The Secretary of Energy has approved today's technical and administrative regulatory amendments in order to conform 10 CFR part 765 to legislative amendments to Title X of the Energy Policy Act of 1992 (sections 1001-1004 of Pub. L. 102-486) and the need to make other corrections to the original rule published on May 23, 1994 (59 FR 26714). Congress has amended the original legislation four times since it was enacted on October 24, 1992. In 1996, Public Law 104-259 amended Title X to increase the authorized reimbursement amounts for uranium and thorium licensees from $270 million and $40 million to $350 million and $65 million, respectively, for an aggregate authorized reimbursement amount of $415 million; and to increase the maximum amount that may be reimbursed to uranium licensees per dry short ton of Federal-related byproduct material from $5.50 to $6.25. In 1998, Public Law 105-388 further amended Title X to increase the authorized reimbursement amount for the thorium licensee from $65 million to $140 million, for an aggregate authorized reimbursement amount to uranium and thorium licensees of $490 million. In 2000, Public Law 106-317 amended Title X to change the date for determining the availability of excess funds for reimbursement to uranium licensees from July 31, 2005, to December 31, 2008; to change the date after which work must be completed in accordance with an approved plan for subsequent remedial action to be eligible for reimbursement from December 31, 2002, to December 31, 2007; and to eliminate the requirement for the Department to place certain reimbursement funds in escrow. In 2002, Public Law 107-222 amended Title X to increase the authorized reimbursement amount for the thorium licensee from $140 million to $365 million, for an aggregate authorized reimbursement amount to uranium and thorium licensees of $715 million.

Part 765 is amended in several places to reflect these statutory provisions. Other technical corrections to the original rule are discussed in the following paragraphs.

Section 765.21(e) is revised to provide a licensee with an additional opportunity to provide reasonable documentation, as specified in § 765.20, for claims or portions of claims that DOE has denied during the claim year. The revised rule now gives a licensee 45 days after DOE issues a written decision to deny the claim, in which to provide the documentation for DOE reconsideration of the claim. If a licensee chooses not to submit the documentation, the licensee still has the right to file a formal appeal to the DOE's claim denial in accordance with § 765.22. If a licensee chooses to submit the documentation, DOE will consider whether the documentation results in the DOE's reversal of its initial decision to deny the claim and will inform the licensee of the DOE's subsequent decision. A licensee may also appeal that decision in accordance with § 765.22. By providing this additional opportunity to a licensee, DOE believes that both DOE and the licensee may save time and money by minimizing the number of appeals.

Section 765.23 is amended to indicate the new address for obtaining copies of the DOE status report on the reimbursement program.

Section 765.30(b) presents the procedure for submitting a plan for subsequent remedial action. The original rule indicated that licensees may submit this plan any time after January 1, 2000, but no later than December 31, 2001. Because Congress changed the date after which work must be completed in accordance with an approved plan for subsequent remedial action to be eligible for reimbursement from December 31, 2002, to December 31, 2007, this final rule correspondingly changes the dates for submitting a plan to DOE to any time after January 1, 2005, but no later than December 31, 2006.

Section 765.30(d) outlines the process for resubmitting a revised plan for subsequent remedial action if the original plan is rejected by DOE. The original rule indicated that a licensee may continue to submit revised plans for subsequent remedial action until DOE approves a plan, or September 30, 2002, whichever occurs first. This final rule changes the September 30, 2002, deadline to September 30, 2007, to correspond with the new statutory deadline for making reimbursements in accordance with a subsequent plan for remedial action.

Section 765.30(e) presents the procedures for determining the maximum amounts for which licensees may be eligible for reimbursement for work performed as described in their plans for subsequent remedial action submitted to and approved by DOE. The original rule indicated that a licensee is eligible for the lesser of two amounts: (1) The total cost of remedial action multiplied by the Federal reimbursement ratio; or (2) $5.50, as adjusted for inflation, multiplied by the number of Federal-related dry short tons of byproduct material. As drafted, the original rule could have been construed to apply the per dry short ton limit to both uranium and thorium licensees. Since Title X (42 U.S.C. § 2296a(b)(2)(A)) limits the applicability of the per dry short ton limit to uranium licensees, this final rule amends § 765.30(e)(2) to clarify that the per dry short ton limit only applies to uranium licensees.

In accordance with § 765.30(b), because licensees' plans for subsequent remedial action are now due no later than December 31, 2006, this final rule amends § 765.30(e)(2) to clarify that the potential additional reimbursement for which a licensee may be entitled will be adjusted after the approval of claims for work performed through December 31, 2007, to account for the actual approved costs of work performed through 2007.

As originally prescribed, § 765.31(a) outlined the procedures for designating specific amounts on deposit in the Uranium Enrichment Decontamination and Decommissioning Fund established at the United States Department of the Treasury for reimbursement of costs incurred in accordance with an approved plan for subsequent remedial action. The purpose of this paragraph was to implement the original requirement of § 1001(b)(1)(B)(ii) of Pub. L. 102-486 that funds be placed in escrow not later than December 31, 2002, in accordance with an approved plan for subsequent remedial action. Because Pub. L. 106-317 amended the original legislation by striking the requirement to place funds in escrow, this final rule removes this paragraph and renumbers the subsequent paragraphs in this section.

Today's regulatory action has been determined not to be “a significant regulatory action” under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Accordingly, this action was not subject to review under that Executive Order by the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB).

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” (61 FR 4729, February 7, 1996) imposes on Executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of Executive Order 12988.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires preparation of an initial regulatory flexibility analysis for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. There is no legal requirement to propose today's rule for public comment, and therefore, the Regulatory Flexibility Act does not apply to this rulemaking proceeding.

No new collection of information or recordkeeping requirements is imposed by this final rule. Accordingly, no clearance by OMB is required under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

Executive Order 13132 (64 FR 43255, August 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. DOE has examined today's rule and has determined that it does not preempt State law and does 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. No further action is required by Executive Order 13132.

Pursuant to the Council on Environmental Quality Regulations (40 CFR parts 1500—1508), DOE has established guidelines for compliance with the provisions of the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq. ). This rule makes technical corrections to procedures for the reimbursement of eligible remedial action costs incurred by licensees at active uranium and thorium processing sites. Implementation of this rule will not affect the legally required cleanup of the sites or result in any other environmental impacts. The Department has therefore determined that this rule is covered under the Categorical Exclusion found at paragraph A6 of Appendix A to subpart D, 10 CFR part 1021, which applies to the establishment of procedural rulemakings such as procedures for the review and approval of applications for grants and cooperative agreements. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to assess the effects of Federal regulations on States, local, and tribal governments and the private sector. DOE has determined that today's regulatory action does not impose a Federal mandate on State, local, or tribal governments or on the private sector.

As required by 5 U.S.C. 801, DOE will report to Congress promulgation of the rule prior to its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(3).

NCUA identified part 703 of its rules as in need of revision. To that end, NCUA issued an advance notice of proposed rulemaking (ANPR) on October 18, 2001. 66 FR 54168 (October 26, 2001). After considering the comments to the ANPR submitted by 38 commenters, NCUA issued a proposed rule on December 19, 2002. 67 FR 78996 (December 27, 2002). NCUA received 14 comment letters regarding the proposed rule: five from FCUs, one from a State credit union, five from financial services entities, and three from credit union trade organizations. The comments were generally supportive of the proposal.

Throughout the rulemaking process, NCUA has expressed concern about the purchase of some brokered certificates of deposit (CDs). Deceptive practices or outright fraud on the part of some broker-dealers and safekeepers have caused losses for FCUs. NCUA does not believe, however, that more stringent standards on broker-dealers or safekeepers, such as those contemplated by the ANPR, would prevent losses. NCUA believes continued guidance to FCUs and prudent due diligence by FCUs is the best course of action. Therefore, NCUA is not making any substantive changes to broker-dealer and safekeeping requirements in this regard. The commenters generally supported this position.

The proposed rule permits the use of depository institutions whose broker-dealer activities are regulated by a State regulatory agency. This provides FCUs with greater access to broker-dealers. NCUA also believes additional broker-dealer competition promotes improved service, better execution, and reduced costs. The commenters supported this proposal. The Board adopts this proposed revision in the final rule.

Former § 703.50(c) exempts CD finders from the broker-dealer requirements. It was always NCUA's intent to carry this exemption forward in proposed § 703.8 as indicated in the preamble to the proposed rule. 67 FR 78996, 78996-97 (December 27, 2002). Specifically, if an FCU purchases a CD or share certificate directly from a bank, credit union, or other depository institution that issues the certificate, the FCU will not be bound by the broker-dealer requirements. This exemption was inadvertently omitted in the regulatory language in § 703.8 of the proposed rule through a clerical error. As stated in the proposal's preamble, NCUA indicated it was making no changes to the broker-dealer section of the rule in this regard. Thus, the inclusion of this exemption in the final rule will not change the requirements pertaining to the use of broker-dealers.

To be consistent with the broker-dealer requirements, the proposed rule added a due diligence requirement that calls for an FCU to review a safekeeper's financial condition, in addition to its registration status, and retain the documentation used to approve a safekeeper. NCUA believes these requirements represent prudent, minimum practices that FCUs should follow when evaluating a safekeeper. In addition, the proposed rule permitted State-regulated trust companies to be safekeepers for FCUs. NCUA recognizes these firms can provide a sound alternative for FCUs.

The commenters overwhelmingly concurred with this aspect of the proposed rule. NCUA adopts this proposal in the final rule.

The Federal Credit Union Act (Act) enumerates FCU investment powers. 12 U.S.C. 1757(7), (8), and (15). NCUA has adopted regulatory prohibitions against certain investments and investment activities permitted by the Act on the basis of safety and soundness concerns. In revising the rule, NCUA has explored ways to expand FCU investment powers. Generally, those investments currently prohibited by regulation exhibit high risks or are unsuitable for many FCUs, such as stripped mortgage-backed securities or variable rate investments tied to non-domestic interest rates.

As one means of expanding investment powers, the proposed rule permits some FCUs to purchase commercial mortgage related securities (CMRS), subject to certain restrictions. Specifically, the proposed rule limits the purchase of CMRS, which are not otherwise permitted by § 107(7)(E) of the Act, 12 U.S.C. 1757(7)(E), to RegFlex eligible FCUs. 12 CFR part 742. Further, a RegFlex eligible FCU may purchase CMRS if the CMRS: (1) Are rated in one of the two highest rating categories by at least one nationally-recognized statistical rating organization; (2) otherwise meet the definitions of mortgage related security as defined in 15 U.S.C. 78c(a)(41) and CMRS as defined in proposed § 703.2; and (3) have an underlying pool of loans containing more than 50 loans with no one loan representing more than 10 percent of the pool. A RegFlex eligible FCU is limited to purchasing CMRS in an aggregate amount of up to 50 percent of its net worth. Most commenters supported NCUA's proposal to permit RegFlex eligible FCUs to purchase CMRS with certain limitations. NCUA adopts this proposal as final.

A few commenters suggested NCUA should adopt additional requirements or restrictions to address sound risk management practices for CMRS. NCUA believes no changes are necessary in this regard, but reminds FCUs that former § 703.30 already requires FCUs to develop investment policies that address credit, liquidity, interest rate, and concentration risks. 12 CFR 703.30. The policy must also stipulate the characteristics of any investments that are suitable for the FCU. These requirements carry over to the final rule. Thus, FCUs that purchase CMRS must develop sound risk management policies and construct limits that represent the FCU board's risk tolerance.

NCUA also proposed to permit FCUs to purchase equity options for the sole purpose of offering dividends based on the performance of an equity index. This proposal evolved from the experience gained monitoring an investment pilot program. The pilot program enabled NCUA to review the demands and risks associated with such a program before developing a regulation. Commenters agreed that the proposed regulatory language was prudent and would not pose any undue burden on FCUs. NCUA adopts the proposal.

NCUA has determined that other currently prohibited investments should remain prohibited due to the complexity of the instruments or the difficulty in managing their associated risks. However, NCUA encourages FCUs that believe they possess the skills and resources to manage such investments to apply for a pilot program. The commenters generally supported this approach to expanding investment powers. NCUA remains committed to publishing standards for pilot programs that have been approved to facilitate future applications. These guidelines will be available on the NCUA website or by contacting the appropriate NCUA regional office. Additionally, investment pilot program applicants are encouraged to submit alternative proposals for NCUA's consideration.

Former § 703.40(c)(6) authorizes an FCU to delegate to an outside third party discretionary control over the purchase and sale of investments, up to 100 percent of the FCU's net capital at the time of delegation. 12 CFR 703.40(c)(6). RegFlex eligible FCUs are exempt from this cap. 12 CFR 742.4.

NCUA proposed that FCUs conduct an annual evaluation of the amount of investments under discretionary control. Further, the proposal required an FCU to notify its board of directors and the appropriate regional director if the amount under discretionary control exceeds the cap at the time of the annual evaluation. An FCU must develop a plan to bring itself into compliance with the cap within a reasonable period of time.

Generally, commenters supported this proposal, although a few commenters suggested that NCUA permit all FCUs to exceed the cap, not just RegFlex eligible FCUs. These commenters stated that FCUs not meeting RegFlex eligibility may benefit most from having an investment professional manage an FCU's investments. NCUA has determined not to lift the cap for FCUs ineligible for RegFlex. NCUA notes that an FCU currently not meeting RegFlex eligibility requirements may petition its regional director for a RegFlex designation. The Board adopts the proposed revisions.

