In this rulemaking document, OGE is adopting final rules under the Privacy Act, 5 U.S.C. 552a. On January 22, 2003, at 68 FR 2923-2929, OGE published a proposed rule that would establish procedures relating to OGE systems of records under the Privacy Act, for codification at 5 CFR part 2606. The proposed rule invited comments from the public, to be received by OGE on or before March 24, 2003. No comments were received. After consultation with the Office of Management and Budget during the course of Executive Order 12866 review of this final rule, OGE has determined that only two minor changes are needed to the proposed rule in adopting it as final. The first change is that OGE is dropping the proposed reference in § 2606.203(c) to any possible fee for certified copies of records when such are provided. Instead, the section simply provides that OGE and concerned agencies generally will not furnish certified copies of records. The second change is that OGE is clarifying in § 2606.206(a)(2)(ii)(B) that only a previous failure to timely pay a Privacy Act fee can serve as an alternate basis for the possible requirement of an advance payment for additional copies of records being provided under the Privacy Act.

In addition, OGE published in the Federal Register on January 22, 2003 (in a separate part II), at 68 FR 3097-3109, a notice of proposed new and revised systems of records under the Privacy Act. Public comments were invited, to be received by OGE by March 24, 2003. Likewise, OGE did not receive any comments on the notice. Pursuant to that notice, the new and revised records systems will become effective on May 22, 2003 without change (except for the correction of some minor errors, see 68 FR 24744 (May 8, 2003)). Therefore, OGE is making this final rule effective on the same date, May 22, 2003.

Pursuant to 5 U.S.C. 553(d), as Director of the Office of Government Ethics, I find good cause exists for waiving the 30-day delay in effectiveness as to this final rule. The delayed effective date provision is being waived in part because this final OGE Privacy Act rule makes only two minor changes to the previously published proposed rule (as explained above). Furthermore, it is in the public interest that this OGE Privacy Act regulation become effective on the same date, May 22, 2003, as OGE's new and revised Privacy Act systems of records.

In promulgating this final rule, the Office of Government Ethics has adhered to the regulatory philosophy and the applicable principles of regulation set forth in section 1 of Executive Order 12866, Regulatory Planning and Review. This regulation has also been approved by the Office of Management and Budget under the Executive order.

As Director of the Office of Government Ethics, I have reviewed this final rule in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.

As Director of the Office of Government Ethics, I certify under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this regulation will not have a significant economic impact on a substantial number of small entities, because it will primarily affect current and former executive branch Federal employees.

For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 25, subpart II), this regulation would not significantly or uniquely affect small governments and would not result in increased expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year.

The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply to this regulation because it does not contain information collection requirements that require the approval of the Office of Management and Budget.

The Office of Government Ethics has determined that this regulation involves a nonmajor rule under the Congressional Review Act (5 U.S.C. chapter 8) and will submit a report thereon to the U.S. Senate, House of Representatives and General Accounting Office in accordance with that law at the same time this rulemaking document is sent to the Office of the Federal Register for publication in the Federal Register .

A proposed rule detailing the revisions was published in the Federal Register on March 31, 2003. (68 FR 15385). A 15-day comment period was provided for interested persons to respond to the proposed rule. No comments were received and no changes have been made in the provisions of the final rule.

This final rule has been determined to be not significant for purposes of Executive Order 12866; and, therefore has not been reviewed by the Office of Management and Budget (OMB).

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule would not preempt any state or local laws, regulations, or policies unless they present an irreconcilable conflict with this rule. There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this rule.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) AMS has considered the economic impact of this action on small entities and has determined that its implementation will not have a significant economic impact on a substantial number of small businesses.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. There are an estimated 35,000 cotton growers in the U.S. who voluntarily use the AMS cotton classing services annually, and the majority of these cotton growers are small businesses under the criteria established by the Small Business Administration (13 CFR 121.601). Continuing the user fee at the 2002 crop level as stated will not significantly affect small businesses as defined in the RFA because:

(1) The fee represents a very small portion of the cost-per-unit currently borne by those entities utilizing the services. (The 2002 user fee for classification services was $1.45 per bale; the fee for the 2003 crop will be maintained at $1.45 per bale; the 2003 crop is estimated at 17,200,000 bales).

(2) The fee for services will not affect competition in the marketplace; and

(3) The use of classification services is voluntary. For the 2002 crop, 17,145,000 bales were produced; and, virtually all of these bales were voluntarily submitted by growers for the classification service.

(4) Based on the average price paid to growers for cotton from the 2001 crop of 29.8 cents per pound, 500 pound bales of cotton are worth an average of $149 each. The user fee for classification services, $1.45 per bale, is less than one percent of the value of an average bale of cotton.

In compliance with OMB regulations (5 CFR part 1320), which implement the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), the information collection requirements contained in the provisions to be amended by this proposed rule have been previously approved by OMB and were assigned OMB control number 0581-0009 under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The user fee charged to cotton producers for High Volume Instrument (HVI) classification services under the Cotton Statistics and Estimates Act (7 U.S.C. 473a) was $1.45 per bale during the 2002 harvest season as determined by using the formula provided in the Uniform Cotton Classing Fees Act of 1987, as amended by Public Law 102-237. The fees cover salaries, costs of equipment and supplies, and other overhead costs, including costs for administration, and supervision. These changes will be made effective July 1, 2003, as provided by the Cotton Statistics and Estimates Act.

This final rule establishes the user fee charged to producers for HVI classification at $1.45 per bale during the 2003 harvest season.

Public Law 102-237 amended the formula in the Uniform Cotton Classing Fees Act of 1987 for establishing the producer's classification fee so that the producer's fee is based on the prevailing method of classification requested by producers during the previous year. HVI classing was the prevailing method of cotton classification requested by producers in 2002. Therefore, the 2003 producer's user fee for classification service is based on the 2002 base fee for HVI classification.

The fee was calculated by applying the formula specified in the Uniform Cotton Classing Fees Act of 1987, as amended by Public Law 102-237. The 2002 base fee for HVI classification exclusive of adjustments, as provided by the Act, was $2.28 per bale. An increase of .84 percent, or 2 cents per bale, increase due to the implicit price deflator of the gross domestic product added to the $2.28 would result in a 2003 base fee of $2.30 per bale. The formula in the Act provides for the use of the percentage change in the implicit price deflator of the gross national product (as indexed for the most recent 12-month period for which statistics are available). However, gross national product has been replaced by gross domestic product by the Department of Commerce as a more appropriate measure for the short-term monitoring and analysis of the U.S. economy.

The number of bales to be classed by the United States Department of Agriculture from the 2003 crop is estimated at 16,793,610 bales. The 2003 base fee was decreased 15 percent based on the estimated number of bales to be classed (1 percent for every 100,000 bales or portion thereof above the base of 12,500,000, limited to a maximum adjustment of 15 percent). This percentage factor amounts to a 35 cents per bale reduction and was subtracted from the 2003 base fee of $2.30 per bale, resulting in a fee of $1.95 per bale.

With a fee of $1.95 per bale, the projected operating reserve would be 51.09 percent. The Act specifies that the Secretary shall not establish a fee which, when combined with other sources of revenue, will result in a projected operating reserve of more than 25 percent. Accordingly, the fee of $1.95 must be reduced by 50 cents per bale, to $1.45 per bale, to provide an ending accumulated operating reserve for the fiscal year of 25 percent of the projected cost of operating the program. This would establish the 2003 season fee at $1.45 per bale.

Accordingly, § 28.909, paragraph (b) would be revised to reflect the continuation of the HVI classification fee at $1.45 per bale.

As provided for in the Uniform Cotton Classing Fees Act of 1987, as amended, a 5 cent per bale discount would continue to be applied to voluntary centralized billing and collecting agents as specified in § 28.909 (c).

Growers or their designated agents receiving classification data would continue to incur no additional fees if only one method of receiving classification data was requested. The fee for each additional method of receiving classification data in § 28.910 would remain at 5 cents per bale.

Growers or their designated agents receiving classification data would continue to incur no additional fees if only one method of receiving classification data was requested. The fee in § 28.910 (b) for an owner receiving classification data from the central database would remain at 5 cents per bale, and the minimum charge of $5.00 for services provided per monthly billing period would remain the same. The provisions of § 28.910 (c) concerning the fee for new classification memoranda issued from the central database for the business convenience of an owner without reclassification of the cotton will remain the same.

The fee for review classification in § 28.911 would be maintained at $1.45 per bale.

The fee for returning samples after classification in § 28.911 would remain at 40 cents per sample.

For the reasons set forth in the preamble, 7 CFR Part 28 is amended as follows:

The Office of Management and Budget has waived the review process required by Executive Order 12866 for this action.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule would not preempt any state or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Cotton Research and Promotion Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 12 of the Act, any person subject to an order may file with the Secretary a petition stating that the order, any provision of the plan, or any obligation imposed in connection with the order is not in accordance with law and requesting a modification of the order or to be exempted therefrom. Such person is afforded the opportunity for a hearing on the petition. After the hearing, the Secretary would rule on the petition. The Act provides that the District Court of the United States in any district in which the person is an inhabitant, or has his principal place of business, has jurisdiction to review the Secretary's ruling, provided a complaint is filed within 20 days from the date of the entry of ruling.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) AMS has considered the economic impact of this action on small entities and has determined that its implementation will not have a significant economic impact on a substantial number of small businesses.

There are an estimated 10,000 importers who are presently subject to rules and regulations issued pursuant to the Cotton Research and Promotion Order. This rule would affect importers of cotton and cotton-containing products. The majority of these importers are small businesses under the criteria established by the Small Business Administration. This rule would lower the assessments paid by the importers under the Cotton Research and Promotion Order. Even though the assessment would be lowered, the decrease is small and will not significantly affect small businesses. The current assessment on imported cotton is $0.00862 per kilogram of imported cotton. The new assessment is $0.008267, a decrease of $0.000353 or a 4.1 percent decrease. From January through December 2002 approximately $24 million was collected. Should the volume of cotton products imported into the U.S. remain at the same level in 2003, one could expect the decreased assessment to generate approximately $23 million or a 4.1 percent decrease from 2002.

In compliance with Office of Management and Budget (OMB) regulations (5 CFR part 1320), which implement the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), the information collection requirements contained in the regulation to be amended have been previously approved by OMB and were assigned control number 0581-0093.

The Cotton Research and Promotion Act Amendments of 1990 enacted by Congress under Subtitle G of Title XIX of the Food, Agriculture, Conservation and Trade Act of 1990 on November 28, 1990, contained two provisions that authorized changes in the funding procedures for the Cotton Research and Promotion Program.

These provisions are: (1) The assessment of imported cotton and cotton products; and (2) termination of the right of cotton producers to demand a refund of assessments.

An amended Cotton Research and Promotion Order was approved by producers and importers voting in a referendum held July 17-26, 1991, and the amended Order was published in the Federal Register on December 10, 1991, (56 FR 64470). A proposed rule implementing the amended Order was published in the Federal Register on December 17, 1991, (56 FR 65450). Implementing rules were published on July 1 and 2, 1992, (57 FR 29181) and (57 FR 29431), respectively.

This rule will decrease the value assigned to imported cotton in the Cotton Board Rules and Regulations (7 CFR 1205.510(b)(2)). This value is used to calculate supplemental assessments on imported cotton and the cotton content of imported products. Supplemental assessments are the second part of a two-part assessment. The first part of the assessment is levied on the weight of cotton produced or imported at a rate of $1 per bale of cotton which is equivalent to 500 pounds or $1 per 226.8 kilograms of cotton.

Supplemental assessments are levied at a rate of five-tenths of one percent of the value of domestically produced cotton, imported cotton, and the cotton content of imported products. The agency has adopted the practice of assigning the calendar year weighted average price received by U.S. farmers for Upland cotton to represent the value of imported cotton. This is done so that the assessment on domestically produced cotton and the assessment on imported cotton and the cotton content of imported products remain similar. The source for the average price statistic is “Agricultural Prices,” a publication of the National Agricultural Statistics Service (NASS) of the Department of Agriculture. Use of the weighted average price figure in the calculation of supplemental assessments on imported cotton and the cotton content of imported products yields an assessment that approximates assessments paid on domestically produced cotton in the prior calendar year.

The current value of imported cotton as published in the Federal Register (67 FR 36793) on May 28, 2002, for the purpose of calculating supplemental assessments on imported cotton is $.8422 per kilogram. This number was calculated using the annual weighted average price received by farmers for Upland cotton during the calendar year 2001 which was $0.382 per pound and multiplying by the conversion factor 2.2046. Using the Average Weighted Price Received by U.S. farmers for Upland cotton for the calendar year 2002, which is $0.35 per pound, the new value of imported cotton is $0.7716 per kilogram. The amended value is $.0706 per kilogram less than the previous value.

An example of the complete assessment formula and how the various figures are obtained is as follows:

One bale is equal to 500 pounds.

One kilogram equals 2.2046 pounds.

One pound equals 0.453597 kilograms.

