 until 1919. After this time, the site was leased for mining and grazing. The tailings from the milling operations were deposited at the headwaters of the Little Walnut Creek and both the soil and the surface water were contaminated with Site-related hazardous substances.

The Site was proposed for inclusion on the NPL on June 24, 1988, and inclusion was finalized on March 31, 1989, pursuant to section 105 of CERCLA, 42 U.S.C. 9605, identifying the Site as a priority for long-term remedial evaluation and response.

From August 1990 through March 1992, NMED, under an agreement with EPA, conducted a Remedial Investigation (RI) at the Cleveland Mill Superfund Site to determine the nature and extent of the problem presented by the release of hazardous substances, pollutants or contaminants at the Site. Hazardous substances were detected in soil and other surface materials at the site at concentration levels that exceed health-based standards: arsenic ranged from 4.1 to 3,020 milligrams per kilogram (mg/kg); beryllium ranged from 0.25 to 12.8 mg/kg; cadmium ranged from 0.15 to 376 mg/kg; lead ranged from 5.8 to 13,500 mg/kg; and zinc ranged from 57.3 to 122,000 mg/kg. The NMED also conducted a Feasibility Study (FS) on the Site, under an agreement with EPA. The primary objective of the FS, completed in March 1993, was to ensure that appropriate remedial alternatives were developed and evaluated such that relevant information concerning the remedial action options could be presented to a decision-maker (in this case the EPA Region 6 Regional Administrator) and an appropriate remedy selected.

On April 9, 1993, the EPA released the RI and FS Reports. The RI concluded that if no action was taken at the Site, there would be a threat to human health because Site visitors may be exposed to dangerous concentrations of hazardous substances in tailings, sediment, and surface water at the Site. Moreover, there was a potential for the wells of nearby residents to become contaminated. These residents rely on ground water for drinking.

On September 24, 1993, after consideration of public comments, the EPA, with the concurrence of the NMED, issued a Record of Decision (ROD) memorializing its selection of a remedy to address the contamination at the Site. The remedy was chosen in accordance with CERCLA and the NCP. The ROD was based on the administrative record for the Site. The overall Site remedy, as described in the 1993 ROD, called for excavation of the contaminated mill waste material, transportation of the waste material to a reprocessor for treatment, and disposal of the treatment residuals at the reprocessing facility in an area where other tailings and residuals from ore-processing were disposed. The remedy in the 1993 ROD did not include a remedy for the shallow on-site aquifer because the EPA believed that the contamination would attenuate once the source (i.e., the contaminated waste material) was removed. Therefore, the 1993 ROD included ground water monitoring, to ensure that the contamination did not worsen or spread to nearby residential wells prior to the excavation and removal of the source of the contamination, and to verify that the ground water quality improved once the source was removed.

In a June 1995, Consent Decree (CD), the participating companies agreed to implement the remedy specified in the 1993 ROD. However, the 1993 ROD remedy was not implemented because the search for an acceptable off-site disposal facility was ultimately unsuccessful, and because, during the search, unanticipated and powerful rainfall events caused hazardous substances from the Site to migrate in contaminated runoff. This unanticipated contaminant migration posed an immediate increased risk to human health and the environment.

On July 11, 1997, to address the immediate risk, the EPA, with the concurrence of the NMED, issued an Action Memorandum that authorized a time-critical removal action to physically address the Site contamination and to restore affected surface areas at the Site. The participating companies agreed to implement this removal action through an EPA Administrative Order on Consent (AOC) which became effective on September 23, 1997. As described below, the removal action included the excavation of the contaminated material, and the placement of that material in an on-Site containment cell. The field activities required by the AOC were completed on November 19, 1998, the date on which the seeds of native plants were sown on the last area of the Site in order to provide vegetative cover. Completion of the final AOC requirement occurred on December 10, 1998, the date the participating companies submitted the Removal Action Final Report which was accepted by EPA.

The cleanup activities at the Site were conducted from September 1997 through December 1998 during the time-critical removal action. The time-critical removal action included:

• Excavation of 164,960 cubic yards of contaminated tailings and sediment from the mine area, the mill area, and the streambed;

• Neutralization of the acidic excavated material through admixing with limestone;

• Disposal of the neutralized material in a limestone cell constructed at the Site;

• Covering of the cell with a multi-layered cap,

• Construction of erosion control measures such as terraces; and

• Reseeding of the disturbed areas of the Site and the disposal cell cap.

Contaminated materials were removed from Site soils and sediments until concentrations of contaminants remaining on the Site met the health-based remediation goals specified in the 1993 ROD (these goals were referred to as “Remedial Action Goals” in the ROD) and incorporated into the Action Memorandum as soil and sediment “cleanup levels.” Cleanup levels for soil and sediment included: arsenic, 30 milligrams per kilogram in soil (mg/kg); beryllium, 4 mg/kg; cadmium, 140 mg/kg; lead, 500 mg/kg; and zinc, 82,000 mg/kg. At the conclusion of the time-critical removal action, confirmatory samples were taken at all excavated areas of the Site to verify that all soils (including tailings) and sediment with concentrations of contaminants higher than the cleanup levels (i.e., the remediation goals established in the ROD) had been removed.

The environmental threat at the Site was addressed through this time-critical removal. As part of this removal, the waste material in the mill area and in the stream was excavated, the waste material was treated with limestone to neutralize its acidity, the treated material was disposed of in a limestone cell constructed at the Site, and the cell was covered by a multi-layered cap.

The EPA issued an Amended ROD for the Site on September 20, 1999, stating that no further response action was necessary; however, as explained in the Amended ROD, the continuation of ground water and surface water monitoring, operation and maintenance (O&M) of the constructed remedy, and implementation of the existing institutional controls will continue. The O&M activities include inspections to ensure that erosion does not compromise the remedy and to ensure that the revegetation efforts are successful. Institutional controls include restrictive covenants warning against the use of ground water and advising future owners about the risks of disturbing the cover and/or the underlying material.

The original selected remedy, the time-critical removal action and the remedy selected in the Amended ROD (collectively the “Site remedies”) are protective of public health and the environment, comply with federal and state requirements that are legally applicable or relevant and appropriate to the remedial action, and are cost effective. The Site remedies utilized permanent solutions to the maximum extent practicable for this Site. This Site meets all the completion requirements as specified in “Close Out Procedures for National Priorities List Sites,” OSWER Directive 9320.2-09A-P (2000), and in the June 16, 2000, Site Close Out Report prepared by the EPA Region 6 Superfund Division.

Because the implementation of the Site remedies resulted in hazardous substances remaining on-site at concentration levels above levels that allow for unlimited use and unrestricted exposure (see 42 U.S.C. 9621(c), and 40 CFR 300.430(f)(4)(ii)), a review will be conducted at least every five years after commencement of the remedial action (which, at this Site for the purposes of the five-year review only, is considered to be the start of the time-critical removal action) to assure that human health and the environment are being protected by the response action. The five-year reviews will be conducted pursuant to “Structure and Components of Five-Year Reviews,” OSWER Directive 9355.7-02 (May 23, 1991) and “Supplemental Five-Year Review Guidance,” OSWER Directive 9355.7-02A (July 26, 1994) or other EPA guidance current at the time of the review. All response activities have been completed at the Site other than O&M and five-year reviews.

Public participation activities have been satisfied as required by CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. Documents in the deletion docket which EPA relied on for its decision to delete the Site from the NPL are available to the public at the information repositories.

The EPA, with concurrence of the NMED, has determined that responsible parties have implemented all appropriate response actions required at the Site and that no further response actions, under CERCLA, other than O&M and five-year reviews, are necessary. Therefore, EPA is deleting the Site from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effective July 23, 2001 unless EPA receives adverse comments by June 21, 2001. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and it will not take effect and EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

EPA Region III is publishing this direct final deletion of the Brodhead Creek Superfund Site from the NPL.

The EPA identifies sites that appear to present a significant risk to public health or the environment and maintains the NPL as the list of those sites. As described in § 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for remedial actions if conditions at a deleted site warrant such action.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effective July 23, 2001 unless EPA receives adverse comments by June 21, 2001. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Brodhead Creek Superfund Site and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete the Site from the NPL unless adverse comments are received during the public comment period.

Section 300.425(e) of the NCP provides that releases may be deleted from the NPL where no further response is appropriate. In making a determination to delete a release from the NPL, EPA shall consider, in consultation with the State, whether any of the following criteria have been met:

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

ii. All appropriate Fund-financed (Hazardous Substance Superfund Response Trust Fund) response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

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

Even if a site is deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the deleted site above levels that allow for unlimited use and unrestricted exposure, CERCLA Section 121(c), 42 U.S.C. 9621(c) requires that a subsequent review of the site be conducted at least every five years after the initiation of the remedial action at the deleted site to ensure that the action remains protective of public health and the environment. If new information becomes available which indicates a need for further action, EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to deletion of the Site:

(1) The EPA consulted with the Commonwealth of Pennsylvania on the deletion of the Site from the NPL prior to developing this direct final deletion.

(2) The Commonwealth of Pennsylvania concurred with the deletion of the Site from the NPL.

(3) Concurrently with the publication of this direct final deletion, a notice of the availability of the parallel notice of intent to delete published today in the “Proposed Rules” section of the Federal Register is being published in a major local newspaper of general circulation at or near the Site and is being distributed to the appropriate federal, state, and local government officials and other interested parties; the newspaper notice announces the 30-day public comment period concerning the notice of intent to delete the Site from the NPL.

(4) The EPA placed copies of documents supporting the deletion in the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received.

Deletion of a Site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such action.

The following information provides EPA's rationale for deleting the Site from the NPL:

The Brodhead Creek Site occupies approximately 12 acres of a flood plain area on the western bank of Brodhead Creek at the confluence of Brodhead Creek and McMichael Creek in the Borough of Stroudsburg in Monroe County, Pennsylvania.

The Site is the former location of a coal gasification plant which operated from approximately 1888 to 1944. A waste product from these operations was a black tar-like liquid (“coal tar”) which has a density greater than water and which is principally composed of polynuclear aromatic hydrocarbons (“PAHs”). The coal tar was placed in an open pit located on the Site. This practice continued to the mid-1940s when the plant was abandoned.

On October 7, 1980, during construction repairs to the flood control levee at the Site, materials identified as coal tar were observed seeping into Brodhead Creek. As a result, several investigations and emergency response measures were initiated by EPA, PADEP, and Pennsylvania Power and Light Company (PP&L) from 1981 through 1984, including: (1) Installation of temporary filter fences and underflow dams to intercept coal tar seepage; (2) installation of a temporary coal tar recovery pit on the west bank of Brodhead Creek; (3) construction of a slurry wall by EPA to mitigate coal tar migration from the Site toward Brodhead Creek; (4) excavation of a backwater channel area where coal tar seepage appeared to be particularly significant; and (5) installation of recovery wells in the main coal tar pool by PP&L, with the subsequent recovery of approximately 8,000 gallons of coal tar.

The Site was placed on the NPL in December 1982, with a Hazard Ranking Score of 31.09.

On August 20, 1987, PP&L and Union Gas Company (UGC) entered into a Consent Order and Agreement with the Commonwealth of Pennsylvania to conduct the original remedial investigation and feasibility study (RI/FS) for the Brodhead Creek Site. The original RI/FS was completed in 1991.

The results of the original RI indicated that coal tar from the former coal gasification operations had migrated vertically through the unsaturated and saturated portions of the stream gravel unit underlying the Site to the interface with the silty sand. The silty sand prevents further downward movement of the coal tar because of the higher capillary pressures within that unit. Approximately 4.28 acres of the gravel unit at the Site were contaminated with free and residual coal tar. The free coal tar (i.e., coal tar at 100% pore volume saturation) is limited to a small area of a stratigraphic depression east of the slurry wall near monitoring well MW-2 (the MW-2 Area) and to the lowest portion of the stratigraphic depression located west of the slurry wall (the RCC Area). Both of these free coal tar accumulations are confined from further downward migration by the top of the silty sand unit. Residual coal tar (i.e., coal tar at less than 100% pore volume saturation) can be found throughout the remainder of the 4.28 acres.

The total volume of free coal tar at the Site was estimated to be 9,000 gallons, 8,715 gallons at the RCC Area and 338 gallons at the MW-2 Area. The extent of residual coal tar contamination at the Site was estimated to be from 303,000 gallons to 409,000 gallons.

The risk assessment in the original RI identified PAHs, benzene, and arsenic as the primary contaminants of concern at the Site. Federal Maximum Contaminant Levels (MCLs) for drinking water established pursuant to the Safe Drinking Water Act, 42 U.S.C. 300f et seq. , were exceeded for arsenic, benzene, and benzo(a)pyrene in the subsurface gravel unit. Proposed MCLs were exceeded in the ground water in the gravel unit for the following PAHs: benzo(a)anthracene; benzo(b)fluoranthene; benzo(k)fluoranthene; chrysene, dibenz(a,h)anthracene; and indenopyrene. These PAHs, as well as arsenic and benzene, are “hazardous substances” as defined in Section 101(14) of CERCLA.

After reviewing the results of the original RI/FS, EPA divided the remedial work to be undertaken at the Site into two operable units (“OUs”). These were as follows:

EPA determined that an interim remedial action should be taken for OU-1 to initiate reduction of the toxicity, mobility, and volume of contaminants in the stream gravel unit at the Site. The interim remedial action would entail the removal of the free coal tar from the stream gravel unit. The free coal tar was a principal threat to human health and the environment since it imparted high levels of contaminants to the ground water in the stream gravel unit and could serve as a potential source of release of contamination to the ground water in bedrock. Implementation of an interim remedial action would remove the source of the highest level of contamination and would reduce further leaching of contaminants into the ground water. Data generated during the implementation of the interim action and further investigations for OU-2 would provide the information necessary to assist EPA in determining whether (and where) restoration of ground water to beneficial use was feasible. This in turn would enable EPA to issue a final Record of Decision for the Brodhead Creek Site.

In a Record of Decision (ROD) issued on March 29, 1991, EPA selected an interim remedial action for OU-1 which included the following major components:

On September 2, 1992, EPA, PP&L and UGC entered into a Consent Decree under which the companies agreed to implement the remedial design/remedial action (RD/RA) for OU-1 at the Site. The original performance standard in the ROD required that at least 60% of the free coal tar in the subsurface soils be removed. On July 14, 1994, EPA issued an Explanation of Significant Differences (ESD) which revised the performance standard in the ROD by requiring the operation of the CROW process until the increase in cumulative recovery of the coal tar dropped to 0.5% or less per pore volume flushed through the formation. This revision of the performance standard was based on EPA's determination that accurate measurement of the removal of 60% of the free coal tar would not be possible because of the geology of the Site and the nature of the subsurface coal tar contamination. By June of 1996, approximately 1,500 total gallons of coal tar had been removed from the RCC Area and the performance standard had been met.

EPA determined during the CROW operational period that it would not be practical to implement CROW at the MW-2 Area (the area located at monitoring well MW-2) since the MW-2 Area contained only a small amount of free coal tar. Instead, EPA determined that the relatively minor amount of coal tar in the MW-2 Area wells should be removed via intermittent pumping. Approximately 100.5 gallons of coal tar were recovered from the MW-2 Area between February 1996 and March 1997.

Because of the variable nature of the coal tar recovery effort at the MW-2 wells, EPA determined that continued active intermittent pumping of the MW-2 wells could be suspended. However, as part of operation and maintenance of the Site, EPA has required that the MW-2 wells, and any wells in the RCC Area that have historically contained coal tar, be monitored for a free coal tar surface as part of the long-term ground water monitoring requirement at the Site. If a coal tar layer greater than six inches is discovered, it will be removed by pumping at that time.

These changes for the MW-2 Area were documented in a second Explanation of Significant Differences dated September 30, 1997. This second ESD also converted the interim remedy in the ROD for OU-1 into the final remedy for the Site and described the long-term monitoring strategy for the Site.

On June 3, 1992, EPA, PP&L and UGC entered into a Consent Order under which the companies agreed to conduct a Focused RI/FS for OU-2 to further investigate ground water contamination at the Site. On June 30, 1995, EPA issued a ROD for OU-2 at the Brodhead Creek Site. This ROD addressed ground water contamination and residual coal tar contamination in the subsurface soils. In the ROD for OU-2, EPA selected a No Further Action alternative and established a technical impracticability (“TI”) zone within which the Agency determined it would be impracticable to remediate ground water and residual coal tar contamination. EPA waived federal MCLs and Pennsylvania's Applicable or Relevant and Appropriate Requirement (ARAR) for cleanup to “background” levels of contamination on the basis of “Technical Impracticability.” Several Site-specific constraints made the implementation of engineering solutions to the residual coal tar contamination impracticable. As stated in the OU-2 ROD, these included: (1) the need to temporarily reroute Brodhead Creek to access coal tar-impacted soils beneath the creek bed; (2) the need to reinforce the existing interstate I-80 bridge abutments in order to protect them from the increased velocity and height of the creek which would result from rerouting the creek; and (3) the need to restore wetlands which would be impacted by any remediation alternative. In addition, the existing earthen levee which currently bisects the Site, and which protects the Borough of Stroudsburg and the slurry wall installed by EPA as an emergency action in the early 1980s, would probably sustain damage from the implementation of any engineering alternative, and require repair.

In the ROD for OU-2, EPA determined that the No Further Action alternative, in conjunction with the OU-1 selected remedy, is protective of human health and the environment. Implementation of the OU-1 enhanced recovery program for the free coal tar areas on-site reduced the areas of highest subsurface soil contamination. The OU-1 monitoring program will provide the data required to evaluate the fate of the coal tar-related constituents, the integrity of the slurry wall and the “health” of the biological community in Brodhead Creek. This will provide long term protection against the unlikely event that Site conditions might change and potential exposures increase. In addition, the slurry wall installed at the Site will continue to prevent free coal tar from discharging to Brodhead Creek.

