On October 2, 2000, with the concurrence and co-signature of OGE, USDA published its final rule establishing supplemental standards of ethical conduct for employees of USDA (65 FR 58635-58638). Section 8301.103 addressed additional rules applicable to employees of the Farm Service Agency (FSA). Paragraph (c) of § 8301.103 prohibited FSA employees and spouses and minor children of FSA employees from seeking directly or indirectly a “direct loan” under paragraph (a)(9) of section 33 of the Consolidated Farm and Rural Development Act (CFRDA), 7 U.S.C. 1991(a)(9). On May 13, 2002, President Bush signed into Public Law 107-171, the Farm Security and Rural Investment Act of 2002 (Act). Section 5321 of the Act amended Subtitle D of the CFRDA by adding section 377 which states that the Secretary of Agriculture “shall not prohibit,” inter alia , “an employee of the Department of Agriculture from obtaining a loan or loan guarantee” under the CFRDA. This provision, in essence, provides that Federal employees of the Department of Agriculture, including employees of FSA, may now obtain FSA direct loans that have been prohibited under paragraph (c) of § 8301.103 of the Supplement. Pursuant to section 5321 of the Act, that regulatory paragraph is null and void. Therefore, the USDA is removing it in this amendatory rulemaking which redesignates the following paragraphs of § 8301.103.

As the amendment is required in order to comply with an express, specific mandate of Congress, notice of proposed rulemaking is unnecessary.

The Department has found that this rulemaking is not a rule as defined in 5 U.S.C. 804, and, thus, does not require review by Congress. This rulemaking is related to Department personnel.

Since this rule relates to Department personnel, it is exempt from the provisions of Executive Orders Nos. 12866 and 12988.

The Department has determined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) that this regulation will not have a significant economic impact on a substantial number of small entities because it affects only Department employees and their immediate families.

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

This decision will not have a significant impact upon the quality of the human environment or the conservation of energy resources.

The pink bollworm ( Pectinophora gossypiella (Saunders)) is a destructive cotton pest found throughout many of the cotton-growing regions of the world. The larvae of the pink bollworm feed inside growing cotton bolls, destroying the cotton.

The regulations in Subpart—Pink Bollworm (7 CFR 301.52 through 301.52-10, referred to below as the regulations) contain quarantine restrictions aimed at preventing the spread of the pink bollworm. Section 301.52 contains, among other things, lists of quarantined States and regulated articles.

In an interim rule effective and published in the Federal Register on May 16, 2002 (67 FR 34817-34818, Docket No. 02-031-1), we amended the regulations by removing the State of Oklahoma from the lists of quarantined States and regulated areas. This interim rule also made nonsubstantive editorial changes to § 301.52-1 of the regulations.

Comments on the interim rule were required to be received on or before July 15, 2002. We did not receive any comments. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.

This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Orders 12372 and 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

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

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have a retroactive effect. The Act states that the statute is intended to occupy the field of promotion and consumer education involving pork and pork products and of obtaining funds thereof from pork producers and that the regulation of such activity (other than a regulation or requirement relating to a matter of public health or the provision of State or local funds for such activity) that is in addition to or different from the Act may not be imposed by a State.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under § 1625 of the Act, a person subject to an order may file a petition with the Department of Agriculture (USDA) stating that such order, a provision of such order or an obligation imposed in connection with such order is not in accordance with the law; and requesting a modification of the order or an exemption from the order. Such person is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in the district in which a person resides or does business has jurisdiction to review USDA's determination, if a complaint is filed not later than 20 days after the date such person receives notice of such determination.

This action also was reviewed under the Regulatory Flexibility Act (5 United States Code (U.S.C.) 601 et seq. ). The effect of the Order upon small entities initially was discussed in the September 5, 1986, issue of the Federal Register (51 FR 31898). It was determined at that time that the Order would not have a significant effect upon a substantial number of small entities. Many of the estimated 81,000 pork producers and 500 importers may be classified as small entities under the Small Business Administration definition (13 CFR 121.201).