A 500 pound bale equals 226.8 kg. (500 × .453597).

$1 per bale assessment equals $0.002000 per pound (1/500) or $0.004409 per kg. (1/226.8).

The 2002 calendar year weighted average price received by producers for Upland cotton is $0.35 per pound or $0.7716 per kg. (0.35 × 2.2046).

Five tenths of one percent of the average price in kg. equals $0.003858 per kg. (0.7716 × .005).

The total assessment per kilogram of raw cotton is obtained by adding the $1 per bale equivalent assessment of $0.004409 per kg. and the supplemental assessment $0.003858 per kg. which equals $0.008267 per kg.

The current assessment on imported cotton is $0.008620 per kilogram of imported cotton. The amended assessment is $0.008267, a decrease of $0.000353 per kilogram. This decrease reflects the decrease in the Average Weighted Price of Upland Cotton Received by U.S. Farmers during the period January through December 2002.

Since the value of cotton is the basis of the supplemental assessment calculation and the figures shown in the right hand column of the Import Assessment Table 1205.510(b)(3) are a result of such a calculation, the figures in this table have been revised. These figures indicate the total assessment per kilogram due for each Harmonized Tariff Schedule (HTS) number subject to assessment.

A proposed rule with request for comments was published in the Federal Register (68 FR 12310) on March 14, 2003. No comments were received during the period (March 14 through April 14, 2003).

On March 25, 2003 (68 FR 14307), the NRC published in the Federal Register a direct final rule amending its regulations in 10 CFR part 20 requiring licensees to clearly label any section of the written event report containing personal information “Privacy Act Information: Not for Public Disclosure.” In the direct final rule, NRC stated that if no significant adverse comments were received, the direct final rule would become final on June 9, 2003. The NRC did not receive any comments that warranted withdrawal of the direct final rule. Therefore, this rule will become effective as scheduled.

In a notice published in the Federal Register of August 28, 2002 (67 FR 55269), FDA announced that a food additive petition (FAP 2248) had been filed by ADM Alliance Nutrition, Inc., 1000 North 30th St., P.O. Box C1., Quincy, IL 62305-7100. The petition proposed to amend the food additive regulations in Part 573 Food Additives Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to provide for the use of feed grade biuret in the diets of lactating dairy cows. The notice of filing provided for a 75-day comment period on the petitioner's environmental information. No substantive comments have been received.

FDA has evaluated data submitted by the sponsor of the petition and concludes that the data establish the safety and functionality of feed-grade biuret for use as proposed.

In accordance with § 571.1(h) (21 CFR 571.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Veterinary Medicine by appointment with the information contact person listed above. As provided in § 571.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

The agency has determined under 21 CFR 25.32(r) 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.

Any person who will be adversely affected by this regulation may at any time on or before July 23, 2003, file with the Dockets Management Branch (address above) written objections thereto. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents shall be submitted and shall be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Section 740 of the Wendell H. Ford Aviation Investment and Reform Act for the 21st Century (Public Law 016-181, 114 Stat. 173) states that, notwithstanding section 202 of the Federal Property and Administrative Services Act of 1949 (40 U.S.C. 483) and subject to subsections (b) and (c), the Secretary of Defense may sell, during the period beginning on the date of enactment of this Act and ending September 30, 2002, certain aircraft and aircraft parts to a person or entity that provides oil spill response services (including the application of oil dispersants by air) pursuant to an oil spill response plan that has been approved by the Secretary of the Department in which the Coast Guard is operating. Section 740 states that, as soon as practicable after the date of enactment of the Act, the Secretary of Defense, in consultation with the Secretary of Transportation and the Administrator of General Services, shall prescribe regulations relating to the sale of aircraft and aircraft parts under this section. Section 1051 of the National Defense Authorization Act for Fiscal Year 2003 (Pub. L. 107-314, 116 Stat. 2648) provides for a four-year extension to this authority. This interim final rule prescribes such regulations.

It has been determined that 32 CFR 207 is not a significant regulatory action. The rule does not (1) have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of the recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President priorities, or the principles set forth in this Executive Order.

It has been certified that 32 CFR part 207 does not contain a Federal Mandate that my result in the expenditure by State, local, and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

It has been determined that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. This rule applies only to the sale of certain aircraft and aircraft parts to those entities that provide oil spill response services. The U.S. Department of Transportation provides the list of eligible entities that may bid on aircraft and aircraft parts.

It has been certified that 32 CFR part 207 does not impose any reporting or record-keeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 44).

It has been certified that 32 CFR part 207 does not have federalism implications, as set forth in Executive Order 13132.

On February 28, 2003, the Coast Guard published its “Notification of Arrival in U.S. Ports” in the Federal Register (68 FR 9537). This final rule, which became effective on April 1, 2003, permanently replaced the Coast Guard's temporary requirements for Notification of Arrival in U.S. Ports published on October 4, 2001, in the Federal Register (66 FR 50565) and was in addition to the Customs October 31, 2002 rule requiring cargo information 24 hours prior to lading (67 FR 66318).

This final rule requires electronic submission of cargo manifest (Customs form 1302) to Customs and Border Protection via the Automated Manifest System (AMS). Implementation of the requirement for electronic submission of cargo manifest is not required until July 1, 2003.

The cargo manifest submission requirement was established to capture electronically the information on cargo manifest from vessels that were not filing the information electronically with the Customs and Border Protection. While July 1, 2003, is the date for implementing the requirement to electronically transmit data through AMS that is set forth in the Final Rule published on February 28, 2003, the Coast Guard, in consultation with Customs and Border Protection, has decided to suspend the July 1, 2003 implementation date. The date is suspended pending further Custom and Border Protection regulatory action under recent legislation, including the Trade Act of 2002, which should eliminate the need for this requirement in Coast Guard regulations. In that event, the Coast Guard would remove the suspended provisions from its regulation.

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

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

(ii) The initials CO mean or refer to carbon monoxide.

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

(iv) The initials SIP mean or refer to State Implementation Plan.

(v) The initials SO2 mean or refer to sulfur dioxide.

(vi) The words State or Montana mean the State of Montana, unless the context indicates otherwise.

(vii) The initials SWS mean or refer to sour water stripper.

(viii) The initials YELP mean or refer to the Yellowstone Energy Limited Partnership.

We are approving the following provisions:

• YELP's emission limits in sections 3(A)(1) through (3) and reporting requirements in section 7(C)(1)(b) of YELP's exhibit A submitted on May 4, 2000.

• Provisions related to the burning of SWS overheads in the F-1 Crude Furnace (and exhausted through the F-2 Crude/Vacuum Heater stack) at ExxonMobil in sections 3(E)(4) and 4(E) (excluding “or in the flare” and “or the flare” in both sections), 3(A)(2), and 3(B)(3) of ExxonMobil's exhibit A, submitted on July 29, 1998 and method #6A-1 of attachment #2 of ExxonMobil's exhibit A, submitted on May 4, 2000.

• Minor changes in sections 3, 3(A) and 3(B) (only the introductory paragraphs); and sections 3(E)(3), 6(B)(7), 7(B)(1)(d), 7(B)(1)(j), 7(C)(1)(b), 7(C)(1)(d), 7(C)(1)(f), and 7(C)(1)(l) of ExxonMobil's exhibit A, submitted on May 4, 2000.

We are limitedly approving and limitedly disapproving the following provisions:

• Provisions related to the fuel gas combustion emission limitations at ExxonMobil in sections 3(B)(2), 4(B), and 6(B)(3) of ExxonMobil's exhibit A, submitted on July 29, 1998 and section 3(A)(1) of ExxonMobil's exhibit A, submitted on May 4, 2000.

• Provisions related to ExxonMobil's coker CO-boiler emission limitation in sections 2(A)(11)(d), 3(B)(1) and 4(C) of ExxonMobil's exhibit A, submitted on May 4, 2000.

• Provisions related to the burning of SWS overheads at Cenex in sections 3(B)(2) and 4(D) (excluding “or in the flare” and “or the flare” in both sections), 3(A)(1)(d), and 4(B) of Cenex's exhibit A, submitted on July 29, 1998, and method #6A-1 of attachment #2 of Cenex's exhibit A, submitted on May 4, 2000.

We caution that if sources are subject to more stringent requirements under other provisions of the Act ( e.g. , section 111 new source performance standards; Title I, Part C, (prevention of significant deterioration); or SIP-approved permit programs under Title I, Part A), our approval and limited approval of the SIP (including emission limitations and other requirements), would not excuse sources from meeting these other more stringent requirements. Also, our action on this SIP is not meant to imply any sort of applicability determination under other provisions of the Act ( e.g. , section 111; Title I, Part C; or SIP-approved permit programs under Title I, Part A).

On May 2, 2002, 67 FR 22242, we proposed action on portions of the State of Montana's July 29, 1998 submittal and all of the May 4, 2000 submittal. No comments were received on our proposed action. We are finalizing our action as proposed. For further information regarding the basis for this action, the reader should refer to our proposed action.

Once we approve a SIP, or parts of a SIP, the portions approved are legally enforceable by us and citizens under the Act. Once we limitedly approve/disapprove a SIP, or parts of a SIP, the portions limitedly approved/disapproved are also legally enforceable by us and citizens under the Act. Under a limited approval/disapproval action, we approve and disapprove the entire rule even though parts of it do and parts do not satisfy requirements under the Act. The rule remains a part of the SIP, however, even though there is a disapproval, because the rule strengthens the SIP. The disapproval only concerns the failure of the rule to meet specific requirements of the Act and does not affect incorporation of the rule as part of the approved, federally enforceable SIP. By disapproving parts of the plan, we are determining that the requirements necessary to demonstrate attainment in the area have not been met and we may develop a plan or parts of a plan to assure that attainment will be achieved.

EPA believes partially and limitedly approving the Billings/Laurel SO2 SIP meets the requirements of section 110(l) of the Act. The provisions of the plan that we are partially and limitedly approving strengthen the Montana SIP by providing specific emission limits for several SO2 sources in Billings/Laurel. This will achieve progress toward attaining the SO2 NAAQS.

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

Under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , OMB must approve all “collections of information” by EPA. The Act defines “collection of information” as a requirement for “answers to * * * identical reporting or recordkeeping requirements imposed on ten or more persons * * *” 44 U.S.C. 3502(3)(A). Because this rule does not impose an information collection burden, the Paperwork Reduction Act does not apply.

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 partial and limited approval 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. 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).

Moreover, EPA's limited disapproval will not have a significant impact on a substantial number of small entities because the limited disapproval action only affects two industrial sources of air pollution in Billings/Laurel, Montana: Cenex Harvest Cooperatives and ExxonMobil Company, USA. Only a limited number of sources are impacted by this action. Furthermore, as explained in this action, the submission does not meet the requirements of the Clean Air Act and EPA cannot approve the submission. The limited disapproval will not affect any existing State requirements applicable to the entities. Federal disapproval of a State submittal does not affect its State enforceability. Therefore, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Under section 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 partial and limited approval and limited disapproval actions do 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 partially and limitedly approves and limitedly disapproves 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 partially or limitedly approves and limitedly disapproves 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 6, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” 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. This action does not involve or impose any requirements that affect 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. Section 804, however, exempts from section 801 the following types of rules: rules of particular applicability; rules relating to agency management or personnel; and rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding this action under section 801 because this is a rule of particular applicability.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 21, 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).)

Table of Contents I. What action is EPA taking today? II. What is the origin of the requirements? III. When did the requirements first become known? IV. When did Vermont submit its negative declaration? V. Regulatory Assessment Requirements I. What Action Is EPA Taking Today?

EPA is approving the negative declaration submitted by the state of Vermont on August 20, 1996.

EPA is publishing this negative declaration without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register , EPA is publishing a separate document that will serve as the proposal to approve this negative declaration should relevant adverse comments be filed. If EPA receives no significant adverse comment by June 23, 2003, this action will be effective July 21, 2003.

If EPA receives significant adverse comments by the above date, we will withdraw this action before the effective date by publishing a subsequent document in the Federal Register . EPA will address all public comments received in a subsequent final rule based on the parallel proposed rule published in today's Federal Register . EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. If EPA receives no comments, this action will be effective July 21, 2003.

Under section 111(d) of the Clean Air Act, EPA published regulations at 40 CFR part 60, subpart B which require states to submit plans to control emissions of designated pollutants from designated facilities. In the event that a state does not have a particular designated facility located within its boundaries, EPA requires that a negative declaration be submitted in lieu of a control plan.

On May 30, 1991 (56 FR 24468), EPA proposed emission guidelines for existing MSW landfills. This action enabled EPA to list existing MSW landfills as designated facilities. EPA specified non-methane organic compounds (NMOC) as a designated pollutant by proposing the emission guidelines for existing MSW landfills. These guidelines were published in final form on March 12, 1996 (61 FR 9905).

On August 20, 1996, the Vermont Department of Environmental Conservation (DEC) submitted a letter certifying that there are no existing MSW landfills subject to 40 CFR part 60, subpart B. Section 111(d) and 40 CFR 62.06 provide that when no such designated facilities exist within a state's boundaries, the affected state may submit a letter of “negative declaration” instead of a control plan. EPA is publishing this negative declaration at 40 CFR 62.11485.