Operation and Maintenance (O&M) activities, which are performed by PP&L(now known as PPL Electric Utilities Corporation (PPL)) with EPA oversight, include periodic inspections, ground water monitoring, stream sediment and biota monitoring, and the removal of relatively minor amounts of free coal tar from the two stratigraphically isolated areas of the Site, as necessary, but no less often than annually, and any other activities necessary to ensure continued protection of public health and the environment. The free coal tar removal, in conjunction with long-term ground water monitoring, will continue to ensure the effectiveness of the completed remedy at the Brodhead Creek Site.

CERCLA requires a five-year review of all sites with hazardous substances remaining above the health based levels for unrestricted use of the Site. Since residual coal tar contamination and ground water contamination remain at the Site, the five-year review process will be used to ensure that the selected remedy continues to be protective of human health and the environment. EPA completed the first five-year review of the Brodhead Creek Site on May 28, 1999. In that five-year review, EPA determined that the remedy was not completely protective of human health and the environment because institutional controls on future land use at the Site had not yet been implemented. On September 22, 2000, institutional controls which limit future land use at the Brodhead Creek Site were implemented by PPL and UGC (now known as PFG Gas, Inc.), and recorded at the Monroe County Courthouse, Recorder of Deeds Office, in Stroudsburg, Pennsylvania. These controls include restricting use of ground water at the Site and prohibiting excavation at the Site unless prior written approval is provided by the property owner, EPA, and PADEP. These institutional controls will reinforce the protectiveness of the selected remedy. EPA has determined that all requirements of the ROD for OU-1, as modified by the ESDs dated July 14, 1994 and September 30, 1997, have been achieved at the Site and the Site is protective of human health and the environment. EPA plans to complete the next five year review prior to May 28, 2004.

Public participation activities have been satisfied as required in CERCLA Section 113(k), 42 U.S.C. 9613(k), and CERCLA Section 117, 42 U.S.C 9617. Documents in the deletion docket which EPA relied on for recommendation of the deletion from the NPL are available to the public in the information repositories.

The EPA, with the concurrence of the Commonwealth of Pennsylvania, has determined that all appropriate responses under CERCLA have been completed, and that no further response actions, under CERCLA, other than O&M and five-year reviews, are necessary. Therefore, EPA is deleting the Site from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effective July 23, 2001 unless EPA receives adverse comments by June 21, 2001 on this document. If adverse comments are received within the 30-day public comment period on this document to delete, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

EPA—New England is publishing this direct final notice of deletion of the Salem Acres Superfund Site from the NPL.

The EPA identifies sites that appear to present a significant risk to public health or the environment and maintains the NPL as the list of those sites. As described in § 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for remedial actions if conditions at a deleted site warrant such action.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will be effective July 23, 2001 unless EPA receives adverse comments by June 21, 2001 on this document. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses the procedures that EPA is using for this action. Section IV discusses the Salem Acres Superfund Site and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete the site from the NPL unless adverse comments are received during the public comment period.

Section 300.425(e) of the NCP provides that release may be deleted from the NPL where no further response is appropriate. In making a determination to delete a release from the NPL, EPA shall consider, in consultation with the State, whether any of the following criteria has been met:

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

(ii) All appropriate Fund-financed (Hazardous Substance Superfund Response Trust Fund) response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

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

Even if a site is deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the deleted site above levels that allow for unlimited use and unrestricted exposure, CERCLA Section 121(c), 42 U.S.C. 9621(c) requires that a subsequent review of the site will be conducted at least every five years after the initiation of the remedial action at the deleted site to ensure that the action remains protective of public health and the environment. In the case of this Site, a five year review is not necessary since all hazardous substances, pollutants and contaminants have been removed from the Site. If new information becomes available which indicates a need for further action, EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without the application of the hazard ranking system.

The following procedures apply to deletion of the Site:

(1) The EPA consulted with the Commonwealth of Massachusetts on the deletion of the Site from the NPL prior to developing this direct final deletion.

(2) The Commonwealth of Massachusetts concurred with the deletion of the Site from the NPL.

(3) Concurrently with the publication of this direct final deletion, a notice of the availability of the parallel notice of intent to delete published today in the “Proposed Rules” section of the Federal Register is being published in a major local newspaper of general circulation at or near the Site and is being distributed to appropriate federal, state and local government officials and other interested parties; the newspaper notice announces the 30-day public comment period concerning the notice of intent to delete the Site from the NPL.

(4) The EPA places copies of the documents supporting the deletion in the Site information repositories identified.

(5) If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely notice of withdrawal of this direct final deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.

The following information provides EPA's rationale for deleting the Site from the NPL:

The Salem Acres Superfund Site (Site) is an approximately two hundred and thirty-five (235) acre parcel of land located in the Cities of Peabody and Salem, Massachusetts. The entire Site is zoned residential but remains undeveloped. The actual contaminated portion of the Site was confined to the southernmost thirteen acres of the property. This area borders a residential area to the south, wetlands to the east and west and undeveloped upland to the north.

The contaminated area consisted of three adjacent and separate disposal areas. There is a Responsible Party (RP) associated with each area. The first area where hazardous substances were located consisted of eight unlined sludge lagoons containing industrial sewage sludge originating from and disposed of by the South Essex Sewerage District (SESD), a wastewater treatment plant located in Salem, MA. The second area containing hazardous substances consisted of a coal fly ash pile disposed of by the Massachusetts Electric Company (MEC). Disposal activities by SESD and MEC occurred between the mid 1940's and 1969. The third and final area containing hazardous substances included an old landfill and three debris piles (collectively Landfill) which existed prior to the present ownership of the property. The owner of the property, Ugo DiBiase Salem Realty Trust (DiBiase) is the RP for the Landfill. Generation and disposal of the landfill and debris piles is not known. Although DiBiase did not contribute any waste to the Site, it was deemed liable by virtue of property ownership and failing to take any action to minimize exposure to contaminants. Operable Unit No. 1 includes the entire Site.

EPA conducted two Emergency Removal Actions (ERAs) at the Site, one in 1987 and one in 1990. EPA funded the first action and a portion of the second action with SESD performing and funding the remaining portion of the second action. The first action consisted of lagoon water removal and disposal, capping the lagoons, constructing a slurry wall and provide fencing to preclude site access. The second action consisted drum repacking and storage, fence and gate replacement and installation of signs.

The SESD completed a site-wide Remedial Investigation (RI) on May 29, 1992. They then conducted a Feasibility Study (FS) which was completed in June 1992. Results of the RI showed the nature and extent of contamination and assessed the associated risks from exposure. The contaminants of concern include polynuclear aromatic hydrocarbons (PAHs), polychlorinated biphenyls PCBs, dioxins/furans, volatile organic compounds (VOCs), semi-VOCs (sVOCs), chromium, arsenic, beryllium, vanadium and thallium. The concentration levels for the dioxin equivalent 2,3,7,8-TCDD found during the RA were below the cleanup level of 1 part per billion. The primary exposure pathways for both existing and future land use (residential) that showed unacceptable risk include: ingestion, dermal contact and inhalation of (airborne particulates originating from) sludge, fly ash and contaminated soil.

The FS developed and evaluated various remedies for each contaminated area, including RCRA capping, incineration, immobilization, thermal desorption, solvent extraction, in-situ vitrification, sludge fixation, excavation and off-site disposal.

A Record of Decision (ROD) was signed on March 25, 1993. The ROD required a preferred remedy of soil/sludge fixation, excavation and off-site disposal at a permitted landfill. Implementation of the preferred remedy required that certain conditions be met which included that the waste must be classified as non-hazardous under RCRA before shipment off-site. If these conditions could not be met, the ROD required construction of a RCRA cap over the hazardous substances to minimize possible exposure, implementation of institutional controls and long term monitoring to assure cap integrity. All areas to be remediated on Site are identified as Operable Unit No. 1. If the preferred remedy proved to be feasible, then no institutional controls or long term monitoring would be required.

On April 11, 1997, EPA issued an Explanation of Significant Difference (ESD). Based on updated toxicity data regarding carcinogenic polyaromatic hydrocarbons (cPAHs), EPA recalculated cleanup values for soils using this new information. The cleanup risk value established in the ROD for the Site was held constant, providing the same level of protectiveness. Each cPAH was given a separate cleanup value rather than a total cPAH value 1.2 parts per million (ppm) provided in the ROD. In addition, EPA calculated a new cleanup value for beryllium after a background study was performed. EPA redefined the background concentration of beryllium in soils as 1.0 ppm and revised the cleanup level from 0.42 ppm to 1.0. The excess lifetime cancer risk resulting from exposure to 1 ppm beryllium in soils given the exposure scenario and assumptions specified in the HRA is 2 × 10 -6 which is consistent with EPA's goal for remedial actions (clean up to within the acceptable risk range of 1 × 10 -4 to 1 × 10 -6 ).

The risk assessment performed as part of the RI for existing and future use scenarios determined that unacceptable risks exist from exposure to cPAHs, PCBs, dioxins/furans, VOCs, sVOCs, chromium, arsenic, beryllium, vanadium and thallium. The primary exposure pathways for both existing and future land use (residential) that showed unacceptable risk include: ingestion, dermal contact and inhalation of (airborne particulates originating from) sludge, fly ash and contaminated soil.

Each of the three RPs entered into separate Consent Decrees to pay for past costs expended at the Site, all future costs incurred at the Site and to perform separate remedial designs (RDs) (SESD and MEC only) and remedial actions (RAs) for each responsible area. The U.S. Army Corps of Engineers, on behalf of the EPA, performed the RD for the Landfill with Fund-lead monies. Just prior to the start of a fund lead RA, DiBiase entered into a Consent Decree to perform the RA and to cover certain past and all future costs associated with its cleanup. All future costs incurred by EPA and DEP for each of the three RD/RAs were covered by each respective RP. EPA retained the Corps to provide design review and evaluation, oversight of the remedial actions, including evaluation of quality assurance/quality control (QA/QC) procedures, performance standards and verified that the validated data met the established data quality objectives (DQOs) for each project.

For the first RA, DiBiase excavated approximately 2,000 cubic yards (cy) of material and disposed of it at an off-site permitted landfill. During the remedial action, fly ash was shown to be present well into the landfill. DiBiase removed approximately 1,500 cy of fly ash and MEC agreed to incur the costs associated with this work. Final site restoration of the Landfill and debris piles was performed in the spring of 1996.

MEC commenced RA activities in August 1995 and was substantially completed but discontinued in December 1995 at the boundary of the fly ash area and the adjacent wetland. Approximately 11,000 cy of fly ash and approximately 6,100 cy of adjacent contaminated soils were excavated and shipped off-site to a permitted special waste landfill located in New Hampshire. Site restoration was performed in the spring of 1996.

MEC excavated the remaining fly ash found in the wetlands in August 1999. Approximately 1,000 cy of fly ash was removed from the wetland and shipped off-site to an appropriate landfill. Restoration of the wetland included seeding the slopes with an appropriate wetland soils and seed mix. A final inspection was performed on August 18, 1999. This is the date for which all construction activities were considered complete for the entire Site.

SESD performed treatability tests for the fixation of the sludges during the pre-design phase. The purpose of fixation was to render any ignitable sludges non-ignitable. The treatability study shown that the sludges were non-ignitable and non-RCRA toxic and thus not RCRA-characteristic hazardous waste. SESD implemented the remedy of excavation and off-site disposal. The remedial work commenced in September 1996 and substantially completed in September 1997. Final site restoration was completed in the spring of 1998. A final site inspection for the sludge areas occurred on April 29, 1999.

A total of 28,755 tons of sludge were excavated and disposed of off-site at a permitted solid waste disposal facility located in Maine. A total of 60,304 tons of soil were excavated and disposed of at a solid waste disposal facility in Massachusetts. The slurry wall, sludge lagoon HDPE covers installed during the 1987 ERA and other demolition debris were also removed and sent to the Massachusetts disposal facility. A total of approximately 7.5 million gallons of site water accumulated in the excavated areas were collected and discharged to the SESD treatment plant for treatment via municipal sewer. The water was tested regularly to ensure compliance with the plant's pre-treatment limits. The high volume of water that accumulated in the excavated areas was due to the occurrence of a hundred year storm event, unanticipated depth of excavation and contractor delays based on cost claims with SESD.

Each of the RPs monitored surface water and sediments in the wetlands prior to and after their remediation. SESD was also tasked to monitor Site ground water during and after remediation. The last and final ground water sampling event occurred in May of 1999. The results showed that ground water was not impacted by any remediation. Ground water had also not been impacted by past disposal of materials at the Site.

Remedial action cleanup activities at the Site were consistent with the NCP, the ROD, the ESD and with each RD/RA Consent Decree and provides protection to human health and the environment. RD/RA plans for all phases of construction included a Quality Assurance Project Plan (QAPPs) and incorporated all EPA and State quality assurance and quality control procedures and protocols (where necessary). All procedures and protocol were followed for soil, sediment, water and air sampling during the RA. EPA analytical methods were used for the confirmatory and monitoring samples during all RA activities. EPA has determined that the analytical results, having been Tier III validated, are accurate to the degree needed to assure satisfactory execution of each RA, show that the cleanup standards have been met, and are consistent with the ROD/ESD and the RD plans and specifications.

The Site has been entirely cleaned up in accordance with the ROD, the ESD and the three CDs. There will be no need for operation and maintenance activities at the Site. The Site requires no institutional controls and now provides for unrestricted use. The Site is zoned as residential. The landowner has informally suggested that he may build multi-family residences on the Site but at the time of this writing, no definitive or formal plans have been made public.

No hazardous substances remain at the site above health-based levels after the completion of all remedial actions. Therefore, pursuant to CERCLA Section 121(c) and as provided in OSWER Directive 9355.7-02, Structure and Components of Five-Year Reviews, May 23, 1991 and OSWER Directive 9355.702A, Supplemental Five-Year Review Guidance, July, 26, 1994, five year reviews will not be necessary.

Public participation activities have been satisfied as required in CERCLA Section 113(k), 42 U.S.C. 9613(k), and CERCLA Section 117, 42 U.S.C. 9617. Documents in the deletion docket which EPA relied on for recommendation of the deletion from the NPL are available to the public in the information repositories.

Informal public meetings were held in the neighborhood prior to and after each remedial action. Representatives from EPA, MADEP and the RPs with their consultants and contractors were present. These meetings proved to be extremely helpful in providing the public, especially the immediate neighborhood residents who would be most affected, with important information regarding activities associated with each remedial action. These meetings were also particularly useful for the agencies and the RPs in hearing and addressing the residents' concerns regarding on-site and off-site activities. Some examples of what the agencies and the RPs implemented as a result of these meetings included: prohibiting truck traffic before 8 a.m. and after 5 p.m. and during school bus pickup and drop off periods; setting a speed limit of 15 m.p.h. for all site-related vehicles on residential streets; daily street cleaning; air monitoring at the site gate adjacent to the neighborhood and the RPs agreeing to repave the neighborhood roadway used to transport wastes off-site.

The EPA, with concurrence from the Commonwealth of Massachusetts, has determined that all appropriate responses under CERCLA have been completed, and that no further response actions, under CERCLA are necessary. Therefore, EPA is deleting the Site from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication of a notice of intent to delete. This action will become effective July 23, 2001 unless EPA receives adverse comments by June 21, 2001. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and it will not take effect and, EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

The Environmental Protection Agency, Region 8 announces its deletion of a portion of the California Gulch Superfund Site (Site), located in Lake County, Colorado from the National Priorities List (NPL), which constitutes appendix B of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300, and requests comments on this proposal. This partial deletion pertains to Operable Unit 2 (OU 2), which consists of the Lower Malta Gulch Fluvial Tailing, Leadville Corporation Mill, Malta Gulch Tailing Impoundment, and the Malta Tailing Impoundment.

The Site is divided into 12 Operable Units (OUs) pursuant to agreement reached in a 1994 Consent Decree settlement. The 12 OUs comprising the California Gulch Site are as follows:

1. Yak Tunnel/Water Treatment Plant.

2. Malta Gulch Tailing Impoundments and Lower Malta Gulch Fluvial Tailing.

3. D&RG Slag piles and Railroad Yard/Easement.

4. Upper California Gulch.

5. Asarco Smelter sites/Slag/Mill sites.

6. Starr Ditch/Stray Horse Gulch/Lower Evans Gulch/Penrose Mine Waste Pile.

7. Apache Tailing Impoundments.

8. Lower California Gulch.

9. Residential and Commercial Populated Areas.

10. Oregon Gulch.

11. Arkansas River Valley Floodplain.

12. Site-wide Water Quality.

OUs 2 through 11 were designated in order to facilitate source remediation of specific geographic areas. OUs 2 through 11 pertain to distinct geographical areas corresponding to areas of responsibility for the identified responsible parties with EPA taking responsibility for areas where no responsible party could be identified, the United States was a responsible party, or cash-out settlements had been reached with the responsible parties. OU 12, which covers the entire Site was designated to address Site-wide surface and groundwater after completion of source remediation pursuant to OUs 2 through 11. EPA is deleting the areas addressed by OU 2 because all appropriate CERCLA response actions have been completed in these areas as described in Section IV. However, response activities are not complete for the other areas. Therefore, those areas will remain on the NPL and are not the subject of this partial deletion.

The NPL is a list maintained by EPA of sites that EPA has determined present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). Pursuant to 40 CFR 300.4-25(e) of the NCP, any site or portion of a site deleted from the NPL remains eligible for Fund-financed remedial actions if conditions at the site warrant such action.

EPA will accept any dissenting comments on this partial deletion for thirty days following publication of this document in the Federal Register .