Commenters also questioned whether it was reasonable for an FCU board to be required to notify the appropriate regional director of any violation of the cap within five business days of exceeding the cap. NCUA believes this is reasonable. The regulation stipulates that an FCU only notify its regional director within five business days. An FCU is not required to submit a plan to bring it into compliance within this time frame. An FCU must develop a plan within a reasonable period of time after notification. A reasonable period of time will be decided by the regional director after considering an FCU's circumstances, including the materiality of the breach and the risk to the FCU's earnings and capital.

In response to a commenter's question, NCUA clarifies that mutual funds are not included in the calculation of funds under discretionary control.

As part of the background check of an investment advisor, the proposed rule required that an FCU analyze the background of the firm for whom an investment adviser works, in addition to the investment adviser and his or her associated personnel. No commenters objected to this requirement. This proposed change is adopted in the final rule. Several commenters urged NCUA to clarify the meaning of “associated personnel” as it is used in proposed §§ 703.5 and 703.8. NCUA notes that the proposed rule included a definition for “associated personnel” in proposed § 703.2 and it is adopted in the final.

Borrowing repurchase transactions, formerly referred to as reverse repurchase transactions, enable an FCU to sell securities under an agreement to repurchase in order to borrow funds. 12 CFR 703.100(j). Section 703.100(j)(2) prohibits an FCU from purchasing an investment with the proceeds from a reverse repurchase agreement if the purchased investment matures after the maturity of the reverse repurchase agreement. 12 CFR 703.100(j)(2). NCUA proposed to permit RegFlex eligible FCUs to purchase securities with maturities exceeding the maturity of the borrowing repurchase transaction in an amount not to exceed the FCU's net worth.

Most of the commenters supported the proposal. Three commenters objected to the proposed rule because they believed there should be no restrictions on the maturity of any investment purchased by any FCU. These commenters indicated there are no similar restrictions applicable to other types of borrowing. NCUA believes the limitation is prudent and does not unduly impede any FCU's ability to manage its balance sheet and, therefore, adopts the proposed revision in the final rule.

The proposed rule changed the term “repurchase transactions” to “investment repurchase transactions” and revised the requirements for investment repurchase transactions to be consistent with those of securities lending transactions. Other than these revisions, the proposal did not make any substantive amendments in this regard. No commenter objected. NCUA adopts the proposed revisions.

Former § 703.100(k) addresses securities lending transactions and requires an FCU to take a perfected first priority security interest in all collateral the FCU receives. 12 CFR 703.100(k). Proposed § 703.13 removes the word “perfected”, but still requires a first priority security interest through possession or control of the collateral. In addition, the proposed rule clarifies that an FCU's agent may act in its place in these transactions. No commenter objected. NCUA adopts the proposed revisions as final.

The Act provides that the accounting principles applicable to reports or statements required to be filed with NCUA by insured credit unions, except those with total assets of less than $10 million, must be uniform and consistent with generally accepted accounting principles (GAAP). 12 U.S.C. 1782a(a)(6)(C). NCUA proposed to revise part 703 to clarify that FCUs having total assets of $10 million or more must comply with all GAAP provisions related to the accounting principles applicable to reports or statements required to be filed with NCUA, not just selected ones. While not mandatory for FCUs with total assets of less than $10 million, NCUA encourages them also to comply with GAAP or to account for their investments consistent with the NCUA Accounting Manual for Federal Credit Unions, which can be found on the NCUA website. No commenters objected. NCUA adopts this amendment.

To be consistent with changes in the Act and NCUA's rules, NCUA proposed to replace the term “net capital” with “net worth.” No commenter objected to this change. NCUA adopts it in the final rule.

The proposal changed the question and answer format to a more traditional format to make the rule easier to read and more conducive to finding information quickly. Many commenters supported this amendment and no commenters objected to it. NCUA adopts it in the final rule.

One commenter noted that State-chartered credit unions that make investments that are impermissible for FCUs must reserve for those non-conforming investments. 12 CFR 741.3. The commenter questioned whether State-chartered credit unions need to reserve for non-conforming investments that are permissible for RegFlex eligible FCUs. NCUA believes that, if a State-chartered credit union meets all the criteria for RegFlex eligibility as detailed in § 742.2, then it is not required to reserve for non-conforming investments that are permissible for RegFlex eligible FCUs. 12 CFR 742.2. If at any time a State-chartered credit union fails to meet the RegFlex eligibility criteria, then it must reserve for any non-conforming investments it owns.

Another commenter urged NCUA to revise proposed § 703.1, the purpose and scope section, to clarify that State-chartered credit unions, in addition to complying with the reserve requirement for non-conforming investments in § 741.3, must also comply with the requirements of part 703 concerning transacting business with corporate credit unions, as provided in § 741.219. 12 CFR 741.219. NCUA believes it will be helpful to include this reference in the purpose and scope section and is including it in the final rule as a technical correction.

Proposed § 703.16(a) incorrectly references § 703.14(h). The correct and intended reference, reflected in the final rule, is to § 703.14(g).

Proposed § 703.3(g) stated that only “ those individuals with investment authority may be voting members of an investment-related committee.” (Emphasis added.) The former version of the rule requires that only “ officials and employees of the Federal credit union may be voting members of an investment-related committee.” (Emphasis added.) This was an unintended change in language. NCUA received no comment on this but wishes to clarify that the prior language in part 703 remains unchanged as intended by the proposal.

The Regulatory Flexibility Act requires NCUA to prepare an analysis to describe any significant economic impact a proposed rule may have on a substantial number of small credit unions (those under $1 million in assets). This rule clarifies the investment authority granted to FCUs and conforms the Regulatory Flexibility Program to the investment rule. The final amendments will not have a significant economic impact on a substantial number of small credit unions and, therefore, a regulatory flexibility analysis is not required.

The current Office of Management and Budget control number assigned to part 703 is 3133-0133. NCUA has determined that the final rule would not increase paperwork requirements under the Paperwork Reduction Act of 1995 and regulations of the Office of Management and Budget.

Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on State and local interests. In adherence to fundamental federalism principles, NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order. The final rule would not have substantial direct effects on the States, on the connection between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. NCUA has determined that this final rule does not constitute a policy that has federalism implications for purposes of the executive order.

NCUA has determined that this final rule would not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Pub. L. 105-277, 112 Stat. 2681 (1998).

The Small Business Regulatory Enforcement Act of 1996 (Pub. L. 104-121) provides generally for congressional review of agency rules. A reporting requirement is triggered in instances where NCUA issues a final rule as defined by Section 551 of the Administrative Procedure Act. 5 U.S.C. 551. The Office of Management and Budget has determined that this rule is not a major rule for purposes of the Small Business Regulatory Enforcement Fairness Act of 1996.

The Direction Generale De L'Aviation Civile (DGAC), the airworthiness authority for France, notified the FAA that an unsafe condition may exist on Eurocopter Model AS332C, L, and L1 helicopters. The DGAC advises that a right-hand (RH) hydraulic reservoir drained while in service due to a cracked adapter on the hydraulic reservoir. Such a situation could result in the loss of hydraulic power assistance if leakage occurs on both hydraulic systems at the same time.

Eurocopter has issued Alert Service Bulletin No. 67.00.25, dated January 8, 2003 (ASB), which specifies replacing certain adapters, part number (P/N) DHS613-636-43, on the RH hydraulic reservoir to limit the risk of hydraulic fluid leakage, which can result in the loss of hydraulic power assistance in the event of leakage on both hydraulic systems. The DGAC classified this ASB as mandatory and issued AD 2003-101(A), dated March 5, 2003, to ensure the continued airworthiness of these helicopters in France.

These helicopter models are manufactured in France and are type certificated for operation in the United States under the provisions of 14 CFR 21.29 and the applicable bilateral agreement. Pursuant to the applicable bilateral 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 these type designs that are certificated for operation in the United States.

The previously described unsafe condition is likely to exist or develop on other helicopters of the same type design registered in the United States. Therefore, this AD is being issued to prevent failure of an adapter on the hydraulic reservoir, loss of hydraulic fluid, loss of hydraulic power, and subsequent loss of control of the helicopter. This AD requires replacing each adapter, P/N DHS613-636-43, with a manufacturing code on the hydraulic reservoir end indicating manufacture before January 1, 2002, and not identified with a yellow mark, with an airworthy adapter, P/N DHS613-636-43, with a manufacturing code on the reservoir end indicating manufacture on or after January 1, 2002. This AD requires that both the RH and left-hand (LH) affected adapters be replaced within 15 days even though the manufacturer's service information and the DGAC AD envisioned replacing the RH adapter only. This was driven apparently by an insufficient number of airworthy replacement adapters at the time their service information was released. Now, since there should be sufficient airworthy replacement adapters, both affected RH and LH adapters must be replaced. The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the controllability of the helicopter. Therefore, this AD requires replacing the previously identified adapter with an airworthy adapter within 15 days, and this AD must be issued immediately.

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.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's AD system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. Because we have now included this material in part 39, we are no longer including it in each individual AD.

The FAA estimates that this AD will affect 3 helicopters, and replacing both adapters on each helicopter will take approximately 2 work hours at an average labor rate of $60 per work hour. Required parts will cost approximately $184 (2 adapters per helicopter). Based on these figures, the total cost impact of the AD on U.S. operators is $912.

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

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available 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 mailed comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2003-SW-14-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 .

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 2002-22-07, amendment 39-12932 (67 FR 66043, October 30, 2002), which is applicable to certain Boeing Model 767 series airplanes, was published in the Federal Register on March 5, 2003 (68 FR 10412). The action proposed to continue to require a one-time inspection for missing bolts on the inboard and outboard support of the inboard main flap, and follow-on inspections and corrective actions, if necessary. The action also proposed to require, for certain airplanes that are subject to the existing AD, a new one-time inspection for gaps, a new one-time torque check for loose bolts, corrective actions if necessary, and eventual replacement of existing titanium bolts with steel bolts.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. Because we have now included this material in part 39, we no longer need to include it in each individual AD. However, for clarity and consistency in this final rule, we have retained the language of the NPRM regarding that material.

There are approximately 821 airplanes of the affected design in the worldwide fleet. The FAA estimates that 374 airplanes of U.S. registry will be affected by this AD.

The initial inspection that is currently required by AD 2002-16-05 takes approximately 6 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required inspection on U.S. operators is estimated to be $134,640, or $360 per airplane.

For an affected airplane, the new inspection for gaps that is required by this AD will take approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this required inspection is $60 per airplane.

For an affected airplane, the new torque test that is required by this AD will take approximately 6 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this required torque test is $360 per airplane.

For an affected airplane, the replacement of bolts that is required by this AD will take approximately 10 work hours per airplane to accomplish, at an average labor rate of $60 per work hour. Required parts will cost approximately $1,880 per airplane. Based on these figures, the cost impact of this required replacement is $2,480 per airplane.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this 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.

This preamble provides background information, a regulatory analysis of the amendments, and then a detailed section-by-section analysis of the amendments.

Section 335 of the Tariff Act of 1930 (19 U.S.C. 1335) authorizes the Commission to adopt such reasonable procedures, rules, and regulations as it deems necessary to carry out its functions and duties. To carry out its functions and duties, the Commission has issued rules of practice and procedure. The passage of time has rendered some provisions of the rules outdated. In addition, Commission practice has revealed the need for improvements in certain rules. This rulemaking updates certain outdated provisions and improves other provisions.

Consistent with its ordinary practice, the Commission is issuing these amendments in accordance with the rulemaking procedure in section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553). This procedure entails the following steps: (1) Publication of a notice of proposed rulemaking; (2) solicitation of public comments on the proposed amendments; (3) Commission review of such comments prior to developing final amendments; and (4) publication of final amendments at least thirty days prior to their effective date. The Commission published a notice of proposed rulemaking (67 FR 38614, June 5, 2002) on which the present notice is based. No public comments were received on the notice of proposed rulemaking. Based on a continuing review of the rules to identify references that need correction or clarification, the present notice contains a number of amendments not included in the notice of proposed rulemaking.

A number of the amendments affect interim rules, i.e., sections 201.201, 201.202, 201.204, 206.3. Those interim rules will be replaced with final rules in future rulemakings.

The Commission has determined that these amendments do not meet the criteria described in section 3(f) of Executive Order 12866 (58 FR 51735, Oct. 4, 1993) and thus do not constitute a significant regulatory action for purposes of the Executive Order.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) is inapplicable to this rulemaking because it is not one for which a notice of rulemaking is required under 5 U.S.C. 553(b) or any other statute. Although the Commission has chosen to publish a notice, these amendments are “agency rules of procedure and practice,” and thus are exempt from the notice requirement imposed by 5 U.S.C. 553(b).

These amendments do not contain federalism implications warranting the preparation of a federalism summary impact statement pursuant to Executive Order 13132 (64 FR 43255, Aug. 4, 1999).

No actions are necessary under the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq. ) because the amendments 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.

The amendments are not major rules as defined in the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ). Moreover, they are exempt from the reporting requirements of the Contract With America Advancement Act of 1996 (5 U.S.C. 801 et seq. ) because they concern rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties.

The amendments are not subject to section 3504(h) of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ), since they do not contain any new information collection requirements.

The Commission revises section 201.1 regarding the applicability of part 201 to correctly reference parts 210, 212 and 213 in the reference to rules of special application.