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), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing sections 111(d)/129 State Plans, 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 state plan for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a state plan, to use VCS in place of a 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 July 21, 2003. Interested parties should comment in response to the proposed rule rather than petition for judicial review, unless the objection arises after the comment period allowed for in the proposal. 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).)

Docket. The docket is an organized and complete file of all the information considered by the EPA in the development of the rule. The docket is a dynamic file because material is added throughout the rule development process. The docketing system is intended to allow members of the public and industries involved to readily identify and locate documents so that they can effectively participate in the rule development process. Along with the proposed and promulgated standards and their preambles, the contents of the docket will serve as the record in the case of judicial review. (See section 307(d)(7)(A) of the CAA.) The regulatory text and other materials related to the final rule are available for review in the docket or copies may be mailed on request from the Air and Radiation Docket and Information Center by calling (202) 566-1742. A reasonable fee may be charged for copying docket materials.

Electronic Docket Access. You may access the final rule electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility in the above paragraph entitled “Docket.” Once in the system, select “search,” then key in the appropriate docket identification number.

World Wide Web (WWW). In addition to being available in the docket, an electronic copy of the final rule will also be available on the WWW through the EPA's Technology Transfer Network (TTN). Following signature by the EPA Administrator, a copy of the final rule will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules at http://www.epa.gov/ttn/oarpg . The TTN provides information and technology exchange in various areas of air pollution control. If more information regarding the TTN is needed, call the TTN HELP line at (919) 541-5384.

Regulated Entities. Categories and entities potentially regulated by this action include those listed on the following table. This table is not intended to be exhaustive, but is just a guide to entities likely to be regulated by these standards. It lists the types of entities that may be regulated, but you should examine the applicability criteria in §§ 63.7181 and 63.7182 of the final rule to decide whether your facility is regulated by the standards. If you have any questions about whether your facility is subject to the standards, call the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Judicial Review. Under section 307(b) of the CAA, judicial review of the final rule is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by July 21, 2003. Under section 307(d)(7)(B) of the CAA, only an objection to the rule which was raised with reasonable specificity during the period for public comment can be raised during judicial review. Moreover, under section 307(b)(2) of the CAA, the requirements established by this final action may not be challenged separately in any civil or criminal proceeding we bring to enforce these requirements.

Outline. The information presented in this preamble is organized as follows:

Section 112 of the CAA requires us to list categories and subcategories of major sources and area sources of HAP and to establish NESHAP for the listed source categories and subcategories. On July 16, 1992, major source categories covered by the NESHAP were listed under the Semiconductor Manufacturing industry group (57 FR 31576). Major sources of HAP are those that have the potential to emit considering controls, in the aggregate, 10 tons per year (tpy) or more of any HAP or 25 tpy or more of any combination of HAP.

Section 112 of the CAA requires that we establish NESHAP for the control of HAP from both new and existing major sources. The CAA requires the NESHAP to reflect the maximum degree of reduction in emissions of HAP that is achievable. This level of control is commonly referred to as MACT.

The MACT floor is the minimum control level allowed for NESHAP and is defined under section 112(d)(3) of the CAA. In essence, the MACT floor ensures that the standard is set at a level that assures that all major sources achieve the level of control at least as stringent as that already achieved by the better-controlled and lower-emitting sources in each source category or subcategory. For new sources, the MACT floor cannot be less stringent than the emission control that is achieved in practice by the best-controlled similar source. The MACT standards for existing sources can be less stringent than the standards for new sources, but they cannot be less stringent than the average emission limitation achieved by the best performing 12 percent of existing sources in the category or subcategory (or the best performing five sources for categories with fewer than 30 sources).

In developing MACT, we also consider control options that are more stringent than the floor. We may establish standards more stringent than the floor based on consideration of the cost of achieving the emission reductions, any health and environmental impacts, and energy requirements.

In response to public comments received on the proposed standards, we made several changes in developing the final rule. Some of the changes had a direct effect on the MACT floors and emission limits, while other changes clarified the substantive requirements for the final rule. A more comprehensive summary of comments and responses can be found in Docket No. A-97-15 and E-Docket No. OAR-2002-0086.

Process vents. When we developed the original MACT floors for process vents, we first determined the control efficiency, expressed as percent emission reduction, for each process vent for which we had inlet and outlet HAP concentration data. We then ranked the process vents based on the control efficiency achieved. Based on the best performing five process vents, we determined that thermal oxidation was used for emission control on four of them. Consequently, we selected thermal oxidation as the MACT floor. For the emission limit, we chose 98 percent control as representative of the level of control typically achieved by thermal oxidizers in practice. We decided not to base the emission limit on the reported performance of the thermal oxidizers because, in all cases, the inlet streams were high volume with low concentration of HAP. Under those conditions, measurements of the actual performance of a thermal oxidizer can be unreliable. As such, we believe choosing 98 percent control efficiency is more representative of what the thermal oxidizers can consistently achieve in practice.

One commenter objected to this procedure, stating that the CAA directs us to consider only the actual performance of the sources used to establish the MACT floor. The commenter believed that we should revise the MACT floor and emission limits based on the reported performance of the five best performing sources. While we agree that the CAA directs us to base the MACT floors on actual performance, we believe that the test data do not accurately represent actual performance because of the high-volume, low-concentration nature of the emission streams.

In response to this comment, we decided to reevaluate the process vent MACT floor by considering organic and inorganic streams separately, as suggested by another commenter. By doing so, we can more accurately assess the performance of the different control devices used for these two types of emission streams.

Organic emission streams are almost always controlled by some type of thermal oxidation. As discussed above, measurements of thermal oxidizer performance can be unreliable for high-volume, low-concentration streams. Thus, we continue to believe that the test data for organic HAP emission control we obtained for thermal oxidizers controlling semiconductor manufacturing process vents may not accurately portray actual performance. Thus, our original selection of a known achievable emission reduction percentage, as used for MACT in rules such as the Hazardous Organic NESHAP or HON (57 FR 19402), better represents actual performance as directed by the CAA. For the final rule, we retained 98 percent control as the emission limit for organic emission streams from process vents. We also retained the alternative emission limit of 20 parts per million by volume (ppmv) for organic emission streams.

For inorganic emissions from process vents, all the data we obtained showed that scrubbers were used to control those emissions. Unlike thermal oxidizers, scrubbers experience less erratic performance characteristics with high-volume, low-concentration emission streams. Accordingly, we were able to use the actual performance data to establish the MACT floor for the control of inorganic emissions from process vents. Again, using the top five best performing process vents, we established the MACT floor as 95 percent control. Based on the actual outlet emissions of those five process vents, we established the alternative emission limit as 0.42 ppmv.

Storage tanks. We received comments on whether all of the tanks we included in the MACT floor analysis were the type of tank we intended to regulate through the rulemaking. The comments provided additional clarifying information on a number of the tanks we used to develop the MACT floor. Specifically, the comments questioned whether storage tanks for wastewater with very low concentration of HAP, waste storage tanks already covered under the Resource Conservation and Recovery Act (RCRA), and wastewater treatment tanks should have been included in the MACT floor analysis.

With the exception of wastewater treatment tanks, it was our intent to include all of these types of tanks in the affected source. However, based on the additional information provided by the industry, we have concluded that it was not appropriate to develop one MACT floor for all types of tanks due to the wide range of emissions from the each type of tank. Therefore, we developed separate MACT floors for chemical storage tanks (including waste storage tanks regulated under RCRA) and wastewater storage tanks.

We found that the level of control, based on the top five best performing sources in each data set, is the same for each type of tank. The level of control is to reduce emissions through the use of a scrubber and is identical to the level of control used to establish the MACT floor that was the basis of the emission limits in the proposed rule. However, based on other comments we received, we have decided not to use the same MACT floor procedure for the final rule.

Since the semiconductor industry storage tank emission streams will have similar characteristics to those of process vents ( i.e. , low pollutant concentration), rather than hydrochloric acid production industry storage tanks, we now believe the most representative similar sources for evaluating the MACT floor for storage tanks are the semiconductor industry process vents. Therefore, in response to the comments concerning our use of hydrochloric acid production industry storage tanks as the most representative similar source, we are adopting the process vent inorganic HAP emission limits for all storage tanks required to control emissions in the final rule.

The comments we received clarified that the reported wastewater treatment tanks were not actually storage tanks but flow-through tanks used for certain continuous treatment processes such as pH adjustment. The tank volume merely allows for a buffer so that the treatment can be adequately carried out. All of the flow-through tanks in the data supplied by the industry are controlled by scrubbers. However, the industry also provided information that the purpose of all of these scrubbers was primarily to control ammonia odors. We do not believe that requiring scrubbers on flow-through tanks would result in significant reductions of HAP emissions, nor was it our intent in the proposed rule to regulate such tanks. Therefore, the definition of storage tank that we added to the final rule clarifies that flow-through tanks are not considered storage tanks for the purposes of the final rule.

We made an additional change for the final rule based on our revised storage tank MACT floor analysis. Because we eliminated several tanks from the data set used in the MACT floor analysis, the cutoff for the smallest size tank for which the final rule applies increased from 800 gallons to 1,500 gallons. We also revised our analysis of alternatives more stringent than the MACT floor to reflect the increased tank size. We found that the cost per ton of additional emission reduction (approximately $300,000/ton) is still too great to warrant a more stringent level of control. We have also included a definition for “storage tank” to 40 CFR 63.7195 to clarify which tanks we intended to be subject to the final rule.

As part of our reevaluation of the MACT floors for process vents as described above, we also considered other compliance options to reflect our position on the performance of control devices. While we believe the performance of scrubbers controlling high-volume, low-concentration emission streams can be measured, we also recognize that control efficiency cannot always be reliably predicted for such streams. Also, facilities may choose to use a control device other than a scrubber which may be more difficult to measure performance. For these situations, we have included a compliance option to the final rule (see 40 CFR 63.7187(i)) that allows a source to perform a design evaluation of the add-on control device. If the inlet concentration of inorganic HAP is less than or equal to 20 ppmv, then the facility may choose to perform a design evaluation of the control device that demonstrates the device is capable of achieving the required control efficiency.

We chose 20 ppmv as the cutoff for allowing a design evaluation because the data we obtained showed erratic performance measurement values below this level. The test results show control device performance decreasing as the inlet concentration decreases. However, the last entry shows that even at very low inlet concentrations, control device performance can sometimes be high. These data show the difficulty of measuring control device performance with high-volume, low-concentration inlet streams, and why we believe a design evaluation procedure is necessary. In the final rule, we have adopted the design evaluation procedure alternative from the Pharmaceuticals Production NESHAP (40 CFR part 63, subpart GGG).

During our review of the proposed rule, we realized that we inadvertently omitted Method 26A of 40 CFR part 60, appendix A, for analysis of emission streams for inorganic HAP. The final rule includes this test method.

Comment: One commenter requested that EPA consider providing exemptions that would exclude insignificant sources from regulation. The commenter argued that the administrative burdens associated with the proposed rule are unwarranted for such sources. The commenter further argued that if additional add-on control devices would be required, it would result in insignificant HAP reductions. Another commenter suggested that storage tanks are insignificant HAP emission sources and should be excluded from the final rule.

Response: While we understand the commenters' concern with the burden imposed by regulation of sources with low annual emissions, the CAA does not provide a mechanism by which we can exempt such emission sources from the affected source solely on the basis of emissions. Additionally, some facilities in the semiconductor industry are characterized by multiple point sources of emissions, many of which have low annual emissions. If we exempted all such sources, there is a possibility that a large portion of the emissions from the facility could escape regulation. For these reasons, we are not exempting sources with low HAP emissions from the final rule.

Comment: One commenter contended that EPA's exemption of sources during periods of startup, shutdown, and malfunction is a violation of the requirement for continuous compliance. The commenter argued that EPA may only allow unavoidable deviations from emissions standards and must require that sources use best air pollution control practices during those periods.

Response: We disagree with the commenter's interpretation of the proposed rule. The General Provisions at 40 CFR 63.6(e)(1)(i) require that sources must at all times, including periods of startup, shutdown, and malfunction, maintain the affected source in a manner such that emissions are minimized to the level required by the relevant standard. That section further clarifies that this means to “meet the emission standards or comply with the startup, shutdown, and malfunction plan.” The purpose of the startup, shutdown, and malfunction plan (SSMP), as described in 40 CFR 63.6(e)(3)(i)(A), is to:

A properly written SSMP does not allow the source to emit at whatever levels they want merely because they comply with what they have written in the SSMP. Under the SSMP, the source must detail the procedures that will be used to maintain emissions within the limits set by the rule during periods of startup, shutdown, and malfunction. In this case, the SSMP is analogous to parameter monitoring for evaluating continuous compliance of add-on control devices. Just as maintaining the temperature of a thermal oxidizer at the proper operating temperature as determined during the initial compliance demonstration is deemed to be compliance with the emission limits, following the SSMP is deemed to be compliance with emission limits during periods of startup, shutdown, and malfunction.