The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate to protect public health or the environment. In making such a determination pursuant to § 300.425(e), EPA will consider, in consultation with the State, whether any of the following criteria have been met:

• Section 300.425(e)(1)(i). Responsible parties or other persons have implemented all appropriate response actions required; or

• Section 300.425(e)(1)(ii). All appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

• Section 300.425(e)(1)(iii). The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, taking of remedial measures is not appropriate.

Deletion of an operable unit at a site from the NPL does not preclude eligibility for subsequent Fund-financed actions at the operable unit deleted, it future site conditions warrant such actions. Section 300.425(e)(3) of the NCP provides that Fund-financed actions may be taken at sites that have been deleted from the NPL. A partial deletion of a site from the NPL does no affect or impede EPA's ability to conduct CERCLA response activities at operable units not deleted and remaining on the NPL. In addition, deletion of a portion of a site from the NPL does not affect the liability of responsible parties or impede agency efforts to recover costs associated with response efforts.

Deletion or partial deletion of sites from the NPL does not itself create, alter, or revoke any individual's rights or obligations. The NPL is designed primarily for informational purposes and to assist EPA management. The following procedures were used for the partial deletion of this site:

(1) EPA, Region VIII has recommended the partial deletion of the California Gulch Site and has prepared the relevant documents.

(2) The State of Colorado, through the Colorado Department of Public Health and Environment (CDPHE) has concurred with EPA's recommendation for a partial deletion.

(3) Concurrent with this partial deletion, a public notice has been published in a local newspaper and has been distributed to appropriate Federal, State and local officials, and other interested parties. These notices announce a thirty (30) day public comment period on the deletion package, which commences on the date of publication of this document in the Federal Register and a newspaper of record.

(4) EPA, Region VIII has made all relevant documents available in the Regional Office, Superfund Record Center.

EPA is requesting only dissenting comments on the Direct Final Action to Delete. For deletion of the release from the Site, EPA's Regional Office will accept and evaluate public comments on EPA's action before making a final decision to delete. If necessary, the Agency will prepare a Responsiveness Summary, responding to each significant comment submitted during the public comment period. Deletion of the Site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. The NPL is designed primarily for informational purposes and to assist Agency management. As mentioned in section II of this document, § 300.425 (e)(3) of the NCP states that the deletion of a release from a site from the NPL does not preclude eligibility for future response actions.

The following provides EPA's rationale for deletion of OU 2 from the NPL and EPA's findings that the criteria in 40 CFR 300.425(e) are satisfied.

The California Gulch Superfund Site is located in Lake County, Colorado approximately 100 miles southwest of Denver. The California Gulch Superfund Site was listed on the National Priorities List on September 8, 1983. The Site is in a highly mineralized area of the Colorado Rocky Mountains covering 16 1/2 square miles of a watershed that drains along California Gulch to the Arkansas River. Mining, mineral processing, and smelting activities have occurred at the Site for more than 130 years. The Site includes the City of Leadville, various parts of the Leadville Historic Mining District, and a section of the Arkansas River from the confluence of California Gulch to the confluence of Lake Fork Creek.

A site-wide Phase I Remedial Investigation (Phase I RI), which primarily addressed surface and groundwater contamination, was issued in January 1987. As a result of the Phase I RI, EPA developed the first operable unit at the Site, the Yak Tunnel. This first operable unit was designed to address the largest single source of metallic loading.

The Phase I RI was followed by a number of additional site-wide studies, including the Tailing Disposal Area Remedial Investigation Report, Baseline Human Health Risk Assessment Part A, Part B, and Part C, Ecological Risk Assessment for Terrestrial Ecosystems, Baseline Aquatic Ecological Risk Assessment, Groundwater RI, Surface Water RI, Waste Rock RI, and Site-wide Screening Feasibility Study. In addition, OU 2 specific studies were conducted, including the Malta Gulch Tailing Engineering Evaluation/Cost Analysis and studies conducted by the Hecla Mining Company (Hecla).

In order to expedite the clean-up of the Site, EPA agreed, pursuant to a 1994 Consent Decree settlement, to divide the Site into eleven additional Operable Units. With the exception of OU 12, the operable units pertain to distinct geographical areas corresponding to areas of responsibility for the identified responsible parties and/or to distinct sources of contamination. EPA has taken responsibility for operable units where no responsible party could be identified, the United States was a responsible party, or cash-out settlements had been reached with the responsible parties. Under the settlement agreement reached in 1994, OUs 2 through 11 were designated to deal with areas where the appropriate responsible party or the United States would conduct source remediation. The settlement agreement recognized that additional source remediation or other appropriate response actions related to surface or ground water could occur as part of OU 12 anywhere within the 16.5 square mile of the Site. The OUs are as follows:

1. Yak Tunnel/Water Treatment Plant.

2. Malta Gulch Tailing Impoundments and Lower Malta Gulch Fluvial Tailing.

3. D&RG Slag piles and Railroad Yard/Easement.

4. Upper California Gulch.

5. Asarco Smelter sites/Slag/Mill sites.

6. Starr Ditch/Stray Horse Gulch/Lower Evans Gulch/Penrose Mine Waste Pile.

7. Apache Tailing Impoundments.

8. Lower California Gulch.

9. Residential and Commercial Populated Areas.

10. Oregon Gulch.

11. Arkansas River Valley Floodplain.

12. Site-wide Surface and Ground Water.

The source areas to be addressed by OU 2 included the Malta Gulch Tailing Impoundments, including the Leadville Corporation Mill; the Malta Tailing Impoundment, including the Leadville Silver & Gold Mill facility; and the fluvial tailing in the area known as the Lower Malta Gulch. Pursuant to settlements reached with the responsible parties at each of these properties, EPA is responsible for conducting the appropriate response actions at these properties.

EPA performed four (4) removal/response actions at these sites. In chronological order, the fluvial tailing in Lower Malta Gulch were excavated from the Gulch and placed in a portion of the Malta Gulch Tailing Impoundment. These materials were graded, capped and revegetated. The remainder of the Malta Gulch Tailing Impoundment was capped in 1992 by Leadville Corporation to control fugitive dust emissions. The material in the Malta Tailing Impoundment (Leadville Silver & Gold) was graded, capped and revegetated. And, forty-two drums were removed from the Leadville Corporation Mill and appropriately disposed.

On September 30, 1999, after completion of the removal actions, EPA issued a Record of Decision for OU 2 presenting EPA's decision that no further CERCLA action, as regards source remediation, is necessary to protect human health and the environment. The OU 2 ROD also provided for long-term monitoring of the Impoundments, including monitoring of the present use restrictions to prevent uses incompatible with the response actions would be necessary at the Malta Gulch Tailing Impoundment and the Malta Tailing Impoundment. Monitoring may include minor maintenance. Monitoring and any minor maintenance will be implemented by the Colorado Mountain College and through funds received by the United States in a settlement with a potentially responsible party. In the event that significant maintenance issues are identified by the Colorado Mountain College, EPA will take appropriate action to ensure protectiveness of the remedy. In addition, five-year reviews are also necessary for these sites.

The fluvial tailings in Lower Malta Gulch, also identified as Fluvial Tailing #7 in the Tailing Disposal Area Remedial Investigation Report, lie directly downstream of the Malta Gulch Tailing Impoundments. Malta Gulch runs in a southwesterly direction for about three miles where it joins California Gulch.

The fluvial tailing in Lower Malta Gulch originated from the milling operations conducted by the Ore & Chemical Company (OCC) from the fall of 1943 through August 1946. OCC had constructed a large tonnage sink-float mill near the site of the present day Leadville Corporation Mill. OCC deposited approximately 800,000 tons of tailing behind low profile berms. These berms appear to have been unsuccessful in completely containing the tailing and there appears to have been periodic releases of OCC tailing into the Lower Malta Gulch.

Fluvial Tailing Site #7 covered an area of approximately 26 acres. Sampling at this site found lead levels ranging from 5.5 to 47,800 parts per million (ppm). The Time Critical Removal Action for Lower Malta Gulch Fluvial Tailing was performed in the 1995 and 1996 construction seasons. The materials excavated from Lower Malta Gulch Fluvial Tailing were disposed at the Malta Gulch Tailing Impoundment prior to the Non-Time Critical Removal Action which was planned for Malta Gulch Tailing Impoundment in 1996.

During the 1995 construction season, approximately 34,000 cubic yards of contaminated material was removed from Lower Malta Gulch Fluvial Tailing and deposited in the Malta Gulch Tailing Impoundment. Four check dams, and a diversion berm between the upper and lower portions of Malta Gulch were constructed to manage surface runoff. Revegetation work in Malta Gulch was performed in 1996.

The clean-up standard for this removal was the industrial/commercial clean-up level for California Gulch of 6,700 ppm total lead. Confirmation sampling demonstrated that the excavation and removal had successfully lowered lead levels to below the Site residential clean-up level of 3,500 ppm total lead, thus no institutional controls are necessary at this portion of OU 2. Subsequent monitoring in 1997 and 1998 have verified that the revegetation was successful and no long term monitoring is required.

The Malta Gulch Tailing Impoundment (MGTI) is located at the upper end of Malta Gulch about two miles west of the City of Leadville. The Stringtown portion of the Leadville Mining Area District, which includes the Malta Gulch Tailing Impoundments (MGTI), was developed between 1879 and 1882 as a large group of placer claims.

As explained above, it appears that the earliest use of this area for tailing disposal was from the fall of 1943 through August 1946 by the OCC. The OCC tailing berms became the pre-cursors to the current basins known as Impoundments #1 and #2. From the period of 1945 to 1973, there was no activity at this portion of the Site although ownership of the property changed hands numerous times. The property was purchased by its current owner, Leadville Corporation, in 1968. In 1974, the Hecla Mining Company (Hecla), in conjunction with Day Mines, leased the property as a site for disposal of tailing generated from its milling of ores from the Sherman Mine which was a silver mine in a dolomite formation. The MGTI, in its present configuration, was constructed in 1974 by Hecla/Day. Hecla/Day also constructed 3 tailing impoundments (#1, 2, 3), two water retention impoundments (#4 and 6) and a clarification basin (#5). The entire facility occupies approximately 23 acres. These milling operations were permitted and bonded by the State of Colorado's Division of Minerals & Geology, and the permit remains in effect. Hecla leased the MGTI from Leadville Corporation until 1987. During its leasehold, Hecla/Day operated an on-site flotation mill that generated approximately 680,000 tons of tailing. No cyanide was used in the processing during this time. The Leadville Corp. refitted the mill to use a cyanide leaching process and approximately 50,000 tons of dolomitic tailing were added to the impoundments in 1988.

Hecla completed an engineering evaluation/cost analysis (EE/CA) for the MGTI in July, 1993. Sampling at the MGTI showed lead in the range of 800 to 57,600 parts per million (ppm). Based on the findings of the EE/CA, EPA conducted a non-time critical removal to consolidate, grade, cap, and revegetate the MGTI.

Capping work at the MGTI included the completion of the dust control dolomite gravel caps at Ponds 1, 2, and 3 that was initiated by Leadville Corporation in 1991. EPA work at the MGTI was performed in two field construction seasons. Clean-up activities commenced on October 5, 1995 and were completed on October 15, 1996. Borrow material was obtained from the Leadville Corporation borrow pit immediate north of the impoundments across County Road 3. Borrow material is comprised of non-mineralized glacial moraine deposits. This helped assure that cap materials had lead levels below the 6,700 mg/kg total lead (the commercial/industrial soil lead action level for this property). Borrow was placed at a depth of 6-12 inches. Prior to capping, 30,000 cubic yards of metals-contaminated fluvial tailings from Lower Malta Gulch were also transported and placed in the MGTI Pond 3. These materials were capped, graded, and revegetated. Other elements of the MGTI clean-up included: The construction of a rip-rap geotextile spillway to control runoff, the stabilization of a section of retainment berm, the reestablishment of the local drainage and fencing, and soil hot spot removals and revegetation of areas around the mill building.

In order to ensure continued protectiveness of the remedy, long-term monitoring will be conducted in accordance with the Monitoring Plan to assure that the cover material and vegetation remain effective. In addition, present zoning of the MGTI is Industrial Mining which will not allow uses inconsistent with the remedy. Periodic monitoring and review is necessary to verify that zoning of the MGTI has not been changed to allow uses inconsistent with the remedy, and that groundwater is not being used as a source of drinking water. Monitoring is also necessary to periodically review the status of this DMG permit. Site closure and reclamation will be completed in accordance with the DMG permit requirements. The long-term monitoring program for the MGTI will be implemented by the Colorado Mountain College. This program will commence upon finalization of the work plan submitted in August 2000.

The Malta Tailing Impoundment (MTI), owned by Leadville Silver & Gold, Inc., is located 1.5 miles west of Leadville, 0.8 miles north of Stringtown and 0.6 miles north of California Gulch. Leadville Silver & Gold, Inc. constructed a mill to recover pyritic materials from various tailing and waste materials from nearby properties which had been obtained under leasehold arrangements. This pyritic materials recovery process operated from 1983 through 1988.

Approximately 2,000 tons of pyrite were shipped to various off-site smelters for use as a flux. As a result of this operation, approximately 10,000 cubic yards of tailing were disposed of at the Malta Tailing Impoundment.

The Malta Tailing Impoundment consists of three small impoundments surrounded by berms, and occupies 4.6 acres of nearly flat land at the top of a ridge. The total volume of tailing is estimated to be slightly in excess of 10,000 cubic yards.

Areas within the immediate vicinity of the tailing impoundments were littered with scrap metal, concrete slabs, and other mining/processing material. There was also a stockpile of mine waste, including drums of product, nearby.

Sampling of the tailing showed lead concentrations ranging from 3,850 mg/Kg to 7,250 mg/Kg. The tailing and pyritic material presented a risk to human health and the environment, since they are a source of acid mine drainage.

In the fall of 1996, EPA conducted a removal action to consolidate the acid-generating materials, neutralize the acidic leachate, and grade, cap, and revegetate the MTI. In addition, the piles of pyrite concentrate, and drums were removed during the 1996 construction season, for use as a product.

Confirmation samples showed the revegetated soil surface of the impoundment to be below the 6,700 ppm total lead commercial/industrial Site standard.

In order to ensure continued protectiveness of the remedy, long-term monitoring will be required to assure that the cover material and vegetation remain effective. In addition, present zoning of the MTI is Industrial Mining which will not allow uses inconsistent with the remedy. Periodic monitoring and review is necessary to verify that zoning of the MTI has not been changed to allow uses inconsistent with the remedy, and that groundwater is not used as a source for drinking water. Monitoring may include minor maintenance. Monitoring and any minor maintenance will be implemented by the Colorado Mountain College. In the event that significant maintenance issues are identified by the Colorado Mountain College, EPA will take appropriate action to ensure protectiveness of the remedy. This program commenced in July 2000.

The Leadville Corporation mill is located at the southern boundary of the MGTI. In 1997, officials of the State's Division of Minerals & Geology conducted a mine permit inspection and discovered that 42 drums, in one of the buildings at the Leadville Corporation mill, were corroding and beginning to leak. Since Leadville Corporation did not have the resources to dispose of the drums, the State requested EPA's Emergency Response Team to dispose of them. Thirty-six 55 gallon drums and six 5 gallon drums were involved. The drums contained hazardous substances which represented a threat to human health and the environment. The drums contained acids, bases and flammable liquids.

EPA conducted an emergency removal action in 1998 to address the threats posed by these drums. The drums were over packed and sent off-site for appropriate disposal. This was a complete removal so no monitoring or institutional controls are necessary for this portion of OU 2.

At Leadville, Colorado, the public interest in the clean up of this Superfund Site has been intensive; many public meetings have been held. Numerous Fact Sheets have been released to the public. On August 2, 1993, the public was notified in the local newspaper that the Final Engineering Evaluation/Cost Analysis (EE/CA), Malta Gulch Tailing, Leadville, Colorado, dated July 29, 1993 was available for review and comment. EPA held a public meeting in Leadville on August 12, 1993. The comment period continued through September 1, 1993. EPA responded to all comments on the EE/CA in a Responsiveness Summary which was prepared in September 1993 prior to the issuance of the Action Memorandum on September 10, 1993. The notice of availability of the Proposed Plan and supporting documents was published in the Leadville Herald Democrat on March 13, 1997. The public comment period was held from March 19, 1997 to April 18, 1997. A Public meeting was held on March 19, 1997. Responses to all comments received during the public comment period are included in the Responsiveness Summary attached to the ROD for OU 2. On September 30, 1999, EPA issued a final ROD for OU 2. As described above, the ROD called only for ongoing monitoring of active response actions and use restrictions. EPA's decision is based on information contained in the final Administrative Record for OU 2. The final Administrative Record is available at the California Gulch Site information repository and the EPA Region 8, Superfund Records Center.

Based on the successful completion of the above described removal actions and implementation of the long-term monitoring program for the MGTI and MTI, there are no further response actions planned or scheduled for OU 2.

Because this decision results in hazardous substances remaining on site, above health-based levels, monitoring of the previous response actions will be required. This monitoring will be conducted in addition to site-wide five-year reviews. The next five-year review at the California Gulch Site is scheduled to be initiated in October 2000 for completion in 2001.

While EPA does not believe that any future response action in the Malta Gulch area will be needed, if future conditions warrant such action, the deletion areas of the California Gulch Superfund Site remain eligible for future Fund-financed response actions. Furthermore, this partial deletion does not alter the status of the other OUs of the Site which are not being deleted and remain on the NPL. EPA, with concurrence from the State of Colorado, has determined that all appropriate CERCLA response actions have been completed at OU 2 and protection of human health and the environment has been achieved in this area. Therefore, EPA is deleting the Malta Gulch area of the California Gulch Superfund Site from the NPL. This action will be effective July 23, 2001. However, if EPA receives dissenting comments by June 21, 2001, EPA will publish a document that withdraws this action.