The Commission amends section 201.2 by revising paragraph (c), which defines the term “Tariff Act,” to include citations to 19 U.S.C. 1677m and 1677n.

The Commission amends section 201.3 by revising paragraph (c) to clarify that any document filed after Commission business hours will be considered filed the next business day, and that if filing on that day means the document is untimely filed then the document may not be accepted unless it is accompanied by a request for permission to make a late filing.

The Commission amends section 201.3a by revising paragraph (a) to update the Commission's designated point of contact for using its penalty mail in locating and recovering missing children.

The Commission amends section 201.4 by revising paragraph (d) to correctly cite to section 202 of the Trade Act of 1974 (19 U.S.C. 2252), eliminate the citation to the former 19 U.S.C. 1303, which has been repealed, and add “ et seq. ” to the citation to 19 U.S.C. 1673 to correctly refer to all of the antidumping provisions.

The Commission amends section 201.6 by revising paragraph (a)(2) to include section 206.17 as a section having special rules for the handling of nondisclosable confidential business information. The Commission also revises paragraph (d) of section 201.6 regarding the approval or denial of requests for confidential treatment. The revision will provide for consistency by stating that approvals, like denials, would be in writing. The Commission also revises paragraph (e)(3) of section 201.6 by replacing “his consideration” with the updated reference “consideration.” The Commission revises paragraph (g) of section 201.6 regarding granting confidential status to business information to clarify when business information deemed not entitled to confidential treatment will be treated as public information. The revised paragraph (g) will impose a five-day deadline for withdrawing such business information after which time it would become public.

The Commission amends section 201.8 by revising paragraph (a) to state that filings made within the Commission's official hours of operation will be deemed filed on the date received by the Commission, consistent with the revised paragraph (c) of section 201.3 regarding Commission hours. The Commission also amends section 201.8 by revising paragraph (c), to provide that all documents filed, other than one or two-page documents, must be double-spaced, to improve the readability of documents. In addition, the Commission amends paragraph (d) of section 201.8 to require submitters to specify when a document is being filed with no confidential counterpart.

The Commission amends section 201.13 by revising paragraph (f) to provide, for ease of consideration, that supplementary materials in nonadjudicative hearings must be marked with the name of the organization submitting them. The same paragraph is also revised to remove the page limit on supplementary material that can be filed at a hearing, so that parties may present their arguments without such a limitation. The Commission revises paragraph (i)(1) of section 201.13, to delete the unnecessary reference to the requirement to file 14 copies of briefs with the Secretary, since paragraph (d) of section 201.8 already contains a requirement concerning the requisite number of copies to be filed.

The Commission amends section 201.14 by revising paragraph (a) to simplify filing requirements. In the event of an early or all-day closing of the Commission on a business day, the revision will allow the Secretary to accept filings due the day of the early or all-day closing on the next business day, without requiring the submitter to file a request for an extension of time.

The Commission amends section 201.17 by revising paragraph (a)(1) to permit the filing of requests electronically. Similarly, paragraph (b) of section 201.18 is revised to permit the filing of appeals by such means. The Commission has the capability of accepting electronic filing of requests at its World Wide Web site, at http://www.usitc.gov/foia.htm.

The Commission amends section 201.18 by revising paragraphs (b), (d) (introductory text), and (e) to permit electronic filing of requests under the Freedom of Information Act and to correctly state that paragraph (c), and not paragraphs (a) and (b), provides for extension of time for deciding appeals of denials.

The Commission amends section 201.19 by revising paragraph (b) to clarify that the term “[s]ubmitter” includes contractors, bidders, vendors and others who have an administrative relationship with the Commission, and who provide confidential business information to the Commission. Under the amended provision, persons or entities having an administrative relationship to the Commission will qualify to receive notice before release of their confidential submission under FOIA.

The Commission amends section 201.21 by revising paragraph (a) to provide information about the Commission's World Wide Web site, consistent with the electronic reading room provisions of the FOIA.

The Commission amends section 201.31 by revising the section heading and adding paragraph (c) to include employee conduct as part of the section and to rename the section heading to reflect this change. Consequently, the Commission removes section 201.33, which currently deals with employee conduct, and adds its text to section 201.31. This eliminates the current duplication of section numbers.

The Commission amends section 201.170 by revising paragraph (c) to provide an updated contact point.

The Commission amends subpart H, regarding debt collection, to update all references to “Office of Finance and Budget” to read “Office of Finance.” The Commission also amends subpart H to update citations to applicable statutes and rules, and in particular to take into account the move of the Federal Claims Collection Standards from title 4 of the Code of Federal Regulations to title 31. The revisions affect the authority citation for subpart H; paragraphs (f), (i), and (m) of section 201.201; paragraphs (a) and (b)(4) of section 201.202; paragraphs (a)(16)(ii), (g)(1), (g)(2), (h)(1)(iii), (h)(2)(iii), (h)(3), (h)(4)(ii), (j), and (n) of section 201.204; paragraphs (d), (f)(3), and (g)(1)(iv) of section 201.206; and paragraph (b)(3) of section 201.207.

In section 204.1, the Commission redesignates footnote 5 as footnote 1. In section 204.2, the Commission redesignates footnote 6 as footnote 2. These changes correct a misnumbering of those footnotes. The Commission also revises the authority citation to simplify the citations.

The Commission amends section 206.3 by revising paragraph (b) to include in the notice of institution any limits on page lengths for posthearing briefs.

The Commission amends section 206.8 by revising paragraph (b) to provide that the Secretary shall promptly notify a petitioner of approval of an application for disclosure of confidential business information under administrative protective order (APO), and that the petitioner shall then serve a copy of the confidential petition on those approved applicants within two (2) calendar days of receiving that notification. Under the revised paragraph, which is consistent with section 207.10(b)(1)(i), approved applicants will receive a copy of the confidential petition more quickly, and without having to wait for the Secretary's issuance of the service list.

The Commission amends section 206.17 by revising paragraphs (a)(2), (b)(2), (g)(1) and (g)(3). The Commission revises paragraph (a)(2) to require only a signed APO application and five (5) copies to be filed with the Commission. Filing a signed original and fourteen (14) copies pursuant to section 201.8(d) provides the Commission with unnecessary copies. Paragraph (b)(2) is revised to clarify that confidential business information can only be used in representing an interested party. The Commission revises paragraph (g)(1) to include the definition of nondisclosable confidential business information from section 201.6(a)(2) to make the rule easier to understand. The Commission also revises paragraph (g)(3) to make it consistent with existing section 207.7 (g)(3), the analogous provision in part 207.

The Commission removes section 207.6 regarding reports of progress of investigation as unnecessary as duplicative of the statute. Moreover, amendments to the statute, the Commission's rules, and Commission practice have resulted in information being disseminated as a matter of course about an investigation's schedule and status. The section number is reserved.

The Commission amends section 207.7 by revising paragraph (a)(2) to require only a signed APO application and five (5) copies to be filed with the Commission, consistent with the changes in part 206. The Commission further revises paragraph (a)(2) of section 207.7 for consistency to include a deadline for adding attorneys under the APO in remanded investigations. Paragraph (b)(2) is revised to clarify that business proprietary information can only be used in representing an interested party.

The Commission amends section 207.62 by revising paragraph (b)(2) to delete the reference to “per group,” as unnecessary, since a grouped review only involves one “group.”

The Commission amends section 207.64 by revising paragraph (b), regarding staff reports, to conform with agency practice by providing that the final staff report will be placed in the record.

The Commission revises paragraph (f)(2) of section 210.4 and paragraph (a) of section 210.8 to reduce the number of copies submitters must file of documents to the minimum needed by the agency. Submitters must file an original and 12—rather than 14—copies of each submission if the investigation or related proceeding is before the Commission, except that a submitter shall file the original and 6 copies of any exhibits filed with a request or petition for related proceedings. The Commission previously had effected a partial version of this reduction in the number of required copies by publishing notice of a waiver of its rules at 66 FR 58523 (Nov. 21, 2001).

The Commission amends section 212.29, regarding payment of awards, to update all references to “Finance and Budget Division” to read “Office of Finance.”

In the January 2000 final rule, FDA amended its regulations in § 201.323 (21 CFR 201.323) to enact certain requirements regarding aluminum levels in large volume parenterals (LVPs), SVPs, and PBPs used in TPN. The January 2000 final rule was originally scheduled to become effective on January 26, 2001. In the Federal Register of January 26, 2001 (66 FR 7864), the agency published a document delaying the effective date to January 26, 2003. In the Federal Register of November 26, 2002 (67 FR 70691), the agency published a document further delaying the effective date to January 26, 2004.

Section 201.323(c) of the January 2000 final rule required the product's maximum level of aluminum at expiry to be stated on the immediate container label of SVPs and PBPs used in the preparation of TPN solutions. The January 2000 final rule required that the statement on the immediate container label read as follows: “Contains no more than _ μg/L of aluminum.” For those SVPs and PBPs that are lyophilized powders used in the preparation of TPN solutions, the January 2000 final rule required that the maximum level of aluminum at expiry be printed on the immediate container label as follows: “When reconstituted in accordance with the package insert instructions, the concentration of aluminum will be no more than _ μg/L.” The January 2000 final rule also required that the maximum level of aluminum be stated as the highest of: (1) The highest level for the batches produced during the last 3 years, (2) the highest level for the latest five batches, or (3) the maximum historical level, but only until completion of production of the first five batches after the effective date of the rule.

In the Federal Register of August 12, 2002 (67 FR 52429), FDA proposed to amend § 201.323 to permit the immediate container labels of SVPs and PBPs containing 25 μg/L or less of aluminum to state: “Contains no more than 25 μg/L of aluminum” instead of stating the exact amount of aluminum they contain (the 2002 proposed rule). The proposed amendment was prompted by a request from the Health Industry Manufacturers Association (HIMA, now called AdvaMed). A complete discussion of HIMA's arguments in support of the revision can be found in the 2002 proposed rule.

The agency agreed with HIMA's request for the following reasons. FDA has already determined that 25 μg/L is a safe upper limit for manufacturers to include in LVPs and believes that it is similarly appropriate for SVPs and PBPs. If an SVP or PBP that contains 25 μg/L of aluminum is added to a TPN solution that contains 25 μg/L of aluminum, the concentration of aluminum in the mixture will still be 25 μg/L. Consistent with its approach to LVPs (to which SVPs and PBPs are added) that are permitted to contain 25 μg/L, FDA believes health care practitioners will be provided with sufficient information on the aluminum content of SVPs and PBPs if the label states that the product contains no more than 25 μg/L of aluminum.

In the 2002 proposed rule, the agency also announced its intent to extend the effective date for § 201.323 as necessary to provide time for the proposal to be finalized.

The agency received one comment on the 2002 proposed rule. The comment agreed with the proposal. The comment supported the agency's plan to extend the effective date of § 201.323 until the proposed rule could be finalized. The comment asked that the effective date be extended at least 18 months after January 26, 2003, to give industry sufficient time to comply with § 201.323. The comment also asked FDA to clarify that a delay of the effective date would apply to all products subject to § 201.323.

In response to this comment, the agency is delaying the effective date of § 201.323 until July 26, 2004. This delay applies to all products subject to § 201.323.

The final rule delays the effective date of § 201.323 to July 26, 2004. The final rule also changes § 201.323(c)(3) to reflect the fact that the effective date has been delayed. Section 201.323(c)(3) provides that a manufacturer may state the maximum level of aluminum in terms of historical levels, but only until completion of production of the first five batches after the effective date of the January 2000 final rule. That effective date is the date by which manufacturers are to submit supplements describing the validated assay method used to determine aluminum content. Because manufacturers now have until July 26, 2004, to submit supplements, the final rule changes the date in § 201.323(c)(3) to July 26, 2004. The final rule also slightly modifies the introductory language in § 201.323(c) to clarify that the language “except as provided in paragraph (d) of this section” applies to both the second and third sentences in § 201.323(c). That is, the “exception” language applies generally to SVPs and PBPs used in the preparation of TPN and also to SVPs and PBPs that are lyophilized powders that are reconsituted and used in the preparation of TPN.

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

FDA concludes that this final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

FDA has examined the impacts of this amendment to § 201.323 under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq. ). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive order and in these two statutes.

The purpose of this final rule is to relax the requirements of the January 2000 final rule for labeling aluminum content in SVPs and PBPs used in TPN. Specifically, this final rule allows manufacturers to use a standard statement of quantity of aluminum content in place of the exact amount for affected products that contain no more than 25 μg/L of aluminum. FDA determined that the proposed rule would not be a significant action as defined by the Executive order. FDA received one comment to the proposed rule, but the comment did not address the Analysis of Impacts section of the proposed rule.

In the Analysis of Impacts section of the January 2000 final rule, the agency relied on the Eastern Research Group (ERG) report entitled “Addendum to Compliance Cost Analysis for a Regulation for Parenteral Drug Products Containing Aluminum.” In that report, ERG calculated the total relabeling costs for SVPs and PBPs to be about $523,000, or about $3,500 per product (equivalent to annualized costs totaling $128,000, or about $850 per product, discounted at 7 percent over 5 years). To the extent that manufacturers of SVPs and PBPs containing no more than 25 μg/L of aluminum use the added flexibility in labeling that this final rule provides, the compliance burden cited above could be reduced.

