Section 121 of the Gramm-Leach-Bliley Act (GLB Act) (Pub. L. 106-102; 113 Stat. 1373-82) authorizes qualifying state member banks to own or control a new type of subsidiary—referred to as a financial subsidiary. A financial subsidiary may engage in activities that have been determined to be financial in nature or incidental to financial activities under the GLB Act, including general insurance agency activities in any location and travel agency activities. In addition, a financial subsidiary may engage in underwriting, dealing in and making a market in all types of securities—activities previously prohibited for subsidiaries of state member banks by the Glass-Steagall Act. A financial subsidiary of a state member bank also may conduct any activity that the bank is permitted to conduct directly.

The GLB Act prohibits financial subsidiaries from engaging in certain types of activities. As a general matter, a financial subsidiary may not engage as principal in underwriting insurance, providing or issuing annuities, real estate development or real estate investment, and merchant banking and insurance company investment activities.

In March 2000, the Board adopted and requested comment on an interim rule that implemented the financial subsidiary provisions of the GLB Act for state member banks (65 FR 14810). The interim rule set forth the criteria that a state member bank and its depository institution affiliates must meet for the bank to own or control a financial subsidiary; the activities that a financial subsidiary may and may not conduct; the procedures that a state member bank must follow to establish a financial subsidiary; and the procedures and restrictions that would apply if a state member bank or any of its depository institution affiliates ceased to continue to meet the requirements of the rule. The interim rule paralleled the rule adopted by the Office of the Comptroller of the Currency (OCC) governing financial subsidiaries of national banks. ( See 65 FR 12905.)

The Board received three comments from the public on the interim rule, each of which was submitted by a trade association for the banking industry. All commenters supported the interim rule and one commenter noted that the interim rule was conveniently formatted and easy to understand. Commenters also asked that the Board modify the rule in minor respects or address issues suggested by the commenter. For example, one commenter suggested that the Board make available a list of the newly authorized financial activities that may be conducted by a financial subsidiary. Another commenter requested that the Board further streamline the 15-day prior notice process established by the interim rule for obtaining the Federal Reserve System's approval to establish a financial subsidiary or commence a new financial activity through an existing financial subsidiary.

In addition, one commenter urged the Board and the other Federal banking agencies to closely monitor financial subsidiaries of banks to ensure that these newly authorized entities do not threaten the safety and soundness of affiliated depository institutions. Another commenter asserted that the Board should allow a state member bank that has received a less-than-satisfactory management rating or rating under the Community Reinvestment Act (12 U.S.C. 2901 et seq. ) (CRA) to request that a follow-up examination occur expeditiously and, thereby, permit the bank the opportunity to quickly restore its compliance with the rule's criteria.

The Board has carefully reviewed the comments received on the interim rule. As described further below, the Board has modified certain provisions of the interim rule in light of these comments and the Federal Reserve System's experience in administering the interim rule since March 2000. The final rule remains substantially similar to the Board's interim rule and the financial subsidiary rule adopted by the OCC.

The final rule, like the interim rule, permits qualifying state member banks to control, or hold an interest in, a new type of subsidiary, referred to as a “financial subsidiary.” A financial subsidiary is defined as any company that is controlled by one or more insured depository institutions, but does not include (1) a subsidiary that the state member bank is specifically authorized to hold by the express terms of a Federal statute (other than section 9 of the Federal Reserve Act), such as an Edge Act subsidiary held under section 25 of the Federal Reserve Act, or (2) a subsidiary that engages only in activities that the parent bank may conduct directly and that are conducted on the same terms and conditions that govern the conduct of the activity by the state member bank. As discussed further below, a financial subsidiary of a bank may only engage in activities permissible for the parent bank and certain other financial activities. The final rule clarifies that a financial subsidiary includes any of its direct or indirect subsidiaries.

The authority for a state member bank to own or control a financial subsidiary is in addition to the existing authority of state member banks to establish operations subsidiaries, which are subsidiaries that engage only in activities that the parent bank may conduct directly and that are conducted on the same terms and conditions that govern the conduct of these activities by the bank. See 12 CFR 250.141. State member banks may continue to retain and establish new operations subsidiaries permitted under state law and the Board's interpretations without complying with the requirements of this rule. 1

Under the GLB Act, a state member bank may control, or hold an interest in, a financial subsidiary only if certain criteria are met. Section 208.71 of the rule sets forth these criteria.

First, the state member bank and each of its depository institution affiliates must be well capitalized and well managed. An insured depository institution is well capitalized if it meets or exceeds the capital levels designated as “well capitalized” by the institution's appropriate Federal banking agency under section 38 of the Federal Deposit Insurance Act (12 U.S.C. 1831o) (FDI Act). The final rule provides that an uninsured depository institution will be considered “well capitalized” if it has and maintains at least the capital levels its appropriate Federal banking agency has established under section 38 of the FDI Act for an insured depository institution to be well capitalized. 2

Well managed is defined by reference to the achievement of specific examination ratings. 3 The FDI Act allows the appropriate Federal banking agency for a depository institution to use an examination conducted by a state banking agency in lieu of a Federal examination if the state examination meets the criteria set forth in section 10(d) of the FDI Act (12 U.S.C. 1820(d)). Accordingly, the final rule allows a depository institution to be deemed “well managed” on the basis of a qualifying state examination. 4 The final rule continues to provide that a depository institution that has not been examined will be considered well managed if its appropriate Federal banking agency determines that the institution's managerial resources are satisfactory.

In the course of administering the interim rule, questions have arisen concerning whether a well managed depository institution would retain its well managed status if it merged with another depository institution. The final rule clarifies that a depository institution that results from the merger of two or more well managed depository institutions will be considered well managed unless the appropriate Federal banking agency for the resulting institution determines otherwise. However, where a merger involves an institution that is not well managed, the managerial status of the combined organization likely will depend on the facts and circumstances of the particular case. Accordingly, the final rule provides that a depository institution resulting from the merger of a well managed institution with an institution that is not well managed or that has not been examined will be considered well managed if the appropriate Federal banking agency determines that the resulting institution is well managed.

Under the GLB Act and the rule, the aggregate consolidated total assets of the bank's financial subsidiaries may not exceed the lesser of 45 percent of the bank's consolidated total assets or $50 billion. The GLB Act requires the Board and the Secretary of the Treasury to establish a mechanism for indexing the $50 billion limit. 5

If the state member bank is one of the largest 100 insured banks, the bank must have at least one issue of outstanding eligible debt that is currently rated in one of the three highest investment grade rating categories by a nationally recognized statistical rating organization. Eligible debt refers to unsecured debt that has an initial maturity of more than 360 days. The debt must be issued and outstanding, may not be supported by any form of credit enhancement, and may not be held in whole or in any significant part by affiliates or insiders of the bank or by any other person acting on behalf of or with funds from the bank or an affiliate.

If the state member bank is one of the second 50 largest insured banks, the GLB Act allows the bank to meet this debt rating requirement or an alternative criteria established jointly by the Board and the Secretary of the Treasury by regulation. The final rule includes the alternative criteria established by the Board and the Secretary of the Treasury ( see 66 FR 8748). A bank meets this alternative criteria if the bank has a current long-term issuer credit rating (as defined in § 208.77(f) of the rule) from at least one nationally recognized statistical rating organization that is within the three highest investment grade rating categories used by the organization. 6 The debt rating and alternative criteria do not apply to a large bank if its financial subsidiaries do not engage in any newly authorized financial activity as principal.

Finally, the state member bank must obtain the Federal Reserve's approval to acquire control of, or an interest in, the financial subsidiary using the streamlined notice procedures set forth in § 208.76 of the rule. The state member bank also must obtain any necessary approvals from its state supervisory authority.

A financial subsidiary of a state member bank may conduct only three types of activities.

First, a financial subsidiary may engage in activities that section 4(k)(4) of the Bank Holding Company Act of 1956 (BHC Act) defines by statute to be financial in nature or incidental to a financial activity and permissible for a financial holding company. These activities are listed in § 225.86(a), (b) and (c) of the Board's Regulation Y (12 CFR 225.86(a), (b) and (c)) and include securities underwriting and dealing, selling insurance as agent, and operating a travel agency in connection with the offering of other financial services.

Second, a financial subsidiary may engage in activities that the Secretary of the Treasury, in consultation with the Board, determines to be financial in nature or incidental to financial activities and permissible for financial subsidiaries of national banks pursuant to section 5136A(b) of the Revised Statutes of the United States (12 U.S.C. 24a(b)). These activities currently are listed in 12 CFR 1501.2 of the Treasury Department's rules. 7

Third, a financial subsidiary of a state member bank may engage in activities that the bank is permitted to engage in directly, subject to the same terms and conditions that govern the conduct of the activity by the state member bank.

As required by the GLB Act, the rule prohibits a financial subsidiary of a state member bank from engaging as principal in insurance underwriting (except to the extent permitted under state law and the GLB Act), providing or issuing annuities, real estate investment or development (except to the extent expressly authorized by applicable state and Federal law), and merchant banking and insurance company investment activities permitted for financial holding companies under sections 4(k)(4)(H) or (I) of the BHC Act.

As noted above, one commenter requested that the Board make available a list of the financial activities that a financial subsidiary may conduct. The Board expects to issue shortly a list of the newly authorized financial activities permissible for a financial subsidiary. This list, which may be obtained from the Reserve Banks, will not identify activities that a state member bank may be permitted to engage in directly and that would, therefore, also be permissible for a financial subsidiary of the bank.

The GLB Act requires that a state member bank that owns or controls a financial subsidiary comply with a number of prudential safeguards. Section 208.73 of the rule implements these requirements.

For purposes of determining its compliance with all applicable regulatory capital standards, the state member bank must “de-consolidate” the assets and liabilities of its financial subsidiaries from those of the bank and then deduct the aggregate amount of its equity investment (including retained earnings) in all financial subsidiaries from the bank's capital and assets. The final rule clarifies how to make the capital adjustments required by the GLB Act. Specifically, the bank must deduct (i) 50 percent of the aggregate amount of its equity investment (including retained earnings) in all financial subsidiaries from both the bank's Tier 1 capital and Tier 2 capital for purposes of determining its risk-based capital ratios, (ii) 50 percent of the aggregate amount of its equity investment (including retained earnings) in all financial subsidiaries from the bank's Tier 1 capital for purposes of determining its leverage ratio, and (iii) 100 percent of the aggregate amount of its equity investment (including retained earnings) in all financial subsidiaries from its tangible equity for purposes of determining its tangible equity capital ratio. 8 In addition, the bank must deduct the entire amount of its equity investment (including retained earnings) in all financial subsidiaries from the bank's risk-weighted assets, average total assets and total assets for purposes of determining its risk-based, leverage and tangible capital ratios, respectively.

The bank must meet all applicable capital requirements—including the well capitalized requirement of § 208.71 and the capital levels established by the Board under section 38 of the FDI Act—after these adjustments. In addition, although the GLB Act requires a bank to “de-consolidate” the assets and liabilities of any financial subsidiary for regulatory capital purposes, a financial subsidiary remains a subsidiary of a state member bank and the Board will continue to review the operations and financial and managerial resources of the bank on a consolidated basis as part of the supervisory process. The Board may take appropriate supervisory action if the Board believes that the bank, either on a fully consolidated basis or on a basis that de-consolidates the bank's financial subsidiaries, does not have the appropriate financial and managerial resources (including capital resources and risk management controls) to conduct its direct or indirect activities in a safe and sound manner.

The rule also requires that the state member bank establish and maintain policies and procedures to manage the financial and operational risks arising from its ownership of a financial subsidiary and preserve the bank's separate corporate identity. A financial subsidiary also is considered a subsidiary of a bank holding company (and not a subsidiary of a bank) for purposes of the anti-tying prohibitions of the Bank Holding Company Act Amendments of 1970.

In addition, the rule specifies that a financial subsidiary of a state member bank is considered an affiliate (and not a subsidiary) of the bank for purposes of sections 23A and 23B of the Federal Reserve Act, and includes the GLB Act's special provisions governing the application of section 23A to investments in, and extensions of credit to, a financial subsidiary. The Board recently requested comment on a new rule (Regulation W) that would implement all aspects of sections 23A and 23B of the Federal Reserve Act, including the provisions of sections 23A and 23B that relate to financial subsidiaries of banks. 9 Proposed Regulation W addresses, among other things, the definition of a “financial subsidiary” for purposes of sections 23A and 23B, how to value a bank's investment in a financial subsidiary for purposes of section 23A, and when extensions of credit by an affiliate of a state member bank to a financial subsidiary of the bank will be considered an extension of credit by the bank itself under the GLB Act's special anti-evasion rules applicable to financial subsidiaries. 10 The Board may make modifications to this rule as appropriate in connection with the adoption of a final Regulation W.

The Board will give notice to a state member bank that owns or controls a financial subsidiary if the Board finds that the state member bank or any of its depository institution affiliates fails to continue to be well capitalized and well managed, that the assets of the bank's financial subsidiaries exceed the asset limitation imposed on financial subsidiaries, or that the state member bank has failed to comply with the operational safeguards required by the rule.

To assist the Board in enforcing the requirements of the GLB Act, the final rule continues to require that a state member bank notify the appropriate Reserve Bank if the bank becomes aware that any of its depository institution affiliates has ceased to be well capitalized and well managed. The final rule provides that the bank must submit this notice within 15 calendar days of becoming aware of the change in the affiliate's capital or managerial status, and that the notice must identify the relevant depository institution affiliate and the area(s) of noncompliance.