On January 22, 2001, we published an interim final rule with comment period (66 FR 7148) that defined a “psychiatric residential treatment facility” that is not a hospital and that may furnish covered Medicaid inpatient psychiatric services for individuals under age 21. The interim final rule established standards for the use of restraints or seclusion in psychiatric residential treatment facilities to protect the health and safety of residents.

Section 3207 of the Children's Health Act of 2000 (Pub. L. 106-310) requires that health care facilities receiving support in any form from any program supported in whole or part with funds appropriated to any Federal department or agency shall protect and promote the rights of each resident of a facility, including the right to be free from any restraint or involuntary seclusion imposed for purposes of discipline or convenience. This Act permits the Secretary to issue regulations that afford residents greater protections regarding restraint and seclusion than the standards published in the new law. Our interim final rule provides greater protections than those required in section 3207.

This document clarifies the facilities that are subject to the requirements of the January 22, 2001 interim final rule. It became apparent from the number of comments we received to the interim final rule that many facilities are unclear whether or not they are subject to the requirements of the interim final.

The interim final rule applies to psychiatric residential treatment facilities that receive payment for providing the Medicaid inpatient psychiatric services benefit for individuals under age 21. The Medicaid inpatient psychiatric services benefit for individuals under age 21 may be provided in a psychiatric hospital (that meets the applicable hospital conditions of participation set forth in 42 CFR part 482) or in “another inpatient setting that the Secretary has specified in regulations” pursuant to section 1905(h) of the Social Security Act. As set forth in the interim final rule, psychiatric residential treatment facilities are facilities that are not licensed as hospitals but meet the requirements in 42 CFR part 441 subpart D, the requirements of 42 CFR part 483, subpart G, and have a provider agreement with the state Medicaid agency.

A psychiatric residential treatment facility's payment for inpatient psychiatric services to individuals under age 21 includes compensation for the resident's room and board as well as a comprehensive package of services. This rule does not apply to other providers that receive Medicaid compensation on a service-by-service basis and do not receive Medicaid payment for the individual's room and board. An example would be a facility receiving Medicaid payment for outpatient rehabilitation services.

If a facility is uncertain whether or not this rule applies, it should contact the state Medicaid agency for further information regarding the applicability of this regulation.

Additionally, we have received numerous inquiries regarding the attestation date contained in § 483.374(a)(1). This document does not change the requirement that facilities with a current provider agreement must provide its attestation to the State Medicaid agency by July 21, 2001.

This document also makes amendments to sections of the rule relating to orders for the use of restraint and seclusion; consultation with the resident's treatment team physician; monitoring of the resident in seclusion or restraint; and facility reporting requirements. The changes being made are in response to the serious and immediate concerns raised by comments submitted on the interim final rule. These comments described the severe shortage of registered nurses as well as the unavailability of psychiatrists as the two major reasons why facilities would not be able to comply with the requirements of our interim final rule. They stated that the shortage of these personnel is a national problem. Although we considered the ordinary costs of additional personnel in additional staffing in issuing the interim final rule, we did not take into account the lack of availability of sufficient numbers of trained individuals to meet those staffing needs. We agree that the scope of the shortage of professionals to provide services in psychiatric residential treatment facilities is critical. As a result, we are concerned that substantial numbers of facilities will be unable to meet the conditions of participation to participate in the Medicaid program and that beneficiaries will be left without adequate placements. Therefore, we have reviewed the requirements in the interim final rule and are amending the rule to permit staffing alternatives that ensure sufficient beneficiary protection but are less burdensome for facilities.

This document also amends our definition of “personal restraint” to clarify that briefly holding without undue force a resident for the purpose of comforting him or her, or holding a resident's hand or arm to safely escort him or her from one area to another is not a restraint. Many commenters stated that our definition is so broad that staff would be prohibited from comforting an upset resident, or holding a resident's hand to safely escort him or her across a street. This was not our intention, and we are concerned that this reading could prevent facilities from participating in the Medicaid program, and result in needless displacement of Medicaid beneficiaries.

This document also amends our requirements for facility reporting of serious occurrences. We are adding the requirement that a facility must report the death of any resident to the Health Care Financing Administration (HCFA) regional office. This change is required to ensure that HCFA has sufficient timely information to identify threats to beneficiary health and welfare.

The specific changes made in this document are as follows:

In § 483.352, we are amending the definition of “personal restraint” by adding a clarifying statement that “personal restraint” does not include briefly holding without undue force a resident in order to calm or comfort him or her, or holding a resident's hand to safely escort him or her from one area to another.

We are amending § 483.358(a) to state that orders for restraint or seclusion must be by a physician, or other licensed practitioner permitted by the state and the facility to order restraint or seclusion and trained in the use of emergency safety interventions. We have included “other licensed practitioner permitted by the state and the facility to order restraint or seclusion” to be consistent with the language in the Children's Health Act of 2000. As with all staff, other licensed practitioners permitted by the state and the facility to order restraint or seclusion and trained in the use of restraints and seclusion as set out in § 483.376. Section 441.151 also requires that inpatient psychiatric services for recipients under age 21 be furnished under the direction of a physician.

We are amending § 483.358(b) to state that if the resident's treatment team physician is available, only he or she can order restraint or seclusion.

We are amending § 483.358(c) to state that a physician or other licensed practitioner permitted by the state and the facility to order restraint or seclusion must order the least restrictive emergency safety intervention that is most likely to be effective in resolving the emergency safety situation based on consultation with staff.

We are amending § 483.358(d) to state that if the order for restraint or seclusion is verbal, the verbal order must be received by a registered nurse or other licensed staff, such as a licensed practical nurse. The physician or other licensed practitioner permitted by the state and the facility to order restraint or seclusion must verify the verbal order in a signed written form in the resident's record. The physician or other licensed practitioner permitted by the state and the facility to order restraint or seclusion must be available to staff for consultation, at least by telephone, throughout the period of the emergency safety intervention.

We are amending § 483.358(f) to state that a physician or “other licensed practitioner trained in the use of emergency safety interventions, and permitted by the state and the facility to assess the physical and psychological well being of residents” must conduct a face-to-face assessment of the physical and psychological well being of the resident within 1 hour of the initiation of the emergency safety intervention.

We are amending paragraphs (g)(1) and (g)(3) and (j) to include “other licensed practitioner permitted by the state and the facility to order restraint or seclusion”.

We are amending § 483.360 to state that if a physician or other licensed practitioner permitted by the state and the facility to order restraint or seclusion orders the use of restraint or seclusion, the resident's treatment team physician must be contacted, unless the ordering physician is in fact the resident's treatment team physician.

We are amending § 483.362(b) to state that if the emergency safety situation continues beyond the time limit of the order for the use of restraint, a registered nurse or other licensed staff, such as a licensed practical nurse, must immediately contact the ordering physician or other licensed practitioner permitted by the state and the facility to order restraint or seclusion to receive further instructions.

We are amending § 483.362(c) to state that a physician, or other licensed practitioner permitted by the state and the facility to evaluate the resident's well-being and trained in the use of emergency safety interventions, must evaluate the resident's well-being immediately after the restraint is removed.

We are amending § 483.364(c) to state that if the emergency safety situation continues beyond the time limit of the order for the use of seclusion, a registered nurse or other licensed staff, such as a licensed practical nurse, must immediately contact the ordering physician or other licensed practitioner permitted by the state and the facility to order restraint or seclusion to receive further instructions.

We are amending § 483.364(d) to state that a physician, or other licensed practitioner permitted by the state and the facility to evaluate the resident's well-being and trained in the use of emergency safety interventions, must evaluate the resident's well-being immediately after the resident is removed from seclusion.

We are amending § 483.374 by adding a new paragraph (c) to require that facilities report the death of any resident to the Health Care Financing Administration (HCFA) regional office.

We will be accepting comments concerning the amendments to the interim final rule contained in this document.

Because of the large number of items of correspondence we normally receive on Federal Register documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the “DATES” section of this document, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

In accordance with the requirements of the Administrative Procedures Act (APA), we ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule before the final rule is made effective. The notice of proposed rulemaking required by the APA includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subject matter and issues involved.

In November 1994, we issued a proposed rule that contained limitations on the use of restraints and seclusion by psychiatric residential treatment facilities. The interim final rule clarified and further developed these proposed limitations. To the extent that the interim final rule could not be viewed as a logical outgrowth of the 1994 proposed rule, we found good cause to waive requirements for proposed rulemaking. The APA permits waiver of these requirements if the agency finds good cause that notice and comment procedure is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and its reasons in the rule issued. We found good cause based on the strong public interest in preventing deaths and injuries to children that are the result of inappropriate use of restraint and seclusion in psychiatric residential treatment facilities. The full rationale for this finding was set forth in the preamble to the January 22, 2001 interim final rule.

Because we believe that the amendments and clarifications set forth in this document are essential to the effective implementation of the basic requirements of the January 22, 2001 interim final rule, the same concerns expressed in our waiver of proposed rulemaking for that rule apply here. In addition, without the amendments and clarifications set forth in this document, we believe there is a risk that beneficiaries will be needlessly displaced as substantial numbers of facilities terminate participation in the Medicaid program as psychiatric residential treatment facilities. In particular, absent clarification of the term “personal restraint,” facilities could be terminated for failure to meet conditions of participation for actions that do not warrant concern. Absent changes to staffing requirements, nationwide nurse and psychiatrist shortages could mean that numerous facilities would become unable to meet the conditions of participation. The amendments contained in this document will provide adequate beneficiary protections in a less burdensome manner and will minimize potential beneficary displacement. In addition, the changes in this document to include HCFA in reporting requirements are necessary to ensure that HCFA has timely information to monitor jeopardy to program beneficiaries.

In sum, we find good cause to waive asking for comment on these amendments to the January rule before making them effective, based on the public interest of avoiding displacement and other potential harm to program beneficiaries. We invite parties to submit comments on these changes, which we will consider in crafting the final rule that applies to these psychiatric residential treatment facilities.

In addition, we find good cause to waive requirements for a 30 day delay in the effective date of these clarifications and amendments to the interim final rule. Under the APA, publication of a substantive rule must be not less than 30 days before its effective date, unless otherwise provided by the agency for good cause found and published with the rule. These clarifications and amendments are an integral operational part of the overall interim final rule. A delay in the effective date for these clarifications and amendments would be contrary to public interest because a delay would result in inconsistent standards for affected facilities over a relatively short time period. Moreover, there would be some possibility of disruption of services to program beneficiaries to the extent that facilities elect not to continue participation in the Medicaid program until the amendments and clarifications become effective. Moreover, a delay in the effective date would be impracticable to administer because facility guidance, quality monitoring and surveyor training are not designed to accommodate rapid changes in applicable standards. In sum, we find that a 30 day delay in the effective date would be both impracticable and contrary to the public interest because the delay would not be administratively feasible and would risk inconsistent facility standards and potential disruption of services to beneficiaries.

Under the Paperwork Reduction Act of 1995, we are required to provide a 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (PRA) requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

The information collection requirements in the interim rule published in the Federal Register on January 22, 2001, as well as the amendments made in this regulation have been approved by OMB through November 30, 2001 under OMB control number 0938-0833. We solicited comments on these requirements in the January 22, 2001 interim final rule, and have made minimal changes to the requirements in this rule. We are again soliciting public comment on each of these issues for the sections that contain information collection requirements. Comments will be considered in evaluating these information collection requirements under the Paperwork Reduction Act.

The following is a summary of the information collection requirements contained in both the January 22 interim rule and in this amendment to the interim rule.

Paragraph (a)(4) of this section requires that inpatient psychiatric services for individuals under age 21 must be certified in writing to be necessary in the setting in which the services will be provided (or are being provided in emergency circumstances) in accordance with § 441.152.

The certification requirement of this section is not new. The paperwork burden is contained in the referenced § 441.152, which specifies the certification requirements, has been approved under OMB #0938-0754.

Paragraph (c) of this section, “Notification of facility policy,” requires facility staff to inform each incoming resident (and, in the case of a minor, the resident's parent(s) or legal guardian(s)) at admission, of the facility's policy regarding the use of restraint or seclusion during an emergency safety situation that may occur while the resident is in the facility. Staff must obtain an acknowledgment, in writing, from the resident, or in the case of a minor, the resident's parent(s) or legal guardian(s), that he or she has been informed of the facility's policy. Staff must file the written acknowledgment in the resident's record.

In order to estimate the burden of this requirement on facilities, we used data from National Center for Health Statistics, Health, United States published in 1999 (page 278) which indicated that there were 459 psychiatric residential treatment facilities in 1994, the latest year for which data are available. We estimate an annual growth rate in the number of these facilities to be 2 percent. Using this growth rate, we determined that there would be approximately 475 to 500 psychiatric residential treatment facilities nationally as of FFY 2001. These data showed that there are approximately 70 residents per facility at any one time. This equates to a total nationwide bed capacity approximating 35,000 beds. Through an informal survey of providers, we estimate an average resident length of stay to be 9 months and based on a 9-month stay, each facility would admit an estimated average of 95 residents per year, or an estimated total of up to 47,500 residents nationally. We believe it will take each facility 8 hours to develop a policy statement regarding the use of restraints and seclusion, and an average of 30 minutes to present the information to each incoming resident and the parent(s) or guardian(s), and to obtain and file the acknowledgment.

Thus, there will be a one-time burden of 4,000 hours nationwide to develop the statement and an annual burden of 48 hours per psychiatric residential treatment facility and 23,750 hours nationally to disclose the policy.

In accordance with paragraph (d) of this section, a physician's or other licensed practitioner's verbal order must be obtained by a registered nurse or other licensed staff, such as a licensed practical nurse, while the emergency safety intervention is being initiated by staff, or immediately after the emergency safety situation ends. The verbal order must be followed with the physician's or other licensed practitioner's signature verifying the verbal order.

This document changes the January 22 interim rule to allow a registered nurse or other licensed staff such as a licensed practical nurse to obtain a verbal order from a physician or “other licensed practitioner permitted by the state and the facility to order restraint or seclusion”, and requires the physician or the other licensed practitioner permitted by the state and the facility to order restraint or seclusion that gave the verbal order to verify, by signature, that he or she gave the order.

While the information collection requirement in this paragraph is subject to the PRA, we believe the burden associated with it is exempt as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement are incurred by persons in the normal course of their activities.

In accordance with paragraph (g) of this section, each order for restraint or seclusion must be documented in the resident's record. Documentation must include—

(1) The name of the physician or other licensed practitioner permitted by the state and the facility to order restraint or seclusion;

(2) The date and time the order was obtained;

(3) The emergency safety intervention ordered, including the length of time for which the physician or other licensed physician permitted by the state and the facility to authorize its use;

(4) The time the emergency safety intervention actually began and ended;

(5) The time and results of any 1 hour assessments required in paragraph (f) of this section.

(6) The emergency safety situation that required the resident to be restrained or put in seclusion; and

(7) The name, title, and credentials of staff involved in the emergency safety intervention.

There are an estimated average of 47 situations per month per psychiatric residential treatment facility where restraint or seclusion is used, or approximately 282,000 situations nationally, per year. We estimate that it will take approximately 30 minutes per situation, or 282 hours annually per psychiatric residential treatment facility, for a national total of 141,000 hours annually to comply with the documentation requirements.

In accordance with paragraph (i) of this section, the facility must maintain an aggregate record of all emergency safety situations, the interventions used, and their outcomes.

Based on 15 minutes per situation, we estimate that it will take 141 hours per psychiatric residential treatment facility, and a national total of 70,500 hours annually to comply with this documentation requirement.

In accordance with paragraph (j) of this section, the physician or other licensed practitioner permitted by the state and the facility to order restraint or seclusion must sign the order in the resident's record as soon as possible, but no later than 24 hours after the order is issued.

The revision to this paragraph requires an “other licensed practitioner permitted by the state and the facility to order restraint or seclusion” to sign orders he or she has given. This does not increase the facility's burden, since only one person is still signing.

While these information collection requirements are subject to the PRA, we believe the burden associated with them is exempt as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement are incurred by persons in the normal course of their activities.

This section requires that, if a physician or other licensed practitioner permitted by the state and the facility to order restraint or seclusion orders the use of restraint or seclusion and he or she is not the resident's treatment team physician, then the ordering physician or other licensed practitioner permitted by the state and the facility to order restraint or seclusion must consult with the resident's treatment team physician as soon as possible and inform the team physician of the emergency safety situation that required the resident to be restrained or placed in seclusion and document the time the team physician was consulted.

Paragraph (b) of this section requires the facility to document in the resident's record the date and time the team physician was consulted.

The amendments to the January 22 interim rule, made by this document, require an “other licensed practitioner permitted by the state and the facility to order restraint or seclusion” to follow the same procedures as a physician. This change does not change the burden from that stated in the original interim rule. In that rule, we stated that we estimate that it will take approximately 30 minutes per situation, 282 hours annually per psychiatric residential treatment facility, or 141,000 hours nationally to comply with the documentation and disclosure requirements of this section, based on an assumption that approximately half of the situations will require that the facility staff separately notify the treatment team physician.

If the resident is a minor as defined in § 483.352, paragraph (a) of this section requires the facility to notify the parent(s) or legal guardian(s) of a resident who has been restrained or placed in seclusion as soon as possible after the initiation of each emergency safety intervention.

Paragraph (b) of this section requires the facility to document in the resident's record that the parent(s) or legal guardian(s) has been notified of the emergency safety intervention, including the date and time of notification and the name of the staff person providing the notification.

We estimate that it will take 30 minutes to notify a parent or guardian and 15 minutes to document that notification. The total annual burden will be 423 hours per psychiatric residential treatment facility and 211,500 hours nationally, based on the assumption that virtually all of the residents will be minors as defined in § 483.352.