The single comment to the proposed rule requested that an additional 18 months be added to the effective date of § 201.323. FDA has complied with this request. Since this additional time would allow for more flexibility in implementing the compliance methods for all parts of § 201.323, it could further reduce the compliance burden.

Because this final rule could slightly decrease current compliance costs for the affected industry without imposing any additional costs, FDA has determined that the final rule is not a significant regulatory action as defined by the Executive order and thus is not subject to review under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. FDA made the determination for the January 2000 final rule that very few small firms, if any, would be significantly impacted. Thus, the agency certified that the final rule would not have a significant impact on a substantial number of small entities. This final rule could slightly lessen the economic impact of the January 2000 final rule. Accordingly, FDA certifies that this final rule will not have a significant economic impact on a substantial number of small entities. No further analysis is required under the Regulatory Flexibility Act (as amended).

Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires that agencies prepare a written statement of anticipated costs and benefits before finalizing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year (adjusted annually for inflation).

The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for the final rule because the rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation-adjusted statutory threshold is $110 million.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

In the Federal Register of March 4, 1988 (53 FR 7076), FDA issued a final monograph for OTC ophthalmic drug products in part 349 (21 CFR part 349). Section 349.12 of that monograph included the active ingredient hydroxypropyl methylcellulose. In 2000, the USP proposed (for inclusion in the Third Supplement to USP 24) a name change for this ingredient based on a name adopted by the United States Adopted Names Council (Ref. 1). The new name for hydroxypropyl methylcellulose is hypromellose. This name change became official on March 1, 2001, and was subsequently included in the USP with an effective date of September 1, 2002 (Ref. 2).

The Federal Food, Drug, and Cosmetic Act (the act) in section 502(e)(1)(A)(i) (21 U.S.C. 352(e)(1)(A)(i)) requires the label of a drug to bear the established name of the drug to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula). The established name of the drug is defined as:

Section 508 of the act (21 U.S.C. 358) authorizes FDA to designate an official name for any drug if FDA determines “that such action is necessary or desirable in the interest of usefulness and simplicity.” FDA does not, however, routinely designate official names for drug products under section 508 of the act (§ 299.4(e) (21 CFR 299.4(e))). In the absence of designation by FDA of an official name, interested persons may rely on the current compendial name as the established name (§ 299.4(e)).

FDA has not designated an official name for the active ingredient hydroxypropyl methylcellulose. Thus, its established name is the current compendial name. The USP has now changed the compendial name for hydroxypropyl methylcellulose to hypromellose. To be consistent with the change in this official compendial name, the agency is changing this name in § 349.12 in the ingredient listing. As noted previously, this USP name change became official on March 1, 2001, with a USP effective date of September 1, 2002.

Because section 502(e)(1) and (e)(3) of the act requires the established name of a drug to be used, any ophthalmic drug product initially introduced or initially delivered for introduction into interstate commerce after September 1, 2002, would need to bear the new established name “hypromellose.” However, the agency is aware that many manufacturers of OTC ophthalmic drug products have not yet implemented this name change in their product labeling. Therefore, elsewhere in this issue of the Federal Register , as a matter of its enforcement discretion, the agency is issuing guidance stating its intent to provide manufacturers of affected OTC ophthalmic drug products until September 1, 2003 (1 extra year from the USP effective date), to implement this labeling change. Accordingly, on or after September 1, 2003, any OTC ophthalmic drug product initially introduced or initially delivered for introduction into interstate commerce that contains the ingredient hypromellose (formerly known as hydroxypropyl methylcellulose) must bear labeling that contains the new name for this ingredient.

To the extent that 5 U.S.C. 553 applies to this action, it is exempt from notice and comment because it constitutes a rule of agency procedure under 5 U.S.C. 553(b)(3)(A). Alternatively, the agency's implementation of this action without opportunity for public comment comes within the good cause exceptions in 5 U.S.C. 553(b)(3)(B) in that obtaining public comment is impracticable, unnecessary, and contrary to public interest. This labeling revision represents a minor clarifying change that does not change the substance of the labeling requirements contained in the final regulations. As discussed previously in this document, manufacturers must relabel their products as a result of the USP name change to remain in compliance with the act. This amendment updates the name of one active ingredient in the final monograph for OTC ophthalmic drug products to reflect this official name change that has already been implemented by the USP. In accordance with 21 CFR 10.40(e)(1), FDA is providing an opportunity for comment on whether the regulation should be modified or revoked.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant economic impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. Section 202(a) of the UMRA requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation).

The agency concludes that this final rule is consistent with the principles set out in Executive Order 12866 and in these two statutes. FDA has determined that the final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.

The UMRA does not require FDA to prepare a statement of costs and benefits for this final rule, because the final rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation adjusted statutory threshold is about $110 million.

The purpose of this final rule is to update the final monograph for OTC ophthalmic drug products to incorporate a USP name change for one active ingredient included in the monograph. As discussed in section II of this document, section 502(e)(1) and (e)(3) of the act requires that the established name of a drug be used. Under § 299.4(e), because FDA does not routinely designate official names under section 508 of the act, the established name under section 502(e) of the act ordinarily is the compendial name of the drug. Therefore, because FDA has not designated an official name under section 508 of the act, manufacturers must relabel their products as a result of the USP name change to remain in compliance with the act. Updating the name of the active ingredient in the ophthalmic monograph to reflect its current established name will eliminate possible confusion by the public. Because manufacturers must relabel their products as a result of the USP name change to remain in compliance with the act, this rule does not impose any additional costs on industry. Consequently, the agency certifies that this final rule will not have a significant economic impact on a substantial number of small entities. Therefore, no further analysis is required.

The agency concludes that the labeling requirements in this document are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq .). Rather, the labeling statements are a “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).

The agency has determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

Interested persons may submit to the Dockets Management Branch (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or three paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document and may be accompanied by a supporting memorandum or brief. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

The following references have been placed on display in the Dockets Management Branch (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

The act (21 U.S.C. 301 et seq .), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-629), the Food and Drug Administration Modernization Act (FDAMA) (Public Law 105-115), and the Medical Device User Fee and Modernization Act (MDUFMA) (Public Law 107-250) established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under the 1976 amendments, class II devices were defined as those devices for which there is insufficient information to show that general controls themselves will assure safety and effectiveness, but for which there is sufficient information to establish performance standards to provide such assurance.

SMDA broadened the definition of class II devices to mean those devices for which the general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and any other appropriate actions the agency deems necessary (section 513(a)(1)(B) of the act).

The 1976 amendments also broadened the definition of “device” in 201(h) of the act (21 U.S.C. 321(h)) to include certain articles that were once regulated as drugs. Under the 1976 amendments, Congress classified into class III all transitional devices, i.e., those devices previously regulated as new drugs, including surgical sutures.

In the Federal Register of December 16, 1977 (42 FR 63472), FDA published a notice that identified sutures as class III devices under the transitional provisions of the act. Section 520(l)(2) of the act (21 U.S.C. 360j(l)(2)) provides that the manufacturer or importer of a device classified in class III under the transitional provisions may file a petition for reclassification of the device into class I or class II. Procedures for filing and review of classification petitions are set forth in § 860.136 (21 CFR 860.136).

In accordance with section 520(l)(2) of the act and § 860.136, and after consulting with members of the General and Plastic Surgery Devices Panel, FDA reclassified surgical suture devices from class III to class II as follows:

1. Absorbable poly(glycolide/L-lactide) surgical suture (21 CFR 878.4493), reclassification order (letter) dated September 14, 1989;

2. Stainless steel suture (21 CFR 878.4495), reclassification order (letter) dated July 30, 1986;

3. Absorbable surgical gut suture (21 CFR 878.4830), reclassification order (letter) dated September 19, 1988;

4. Nonabsorbable poly(ethylene terephthalate) surgical suture (21 CFR 878.5000), reclassification order (letter) dated July 5, 1990;

5. Nonabsorbable polypropylene surgical suture (21 CFR 878.5010), reclassification order (letter) dated July 5, 1990;

6. Nonabsorbable polyamide surgical suture (21 CFR 878.5020), reclassification order (letter) dated February 15, 1990;

7. Natural nonabsorbable silk surgical suture (21 CFR 878.5030), reclassification order (letter) dated November 9, 1990; and

8. Nonabsorbable expanded polytetrafluoroethylene surgical suture (21 CFR 878.5035), reclassification order (letter) dated September 9, 1999.

In the Federal Register of December 19, 2002 (67 FR 77678), FDA published a proposed rule to designate a special control for eight surgical suture devices already classified into class II. FDA proposed that surgical suture devices would remain in class II, but would be subject to a special control. The proposed rule identified the special control as an FDA guidance document entitled “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” In the same edition of the Federal Register , FDA announced the availability of the draft guidance that, when final, was intended to serve as a special control (67 FR 77797). FDA invited interested persons to comment on the proposed rule and on the proposed special control guidance document by March 19, 2003.

FDA received no comments on the proposed rule or on the guidance document proposed as the special control. Therefore, under the SMDA authority, FDA is amending the classification regulations for eight surgical suture devices previously reclassified into class II, to designate a special control for those devices. The special control capable of providing reasonable assurance of safety and effectiveness for these devices is a guidance document entitled “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA” that identifies performance, testing, and labeling recommendations for the devices. Elsewhere in this issue of the Federal Register , FDA is announcing the availability of the special control guidance.

Following the effective date of this final rule, any firm submitting a 510(k) premarket notification for a new surgical suture will need to address the recommendations in the special control guidance. However, the firm need only show that its device is as safe and effective as a device that meets guidance recommendations. The firm may use alternative approaches if those approaches address the performance, testing, and labeling issues identified in the guidance.

The agency has determined under 21 CFR 25.34(b) that this final rule is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impact of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, the rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The special controls guidance document does not impose any new burdens on manufacturers of these devices. FDA has granted 201 substantial equivalence orders from 95 manufacturers of these devices in the last 10 years. The guidance document is based upon the review of the information submitted in these premarket notifications. Based on the review of the premarket notifications, FDA believes that manufacturers presently marketing these devices are in conformance with the guidance document and they will not need to take any further action. The guidance document merely assures that, in the future, devices of these generic types will be at least as safe and effective as the presently marketed devices. These devices are already subject to premarket notification and labeling requirements. The guidance document advises manufacturers on appropriate means of complying with these requirements.

The consensus standards in the guidance were recognized under section 514(c) of the act (21 U.S.C. 360d(c)) for the purpose of demonstrating certain aspects of substantial equivalency. The manufacturer may provide a declaration of conformity to a recognized standard to meet a premarket notification requirement. Ordinarily, this will provide a simplified method of meeting the requirement. The manufacturer may choose to submit other data or information to meet the requirement. The guidance document sets out options that the manufacturer has in this respect.

For the foregoing reasons, the agency certifies that this rule will not have a significant economic impact on a substantial number of small entities. In addition, this rule will not impose costs of $100 million or more on either the private sector or State, local, and tribal governments in the aggregate, and therefore a summary statement or analysis under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

The Court Services and Offender Supervision Agency for the District of Columbia (“CSOSA” or “Agency”) is adopting regulations (28 CFR part 802) on the disclosure of records maintained by CSOSA or the District of Columbia Pretrial Services Agency (“PSA” or “Agency”). CSOSA published a proposed rule on this subject in the Federal Register on March 15, 2002 (67 FR 11804). As noted in the proposed rule, PSA is an independent entity within CSOSA.

Subpart A of the proposed regulations provides a general introduction. Subpart B covers procedures for Freedom of Information Act (FOIA) requests; subpart C covers procedures for Privacy Act requests; subpart D covers disclosures in response to subpoenas or other legal demands; and subpart E covers exemptions to CSOSA and PSA Privacy Act systems of records.

The general guidelines for disclosure (§ 802.3) under the FOIA note that a record must be in the possession and control of the agency at the time of the request to be considered subject to release under the regulations. There is no obligation to create, compile, or obtain a record to satisfy a FOIA request. Hard copy of electronic records which are subject to FOIA, but which are available to the public through an established distribution system, the Federal Register , or the Internet at CSOSA's Web site ( http://www.csosa.gov ), normally do not need to be processed under the FOIA. CSOSA will process such requests under the FOIA only if the requester insists on such processing.

Definitions for certain terms used in the subpart are contained in § 802.4. The procedures for submitting and processing FOIA requests are contained in § 802.5. Section 802.6 explains how CSOSA handles requests for documents which relate to or were created by another agency.

Section 802.7 covers the denial of a request. This section also explains how the requester may appeal the denial. Section 802.8 explains how to request expedited processing. Section 802.9 covers procedures for the disclosure of business information which may have been provided to the Agency. The business submitter (any entity which provided the business information to the Agency and which has a proprietary interest in the information) will receive notice of the FOIA request and have an opportunity to object to disclosure. Section 802.10 contains the fee schedule for FOIA requests.

The regulations in subpart C are intended to let you know how you can determine whether CSOSA or PSA maintains records about you, how you can obtain access to your records, and how to have your records corrected or amended.

Definitions for certain terms used in the subpart are contained in § 802.12. Section 802.13 explains how to verify your identity when making a request for your own records and how to document that you have consent when you make a request for information concerning another individual. The procedures for submitting and processing requests for access to records are contained in § 802.14 and have been reorganized and amended to better address the technical requirements for accessing and reviewing records. Section 802.15, which covers the denial of a request, and § 802.16, which explains how the requester may appeal the denial, have similarly been adjusted (for example, appeals based upon an adverse determination of the requester's category or for fee waiver apply to FOIA only and have accordingly been removed from the final rule). Section 802.17 explains how CSOSA or PSA handle requests for documents which relate to or were created by another agency.