If a state member bank receives a notice from the Board that it is not in compliance with the rule's requirements, the bank must execute an agreement with the Board to bring itself back into compliance with the requirements of the rule. The agreement must explain the actions the bank will take to correct the areas of noncompliance and when such actions will be taken and provide any other information the Board may require. If the notice relates to a depository institution affiliate, the affiliate must execute an agreement with its appropriate Federal banking agency to restore itself to well capitalized and well managed status. The Board and the appropriate Federal banking agency may impose conditions on the direct or indirect activities of the state member bank or depository institution affiliate, respectively, until the institution restores its compliance with the rule's requirements. If the deficiencies are not corrected within 180 days (or such longer period as the Board may permit), the Board may require the state member bank to divest its financial subsidiaries.

If a state member bank that is one of the largest 100 insured banks fails to continue to meet the debt rating requirement or alternative criteria of § 208.71(b), if applicable, the state member bank may not acquire any additional equity capital (including debt qualifying as capital) of the financial subsidiary until the bank once again meets these requirements.

The GLB Act requires the Board to prohibit a state member bank from acquiring control of a financial subsidiary, or commencing any additional activity or acquiring control of any company through an existing financial subsidiary, if the bank or any insured depository institution affiliate has received less than a “satisfactory” rating from its appropriate Federal banking agency at its most recent examination under the CRA. 11 Section 208.75 includes these prohibitions. The rule clarifies that, if this prohibition is in effect, the financial subsidiary may not acquire control of another company by acquiring substantially all of the assets of the company. The rule also provides that any prohibition under § 208.75 does not affect the ability of a financial subsidiary to commence any additional activity, or acquire control of a company engaged only in activities, that the state member bank is permitted to engage in directly. The terms of the GLB Act require the Board to apply the prohibitions in § 208.75 if the state member bank “or any of its insured depository institution affiliates has received in its most recent examination under the [CRA] a rating of less than ‘satisfactory record of meeting community credit needs’.” 12 The Board recently considered how a parallel provision in the GLB Act should apply to a financial holding company that acquires an insured depository institution with a less-than-satisfactory CRA rating. The Board concluded, based on the Act's language and purposes, that the activity prohibitions would apply to a financial holding company only when an insured depository institution receives a less-than-satisfactory CRA rating while it is a subsidiary of the financial holding company. 13 For the same reasons discussed in that rulemaking, the Board believes that the parallel restrictions in the GLB Act and § 208.75 concerning financial subsidiaries apply only if the state member bank has a less-than-satisfactory CRA rating or an insured depository affiliate of the bank receives a less-than-satisfactory CRA rating while it is an affiliate of the state member bank. If a state member bank becomes affiliated with an insured depository institution that, at the time of the affiliation, has a less-than-satisfactory CRA rating, the institution must achieve at least a “satisfactory” CRA rating in its first CRA examination after becoming affiliated with the state member bank or the prohibitions in § 208.75 would apply to the state member bank and its financial subsidiaries.

The GLB Act's CRA prohibitions apply only if the state member bank or any of its insured depository institution affiliates has received less than a “satisfactory” CRA rating at its most recent examination under the CRA. Accordingly, the CRA rating requirement does not apply to special purpose banks that are not subject to CRA examination under the Federal banking agencies' CRA regulations, 14 or to de novo insured depository institutions that have not yet received (and are not the successor of an institution that has received) a CRA rating.

One commenter recommended that the Board allow a state member bank that has received a less-than-satisfactory management or CRA rating to request that a follow-up examination occur on an expedited basis. For many banks, the Board's rules and procedures already provide for a shorter safety and soundness and CRA examination cycle if the bank has received a less-than-satisfactory rating. 15 In addition, a Reserve Bank may, on request, move forward the scheduled date of a bank's next examination where such action is appropriate and consistent with available resources.

The final rule retains the streamlined notice procedures included in the interim rule for state member banks to engage in newly authorized financial activities through a financial subsidiary. A state member bank must file a notice with the appropriate Reserve Bank prior to acquiring control of, or an interest in, a financial subsidiary, or engaging in an additional financial activity through an existing financial subsidiary. A notice is not required for a financial subsidiary to engage in an additional activity that the parent state member bank is permitted to conduct directly. The notice must provide basic information on the financial subsidiary and its existing and proposed activities and include a certification that the state member bank and its depository institution affiliates meet the requirements of the GLB Act and the rule. The final rule also provides that a notice must provide the capital ratios for the bank and its depository institution affiliates. The Board has found that the capital data available to a banking organization at times differs from the data available to the Board, and that requiring the filing organization to include this data in a notice assists in ensuring that the organization meets the relevant capital levels required by statute.

If the notice relates to the initial affiliation of the state member bank with a company engaged in insurance activities, the notice also must describe the company's insurance activities and identify the states where the company holds an insurance license. The Board will use this information in fulfilling its obligations to consult with the relevant state insurance authorities under section 307(c) of the GLB Act (15 U.S.C. 6716(c)).

The rule provides that a notice will be deemed approved on the fifteenth day after receipt by the appropriate Reserve Bank of an informationally complete submission unless, prior to that time, the notice is disapproved or the bank is notified that additional time to review the notice is needed. In addition, the appropriate Reserve Bank may approve the notice prior to the expiration of the 15-day period by informing the bank in writing of such action. For purposes of calculating the 15-day review period, the day on which an informationally complete notice is received is considered day zero.

The Board believes that this streamlined 15-day notice procedure provides state member banks with the ability to respond quickly to market conditions while, at the same time, providing the Board adequate time to verify that the bank meets applicable statutory criteria. Accordingly, the Board has not adopted a procedure that would allow a state member bank to acquire a financial subsidiary (or commence a new financial activity through an existing financial subsidiary) immediately upon the filing of a notice with the Federal Reserve.

The GLB Act permits a state member bank to acquire an interest in or control a financial subsidiary if it meets the criteria and requirements set forth in the rule. The Board, however, retains its general supervisory authority for state member banks and may restrict or limit the activities of, or the acquisition or ownership of a subsidiary by, a state member bank if the Board finds the bank does not have the appropriate financial and managerial resources to conduct the activities or acquire or retain ownership of the company.

In accordance with section 4(a) of the Regulatory Flexibility Act (5 U.S.C. 604(a)), the Board must publish a final regulatory flexibility analysis with this rulemaking. The rule implements the new authority granted by the GLB Act to state member banks to acquire financial subsidiaries. Because the rule authorizes state member banks to acquire this new type of subsidiary, and thereby engage in new activities, the rule does not place any additional burden on state member banks and should, in fact, enhance the overall efficiency and flexibility of state member banks. The GLB Act makes this new authority available to all state member banks, provided the bank meets the qualifying criteria established by the Act. Accordingly, the rule applies to all state member banks, regardless of size. As of December 31, 2000, there were 991 state member banks, of which 593 had total assets of less than $150 million. The rule permits a state member bank to take advantage of this new authority by following a streamlined notice procedure, which should impose minimal burdens on small banking organizations.

The Board previously has reviewed, under the authority delegated to the Board by the Office of Management and Budget (OMB), the collection of information requirements of the final rule in accordance with section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Ch. 35; 5 CFR 1320 Appendix A.1). See 66 FR 29325. The OMB control number for this rule is 7100-0292. The Federal Reserve may not conduct or sponsor, and an organization is not required to respond to, any information collection unless the Board has displayed a currently valid OMB control number.

The Federal Reserve has a continuing interest in the public's opinions of our collections of information. At any time, comments regarding the burden estimate, or any other aspect of this collection of information, including suggestions for reducing the burden, may be sent to: Secretary, Board of Governors of the Federal Reserve System, 20th and C Streets, NW., Washington, DC 20551; and to the Office of Management and Budget, Paperwork Reduction Project (7100-0292), Washington, DC 20503.

The provisions of the rule are effective on September 17, 2001, on a final basis. The interim rule became effective, on an interim basis, on March 11, 2000, in order to allow state member banks to immediately take advantage of the new authority granted by the GLB Act to own or control financial subsidiaries. This new statutory authority became effective on March 11, 2000. Pursuant to the Administrative Procedure Act (5 U.S.C. 553), the Board requested comments on all aspects of the interim rule and has amended the rule as appropriate after reviewing the comments received.

Section 722 of the GLB Act requires the Board to use “plain language” in all proposed and final rules published after January 1, 2000. The Board invited comment on whether the interim rule was written in “plain language” and how to make the interim rule easier to understand. Commenters stated that the interim rule was effectively organized and easy to understand. The final rule is substantially similar to the interim rule and the Board believes the final rule is written plainly and clearly.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Boeing 767-300 series airplanes modified by supplemental type certificate (STC) SA5765NM or SA5978NM was published in the Federal Register on March 2, 2001 (66 FR 13192). That action proposed to require removal of the in-flight entertainment (IFE) system installed by those STCs.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the single comment received.

The commenter questions why the FAA is proposing to require removal of IFE systems installed per STC SA5765NM or SA5978NM rather than modification of the installed systems. The commenter states that a modification that transfers power from the main to the utility power bus, or that installs a master power switch for the IFE system on the video control center, along with appropriate changes to flight crew and cabin crew procedures, would adequately address the identified unsafe condition. The commenter also notes that it operates two Boeing Model 767-300 series airplanes affected by the proposed AD and is contracting with the STC holder for modification of the installed IFE system on these airplanes.

We concur with the commenter's request to allow modification of the subject IFE systems in lieu of removal of these systems. We stated in the proposed rule that the STC holder informed us that IFE systems installed by STC SA5765NM or SA5978NM had been removed from all affected airplanes. Based on the commenter's statements, however, we now know that there are at least two Model 767-300 series airplanes in the worldwide fleet with the subject IFE systems still installed.

The FAA concurs with the commenter that it may be possible to modify the subject IFE systems to adequately address the unsafe condition. Therefore, we have revised paragraph (a) of this AD to provide two options for compliance:

1. Removal of the subject IFE system per a method approved by the FAA (as proposed). Or,

2. Modification of the subject IFE system to provide the flight crew or cabin crew with a means of removing electrical power from the IFE system equipment and wiring during a non-normal or emergency situation involving smoke or fire on the flight deck or in the passenger cabin. Depending on the method of modification, it may also be necessary to revise the Airplane Flight Manual and cabin crew procedures manual to provide the airplane crew with information regarding the use of the power switches or controls installed during the modification. If this compliance option is chosen, the modification and any necessary manual revisions must be done per a method approved by the FAA.

Additionally, we have revised the Cost Impact section of this AD based on the information provided by the commenter, and paragraph (b) of this AD to state that installation of an IFE system per STC SA5765NM or SA5978NM after the effective date of this AD is prohibited unless the modification of the IFE system is done per this AD. Lastly, a new Note 2 has been added (and a subsequent note renumbered) to explain that, as part of the modification, it may be necessary to revise crew procedures.

After careful review of the available data, including the comment noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes previously described. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

The holder of the STCs previously informed the FAA that the subject IFE systems have been removed from all affected Boeing Model 767-300 series airplanes modified by STC SA5765NM or SA5978NM. However, based on information provided by a commenter to the proposal, we now know that there are at least 2 Model 767-300 series airplanes of the affected design in the worldwide fleet. These airplanes are currently operated by a non-U.S. operator under foreign registry; therefore, they are not directly affected by this AD action. The FAA knows of no airplanes of U.S. registry that will be affected by this AD. Therefore, the FAA expects that there will be no future cost impact on U.S. operators as a result of the adoption of this rule.

If a U.S.-registered airplane subject to this AD is identified, the FAA estimates that removal of the IFE system, which is provided as one option for compliance with this AD, will take approximately 12 work hours per airplane, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this AD on an affected airplane is estimated to be $720 per airplane.

In lieu of removing the IFE system, this AD provides for modification of the IFE system. Since we have not yet approved any such modification, we do not know what the cost impact would be. However, based on the estimates for modification of another IFE system installed on Model 767-300 series airplanes, if a U.S.-registered airplane subject to this AD is identified, we estimate that it will take approximately 50 work hours per airplane to accomplish the modification, at an average labor rate of $60 per work hour. The cost of required parts is unknown. Based on these figures, we estimate the labor required for such a modification on an affected airplane to be $3,000 per airplane.

The cost impact figures discussed in most AD actions are based on assumptions that no operator has yet accomplished any of the requirements, and that no operator would accomplish those actions in the future if the AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

The Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, notified the FAA that an unsafe condition may exist on certain Airbus Model A319, A320, and A321 series airplanes. The DGAC advises that there have been several reports of the telescopic girt bar of the slide/raft assembly detaching from the door sill fittings and preventing proper deployment of the emergency escape slide. The telescopic girt bar is designed to be retractable and removable from the door sill to ensure the raft is accessible in an emergency evacuation. The telescopic girt bar is normally locked in an extended position by a trigger mechanism that prevents retraction unless pulled. Investigation of the affected girt bars revealed that the trigger mechanism was not operational due to an incorrectly machined chamfer of the girt bar, which allowed the mechanism to retract and detach from the door sill when opening the door. Such conditions, if not corrected, could result in failure of the escape slide/raft to deploy correctly, which could result in the slide being unusable during an emergency evacuation and consequent injury to passengers or airplane crewmembers.