Comment: One commenter was concerned with the burden of compliance as proposed at facilities that are classified as major sources of HAP due to processes other than semiconductor manufacturing and that only conduct minimal production of semiconductors for research and development purposes. The commenter requested that EPA add a de minimis threshold for rule applicability.

Response: Through our data gathering efforts, we found that research and development activities are often integrated into the production activities at semiconductor manufacturing facilities. Such research and development activities are often used in actual production because the technology upon which the manufacturing process is based undergoes substantial change every few years. This extremely short technology life cycle results in constant research and development efforts geared toward developing and implementing new manufacturing technologies. The continual research and development efforts result in an ongoing integration of new technologies into mainstream production operations. New manufacturing operations are typically not developed apart from existing manufacturing operations, but rather side-by-side with them. The new operations are gradually integrated into mainstream production. As such, the majority of research and development work is done in a manner nearly indistinguishable from the existing manufacturing process.

Given the manner in which research and development activities are integrated into production, there is no bright line distinction between research and development and production. They are located in the same clean rooms and, more importantly, share the same exhaust plenums and emission control devices. For these reasons, the research and development activities are considered part of the production process and are within the affected source.

We note, however, that the research and development operations have to be located at a semiconductor manufacturing facility to be considered a semiconductor manufacturing process unit. Therefore, research and development activities that are not used to produce semiconductors for commerce, or produce them only for captive use, would not be semiconductor manufacturing process units and would not be subject to the final rule. Nor would research and development operations that are stand alone activities (that is, not integrated into the production process) be subject to the final rule. We modified 40 CFR 63.7182(b) of the final rule to clarify this point.

Comment: One commenter argued that EPA must regulate all major sources and believed the proposed rule fails to do this because it does not apply to sources that installed add-on control devices after the facility was designed and commenced operation. The commenter interpreted the court's ruling in Alabama Power ( Alabama Power Co. v. U.S. EPA, 636 F.2d 323 (DC Cir. 1979)) as specifying that controls must be incorporated into the original design of the facility in order to be considered when calculating the facility's potential to emit.

Response: We believe the commenter incorrectly interpreted the court's decision in Alabama Power. That case addressed, in part, the interpretation of “potential to emit” in the definition of major source in the prevention of significant deterioration (PSD) regulations (also part of the CAA, but unrelated to hazardous air pollutant regulations). The court found that EPA “must look to the facility's ‘design capacity' a concept which not only includes a facility's maximum productive capacity * * * but also takes into account the anticipated functioning of the air pollution control equipment designed into the facility.” ( Alabama Power, 636 F.2d at 353). The commenter has interpreted this statement to mean that only controls that were part of the original design of the facility can be taken into account when calculating potential to emit. Nowhere does the court state or even imply such a result in its decision. The commenter failed to take into account that the PSD regulations define a preconstruction permitting process. Because the air emission sources under consideration in the PSD process have yet to be constructed, the permitting process must necessarily deal with only designs of future air emission sources. We believe the court's language reflects only this aspect of the PSD review process, not the interpretation given by the commenter.

The NESHAP program, on the other hand, is concerned with air emission sources already in existence, as well as new sources. If we were to apply the wording of Alabama Power to the NESHAP program, our interpretation would be that the phrase “designed into the facility” means any air emission control equipment in use at the facility at the time a major source determination must be made, not the interpretation given by the commenter. This is reflected in our memorandum  1 on the interim policy on federal enforceability of limitations on potential to emit. In this memorandum, we stated:

The phrase “have obtained, or plan to obtain” implies that these sources will be adding controls to limit emissions. Since these controls would be added to an existing facility, they could not have been designed into the facility before it was ever constructed. Thus, the commenter's interpretation is incorrect, and we have made no changes for the final rule in response to this comment.

Comment: One commenter requested that a definition for “process vent” be added to the final rule. Additionally, the commenter further argued that if EPA cannot exclude research and development vents from the definition of process vents, then the final rule must provide an exemption for research and development activities consistent with section 112(c)(7) of the CAA.

A second commenter was also concerned with the absence of a definition for process vent. The commenter pointed out that the absence of a definition results in ambiguity regarding compliance obligations. The commenter also suggested that a process vent definition would allow EPA to exclude categories of emission points with negligible emissions potential.

Response: We agree that a definition of “process vent” would be beneficial in determining which emission points at a semiconductor manufacturing facility are subject to the emission limitations in 40 CFR 63.7184 of the final rule. Because the affected source is defined in terms of semiconductor manufacturing process units (see 40 CFR 63.7182), the process vents subject to regulation necessarily must originate from these process units. Therefore, we have included the following definition to 40 CFR 63.7195: Process vent means the point at which HAP emissions are released to the atmosphere from a semiconductor manufacturing process unit or storage tank by means of a stack, chimney, vent, or other functionally equivalent opening. The HAP emission points originating from wastewater treatment equipment, other than storage tanks, are not considered to be a process vent, unless the wastewater treatment equipment emission points are connected to a common vent or exhaust plenum with other process vents.

We do not believe any of the other process vent exemptions requested by these commenters are appropriate. Research and development operations are considered to be part of the overall semiconductor manufacturing process unless they are stand alone operations. We believe that relief valve discharge points, process analyzers, and conservation vents can be adequately connected to process vent exhaust ducts, if this is not already the case. Emergency electrical generators are not included in the definition of semiconductor manufacturing process unit, so there is no need to exclude them from the definition of process vent.

Comment: One commenter was concerned about the broad definition of “control device” in 40 CFR 63.981(a). According to the commenter, this paragraph could be interpreted to mean that certain devices that are part of the process (not an add-on control device) would be subject to the rule.

Response: We agree that there are certain devices used by the semiconductor industry that could be construed as control devices but are in fact an inherent part of the process, and that clarification is necessary in the final rule. In response, we have included the following definition to 40 CFR 63.7195: Control device means a combustion device, recovery device, recapture device, or any combination of these devices used for the primary purpose of reducing emissions to comply with this subpart. Devices that are inherent to a process or are integral to the operation of a process are not considered control devices for the purposes of this subpart, even though these devices may have the secondary effect of reducing emissions.

Comment: One commenter objected to the EPA's approach of using area source information to establish the MACT floor as being inconsistent with section 112(d)(3) of the CAA. The commenter believed that area sources are not part of the semiconductor manufacturing category for major sources and should not be relied on for establishing the MACT floor.

Response: Section 112(a)(1) of the CAA defines major source as “any stationary source or group of stationary sources * * * that emits or has the potential to emit considering controls, in the aggregate, 10 tpy or more of any hazardous air pollutant or 25 tpy or more of any combination of hazardous air pollutants.” An area source is then defined in section 112(a)(2) as any stationary source that is not a major source. The facilities which we used to establish the MACT floor were “synthetic minor” sources, meaning that they reduced their potential to emit below the major source threshold (here, through the use of add-on control devices and material substitution). Without these controls, these facilities would have the potential to emit at major source levels.

We disagree that the MACT floors must be based solely on major sources of HAP emissions. Section 112(d)(1) of the CAA directs us to promulgate rules for categories of major and area sources of HAP emissions. Then, section 112(d)(2) mandates that these standards “shall require the maximum degree of reduction in emissions * * * achievable for new or existing sources.” Section 112(d)(3) specifies how we are to determine the maximum degree of emission reduction and describes it as “not less stringent than the emission control that is achieved in practice by the best controlled similar source” for new sources, and for existing sources describes it as “the average emission limitation achieved by the best performing 12 percent of the existing sources * * *” Even though Congress saw fit to distinguish between major and area sources in many other places in section 112 of the CAA, they specifically did not require that the floor be based on major sources. Throughout section 112(d), Congress simply used the term “source.” We interpret this to mean that Congress left it to our discretion to determine the most appropriate sources on which to base the MACT floors. Accordingly, for the proposed rule we used both major sources and synthetic minor sources as the basis of the MACT floors. We believe our interpretation of section 112(d) of the CAA is correct, and no changes were made for the final rule as a result of these comments.

Comment: One commenter contended that EPA may not set floors for process vents based on the technology of thermal oxidizers, but must identify the best performing process vents, determine their actual performance, and calculate floors based on the average of that performance. Another commenter questioned the validity of establishing a single concentration for total HAP emissions from process vents and requested that different control and concentration limits be set for the organic HAP and inorganic HAP emissions.

Response: After reviewing the procedure we used to establish the MACT floors in light of these comments, we agree that we should first establish a MACT floor for both organic and inorganic HAP emissions from process vents (other than storage tanks) and then evaluate the appropriate emission limits for each. Based on a revised analysis, we calculated the MACT floor for organic process vents to be 98 percent control, or an organic HAP emission limit of 20 ppmv, which were the emission limits in the proposed rule. For inorganic HAP, we calculated the MACT floor to be 95 percent control or an inorganic emission limit of 0.42 ppmv. We have written 40 CFR 63.7184 of the final rule to reflect these revised MACT floors.

Comment: One commenter had several concerns with the approach used to establish the MACT floor for storage tanks. The commenter believed that area source semiconductor manufacturing facilities and HCl production sources are not part of the major source semiconductor manufacturing category and should not have been relied on to set the storage tank MACT floor. Two commenters requested that any storage tank limits should be limited specifically to tanks storing HCl or hydrofluoric acid (HF).

Another commenter argued that EPA improperly based floors for storage tanks over 800 gallons on the performance of scrubbers. The commenter stated that EPA must identify the relevant best performing storage tanks, determine their actual performance, and recalculate floors for storage tanks over 800 gallons based on the average of that performance. The commenter also contended that EPA must conduct beyond-the-floor analysis for storage tanks under 800 gallons to determine the maximum degree of emissions reductions achievable.

One commenter argued that any final rule should exclude hazardous waste storage tanks and vessels storing wastewater. The commenter contended that EPA has not made the required MACT finding for hazardous waste storage tanks and vessels storing wastewater. The commenter further argued that hazardous waste storage vessels and vessels storing wastewater have low HAP concentrations and do not warrant regulation beyond RCRA requirements.

Response: We agree that the procedure outlined by these commenters is the best procedure for determining the MACT floors, assuming that the appropriate data are available. In the case of storage tanks, we had no such data. The only data the industry could provide to us were the size of the tank, contents of the tank, and whether emissions from the tank were controlled. No performance data were available for the tank emission controls used by the semiconductor industry. For these reasons, we used data on the performance of the most representative similar source for which data were available, which were for scrubbers on HCl storage tanks obtained from the HCl manufacturing industry. Based on these comments, we now believe it is more appropriate to develop separate MACT floors for the different types of storage tanks in the semiconductor industry, and that it was inappropriate to use storage tanks from the HCl production industry as the most representative similar source.

It was always our intent to include all storage and wastewater tanks containing HAP in the affected source. However, based on the additional information provided by the industry, we have concluded that it was not appropriate to develop one MACT floor for all types of tanks due to the wide range of emissions from the each type of tank. While we cannot exempt an emission source solely due to the low annual emissions from that source, we thought that the MACT floor level of control could be influenced by the level of emissions from each type of tank and the existing regulations ( i.e. , RCRA) to which some tanks may be subject. Therefore, we developed separate MACT floors for chemical storage tanks (including waste storage tanks regulated under RCRA), wastewater storage tanks, and wastewater treatment tanks.

We found that the MACT floor level of control for both chemical storage tanks and wastewater storage tanks, based on the top five best performing sources in each data set, is the same for each type of tank. The level of control is to reduce emissions through the use of a scrubber and is identical to the level of control used to establish the emission limits as proposed. However, based on other comments we received, we decided not to use the same procedure to establish the emission limits for the final rule. For wastewater treatment tanks, we determined the MACT floor level of control to be no emissions reduction.

The data set we used to establish the original MACT floor for storage tank emissions included the type of control ( e.g. , scrubbers), but no information on the performance of the control devices or pollutant concentration in the outlet streams. In order to establish emission limits, we previously relied on the performance of controls used by the HCl production industry on HCl storage tanks. We used these data because the majority of tanks reported by the semiconductor industry contained HCl as well. We considered the HCl production industry data to be the most representative similar source for which we had data.

The comments we received questioned whether these storage tanks were representative, similar sources. In response to these comments, we further investigated the similarities and differences of the semiconductor manufacturing industry storage tanks and the HCl production industry tanks. We first determined that there is a large size differential between the tanks used by the semiconductor industry and those used by the HCl production industry. The largest reported semiconductor industry storage tank was 16,000 gallons, and most were less than 10,000 gallons. In contrast, most of the storage tanks reported by the HCl production industry ranged from 200,000 gallons to over 2 million gallons. We then determined that the HCl stored by the semiconductor industry was often diluted, while the HCl production industry almost exclusively stored concentrated HCl. Based on the larger tank size and the higher concentration of material stored, the emission streams from the HCl production industry storage tanks will have a considerably higher pollutant concentration than from the semiconductor industry storage tanks. We believe this is a more important consideration when establishing emission limits than simply looking at the similarity of the material stored. Thus, we expect that the emissions streams from the semiconductor manufacturing industry storage tanks will have a very low concentration of pollutants.