Paragraph (c) of this section requires that staff document in the resident's record that the debriefing sessions required by this section took place.

This documentation will take approximately 30 minutes per situation, or an annual burden of 282 hours per psychiatric residential treatment facility and 141,000 hours nationally.

Paragraph (b) of this section requires the psychiatric residential treatment facility to have affiliations or written transfer agreements in effect with one or more hospitals approved for participation under the Medicaid program that reasonably ensure that—

(1) A resident will be transferred from the facility to the hospital and admitted in a timely manner when a transfer is medically necessary for medical care or acute psychiatric care;

(2) Medical and other information needed for care of the resident in light of such a transfer, will be exchanged between the institutions in accordance with State medical privacy law, including any information needed to determine whether the appropriate care can be provided in a less restrictive setting; and

(3) Services are available to each resident 24 hours a day, 7 days a week.

Paragraph (c) of this section requires that staff document in the resident's record all injuries that occur as a result of an emergency safety situation, including injuries to staff resulting from that intervention.

While these information collection requirements are subject to the PRA, we believe the burden associated with them is exempt as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement are incurred by persons in the normal course of their activities.

Paragraph (a) of this section requires each psychiatric residential treatment facility that provides inpatient psychiatric services to individuals under age 21 to attest, in writing, that the facility is in compliance with our standards governing the use of restraint and seclusion. This attestation must be signed by the facility director.

We estimate that it will take 8 hours per facility to be able to attest to compliance with the standards. This is a one-time burden. The national burden will be 500 multiplied by 8, or 4,000 hours.

Paragraph (b) of this section requires that the facility report serious occurrences involving a resident to both the State Medicaid Agency and, unless prohibited by State law, the State-designated Protection and Advocacy System. The report must include the name of the resident involved in the serious occurrence, a description of the occurrence, and the name, street address, and telephone number of the facility. In the case of a minor, the facility must also notify the parent(s) or legal guardian(s) of the resident involved in a serious occurrence.

Staff must document in the resident's record that the contacts above were made.

The burden for notifying parent(s) or legal guardian(s) is addressed under § 483.366.

We estimate that it will take an additional 15 minutes to document that these contacts were made, for an average annual burden of 141 hours per psychiatric residential treatment facility, with an annual national total of 70,500 burden hours.

In this document, we have added an amendment to § 483.374 by adding a new paragraph (c) to require that the facility report the death of any resident to the HCFA regional office. The report must include the name of the resident involved in the serious occurrence, a description of the occurrence, and the name, street address, and telephone number of the facility. (In the case of a minor, the facility must also notify the parent(s) or legal guardian(s) of the resident involved in a serious occurrence.

We estimate that these notifications will take a total of 15 minutes. This will total an estimated 141 hours per year per facility and 70,500 nationally, for the estimated 282,000 incidents per year.

Paragraph (f) requires facilities to provide for assessments of staff education and training needs by requiring staff to demonstrate their competencies related to the use of emergency safety interventions on a semiannual basis. This section also provides for staff to demonstrate, on an annual basis, their competency in the use of cardiopulmonary resuscitation.

Paragraph (g) of this section requires the facility to document in the staff personnel records that the training required by § 483.376 was successfully completed.

While these information collection requirements are subject to the PRA, we believe the burden associated with them are exempt as defined in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources necessary to comply with the requirement are incurred by persons in the normal course of their activities.

The total information collection requirements associated with this regulation will total an estimated 877,750 hours.

If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following:

We have examined the impact of this interim final rule as required by Executive Order 12866 and the Regulatory Flexibility Act (RFA) (Pub. L. 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).

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $5 million or less annually. For purposes of the RFA, all psychiatric residential treatment facilities are considered to be small entities. Individuals and States are not included in the definition of a small entity. Consistent with the RFA, we prepare a regulatory flexibility analysis unless we certify that a rule will not have a significant economic impact on a substantial number of small entities.

Also, section 1102(b) of the 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 hospitals. That analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 50 beds. This regulation does not have an impact on small rural hospitals. However, to the extent the rule may have significant effects on psychiatric residential treatment facilities and their residents, or be viewed as controversial, we believe it is desirable to inform the public of our projections of the likely effects of the proposals.

The Unfunded Mandates Reform Act of 1995 requires (in section 202) that agencies prepare an assessment of anticipated costs and benefits for any rule that may result in a mandated expenditure in any 1 year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more. This rule has no mandated consequential effect on State, local, or on tribal governments, or the private sector. We have described the anticipated effects of this regulation below.

We have reviewed this interim final rule with comment under the threshold criteria of Executive Order 13132, Federalism. We have determined that this interim final rule with comment does not significantly affect the rights, roles, and responsibilities of States.

This rule is the product of serious concern about improper use of restraints and seclusion in psychiatric residential treatment facilities. This led us to set forth this interim final rule with comment to ensure the protection of residents of these facilities from improper restraint and seclusion practices that could contribute to death or serious injury.

We still maintain that some facilities will need additional staff as a result of the previous interim final rule. The January 22 interim final rule estimated this burden based on the requirement for only registered nurses. This rule does not eliminate that requirement but permits facilities to fullfill this requirement by allowing other licensed practitioners in lieu of registered nurses.

As stated in our impact statement of January 22, 2001, we believe that it is not only reasonable but critical to resident safety that we require these facilities to provide 24-hour onsite coverage by a registered nurse or other licensed practitioner permitted by the State and the facility. We believe it is appropriate to extend the same level of protections to children and adolescents in these facilities that are provided to them in a hospital.

We are adding a requirement for facilities to report the death of any resident to the HCFA regional office. We are soliciting comments only on this additional HCFA reporting requirement. We believe this additional reporting requirement will have a minimal financial impact on facilities.

Because of our modification of the rule concerning the use of registered nurses, we have revised this section of the impact statement concerning new staff costs. We recognize that some facilities will need to hire either additional registered nurses or other licensed practitioners permitted by the State and the facility to meet the requirement for 24-hour per day coverage in these facilities. As a result of our modification of the rule, each facility would have to provide for one additional FTE registered nurse or other licensed practitioner permitted by the state and the facility. We did not change the overall estimated numbers of additional FTEs to provide the necessary coverage in all facilities. Our earlier impact analysis can be found in the January, 22, 2001 interim final rule.

The changes made in this document are being made after further consideration of alternatives discussed in the January 22, 2001 interim final rule.

The CoP for psychiatric residential treatment facilities sets forth a series of requirements to ensure each resident's physical and emotional health and safety. These requirements address each resident's right to be free from restraint or seclusion, of any form, used as a means of coercion, discipline, convenience, or retaliation. The CoP is a new requirement for facilities that provide inpatient psychiatric residential treatment services to Medicaid eligible individuals under age 21. In accordance with the Regulatory Flexibility Act, we have examined the burden this rule may impose on small entities and certify that this rule will not have a significant impact on a substantial number of entities.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

This is a summary of the Commission's First Report and Order in CC Docket No. 00-257 and Fourth Report and Order in CC Docket No. 94-129 released on May 15, 2001. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 Twelfth Street, SW., Washington, DC, 20554.

1. As part of our biennial regulatory review effort, we are amending our carrier change rules to provide a streamlined process for compliance with section 258 of the Communications Act of 1934 (Act), as amended by the Telecommunications Act of 1996 (1996 Act) in situations involving the carrier-to-carrier sale or transfer of subscriber bases. The streamlined procedures we adopt in this Order will replace the current, more burdensome waiver process. Our new procedures provide for an acquiring carrier to simply self-certify to the Commission, in advance of the transfer, that the carrier will follow the required procedures. This will protect the interests of the affected subscribers, consistent with section 258 and our rules, by giving them adequate advance notice of the carrier change and ensuring that the change will not cause them financial harm.

2. The Commission adopted carrier change authorization and verification requirements to protect consumers from fraudulent changes in presubscribed carriers. It has become clear, however, that the need to obtain a waiver of these requirements imposes undue burdens on carriers seeking to buy, sell, or transfer customer accounts and on the Commission that could be avoided without sacrificing consumer protection. These burdens include the time and resources required to prepare and process the waiver petition and any supplemental filings, the regulatory uncertainty inherent in any waiver process, and, oftentimes, delay. Given the dynamic marketplace, and the likelihood that carriers will continue to buy, sell, and transfer customer lines in the future, we believe it is appropriate to streamline our carrier change rules to ensure that they do not inadvertently inhibit routine business transactions, while ensuring that consumers are protected from fraudulent carrier changes, consistent with section 258 and our rules.

9. A telecommunications carrier currently must file a request for waiver of our carrier change authorization and verification rules in order to acquire part or all of a subscriber base from another carrier without obtaining individual subscriber consent. We received 51 such requests for waiver in 2000, and we received 12 more in the first four months of 2001. The preparation of these waiver petitions imposes burdens both on carriers and the Commission. These burdens are not limited to the initial filing. Often carriers consult with Commission staff prior to their initial waiver request, and, on occasion, carriers supplement that filing, a time-consuming process. Moreover, carriers have no way of knowing when they will receive a ruling on their waiver requests. Although some carriers have received grants of emergency petitions in as little as one week, it is more typical for carriers to wait at least a month for a ruling because of the heavy volume of these filings, and several petitioners have experienced much longer delays. Incorporating a streamlined certification and notification process into the current rules will significantly reduce the burden on carrier and Commission resources while still protecting consumers' interests. Indeed, all commenters support our proposal to amend our rules to address the sale or transfer of subscriber bases. All commenters also endorse our stated goals: to reduce regulatory burdens, and thereby produce greater certainty in the marketplace, while providing adequate consumer protection consistent with section 258 and our carrier change rules. As discussed in greater detail, the streamlined process for the sale or transfer of subscriber bases adopted in this Order achieves both of these goals.

10. We amend § 64.1120 of our rules to establish a streamlined self-certification process for the carrier-to-carrier sale or transfer of subscriber bases, thereby eliminating the need to obtain a waiver of Commission rules prior to closing a transaction. This process is designed to ensure that the affected subscribers have adequate information about the carrier change in advance, that they are not financially harmed by the change, and that they will experience a seamless transition of service from their original carrier to the acquiring carrier. This process also will provide the Commission with information it needs to fulfill its consumer protection obligations. Under the revised rules, carriers need not obtain individual authorization and verification for carrier changes associated with the carrier-to-carrier sale or transfer of a subscriber base, provided that, not later than 30 days before the planned carrier change, the acquiring carrier notifies the Commission, in writing, of its intention to acquire the subscriber base and certifies that it will comply with the required procedures, including the provision of advance written notice to all affected subscribers.

11. We find that it is in the public interest to adopt a carrier self-certification process as the streamlined procedure for notifying the Commission prior to the sale or transfer of a subscriber base. The acquiring carrier must certify, at least 30 days before the intended transaction date, that it will comply with the requirements established in this Order, including the provision of reasonable advance notice to the affected subscribers. The Commission will be able to ensure that consumer interests are protected if it has advance knowledge of such transactions and certification of compliance with the requirements of this streamlined process.

12. Under the streamlined process we adopt in this Order, the acquiring carrier will simply file a letter in CC Docket No. 00-257 with the Secretary of the Commission, no later than 30 days prior to the transfer of the subscriber base to the new service provider, that includes the names of the parties to the transaction, the types of telecommunications services provided to the affected subscribers, the date of the transfer of these subscribers to the acquiring carrier, a certification of compliance with the requirements of this process, and an attached copy of the notice sent to the affected subscribers. In the rare case in which, after the filing of the certification, there is a material change to the required information, such as a change in the date of the subscriber transfer, the acquiring carrier must file written notification of the change(s) with the Commission no more than 10 days after the transfer date designated in the prior filing. While we reserve the right to require the acquiring carrier to send an additional notice to the affected subscribers regarding such material changes, we expect that we will exercise this right infrequently. We disagree with commenters who contend that a self-certification requirement is no less burdensome than the current waiver process, or that this requirement undermines our streamlining efforts. Under this streamlined approach, in contrast to the waiver process, the carrier need not obtain Commission approval in order to complete the transaction.

13. A telecommunications carrier must comply with this streamlined process whenever it acquires subscribers from another carrier through a sale or transfer. For example, if a carrier plans to acquire the subscriber base of another carrier owned by the same parent company, and if, after the transfer, the subscribers' preferred carrier will have a different name, contact number, billing address, and set of rates, terms, and conditions, the acquiring carrier must comply with the procedures adopted in this Order. However, we note that, when a carrier is simply undergoing a name change, it is not in fact acquiring customers through a sale or transfer, and therefore it need not comply with these procedures. As another example, a change in corporate structure that is invisible to the affected subscribers does not constitute a sale or transfer for purposes of section 258 that implicates this streamlined process.

14. The rule amendments we adopt in this Order expressly prohibit use of the streamlined procedure to avoid liability for slamming rule violations by transferring subscribers to another corporation. We caution carriers that the Commission will continue its vigorous slamming enforcement efforts and will not tolerate carrier attempts to avoid liability for slamming rule violations by, for example, transferring subscribers to a sham company. The Commission's Enforcement Bureau will be vigilant in monitoring subscriber transfers effected under these procedures for indications of fraud and will pursue enforcement action against carriers that violate the proscription. We believe that our streamlined process for carrier changes associated with sales or transfers, coupled with vigorous enforcement of our slamming rules, will be sufficient to protect consumers from unscrupulous carriers.

15. We conclude that carriers acquiring subscribers should provide those subscribers with reasonable advance notice of a carrier change associated with a sale or transfer. We agree with those commenters that support our proposed 30-day advance notice period. We believe that, if an affected subscriber receives notice of the transaction at least 30 days before it occurs, the subscriber will be able to make an informed decision as to whether to accept the acquiring carrier as his or her preferred carrier. We are not persuaded that a 30-day notice requirement will be burdensome and costly to the carriers involved. Based on our extensive experience with waiver petitions related to subscriber sales or transfers, we believe that 30 days is a reasonable notice period to provide subscribers with sufficient opportunity to make an informed decision without creating a burdensome delay for the carriers involved.

16. We conclude that the carrier acquiring a subscriber base should be responsible for notifying the affected subscribers. We note that, in the absence of a waiver or the streamlined process adopted in this Order, the acquiring carrier would be required by the Commission's carrier change authorization and verification rules, and by section 258, to obtain each subscriber's express authorization and verification for the carrier change. We do not agree with SBC that the acquiring carrier will lack access to the necessary subscriber list information. We believe that, in most cases, sufficient subscriber list information will be available to the acquiring carrier and that it is unlikely that a carrier would consummate a purchase of a subscriber base without having immediate access to the subscriber list upon the closing of the purchase agreement. We are confident that carriers can, through normal business negotiations, make arrangements for the acquiring carrier to obtain the necessary information.

17. We further find that the written notice to the affected subscribers should not differ based on the types of service provided or the size of the carriers involved. Because a change in presubscribed service provider affects all subscribers similarly, regardless of the service type or the size of the original or acquiring carrier, there is no basis for varying the notice requirements.

18. We decline to require the acquiring carrier to send a second notice to the affected subscribers. We agree with commenters that argue that the affected subscribers do not need to receive a second written notice that simply reiterates the information provided in the first notice. We recognize that some affected subscribers may fail to read the notice sent prior to the change in service providers; however, as pointed out by several commenters, the affected subscribers will receive notification of the new service provider on their bills under the highlighting requirement of the Commission's truth-in-billing rules. Moreover, we expect that most acquiring carriers will contact the affected subscribers after the transfer as a matter of good business practice. We believe that a second notice may also be costly for carriers, especially smaller carriers.

19. Because section 255 and the Commission's existing rules impose disability accessibility requirements on carriers, we decline to impose additional requirements regarding advance subscriber notices sent to blind or visually-impaired consumers but will incorporate by reference the existing requirements in our amendment to § 64.1120. We believe that our existing rules are sufficient to ensure that the requirements of section 255 are met. We will monitor the situation and, if necessary, will take further action, as appropriate. We also believe that carriers should have the flexibility to meet the needs of the disabled community consistent with statutory and Commission requirements.

20. We note that several incumbent local exchange carriers have raised an issue regarding the application of our rules in situations where a competitive local exchange carrier is leaving a particular market and is required by state law to transfer its customer base to the incumbent. We disagree with these commenters that the streamlined procedures for the sale or transfer of subscriber base adopted in this Order should not be applied to incumbents that must assume the subscribers of a competitive local exchange carrier exiting the market. We believe that the affected subscribers of competitive local exchange carriers are entitled to the same protections and notice as any other subscriber whose carrier is changed due to a sale or transfer. To the extent a situation arises where it is impossible to comply precisely with the requirements set forth in this Order, we delegate authority to the Common Carrier Bureau to resolve on a case-by-case basis.

21. We have carefully evaluated the individual elements that comprise the advance subscriber notice under our streamlined process. We have determined that these requirements are necessary to ensure that the affected subscribers have adequate information about the carrier change, in advance, that they will not suffer financial harm from the involuntary change, and that they will experience a smooth transition to the new service provider. Not later than 30 days before the planned carrier change, the acquiring carrier must give each affected subscriber written notice of the date on which it will become the subscriber's new provider of telecommunications service and of other essential information. As discussed more fully, the advance subscriber notice must disclose: (1) The rates, terms, and conditions of the service(s) to be provided by the acquiring carrier; (2) the fact that the acquiring carrier will be responsible for any carrier change charges associated with the transaction; (3) the subscriber's right to select a different preferred carrier, if an alternative carrier is available; (4) a toll-free customer service telephone number for inquiries about the transfer; (5) the fact that all subscribers receiving the notice, including those who have arranged preferred carrier freezes through their local service providers, will be transferred to the new carrier if they do not select a different preferred carrier before the transfer date; and (6) whether the acquiring carrier will be responsible for resolving outstanding complaints against the selling or transferring carrier.