Following the incidents previously described, Airbus Industrie issued All Operators Telex A320-52A1110, dated April 11, 2001, to address the identified unsafe condition. However, one report was received that, during accomplishment of the functional test specified in that AOT, an operator did the scheduled slide deployment and the girt bar detached from the door sill. Investigation revealed that the chamfer was slightly out of tolerance and damage was found in the area of the trigger lever. The girt bar trigger end deviated from the production drawing and the deviation was not identified until after the AOT had been issued. Subsequently, it has been determined that the actions specified in that AOT are not sufficient to identify all defective girt bars, and a new AOT has been issued.

Airbus Industrie has issued AOT A320-52A1111, Revision 01, dated July 23, 2001, including Technical Disposition 959.1492/01, Issue C, dated July 17, 2001; which describes procedures for modification of the telescopic girt bar of the escape slide/raft assembly, and follow-on actions. The modification consists of rework of the trigger end of the telescopic girt bar, and installation of a U-shaped reinforcement section on the bar. The follow-on actions include repetitive inspections of the telescopic girt bar for discrepancies (damage or corrosion), and functional tests of the telescopic girt bar to ensure it does not retract when a measured force (34 to 45 pounds) is applied. If discrepancies are found, the service bulletin describes procedures for replacement of the U-shaped section or rivets with new parts.

The DGAC classified AOT A320-52A1111, dated July 5, 2001, as mandatory and issued French airworthiness directive 2001-275(B), dated July 11, 2001, in order to assure the continued airworthiness of these airplanes in France.

These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. The FAA has examined the findings of the DGAC, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD is being issued to prevent failure of the escape slide/raft to deploy correctly, which could result in the slide being unusable during an emergency evacuation and consequent injury to passengers or airplane crewmembers. This AD requires modification of the telescopic girt bar of the escape slide/raft assembly, and follow-on actions. The actions are required to be accomplished in accordance with the AOT described previously, except as discussed below.

The AOT specifies performing a “visual inspection” of the U-shaped section and rivet heads of the girt bar within 18 months after the modification, and repeat the inspection at intervals not to exceed 18 months. As the compliance time would allow opportunity for public comment, the FAA may consider additional rulemaking to require these inspections.

Additionally, the AOT does not describe procedures for corrective action if the telescopic girt bar retracts when performing the functional test; however, this AD requires replacement of any discrepant parts with new parts and accomplishment of another functional test after replacement of the parts to ensure the girt bar does not retract.

This is interim action. The manufacturer has advised that a new modification is currently being developed that will positively address the unsafe condition addressed by this AD. Once that modification is developed, approved, and available, the FAA may consider additional rulemaking.

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

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

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification (e.g., reasons or data) for each request.

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2001-NM-138-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

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

Today we are adopting an updated EDGAR Filer Manual (Filer Manual). The Filer Manual describes the technical formatting requirements for the preparation and submission of electronic filings through the Electronic Data Gathering, Analysis, and Retrieval (EDGAR) system. 1 It also describes the requirements for filing using modernized EDGARLink. 2

The Filer Manual contains all the technical specifications for filers to submit filings using the new modernized EDGAR system. Filers must comply with the applicable provisions of the Filer Manual in order to assure the timely acceptance and processing of filings made in electronic format. 3 Filers should consult the Filer Manual in conjunction with our rules governing mandated electronic filing when preparing documents for electronic submission. 4

EDGAR Release 7.5.b, the most recent step in the Commission's modernization project, was implemented on July 30, 2001. The main purpose of EDGAR Release 7.5.b is to deploy internal Commission software. At the same time, as detailed below, certain corrections and improvements are being made to the modernized EDGARLink software. These changes are now reflected in the updated Filer Manual.

We have updated the template screens of the EDGARLink software. Certain fields have been expanded (including phone number and group members); redundant and unnecessary fields have been removed; and validation of some template fields has been improved. The new EDGARLink filer software contains an Integrity Checker that allows filers to verify the correct installation of each portion of their EDGARLink software.

In addition, we have also made improvements to and updated the EDGAR Filing Web Site <https://www.edgarfiling.sec.gov>. Filers must use this site to transmit their documents to the Commission. They can download the latest version of the EDGARLink software, receive notification of a filing's status, change their password and company information, receive on-line help, and perform other functions. Error messages for password changes are more specific, certain fields have been designated as “non-critical” when a filer changes company information (and are therefore not required) and all SGML header tags have been removed from Return Copies.

We have updated old error messages and created new ones for the new Receipt and Acceptance system to enhance the clarity of error-reporting within the suspense notifications that filers receive. Test filings that require fees will generate a warning if fees are not present in the payor's account at the time of processing. Test submissions will also be checked for duplicates (if applicable) against all similar live, accepted submissions. Those filers who transmit filings to the Commission using a dedicated leased line will undergo a modernization of the software used with those lines. Finally, modules containing more than one document are not supported in the modernized system.

Since the Legacy EDGAR system was discontinued as of April 20, 2001, we are also eliminating the former Volume I of the Filer Manual, which described that system, and renumbering the remaining volumes. The Manual will now consist of these two parts: EDGAR Filer Manual (Release 7.5), Volume I—Modernized EDGARLink; and EDGAR Filer Manual (Release 7.0), Volume II—N-SAR Supplement.

Finally, we are amending Rule 301 of Regulation S-T to provide for the incorporation by reference into the Code of Federal Regulations of today's revisions to the Filer Manual. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

You may obtain paper copies of the updated Filer Manual at the following address: Public Reference Room, U.S. Securities and Exchange Commission, 450 Fifth Street, NW., Washington DC 20549-0102. We will post electronic format copies on the Commission's Web Site; the address for the Filer Manual is <http://www.sec.gov/info/edgar/filermanual.htm>. You may also obtain copies from Disclosure Incorporated, the paper and microfiche contractor for the Commission, at (800) 638-8241.

Since the Filer Manual relates solely to agency procedures or practice, publication for notice and comment is not required under the Administrative Procedure Act (APA). 5 It follows that the requirements of the Regulatory Flexibility Act  6 do not apply.

The effective date for the updated Filer Manual and the rule amendments is August 16, 2001. In accordance with the APA, 7 we find that there is good cause to establish an effective date less than 30 days after publication of these rules. The EDGAR system upgrade to Release 7.5.b took place on July 30, 2001. The Commission believes that it is necessary to coordinate the effectiveness of the updated Filer Manual with the scheduled system upgrade in order to minimize confusion to EDGAR filers.

We are adopting the amendments to Regulation S-T under Sections 6, 7, 8, 10, and 19(a) of the Securities Act, 8 Sections 3, 12, 13, 14, 15, 23, and 35A of the Securities Exchange Act of 1934, 9 Section 20 of the Public Utility Holding Company Act of 1935, 10 Section 319 of the Trust Indenture Act of 1939, 11 and Sections 8, 30, 31, and 38 of the Investment Company Act of 1940. 12

Dichloralphenazone (also known as dichloralantipyrine) is a compound containing two molecules of chloral hydrate (2,2,2-trichloro-1,1-ethanediol) and one molecule of phenazone (1,2-dihydro-1,5-dimethyl-2-phenyl-3H-pyrazol-3-one); CAS No. 480-30-8. Dichloralphenazone is a sedative typically used in combination with isometheptene mucate and acetaminophen in formulating prescription pharmaceuticals for the relief of tension and vascular headaches. When dichloralphenazone is administered or placed in an aqueous solution (a liquid preparation of any substance dissolved in water) it dissociates to form chloral hydrate and phenazone.

Schedule IV controlled substances are listed in 21 CFR 1308.14. Section 1308.14(c) lists 49 depressants, including chloral hydrate, that are Schedule IV controlled substances. The first sentence of 21 CFR 1308.14(c) states that the category of Schedule IV depressants includes “any material, compound, mixture, or preparation which contains any quantity of” the substances listed in the section. Since dichloralphenazone is a compound containing chloral hydrate, it is likewise a Schedule IV depressant.

Since dichloralphenazone has not been recognized as a compound containing chloral hydrate and confusion has existed with regard to its control status, the DEA published a proposed rule in the Federal Register on December 11, 2000 (65 FR 77328) to expressly list dichloralphenazone as a Schedule IV depressant. This proposed rule provided 60 days for comments.

The DEA received two comments regarding the proposal. The Healthcare Distribution Management Association (formerly the National Wholesale Druggists' Association), whose members operate over 200 distribution centers throughout the U.S., requested an additional 30 days from the date of publication of this final rule to comply with security, inventory, recordkeeping and reporting, and importing and exporting requirements for the handling of dichloralphenazone. They felt that moving dichloralphenazone from an uncontrolled status to a controlled status required system and operational changes that could not be implemented immediately upon publication of this final rule. The DEA has no objection to the additional 30 days and is incorporating this change into this final rule.

Elan Pharmaceuticals, manufacturer of Midrin® (a prescription product containing isometheptene, dichloralphenazone and acetaminophen marketed in the U.S. for over 30 years) commented that federal and state authorities have not regulated dichloralphenazone as a Schedule IV substance, physicians and pharmacists have not treated Midrin® as a controlled drug product and major drug compendiums ( Physician's Desk Reference, Merck Index, Drug Facts and Comparisons ) have not identified dichloralphenazone or Midrin® as a controlled substance. In addition they noted that the DEA interpretation that Midrin® is a scheduled drug would likely affect prescribing practices and raise DEA registration, labeling, recordkeeping and reporting issues and create confusion among practitioners and patients. Further, Elan poses that there is little evidence that Midrin® or any other dichloralphenazone product has been misused, abused or diverted. The DEA received a formal request from Elan Pharmaceuticals for an exemption for Midrin® as an exempt non-narcotic prescription product. That request will be evaluated according to 21 CFR 1308.31.

The DEA is aware that dichloralphenazone and products containing this substance have not been identified or treated as controlled substances. The determination that dichloralphenazone is a controlled substance is based, in part, on its status as a compound containing chloral hydrate. In addition, numerous drug abuse emergency room episodes have involved Midrin®. The DEA has made every effort to reduce any confusion on the part of handlers of dichloralphenazone or products containing this substance and chose to expressly list this substance in order to eliminate confusion. The DEA invites any other company to submit a formal request for an exemption from Schedule IV regulation for any dichloralphenazone product. The data submitted under 21 CFR 1308.31 are evaluated to determine if such an exemption is warranted.

Persons who manufacture, distribute, dispense, import, export, store or engage in research with dichloralphenazone must comply with the following regulatory requirements:

1. Registration. Any person who manufactures, distributes, dispenses, imports or exports dichloralphenazone or engages in research or conducts instructional activities or chemical analysis with respect to this preparation must be registered to conduct such activities in accordance with 21 CFR part 1301. Any person who is currently engaged in any of the above activities must submit an application for registration by September 17, 2001 and may continue their activities until the DEA has approved or denied that application.

2. Disposal of stocks. Any person who elects not to obtain a Schedule IV registration or is not entitled to such registration must surrender all quantities of currently held dichloralphenazone in accordance with procedures outlined in 21 CFR 1307.21 on or before September 17, 2001, or may transfer all quantities of currently held dichloralphenazone to a person registered under the CSA and authorized to possess Schedule IV control substances on or before September 17, 2001. Dichloralphenazone to be surrendered to DEA must be listed on a DEA Form 41, “Inventory of Controlled Substances Surrendered for Destruction.” DEA Form 41 and instructions can be obtained from the nearest DEA office.

3. Security. Dichloralphenazone must be manufactured, distributed and stored in accordance with 21 CFR 1301.71, 1301.72(b), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c) and 1301.76 after September 17, 2001.

4. Labeling and packaging. All commercial containers of dichloralphenazone that are packaged on or after February 12, 2002 must have the appropriate Schedule IV labeling and packaging as required by 21 CFR 1302.03-1302.07. Commercial containers of dichloralphenazone packaged before February 12, 2002 and not meeting the requirements specified in 21 CFR 1302.03-1302.07 may be distributed until May 13, 2002. On and after May 13, 2002 all commercial containers of dichloralphenazone must bear the CIV labels as specified in 21 CFR 1302.03-1032.07.

5. Inventory. Registrants possessing dichloralphenazone are required to take inventories pursuant to 21 CFR 1304.03, 1304.04 and 1304.11 after September 17, 2001.

6. Records. All registrants must keep records pursuant to 21 CFR 1304.03, 1304.04 and 1304.21-1304.23 after September 17, 2001.

7. Prescriptions. All prescriptions for dichloralphenazone or prescriptions for products containing dichloralphenazone or prescriptions for products containing dichloralphenazone are to be issued pursuant to 21 CFR 1306.03-1306.06 and 1306.21-1306.26. All prescriptions for dichloralphenazone or products containing dichloralphenazone issued on or before October 15, 2001, if authorized for refilling, shall, as of that date, be limited to five refills and shall not be refilled after February 12, 2002.

8. Importation and Exportation. All importation and exportation of dichloralphenazone shall be in compliance with 21 CFR part 1312 after September 17, 2001.

9. Criminal Liability. Any activity with dichloralphenazone not authorized by, or in violation of, the CSA or the Controlled Substances Import and Export Act shall be unlawful on or after August 16, 2001, except as authorized in this rule.