Since the semiconductor industry storage tank emission streams will have similar characteristics to those of process vents ( i.e. , low pollutant concentration), we now believe the most representative similar sources for evaluating the MACT floor for storage tanks are the semiconductor industry process vents. Therefore, in response to the comments concerning our use of HCl production industry storage tanks as the most representative similar source, we are adopting the process vent inorganic HAP emission limits for storage tanks in the final rule.

We also agree that we should have given further consideration to controls more stringent than the MACT floor for storage tanks less than 800 gallons (now 1,500 gallons in the final rule as discussed below) and wastewater treatment tanks. The MACT floor for both of these types of tanks was determined to be no control. However, controls more stringent than the MACT floor ( i.e. , scrubbers) are technically feasible as demonstrated by the data provided by the industry on tanks greater than 1,500 gallons.

In order to include emission limits more stringent than the MACT floor level of control in the final rule, they must be feasible on both a technical and cost basis. Technical feasibility is assumed based on similar control on larger tanks as reported by the industry. To evaluate cost feasibility, we estimated the HAP emissions from a 1,500 gallon tank containing concentrated HCl, assuming one complete turnover per day. These parameters will result in the maximum amount of HAP emissions from the tank that we would expect for the semiconductor manufacturing industry. We then estimated the cost of a scrubber to control these emissions by 99 percent. Finally, we calculated the cost per ton of additional HAP emission reduction achieved above the MACT floor level of control, which was more than $285,000 per ton. Based on this result, we considered this level of control to be infeasible on a cost basis and did not require emission control more stringent than the MACT floor for storage tanks less than 1,500 gallons or wastewater treatment tanks in the final rule.

We made an additional change for the final rule based on our revised storage tank MACT floor analysis. Because we eliminated several tanks from the data set used in the MACT floor analysis, the cutoff for the smallest size tank for which the final rule applies increased from 800 gallons to 1,500 gallons.

While the storage tanks that were used to establish the MACT floor level of control stored either HCl or HF, we believe this level of control is applicable to any material stored by a semiconductor manufacturing facility. Therefore, we do not believe that the emission limits must necessarily be limited to these two chemicals, as suggested by one of the commenters.

In our final analysis, we determined that the level of control already existing on waste storage tanks regulated under RCRA is equivalent to the storage tank MACT floor level of control. We also determined that the MACT floor for wastewater treatment tanks was no emissions reduction. Accordingly, we excluded both types of tanks from any requirements in the final rule. We added the following definition (based on the definition of “tank” in 40 CFR 63.901, (subpart OO—National Emission Standards for Tanks-Level 1) and 40 CFR 63.1101 (subpart YY—National Emission Standards for Hazardous Air Pollutants for Source Categories: Generic Maximum Achievable Control Technology Standards)) for “storage tank” to 40 CFR 63.7195 that clarifies which tanks we intended to be covered under the final rule: Storage tank means a stationary unit that is constructed primarily from nonearthen materials (such as wood, concrete, steel, fiberglass, or plastic) which provides structural support and is designed to hold an accumulation of liquids or other materials used in or generated by a semiconductor manufacturing process unit. The following are not storage tanks for the purposes of the final rule:

• Tanks permanently attached to motor vehicles such as trucks, railcars, barges, or ships;

• Flow-through tanks where wastewater undergoes treatment (such as pH adjustment) before discharge, and are not used to accumulate wastewater;

• Bottoms receiver tanks; and

• Surge control tanks.

Comment: One commenter reiterated a previous request for EPA to delist the Semiconductor Manufacturing source category and provided information to support their request. The commenter claimed that this information shows that there will be no stand alone semiconductor manufacturing facilities. Therefore, since EPA listed this category on the MACT source category list at a time when there were stand alone facilities that were major sources, the basis for listing the category no longer exists. The commenter cited the preamble language from the initial source category listing notice (57 FR 31576, July 16, 1992) and the first notice revising the list (61 FR 28200, June 4, 1996) to support their interpretation of when a category should be included on the source category list. The commenter stated that if a stand alone major source did come into existence in the future, EPA could promulgate a MACT standard at that time. Additionally, the commenter pointed out that case-by-case MACT determinations under section 112(g) of the CAA could also be used to control emissions from such a source.

The commenter also pointed to other EPA actions to support their position. The commenter noted that EPA guidance issued after the National Mining Association court case ( National Mining Association v. U.S. EPA, 59 F.3d 1351 (D.C. Cir. 1995)) states that section 112(d) standards should be applied to source categories that contain stand alone major sources or that have sources “commonly located” at major source facilities. The commenter also noted that EPA, in promulgating MACT standards for industrial process cooling towers (IPCT), had found that co-location of an IPCT on a major source site is not sufficient to trigger applicability of the rule, rather, the IPCT must be co-located and an integral part of the facility.

The commenter disagreed with EPA's interpretation that a source category delisting can proceed only under section 112(c)(9) of the CAA. The commenter believed that EPA has a non-discretionary duty under section 112(c)(1) to periodically revise the list in response to new information. Under the provisions specified in section 112(c)(1), which the commenter believes are wholly separate from the delisting procedure in section 112(c)(9), EPA has the authority and the latitude to remove a previously listed source category from the MACT standard source category list.

Response: In the preamble to the proposed rule for semiconductor manufacturing, we acknowledged receipt of the pre-proposal request to remove the Semiconductor Manufacturing source category from the list of source categories and indicated we would respond in the final rulemaking (67 FR 30852, May 8, 2002).

Section 112(d)(1) of the CAA directs EPA to promulgate regulations for categories of major sources of HAP emissions. We interpret section 112(a) as requiring consideration of all emissions sources in determining major source status. Thus, if a source emits 10 tons or more per year of any single HAP or 25 tons or more per year of any combination of HAP, it is a major source. Similarly, if a source is co-located with sources in other categories and the aggregate emissions of the combined sources is 10 or more tons per year of a single HAP or 25 tons or more per year of any combination of HAP, that group of co-located sources is a major source. This interpretation is consistent with the legislative history on the definition of “major source,” which indicates clearly that all portions of a major source are subject to MACT even if, standing alone, individual portions of that source would not qualify as major. [136 Cong. Rec. S. 16927 (October 27, 1990)].

The definition of major source also includes provisions to assure that stationary sources which would otherwise be subject to the emissions standards are not excluded from control requirements as the result of arbitrary subdivision or description of the source. A stationary source potentially subject to an emissions standard because it emits a listed air pollutant is to be defined to include all emission points and units of such source located within a contiguous area and under common control.

Because the statute instructs EPA to consider co-located sources as major sources, we believe we must list and promulgate standards for source categories that are major sources as a result of co-location. Accordingly, when we published the initial list of source categories, we “includ[ed] categories of major sources where there was reasonable certainty that at least one stationary source is a major source or where sources in the category [were] commonly located on the premises of major sources.” (57 FR 31576, July 16,1992). The EPA continues to believe that major source determinations must be based on facility-wide emissions and that a major source can be either a stand alone major source or co-located with other sources that in combination emit or have the potential to emit over the major source threshold.

We disagree with the commenter's reading of the preamble to the IPCT MACT standard. In promulgating the MACT standard, we said that even though no individual source in the IPCT source category is itself a major source, we promulgated a MACT standard in light of IPCT being co-located with other major sources of HAP (59 FR 46339, September 8, 1994). The IPCT MACT provides clear precedent both for promulgating a semiconductor MACT standard and to not remove the Semiconductor Manufacturing source category from the list of source categories.

Accordingly, because section 112(d) requires EPA to promulgate MACT standards for all major sources, and since the Semiconductor Manufacturing source category is a category of major sources, albeit, because existing sources are co-located with other sources that in combination emit or have the potential to emit over the major source thresholds, EPA will not revise the list of source categories to remove the Semiconductor Manufacturing source category.

Finally, we also believe this source category is not static and that changes (either economic or process) may trigger operational changes that could result in increased HAP emissions. Thus, it is not entirely clear whether those sources that are currently “synthetic area sources” will continue to be “synthetic area sources.” And accordingly, it is not inconceivable that the MACT standards promulgated today will eventually be applicable to more than the one currently co-located facility. In addition, there is always the possibility of new major sources being constructed in the future.

Comment: One commenter requested that EPA reconsider delisting this source category using de minimis principles under section 112(c)(1) of the CAA. The commenter proposed exemption of all nonmajor semiconductor process units from regulation in a manner consistent with the approach to applicability in section 112(g) of the CAA.

Response: The commenter's suggested de minimis cutoff levels are inconsistent with the CAA's prescribed method for determining the MACT floor. We do not believe that the CAA authorizes exempting an emission source solely due to the low annual emissions from that source. The outlet concentration limits for both inorganic and organic emissions serve as the minimum applicable limits for the affected sources. If the outlet concentration is below the applicable emission limit, no controls are required to demonstrate compliance.

The Semiconductor Manufacturing source category includes operations used to manufacture p-type and n-type semiconductors and active solid-state devices from a wafer substrate. Research and development activities located at a site manufacturing p-type and n-type semiconductors and active solid-state devices are integrated into the manufacturing process (that is, they are not stand alone operations), and these are included in the definition of semiconductor manufacturing. Examples of semiconductor or related solid-state devices include semiconductor diodes, semiconductor stacks, rectifiers, integrated circuits, and transistors. The source category includes all manufacturing from crystal growth through wafer fabrication, and test and assembly.

The crystal growing stage is where crystalline wafers of silicon or other specific semiconducting materials are manufactured for use as the substrate in the wafer fabrication process. Crystal growing begins with storage of the raw materials (usually trichlorosilane, which is refined from ordinary sand) and ends with the final polishing of a wafer.

The wafer fabrication process is where a group of integrated circuits are created on the wafer through a series of pattern-forming processes. Wafer fabrication begins at the point where the wafer receives its first protective oxidative layer and ends when a functional integrated circuit or circuits have been created on a wafer.

The test and assembly process is the final step in the integrated circuit manufacturing process and begins when a wafer is cut into individual chips. The chips are then mounted onto a metal frame, connected to the leads, and enclosed in a protective housing. The process endpoint is the last test performed at an assembly facility to verify proper function of a completed integrated circuit housing.

We define an affected source as a stationary source, group of stationary sources, or part of a stationary source to which specific NESHAP apply. Within a source category, we select the specific emission sources (emission points or groupings of emission points) that will make up the affected source for that category. To select these emission sources, we mainly consider the constituent HAP and quantity emitted from individual or groups of emission points.

For the Semiconductor Manufacturing source category, the affected source includes the collection of all semiconductor manufacturing units used to manufacture p-type and n-type semiconductors and active solid-state devices from a wafer substrate, research and development activities integrated into the manufacturing process at a semiconductor manufacturing site, and storage tanks located at a major source.

A semiconductor manufacturing process unit is the equipment assembled and connected by duct work or hard piping including: Furnaces and associated unit operations; associated wet and dry work benches; associated recovery devices; feed, intermediate, and product storage tanks; product transfer racks and connected ducts and piping; pumps, compressors, agitators, pressure-relief devices, sampling connection systems, open-ended valves or lines, valves, connectors, and instrumentation systems; and control devices. We have identified three distinct processes used in the manufacture of these semiconductors and devices: Crystal growing, wafer fabrication, and assembly and test. A semiconductor manufacturing unit is typically engaged in one of these processes.

Emission limits. We are promulgating standards that regulate HAP emissions from process vents and storage tank vents at semiconductor manufacturing facilities. The standards are the same for existing and new sources. All major sources must reduce process vent organic HAP outlet concentrations by 98 percent from their uncontrolled levels and reduce uncontrolled inorganic HAP outlet concentrations by 95 percent. As an alternative, process vents may be controlled to a level below 20 ppmv organic HAP and 0.42 ppmv inorganic HAP. In addition, all major sources must reduce storage tank vent HAP outlet inorganic HAP concentrations by 95 percent from their uncontrolled levels. As an alternative, storage tank vents may be controlled to a level below 0.42 ppmv inorganic HAP.

General Provisions. The General Provisions (40 CFR part 63, subpart A) also apply to you as outlined in the final rule. The General Provisions codify certain procedures and criteria for all 40 CFR part 63 NESHAP. The General Provisions contain administrative procedures, preconstruction review procedures for new sources, and procedures for conducting compliance-related activities such as notifications, reporting, and recordkeeping, performance testing, and monitoring. The final rule refers to individual sections of the General Provisions to emphasize key sections that you should be aware of. However, unless otherwise specifically excluded in the final rule, all of the relevant General Provisions requirements apply to you.

Existing semiconductor manufacturing affected sources must comply with the final rule no later than 3 years after May 22, 2003. The effective date is May 22, 2003. New or reconstructed affected sources must comply upon start-up or May 22, 2003, whichever is later. Details of the compliance requirements can be found in the General Provisions, as outlined in Table 2 to the subpart.