22. We conclude that the advance subscriber notice provided by the acquiring carrier must contain detailed information on the rates, terms, and conditions of the service(s) the acquiring carrier will provide. The notice must advise the affected subscribers that the stated rates, terms, and conditions will apply on the date that the acquiring carrier becomes their service provider, and it must also disclose the method by which the carrier will inform them of any post-transfer changes. We believe that having such information in advance will enable consumers to make an informed decision regarding the transaction and their choice of preferred carrier, consistent with the goals of section 258.

23. We do not believe it appropriate to permit carriers to simply refer the affected subscribers to the acquiring carrier's website for this information, as several commenters suggested. We recognize that, under our detariffing rules, long distance carriers will be required to provide information on their rates and service offerings on their websites. We note, however, that not all consumers have website access. Moreover, we believe that the involuntary nature of carrier changes associated with a sale or transfer entitles subscribers to receive direct initial notice of the applicable rates, terms, and conditions of the new service offerings. For similar reasons, we reject the proposals made by some commenters to require the advance subscriber notice to include only the rates of the acquiring carrier or no information at all regarding the new carrier's terms or conditions of service.

24. We decline to require the acquiring carrier to continue to charge affected subscribers the same rates as those charged by the selling or transferring carrier for a specified period after the transfer. Several commenters assert that such a requirement may prove difficult and costly, if not impossible, and may serve as a major impediment to these transactions in the marketplace. We believe that such a requirement is unnecessary because the information the affected subscribers will receive in the 30-day advance subscriber notice about the acquiring carrier's rates, terms, and conditions for the telecommunications services at issue, coupled with the reminder of their right to select a different carrier, will enable them to make an informed decision about who their carrier should be and the rates they pay for these services, consistent with the goals of section 258.

25. We conclude that it is appropriate, and consistent with section 258, to require the acquiring carrier to be responsible for any carrier change charges associated with the transaction. We believe that, because carrier changes associated with a carrier-to-carrier sale or transfer are involuntary, subscribers should not bear the burden of the cost of changing service providers. Moreover, we believe that the acquiring carrier is in the best position to cover carrier change charges because it has the billing relationship with the customer after the transfer. We modify slightly our proposal in the Third Further Notice, 66 FR 8093, January 29, 2001, to require the advance subscriber notice to state that no carrier charges will be imposed as a result of the transaction because we recognize that some acquiring carriers may not be able to prevent the assessment of a carrier change charge. We recognize that acquiring carriers may need the flexibility to credit or reimburse affected subscribers for such charges, if such charges are imposed outside of the acquiring carrier's control. Our amended rules require the acquiring carrier to take responsibility for any carrier change charges associated with the transaction and to make this fact clear in the advance subscriber notice.

26. We agree with commenters that subscribers being transferred from one carrier to the next in a transaction must know that they have the right to make another preferred carrier selection, if an alternative carrier is available. The affected subscribers did not choose the acquiring carrier and should receive reasonable notice that they have the right to select a new carrier if they do not want to be served by the acquiring carrier. Consistent with section 258, we therefore require the acquiring carrier to include such a statement in its advance notice to each of the affected subscribers. We recognize that transfers may include customers who have signed term contracts with the selling or transferring carrier, and that such term contracts may be viewed by the acquiring company as a valuable component of the transaction. While we decline to make an exception to this requirement for term contracts, we conclude that a carrier may state in its notice to an affected term contract subscriber that the subscriber may face termination penalties if the subscriber selects another carrier prior to the expiration of the term contract, if that is the case.

27. We further require the acquiring carrier to include a toll-free customer service telephone number in the advance subscriber notice, in order to address any questions or problems that the subscriber may have concerning the change in service providers. This requirement will help ensure that the affected subscribers experience a seamless transition to the new service provider. We note that this requirement does not impose a new regulatory burden on most carriers because the Commission's truth-in-billing rules already require most carriers to provide a toll-free inquiry and dispute resolution number on consumers' telephone bills. Accordingly, this aspect of the subscriber notification requirement merely provides information that most subscribers would obtain, at a minimum, upon receipt of the first bill.

28. We will require the acquiring carrier to make clear in the advance subscriber notice that all subscribers receiving the notice, including those who have arranged preferred carrier freezes through their local service providers on the service(s) involved in the transfer, will be transferred to the new carrier if they do not select a different preferred carrier before the transfer date. We will also require the acquiring carrier to inform subscribers that existing preferred carrier freezes on the service(s) involved in the transfer will be lifted and that, if they would like to have freeze protection after the transfer, they must contact their local service providers to obtain this service. Section 64.1190 of our rules permits local service providers to offer their subscribers the option of requesting a preferred carrier freeze, an additional measure of protection against unauthorized carrier changes that is consistent with section 258. With such a freeze in place, the subscriber is assured that his or her preferred carrier will not be changed without the subscriber's express consent. Under the circumstances involved in the sale or transfer of a subscriber base, however, a subscriber with a freeze could be left without presubscribed service when the selling or transferring carrier ceases to provide service, if that customer failed to give consent and was not automatically switched to the acquiring carrier. We believe that, under such circumstances, it is preferable, and more consistent with section 258, to permit the transfer of such a subscriber to the acquiring carrier, after adequate advance notice, rather than risk having the subscriber lose presubscribed service altogether. In our experience, there has occasionally been some confusion regarding the status of “frozen” subscribers who are part of a subscriber base being acquired by another carrier pursuant to a sale or transfer. We believe that it is appropriate to ensure that subscribers with preferred carrier freezes in place do not lose presubscribed service even if they fail to respond to notice of an impending carrier change. Under the procedures adopted in this Order, “frozen” subscribers who prefer not to receive service from the acquiring carrier will have sufficient notice of their ability to select another provider, in a manner consistent with section 258. In addition, “frozen” subscribers will have notice of the need to contact their local service providers if they wish to continue to have preferred carrier freeze protection for the service(s) involved in the transfer after the transfer occurs.

29. Finally, we conclude that the acquiring carrier must include in the advance subscriber notice whether it will be assuming responsibility for handling the outstanding complaints that the affected subscribers may have against the selling or transferring carrier. As part of the transaction, an acquiring carrier may agree to assume responsibility for outstanding complaints against the selling or transferring carrier. In order to provide maximum information to affected subscribers, we believe it is appropriate to require the acquiring carrier to provide information about complaint administration to the affected subscribers if the acquiring carrier is assuming responsibility for such complaints.

30. We decline to require the acquiring carrier to handle outstanding complaints against the selling or transferring carrier. While some commenters support requiring the acquiring carrier to commit to handling customer complaints regarding the service of the original carrier and the transfer itself to ensure that transferred subscribers are not deprived of recourse after the transfer, other commenters strongly oppose this approach, and some believe we should place the liability for handling previous complaints on the selling or transferring carrier. We recognize that carriers often factor the costs of complaint administration into their transaction agreements, and we are reluctant to interfere with this process. We believe that it is sufficient to require the acquiring carrier to disclose in the advance subscriber notice whether it has assumed responsibility for handling outstanding complaints against the selling or transferring carrier.

31. As required by the Regulatory Flexibility Act (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated into the Third Further Notice in this proceeding. The Commission sought written public comment on the proposals in the Third Further Notice, including comment on the IRFA. The comments received are discussed. This Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

32. Section 258 of the Act makes it unlawful for any telecommunications carrier “to submit or execute a change in a subscriber's selection of a provider of telephone exchange services or telephone toll service except in accordance with such verification procedures as the Commission shall prescribe.” In the Section 258 Order, 64 FR 7763, February 16, 1999, the Commission established a comprehensive framework of rules to implement section 258 and strengthen its existing anti-slamming rules. Since the release of the Section 258 Order, the Commission has received many requests for waiver of its carrier change and authorization rules as a result of carriers selling or transferring their subscriber bases to other carriers, and the carriers desire not to get authorization from each affected subscriber in order to transition in a seamless, efficient manner. The objectives of the modified rules adopted in this Order are to address these types of transactions and provide for a streamlined approach that would meet the consumer protection goals of section 258 and also permit carriers to efficiently transfer customers without the need for Commission approval of a waiver petition.

33. The Commission received no comments directly in response to the IRFA.

34. Difference in Advance Notice to Affected Subscribers Based on Types of Service Provided and/or Size of Carrier. The Commission specifically sought comment on whether the subscriber advance notice requirement should differ in some manner based on the type of service being provided, such as local, intraLATA toll, or interLATA toll service, or upon the size of the carrier(s) involved. All commenters on this issue agree that the advance notice requirement should be the same for all carriers. The Commission determined that, because a change in presubscribed service provider affects all subscribers similarly, regardless of the service type or the size of the original or acquiring carrier, there is no basis for varying the notice requirements.

35. Second Notice to Affected Subscribers. The Commission invited parties to comment on whether acquiring carriers should be required to provide each affected subscriber with a second written notice after the transfer has occurred reiterating the same information provided in the pre-transfer notification. Many commenters contend that the requirement of a second notice to the affected subscribers is overly burdensome and costly for carriers with little benefit to the affected subscribers. ITAA specifically noted that a second notice requirement would be particularly burdensome for smaller and midsize carriers, which would be less able to absorb doubling the costs of the subscriber notice requirement. These comments are discussed in more detail. The Commission agrees with these commenters, and others, that affected subscribers do not need to receive a second written notice that simply reiterates the information provided in the first notice. The Commission recognized that, while some affected subscribers may fail to read the notice sent prior to the change in service providers, they will receive notification of the new service provider on their bills under the highlighting requirement of the Commission's truth-in-billing rules. The Commission also concluded that a second notice would be costly for carriers, especially smaller carriers.

36. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” is defined as a “small business concern” under section 3 of the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). A small organization is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of 1992, there were approximately 275,801 small organizations. “Small governmental jurisdiction” generally means “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than 50,000.” As of 1992, there were approximately 85,006 governmental entities in the United States. This number includes 38,978 counties, cities, and towns; of these, 37,566, or 96 percent, have populations of fewer than 50,000. The Census Bureau estimates that this ratio is approximately accurate for all governmental entities. Thus, of the 85,006 governmental entities, we estimate that 81,600 (96 percent) are small entities. According to SBA reporting data, there were 4.44 million small business firms nationwide in 1992. We further describe and estimate the number of small entity licensees and regulatees that may be affected by the rules.

37. The most reliable source of information regarding the total numbers of certain common carrier and related providers nationwide, as well as the number of commercial wireless entities, appears to be data the Commission publishes in its Trends in Telephone Service report. In a recent news release, the Commission indicated that there are 4,822 interstate carriers. These carriers include, inter alia, local exchange carriers, wireline carriers and service providers, interexchange carriers, competitive access providers, operator service providers, pay telephone operators, providers of telephone service, providers of telephone exchange service, and resellers.

38. The SBA has defined establishments engaged in providing “Radiotelephone Communications” and “Telephone Communications, Except Radiotelephone” to be small businesses when they have no more than 1,500 employees. We discuss the total estimated number of telephone companies falling within the two categories and the number of small businesses in each, and we then attempt to refine further those estimates to correspond with the categories of telephone companies that are commonly used under our rules.

39. We have included small incumbent LECs in this present RFA analysis. As noted, a “small business” under the RFA is one that, inter alia, meets the pertinent small business size standard ( e.g., a telephone communications business having 1,500 or fewer employees), and “is not dominant in its field of operation.” The SBA's Office of Advocacy contends that, for RFA purposes, small incumbent LECs are not dominant in their field of operation because any such dominance is not “national” in scope. We have therefore included small incumbent LECs in this RFA analysis, although we emphasize that this RFA action has no effect on FCC analyses and determinations in other, non-RFA contexts.

40. Total Number of Telephone Companies Affected. The U.S. Bureau of the Census (“Census Bureau”) reports that, at the end of 1992, there were 3,497 firms engaged in providing telephone services, as defined therein, for at least one year. This number contains a variety of different categories of carriers, including local exchange carriers, interexchange carriers, competitive access providers, cellular carriers, mobile service carriers, operator service providers, pay telephone operators, covered specialized mobile radio providers, and resellers. It seems certain that some of these 3,497 telephone service firms may not qualify as small entities because they are not “independently owned and operated.” For example, a PCS provider that is affiliated with an interexchange carrier having more than 1,500 employees would not meet the definition of a small business. It is reasonable to conclude that 3,497 or fewer telephone service firms are small entity telephone service firms that may be affected by the new rules.

41. Wireline Carriers and Service Providers. The SBA has developed a definition of small entities for telephone communications companies except radiotelephone (wireless) companies. The Census Bureau reports that there were 2,321 such telephone companies in operation for at least one year at the end of 1992. According to the SBA's definition, a small business telephone company other than a radiotelephone company is one employing no more than 1,500 persons. All but 26 of the 2,321 non-radiotelephone companies listed by the Census Bureau were reported to have fewer than 1,000 employees. Thus, even if all 26 of those companies had more than 1,500 employees, there would still be 2,295 non-radiotelephone companies that might qualify as small entities. We do not have data specifying the number of these carriers that are not independently owned and operated, and thus are unable at this time to estimate with greater precision the number of wireline carriers and service providers that would qualify as small business concerns under the SBA's definition. Consequently, we estimate that 2,295 or fewer small telephone communications companies other than radiotelephone companies are small entities that may be affected by the new rules.

42. Local Exchange Carriers. Neither the Commission nor the SBA has developed a definition for small providers of local exchange services (LECs). The closest applicable definition under the SBA rules is for telephone communications companies other than radiotelephone (wireless) companies. According to the most recent Telecommunications Industry Revenue data, 1,335 incumbent carriers reported that they were engaged in the provision of local exchange services. We do not have data specifying the number of these carriers that are either dominant in their field of operations, are not independently owned and operated, or have more than 1,500 employees, and thus are unable at this time to estimate with greater precision the number of LECs that would qualify as small business concerns under the SBA's definition. Consequently, we estimate that 1,335 or fewer providers of local exchange service are small entities that may be affected by the new rules.

43. Interexchange Carriers. Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to providers of interexchange services (IXCs). The closest applicable definition under the SBA rules is for telephone communications companies other than radiotelephone (wireless) companies. According to the most recent Trends in Telephone Service data, 204 carriers reported that they were engaged in the provision of interexchange services. We do not have data specifying the number of these carriers that are not independently owned and operated or have more than 1,500 employees, and thus are unable at this time to estimate with greater precision the number of IXCs that would qualify as small business concerns under the SBA's definition. Consequently, we estimate that there are 204 or fewer small entity IXCs that may be affected by the new rules.

44. Competitive Access Providers. Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to competitive access services providers (CAPs). The closest applicable definition under the SBA rules is for telephone communications companies other than radiotelephone (wireless) companies. According to the most recent Trends in Telephone Service data, 349 CAP/CLECs carriers and 60 other LECs reported that they were engaged in the provision of competitive local exchange services. We do not have data specifying the number of these carriers that are not independently owned and operated, or have more than 1,500 employees, and thus are unable at this time to estimate with greater precision the number of CAPs that would qualify as small business concerns under the SBA's definition. Consequently, we estimate that there are 349 or fewer small entity CAPs and 60 other LECs that may be affected by the new rules.

45. Operator Service Providers. Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to providers of operator services. The closest applicable definition under the SBA rules is for telephone communications companies other than radiotelephone (wireless) companies. According to the most recent Trends in Telephone Service data, 21 carriers reported that they were engaged in the provision of operator services. We do not have data specifying the number of these carriers that are not independently owned and operated or have more than 1,500 employees, and thus are unable at this time to estimate with greater precision the number of operator service providers that would qualify as small business concerns under the SBA's definition. Consequently, we estimate that there are 21 or fewer small entity operator service providers that may be affected by the new rules.

46. Pay Telephone Operators. Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to pay telephone operators. The closest applicable definition under SBA rules is for telephone communications companies other than radiotelephone (wireless) companies. According to the most recent Trends in Telephone Service data, 758 carriers reported that they were engaged in the provision of pay telephone services. We do not have data specifying the number of these carriers that are not independently owned and operated or have more than 1,500 employees, and thus are unable at this time to estimate with greater precision the number of pay telephone operators that would qualify as small business concerns under the SBA's definition. Consequently, we estimate that there are 758 or fewer small entity pay telephone operators that may be affected by the new rules.

47. Resellers (including debit card providers). Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to resellers. The closest applicable SBA definition for a reseller is a telephone communications company other than radiotelephone (wireless) companies. According to the most recent Trends in Telephone Service data, 454 toll and 87 local entities reported that they were engaged in the resale of telephone service. We do not have data specifying the number of these carriers that are not independently owned and operated or have more than 1,500 employees, and thus are unable at this time to estimate with greater precision the number of resellers that would qualify as small business concerns under the SBA's definition. Consequently, we estimate that there are 454 or fewer small toll entity resellers and 87 small local entity resellers that may be affected by the new rules.

48. Toll-Free 800 and 800-Like Service Subscribers. Neither the Commission nor the SBA has developed a definition of small entities specifically applicable to 800 and 800-like service (“toll free”) subscribers. The most reliable source of information regarding the number of these service subscribers appears to be data the Commission collects on the 800, 888, and 877 numbers in use. According to our most recent data, at the end of January 1999, the number of 800 numbers assigned was 7,692,955; the number of 888 numbers that had been assigned was 7,706,393; and the number of 877 numbers assigned was 1,946,538. We do not have data specifying the number of these subscribers that are not independently owned and operated or have more than 1,500 employees, and thus are unable at this time to estimate with greater precision the number of toll free subscribers that would qualify as small business concerns under the SBA's definition. Consequently, we estimate that there are 7,692,955 or fewer small entity 800 subscribers, 7,706,393 or fewer small entity 888 subscribers, and 1,946,538 or fewer small entity 877 subscribers may be affected by the new rules.