The Acting Administrator hereby certifies that this rulemaking has been drafted in a manner consistent with the principles of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). It will not have a significant economic impact on a substantial number of small business entities. Most handlers of dichloralphenazone or prescription products containing this substance are already registered to handle controlled substances and are subject to the regulatory requirements of the CSA.

The Acting Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 section 1(b). DEA has determined that this is not a significant rulemaking action. Therefore, this action has not been reviewed by the Office of Management and Budget.

This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

This rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The Drug Enforcement Administration makes every effort to write clearly. If you have suggestions as to how to improve the clarity of this regulation, call or write Patricia M. Good, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, telephone (202) 307-7297.

Under the authority vested in the Attorney General by section 201(a) of the CSA [21 U.S.C. 811(a)], and delegated to the Administrator of the DEA by the Department of Justice regulations (21 CFR 0.100), the Acting Administrator hereby rules that 21 CFR part 1308 be amended as follows:

Anhydrous hydrogen chloride is the water free form of hydrochloric acid and is a List II chemical under the Controlled Substances Act (CSA). The statutory term “hydrochloric gas” used in the MCA refers to a form of hydrogen chloride more properly called anhydrous hydrogen chloride. Anhydrous hydrogen chloride is hydrogen chloride that is free from water. At ambient temperature and normal atmospheric pressure, anhydrous hydrogen chloride exists as a gas. Therefore, sometimes anhydrous hydrogen chloride is referred to as hydrogen chloride gas or hydrochloric gas.

When the atmospheric pressure is increased and/or the temperature is decreased, anhydrous hydrogen chloride can change from a gas to a liquid. This is sometimes referred to as refrigerated hydrogen chloride. Refrigerated hydrogen chloride is the same as anhydrous hydrogen chloride although the physical state has been changed from a gas to a liquid.

The DEA is finalizing the interim portion of the Final Rule “Listed Chemicals; Final Establishment of Thresholds for Iodine and Hydrochloric Gas (Anhydrous Hydrogen Chloride),” published on August 2, 2000 (65 FR 47309). That rulemaking provided that there would be a zero threshold for domestic transactions involving anhydrous hydrogen chloride. However, it also provided an exemption, on an interim basis, from the recordkeeping and reporting requirements for transactions of anhydrous hydrogen chloride involving pipeline distributions and distributions of 12,000 pounds (net weight) or more in a single container. That is, two new paragraphs were added to Title 21 Section 1310.08 to exclude these types of transactions from the definition of regulated transactions. Although the exemption for these categories became effective upon publication in the Federal Register , the DEA sought public comment on these exemptions.

The CSA authorizes DEA, pursuant to 21 U.S.C. 802(39)(A)(iii), to remove certain transactions in listed chemicals from the definition of regulated transaction. DEA has determined that transactions in anhydrous hydrogen chloride in the form of refrigerated liquid and transactions involving the direct transfer of anhydrous hydrogen chloride by pipeline are unlikely sources for diversion and should be removed from the definition of regulated transaction. DEA became aware of these types of transactions by the comments received in response to the Federal Register proposal to establish thresholds for iodine and anhydrous hydrogen chloride (62 FR 51072).

To better evaluate this request, DEA collected additional information from the affected industry. DEA learned that rail and truck carriers ship refrigerated liquid only in large containers. The average payload of a rail car is approximately 135,000 pounds. The capacity for tank trucks is approximately 12,000 to 30,000 pounds. These shipments are in single containers holding the specified weights. Specialized equipment and engineering skills are needed to off-load this commodity. Distributors are aware of their customers and are involved in tracking shipments. The DEA believes that anhydrous hydrogen chloride in this form and in these quantities is not likely to be diverted.

DEA has not identified any shipment of refrigerated anhydrous hydrogen chloride less than the tank truck size of approximately 12,000 pounds. Therefore, domestic distributions of anhydrous hydrogen chloride in single container shipments of 12,000 pounds (net weight) or more will be excluded from the definition of regulated transaction. Transactions that involve multiple containers, each containing less than 12,000 pounds of the chemical are regulated transactions even if the aggregate weight is over 12,000 pounds.

The DEA received two comments on the exemption of certain transactions of anhydrous hydrogen chloride. Both favored the exemptions as written. One comment supports the exempt categories because of technological restraints that prevent diversion from these sources. The other comment states that these exemptions are in concert with DEA's desire to control sales of cylinders that are used in illicit methamphetamine production.

The DEA will finalize the interim rule without change to exempt the following categories of transactions involving anhydrous hydrogen chloride: (1) Domestic distribution of anhydrous hydrogen chloride weighing 12,000 pounds (net weight) or more in a single container; and (2) Domestic distribution of anhydrous hydrogen chloride by pipeline. Therefore, the interim rule amending 21 CFR Part 1310, which was published in the Federal Register on August 2, 2000, at 65 FR 47309 is adopted as a final rule.

This regulation will not have a significant economic impact upon a substantial number of small entities that trade in anhydrous hydrogen chloride. This Final Rule excludes from the definition of “regulated transaction” domestic transactions involving anhydrous hydrogen chloride in bulk quantities of 12,000 pounds (net weight) or more and domestic distribution made by pipeline.

The Administrator in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact upon a substantial number of small entities for the following reasons: This Rulemaking removes recordkeeping and reporting requirements for certain transactions in anhydrous hydrogen chloride. This action is being taken in response to industry's request to relieve them of regulatory burdens.

This regulation has been drafted and reviewed in accordance with Executive Order 12866, Section 1(b), Principles of Regulation. The DEA has determined that this rule is not a “significantly regulatory action” under Executive Order 12866, Section 3(f), Regulatory Planning and Review, and accordingly this rule has not been reviewed by the Office of Management and Budget.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in cost or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete in domestic and export markets.

This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 12612, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.

The Drug Enforcement Administration makes every effort to write clearly. If you have suggestions as to how to improve the clarity of this regulation, call or write Patricia M. Good, Chief, Liaison and Policy Section, Drug Enforcement Administration, Office of Diversion Control, Washington, DC 20537, Telephone (202) 307-7297.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The permit application did not allow sufficient time for publication of an NPRM followed by a temporary final rule effective 30 days after publication. Any delay of the effective date of this rule would be contrary to the public interest by exposing the public to the known dangers associated with fireworks displays and the possible loss of life, injury, and damage to property.

This safety zone is established to safeguard the public from the hazards associated with launching of fireworks from Harbor Island in the outer Milwaukee Harbor. The size of the zone was determined by using previous experiences with fireworks displays in the Captain of the Port Milwaukee zone and local knowledge about wind, waves, and currents in this particular area.

The safety zone will be in effect on both September 7 and 8, 2001, from 9:45 p.m. until 10:45 p.m. (CST). The safety zone will encompass all waters of Lake Michigan bounded by the following coordinates: from the point of origin at 43° 02.209′N, 087° 53.714′W, southeast to 43° 02.117′N, 087° 53.417′W, south to 43° 01.767′N, 087° 53.417′W, southwest to 43° 01.555′N, 087° 53.772′W, and then north along the shoreline back to the point of origin. This also includes the Harbor Island Lagoon area.

All persons and vessels shall comply with the instructions of the Captain of the Port Milwaukee or his designated on scene patrol personnel. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Milwaukee or his designated on scene representative. The Captain of the Port Milwaukee may be contacted via VHF Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979).

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities: the owners or operators of vessels intending to transit or anchor in the vicinity of Harbor Island in Milwaukee's outer harbor from 9:45 p.m. until 10:45 p.m. (CST) on both September 7 and 8, 2001.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be in effect for only one hour on two days and late in the day when vessel traffic is minimal. Vessel traffic may enter or transit through the safety zone with the permission of the Captain of the Port Milwaukee or his designated on scene representative. Before the effective period, we will issue maritime advisories widely available to users of Port Washington harbor.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Marine Safety Office Milwaukee (See ADDRESSES. )

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

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

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

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

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

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

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

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

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

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM, and, under 5 U.S.C. 553(d)(3), good cause exists for making this rule it effective less than 30 days after publication in the Federal Register . The Coast Guard had insufficient advance notice to publish an NPRM followed by a temporary final rule. Publication of a notice of proposed rulemaking and delay of effective date would be contrary to the public interest because immediate action is necessary to prevent possible loss of life, injury, or damage to property.

A temporary safety zone is necessary to ensure the safety of spectators and vessels during the setup, loading and launching of a fireworks display in conjunction with the City of Rossford's Hometown Celebration Fireworks. The fireworks display will occur between 2 p.m. and 10 p.m. on September 1, 2001.

This safety zone will encompass all waters and the adjacent shoreline of the Maumee River, Rossford, Ohio, bounded by an arc of a circle with a 420-foot radius with its center in approximate position 41°36′59″N, 083°33′59″W. The Captain of the Port Toledo or his designated on scene representative has the authority to terminate this event.

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on scene patrol personnel. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Toledo or his designated on scene representative. The Captain of the Port or his designated on scene representative may be contacted via VHF Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979). This finding is based on the historical lack of vessel traffic during this time of year.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners and operators of vessels intending to transit or anchor in a portion of the Maumee River off Rossford, Ohio.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: this rule will be in effect for only eight hours for one event and vessel traffic can pass safely around the safety zone. In the event that shipping is affected by this temporary safety zone, commercial vessels may request permission from the Captain of the Port Toledo to transit through the safety zone.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Marine Safety Office Toledo (see ADDRESSES .)

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

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

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

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

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

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

The Coast Guard considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.lC, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES .

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

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

EPA is approving Wisconsin's enhanced I/M plan for the Milwaukee-Kenosha-Racine and Sheboygan areas. Wisconsin originally submitted the I/M SIP to EPA on November 15, 1992, and made several supplements, dated January 15, 1993, November 15, 1993, July 28, 1994, February 13, 1996, July 3, 1997, August 11, 1998, December 30, 1998, December 22, 2000, and July 27, 2001.

On November 15, 1992, the Wisconsin Department of Natural Resources (WDNR) submitted its original I/M SIP revision to the EPA. Since that time, the state has made a number of program revisions to address changes to federal I/M regulations and to meet subsequent I/M program submittal deadlines. As the state made changes to its I/M program, the WDNR submitted additional I/M SIP revisions to the EPA. The following list contains a general description of the contents of each supplement to Wisconsin's I/M SIP. Full copies of the SIP revisions are located in EPA's docket.

These submittals revise the Wisconsin SIP for the enhanced I/M program, which is required by EPA's I/M regulation, codified at 40 CFR part 51, subpart S—Requirements for Preparation, Adoption, and Submittal of Implementation Plans (I/M regulation). This approval will apply to the I/M program that is now operating in the state and will not require any changes to the program. Motor vehicle testing is required in the Milwaukee-Kenosha-Racine severe ozone nonattainment area, comprised of Kenosha, Racine, Milwaukee, Waukesha, Ozaukee, and Washington Counties, and in the Sheboygan moderate ozone nonattainment area (Sheboygan County). Wisconsin's rules require testing every two years, using the IM240 loaded mode, transient emission test using a dynamometer. Starting in July 2001, Wisconsin will test 1996 and newer vehicles through a computer link to the OBD system, instead of the tailpipe test. Wisconsin enforces the program through registration denial.

The revisions include a narrative description of the program, copies of the pertinent Wisconsin statutes, the WDNR and Wisconsin Department of Transportation (WDOT) regulations, equipment and test specifications, emission factor modeling, the I/M contract, which contains information on vehicle inspection procedures, the quality assurance and quality control plan, technician training information, and a public awareness plan.

On January 12, 1995 (60 FR 2882), EPA approved many of the Wisconsin I/M program elements. At that time, however, EPA could not approve the entire program because the state had not finalized all of its I/M regulations and had not yet signed a formal contract with the contractor that performs the I/M inspections. Wisconsin has now completed these activities and EPA has reviewed Wisconsin's revised submittal to ensure that the program meets all aspects of the CAA and EPA's I/M regulation. The I/M program requirements and the analysis of Wisconsin's program are summarized below:

Sections 182(c)(3) of the CAA and 40 CFR 51.350(a)(2) require states that contain ozone nonattainment areas, which are classified as serious or worse, with populations of over 200,000 to implement enhanced I/M programs. In addition, section 182(b)(4) of the CAA and 40 CFR 51.530(a)(3) require states that contain moderate ozone nonattainment areas, which were required to implement I/M programs prior to November 15, 1990, to upgrade those programs to meet the basic I/M program requirements.

Wisconsin contains two nonattainment areas that meet these criteria, the Milwaukee-Kenosha-Racine severe ozone nonattainment area and the Sheboygan moderate ozone nonattainment area. Wisconsin's program covers all required areas, and EPA approved Wisconsin's authorities establishing program boundaries in the January 1995 (60 FR 2882) approval of the program.

The I/M program must be designed and implemented to meet or exceed a minimum performance standard, which is expressed as emission levels in area-wide average grams per mile (gpm) for certain pollutants. The performance standards are established using local characteristics, such as vehicle age mix and local fuel controls, and the following model I/M program parameters: network type, start date, test frequency, model year, vehicle type coverage, exhaust emission test type, emission standards, emission control device inspection, evaporative system function checks, stringency, waiver rate, compliance rate and evaluation date. The emission levels achieved by the state's program design must be calculated using the most current version of the EPA's computerized mobile source emission factor model at the time of submittal, MOBILE5a. Areas must meet the performance standard for the pollutants which cause them to be subject to enhanced I/M requirements. In the case of ozone nonattainment areas, the performance standard must be met for both nitrogen oxides (NO X ) and hydrocarbons (HC). Since the Milwaukee-Kenosha-Racine area is a severe ozone nonattainment area, Wisconsin must meet the enhanced I/M performance standard for HC and NO X . The state must meet the basic I/M performance standard for the Sheboygan moderate ozone nonattainment area.