In addition to the specific testing and monitoring requirements specified below for the affected source, the final rule adopts the testing requirements specified in 40 CFR 63.7.

We are promulgating testing and initial and continuous compliance requirements that are, where appropriate, based on procedures and methods that we have previously developed and used for sources similar to those for which standards are being promulgated today. For example, we are promulgating compliance determination procedures, performance tests, and test methods to determine what level of control a process vent needs to achieve to demonstrate compliance with the standards. We are promulgating compliance procedures to determine process vent and storage tank vent flow rates and HAP concentrations. The promulgated test methods parallel what we have used for process vents in previous organic HAP emissions standards ( e.g. , the HON) and inorganic HAP emission standards. For measuring vent stream flow rate, you must use Method 2, 2A, 2C, 2D, 2F, or 2G of 40 CFR part 60, appendix A. For measuring total vent stream organic HAP concentration to determine whether it is below a specified level, you must use Method 18 of 40 CFR part 60, appendix A. For measuring the total HAP concentration of emission streams with inorganic HAP to determine if it is below a specified level, you must use Method 320 of 40 CFR part 60, appendix A. For measuring inorganic HAP that are hydrogen halides, such as HCl or HF, you must use Method 26A of 40 CFR part 60, appendix A.

Additionally, we are requiring initial performance tests for all process vent and storage tank vent HAP emission control devices other than flares and certain boilers and process heaters. For vents controlled using flares, we are not requiring performance tests because we have developed design specifications that ensure these devices will achieve 98 percent destruction efficiency. As with the HON, we are not promulgating a requirement to perform an initial performance test for boilers and process heaters larger than 44 megawatts (MW) because they operate at high temperatures and residence times. In general, the higher the temperature and residence time, the greater the level of HAP destruction that is achieved by a control device. Therefore, boilers and process heaters larger than 44 MW easily achieve the required 98 percent destruction efficiency or the alternative requirement to reduce outlet concentrations below 20 ppmv.

For all other types of control devices, the final rule requires you to conduct a performance test to demonstrate that the control device can achieve the required control level and to establish operating parameters to be maintained to demonstrate continuous compliance. The testing requirements for semiconductor manufacturing list the parameters that can be monitored for the common types of combustion devices. For other control devices, we require that you establish site-specific parameter ranges for monitoring purposes through the Notification of Compliance Status report and through the facility's operating permit. Parameters selected are required to be good indicators of continuous control device performance.

We are promulgating notification, recordkeeping, and reporting requirements in accordance with 40 CFR part 63, subpart A and other previously promulgated NESHAP for similar source categories.

We are requiring that owners or operators of semiconductor manufacturing affected sources submit the following four types of reports: An Initial Notification report, a Notification of Compliance Status report, periodic compliance reports, reports of changes and other specified events. Records of reported information and other information necessary to document compliance with the promulgated standards are required to be kept for 5 years. Equipment design records would be required to be kept for the life of the equipment.

For the Initial Notification report, we are requiring that you list the semiconductor manufacturing operations at your facility, and the provisions of the final rule that may apply. The Initial Notification report must also state whether your facility can achieve compliance by the specified compliance date. You must submit this notification by May 21, 2004, for existing sources, and within 180 days before commencement of construction or reconstruction of an affected source.

For the Notification of Compliance Status report, we are requiring that you submit the information necessary to demonstrate that compliance has been achieved, such as the results of performance tests and design analyses. For each test method that you use for a particular kind of emission point ( e.g. , process vent), you must submit one complete test report. This notification must also include the specific range established for each monitored parameter for each emission point for demonstrating continuous compliance, and the rationale for why this range indicates proper operation of the control device.

We are requiring that you submit semiannual compliance reports. These reports must include a statement that no deviations from the emission limitations occurred during the reporting period, and that no continuous monitoring system (CMS) was inoperative, inactive, malfunctioning, out-of-control, repaired, or adjusted. Additionally, a statement must be included if you had a startup, shutdown, or malfunction during the reporting period, and you took actions consistent with your SSMP. For process and storage tank vents, records of continuously monitored parameters must be kept. Records that such inspections or measurements were performed must be kept, but results are included in your periodic report only if there is a deviation from the operating limit. For each deviation from an emission limit, the semiannual compliance reports must document the time periods of each deviation; its cause; whether it occurred during a period of startup, shutdown, or malfunction; and whether and what time periods the CMS was inoperative or out of control.

We are requiring that you submit an immediate startup, shutdown, and malfunction report if you had a startup, shutdown, or malfunction that is not consistent with your SSMP.

Other reporting requirements include reports to notify the regulatory authority before or after a specific event ( e.g. , if a process change is made, requests for extension of repair period).

This section presents projected impacts for existing sources only. We did not calculate impacts for new sources because we do not project any new major sources will commence construction in the foreseeable future. We expect that any new sources will have HAP emissions below major source thresholds. The industry trend over the past several years has been that HAP emissions have decreased while semiconductor production has increased. As a result, only one source in the industry is still a major source of HAP, and only because it is collocated at a facility with other HAP-emitting operations. We do not project that any other new semiconductor sources will be built on the site of another major HAP emitting operation. We also project that the types of technologies that have evolved ( e.g. , producing larger wafers), which are in general emit fewer HAP per chip manufactured, will continue.

We do not anticipate any significant increase in national annual energy usage as a result of the final rule. Energy impacts include changes in energy use, typically increases, and secondary air impacts associated with increased energy use. Increases in energy use are associated with the operation of control equipment—in this case, the use of thermal oxidizers and scrubbers—to control process vents. Secondary air impacts associated with increased energy use are the emission of particulates, sulfur oxides (SO X ), and nitrogen oxides (NO X ). These secondary impacts are associated with power plants that would supply the increased energy demand. Since we project the final rule will apply to only one existing major source, no significant new control equipment requirements are expected. Therefore, secondary and energy impacts will be negligible.

Although we estimate there are approximately 127 facilities engaged in semiconductor production, we estimate that the source category contains only one existing major source subject to the regulatory provisions specified under the final rule. The remaining facilities are either area sources or synthetic minor sources, which are sources that have the potential to emit above major source thresholds but have taken enforceable permit conditions limiting their HAP emissions to below these major source thresholds.

We estimate the annualized cost for the one major source affected by this final rule to be $2,300, solely to comply with monitoring, inspecting, reporting and recordkeeping requirements. ( Note: This source meets the CAA section 112 definition of “major source” not because it emits 10 tons or more of any one HAP or 25 tons or more of HAP in aggregate, but because it is collocated at a plant site that is a major source subject to other NESHAP. We estimate this semiconductor manufacturing source emits less than one ton of HAP per year.) We project there will be no capital or operating costs for control equipment. Further, we estimate a one-time total cost of $33,000 for the approximately 126 non-major sources to read the rule. We estimate that there will be no impacts on new sources because we do not project that any new major sources will be built over the next 3 years.

The final rule applies to only one major existing source, and no significant new control equipment requirements are expected. We estimate the MIRR costs for this facility to be only $6,956 over a 3-year period. Therefore, no economic impact on the industry is expected.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), we must determine whether the regulatory action is “significant” and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. The Executive Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligation of recipients thereof; or

(4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

It has been determined that this rule is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to OMB review.

The information collection requirements in the final rule have been submitted for approval to OMB under the Paperwork Reduction Act, 44 U.S.C. 3501, et seq. An Information Collection Request (ICR) document has been prepared by EPA (ICR No. 2042.01) and a copy may be obtained from Susan Auby by mail at the Collection Strategies Division (2822), U.S. EPA, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, by e-mail at auby.susan@epa.gov, or by calling (202) 566-1672. A copy may also be downloaded off the internet at http://www.epa.gov/icr . The information requirements are not enforceable until OMB approves them.

The information requirements are based on notification, recordkeeping, and reporting requirements in the NESHAP General Provisions (40 CFR part 63, subpart A), which are mandatory for all operators subject to national emission standards. These recordkeeping and reporting requirements are specifically authorized by section 114 of the CAA (42 U.S.C. 7414). All information submitted to EPA pursuant to the recordkeeping and reporting requirements for which a claim of confidentiality is made is safeguarded according to Agency policies set forth in 40 CFR part 2, subpart B.

The annual monitoring, reporting, and recordkeeping burden for this collection, as averaged over the first 3 years after the effective date of the rule, is estimated to be 41 labor hours per year at a total annual cost of $2,319. This estimate includes a one-time plan for demonstrating compliance, annual compliance certification reports, notifications, and recordkeeping. Total labor burden associated with the monitoring requirements over the 3-year period of the ICR are estimated at $6,956.

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

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR, chapter 15. The OMB control number for the information collection requirements in this rule will be listed in an amendment to 40 CFR part 9 in a subsequent Federal Register document after OMB approves the ICR.

The EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with the final rule. The EPA has also determined that this final rule will not have a significant economic impact on a substantial number of small entities. For purposes of assessing the impacts of this final rule on small entities, small entity is defined as: (1) A small business according to Small Business Administration (SBA) size standards for NAICS code 334413 ( i.e. , semiconductor crystal growing facilities, semiconductor wafer fabrication facilities, semiconductor test and assembly facilities) whose parent company has 500 or fewer employees; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule on small entities, EPA has concluded that this action will not have a significant economic impact on a substantial number of small entities. Based on the above definition of small entities, the EPA has determined that there are no small businesses within this source category that would be subject to the final rule.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rule with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

The EPA has determined that the final rule does not contain a Federal mandate that may result in expenditures of $100 million or more to State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. The maximum total annual cost of the final rule for any year has been estimated to be about $35,800. Thus, the final rule is not subject to the requirements of sections 202 and 205 of the UMRA. In addition, EPA has determined that the standards contains no regulatory requirements that might significantly or uniquely affect small governments because it contains no requirements that apply to such governments or impose obligations upon them.

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

The final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to the rule. Although section 6 of Executive Order 13132 does not apply to the rule, EPA did consult with State and local officials to enable them to provide timely input in the development of the final rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires the EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” The final rule does not have tribal implications, as specified in Executive Order 13175. No tribal governments own or operate semiconductor manufacturing facilities. Thus, Executive Order 13175 does not apply to the final rule.

Executive Order 13045 (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 EPA must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. The final rule is not subject to Executive Order 13045 because it is based on technology performance and not on an assessment of health or safety risks. Furthermore, the final rule has been determined not to be “economically significant” as defined under Executive Order 12866.

The final rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) of 1995 (Pub. L. No. 104-113; 15 U.S.C. 272 note) directs the EPA to use voluntary consensus standards in their regulatory and procurement activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, business practices) developed or adopted by one or more voluntary consensus bodies. The NTTAA directs EPA to provide Congress, through annual reports to the Office of Management and Budget (OMB), with explanations when an agency does not use available and applicable voluntary consensus standards.

The final rule involves technical standards. The EPA cites the following standards in this rule: EPA Methods 1, 1A, 2, 2A, 2C, 2D, 2F, 2G, 3, 3A, 3B, 4, 18, 25, 25A, 26, 26A, and 320. Consistent with the NTTAA, EPA conducted searches to identify voluntary consensus standards in addition to these EPA method. No applicable voluntary consensus standards were identified for EPA Methods 1A, 2A, 2D, 2F, 2G. The search and review results have been documented and are placed in the docket A-97-15 for the final rule.

The voluntary consensus standard ASTM D6420-99, “Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry (GC/MS),” is appropriate in the cases described below for inclusion in this rule in addition to EPA Method 18 codified at 40 CFR Part 60 Appendix A for the measurement of toluene and total organic HAP.

Similar to EPA's performance-based Method 18, ASTM D6420-99 is also a performance-based method for measurement of gaseous organic compounds. However, ASTM D6420-99 was written to support the specific use of highly portable and automated GC/MS. While offering advantages over the traditional Method 18, the ASTM method does allow some less stringent criteria for accepting GC/MS results than required by Method 18. Therefore, ASTM D6420-99 is a suitable alternative to Method 18 only where: (1) The target compound(s) are those listed in Section 1.1 of ASTM D6420-99, and (2) the target concentration is between 150 ppbv and 100 ppmv.

For target compound(s) not listed in Section 1.1 of ASTM D6420-99, but potentially detected by mass spectrometry, the regulation specifies that the additional system continuing calibration check after each run, as detailed in Section 10.5.3 of the ASTM method, must be followed, met, documented, and submitted with the data report even if there is no moisture condenser used or the compound is not considered water soluble. For target compound(s) not listed in Section 1.1 of ASTM D6420-99, and not amenable to detection by mass spectrometry, ASTM D6420-99 does not apply.

As a result, EPA will cite ASTM D6420-99 in this rule. The EPA will also cite Method 18 as a gas chromatography (GC) option in addition to ASTM D6420-99. This will allow the continued use of GC configurations other than GC/MS.