49. Cellular Licensees. Neither the Commission nor the SBA has developed a definition of small entities applicable to cellular licensees. Therefore, the applicable definition of small entity is the definition under the SBA rules applicable to radiotelephone (wireless) companies. This provides that a small entity is a radiotelephone company employing no more than 1,500 persons. According to the Census Bureau, only twelve radiotelephone firms from a total of 1,178 such firms which operated during 1992 had 1,000 or more employees. Therefore, even if all twelve of these firms were cellular telephone companies, nearly all cellular carriers were small businesses under the SBA's definition. In addition, we note that there are 1,758 cellular licenses; however, a cellular licensee may own several licenses. In addition, according to the most recent Trends in Telephone Service data, 806 carriers reported that they were engaged in the provision of either cellular service or Personal Communications Service (PCS) services, which are placed together in the data. We do not have data specifying the number of these carriers that are not independently owned and operated or have more than 1,500 employees, and thus are unable at this time to estimate with greater precision the number of cellular service carriers that would qualify as small business concerns under the SBA's definition. Consequently, we estimate that there are 806 or fewer small cellular service carriers that may be affected by the new rules.

50. We analyze the projected reporting, recordkeeping, and other compliance requirements that might affect small entities.

51. Notice to the Commission. The Commission concludes that adopting a carrier self-certification process as the streamlined procedure for notifying the Commission prior to the sale or transfer of a subscriber base is in the public interest. Accordingly, the Commission directs carriers to file a notification letter with the Secretary of the Commission, no later than 30 days prior to the actual transfer of the subscriber base to the new service provider. This notification letter shall include the names of the parties to the transaction, the types of telecommunications services provided to the affected subscribers, the date of the transfer of these subscribers to the acquiring carrier, a certification of compliance with the statutory and Commission requirements that apply to this process, and an attached copy of the notice sent to the affected subscriber. This is a minimal filing requirement for small and large carriers in comparison to the Commission waiver process requirements and, unlike the waiver process, it will not require the carriers to obtain Commission action before completing the transaction. The self-certification to the Commission will serve enforcement and consumer information purposes through providing the Commission with advance notice of these transactions. Certification of these transactions will help ensure compliance with the Commission's rules and will better inform Commission of the status of these transactions in the marketplace so that the Commission can better serve and provide information to affected consumers.

52. Notice to the Affected Subscribers. The Commission amends its carrier change and authorization rules to provide a streamlined procedure for all telecommunications carriers that purchase or transfer all or part of their subscriber base. This streamlined approach will benefit all carriers, small and large, by eliminating the time-consuming and resource-intensive Commission waiver process. The Commission concludes that carriers acquiring subscribers should provide those subscribers with reasonable advance notice ( i.e., at least 30 days) of a carrier change associated with a sale or transfer. The Commission states that, based on its extensive experience with waiver petitions related to subscriber sales or transfers, 30 days is a reasonable notice period to provide subscribers with sufficient notice and opportunity to make an informed decision without creating a burdensome delay for the carriers involved.

53. Advance Notice to the Affected Subscribers. The Commission has considered whether the advance subscriber notice requirement adopted herein will impose significant additional costs or administrative burdens on small carriers. The Commission concludes that this requirement would not impose significant additional costs or administrative burdens on small carriers. In this regard, the Commission notes that all carriers, including small carriers, already provide these types of notices as part of the waiver process and do not object to continuing to provide them under the streamlined approach prescribed in the Third Further Notice. Accordingly, the Commission concludes that the advance notice requirement is not burdensome.

54. Second Notice to Affected Subscribers. To minimize the administrative burden on carriers, particularly small carriers, the Commission has not incorporated a second notice to the affected subscribers into the streamlined process. The Commission recognizes that such a requirement may be costly and therefore burdensome to small carriers. In addition, we note that consumers will receive a de facto second notice through the highlighting of new service providers on telephone bills required by the Commission's truth-in-billing rules. Our decision not to adopt the proposed alternative of a required second subscriber notice is consistent with comments filed, including those addressing small entity concerns.

55. Rates, Terms, and Conditions of the New Service Provider. The Commission has considered whether to require the acquiring carrier to continue to charge affected subscribers the same rates as those charged by the selling or transferring carrier for a specified period after the transfer. The Commission has determined that such a requirement is not necessary because the information the affected subscribers will receive in the 30-day advance subscriber notice about the acquiring carrier's rates, terms, and conditions for the telecommunications services at issue will enable them to make an informed decision about the rates they pay for these services.

56. The Commission will send a copy of the Order, including this FRFA, in a report to Congress pursuant to the Congressional Review Act. In addition, the Commission will send a copy of the Order, including the FRFA, to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the Order and FRFA (or summaries thereof) also will be published in the Federal Register .

57. The action contained herein has been analyzed with respect to the Paperwork Reduction Act of 1995 and found to impose new or modified reporting and recordkeeping requirements or burdens on the public. This document contains information collection requirements that have not been approved by the Office of Management Budget (OMB). The Commission will publish a document in the Federal Register announcing the effective date of that section.

58. Pursuant to sections 1, 4, 201-205, 255, and 258 of the Communications Act of 1934, as amended, the policies, rules, and requirements set forth herein are adopted. Part 64 is amended as set forth.

59. This document contains information collection requirements that have not been approved by the Office of Management Budget (OMB). The Commission will publish a document in the Federal Register announcing the effective date of that section.

60. The Commission's Consumer Information Bureau, Reference Information Center, shall send a copy of this Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

The Preble's meadow jumping mouse ( Zapus hudsonius preblei ), a subspecies of the meadow jumping mouse ( Zapus hudsonius ), occurs only along the Rocky Mountain-Great Plains Interface (the Front Range) of eastern Colorado and Southeastern Wyoming. The final rule listing the Preble's as a threatened species under the Act was published in the Federal Register on May 13, 1998 (63 FR 26517). Section 4(d) of the Act (16 U.S.C. 1533 (d)) provides that, whenever a species is listed as a threatened species, the Secretary of the Department of the Interior will issue regulations deemed necessary and advisable to provide for the conservation of the species. This is done in either of two ways.

First, the Act authorizes imposition of take prohibitions to endangered species. We, the Fish and Wildlife Service, have issued regulations (50 CFR 17.31) that generally apply to threatened wildlife virtually all the prohibitions that section 9 of the Act (16 U.S.C. 1538) establishes with respect to endangered wildlife. These universal prohibitions, in part, make it illegal for any person subject to the jurisdiction of the United States to “take” any listed wildlife species, i.e., to harass, harm, pursue, hunt, shoot, wound, kill, trap, or collect any threatened or endangered species or to attempt to engage in any such conduct (16 U.S.C. 1532 (19)).

Second, our regulations for threatened wildlife also provide that a “special rule” under section 4(d) of the Act can be tailored for a particular threatened species. In that case the general regulations applying most section 9 prohibitions do not apply to that species, and the special rule contains the prohibitions (and exemptions) necessary and appropriate to conserve that species.

At the time the Preble's was listed, we did not promulgate a special section 4(d) rule; therefore, the section 9 prohibitions, including the take prohibitions, became applicable to the species. On December 3, 1998, a proposed special rule identifying specific circumstances under which section 9 prohibitions would not apply to the Preble's was published in the Federal Register (63 FR 66777). This proposal initiated a 60-day public comment period, which closed February 1, 1999. The public comment period was extended for an additional 45 days through March 5, 1999 (64 FR 4607), and was reopened from March 16 through April 30, 1999 (64 FR 12924).

Briefly, the proposed special rule provided exemptions from section 9 prohibitions for—(1) all activities outside of specified Mouse Protection Areas (areas where Preble's had been documented) and Potential Mouse Protection Areas (areas judged to have high potential to support Preble's); (2) rodent control, ongoing agriculture, maintenance and replacement of existing landscaping, and existing uses of water anywhere within the Preble's range; and (3) under specified standards, alteration of up to 4 percent of Mouse Protection Areas and Potential Mouse Protection Areas as approved by State or local government. After review of comments received, this proposed special rule has been finalized in a modified form, adopting only the second exemption listed above for rodent control, ongoing agriculture, maintenance and replacement of existing landscaping, and existing uses of water anywhere within the Preble's range.

We anticipate that this rule will prohibit actions that threaten the Preble's to the extent necessary to provide for the conservation of the Preble's. The rule also provides flexibility to private landowners for ongoing activities that will not impede the conservation of the species. We also believe that this rule will garner support of State and local governments, private landowners, and other interested parties and contribute to a lasting, cooperative approach for the long-term conservation of the species.

This rule is best understood in the context of other regulations and actions, already in place or in development, to provide for conservation of the Preble's. First, it is important to understand that an activity prohibited under the general regulations might still be allowed under section 10 of the Act. That section provides for a person to obtain from us, in appropriate circumstances, a permit allowing the “incidental” taking of Preble's. One of the purposes of this rule is to make, in advance, general decisions that certain types of activities are consistent with the conservation of the Preble's, without requiring people to seek additional section 10 permits authorizing those activities. Additional activities that result in take of Preble's that are not exempted by this special rule still can be permitted by the Service under section 10 of the Act.

Currently, the State of Colorado, the Service, and various local governments in Colorado and Wyoming are working together to develop plans to conserve the Preble's and its habitat. This collaborative approach is expected to result in the development of Habitat Conservation Plans and applications to the Service for incidental take permits under section 10 of the Act. These Habitat Conservation Plans will provide an important component of a lasting, effective, and efficient conservation and recovery program for the Preble's.

We are committed to development of a recovery plan for the Preble's that achieves long-term conservation and development solutions. We believe that a recovery program that integrates both biological as well as social factors will have the highest chance of success. One of the purposes of this special rule is to foster cooperation among the Service, the States, local governments, and the private sector in pursuing recovery of the Preble's.

The second important component of the context for this special rule is that Federal agencies are required under section 7 of the Act to utilize their authorities to conserve listed species and to consult with the Service to ensure that their actions are not likely to jeopardize the Preble's. For consultations that involve the use of Federal land, we expect that those lands will be managed in furtherance of the conservation of the species to the maximum extent possible. Other types of section 7 consultations involve actions that are similar to those that are considered under the section 10 process. For example, many of the activities likely to affect Preble's undertaken outside of Federal land, but wholly or partly in wetlands, will be subject to permitting requirements of the Clean Water Act, such as section 404 permits issued by the Army Corps of Engineers.

Third, a variety of Federal, State, and local programs are available to help preserve the Preble's through the acquisition, preservation, and management of its habitat. These include the Service's Partners for Fish and Wildlife Program, the Natural Resource Conservation Service's wetland/riparian habitat protection programs, grant programs administered by Great Outdoors Colorado, city and county open space programs, and activities of local land trusts. In particular, our Partners for Fish and Wildlife Program has proven to be an especially effective approach for wildlife conservation on agricultural lands by providing funding for restoration of wetlands and riparian habitats.

In the December 3, 1998, proposed 4(d) rule and associated notifications, and in subsequent notices to extend or reopen the public comment period, we asked all interested parties to submit comments on the proposed rule. We held two public meetings on December 16, 1998, in Lakewood, Colorado. The proposed rule was explained, followed by a question and answer session. Attendance at the afternoon session totaled 104 individuals, while attendance at the evening session totaled 24. We received 614 comment letters in response to the proposed 4(d) rule, including comments from 23 municipal and county governments, 14 environmental organizations, and 60 development, irrigation, and ranching-related organizations. Comments also were received from a member of the Wyoming congressional delegation and from the Governors of Wyoming and Colorado. Almost half of all letters received were associated with various letter-writing campaigns that reflected the same or very similar content.

Written comments, and oral statements presented in the public meetings or received during the comment periods, that are specific to the proposed rule are addressed in the following summary. Comments of a similar nature are grouped under a number of general issues.

Issue 1 —The proposed duration of this temporary rule, 18 months, may not provide enough time to develop Habitat Conservation Plans and other long-term strategies to conserve the Preble's.

Response —Based on the progress of ongoing efforts to develop Habitat Conservation Plans, we lengthened the duration of the rule to 36 months. This should provide time not only for completion of Habitat Conservation Plans but for completion of a recovery plan and other conservation efforts for the Preble's. The level of take anticipated to occur from this rule within either an 18-month or 36-month period is not considered to be biologically significant to recovery of the Preble's.

Issue 2 —Refinement is needed in mapping Mouse Protection Areas and Potential Mouse Protection Areas that were developed in support of the proposed exemption for activities outside of likely Preble's habitat. Survey data that serve as a basis for the maps are scant, especially on private lands. Preble's use of habitat across its range has not been thoroughly studied. Proposed limits of the exemption as measured outward from occupied or potentially occupied streams and wetlands may be excessive or may be inadequate to include Preble's habitat. Designation of Mouse Protection Areas and Potential Mouse Protection Areas has been characterized by some as de facto designation of critical habitat.

Response —Because of these and other issues, the proposed designation of Mouse Protection Areas and Potential Mouse Protection Areas and the proposed exemption for incidental take outside of such areas have been dropped from the final rule. We will continue to use the best science available to determine distribution, presence, and habitat requirements of the Preble's. We will make such information available through our Colorado and Wyoming Field Offices and our web page. Determinations of Preble's presence and potential for human activities to impact Preble's will continue to occur on a site-by-site basis. Detailed local information on Preble's may be further developed to support Habitat Conservation Plans.

Issue 3 —The proposed exemption to allow up to 4 percent of a Mouse Protection Area to be altered under a system of local review is considered by some as arbitrary and without firm scientific support. In addition, local government may not have the funds, expertise, or enforcement authority to take on this responsibility. Local government also may assume increased liability under this exemption.

Response —Because of these and other issues, this proposed exemption from take was dropped from the final rule.

Issue 4 —The proposed exemption for rodent control may be used as a means to eliminate Preble's from an area.

Response —As with all exemptions in this rule, only incidental take of Preble's that meets the specific provisions of the rule is exempted. Purposeful take of Preble's would still be prohibited.

Issue 5 —Agriculture is often beneficial to the Preble's, and farmers and ranchers are good stewards of land. Flexibility to change agricultural practices within Preble's habitat is needed by farmers and ranchers, yet the proposed exemption would cover only established, ongoing activities.

Response —The exemption for ongoing agriculture recognizes that certain agricultural practices have proven compatible with survival of Preble's. Changes in agricultural practices that are positive or neutral to the Preble's are unlikely to result in take. Recognizing that continuation of existing agricultural activities is likely to result in minimal levels of take, this rule exempts ongoing agricultural activities from take. New agricultural activities could significantly expand the area or degree of take, potentially having larger impacts to the species; therefore, take from new or expanded agricultural activities is not exempted in this rule. Under the appropriate circumstances, section 10 permits can be obtained to allow take of Preble's due to new or expanded agricultural activities.

Issue 6 —Exempted agricultural practices need to be better defined. A list of what is not exempted would be useful.

Response —This rule exempts incidental take of Preble's that may result from ongoing agricultural activities. Ongoing agricultural activities would be considered those activities in place at the time of the 1998 listing of the Preble's. We provide this exemption because lands that are currently under agricultural production are believed to have minimal habitat for the Preble's, and because agricultural activities are being conducted in a manner that causes minimal take of Preble's. We are not providing exemption in situations where larger amounts of take may occur. Therefore, this exemption applies to practices customary and necessary for the continuation of existing agricultural production. It does not apply to new activities or to expansion of activities that change the existing activity footprint in size or location. New or expanded activities may remove or significantly alter habitat that is currently occupied by Preble's and, therefore, are not included in this exemption. Questions regarding application of this exemption to specific practices in Colorado may be addressed to our Colorado Field Office, and in Wyoming questions may be addressed to our Wyoming Field Office (see ADDRESSES and FOR FURTHER INFORMATION CONTACT sections).

Issue 7 —Practices such as crop rotation should be covered under the exemption for ongoing agriculture.

Response —Actions that reflect regular past uses are considered ongoing. Crop rotation consistent with a past pattern would be exempted from take. The ability to document past use may be important if any changes result in take of Preble's.

Issue 8 —Exemptions from take should be provided when land enrolled in conservation reserve programs, that provides habitat for the subspecies, is later returned to agricultural production.

Response —This rule does not exempt take when lands maintained for conservation under various government programs are returned to agricultural production. Returning lands to agricultural production after the period of time in which the lands were enrolled in a conservation reserve program represents a change in use. It would not be considered an “existing” agricultural activity and, therefore, would not qualify for the exemption for “existing” agricultural uses. However, take associated with the return of lands from conservation reserve programs to agricultural production may still be authorized under the Habitat Conservation Plan provisions of section 10(a)(1)(B) of the Act.

Issue 9 —The exemption from take for maintenance and replacement of existing landscaping also exempts maintenance and replacement of “related structures and improvements.” The intent of this exemption should be explained.

Response —Walkways, retaining walls, and other nonvegetative components of landscaping may be maintained and replaced as needed under this exemption. These structures do not normally provide habitat for the Preble's, and maintenance of such structures would likely result in minimal take, if any. “Related structures and improvements” should be viewed in the context of landscaping and not expanded to include houses, garages, or outbuildings. While maintenance or replacement of these larger structures would generally not result in take, on occasion such activity may entail a larger area and duration of disturbance, use of heavy machinery in the surrounding area, and staging of construction materials. In some circumstances, such activity could cause more than minimal take; therefore, while most of this type of activity would not result in any take, we have chosen not to exempt such activity due to those instances where take could be substantial.

Issue 10 —The rule does not specify an exemption from take for maintenance of roadsides through mowing, which may occur in or near Preble's habitat. Such activity could result in take of Preble's.