The Wisconsin submittal includes a MOBILE5a analysis with the following program design parameters:

Wisconsin has submitted modeling demonstrations using the EPA computer model MOBILE5a showing that the low enhanced performance standard reductions will be met in 2000, 2003, 2006, and 2008, (the years required by EPA's I/M regulation) with the existing program, as well as with planned program changes. This demonstration assumed a 96% compliance rate, 3% waiver rate, and full IM240 credits.

Wisconsin's modeling shows that the program will meet the low enhanced I/M performance standard for HC and NO X for all evaluation years. This part of the submittal meets the requirements of 40 CFR 51.351 of the federal I/M regulation.

The enhanced program must include an ongoing evaluation to quantify the emission reduction benefits of the program, and to determine if the program is meeting the requirements of the CAA and the federal I/M regulation. The SIP must include details on the program evaluation and must include a schedule for submittal of biennial evaluation reports, data from a state monitored or administered mass emission test of at least 0.1% of the vehicles subject to inspection each year, description of the sampling methodology, the data collection and analysis system and the legal authority enabling the evaluation program.

Wisconsin operates a centralized I/M program and has made all necessary commitments and schedules for program evaluation. EPA approved these program elements in the January 1995 approval of the program.

The federal I/M regulation requires Wisconsin to demonstrate that adequate funding of the program is available. A portion of the test fee or separately assessed per vehicle fee must be collected, placed in a dedicated fund and used to finance the program. Alternative funding approaches are acceptable if it is demonstrated that the funding can be maintained. Reliance on funding from the state or local General Fund is not acceptable unless doing otherwise would be a violation of the state's constitution. The SIP must include a detailed budget plan that describes the source of funds for personnel, program administration, program enforcement, and purchase of equipment. The SIP must also detail the number of personnel dedicated to the quality assurance program, data analysis, program administration, enforcement, public education and assistance and other necessary functions.

EPA approved this program element in the January 1995 approval of the program.

The enhanced I/M performance standard assumes an annual test frequency; however, other schedules may be approved if the performance standard is achieved. The SIP must describe the test year selection scheme and how the test frequency is integrated into the enforcement process, and must include the legal authority, regulations or contract provisions to implement and enforce the test frequency. The program must be designed to provide convenient service to the motorist by ensuring short wait times, short driving distances and regular testing hours.

The Wisconsin program calls for biennial testing in a centralized, test-only network. The state has included this test frequency in its performance standard modeling and still meets the applicable standards. EPA approved this program element in the January 1995 approval of the program.

The performance standard for enhanced I/M programs assumes coverage of all 1968 and later model years light duty vehicles and light duty trucks up to 8,500 pounds gross vehicle weight rating (GVWR), and includes vehicles operating on all fuel types. Other levels of coverage may be approved if the necessary emission reductions are achieved. Vehicles registered or required to be registered within the I/M program area boundaries and fleets primarily operated within the I/M program area boundaries and belonging to the covered model year and vehicle classes comprise the subject vehicles. Fleets may be officially inspected outside of the normal I/M program test facilities, if such alternatives are approved by the program administration, but must be subject to the same test requirements using the same quality control standards as non-fleet vehicles and must be inspected in the same type of test network as other vehicles in the state, according to the requirements of 40 CFR 51.353(a).

The federal I/M regulation requires that the SIP include the legal authority or rule necessary to implement and enforce the vehicle coverage requirement, a detailed description of the number and types of vehicles to be covered by the program and a plan for how those vehicles are to be identified, including vehicles that are routinely operated in the area but may not be registered in the area, and a description of any special exemptions, including the percentage and number of vehicles to be impacted by the exemption. Such exemptions must be accounted for in the analysis of the program's potential emission reduction.

The Wisconsin program tests 1968 and newer light and heavy duty gasoline vehicles. Legal authority is provided in section 110.20(6)(a) of the Wisconsin Statutes and TRANS 131.03(2). In the July 3, 1997 submittal letter, Wisconsin provides an estimate of covered vehicles, the methods for identifying covered vehicles, and a description of exempted vehicles. The MOBILE5a modeling uses this data in making the performance standard demonstration. Starting in July 2001, Wisconsin will exempt 1996 and newer model year vehicles from the tailpipe portion of the emissions test. Instead, Wisconsin will perform an inspection of the OBD systems on these vehicles. This is consistent with recent changes to 40 CFR 51.356 that EPA published on April 5, 2001 (66 FR 18156). This part of the submittal meets the requirements of 40 CFR 51.356.

Federally owned vehicles operated in Wisconsin are required to meet the same requirements as Wisconsin registered vehicles. However, EPA is not requiring states to implement 40 CFR 51.356(a)(4) dealing with federal installations within I/M areas at this time. The Department of Justice has recommended to EPA that this regulation be revised since it appears to grant states authority to regulate federal installations in circumstances where the federal government has not waived sovereign immunity. It would not be appropriate to require compliance with this regulation if it is not constitutionally authorized. EPA will be revising this provision in the future and will review state I/M SIPs with respect to this issue when this new rule is final. Therefore, for these reasons, EPA is not proposing approval or disapproval of the specific requirements which apply to federal facilities at this time.

Written test procedures and pass/fail standards must be established and followed for each model year and vehicle type included in the program. Test procedures and standards are detailed in 40 CFR 51.357 and in the EPA documents entitled “High-Tech I/M Test Procedures, Emission Standards, Quality Control Requirements, and Equipment Specifications,” EPA-AA-EPSD-IM-93-1, dated April 1994. EPA's test procedure requirements were recently revised on April 5, 2001 (66 FR 18156) to incorporate new OBD test procedures for 1996 and newer vehicles. These new requirements provide detailed procedures and pass/fail standards for performing tests on OBD equipped vehicles as a replacement to the tailpipe test.

Wisconsin submitted its test procedures to EPA in its February 16, 1996, July 3, 1997, and July 27, 2001 submittals. Test procedures and standards are specified in: (1) Section C.7.b of the final I/M contract; (2) TRANS 131.03(4)-(9); and (3) NR 485.04. The OBD test procedures are contained in TRANS 131.03(6)(d). This part of the rule contains detailed procedures for connecting to the OBD system in 1996 and newer vehicles, information on readiness codes for OBD tests, and pass/fail standards for OBD equipped vehicles. This part of the submittal meets the requirements of 40 CFR 51.357 of the federal I/M regulation.

Computerized test systems are required for performing any measurement on subject vehicles. The federal I/M regulation requires that the state SIP submittal include written technical specifications for all test equipment used in the program. The specifications must describe the emission analysis process, the necessary test equipment, the required features, and written acceptance testing criteria and procedures.

Wisconsin provides the technical specifications for program test equipment in section C.4 of the I/M contract and in TRANS 131.12(2). These requirements mirror EPA's requirements and guidance on test equipment specifications. This part of the submittal meets the requirements of 40 CFR 51.358 of the federal I/M regulation.

Quality control measures must ensure that emission measurement equipment is calibrated and maintained properly and that inspection, calibration records, and control charts are accurately created, recorded and maintained.

Wisconsin's quality control requirements are specified in section C.7.g of the I/M contract and in TRANS 131.12(1) and (3). In addition, quality control procedures are outlined in the document entitled “Wisconsin Vehicle Inspection Program, Quality Assurance Procedures”, which Wisconsin submitted in the July 3, 1997 submittal. These requirements mirror EPA's recommended quality control procedures contained in the EPA “High Tech Guidance” document and include detailed procedures on system calibration surveillance and equipment maintenance. This part of the submittal meets the requirements of 40 CFR 51.359 of the federal I/M regulation.

The federal I/M regulation allows for the issuance of a waiver, which is a form of compliance with the program requirements that allows a motorist to comply without meeting the applicable test standards. An expenditure of at least $450 in repairs, adjusted annually to reflect the change in the Consumer Price Index (CPI) as compared to the CPI for 1989, is required in order to qualify for a waiver in enhanced I/M areas. An expenditure of at least $75 for pre-1981 vehicles and $200 for 1981 and newer vehicles is required in order to qualify for a waiver in basic I/M areas. Waivers can only be issued after a vehicle has failed a retest performed after all qualifying repairs have been made. Any available warranty coverage must be used to obtain repairs before expenditures can be counted toward the cost limit. Tampering related repairs must not be applied toward the cost limit. Repairs must be appropriate to the cause of the test failure. Repairs for 1980 and newer model year vehicles must be performed by a recognized repair technician. The federal regulation allows for compliance via a diagnostic inspection after failing a retest on emissions and requires quality control of waiver issuance. The SIP must set a maximum waiver rate and must describe corrective action that would be taken if the waiver rate exceeds that committed to in the SIP.

Wisconsin establishes waiver limits in section 110.20(13) of the Wisconsin Statutes and in NR 485.045(1). This regulation requires an expenditure of at least $75 for pre-1981 vehicles and $200 for 1981 and newer vehicles is required in order to qualify for a waiver in Sheboygan County and an expenditure of at least $450 in repairs, adjusted annually to reflect the change in the Consumer Price Index (CPI) as compared to the CPI for 1989, as established by the EPA, for the remaining I/M counties. Wisconsin is not currently making the CPI adjustment, pending the resolution of several issues associated with it. The Wisconsin regulation provides for this adjustment once the issues are resolved. Actual waiver rates in the area remain within the 3% assumed in the performance standard modeling, and emission reduction credit is unaffected. Therefore, EPA is approving this part of the regulation.

A description of the corrective action if waiver rates assumed in the performance standard modeling are not met are contained in the document entitled “U.S. EPA's Enhanced I/M Performance Standard, Wisconsin's Demonstration with Discussion,” written by the Wisconsin Department of Natural Resources and dated July 28, 1994, which is part of “Exhibit C” of the July 28, 1994, submittal. Waiver issuance procedures are specified in TRANS 131.04. This part of the submittal is part of the basis for EPA's approval of the I/M SIP.

The federal regulation requires that compliance be ensured through the denial of motor vehicle registration in enhanced I/M programs unless an exception for use of an existing alternative is approved.

Wisconsin's program uses registration denial and has committed to a 96 percent compliance rate. EPA approved this program element in the January 1995 approval of the program.

The federal I/M regulation requires that the enforcement program be audited regularly and follow effective program management practices, including adjustments to improve operation when necessary. The SIP must include quality control and quality assurance procedures to be used to ensure the effective overall performance of the enforcement system. The regulation requires the establishment of an information management system that will characterize, evaluate, and enforce the program.

Contractor requirements pertaining to these enforcement program oversight activities are specified in section C.7.j of the I/M contract. This part of the contract requires the contractor to report test data to a centralized computer database which the state uses to ensure effective performance of the enforcement system. The contract also contains provisions regarding proper document handling and inspection procedures. This part of the submittal satisfies the requirements of 40 CFR 51.362 of the federal I/M regulation.

The state must implement an ongoing quality assurance to discover, correct and prevent fraud, waste, and abuse in the program. The program must include covert and overt performance audits of the inspectors, audits of station and inspector records, equipment audits, and formal training of all state I/M enforcement officials and auditors. The state must submit as part of the SIP a description of the quality assurance program that includes written procedure manuals on the above discussed items.

Requirements for audits of testing equipment, procedures, personnel and records are specified in TRANS 131.11 and 131.13(4). Section C.7.g(2) of the I/M contract sets forth the contractor requirements pertaining to 40 CFR 51.363. The requirements in the state rules and the I/M contract mirror EPA's recommendations for quality assurance procedures. In addition, the contractor's quality assurance procedures are presented in the document entitled “Wisconsin Vehicle Inspection Program, Quality Assurance Procedures” and the state's quality assurance and auditing procedures are presented in “Section 6000—Contractor Audit Procedures,” which Wisconsin included in its July 3, 1997 submittal. This part of the submittal meets the requirements of 40 CFR 51.363.

Enforcement against licensed stations, contractors and inspectors must include swift, sure, effective, and consistent penalties for violations of program requirements. The federal I/M regulation requires the establishment of minimum penalties for violations of program rules and procedures that can be imposed against stations, contractors and inspectors. The state must include in the SIP the legal authority for establishing and imposing penalties, civil fines, license suspensions and revocations. State quality assurance officials must have the authority to temporarily suspend station and/or inspector licenses immediately upon finding a violation that directly affects emission reduction benefits, unless constitutionally prohibited. An official opinion explaining any state constitutional impediments to immediate suspension authority must be included in the submittal. The SIP must describe the administrative and judicial procedures and responsibilities relevant to the enforcement process, including which agencies, courts and jurisdictions are involved, who will prosecute and adjudicate cases and the resources that will support this function.

The requirements for penalties for stations, contractors, and inspectors are specified in TRANS 131.11(3) and 131.13(5). Appendix G of the I/M contract sets forth the penalty schedules for stations, contractors, and inspectors. Appendix G includes penalties for a broad variety of improper practices, including failure to calibrate equipment, improper test procedures, extended wait times at test stations, and failure to provide proper training to technicians. Penalties are clearly specified and increase with subsequent violations. This part of the submittal meets the requirements of 40 CFR 51.364.