In addition to the voluntary consensus standard EPA cites in this rule, the search for emissions measurement procedures identified 14 other voluntary consensus standards. The EPA determined that 11 of these 14 standards identified for measuring emissions of the HAPs or surrogates subject to emission standards in this rule were impractical alternatives to EPA test methods for the purposes of this rule. Therefore, EPA does not intend to adopt these standards for this purpose. The reasons for this determination for the 11 methods are discussed in the docket.

Two of the 14 voluntary consensus standards identified in this search were not available at the time the review was conducted for the purposes of the final rule because they are under development by a voluntary consensus body: ASME/BSR MFC 13M, “Flow Measurement by Velocity Traverse,” for EPA Method 2 (and possibly 1); and ASME/BSR MFC 12M, “Flow in Closed Conduits Using Multiport Averaging Pitot Primary Flowmeters,” for EPA Method 2.

The voluntary consensus standard ASTM D6348-98, “Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform (FTIR) Spectroscopy,” has been reviewed by the EPA as a potential alternative to EPA Method 320. Suggested revisions to ASTM D6348-98 were sent to ASTM by the EPA that would allow the EPA to accept ASTM D6348-98 as an acceptable alternative. The ASTM Subcommittee D22-03 is currently undertaking a revision of ASTM D6348-98. Because of this, we are not citing this standard as a acceptable alternative for EPA Method 320 in the final rule today. However, upon successful ASTM balloting and demonstration of technical equivalency with the EPA FTIR methods, the revised ASTM standard could be incorporated by reference for EPA regulatory applicability. In the interim, facilities have the option to request ASTM D6348-98 as an alternative test method under 40 CFR 63.7(f) and 63.8(f) on a case-by-case basis.

Table 1 to subpart BBBBB lists the EPA testing methods included in the final rule. Under 40 CFR 63.7(f) and 63.8(f) of subpart A, a source may apply to EPA for permission to use alternative test methods or alternative monitoring requirements in place of any of the EPA testing methods, performance specifications, or procedures.

The Congressional Review Act, 5 U.S.C. 801, et seq. , as added by the SBREFA, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing the rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). The rule will be effective May 22, 2003.

Table of Contents I. Introduction II. NPL Deletion Criteria III. Deletion Procedures IV. Basis for Site Deletion V. Deletion Action I. Introduction

EPA Region 8 is publishing this Direct Final Notice of the Deletion of the Rose Park Sludge Pit Superfund Site from the NPL.

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

Because EPA considers this action to be noncontroversial, this action is being taken without prior publication of a notice of intent to delete. This action will be effective June 30, 2003 unless EPA receives adverse comments by June 23, 2003 on this document. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of this Notice and the comments already received. There will be no additional opportunity to comment on this deletion process.

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

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

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

The following procedures apply to deletion of the Site:

(1) The EPA, lead agency for the Site, consulted with Utah on the deletion of the Site from the NPL prior to developing this direct final notice of deletion.

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

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

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

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

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

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

The Site is located in Salt Lake City, Utah at approximately 1300 North Boy Scout Drive (1200 West). The Site is bordered by vacant, undeveloped land to the north and Rose Park to the east, west, and south. Rose Park is maintained by Salt Lake City Corporation and includes tennis courts, baseball and soccer fields, picnic areas, parking lots, and restrooms. Residential neighborhoods are located south of Rose Park.

Utah Oil and Refining Company disposed of acidic waste sludges in an unlined pit on-site from the 1930s until 1957. This waste material was generated from the petroleum refinery located east of the site. Salt Lake City purchased the property in 1957 to prevent further dumping of the waste material. In 1960 Salt Lake City Corporation removed 40 to 100 truck-loads of sludge and covered the remaining waste sludge with a soil cap.

Salt Lake City rediscovered the waste disposal site in 1976 during expansion of the adjacent city park. Due to state and local concerns, EPA and Amoco conducted a number of site investigations between 1979 and 1981. The sludge pit covered an area of approximately 5.5 acres and the waste material was found as deep as 20 feet below ground surface (bgs). The shallow, unconfined aquifer was approximately eight to ten feet bgs and flowed towards the northwest. Because the Site was considered the State of Utah's top priority, it was listed on the NPL on September 8, 1983.

Salt Lake City Corporation, Salt Lake City/County Health Department, the Utah State Department of Health, EPA, and Amoco Oil Company signed an Intergovernmental/Corporate Cooperation Agreement (ICCA) on October 29, 1982. The ICCA required Amoco to conduct remedial activities on-site, which included constructing a bentonite slurry wall around the perimeter of the site and capping the waste material. The primary objectives of the containment remedy were to prevent exposure to the acid waste sludge, eliminate potentially unhealthy odors and vapors, and prevent off-site migration of the sludge through surface water and groundwater.

Amoco conducted remedial activities at the Site between 1982 and 1984. First, a two-foot wide and 30-feet deep bentonite slurry wall was constructed around the perimeter of the site. This wall was installed ten feet below the deepest known contamination. Construction of the slurry wall was completed on January 17, 1983. Following installation of the slurry wall, Amoco constructed a cap over the waste material. This protective cover included a sand layer, fabric membrane, compacted clay layer, and 18-inches of soil. Placement of the cap was completed on July 22, 1983. The surface of the cap was then graded to control surface water run-on and run-off. The final seeding of the topsoil was completed in the spring of 1984. Lastly, vehicular barriers and warning signs were placed around the perimeter of the repository in October 1984.

The U.S. Army Corps of Engineers (COE) provided construction oversight for the EPA. The COE indicated in their progress reports that the slurry wall and cap were constructed according to the design and there were no deficiencies. EPA also determined the remedy; as designed and implemented; was protective of human health and the environment because all exposure pathways had been addressed.

ICs and O&M requirements for the Site were also included in the ICCA. The ICs prevent excavation activities or the installation of any underground utilities on the Site. BP/Amoco recorded the ICCA in the chain-of-title for the Site at the Salt Lake County Recorders Office in 1985. The recording provides a public record of the ICs and background information in the event of a transfer of ownership.

O&M activities at the Site included groundwater monitoring and sampling, site inspections, and well integrity testing. Salt Lake City Corporation conducted O&M activities from 1984 through 1992. Because the EPA, State of Utah, and BP/Amoco identified several deficiencies regarding O&M activities during this time period, BP/Amoco took over the responsibility of O&M from the Salt Lake City Corporation in 1992. Since taking over this duty in 1992, BP/Amoco has documented the O&M activities from each year in an annual report.

Three Five-Year Reviews have been conducted at the Site. The reviews were completed on June 1, 1992, August 5, 1997 and September 19, 2002, respectively. These reviews indicated that the remedy was protective of human health and the environment.

The last review, conducted by UDEQ, found that the cap is in good condition thus preventing exposure to the waste material in the repository. A chain-link fence and guardrail around the perimeter of the repository prevent public access to the Site and caution signs on each side of the repository warn park visitors of the Site. Ground-water monitoring data indicate the waste material remains contained within the repository. ICs for the Site prevent excavation activities or the installation of underground utilities on the Site. Three issues that did not immediately impact protectiveness were identified and have subsequently been addressed by BP/Amoco.

Policy reviews are required at the Site every five years because remedial activities were completed prior to the passage of the Superfund Amendments and Reauthorization Act (SARA) of 1986 and waste material was left on-site, which prevents unrestricted exposure and unlimited use of the Site. Therefore, the next Five-Year Review for this Site will be conducted by September 19, 2007.

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

The EPA, with concurrence from the State of Utah through UDEQ, has determined that all appropriate responses under CERCLA have been completed, and that no further response actions, under CERCLA, other than five-year reviews and operation & maintenance, are necessary. Therefore, EPA is taking this action to delete the Site from the NPL.

Because EPA considers this action to be noncontroversial, this action is being taken without prior publication of a notice of intent to delete. This action will be effective June 30, 2003, unless EPA receives adverse comments by June 23, 2003. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment on this deletion process.

EPA Region 8 is publishing this Direct Final Notice of Deletion of the Petrochem Recycling Corp./Ekotek, Inc., Superfund Site from the NPL.

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

Because EPA considers this action to be noncontroversial, this action is being taken without prior publication of a notice of intent to delete. This action will be effective June 30, 2003 unless EPA receives adverse comments by June 23, 2003 on this document. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of this Notice and the comments already received. There will be no additional opportunity to comment on this deletion process.

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

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

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

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

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

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

The following procedures apply to deletion of the Site:

(1) The EPA, lead agency for the Site, consulted with Utah on the deletion of the Site from the NPL prior to developing this direct final notice of deletion.

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

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

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

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

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

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

The Site is located in Township 1 North, Range 1 West, Section 23, and occupies approximately seven acres in an industrial corridor in the northern section of Salt Lake City, Utah. The Site was originally owned and operated as an oil refinery by O. C. Allen Oil Company, from 1953 to 1968. In 1968, Flinco, Inc., purchased the facility and operated the refinery until 1978. During that time Flinco changed its name to Bonus International Corp. In 1978, Axel Johnson, Inc., acquired the facility and operated it through its Delaware-based subsidiary, Ekotek, Inc. At that time, Ekotek, Inc., converted the Site into a hazardous waste storage and treatment and petroleum recycling facility. In 1981, the Site was reincorporated as Ekotek Incorporated, a Utah corporation.

From 1980 to 1987, the facility operated under Resource Conservation and Recovery Act (RCRA) Interim Status, and received a hazardous waste storage permit, issued by UDEQ, in July 1987 for a limited number of activities. Ekotek, Inc., declared bankruptcy in November of 1987. Petrochem Recycling Corp. leased the facility in 1987 from Ekotek, Inc., and continued operations until February 1988.

Site operations were shut down in February 1988 after the issuance to Petrochem Recycling Corp. of a Notice of Violation by the Utah Bureau of Solid and Hazardous Waste and the Bureau of Air Quality. In November 1988, Region 8 EPA Emergency Response Branch initiated an emergency surface removal action at the Site.

On August 2, 1989, an Administrative Order on Consent (AOC) for Emergency Surface Removal (Docket CERCLA-VIII-89-25) was issued to 27 Potentially Responsible Parties (PRPs) to undertake actions to clean up the Site. These PRPs operated as members of a voluntary association termed the ESRC (Ekotek Site Remediation Committee.) As part of the emergency surface removal action, the ESRC removed surface and underground storage tanks, containers, contaminated sludges, pooled liquids and processing equipment from the Site.

In November 1989, EPA began site assessment field operations. The Site was proposed for listing on the National Priorities List (NPL) on July 29, 1991. The Site was listed on the NPL on October 14, 1992. Only one operable unit was designated for the Site.

An Administrative Order on Consent (AOC) for the performance of the Remedial Investigation/Feasibility Study (RI/FS) was signed in July 1992 (Docket No. CERCLA (106) VIII-92-21). Members of the ESRC were Respondents for the RI/FS AOC. The Phase I field investigation was undertaken from December 1992 to March 1993 and Phase II investigations were conducted from August to October 1993. A final RI report was issued in July 1994 and the final FS report was issued in January 1995. Two addenda to the FS were submitted on February 24, 1995 and April 7, 1995. EPA published the notice of completion for the FS and the Proposed Plan for remedial action on July 19, 1995.

The results of the remedial investigation indicated that surface soils on the property contained petroleum hydrocarbon contaminants, including semivolatile organic compounds (SVOCs) and polychlorinated biphenyls (PCBs). Contaminated soil extended to the water table in the vicinity of the former tank farm/processing area where a plume of light non-aqueous phase liquids (LNAPL) was present. Groundwater analytical results collected during the RI indicated that vinyl chloride, cis-1,2-DCE, benzene, and arsenic were present at concentrations above their maximum contaminant levels (MCLs). The feasibility study was completed in January 1995 and included development and evaluation of ten site-wide remedial alternatives. The alternatives consisted of various combinations of technologies for soil and groundwater remediation, including soil excavation and disposal or treatment, containment, LNAPL removal, groundwater extraction and disposal, and intrinsic groundwater remediation.

EPA's remedy decision was embodied in a final ROD signed on September 27, 1996. The components of the selected remedy included:

• Removal/Disposal of Hot Spot Soils

• Consolidation/Capping of Soils that Exceed Soil Performance Standards

• Partial Removal/Disposal of Soil and Buried Debris and Cap Remaining Debris

• Removal/Treatment of 100% of the LNAPL

• Natural Attenuation/Intrinsic Remediation of Ground Water

• Access and Land Use Restrictions for the Site

An ESD was issued on December 9, 1997, by EPA to modify certain remediation criteria established in the 1996 Record of Decision. The significant differences addressed in the ESD were: corrected and revised soil performance standard values for 2,3,7,8,-TCDD(TEF) and PCBs; revised soil hot spot performance standard value for PCBs; and an alternative to permit discharge of water to re-injection wells or to a surface water/storm drain via the substantive requirements of a UPDES permit.

A second ESD was issued on May 11, 1999, by EPA. The second ESD modified two aspects of the 1996 Record of Decision; first it deleted manganese as a designated contaminant of concern in the ground water, and second it increased the volume of contaminated soil destined for off-site disposal.