Section 802.18 explains how you may request to correct or amend a record about you which the Agency maintains. Section 802.19 contains procedures for appealing a denial to correct or amend your record. Section 802.19 now specifies that the system manager is responsible for granting or denying requests for corrections of records.

Section 802.20 contains the procedures for accounting for disclosures, and § 802.21 notes your appeal rights for a denial of a request for an accounting. Section 802.20 has been amended to clarify that disclosures made under the FOIA are exempt from accounting and that no accounting will be provided to the record subject for disclosures made to law enforcement agencies. Fees for Privacy Act requests are described in § 802.22 and have been reworded slightly for the sake of clarity. Section 802.23 explains the Agency's policy on the use and disclosure of social security numbers.

Subpart D contains procedures for the production of records in response to subpoenas or demands of courts or other authorities in connection with a proceeding to which the Agency is not a party. These regulations establish a systematic means by which the Agency can evaluate requests for production of official agency information. The regulations are intended to: (1) Conserve Agency employee's time for conducting official business, (2) minimize the possibility of involving the Agency in controversial issues that are not related to the mission of the Agency, (3) prevent the possibility that the public will misconstrue variances between personal opinions of Agency employees and Agency policy, (4) avoid spending the government's time and money for private purposes, (5) preserve the integrity of the administrative process, and (6) protect confidential, sensitive information and the deliberative process of the Agency. In adopting these provisions as final, CSOSA is clarifying the provisions in § 802.27(d) to refer to these reasons when considering factors pertinent to whether a demand should be complied with.

The Privacy Act permits specific systems of records to be exempt from some of its requirements. Subpart E identifies these exemptions and explains the basis for making the exemptions. CSOSA exemptions are contained in § 802.28; PSA exemptions are contained in § 802.29. The CSOSA exemption for Employment Profile, previously identified as CSOSA-14, has been removed as that system of record is no longer in use. The full text of CSOSA and PSA systems of records appeared in a separate notice document in the March 15, 2002 Federal Register (67 FR 11816).

CSOSA did not receive any comments on the proposed rule. CSOSA accordingly is adopting the proposed provisions as a final rule without further change other than the technical amendments to the Privacy Act procedures and the clarification to § 802.27(d) noted above.

In accordance with the Administrative Procedure Act, CSOSA published a proposed rule on this subject in the Federal Register . This final rule will become effective as noted above.

This proposed rule has been determined to be significant under Executive Order 12866 and has been reviewed by the Office of Management and Budget (OMB).

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. Therefore, in accordance with Executive Order 13132, the Director of CSOSA has determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

The Director of CSOSA, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this rule and by approving it certifies that this rule will not have a significant economic impact upon a substantial number of small entities. This rule pertains to agency management, and its economic impact is limited to the agency's appropriated funds.

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 it will not significantly or uniquely affect small governments. Therefore, the Director of CSOSA has determined that no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by sec. 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.

If you have suggestions on how to improve the clarity of these regulations, write, e-mail, or call the Records Manager (Roy Nanovic) at the address or telephone number given above in the Addresses and For Further Information Contact captions.

On May 28, 2003, the Coast Guard published a final rule (68 FR 31609) establishing safety zones, in 33 CFR 165.1314, to provide for the safety of vessels in the vicinity of fireworks displays one of which is the Fort Vancouver fireworks display. The safety zone will include all waters of the Columbia River at Vancouver, Washington bounded by a line commencing at the northern base of the Interstate 5 highway bridge at latitude 45°37″16.5 seconds N, longitude 122°40″22.5′ W; thence south along the Interstate 5 highway bridge to Hayden Island, Oregon at latitude 45°36″51.5′ N, longitude 122°40″39′ W; thence east along Hayden Island to latitude 45°36″36′ N, longitude 122°39″48′ W (not to include Hayden Bay); thence north across the river thru the preferred channel buoy, RG Fl(2+1)R 6s, to the Washington shoreline at latitude 45°37′1.5′ N, longitude 122°39″29′ W; thence west along the Washington shoreline to the point of origin. Entry into this zone is prohibited unless authorized by the Captain of the Port or his designee. The Captain of the Port Portland will enforce this safety zone on July 4, 2003, from 9:30 p.m. (P.d.t.) until 11 p.m. (P.d.t.). The Captain of the Port may be assisted by other Federal, State, or local agencies in enforcing this security zone.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and (d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and for making this regulation effective less than 30 days after publication in the Federal Register . Based upon the warnings from national security and intelligence personnel, this rule is urgently required to protect the plant from subversive activity, sabotage or possible terrorist attacks initiated from the waters surrounding the plants.

Delaying the effective date of the rule would be contrary to the public interest, since immediate action is needed to protect the persons at the facilities, the public and surrounding communities from the release of nuclear radiation. This security zone should have minimal impact on vessel transits due to the fact that the security zone does not block the channel.

Due to the continued warnings from national security and intelligence officials that future terrorist attacks are possible, such as those launched against New York and Washington, DC on September 11, 2001, heightened security measures are necessary for the area surrounding the Salem and Hope Creek Generation Stations. This rule will provide the Captain of the Port Philadelphia with enforcement options to deal with potential threats to the security of the plants. The Coast Guard intends to implement a permanent security zone surrounding the plants. The Coast Guard will be publishing a NPRM to establish a permanent security zone that is temporarily effective under this rule. The Coast Guard will use the effective period of this Temporary Final Rule to engage in notice and comment rulemaking to develop a permanent regulation tailored to the present and foreseeable security environment within the Captain of the Port, Philadelphia, Pennsylvania zone.

No person or vessel may enter or remain in the prescribed security zone at any time without the permission of the Captain of the Port, Philadelphia, PA or designated representative. Federal, State, and local agencies may assist the Coast Guard in the enforcement of this rule.

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 Homeland Security (DHS).

The primary impact of this rule will be on vessels wishing to transit the affected waterway. Although this rule restricts traffic from freely transiting portions of the Delaware River, that restriction affects only a limited area and will be well publicized to allow mariners to make alternative plans.

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

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

This rule may affect the following entities, some of which may be small entities: Owners or operators of fishing vessels and recreational vessels wishing to transit the portions of the Delaware River.

The rule will not have a significant impact on a substantial number of small entities for the following reasons: the restrictions affect only a limited area and traffic will be allowed to transit through the zone with permission of the Coast Guard or designated representative. The opportunity to engage in recreational and charter fishing outside the geographical limits of the security zone will not be disrupted. Therefore, this regulation should have a negligible impact on recreational and charter fishing activity.

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

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

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

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

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

This rule will not affect 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 Security Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to security that may disproportionately affect children.

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

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

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(f) and (g), of Commandant Instruction M16475.lD, from further environmental documentation.

A final “Environmental Analysis Checklist” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES.

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. A final rule, which established safety zones around fireworks displays for the Captain of the Port Portland area of responsibility, was recently published in the Federal Register (CGD13-03-008, 33 CFR 165.1315, 68 FR XXXX, May 30, 2003). An amendment cannot be successfully be made to 33 CFR 165.1315 in time to ensure the safety of vessels and spectators gathering in the vicinity of these fireworks display. The Coast Guard intends to amend 33 CFR 165.1315 using normal rule-making procedures in the near future by adding these safety zone to that regulation.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Waiting 30 days for this rule to be effective is contrary to public interest. Due to the complex planning and coordination of the event, the event sponsor was unable to provide the Coast Guard with notice of details of the event in time to allow for notice and comment and a 30-day waiting period prior to the effective date after publication. Because immediate action is necessary to ensure the safety of vessels and spectators gathered in the vicinity of the fireworks launching barges it is in the public interest to make the rule effective less than 30 days after publication in the Federal Register .

The Coast Guard is establishing temporary safety zone regulations to allow for safe fireworks displays. These safety zones will be in effect from 9:15 p.m. (P.d.t.) to 10 p.m. (P.d.t.) on the Willamette River and from 9:30 p.m. (P.d.t.) to 10:30 p.m. (P.d.t.) on the Siuslaw River. These events will result in a large number of vessels congregating near the fireworks launching area. These safety zones are needed to provide for the safety of spectators and their watercraft from the inherent safety hazards associated with fireworks displays. Without providing an adequate safety zone, the public could be exposed to falling burning debris and would likely be within the blast range should a catastrophic accident occur on the launching barge. These safety zones will be enforced by representatives of the Captain of the Port, Portland, Oregon. The Captain of the Port may be assisted by other federal and local agencies.

This rule, for safety concerns, will control vessel movements in a regulated area surrounding a fireworks launching barge. Entry into this zone would be prohibited unless authorized by the Captain of the Port, Portland or his designated representative. Coast Guard personnel would enforce this safety zone. The Captain of the Port may be assisted by other federal and local agencies.

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 Homeland Security (DHS). We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This expectation is based on the fact that the regulated area established by the proposed regulation will encompass less than one-half of a mile of the Willamette and Siuslaw Rivers for 75 minutes in the late evening when vessel traffic is low.

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 or operators of vessels intending to transit a portion of the Willamette and Siuslaw Rivers between 9:15 p.m. (P.d.t.) and 10:30 p.m. (P.d.t.) on July 4, 2003. These safety zones will not have significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for 75 minutes at night when vessel traffic is low. Traffic will be allowed to pass through the zone with the permission of the Captain of the Port or his designated representatives on scene, if it is deemed safe to do so. Because the impacts of this rule are expected to be so minimal, the Coast Guard certifies under 5 U.S.C. 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601-612) that this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want 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 will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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).

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Instruction, from further environmental documentation.

On December 6, 2001 and November 6, 2002, the State of Maryland submitted formal revisions to its State Implementation Plan (SIP). The SIP revisions, submitted by the Maryland Department of the Environment (MDE), consist of amended volatile organic compound requirements to specific processes Code of Maryland Administrative Regulations (COMAR) 26.11.19. The December 6, 2001 revision (#01-15) was published in the Maryland Register on September 21, 2001, a public hearing was held on October 23, 2001, adopted on November 6, 2001 and became effective on December 10, 2001. The November 6, 2002 revision (#02-07) was published in the Maryland Register on August 9, 2002, a public hearing was held on September 11, 2002, adopted on October 3, 2002 and became effective on November 11, 2002.

(A) On December 6, 2001, MDE submitted amendments to COMAR 26.11.19.30. The existing regulation establishes reasonably available control technology (RACT) for chemical plants that produce organic chemicals. The revised regulation is being expanded to include VOC requirements for chemical production facilities and PTFE products facilities.

(1) The revisions to COMAR 26.11.19.30B add the following definitions: (a) Dipping trough, (b) inorganic chemical production installation, (c) PTFE, (d) PTFE installation, and (e) product condenser.

(2) COMAR 26.11.19.30C, which addresses applicability, is revised to include inorganic chemical production installations and PTFE installations.

(3) COMAR 26.11.19.30D is revised to address general requirements for both organic and inorganic chemical production facilities. In addition, the date to implement good operating practice and procedures is revised from March 30, 2001 to March 30, 2002.

(4) COMAR 26.11.19.30E is revised to create general requirements for PTFE installations. These requirements are as follows: (a) A person who owns or operates a PTFE installation that has uncontrolled VOC emissions of 50 pounds or more per day shall vent the emissions into a thermal oxidizer or use other approved methods to destroy or reduce VOC emissions by 85 percent or more. (b) If a thermal oxidizer is installed, the oxidizer combustion chamber shall be operated at a specified minimum temperature that is demonstrated to achieve compliance with the regulation. In addition, the thermal oxidizer combustion chamber should be equipped with a continuous temperature monitor, an alarm system for safety, and with an interlock system. (c) If a source uses an approved alternative control method, it shall be monitored. (d) Emission treatment or monitoring equipment shall be operated, maintained and calibrated in accordance with the equipment vendor's specifications. (e) A person who owns or operates a PTFE compounding and tape or shape-forming installation shall minimize fugitive VOC emissions by enclosing all wet PTFE and covering dipping troughs when not in operation.

(B) On November 6, 2002, MDE submitted amendments to COMAR 26.11.19.30. These amendments include (a) Minor modification to the definition of PTFE, (b) Deletion of the definition of PTFE installation, and (c) The addition of definitions for PTFE coating installation, PTFE process installation and total actual uncontrolled VOC emissions. In addition, these amendments clarify applicability requirements for PTFE coating and process installations found at COMAR 26.11.19.30C. COMAR 26.11.19.30E is modified to address general requirements for PTFE process installations and to add requirements for PTFE coating installation. The new PTFE coating installation requirement states that an installation that has actual uncontrolled VOC emissions of 20 pounds or more per day may not use a coating that has a VOC content exceeding 2.9 pounds per gallon unless it is equipped with a control device that meets specified requirements. These new requirements comport with EPA standards for coating operations.