Accurate data collection is essential to the management, evaluation and enforcement of an I/M program. The federal I/M regulation requires data to be gathered on each individual test conducted and on the results of the quality control checks of test equipment required under 40 CFR 51.359.

A detailed description of these data is contained in section C.7.l of the I/M contract. This section requires data to be collected for each test, including data on waivers, quality control, repairs, and other program features. This part of the submittal meets the requirements of 40 CFR 51.365.

Monitoring and evaluation of the program by the state and EPA require data analysis and reporting. The federal I/M regulation requires annual reports to be submitted that provide information and statistics and that summarize activities performed for each of the following programs: testing, quality assurance, quality control and enforcement. These reports are due in July and must provide statistics for the period of January to December of the previous year. The state must submit a biennial report to EPA, which addresses changes in program design, regulations, legal authority, and program procedures, identifies any weaknesses found in the program during the two-year period and states how these problems will be or were corrected.

These procedures, including provisions for all required reports, are specified in section C.8 of the I/M contract. The state also commits to submit annual and biennial reports to the EPA in accordance with the I/M regulation and any ensuing EPA guidance in its July 3, 1997 submittal. This part of the submittal meets all of the requirements of 40 CFR 51.366 of the federal I/M regulation and is part of the basis for approving the Wisconsin I/M SIP.

The federal I/M regulation requires all inspectors to be formally trained and licensed or certified to perform inspections.

Requirements for the training and licensing of inspectors are specified in TRANS 131.13 and in section C.5.i of the I/M contract. This section requires all inspectors to undergo training prior to performing vehicle inspections. The training requires inspectors to pass a written and a practical exam administered by a third party for inspector licensing. In addition, Attachment I of the July, 3, 1997 submittal contains the contractor's training plan and Attachment J contains part of the contractor's training manual for new employees. This part of the submittal meets the requirements of 40 CFR 51.367 of the federal I/M regulation.

The federal I/M regulation requires the SIP to include public information and consumer protection programs.

Public information provisions are specified in appendix E of the I/M contract, and in TRANS 131.03(15)(b) and (c) and 131.15(3)(b). Consumer protection program elements are specified in TRANS 131.13(6) and in sections C.5.c, and C.7.h(2) of the I/M contract. Wisconsin operates an extensive public information program that notifies the public of testing requirements, program changes, and environmental benefits of I/M testing. In addition, the I/M contract has detailed provisions for handling customer complaints, customer challenge mechanisms, and dispute resolution mechanisms. This part of the submittal meets the requirements of 40 CFR 51.368 of the federal I/M regulation.

Effective repairs are the key to achieving program goals. The federal regulation requires states to take steps to ensure that the capability exists in the repair industry to repair vehicles. The SIP must include a description of the technical assistance program to be implemented, the procedures and criteria to be used in meeting the performance monitoring requirements of the federal regulation, and the repair technician training resources available in the community.

Requirements and procedures pertaining to technical assistance and repair facility monitoring are specified in TRANS 131.03(10)(a)2., 131.15, and 131.16 and in section C.9 of the I/M contract. In addition, WDOT periodically publishes a newsletter, “The Analyzer,” which presents information on the state's I/M program and vehicle diagnosis and repair. The last page of this newsletter lists the repair technician training resources available in the program area. This part of the submittal meets the requirements of 40 CFR 51.369 of the federal I/M regulation.

The federal regulation requires the states to establish methods to ensure that vehicles that are subject to enhanced I/M and are included in an emission related recall receive the required repairs prior to completing the emission test and/or renewing the vehicle registration.

EPA will adopt regulations to require submittal of this information by manufacturers to develop a database to support this requirement.

Requirements and procedures for compliance with recall notices are presented in TRANS 131.03(11)(j) and in section C.7.a(3) of the I/M contract. These procedures call for the operation of a recall database on the centralized host computer system. This database will be used to notify motorists of recall issues, as well as to determine whether vehicles have been repaired in accordance with recall notices. This part of the submittal meets the requirements of 40 CFR 51.370 of the federal I/M regulation.

On-road testing is required in enhanced I/M areas. The use of either remote sensing devices (RSD) or roadside pullovers including tailpipe emission testing can be used to meet the federal regulations. The program must include on-road testing of 0.5% of the subject fleet or 20,000 vehicles, whichever is less, in the nonattainment area or the I/M program area.

Requirements and procedures for the onroad testing program are presented in TRANS 131.14 and in appendix J of the I/M contract. The on-road testing program meets the minimum testing requirements of the federal I/M regulation.

The official record for this direct final rule is located at the addresses in the ADDRESSES section at the beginning of this document. The addresses for sending comments are also provided in the ADDRESSES section at the beginning of this document. If EPA receives adverse written comments on this action, we will withdraw this final rule and address the comments received in response to this action in a final rule on the related proposed rule. We will not open a second public comment period. Parties interested in commenting on this action should do so at this time.

EPA is approving the Wisconsin I/M program as a revision to the Wisconsin SIP.

Nothing in this action should be construed as permitting or establishing a precedent for any future request for a revision to any SIP. Each request for a revision to the SIP must be considered separately in light of specific technical, economic, and environmental factors and in relation to relevant statutory and regulatory requirements.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

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.

This rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). Executive Order 13132 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 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. EPA also may not issue a regulation that has federalism implications and that preempts state law unless the Agency consults with state and local officials early in the process of developing the proposed regulation.

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, 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. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

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.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D, of the Clean Air Act do not create any new requirements but simply approve requirements that the state is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the federal-state relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA , 427 U.S. 246, 255-66 (1976).

Under sections 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a federal mandate that may result in estimated costs to state, local, or tribal governments in the aggregate; or to the private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small government that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either state, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under state or local law, and imposes no new requirements. Accordingly, no additional costs to state, local, or tribal governments, or to the private sector, result from this action.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective October 15, 2001 unless EPA receives adverse written comments by September 17, 2001.

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

The EPA believes that VCS are inapplicable to this action, because it does not require the public to perform activities conducive to the use of VCS.

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 October 15, 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 February 20, 2001, the District issued a revised Authority to Construct (ATC) to TMP for the construction of a new electricity generating plant in Burney, CA. The revised ATC reflected information and comments provided by TMP, interested parties, and the public through February 20, 2001. The revised ATC also constituted a final PSD Permit pursuant to 40 CFR 52.21, the terms and conditions of the District's delegation of authority from the U.S. EPA under 40 CFR 52.21(u), and Section 7 of the federal Endangered Species Act. Subsequent to the issuance of the revised ATC, the Burney Resources Group filed a petition for review of the ATC with the Board on March 21, 2001. On May 30, 2001, the Board denied review of the petition for the following reasons: (1) Petitioner has not shown that the District's selection of a 2.5 ppm (averaged over one hour) NO X limit as BACT to be clearly erroneous or an exercise of discretion or an important policy consideration that the Board should, in its discretion, review; (2) the District's selection of a 4 ppm (averaged over three hours) CO limit is consistent with the BACT limit established for other sources in Region IX; (3) the District's elimination of SCONO X , a new control technology, during the BACT review did not materially affect the final determination of the limit constituting BACT, since this limit would be achieved with either a selective catalytic reduction (SCR) system or SCONO X ; (4) the District's selection of a 5 ppm ammonia slip is the most stringent ammonia control in PSD permits issued in Region IX and Petitioner's argument that the ammonia slip will form secondary PM 10 is highly speculative in nature; and (5) issues regarding PM 10 and SO 2 offsets and mitigation measures are not within the purview of the federal PSD program. ( See In re: Three Mountain Power, LLC , PSD Appeal No. 01-05.)

Pursuant to 40 CFR 124.19(f)(1), for purposes of judicial review, final Agency action occurs when a final PSD permit is issued and Agency review procedures are exhausted. This document is being published pursuant to 40 CFR 124.19(f)(2), which requires notice of any final agency action regarding a permit to be published in the Federal Register . This action being published today in the Federal Register constitutes notice of the final Agency action denying review of the PSD permit and, consequently, notice of the District's issuance of final PSD permit No. 99-PO-01 to Three Mountain Power, LLC, on February 20, 2001.

The proposed power plant, located near the town of Burney, Shasta County, California, will have a nominal electrical output of 500 MW and will be fired on natural gas. The proposed facility will be subject to PSD for Nitrogen Oxides (NO X ), Carbon Monoxide (CO), Volatile Organic Compounds (VOC), and Particulate Matter (PM 10 ). The permit includes the following Best Available Control Technology (BACT) emission limits: NO X at 2.5 ppmvd (based on 1-hour averaging at 15% O 2 ), 4 ppmvd CO (based on 3-hour averaging at 15% O 2 ), 2 ppmvd VOC (based on 1-hour averaging at 15% O 2 ), and PM 10 at 0.0012 grain/dscf (based on 1-hour averaging at 3% CO 2 ). The BACT requirements include use of Selective Catalytic Reduction (SCR) for the control of NO X emissions, an oxidation catalyst for CO and VOC emissions, and a combination of good combustion control and natural gas for the control of PM 10 emissions. Continuous emission monitoring is required for NO X , CO and opacity. The facility is also subject to New Source Performance Standards, Subparts AA and GG, and the Acid Rain program under title IV of the Clean Air Act.

If available, judicial review of these determinations under section 307(b)(1) of the CAA may be sought only by the filing of a petition for review in the United States Court of Appeals for the appropriate circuit within 60 days from the date on which this document is published in the Federal Register . Under section 307(b)(2) of this Act, this determination shall not be subject to later judicial review in any civil or criminal proceedings for enforcement.

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person . The Agency has established an official record for this action under docket control number OPP-301129. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of May 3, 2000 (65 FR 25719) (FRL-6553-2), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the filing of a pesticide tolerance petition (PP) OE6066 by Monsanto. This notice included a summary of the petition prepared by the petitioner Monsanto. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.1216 be amended by establishing an exemption from the requirement of a tolerance for residues of B -D-glucuronidase derived from E. coli and the genetic material necessary for its production.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” Additionally, section 408(b)(2)(D) requires that the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity. ”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Several types of data are required for proteinaceous plant-pesticide ingredients to provide a reasonable certainty that no harm will result from the aggregate exposure to these proteins. The information is intended to show that a proteinaceous plant-pesticide behaves as would be expected of a typical dietary protein, is not structurally related to any known food allergen or protein toxin, and does not display any oral toxicity when administered at high doses. These data consist of an in vitro digestion assay, amino acid sequence homology comparisons and an acute oral toxicity test. The acute oral toxicity test is done at a maximum hazard dose using purified protein of the plant-pesticide as a test substance.

EPA believes that protein instability in digestive fluids and the lack of adverse effects using the maximum hazard dose approach in general eliminate the need for longer-term testing of Bt protein plant-pesticide ingredients. Dosing of these animals with the maximum hazard dose, along with the product characterization data should identify potential toxins and allergens, and provide an effective means to determine the safety of these protein. The adequacy of the current testing requirements was discussed at the June 7, 200 Scientific Advisory Panel (SAP) meeting.

Toxicity studies submitted in support of this tolerance exemption included the following:

Acute oral toxicity (44988-01). One hundred CD-1 albino mice divided into groups of 10 male and 10 female each were treated with 1.0 milligrams/kilograms (mg/kg), 10.0 mg/kg or 100.0 mg/kg of the test substance (GUS protein) or 100.0 mg/kg control substance (bovine serum albumin). Treatment was administered by oral gavage at 33 ml/kg body weight. Three unscheduled deaths occurred on day 5. These animals were in each of the following groups: 100.0 mg control substance, 10.0 mg or 100.0 mg test substance. Since the deaths appeared in both control and test substance groups, there were no abnormal observations upon gross necropsy of the animals that died prematurely, the deaths were not dose related and only three deaths were seen in the one hundred animals of the study, it appears that the deaths were not related to the test substance. Minor weight loss was recorded in all groups and routine, minor organ abnormalities were also seen in both the treated and control groups during gross necropsy at schedules sacrifice. Based upon the data, there were no significant adverse effects reported upon dosing mice with up to 100.0 mg/kg body weight GUS protein.

In vitro digestibility (449394-07). This study was performed on B -D-glucuronidase purified from E. coli strain K12 engineered to express the GUS protein to determine the digestive fate of the protein in simulated gastric and intestinal fluid. The data submitted indicate that the GUS protein is broken down rapidly with incubation in simulated gastric fluids but is relatively stable in simulated intestinal fluids. GUS protein enzymatic activity rapidly disappears after incubation in simulated gastric fluid (2 minutes, the first timepoint examined). GUS protein also disappears when examined immunologically by western blot as quickly as 15 seconds after incubation in simulated gastric fluid. Although still degraded, GUS protein is more stable to intestinal digestion disappearing by 240 minutes by western blot yet still being detected by enzymatic activity (decreased about 90%) at this same time point. These results suggest that the protein breaks down in the human digestive tract as expected of a dietary protein and will not likely pose a risk in foods as part of the human diet.