Changes to the original remedy due to the two ESDs resulted in the following remedy:

• Removal/Disposal of soils exceeding hot spot and soil performance standards

• Removal/Incineration of floating LNAPL down to 0.02 feet thickness

• Natural Attenuation/Intrinsic Remediation of groundwater

• Backfilling excavations with clean soil and regrading/restoration of Site

Removal Action. An Administrative Order on Consent for Removal Action was issued on December 22, 1997 (Docket No. CERCLA (106) VIII-98-05) for the performance of Drum and Sludge Removal. Members of the ESRC were Respondents for the Administrative Order on Consent for Removal Action. The actions under this AOC were completed prior to the Remedial Design and Remedial Action (RD/RA) Consent Decree in order to expedite and facilitate the remedial action. The actions completed under the Drum and Sludge Removal included the following: the characterization of drummed waste and filter cake sludge, the disposal of approximately 230 drums and the associated waste at a permitted RCRA facility and the disposal of approximately 450 cubic yards of filter cake sludge at a permitted RCRA facility. A final Drum and Sludge Removal Completion Report was issued in December 1998.

Remedial Actions. EPA and the ESRC representatives negotiated an agreement to implement the remedy selected in the ROD. This agreement, in the form of a consent decree for remedial design and remedial action (RD/RA Consent Decree), was lodged on March 4, 1998, and entered on April 27, 1998, in the U.S. District Court for Utah.

Remedial actions were conducted in four stages:

• Stage 1: Building Demolition

• Stage 2: Site Demolition, Hot Spot and Removal of Buried Debris

• Stage 3: Soil Excavation and Disposal and LNAPL Excavation and Incineration

• Stage 4: Groundwater Studies

All remedial actions were conducted in accordance with the ROD, ESDs, Remedial Design (May 1999) and Consent Decree. Groundwater studies supported the choice of monitored natural attenuation/intrinsic remediation for the groundwater component of the remedy. Confirmatory sampling verified that the Site achieved the ROD cleanup objectives for soil and groundwater and that all cleanup actions specified in the ROD and ESDs had been implemented.

Disposal of hazardous materials, identified in the ROD and ESDs, to a permitted off-site disposal facility and the achievement of the groundwater remediation levels has eliminated the need for O&M at the Site.

Pursuant to CERCLA section 121(c), 42 U.S.C. 9621(c), five-year reviews are required at sites with remaining hazardous substances, pollutants, or contaminants above levels that allow for unlimited use and unrestricted exposure. Hazardous substances above health-based levels were removed from the Site, eliminating the five-year review requirement.

The impacted community, near the Site, has been represented by the Capital Hill Neighborhood Council (Council). The Council was funded by a Technical Assistance Grant from EPA. Mr. Paul Anderson acted as the Council's advisor and actively participated as a stakeholder during the planning and cleanup of the Site. Community relation activities included public meetings, site tours and fact sheets.

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

The EPA, with concurrence from the State of Utah through UDEQ, has determined that all appropriate responses under CERCLA have been completed, and that no further response actions, under CERCLA are necessary. Therefore, EPA is taking this action to delete the Site from the NPL.

Because EPA considers this action to be noncontroversial, this action is being taken without prior publication of a notice of intent to delete. This action will be effective June 30, 2003, unless EPA receives adverse comments by June 23, 2003. If adverse comments are received within the 30-day public comment period on this document, EPA will publish a timely withdrawal of this direct final deletion before the effective date of the deletion and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment on this deletion process.

The changes in this final rule clarify existing sections of chapter 301 as follows:

1. In § 301-53.2 a new note is added.

2. Section 301-53.3 is revised.

3. Section 301-74.1 is revised by redesignating paragraph (d) as paragraph (e) and adding a new paragraph (d).

This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

This final rule is not required to be published in the Federal Register for notice and comment; therefore, the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , does not apply.

The Paperwork Reduction Act does not apply because the changes to the FTR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

This final rule is also exempt from congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel.

In a rule document published in the Federal Register of January 17, 2001 (66 FR 4076, January 17, 2001), the Substance Abuse and Mental Health Services Administration (SAMHSA) issued final regulations for the use of narcotic drugs in maintenance and detoxification treatment of opioid addiction. That final rule established an accreditation-based regulatory system under 42 CFR part 8 (“Certification of Opioid Treatment Programs,” “OTPs”). The regulations also established (under § 8.12) the Secretary's standards for the use of opioid medications in the treatment of addiction, including standards regarding the quantities of opioid drugs which may be provided for unsupervised use.

Section 8.12(h) sets forth the standards for medication administration, dispensing and use. Under this section, OTPs shall use only those opioid agonist treatment medications that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of opioid addiction. The regulation listed methadone and levomethadyl acetate (ORLAAM®) as the opioid agonist treatment medications considered to be approved by the FDA for use in the treatment of opioid addiction.

On October 8, 2002, FDA approved two new opioid treatment medications, buprenorphine and buprenorphine combination for the treatment of opioid addiction. These medications are controlled under schedule III of the Controlled Substances Act (“CSA,” 21 U.S.C. 812). See final rule published October 7, 2002 (67 FR 62354). By adding these two medications to the previous list of approved opioid treatment medications, the Secretary allows OTPs to use buprenorphine and buprenorphine combination for the treatment of opioid addiction. OTPs will apply the same treatment standards that were finalized on January 17, 2001, for methadone and ORLAAM®.

The opioid treatment program regulations (42 CFR part 8) establish the procedures by which the Secretary will determine whether a practitioner is qualified under section 303(g) of the CSA (21 U.S.C. 823(g) (1)) to dispense certain therapeutic narcotic drugs in the treatment of individuals suffering from narcotic addiction. These regulations also establish the Secretary's standards regarding the appropriate quantities of narcotic drugs that may be provided for unsupervised use by individuals undergoing such treatment (21 U.S.C. 823(g) (3)). ( See also 42 U.S.C. 257a.)

This interim final rule does not change any of the provisions in subpart A (Accreditation) or subpart C (Procedures for Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an Accreditation Body). Instead, the rule provides for a minor amendment to subpart B, Certification and Treatment Standards. The rule amends only one section of subpart B, section 8.12(h)(2) Medication administration, dispensing, and use.

Under 42 CFR 8.12(h)(2), OTPs are limited to using only those opioid agonist treatment medications that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). This section notes that “currently the following medications will be considered to be approved by the Food and Drug Administration for use in the treatment opioid addiction: (i) Methadone; and (ii) levomethadyl acetate (LAAM).” The effect of this rule is to add buprenorphine and buprenorphine combination to this list by adding a new item (iii).

The Administrative Procedure Act (5 U.S.C. 553) requires agencies to follow certain procedures for informal rulemaking, including publication of proposed rules in the Federal Register with an opportunity for public comment. Section 553(b)(B) allows agencies to dispense with prior notice and opportunity for public comment if the agency finds for good cause that use of such procedures is impracticable, unnecessary, or contrary to the public interest. Section 553(d)(3) permits the Secretary to waive the 30 day effective date if it is contrary to the public interest.

The Secretary has determined that good cause exists for publication of this rule without prior notice and opportunity for public comment and without a delayed effective date since such procedures are contrary to the public interest and unnecessary. It is contrary to the public interest to deny OTPs' access to this important new medication for the treatment of persons addicted to opioids. As compared to methadone and ORLAAM ®, buprenorphine and buprenorphine combination are particularly useful in treating patients who have had a shorter course of addiction. Similarly, it would be contrary to the public interest to deny patients access to such prescription drugs from OTPs particularly in areas in which there are no physicians who have obtained a waiver under the Drug Addiction Treatment Act of 2000 (“DATA,” section 3502 of Pub. L. 106-310).

To further elaborate, while OTPs may continue to use methadone and ORLAAM ® for medicated assisted treatment, buprenorphine and buprenorphine combinations will provide OTPs with an important additional option for the treatment of addiction. Indeed, because of its “partial” agonist pharmacology, buprenorphine will provide programs with more flexibility in finding the most appropriate medication for each patient. It would thus be contrary to the public interest to delay the availability of buprenorphine products.

In addition to the public interest in having buprenorphine and buprenorphine combination products available for treatment use as soon as possible, prior notice and comment procedures are unnecessary. Currently, the rule states: “OTPs shall use only those opioid agonist treatment medications that are approved by the Food and Drug Administration * * * for use in the treatment of opioid addiction * * *. Currently the following opioid agonist treatment medications will be considered to be approved by the Food and Drug Administation for use in the treatment of opioid addiction: (i) Methadone; and (ii) Levomethadyl acetate (LAAM).” Because the buprenorphine products have been approved by the FDA as required by section 8.12(h)(2), the proposed modification is technical in nature in that it simply adds buprenorphine and buprenorphine combination to the list of FDA-approved medications that may be used by OTPs. Thus, comment is not necessary before finalizing this change to the regulation.

Although we are making the rule effective immediately without first obtaining public comment, we are providing for a 60-day comment period after publication. Specifically, we seek comments on the applicability of the existing OTP rules to these newly approved medications.

The Secretary has examined the impact of this interim final rule under Executive Order 12866. Executive Order 12866 directs Federal 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). This interim final rule does not establish additional regulatory requirements, it allows an activity that is otherwise prohibited. According to Executive Order 12866, a regulatory action is “significant” if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million; adversely affecting in a material way a sector of the economy, competition, or jobs; or if it raises novel legal or policy issues. A detailed discussion of the Secretary's analysis is contained in the recent opioid treatment final rule published in the Federal Register of January 17, 2001 (66 FR 4086-4090). That notice described the impact of the opioid treatment regulations, analyzed alternatives, and considered comments from small entities.

The Secretary also finds that this rule is a not a significant regulatory action as defined by Executive Order 12866. The rule merely adds buprenorphine and buprenorphine combination products to the list of medications that may be used in the detoxification or maintenance treatment of opioid dependence. If opioid treatment programs choose to use the new medications, the new medications will be used in accordance with the standards set forth in the January 17, 2001, final rule (66 FR 4090). No new regulatory requirements are imposed by this interim final rule.

For the reasons outlined above, the Secretary has determined that this interim final rule will not have a significant impact upon a substantial number of small entities within the meaning of the Regulatory Flexibility Act (5 U.S.C. 605(b)). Therefore an initial regulatory flexibility analysis is not required for this interim final rule.

The Secretary has determined that this rule is not a major rule for the purpose of congressional review. For the purpose of congressional review, a major rule is one which is likely to cause an annual effect on the economy of $100 million; a major increase in costs or prices; significant effects on competition, employment, productivity, or innovation; or significant effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets. This is not a major rule under the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA).

The Secretary has examined the impact of this rule under the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This rule does not trigger the requirement for a written statement under section 202(a) of the UMRA because it does not impose a mandate that results in an expenditure of $100 million (adjusted annually for inflation) or more by State, local, and tribal governments in the aggregate, or by the private sector, in any one year.

The Secretary has previously considered the environmental effects of this rule as announced in the final rule (66 FR 4076 at 4088). No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that neither an environmental assessment nor an environmental impact statement is required.

The Secretary has analyzed this interim final rule in accordance with Executive Order 13132: Federalism. Executive Order 13132 requires Federal agencies to carefully examine actions to determine if they contain policies that have federalism implications or that preempt State law. As defined in the Order, “policies that have federalism implications” refer to regulations, legislative comments or proposed legislation, and other policy statements or actions 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.

The Secretary is publishing this interim final rule to modify minimally treatment regulations that provide for the use of approved opioid agonist treatment medications in the treatment of opiate addiction. The Narcotic Addict Treatment Act (the NATA, Pub. L. 93-281) modified the Controlled Substances Act (CSA) to establish the basis for the Federal control of narcotic addiction treatment by the Attorney General and the Secretary. Because enforcement of these sections of the CSA is a Federal responsibility, there should be little, if any, impact from this rule on the distribution of power and responsibilities among the various levels of government. In addition, this interim final rule does not preempt State law. Accordingly, the Secretary has determined that this interim final rule does not contain policies that have federalism implications or that preempt State law.

This interim final rule adds buprenorphine and buprenorphine combination products to the list of approved medications that may be used in SAMHSA-certified opioid treatment programs. The interim final rule establishes no new reporting or recordkeeping requirements beyond those discussed in the January 17, 2001, final rule (66 FR 4076 at 4088). The Office of Management and Budget has approved the information collection requirements of the final rule under control number 0930-0206.

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

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

This is a synopsis of the Commission's Report and Order, MB Docket No. 02-255, adopted April 30, 2003, and released May 5, 2003. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 Twelfth Street, SW., Washington, DC. This document may also be purchased from the Commission's duplicating contractors, Qualex International, Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 202-863-2893, or via e-mail qualexint@aol.com.

This is a synopsis of the Commission's Report and Order, MB Docket No. 02-199, adopted, April 28, 2003, and released April 30, 2003. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 445 12th Street, SW., Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC, 20554, telephone 202-863-2893, facsimile 202-863-2898, or via e-mail qualexint@aol.com.