EPA is approving SIP revisions submitted by MDE on December 6, 2001 and November 6, 2002. The amendments establish specific VOC requirements for the production facilities that produce organic, inorganic chemicals and PTFE products. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on August 4, 2003, without further notice unless EPA receives adverse comment by July 3, 2003. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note ) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 4, 2003. 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 pertains to Maryland's amendments to VOC requirements from chemical production and PTFE installations and may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

On April 29, 1996 and September 21, 2000, West Virginia submitted revisions to a regulation (45CSR10) to prevent and control air pollution from the emission of sulfur oxides as formal revisions to its State Implementation Plan (SIP). The first SIP revision went to public hearing on July 6, 1993 and became effective on April 26, 1994. This SIP revision proposes approval of a temporary sulfur dioxide emissions control and mitigation plan which would be used during periods when maintenance of coke oven desulfurization equipment is being carried out. The second SIP revision went to public hearing on July 19, 1999 and became effective on August 31, 2000. This SIP revision includes additional and revised definitions; new provisions for the establishment of alternative individual stack sulfur dioxide limits; a manufacturing process compliance test averaging time change; additions and revisions to compliance testing, monitoring, and recordkeeping provisions; exemptions from compliance determination requirements for gas, oil, and wood-fired fuel burning units; deletion of outdated compliance schedule provisions; and the addition of a circumvention section. Since the most recent of the SIP revisions incorporates all of the changes from the earlier SIP revisions, EPA will incorporate by reference the version of 45CSR10 submitted to EPA on September 21, 2000 into the SIP.

(A) The following definitions were added: “Continuous Emission Monitoring System,” “Distillate Oil,” “Indirect Heat Exchanger,” “Malfunction,” “Natural Gas,” “Potential to Emit,” and “Process Heater.” The following definition was deleted: “Division of Environmental Protection.” The following definitions were revised: “Director;” and “Person.”

(B) The SIP revision provides that no person may permit the combustion of any refinery process gas stream or any other process gas stream that contains hydrogen sulfide in a concentration greater than 50 grains per 100 cubic feet except in the case of a person operating in compliance with an emission control and mitigation plan approved by the Director and EPA. The SIP revision also establishes the conditions for approval for such a plan.

(C) The SIP revision adds provisions allowing the operator of a source subject to sulfur dioxide weight emission standards for fuel burning units which have more than one stack to petition the Director for individual stack allowable emission rates different from those calculated under subdivision 3.4.a of the regulation. These alternative stack emissions cannot be used where stack emission changes are a result of a physical change or a change in method of operation that would otherwise require pre-construction permitting. The West Virginia Department of Environmental Protection (WVDEP) submitted a letter to EPA on March 19, 2003, clarifying that 45CSR10 requires that alternative standards be embodied in a federally enforceable permit issued under the authority of 45CSR13. The letter also states that prior to issuing the permit, WVDEP will submit the permit establishing alternative emission limitations to EPA for review and approval. The letter further clarifies that a petition for alternative emission limitations in no way supercedes any provisions regarding pre-construction review (45CSR14) or new or modified sources (45CSR19). This letter has been included in the administrative record for the rulemaking action on this SIP revision.

A revision to compliance requirements for fuel burning units clarifies that a continuous twenty-four (24) hour period is defined as one (1) calendar day.

(D) An exemption is provided for the owner or operator of a manufacturing process source operation which has the potential to emit less than 500 pounds per year of sulfur oxides from the provisions of the emission standards for manufacturing source operations. The SIP revision also revises the compliance determination for the allowable sulfur dioxide concentration limitations from manufacturing process source operations to be based on a block three (3) hour averaging time rather than the previous averaging time of two (2) hours.

(E) A provision has been added requiring that compliance with the allowable hydrogen sulfide concentration limitations for combustion sources be based on a block three (3) hour averaging time.

(F) Specific permit time filing and review requirements have been deleted and revisions include references to the permit requirements of 45CSR13, 14, 19, and 20.

(G) Testing provisions have been revised to define the requirements applicable to any fuel burning unit(s), manufacturing process source(s) or combustion source(s) and requires those sources to comply with the emission limitations for such sources (subsections 3, 4, or 5). The provisions also require that testing be conducted in accordance with the appropriate test method set forth in 40 CFR part 60, appendix A, Method 6, Method 15, or another equivalent EPA testing method approved by the Director. The Director or his duly authorized representative, may conduct other tests deemed necessary to evaluate air pollution emissions other than sulfur dioxide. As noted previously, WVDEP submitted a letter, which is part of the administrative record for this rulemaking action, to EPA on March 19, 2003, clarifying the interpretation and implementation of certain regulations on air pollution control. In that letter, WVDEP clarified that these tests are for pollutants in addition to sulfur dioxide.

The SIP revision allows the owner or operator of fuel burning unit(s), manufacturing process source(s) or combustion source(s) to demonstrate compliance with the requirements for such sources (sections 3, 4 and 5) by testing and/or monitoring in accordance with one or more of the following: 40 CFR part 60, appendix A, Method 6, Method 15, continuous emissions monitoring systems (CEMS) or fuel sampling and analysis as set forth in an approved monitoring plan for each emission unit. In their letter dated March 19, 2003, WVDEP clarified that fuel sampling and analysis are required to be conducted in accordance with any applicable method or procedure formally established by EPA or otherwise in accordance with methods established by the American Society for Testing and Materials (ASTM).

(H) This SIP revision provides for excursions of operating parameters in an approved monitoring plan which are not necessarily violations. In their letter dated March 19, 2003, WVDEP clarified that WVDEP enforcement staff evaluate excursions where parametric monitoring is an element of or the primary component of a monitoring plan, on a case-specific basis. In some instances, deviations in an operating parameter would very strongly indicate a probable violation of sulfur dioxide limits or of 45CSR10-3, 4, or 5. The letter also affirms that in a situation involving a likely emission exceedance, the burden of proof would be placed on the source to demonstrate that the parametric excursion did not cause an exceedance of the sulfur dioxide limit. West Virginia has clarified that in such an instance, emissions testing under conditions identical to or very similar to the excursion situation and subsequent analysis would be required to conclude whether a violation actually occurred. It should also be noted that larger sources of sulfur dioxide are now required to use CEMs or ASTM-based fuel monitoring and analysis or periodic emissions tests (EPA Method 6), as the primary compliance determination method.

(I) A section has been added to the SIP for recordkeeping and reporting, requiring the owners or operators of fuel burning unit(s), manufacturing process source(s) or combustion source(s) subject to the regulation requirements for those sources to maintain on-site records of all required monitoring data, pursuant to monitoring plans established in the monitoring provisions of this regulation (subsection 8.2c). These records are required to be available to the Director or his duly authorized representative and are to be retained on-site for a minimum of five years. Periodic exception reports are due to the Director, and are required to detail any excursions outside the range of measured emissions or monitored parameters established in the source's approved monitoring plan. In addition, operators of fuel burning unit(s) or combustion(s) source(s) are required to maintain records of the operating schedule and the quantity and quality of fuel consumed in each unit. Fuel burning sources utilizing CEMs are exempt from this requirement.

(J) An exemption has been revised for any fuel burning unit having a design heat input under 10 million BTUs per hour to include an exemption from the registration, permitting, testing, monitoring, recordkeeping and reporting requirements for such sources (sections 6-8), as well as from the sulfur dioxide emission standards for fuel burning units (section 3). An exemption has been added for fuel burning unit(s) which combust natural gas, wood, or distillate oil, alone or in combination, exempting these units from the testing, monitoring, recordkeeping and reporting requirements for fuel burning units, manufacturing process sources or combustion sources (section 8).

(K) A section entitled, “Circumvention” has been added to this regulation which prohibits any owner or operator subject to the provisions of this regulation to build, erect, install, modify or use any article, machine, equipment or process which purposely conceals an emission which would constitute a violation of an applicable standard.

(L) A section entitled, “Inconsistency Between Rules” has been added to this regulation which provides that any inconsistencies between 45CSR10 and any other WVDEP regulation be resolved by the application of the more stringent requirement.

Additional details pertaining to these revisions are included in the Technical Support Document for this rulemaking.

These revisions strengthen the SIP by clarifying and updating definitions, and revising and streamlining monitoring, recordkeeping and reporting requirements for sulfur dioxide fuel burning units, manufacturing process source operations, and combustion sources. The revision also adds requirements for the registration of alternative emission limits for multiple stacks at a single source.

EPA is approving the revisions to 45CSR10, “To Prevent and Control Air Pollution from the Emission of Sulphur Oxides,” submitted by West Virginia on April 29, 1996, and September 21, 2000. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on August 4, 2003, without further notice unless EPA receives adverse comment by July 3, 2003. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 4, 2003. 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, to prevent and control air pollution from the emission of sulfur oxides in West Virginia, may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

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

Table 1 lists the rules we are approving with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board (CARB).

On August 6, 2002 and December 30, 2002, respectively, these rule submittals were found to meet the completeness criteria in 40 CFR part 51 appendix V, which must be met before formal EPA review.

There are no previous versions of SJVUAPCD Rule 4692 in the SIP. We approved a version of SCAQMD Rule 1171 into the SIP on August 13, 1999 (64 FR 44134). The SCAQMD adopted revisions to the SIP-approved version on October 8, 1999 and CARB submitted them to us on January 21, 2000. While we can act on only the most recently submitted version, we have reviewed materials provided with previous submittals.

The purposes of new Rule 4692 are as follows:

• To reduce emissions of VOCs and PM-10 from chain-driven commercial charbroilers. The charbroiler must be equipped with a catalytic oxidizer control device on the exhaust gases, or a unit certified by the SCAQMD must be used, or another control device may be used if it is as effective as a catalytic oxidizer. The purposes of the changes to SCAQMD 1171 are as follows:

• Paragraph (c)(1)(D)(vi) on UV ink application is changed to include the similar EB ink application.

• Paragraph (c)(1) advances the requirement for lower VOC content from July 1, 2005 forward to January 1, 2003. The cleaning operations affected include (A) product cleaning and surface preparation—general, (B) repair and maintenance cleaning—general, (C) cleaning of ink application equipment—general, flexographic printing, packaging, and removable press components, and (D) cleaning of polyester resin application equipment.

• Paragraph (e)(4) prohibits the use in automotive maintenance and repair of (A) perchloroethylene, (B) methylene chloride, or (C) trichloroethylene solvents.

• Paragraphs (h)(3) and (h)(5) have deleted obsolete exemptions for cleaning of plastics and handwipe cleaning of equipment.

• Paragraph (h)(7) clarifies that the 25 grams/liter limit for general cleaning of ink application equipment shall not take place until July 1, 2005.

• The allowance for a person to apply for a Clean Air Solvent Certificate is deleted.

• Obsolete paragraphs describing future limitations on solvent concentration are deleted.

The TSD has more information about these rules.

Generally, SIP rules must be enforceable (see section 110(a) of the CAA), must require Reasonably Available Control Technology (RACT) for major sources in nonattainment areas (see section 182(a)(2)(A)), and must not relax existing requirements (see sections 110(l) and 193). The SJVUAPCD is a severe ozone nonattainment area and a serious PM-10 nonattainment area (see 40 CFR part 81). There are no major sources of VOC in the chain-driven commercial charbroiling source category in SJVUAPCD, and therefore the rule does not need to fulfill RACT for VOC. Section 189(b) of the CAA requires serious PM-10 nonattainment areas with major sources or significant source categories of PM-10 to adopt best available control measures (BACM), including best available control technology (BACT). BACM is not required for source categories that are not significant ( de minimis ) and there are no major sources. See Addendum to the General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990 , 59 FR 41998 (August 16, 1994). The chain-driven commercial charbroiling source category is de minimis with about 0.02% of the total PM-10 emissions and does not have any major sources. Therefore Rule 4292 does not need to fulfill BACM/BACT for PM-10.

Guidance and policy documents that we used to help evaluate specific enforceability and RACT requirements consistently include the following:

• Requirements for Preparation, Adoption, and Submittal of Implementation Plans , U.S. EPA, 40 CFR part 51.

• Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations , EPA (May 25, 1988) (the Bluebook).

• Guidance Document for Correcting Common VOC & Other Rule Deficiencies , EPA Region 9 (August 21, 2001) (the Little Bluebook).

• Determination of RACT and BARCT for Organic Solvent Cleaning Degreasing Operations , California Air Resources Board (July 7, 1991).

• Control of VOE from Solvent Metal Cleaning , EPA-450-2-77-022 (November 1977).

• General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990 , 57 FR 13498, 13540 (April 16, 1992).

• Addendum to the General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990 , 59 FR 41998 (August 16, 1994).

• PM-10 Guideline Document (EPA-452/R-93-008).

We believe these rules are consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the CAA, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by July 3, 2003, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on August 4, 2003. This will incorporate these rules into the federally enforceable SIP.

Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this direct final rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

VOCs help produce ground-level ozone, smog, and particulate matter which harm human health and the environment. EPA has established National Ambient Air Quality Standards (NAAQS) for ozone. Section 110(a) of the CAA requires states to submit regulations in order to achieve and maintain the NAAQS. Table 2 lists some of the national milestones leading to the submittal of local agency VOC rules.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. 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. section 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 4, 2003. 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 3, 1999, the state of Tennessee through the Tennessee Department of Environment and Conservation submitted a revision to chapter 1200-3-18, Volatile Organic Compounds, which provides SIP definitions. The revision to chapter 1200-3-18 provides greater clarity to the existing definition. The additional compounds HFC43-10mee, HCFC-225ca, and HCFC-225cb are added to the list of exempt compounds on the basis that they have negligible contribution to the tropospheric ozone formation.

EPA is approving the aforementioned changes to the State of Tennessee's SIP because they are consistent with the CAA and EPA policy. The EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective August 4, 2003 without further notice unless the Agency receives adverse comments by July 3, 2003.