The B -D-glucuronidase which is the subject of this rule is a protein originally isolated from E. coli and introduced into plants to serve as a transformation marker. GUS ( B -D-glucuronide glucouronosohydrolase; E.C.3.2.1.31) from E. coli is a homotetrameric enzyme with an individual monomeric weight of 68kD. Individual subunits do not have enzymatic activity. GUS has a pH optima near 7.0 and maintains enzymatic activity for approximately 2 hours at 55 degrees C but is rapidly degraded at 60 degrees C. This bacterial enzymatic activity is ubiquitous in the digestive system of humans and other vertebrates. As a protein component of the normal microflora of the intestinal tract, there will be no change in exposure from the presence of this protein as a transformation marker. In addition, other types of GUS enzyme are present in the liver, spleen, kidneys, salivary glands, breast milk and a variety of other tissues in humans, other vertebrates and a number of invertebrates. While these proteins have similar activity, the mammalian safety data generated to date has been specifically for the E. coli derived GUS so the present tolerance is limited to that form.

Allergenic responses are very unlikely to occur and the Agency is currently unaware of any allergic reactions to this protein. The highest activity of the mammalian GUS protein is found primarily in the liver and kidneys. However, activity has also been seen in the spleen, breast milk, adrenal gland and alimentary tract. GUS protein is also found in many other bacteria besides E. coli and is also present in the environment (Ref. 1). The GUS protein is used as a marker gene during the plant transformation process in the development of genetically modified plants. During the plant transformation process, the GUS protein serves as an identifier which enables the separation of transformed plant cells containing an added gene from those plant cells that have failed to take up or maintain the additional gene of interest. Thus, the GUS protein allows a cell expressing that marker gene to be readily identified.

The mammalian health and safety of the GUS protein is based on its ubiquitous presence in the digestive system of humans and other tissues (Refs. 2 and 6), as well as its presence in anaerobic bacteria (Ref. 3), and other environmental bacteria (Ref. 7). Further, the mammalian health and safety of the GUS protein is based on the long history of safe consumption of the protein in the human and domestic animal food supply (Ref. 2), and in the tissue of various plant species from which foods such as potatoes, apples, almonds, rye, sugar beets, etc., are derived (Refs. 4, 8, and 9). There have been no reports of adverse effects to humans or domestic animals from the consumption of the GUS protein. Toxicity studies conducted in support of this tolerance exemption indicated a lack of toxicity of the E. coli derived GUS protein in mice. Moreover, in vitro digestibility studies further validate earlier findings that the E. coli derived GUS protein is broken down under conditions in mammalian digestive fluids. Therefore, the Agency concludes that the risk to humans when consuming foods containing the GUS protein is minimal to non-existent. The lack of heat stability of the GUS protein suggests that cooking foods would eliminate the protein activity (Ref. 5). Further, the data submitted suggest that upon ingestion, the GUS protein rapidly degrades in the digestive tract thus posing no risks of adverse effects to humans.

The genetic material necessary for the production of the plant pesticide inert ingredient are the nucleic acids (DNA) which comprise genetic material encoding the protein and their regulatory regions. Regulatory regions are the genetic material that control the expression of the genetic material encoding the proteins, such as promoters, terminators, and enhancers. DNA is common to all forms of plant and animal life and the Agency knows of no adverse effects related to their consumption as a component of food. These ubiquitous nucleic acids as they appear in the subject plant pesticide inert ingredient have been adequately characterized by the applicant. The EPA concludes that no mammalian toxicity is anticipated from dietary exposure to the genetic material necessary for the production of the GUS protein.

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

1. Food . The use of B -D-glucuronidase from E. coli and the genetic material necessary for its production as a plant pesticide inert ingredient will not result in new dietary exposure to human health or to the environment. The GUS protein is ubiquitous in the digestive tract of humans, other vertebrate, invertebrates, bacteria, in the environment and in foods in the human and domestic animal diet. Exposure from this protein has not posed any unreasonable risk or health concerns. The lack of mammalian toxicity and the rapid degradation of the protein by the stomach digestion of the GUS protein provide a scientific rationale for exempting from the requirement of a tolerance B -D-glucuronidase and the genetic material necessary for its production when used as a plant pesticide inert ingredient (Ref. 10). Moreover, there is no evidence indicating adverse effects due to aggregate exposure of the GUS protein through dietary, non-food oral, dermal and inhalation.

2. Drinking water exposure . Potential exposures in drinking water is negligible. Because GUS protein is contained within the cells of the plant and is naturally degraded upon plant senescence, the likely transfer of the GUS protein to drinking water is minimal to non-existent.

Other non-occupational exposure of B -D-glucuronidase via residential and indoor uses e.g., uses around homes, parks, recreation areas, athletic fields and golf courses will be minimal to non-existent as the GUS protein is contained within the plant cells.

1. Dermal exposure . Due to the nature of the GUS protein contained within the plant cells as part of the plant pesticide inert ingredient, exposure through any route (i.e., dermal, respiratory) other than dietary is unlikely to occur. Physical contact with the plant or raw agricultural food from the plant may present some limited opportunity for dermal exposure. However, on a per person basis, the potential amounts involved in this exposure is negligible in comparison to exposure through the dietary route.

2. Inhalation exposure . The occurrence of respiratory exposure of the GUS protein contained within the plant cells is negligible in comparison to potential exposure through the dietary route.

E. coli derived B -D-glucuronidase enzyme and its gene is present as part of a ubiquitous organism in the digestive systems of humans and other vertebrates. Based on the lack of mammalian toxicity and the long history of safe consumption of the protein in the human and domestic animal food supply and the rapid degradation of the protein in the digestive tract, no cumulative effects with other substances are expected.

For the U.S. population, including infants and children, B -D-glucuronidase from E. coli and the genetic material necessary for its production as a plant pesticide inert ingredient has no known or reported adverse effects. The Agency's conclusions are based on the extensive use and experience with the GUS protein including the long history of safe consumption of the protein in the human and domestic animal food supply, the lack of mammalian toxicity associated with the protein, the rapid degradation of the protein by the stomach digestion prior to passage to the intestinal tract, along with no reported adverse effects due to aggregate exposure through the dietary, non-food oral, dermal and inhalation routes. Therefore, based on all available information, the EPA concludes that there is reasonable certainty that no harm will result from aggregate exposure of the U.S. population, including infants and children, to the GUS protein when used as a plant pesticide inert ingredient, as expressed in plants in or on all food commodities.

EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredient) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following the recommendations of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen-and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and to the extent that FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

When the appropriate screening and or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been developed, B -D-glucuronidase from E. coli and the genetic material necessary for its production may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption. Based on the weight of the evidence of available data, no endocrine system-related effects have been identified.

The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation for the reasons stated above. For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purposes for B -D-glucuronidase from E. coli and the genetic material necessary for its production.

There are no Codex Maximum Residue Levels (MRL's) established for residues of B -D-glucuronidase from E. coli and the genetic material necessary for its production.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301140 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 15, 2001.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket number OPP-301140, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

1. Fuchs, R.L. and Astwood, J.D. 1996. Allergenicity assessment of foods derived from genetically modified plants. Food Technology 50: 83-88.

2. Gilissen, L. J. W., P. L. J. Metz, W. J. Stiekema and J. P. Nap. 1998. Biosafety of E. coli b -glucuronidase (GUS) in plants. Trans. Res. 7:157-163.

3. Hawkesworth, G., B.S. Draser and M.J. Hill. 1971. Intestinal bacteria and the hydrolysis of glycosidic bonds. J. Med. Microbiol . 4:451-9.

4. Hodal, L. A. Bochardt, J.E. Nielsen, O. Mattsson, and F.T. Okk. 1992. Detection, expression and specific elimination of endogenous b -glucuronidase activity in transgenic and non-transgenic plants. Plant Science. 87:115-22.

5. Jefferson, R.A. and K.J. Wilson. 1991. The GUS gene fusion system. Plant Mol. Biol. Manual B14:1-33.

6. Jefferson, R. A., T. A. Kavanagh, and M. W. Bevan. 1986. B -Glucuronidase from Escherichia coli as a gene-fusion marker. Proc. Natl. Acad. Sci. USA 83: 8447-8451.

7. Levvy, G.A. and C.A. Marsh. 1959. Preparation and properties of b -glucuronidase. Adv. Carbohydrate Chem. 14:381-428.

8. Schulz, M. and G. Weissenbock. 1987. Dynamics of the tissue-specific metabolism of lutolin glucuronides in the mesophyll of rye primary leaves ( Secale cereale ) Z. Naturforsh. 43c: 187-93.

9. Wozniak, C.A. and L.D. Owens. 1994. Native B -glucuronidase activity in sugarbeet ( Beta vulgaris ). Physiol. Plant . 90: 763-771.

10. Kough, J. 2001. Note to file: Safety assessment of B -glucuronidase as a worker gene/inert ingredient.

This final rule establishes an exemption from the tolerance requirement under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104 -4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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 this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

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

On September 12, 2000 (65 FR 59955) EPA published a final rule for the Project XL Site-Specific Rulemaking for the IBM Semiconductor Manufacturing Facility in Essex Junction, Vermont. In this rule, EPA promulgated a site-specific exemption in 40 CFR 261.4(b) for the copper metallization process at the IBM Vermont facility from the F006 hazardous waste listing description. This rule was promulgated pursuant to non-HSWA authority. Since Vermont has received authority to implement non-HSWA regulations that specifically identify hazardous wastes by listing them, the rule to modify the listing for F006 would not be effective until Vermont adopted the modification. Vermont adopted the rule on March 15, 2001 and applied for Final authorization on April 10, 2001.

We conclude that Vermont's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we grant Vermont Final authorization to operate its hazardous waste program with the changes described in the authorization application. Vermont has responsibility for permitting Treatment, Storage, and Disposal Facilities (TSDFs) within its borders and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA).

The effect of this decision is that the IBM semiconductor manufacturing site, subject to RCRA, in Essex Junction, Vermont will now have to comply with the authorized State requirements in lieu of Federal requirements in order to comply with RCRA. Vermont has enforcement responsibilities under its state hazardous waste program for violations of such program, but EPA retains its full authority under RCRA sections 3007, 3008, 3013, and 7003.

This action does not impose additional requirements on the IBM Essex Junction facility because the regulation for which Vermont is being authorized by today's action is already effective under state law, and is not changed by today's action.

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

If EPA receives comments that oppose this authorization, we will withdraw this rule by publishing a document in the Federal Register before the rule becomes effective. EPA will base any further decision on the authorization of the state program change on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time.

If we receive comments that oppose only the authorization of a particular change to the State hazardous waste program, we will withdraw that part of this rule but the authorization of the program changes that the comments do not oppose will become effective on the date specified above. The Federal Register withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn.

Vermont initially received Final authorization on January 7, 1985, effective January 21, 1985 (50 FR 775) to implement the RCRA hazardous waste management program. The Region published an immediate final rule for certain revisions to Vermont's program on May 3, 1993 (58 FR 26242) and reopened the comment period for these revisions on June 7, 1993 (58 FR 31911). The authorization became effective August 6, 1993 (58 FR 31911). The Region granted authorization for further revisions to Vermont's program on September 24, 1999 (64 FR 51702), effective November 23, 1999. On October 18, 1999 (64 FR 56174) the Region published a correction to the immediate final rule published on September 24, 1999, with the effective date of November 23, 1999. The Region granted authorization for further revisions to Vermont's program on October 26, 2000 (65 FR 65164), effective December 26, 2000.

On April 10, 2001 in accordance with 40 CFR 271.21(h), Vermont submitted a final complete program revision application seeking authorization for its revision adopted March 15, 2001. We now make an immediate final decision, subject to receipt of written comments that oppose this action, that Vermont's hazardous waste program revision satisfies all of the requirements necessary to qualify for Final authorization. Therefore, we grant Vermont Final authorization for the following program changes:

There are no differences between the Federal rule and the revised state rule.

Vermont will issue permits for all the provisions for which it is authorized and will administer the permits it issues. EPA will not issue any more new permits or new portions of permits for the provisions listed in the Table above after the effective date of this authorization. EPA will continue to implement and issue permits for HSWA requirements for which Vermont is not yet authorized.

Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. We do this by referencing the authorized State rules in 40 CFR part 272. EPA is authorizing but not codifying Vermont's updated program at this time. We reserve the amendment of 40 CFR part 272, subpart UU for this State program until a later date.

The Office of Management and Budget has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB.

This action authorizes state requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by state law. This rule will not have a significant impact on a substantial number of small entities because it only affects the IBM facility in Essex Junction, VT, and it is not a small entity. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this action is applicable only to one facility in Vermont, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). There are no communities of Indians tribal governments located in Vermont. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this action. This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes state requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make new decisions based on environmental health or safety risks.

Under RCRA 3006(b), EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for EPA, when it reviews a State authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, 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 document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action, nevertheless, will be effective sixty (60) days after publication pursuant to the procedures governing immediate final rules.

On April 30, 2001, the Coast Guard published a notice of proposed rulemaking NPRM entitled Chemical Testing in the Federal Register (66 FR 21502). On the same day, DOT published a common preamble (66 FR 21492) in the Federal Register as referred to in our NPRM. In our NPRM we proposed amendments that conformed our drug testing regulations with the Department of Transportation's (DOT) final rule entitled Procedures for Transportation Workplace Drug and Alcohol Testing published in the Federal Register (December 19, 2000 (65 FR 79462)). No public hearing was requested and none was held.

As discussed above, DOT published a comprehensive revision to their drug and alcohol testing procedural rules (49 CFR Part 40). The DOT final rule makes numerous changes in the way that drug and alcohol testing will be conducted. The DOT final rule is effective on August 1, 2001.