Response —We agree that maintenance of roadsides could in some situations result in take, and if occupied habitat is removed as part of such activities, then the resulting take would probably be more than minimal. For this reason we have not included an exemption from take for roadside maintenance activities. As such activities are not usually undertaken by individuals, we encourage all jurisdictions that engage in maintenance mowing to modify such practices where Preble's may be present to avoid the likelihood of take, or to seek a section 10 permit when the potential for take cannot be avoided.

Issue 11 —Water utilization was identified as a factor leading to listing of the Preble's, but is being exempted under this rule.

Response —Only take resulting from existing uses of water associated with perfected water rights is being exempted. Much as with agricultural activities, some existing patterns of water use appear compatible with maintenance of Preble's populations. In some locations, such as in water conveyance ditches, the Preble's exists only because of human manipulation of water flows. The relationship of water use and maintenance of the Preble's and its habitat is complex. During the period of this rule, existing patterns of water use will be exempted.

Issue 12 —Some respondents requested clarification on our interpretation of “existing water uses” and “perfected water rights.”

Response —An explanation has been added to the final rule which states that existing water uses refers to historical water use practices. In general, any change in water use practices that would require a change of water right or a change in a water use permit will not be exempted in the final rule.

Issue 13 —Several respondents requested a broader exemption for any water use permitted or decreed by State governments. Many Colorado municipalities and water suppliers requested exemption for transfers of perfected water rights and exercise of conditional water rights.

Response —We are not granting a range-wide exemption for water rights transfers, conditional water rights, and other water uses that are not considered “perfected.” These actions have a much higher potential to take Preble's than the exercise of perfected water rights. For example, exercise of conditional water rights could result in new flooding of Preble's habitat, and transfer of a historical irrigation right may result in abandonment of a ditch that supports Preble's habitat. We anticipate that exercise of most conditional water rights and transfers will not result in take of Preble's; therefore, in these cases no exemptions from take are needed. If take is likely from such changes, a process exists for pursuing a take permit under section 10 of the Act.

Issue 14 —Many commentors requested exemption from take for maintenance of water supply ditches. Ongoing agriculture and use of perfected water rights are exempted from take. Logically, ditches must be maintained to convey water to support these activities (for example, from reservoirs to the agricultural fields). If water supply ditches that currently support Preble's are not maintained, they will ultimately cease to function. If abandoned, they will not convey water or support habitat of value to Preble's.

Response —We are considering proposing an amendment to this rule that provides an exemption from take for certain maintenance practices on water supply ditches.

Issue 15 —An exemption from take for the control of noxious weeds may be appropriate. Currently, weed control programs in occupied or potential Preble's habitat are being curtailed for fear that they will be in violation of the Act. Ultimately, this may result in spread of noxious weeds that will, in turn, result in degradation of Preble's habitat.

Response —We are considering proposing an amendment to this rule to provide an exemption from take for certain activities relating to control of noxious weeds.

Issue 16 —We received suggestions for additional range-wide exemptions from take covering a number of activities. A partial list includes exemptions for construction of trails, actions to promote public health and safety, construction and maintenance of infrastructure including utility lines and wastewater facilities, maintenance of roads and parking lots, and maintenance activities within waterways.

Response —These activities have the potential for more than minimal amounts of take; therefore, we believe that these additional exemptions are not appropriate or consistent with the conservation of the Preble's. Under appropriate circumstances, permits could be obtained to allow take that may result from these activities. Some of these activities may be addressed through future Habitat Conservation Plans or section 7 consultations.

Issue 17 —Voluntary conservation efforts are sufficient to protect the Preble's on private lands.

Response —This rule does not require any conservation measures for the Preble's nor does it prevent individuals from undertaking voluntary conservation measures. We support any parties who wish to undertake voluntary conservation measures and welcome discussions with any party who wishes to consider developing a conservation agreement for the Preble's or its riparian habitat. If the species' status can be improved and threats reduced as a result of voluntary conservation measures, then we may be able to consider removing the Preble's from the list of endangered and threatened species under the Act.

Issue 18 —The Service should provide updated maps of known Preble's locations and locations of unsuccessful trapping efforts on a web site accessible to the public.

Response —We are investigating various means to make this information more readily available to the public. In the meantime, the most recent information on known Preble's distribution is available from our Colorado and Wyoming Field Offices. (See ADDRESSES and FOR FURTHER INFORMATION CONTACT sections.)

Issue 19 —The relationship of this rule to a future recovery plan for the Preble's should be explained.

Response —This temporary rule contributes to the conservation of the Preble's and does not compromise the development of a recovery plan. We anticipate developing a recovery plan prior to the termination of this rule.

Issue 20 —The Service should provide for an accounting of take occurring under this rule.

Response —This rule provides exemptions from take for specific activities and under limited circumstances. In our best professional judgment, the exemptions provided are consistent with the conservation of the species. The proposed exemptions are not tied to a specific threshold of what would, without the rule, be considered take. We prepared a Biological Opinion under section 7 of the Act to address the likely effects of this rule on the Preble's.

Issue 21 —The relationship of this rule to future Habitat Conservation Plans should be explained.

Response —Exemptions provided by this rule are independent of any Habitat Conservation Plan that may be submitted to us. Similar activities may or may not be addressed in a Habitat Conservation Plan at the discretion of the entity developing the plan. We anticipate that comprehensive Habitat Conservation Plans will be developed for the Preble's during the 36-month duration of this rule.

Issue 22 —The relationship of this rule to review of Federal activities under section 7 of the Act should be explained.

Response —This rule does not alter Federal agency responsibilities under section 7 of the Act. Federal agencies would be exempt from section 9 prohibitions on take from the activities covered by this rule; however, Federal agencies would not be relieved of any section 7 responsibilities, even for activities exempted by this rule. Any Federal agency that funds, permits, or authorizes an activity that may affect Preble's would still be required to undergo section 7 consultation, even if take from that activity is covered by the exemption in this rule.

This rule will be effective for a period not to exceed 36 months from May 22, 2001. We expect that, during this time period, comprehensive Habitat Conservation Plans for the Preble's will be developed. Anytime during this 36 months, we could propose to extend this rule. Any proposal to extend the rule would be published in the Federal Register and would be made available for public review and comment.

Virtually all of the prohibitions under section 9(a) of the Act that apply to endangered species continue to apply to the Preble's, to the same extent that they apply to other threatened species under our general regulations, except that certain activities would be exempted. Except for the exemptions below, it is illegal for any person subject to the jurisdiction of the United States to take any Preble's (i.e., to harass, harm, pursue, hunt, shoot, wound, kill, trap, or collect a Preble's or to attempt any of those actions). It would still be illegal to import or export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any Preble's, or to possess, sell, deliver, carry, transport, or ship any Preble's that have been taken illegally.

The following activities are exempt from the general take provisions listed above, provided that the activities resulting in such take are conducted in accordance with the requirements identified in this special rule. These four exemptions apply anywhere within the Preble's range.

a. Rodent control within 10 feet of or inside of any structure —Preble's are generally not found in association with structures such as barns, houses, or other buildings. We believe that any Preble's mortality associated with trapping near these structures would be insignificant and that this exemption will promote public support for Preble's conservation efforts.

b. Ongoing agricultural activities —This exemption applies to ongoing agricultural practices but does not apply to new agricultural practices that increase impacts to, or further encroach upon, Preble's habitat. For example, a change from existing grazing practices that would adversely impact Preble's habitat, or a change in mowing practices such as mowing hay closer to a stream supporting Preble's, would not be exempted from take provisions by this rule.

Situations where Preble's populations coexist with ongoing agriculture may provide valuable insight into habitat conditions required by the Preble's and the specific types of grazing and farming practices that are compatible with the Preble's. We believe that the exemption for ongoing agricultural practices will provide a positive incentive for agricultural interests to engage in voluntary conservation activities and will remove some of the existing reluctance by private agricultural landowners to allow Preble's surveys on their lands. Surveys lead to a more complete understanding of the status and distribution of the species, especially within areas largely composed of privately owned farms and ranches. With this knowledge, our ability to develop an effective long-term recovery program will be enhanced.

c. Maintenance and replacement of existing landscaping and related structures and improvements —Some existing landscaping activities, such as lawn-mowing and gardening associated with residential or commercial development, golf courses, and parks, have disrupted Preble's habitat in certain areas. However, because take associated with continued landscaping of an area is expected to be minimal, exempting these activities from take provisions is not expected to adversely affect Preble's conservation and recovery efforts.

d. Existing uses of water associated with the exercise of perfected water rights under State law and interstate compacts and decrees —In Colorado, perfected water rights refers to uses of water that have been decreed as absolute water rights by any of the Colorado water courts. In Wyoming, perfected water rights refers to water uses that have been granted a permit and a final certificate of appropriation by the Office of the State Engineer. The cumulative effect of the development and exercise of water rights has impacted riparian communities and Preble's in some areas; however, the exercise of certain water rights and water development may benefit riparian communities and Preble's. Take associated with new water development is not exempted.

Existing uses of perfected water rights are exempt only to the extent that they do not exceed the historic amount of diversions and that they occur at the historic locations of use and at historic diversion points. For water rights or permits that have been exercised at less than the decreed or permitted diversion rate, only the historic water use practice will be considered exempt. Existing uses of water rights that are considered exempt include augmentation plans, replacement plans, and exchanges of water that have been recognized by decree or certificate of appropriation.

New actions that are not considered exempt include—any expansion of the existing use of water; changes in time, place, or amount; new exercise of conditional water rights and undecreed exchanges in Colorado; and new exercise of water use permits in Wyoming that have not yet been awarded a final certificate of appropriation. Under appropriate circumstances, permits may be obtained for take from non-exempted actions, including water uses that take Preble's.

The standard for issuing a 4(d) rule as described in the Act is “whenever any species is listed as a threatened species, the Secretary of the Interior will issue such regulations as he deems necessary and advisable to provide for the conservation of the species.” This rule meets this standard, in that it is protective of the Preble's while providing flexibility in managing its conservation and recovery. The rule provides only those temporary exemptions to take provisions of the Act that neither jeopardize the Preble's nor detract from its future recovery.

The exemptions to take prohibitions under section 9 of the Act incorporated into this rule will support the development of meaningful conservation efforts for the Preble's by State and local governments, agricultural interests, and the general public. Exemptions regarding rodent control and landscaping will elicit support from landowners. Exemptions for ongoing agricultural practices and for the exercise of perfected water rights will provide a positive incentive for agricultural interests to engage in voluntary conservation activities, such as participation in the Partners for Fish and Wildlife program. In addition, such exemptions increase the likelihood that members of the agricultural community will support surveys to determine the status of the Preble's on their lands, thus advancing our understanding of the status, distribution, and ecology of this species and facilitating the development of conservation and recovery plans. Any increased access to private lands will provide opportunities to better define existing Preble's populations and to devise appropriate conservation and recovery plans for the mouse.

Prior to finalization, we have reviewed this rule pursuant to the requirements of section 7 of the Act and the National Environmental Policy Act and an Environmental Assessment has been prepared. We also have prepared a Record of Compliance with rule-making requirements, which has undergone public review. Because this rule is a Federal action that may adversely affect the Preble's, section 7 compliance is required and a biological opinion has been prepared. All documents are available from the Service's Colorado and Wyoming Field Offices.

In accordance with 5 U.S.C. 553 (d)(1), we are making this rule effective upon publication. This rule grants exemptions to the take prohibitions that went into effect upon publication of the final rule listing the Preble's meadow jumping mouse as a threatened species on May 13, 1998.

In accordance with the criteria in Executive Order 12866, we believe that this rule is not a significant regulatory action.

(a) This rule reduces the regulatory burden of the listing of the Preble's, because it provides exemptions to the take prohibitions of section 9 of the Act that currently apply throughout the range of the Preble's.

The exemptions to the take prohibitions of the Act provided by this rule will reduce economic costs of the listing. The economic effect of the rule is a benefit to landowners and the economy. Based on the analysis described in the Record of Compliance, the 4(d) rule, by itself, will not have an annual economic impact of more than $100 million, or significantly affect any economic sector, productivity, jobs, the environment, or other units of government. A cost-benefit and economic analysis is not required.

(b) This rule will not create inconsistencies with other Federal agencies' actions.

Other Federal agency actions are mostly unaffected by this rule, with local government taking the lead in actions relating to the Preble's. The Service is encouraged by State and local governments' efforts to develop effective conservation plans for the Preble's.

(c) This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients.

Because the special rule exempts activities from take prohibitions, effects of the rule on entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients would be positive.

(d) This rule will not raise novel legal or policy issues.

The Service has previously promulgated section 4(d) rules for other threatened species.

Based on the analysis described in the Record of Compliance, we have determined that this rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). A Regulatory Flexibility Analysis is not required. Accordingly, a Small Entity Compliance Guide is not required. This rule reduces the regulatory burden of the listing of the Preble's, because without this rule all take prohibitions of section 9 of the Act would continue to apply throughout the range of the Preble's. The rule exempts four types of activities—rodent control, ongoing agricultural activities, landscaping, and ongoing use of existing water rights—from the take prohibitions, avoiding costs that may be associated with modifying or abstaining from conducting these activities in order to avoid take of Preble's.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule reduces regulatory obligations as discussed in 1 above; therefore, based on the information included in the Record of Compliance, this rule:

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

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

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501, et seq. ), this rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act is not required.

In accordance with Executive Order 12630, the rule does not have significant takings implications. This rule reduces the likelihood of potential takings; therefore, a takings implication assessment is not required.

In accordance with Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. A Federalism Assessment is not required. Currently, the State of Colorado, the Service, and local governmental entities in Colorado and Wyoming are working together to develop plans to conserve the Preble's and its habitat. This collaborative approach is expected to result in the development of Habitat Conservation Plans and applications to the Service for incidental take permits under section 10 of the Act. One of the purposes of this special rule is to foster cooperation among the Service, the States, local governments, and the private sector.

The Service has examined this rule under the Paperwork Reduction Act of 1995 and found it contained no requests for additional information or increase in the collection requirements associated with the Preble's other than those already approved for Federal Fish and Wildlife license permits with Office of Management and Budget approval 1018-0094, which has an expiration date of February 28, 2001. For more information concerning these permits, see 50 CFR 17.32.

The National Environmental Policy Act analysis has been conducted, and an Environmental Assessment has been prepared.

In accordance with the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments (59 FR 22951) and Part 512, Chapter 2 of the Departmental Manual of the U.S. Department of the Interior, we have evaluated possible effects on federally recognized Indian tribes and have determined that there are no effects, because no Indian trust resources occur within the range of this species.

Regulations at 50 CFR part 600, subpart F govern foreign fishing under the Magnuson-Stevens Act (16 U.S.C. 1801 et seq .). The regulations provide for the application and issuance of foreign fishing permits under provisions of section 204 (b) of the Magnuson-Stevens Act. Under section 204 (b), foreign vessels may be permitted to catch, process, scout, support and transship in the EEZ.

Section 204 (b)(10) of the Magnuson-Stevens Act requires the establishment of a schedule of reasonable fees to apply non-discriminatorily to each foreign fishing nation. Regulations at 50 CFR 600.518 require, among other things, that foreign vessels authorized to directly harvest fish in the EEZ pay fees based on the number of metric tons of allocated species harvested. The species potentially available for foreign fishing and the fees associated with those species are found in the table at 50 CFR 600.518 (b)(1). In a proposed rule published on March 8, 2001, at 66 FR 13870, NMFS proposed to amend this table by removing species no longer available for allocation, clarifying listings for certain species appearing in the table, adding Atlantic herring as an allocable species, and establishing the fees to be paid for the resulting list of allocable species.

NMFS believes the fees and other changes to the table at 50 CFR 600.518 (b)(1) discussed in the proposed rule published on March 8, 2001, at 66 FR 13870, constitute, in accordance with section 204 (b)(10) of the Magnuson-Stevens Act, a schedule of reasonable fees to apply non-discriminatorily to each foreign fishing nation. The specific details of all the changes proposed for the table at 50 CFR 600.518 (b)(1) are discussed in the preamble to the proposed rule published on March 8, 2001, at 66 FR 13870, and are not repeated here. The fees and other changes are adopted as final. No comments were received regarding the proposed rule published on March 8, 2001, at 66 FR 13870.

Under NOAA Administrative Order 205-11, 7.01, dated December 17, 1990, the Under Secretary for Oceans and Atmosphere has delegated to the Assistant Administrator for Fisheries, NOAA, the authority to sign material for publication in the Federal Register .

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

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

The 2001 A season Pacific cod TAC apportioned to vessels catching Pacific cod for processing by the offshore component in the Western Regulatory Area of the GOA is 1,098 metric tons (mt) as established by the Final 2001 Harvest Specifications and Associated Management Measures for the Groundfish Fisheries Off Alaska (66 FR 7276, January 22, 2001).

NMFS closed the directed fishery for Pacific cod to vessels catching Pacific cod for processing by the offshore component in the Western Regulatory Area under § 679.20(d)(1)(i) on April 26, 2001 (66 FR 21691, May 1, 2001).

NMFS has determined that approximately 250 mt remain in the directed fishing allowance. Therefore, NMFS is terminating the previous closure and is opening directed fishing for Pacific cod by vessels catching Pacific cod for processing by the offshore component in the Western Regulatory Area of the GOA.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds that the need to immediately implement this action to allow full use of the Pacific cod TAC constitutes good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(3)(B) and 50 CFR 679.20(b)(3)(iii)(A), as such procedures would be unnecessary and contrary to the public interest. Similarly, the need to implement these measures in a timely fashion to allow full use of the Pacific cod TAC constitutes good cause to find that the effective date of this action cannot be delayed for 30 days. In addition, this action relieves a restriction on the harvest of Pacific cod in the Western Regulatory Area of the Gulf of Alaska. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is hereby waived.

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