If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on August 4, 2003 and no further action will be taken on the proposed rule. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 4, 2003. 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 March 29, 1996, December 7, 1998 and September 21, 2000, West Virginia submitted revisions to a regulation (45CSR7) to prevent and control particulate matter air pollution from manufacturing operations as formal revisions to its State Implementation Plan (SIP). The first SIP revision went to public hearing on July 6, 1993 and became effective on April 27, 1994. This SIP revision provides an exemption for ferroalloy electric submerged arc furnaces from visible emissions and fugitive particulate matter standards during blowing taphole, poling and oxygen lancing operations. The second SIP revision went to public hearing on March 27, 1997 and became effective on May 1, 1998. This SIP revision provides alternative stack limits for fiberglass manufacturing operations using the flame attenuation method. The third SIP revision went to public hearing on July 19, 1999. This SIP revision added several exemptions and alternative limitations for visible emission and mass particulate emission standards. Since the most recent of the three SIP revisions incorporates all of the changes from the earlier SIP revisions, EPA will incorporate by reference the version of 45CSR7 submitted to EPA on September 21, 2000 into the SIP.

(A) The following definitions were revised: (1) Definitions of “Commission,” “Ringelmann Smoke Chart,” “Chief of Air Quality,” “Division of Environmental Protection,” were deleted, (2) “Director” was modified to include persons delegated authority by the Director; (3) “Person” was modified to include the State of West Virginia and the United States, and (4) Definitions for “Ferroalloy electric submerged arc furnace,” “Furnace charge,” “Tapping,” “Blowing tap,” “Poling,” “Oxygen lancing,” “Maintenance Operation,” “Malfunction,” “Potential to Emit” were added.

(B) As a result of a petition by Elkem Metals and American Alloys certain events at ferroalloy electric submerged arc furnaces are exempt from fugitive particulate matter and visible emission standards. These events include blowing taphole, poling and oxygen lance operations. Blowing taphole events have been considered by EPA as uncontrollable, unpredictable events best characterized as malfunctions. This rationale was explained in an EPA development document for the federal rule titled “Supplemental Information on Standards of Performance for Ferroalloy Production Facilities,” issued in March 1976, which states that a blowing tap event is “a process malfunction condition which is not wholly preventable. Periods in which the tapping hood is swung aside for poling/lancing or removal of metal or slag from the spout are failures of the process to operate in a normal or usual manner. As malfunctions, these periods are not subject to the standards.” EPA interprets West Virginia's exemption to apply only to the extent that the above operations qualify as malfunctions caused by circumstances beyond the control of the source that could not have been prevented through installation of proper control equipment or proper operation and maintenance.

(C) The SIP revision exempts maintenance operations from particulate matter rate limitations on the condition that such operations are conducted in a manner consistent with good air pollution control practices for minimizing emissions. The State defines maintenance activities as operations having a zero process (input) weight rate. However, process weight rate is defined as the total weight of all materials introduced into a source operation, excluding solid, liquid, and gaseous fuels used solely as fuels and excluding all process and combustion air. This means that sources such as kilns, furnaces and ovens could be exempt from mass emission standards when operated in an idling mode, regardless of the types of fuels being combusted. However, the regulation does not exempt maintenance operations from visible emissions standards. Compliance with a visible emissions standard can be assessed over a broad range of operations, unlike compliance with a weight-based particulate matter limitation which is usually assessed by stack testing during normal and/or peak manufacturing operations. Therefore, a visible emissions standard can be an appropriate means to control emissions during maintenance operations.

(D) Exemptions are provided for insignificant sources, except for particulate matter classified as hazardous air pollutants. EPA believes that these exemptions are for very small sources that have little or no impact on ambient air quality.

All of the above exemptions are predicated on operating and maintaining manufacturing processes in a manner consistent with good air pollution control practices for minimizing emissions. The proposed SIP revision states that the Director may determine whether or not the exemption should be applied based on “information available to the Director.” EPA interprets this subsection to place the burden of proof on the owner or operator to document, as appropriate, that the exemption applies. In other words, failure of the source to provide documentation that it has conducted maintenance operations in a manner consistent with good air pollution control practices should not prevent either the State or EPA from exercising its enforcement authority.

(E) Revisions to 45CSR7 include provisions for alternative emission limitations. As a result of a petition by Schuller International, Inc., West Virginia set alternative particulate matter limits for fiberglass production facilities using flame attenuation in the manufacturing process in lieu of limits that would otherwise be set by the duplicate source provisions in Table 45-7A of 45CSR7. The Schuller facility, now known as John Mansville International, Inc. (JM), is located in Vienna, West Virginia. Under the duplicate source provisions in 45CSR7, the allowable emission rate for each individual source would be established using the ratio of process input weight for the individual stack to the total process input weight, times the allowable emission rate for the combined sources. Since the relationship between the allowable emission rate and the process input rate is less than linear, the duplicate source provisions become more stringent as multiple sources are added. Abatement equipment and techniques to reduce particulate matter emissions were determined by West Virginia to be economically and technically infeasible to meet the duplicate source emission limitations at the John Mansville facility. Therefore, alternative particulate emission rate limits have been set that are based on best actual limits achieved in practice.

These alternative emission limitations are framed such that they generically apply to all fiberglass production facilities that use the flame attenuation process. The John Mansville facility is the only such manufacturing facility in the state and the rule names and applies limits to the specific stacks at this facility. EPA believes that the rule is inconsistent in applying a site-specific set of emission limitations as generic standards for all flame attenuation plants, regardless of whether other plants exist. To resolve this inconsistency, EPA interprets the regulation to apply only to the Johns Mansville facility. Should other flame attenuation plants locate in the State, they will be subject to the duplicate source provisions of 45CSR7.

(F) An owner or operator may petition the Director for alternative visible emission standards during periods of start-up and shut-down. The petitioner must: (1) Demonstrate that it cannot comply with existing standards, (2) document the need for an alternative standard based on monitoring results and inspections, (3) demonstrate that mass emission standards are being met, and (4) maintain and operate manufacturing processes and air pollution control equipment in a manner consistent with good air pollution control practices. Section 110(a)(2)(A) of the Clean Air Act requires SIPs to include federally enforceable emission limitations. The West Virginia Department of Environmental Protection (WVDEP) submitted a letter to EPA on March 19, 2003, clarifying how the State intends to interpret and implement its air control regulations. This letter states that all alternative visible emission standards will be established as specific conditions of permits issued in accordance with federally enforceable permitting programs. The letter also states that prior to issuing such permits, the WVDEP shall submit them to EPA for review. This letter has been included in the administrative record for the rulemaking action on this SIP revision.

(G) A new section titled “Alternative Emission Limits for Duplicate Source Operations” provides a process for owners or operators to apply for alternative mass particulate emission rates. These alternative limits will not allow the overall site limit determined by Tables 45-7A and B in the regulation to be relaxed but will provide some flexibility on what may be emitted from individual stacks. The regulation requires the petitioner to conduct an air quality impact analysis to demonstrate that the alternative standard(s) will not interfere with attainment or maintenance of any federal air quality standard or cause an unacceptable increase over the baseline concentration of particulate matter. In addition, the alternative standard is required to be implemented through 45CSR13, which is a federally enforceable permit program. As noted previously, WVDEP submitted a letter to EPA on March 19, 2003, which is part of the administrative record for this rulemaking action, stating that alternative mass emission limits issued under the authority of 45CSR13 will be established and implemented as conditions of permits issued in accordance with federally approved and enforceable programs and, that prior to issuance such permits shall be submitted to EPA for review. The letter also affirms that a successful petition for alternative emission limits under this subsection may in no way supercede any provisions in 45CSR14 or 45CSR19 regarding pre-construction review of new or modified sources.

(H) The SIP revision removes the restriction that the Director may only require a stack test when there is evidence of a violation. EPA believes that this revision substantially enhances West Virginia's ability to determine compliance with the particulate matter standard.

(I) A section on delayed compliance orders was deleted and a section titled “Inconsistency Between Rules” allows the Director to determine applicability of conflicting rules based on imposing the more stringent provisions.

Additional details and a description of minor revisions are included in the Technical Support Document for this rulemaking.

These revisions strengthen the SIP by clarifying and updating definitions and updating opacity standards. The revisions also require EPA review of alternative emission limits and establish acceptable periods when emission standards do not apply.

EPA is approving the revisions to 45CSR7, “To Prevent and Control Particulate Matter Air Pollution from Manufacturing Processes and Associated Operations”, submitted by West Virginia on September 21, 2000. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on August 4, 2003 without further notice unless EPA receives adverse comment by July 3, 2003. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a State rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 4, 2003. 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, to approve West Virginia's Regulation 45CSR7, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On March 6, 2000, the Commonwealth of Pennsylvania submitted a formal revision to its State Implementation Plan (SIP). The SIP revision consists of the removal of alternative emission reduction limitations for the facilities and pollutants listed in Table 1. Public hearings were held on July 28, July 30 and August 5, 1997. The final rule removing the alternative emission reduction limitations became effective on October 19, 1999.

As part of the Commonwealth's Regulatory Basics Initiative, the PADEP was required to review existing regulations and identify those that were, among other things, obsolete or no longer necessary. As a result of this initiative, PADEP identified certain regulations for source specific alternative emission reduction limitations, codified in title 25, chapter 128 of the Commonwealth's regulations, as no longer necessary due to changes in processes, equipment or the closing of the affected facility. Chapter 128 allows sources to submit proposals to implement an alternative emission reduction option for existing sources known as the “bubble” policy. The specific alternative emission reduction limitations to be removed from the Commonwealth's SIP, including the names of the affected sources and pollutants, are listed in Table 1.

EPA is approving as a revision to the Pennsylvania SIP the removal of alternative emission reduction limitations, codified under 25 PA Code section 128, for eight facilities.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on August 4, 2003, without further notice unless EPA receives adverse comment by July 3, 2003. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action to remove eight alternative emission reduction limitations from the Pennsylvania SIP must be filed in the United States Court of Appeals for the appropriate circuit by August 4, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

The SIP is a living document which the State can revise as necessary to address the unique air pollution problems in the state. Therefore, EPA from time to time must take action on SIP revisions containing new and/or revised regulations as being part of the SIP. On May 22, 1997, (62 FR 27968) EPA revised the procedures for incorporating by reference Federally-approved SIPs, as a result of consultations between EPA and OFR. The description of the revised SIP document, IBR procedures and “Identification of plan” format are discussed in further detail in the May 22, 1997, Federal Register document. On May 21, 1999, EPA published a document in the Federal Register (64 FR 27699) beginning the new IBR procedure for Georgia. In this document EPA is updating the IBR material.

EPA has determined that today's rule falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make a rule effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). Today's rule simply codifies provisions which are already in effect as a matter of law in Federal and approved State programs.

Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” since the codification only reflects existing law. Immediate notice in the CFR benefits the public by updating citations.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 4, 2003. 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).)

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

On February 26, 2003 (68 FR 8869), EPA proposed to approve the following rule into the California SIP.

We proposed to approve this rule because we determined that it complied with the relevant CAA requirements. Our proposed action contains more information on the rule and our evaluation.

EPA's proposed action provided a 30-day public comment period. During this period, we received one comment from the following party:

The commenter fully supports the approval of VCAPCD Rule 74.23 which allows NO X emission limit changes for LM-2500 and LM-5000 turbines. The commenter is affected by this change and encourages the EPA to proceed with this approval as expeditiously as possible.

No comments were submitted that change our assessment that the submitted rule complies with the relevant CAA requirements. Therefore, as authorized in section 110(k)(3) of the Act, EPA is fully approving this rule into the California SIP.

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

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 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); 42 U.S.C. 7410(a)(2).

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 governments 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.

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.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. 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. Thus, Executive Order 13175 does not apply to this rule.

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.

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.

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. Today's action does not require the public to perform activities conducive to the use of VCS.

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 July 3, 2003.

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 August 4, 2003. 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).)

This is a summary of the Commission's Report and Order, ET Docket No. 02-98, FCC 03-105, adopted April 29, 2003, and released May 14, 2003. The full text of this document is available on the Commission's Internet site at http://www.fcc.gov. It is also available for inspection and copying during regular business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The full text of this document also may be purchased from the Commission's duplication contractor, Qualex International, Portals II, 445 12th St., SW., Room CY-B402, Washington, DC 20554; telephone (202) 863-2893; fax (202) 863-2898; e-mail qualexint@aol.com.

1. The amateur radio service, governed by part 97 of the Commission's rules, provides spectrum for amateur radio service licensees to participate in a voluntary noncommercial communications service which provides emergency communications and allows experimentation with various radio techniques and technologies to further the understanding of radio use and the development of new technologies. In the Report and Order (“R&O”), we are providing access to 5 channels in or near the 5250-5400 kHz band on a secondary basis for the amateur service, and upgrading the existing secondary amateur service allocation to primary status in the 2400-2402 MHz band.

2. On May 2, 2002, the Commission adopted a Notice of Proposed Rulemaking (“NPRM”) in response to three Petitions for Rulemaking submitted by the National Association for Amateur Radio (“ARRL”). The first of these petitions requested that a secondary allocation to the amateur service be made in the 135.7-137.8 kHz and 160—190 kHz bands to permit experimentation in the Low Frequency (“LF”) range. The second petition requested a secondary amateur allocation in the 5250-5400 kHz band to enhance amateur emergency communications and experimentation when propagation conditions are not favorable in the 3500 kHz and 7000 kHz bands. The third petition requested an upgrade to primary status for the existing secondary amateur allocation and a new primary allocation for the amateur-satellite service in the 2400-2402 MHz band to protect existing amateur operations from future commercial systems which may utilize the band.