It is important that the six DOT agency rules that cover specific transportation industries be consistent with the DOT final rule to avoid duplication, conflict, or confusion among DOT regulatory requirements. For these reasons, the Coast Guard is revising its drug testing regulations affected by Part 40. Since the DOT rule is effective on August 1, 2001, we are making this final rule effective on the date of publication to ensure that these “conforming amendments” are effective as soon as possible. For these reasons, under 5 U.S.C. 553(b)(3) the Coast Guard finds good cause to make this rule effective in fewer than 30 days after publication in the Federal Register .

This preamble discusses the revisions to Coast Guard chemical testing regulations to ensure consistency with the DOT final rule.

The Coast Guard is revising its chemical drug testing regulations to conform with the Department of Transportation's (DOT) final rule on drug testing procedures in 49 CFR part 40. We are revising 46 CFR parts 4, 5, and 16 by removing obsolete sections and sections duplicating the DOT regulations; adding new definitions required by the DOT regulations; and modifying existing text to incorporate new terms and procedures contained in the DOT procedural requirements.

Some new DOT requirements, such as the requirement for split specimens, are implemented without a revision or conforming amendment to our regulations. In this case, the requirement is in 49 CFR part 40, and our regulations require employers to follow the procedures in that part when conducting required chemical tests for dangerous drugs.

The DOT rule includes new qualification and training requirements for Medical Review Officers (MROs) and Substance Abuse Professionals (SAPs). The Coast Guard is not changing the ability of the MRO to perform a dual MRO/SAP function in the return-to-duty decision process. However, where an individual performs both SAP and MRO functions, Part 40 requires the individual to meet the qualification and training requirements for individuals performing each of these functions.

Another DOT change, the minimum number of follow-up drug tests required during the first year after return to work in a safety-sensitive position, requires a conforming amendment to add this requirement to our existing regulatory text.

The following is a discussion of the comments received addressing the Coast Guard's NPRM published in the Federal Register (April 30, 2001 (66 FR 21502)), as well as a discussion of how the Coast Guard has revised its regulations to conform to DOT's final rule.

In response to the NPRM published on April 30, 2001, we received a total of 48 comment letters to the docket. The comment period closed on June 29, 2001. Twenty of the 48 comment letters received are not specifically discussed in this final rule because they were received after the close of the comment period. We have reviewed the issues presented in those 20 letters, however, and note that they address substantially the same issues raised in the 28 comment letters received during the comment period.

Several of the comment letters addressed issues that concern the requirements in 49 CFR part 40. All of these comments concentrated on discussions, analyses, and regulations published in DOT's final rule and did not address our NPRM. Copies of these comments were forwarded to DOT for inclusion in their docket and are discussed in the DOT common preamble published in Part II of the August 9, 2001 Federal Register .

In addition to having received comments that directly addressed Part 40, we also received five comments that discussed Coast Guard implementation of specific DOT alcohol testing regulations. DOT alcohol testing requirements published in their December 19, 2000, final rule do not apply to the maritime industry. The alcohol testing requirements that the maritime industry must comply with are found in 46 CFR subpart 4.06 and 33 CFR part 95.

We received two comments requesting that we postpone our implementation date. DOT is not delaying any of their final rule provisions. Consequently, we are going forward with our conforming amendments. If there are future changes to Part 40 we will make appropriate revisions to our chemical testing requirements.

We received one comment requesting clarification on who bears the cost of additional testing of a split specimen and return-to-duty testing. More specifically, the commenter wanted to know who pays for the additional drug tests. The Coast Guard and DOT regulations leave these determinations to the employee and the employer.

Another comment requested that we allow Consortium/Third party administrators (C/TPAs) to make refusal to test determinations for an owner or operator or other self-employed individuals in accordance with Part 40. DOT addressed this determination issue in the common preamble. In 49 CFR 40.355(j)(1) DOT authorizes service agents to make refusal determinations with respect to owners or operators and other self-employed individuals when the service agent scheduled the test and the individual fails to appear for it without a legitimate reason for missing the scheduled testing time. The Department's provision adequately meets our needs on this issue and we are not incorporating the suggested provision in our final rule.

We received only one comment addressing several issues in our proposed amendments to part 4. The comment suggested that we:

• Remove paragraph § 4.06-1(f) because we no longer need an implementation schedule. The Coast Guard agrees and is removing the paragraph.

• Revise the testing requirements found in §§ 4.06-5, 4.06-10, 4.06-20, and 4.06-30. In the NPRM we only proposed amending § 4.06-20. We do not agree that the recommended changes to these sections are appropriate at this time, but will consider making them in our next rulemaking on alcohol testing requirements. This rule only changes the cross-references in § 4.06-20.

• Make a couple of changes to § 4.06-40 by removing paragraph (a) and by removing the cross-reference to § 4.06-30 in paragraph (b). The comment stated that Part 40 provided ample guidance on the custody and shipping of testing samples. We are not removing paragraph (a) because its provisions apply to tests not otherwise covered by 49 CFR Part 40. However, we concur with the suggestion to revise the cross-reference in paragraph (b) to conform with Part 40.

• In § 4.06-50, replace paragraphs (a), (b), and (c) with one provision for specimen analysis and follow-up testing procedures that comply with Part 40. We agree that this section needed to be revised but only so that it meets the requirement to comply with Part 40. We have, therefore, changed only the cross-reference in paragraph (b).

Table 5.569. We proposed a clarification to the Table of Appropriate Orders in § 5.569 to distinguish between a Chemical test for dangerous drugs and one for alcohol, because Part 40 treats them separately. We did not receive any comments addressing this proposed change and it is unchanged in this final rule.

The majority of comments were directed to 46 CFR Part 16. We received six comments concerning the inapplicability of Part 16 to foreign-flagged vessels. They stated that by not applying these requirements to foreign-flagged vessels the Coast Guard would create an unfair economic advantage for those vessels over U.S.-flagged vessels. These issues were addressed when Part 16 was established. Foreign-flagged vessels must meet the requirements of 46 CFR subpart 4.06 Mandatory Chemical Testing Following Serious Marine Incidents Involving Vessels in Commercial Service as well as 33 CFR part 95 Operating a Vessel While Intoxicated.

Definitions. We received one comment requesting a revision of our definition of “Refuse to submit.” The comment requested that we clarify in the definition that the specific gravity and creatinine levels would not be used to determine whether or not a substituted sample has been submitted. The Coast Guard disagrees with this request for clarification. Part 40 adequately prescribes the verification process in § 40.145.

New sections. We received two comments requesting a Coast Guard blanket approval for stand-downs for the marine industry. We disagree. DOT has determined that stand-down after a positive drug test should be the exception and not the industry norm. In § 16.107 Waivers, we have established a process for employers to request approval to use stand-down procedures while employee drug test results are being verified.

We proposed adding § 16.109 describing DOT's new Public Interest Exclusion (PIE) in 49 CFR Part 40, subpart R. We did not receive comments addressing this proposed change and it is unchanged in this final rule.

We are adding § 16.115 Penalties. to better inform the public of the penalties prescribed by 46 U.S.C. 2115 for violation of dangerous drug and alcohol testing regulations. We did not receive any comments addressing the addition of this section. However, one commenter suggested we should include a consequence for a refusal to test. This suggestion is beyond the scope of this rulemaking.

Revisions to § 16.201 Application. In § 16.201 we are revising paragraph (a) by requiring all chemical drug tests to be conducted in accordance with the procedures found in 49 CFR Part 40. We are revising paragraph (c) to require a sponsoring organization, like employers and prospective employers, to report a documented or licensed mariner's positive chemical drug test to the nearest Coast Guard Officer in Charge, Marine Inspection. We are updating the cross-reference to § 16.370 in paragraph (e) of this section.

We are adding paragraph § 16.201(f) to this section, which was formerly found at § 16.370(d). Paragraph (f) requires an MRO to determine when an individual is ready to return to work after testing positive and allows the MRO to prescribe follow-up testing for up to 60 months as appropriate. In order to ensure intermodal consistency, DOT has prescribed a mandatory minimum number of follow-up tests after return to work. We are revising this paragraph to include the new DOT requirement for a minimum of 6 follow-up drug tests during the first year after an individual returns to work. This new requirement will be in addition to all other Coast Guard requirements for rehabilitation and education following a positive drug test.

Revisions to § 16.203 Employer, MRO, and SAP responsibilities. We are adding § 16.203 to set out the Coast Guard's requirements that maritime employers, MROs, and SAPs comply with 49 CFR Part 40.

Where an individual performs both SAP and MRO functions, Part 40 requires the individual to meet the qualification and training requirements for individuals performing each of these functions. In our NPRM, we specifically requested that comments address how we should implement this change in our rule. We also asked if an MRO should, in order to perform SAP functions, meet both the SAP and MRO training requirements or should the MRO training requirements satisfy the requirements for SAP training. We received five comments on this question. The comments recommended that the MRO meet the training and qualification standards of a SAP if the MRO is to be responsible for filling the role of a SAP. We agree and have added paragraphs (d) and (f) accordingly. Paragraph (d) sets out the Coast Guard's training and procedure requirements for MROs whereas paragraph (f) sets out the same requirements for SAPs. We also are adding a new definition for “Substance Abuse Professionals (SAP)” in section § 16.105.

We are adding paragraph (e) to this section to clarify our position on Medical Review Officer (MRO) reporting of test results. Medical Review Officers are not prohibited from reporting positive test results to the Coast Guard. Some MROs are currently doing so. The Coast Guard affirms that MROs are encouraged to report positive test results especially for unemployed or self-employed mariners.

Deletion of Subpart C. Most of the requirements in Subpart C are now covered in detail by the revised 49 CFR Part 40 and these sections are no longer needed in Part 16. We have removed the unnecessary sections and moved the remaining paragraphs to appropriate locations in Subparts A and B. Subpart C is removed and reserved.

DOT has assessed the economic impacts of this proposed rulemaking. Because this final rule makes conforming changes to align Coast Guard regulations with the revised 49 CFR Part 40, DOT determined that it has no additional costs to industry. Their analysis is published in their December 19, 2000, final rule, Procedures for Transportation Workplace Drug and Alcohol Testing Programs (OST 1999-6578).

DOT also found no significant impact that would warrant further analysis of this rulemaking in accordance to the Small Business Regulatory Enforcement Fairness Act of 1996, the Paperwork Reduction Act of 1995, Federalism impacts under Executive Order 13132, the Unfunded Mandates Reform Act of 1995, Enhancing the Intergovernmental Partnership under Executive Order 12875, Taking of Private Property under Executive Order 12630, Civil Justice Reform under Executive Order 12988, and the Protection of Children from Environmental Health Risks and Safety Risks under Executive Order 13045.

It is well settled that States are precluded from regulation in categories that are reserved for regulation by the Coast Guard. It is also well settled, now, that all of the categories covered in 46 U.S.C. 3306, 3703(a), 7101 and 8101 (design, construction, repair, alteration, maintenance, operation, equipping, personnel qualification and manning of vessels) as well as casualty reporting and any other categories where Congress intended the Coast Guard to be the sole source of a vessel's obligations are within the field foreclosed from State regulation. ( See the decision of the Supreme Court in the consolidated cases of United States v. Locke and Intertanko v. Locke, 529 U.S. 89, 120 S.Ct 1135 ( March 6, 2000 )). Rules regarding drug and alcohol testing for merchant marine personnel fall into the covered category of personnel certification rules, with the Coast Guard intended to be the sole source of those rules, thereby precluding States from regulation. Because States may not promulgate rules within these categories, preemption is not an issue under Executive Order 13132.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this final rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult LCDR Scott Budka, Coast Guard, telephone 202-267-2026.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

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

We considered the environmental impact of this proposed rule and concluded that, under figure 2-1, paragraphs (34)(a), of Commandant Instruction M16475.lC, this rule is categorically excluded from further environmental documentation. The proposed rule would be promulgated to comply with new DOT regulations. The promulgation of new regulations by the Coast Guard would be editorial or procedural in nature. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES .

Consortium/Third party administrator (C/TPA) means a service agent who provides or coordinates the provision of a variety of drug and alcohol testing services to employers. C/TPAs typically perform administrative tasks concerning the operation of the employers' drug and alcohol testing programs. This term includes, but is not limited to, groups of employers who join together to administer, as a single entity, the DOT drug and alcohol testing programs of its members.

In the document closing directed fishing for the shallow-water species with trawl gear, except for vessels fishing for pollock using pelagic trawl gear in those portions of the GOA open to directed fishing for trawl gear, published at 66 FR 41455, August 8, 2001, FR Doc. 01-19894, the following corrections are made:

1. On Page 41455, under the SUMMARY heading, line 9, “fourth” is corrected to read “third”.

2. On page 41455, under the DATES heading, line 3, “October 1, 2001” is corrected to read “September 1, 2001.”

3. On page 41455, under SUPPLEMENTARY INFORMATION , the following corrections are made:

a. In column 2, paragraph 2 , lines 9 through 13 are corrected to read “FR 17087, March 29, 2001, and 66 FR 37167, July 17, 2001) for the third season, the period July 1, 2001, through September 1, 2001, as 200 metric tons.”

b. In column 3, line 1, “fourth” is corrected to read “third”.

4. On page 41455, under “Classification”, line 7, “fourth” is corrected to read “third” and in line 10 from the bottom of that paragraph, “fourth” is corrected to read “third”.