3. While we agree that amateur experimentation in the 135.7-137.8 kHz and 160-190 kHz portions of the LF spectrum could serve to increase the pool of individuals having knowledge of LF transmissions, we conclude that such operations would pose the potential for harmful interference to systems protecting and controlling the national power grid. Therefore, we find that a new amateur allocation in the LF range of the radio spectrum is not justified when balanced against the greater public interest of an interference-free power grid. Further, we find that the opportunity to experiment with LF operations provided to amateur radio operators under our part 15 rules and through our experimental licensing process, while less attractive to amateur operators than their own proposal, provides the appropriate means for such use in light of the compelling uses in the band.

4. We disagree with ARRL's and the amateur operators' assertions concerning the consideration we should accord incumbent part 15 use in these bands in deciding whether to provide an allocation for amateur services. Our decision must be based upon the facts at hand and our evaluation of any potential changes to the spectral environment due to our decision. In evaluating whether new operations should be added to a band, licensed or not, we must consider the potential for interference conflicts between the operations. While unlicensed Power Line Carrier (“PLC”) operations have no protection status, they provide a vital public service. Therefore, we disagree with amateur comments that we should not consider the impact on unlicensed operations when making spectrum allocation decisions.

5. We note the significant potential for interference between the proposed amateur operations and the incumbent PLCs. ARRL concedes that amateur operations and power lines with attached PLCs would have to be separated in order to prevent interference. We find that separation distances on the order of 950 meters would be necessary to protect the PLCs from interference. We also find that this distance, coupled with the larger-than-expected number of PLCs potentially impacted by this proposed allocation, increases the likelihood that a PLC-equipped powerline will be close enough to an amateur station to receive interference. We will not jeopardize the reliability of electrical service to the public.

6. We believe that the utility companies have raised a valid concern that an allocation to the amateur service could result in the need for PLCs to modify or cease their operations to avoid causing interference to amateurs. Amateur operators have expressed concern that there may be interference to their operations from the power lines and from PLC devices. While it appears that other techniques could be used to control the power grid, we find that the utility companies have come to rely on PLC systems for monitoring and control of the power grid, and that the alternatives suggested may not be as effective, and would be costly. We are persuaded that the costs of replacing PLC systems would be significant, would be disruptive to the public, and are not justified merely to open this band to amateur use on a secondary basis.

7. We decline to make an allocation to the amateur service in the LF spectrum at this time. We do believe there is potential for some limited operation in these bands under individual experimental licenses. Operations at LF under our experimental license program will allow amateur use to be coordinated with utility companies on a case-by-case basis, and allow empirical data to be developed on the sharing possibilities in this band for future consideration. In addition, amateurs may still make use of the 160-190 kHz band under our part 15 rules, which are much more restrictive, and therefore more protective of PLCs, than the limits proposed in the NPRM.

8. We believe that frequencies in the 5250-5400 kHz range may be useful for completing disaster communications links at times when the 3 and 7 MHz bands are not available due to ionospheric conditions, and appreciate the desire of the amateur radio community to assist with disaster communications. At the same time, since the majority of the affected users are Federal government licensees with homeland security responsibilities, we give considerable weight to the concerns NTIA has expressed about the potential for interference to these users. Thus, we conclude that it is not reasonable to grant ARRL's original request for the whole of the 5250-5400 kHz band. NTIA has reviewed its assignments and has found that five channels are lightly used and could be used on a secondary basis by amateur stations. While we recognize that these five channels will not give the amateur service the 150 kilohertz of spectrum in the 5000 kHz range it originally asked for or the flexibility to use multiple transmission modes, this appears to be the best compromise available to give the amateur service access to new spectrum while assuring the Federal government agencies that their use is protected. We also concur with NTIA's basic proposals that amateur service operations on these channels be limited to SSB-SC modulation, upper sideband voice transmissions only, with power not to exceed the equivalent of 50 W PEP transmitter output power into an antenna with a gain of 0 dBd, or 50 W effective radiated power (“e.r.p”). These operating rules will decrease the interference potential between amateur stations and Federal government users. We have amended §§ 2.106, and 97.303 of our rules to provide a secondary allocation to the amateur service on the channels 5332 kHz, 5348 kHz, 5368 kHz, 5373 kHz and 5405 kHz as specified by NTIA, and to require that amateur operations be limited to an (e.r.p.) of 50 W and emission type 2K8J3E, upper sideband voice transmissions only centered on each frequency. For the purpose of computing e.r.p., the transmitter peak envelope power will be multiplied with the antenna gain relative to a dipole or the equivalent calculation in decibels. A half wave dipole antenna will be presumed to have a gain of 0 dBd. Licensees using other antennas must maintain in their station records either manufacturer data on the antenna gain or calculations of the antenna gain. In addition, because we have permitted amateur stations to transmit on five discrete frequencies and are limiting the transmission mode to single sideband only, dividing the band into smaller sub-bands to be used for other emission types is not practical or necessary. Lastly, we have permitted these frequencies to be used by amateur service licensees with a General Class, Advanced Class, or Amateur Extra Class operator license. We believe that the limited number of frequencies and the emission restriction will protect against interference to primary service operations.

9. Because the broadband PLCs would be new services operating in new frequency bands and are not yet deployed, we do not have the same concerns as with the incumbent PLC systems in the 160-190 kHz band. Because these new PLC systems are still in development, we expect that they can be designed to be compatible with the other operations in this band, and we deny the United Power Line Council (“UPLC”) and Power Line Carrier Association (“PLCA”) request to delay action in this proceeding. The power levels we are adopting are 1/30th of the power levels supported by the UPLC and the e.r.p. restriction provides a limit to the antenna height. We believe that the permitted e.r.p limitation will significantly reduce the possibility of interference to and from broadband PLCs. Because the allowable power level will be very low, we do not believe that we need additional out-of-band emission limits for amateur operations in this band.

10. We deny Homeplug's request for a 10-year safe harbor. Unlicensed devices operated in accordance with the part 15 rules should not cause interference to licensed, allocated services. It is not apparent that there will be significant interference from Homeplug devices, whose signals attenuate quickly, to ARRL operations on these frequencies, which are expected to be sporadic. There is ample alternative spectrum on which Homeplug devices can operate. As a practical matter, we would expect amateur services to take into account the extant Homeplug devices, although they are not required to do so.

11. We have upgraded the existing amateur service (except amateur-satellite service) allocation at 2400-2402 MHz from secondary to primary status. This modification will provide additional protection to the amateur service in this band from future licensed operations. The allocation changes we are making will not alter the interference protection rights among the current users of the band. Even under the current secondary allocation, amateur services are entitled to interference protection from part 15 devices, and ISM devices are entitled to protection from both amateur operations and part 15 devices. These relationships will remain the same under the amateur service primary allocation. We observe that the amateur operators have successfully shared this band with part 15 and part 18 operations and we have no reason to believe that this sharing will not continue to be successful. Part 15 devices are limited in power and this interference potential from them is limited to an area very close to their transmit location. We therefore modify rule §§ 2.106, 97.303(j)(2)(iii) and 97.303 (j)(2)(iv) to provide a primary allocation for the amateur service (except amateur-satellite service), consistent with our decision.

12. Our analysis regarding an amateur-satellite service allocation at 2400-2402 MHz differs from the case of terrestrial use in this band. The amateur-satellite service currently operates on a non-interference basis (“NIB”) to other services under international footnote 5.282, not on a secondary basis as some parties suggest. This means that these operations are on an equal footing with part 15 devices. As both the amateur and unlicensed proponents recognize, the sensitivity of amateur satellite receivers makes them more vulnerable to aggregate interference from other users in this band. The 2400-2402 MHz band is heavily used by both part 15 and part 18 devices, and, unlike terrestrial amateur operations, amateur satellite receivers are at greater risk from aggregate interference. We thus conclude that an allocation for the amateur-satellite service would be impractical and difficult to implement, given the protection status afforded ISM devices and the large number of part 15 devices that operate in the band. Further, maintaining NIB status for the amateur-satellite service in this 2 megahertz band is consistent with the NIB status that an amateur satellite system would operate under in the 2400-2450 MHz band, so amateur satellite use of this 2 megahertz band is not prejudiced by our decision. Because we are maintaining NIB status for the amateur-satellite service, we will not place any restrictions on these operations ( e.g. , down-link only operation as some parties suggest).

13. Although ARRL is correct that unlicensed users do not have protection rights vis-a-vis licensed users in a band, it is incorrect when it asserts that we need not consider unlicensed use of this band when deciding whether to modify the allocation. The issue here is whether different uses are compatible and promote efficient use of spectrum. This analysis requires that we consider both licensed and unlicensed use. We conclude that, in the 2400-2402 MHz band, the status quo provides the best mix of uses to promote spectrum efficiency. The extensive use of the band to date by parts 15 and 18 and amateur users under the existing rules supports this conclusion. ARRL's suggestion to license those devices that have the potential to cause interference to licensed services does not alter our analysis. Even among licensed services, we consider whether uses are compatible and promote efficient use of spectrum. ARRL's approach would merely have us identify the priority between the amateur service and another licensed service.

14. We also conclude that, because we are maintaining the relative allocation status in this band, it is not necessary to implement a “safe harbor” for part 15 devices. Unlicensed devices operated in accordance with the part 15 rules should not cause interference to the amateur service, and amateur services can take into account these well known technical characteristics used by unlicensed devices as they operate in the band. The amateur service and unlicensed devices have successfully shared this band in the past, and we have no reason to conclude that these sharing arrangements will not continue to be successful.

15. The Regulatory Flexibility Act of 1980, as amended (RFA), 1 requires that an initial regulatory flexibility analysis be prepared for notice and comment rule making proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” 2 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 3 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. 4 A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). 5

16. In the R&O, we make five channels in or near the 5250-5400 kHz frequency band available on a secondary basis and upgrade the allocation of the 2400-2402 MHz frequency band to the amateur service. The amateur radio service is a voluntary non-commercial communications service comprised of individuals or groups of individuals holding amateur radio licenses issued by the Commission. 6 These individuals are prohibited from using spectrum allocated to the amateur service for communications for hire or for material compensation, or for communications in which the amateur radio operator has a pecuniary interest. 7 Therefore, amateur radio operators do not fit any part of the definition of “small entities” described above, and thus are not classified as such.

17. In addition, even if the amateur radio licensees were hypothetically considered as “small entities,” the rule changes promulgated in this R&O simply make spectrum available for the amateur radio operations and impose no additional fees, costs, or compliance burdens on an operator. Since the amateur radio service is a voluntary service, it would be up to each individual amateur to purchase or modify equipment to use the new bands. There is no cost associated with the upgrade of the allocation. On the contrary, the amateur radio service receives the positive benefits of access to additional spectrum.

18. Lastly, the use of these five new frequencies in or near the 5250-5400 kHz band on a secondary basis by the amateur service does not impact any small entities because it is primarily used by the Federal Government. The allocation upgrade in the 2400-2402 MHz band also does not impact any small entities because there are currently only part 15 and part 18 operations in that frequency band. The part 18 operations maintain their right to operate under international footnote 5.150. 8 The current amateur service allocation status is higher than the status of part 15 operations, so that there will be no additional impact due to this action.

19. Therefore, we certify that the rules in this R&O will not have a significant economic impact on a substantial number of small entities. The Commission will send a copy of the Report and Order, including a copy of this Final Regulatory Flexibility Certification, in a report to Congress pursuant to the Congressional Review Act. 9 In addition, the Report and Order and this Final Certification will be sent to the Chief Counsel for Advocacy of the SBA. 10

20. Pursuant to sections 1, 4, 301, 302(a), and 303(c) and (f), of the Communications Act of 1934, as amended, 47 U.S.C. sections 151, 154, 301, 302(a), and 303(c) and (f), parts 2 and 97 of the Commission's rules have been amended and will be effective July 3, 2003.

21. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of the Report and Order , including the Final Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

A. Background

This rule corrects an oversight in the final rule published at 67 FR 38020 on May 31, 2002, under DFARS Case 2000-D014, Ocean Transportation by U.S.-Flag Vessels. That rule added requirements for contractors to use U.S.-flag vessels when transporting supplies by sea under contracts at or below the simplified acquisition threshold, in accordance with 10 U.S.C. 2631. The rule provided an Alternate III for use with the clause at DFARS 252.247-7023, Transportation of Supplies by Sea, in contracts at or below the simplified acquisition threshold, to minimize the information required from contractors under these contracts. This final rule adds Alternate III of 252.247-7023 to the list of clauses at 252.212-7001, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items, as it was inadvertently omitted from the previous DFARS rule.

DoD published a proposed rule at 67 FR 65528 on October 25, 2002. DoD received no comments on the proposed rule and, therefore, is adopting the proposed rule as a final rule without change.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , because most entities providing ocean transportation of freight are not small businesses, and the rule minimizes the information required from contractors under contracts valued at or below the simplified acquisition threshold.

The information collection requirements in this rule have been approved by the Office of Management and Budget, under Clearance Number 0704-0245, for use through July 31, 2004.