This final rule will decrease the rate of the assessment from 0.45 percent of the market value of porcine animals to 0.40 percent, and will decrease the cents per pound and per kilogram of assessments on imported pork and pork products subject to assessment. Adjusting the rate of assessment from 0.45 percent to 0.40 percent and decreasing the assessment on imported pork and pork products will result in an estimated decrease in assessments of $5 million to $6 million over a 12-month period. Of that amount, approximately $290,000 will be attributed to the decrease in importer assessments. The gross market value of all swine marketed in the United States during 2000 exceeded $11.7 billion. This decrease will reduce the assessment burden on producers. The adjustment in importer assessments also will bring the equivalent market value of live animals from which imported pork and pork products are derived in line with the market value of domestic porcine animals. An HTS number for prepared or preserved pork also will be added to the regulations. Therefore, the economic impact of the assessments will not be a significant part of the total market value of swine. Accordingly, the Administrator of the Agricultural Marketing Service (AMS) has determined that this action will not have a significant economic impact on a substantial number of small entities.

The Act (7 U.S.C. 4801-4819) approved December 23, 1985, authorized the establishment of a national pork promotion, research, and consumer information program. The final Order establishing a pork promotion, research, and consumer information program was published in the September 5, 1986, issue of the Federal Register (51 FR 31898; as corrected, at 51 FR 36383 and amended at 53 FR 1909, 53 FR 30243, 56 FR 4, 56 FR 51635, 60 FR 29963, 61 FR 29002, 62 FR 26205, 63 FR 45936, 64 FR 44643, and 66 FR 67071) and assessments began on November 1, 1986. The program was funded by an initial assessment rate of 0.25 percent of the market value of all porcine animals marketed in the United States and on imported porcine animals with an equivalent assessment on pork and pork products. However, that rate was increased to 0.35 percent effective December 1, 1991 (56 FR 51635), and to 0.45 percent effective September 3, 1995 (60 FR 29963). Based on the assessment rate of 0.45 percent, the total annual assessments collected during 2001 were approximately $57.4 million. Assessments on imported pork and pork products accounted for about $3.7 million of the total.

The Order requires that producers pay to the National Pork Board an assessment of 0.45 percent of the market value of each porcine animal upon sale. However, for purposes of collecting and remitting assessments, porcine animals are divided into three separate categories (1) feeder pigs, (2) slaughter hogs, and (3) breeding stock. The Order specifies that purchasers of feeder pigs, slaughter hogs, and breeding stock shall collect an assessment on these animals if assessments are due. The Order further provides that for the purpose of collecting and remitting assessments persons engaged as a commission merchant, auction market, or livestock market in the business of receiving such porcine animals for sale on commission for or on behalf of a producer shall be deemed to be a purchaser.

The Order requires importers of porcine animals to pay U.S. Customs Service (USCS), upon importation, the assessment of 0.45 percent of the porcine animal's declared value and importers of pork and pork products to pay USCS, upon importation, the assessment of 0.45 percent of the market value of the live porcine animals from which such pork and pork producers were produced.

The Act and § 1230.71 of the Order contain provisions for adjusting the initial rate of assessment. The Delegate Body has the responsibility to recommend the rate of assessment to the USDA. The 2002 Delegate Body, at its annual meeting on March 1-2, 2002, in Denver, Colorado, voted to recommend to the USDA that the rate of assessment of 0.45 percent be decreased to 0.40 percent. There were 167 Delegate Body members appointed by the Secretary in 2002. At the Delegate Body meeting 144 delegates were present during voting and voted 50,750.1 valid share votes. States and importers are allotted one share per $1,000 of the aggregated amount of assessment collected. There were 29,974.9 share votes cast in favor of the 0.05 percent decrease.

The formula in the preamble for the Order at 51 FR 31901 contemplated that it would be necessary to recalculate the equivalent live animal value of imported pork and pork products to reflect changes in the rate of assessment or changes in the annual average price of domestic barrows and gilts to maintain equity of assessments between domestic and porcine animals and imported pork and pork products.

This final rule will decrease the amount of assessment on all of the imported pork and pork products subject to assessment as published in the Federal Register as a final rule December 28, 2001, and effective on January 28, 2002 (66 FR 67071). The assessment decrease reflects the Delegate Body's desire to lessen the assessment burden on producers and make such funds available to pork producers and the industry. The adjustment in importer assessments also will bring the equivalent market value of live animals from which imported pork and pork products are derived in line with the market value of domestic porcine animals. An HTS number for prepared or preserved pork also will be added to the regulations.

The methodology for determining the per-pound amounts for imported pork and pork products was described in the supplementary information accompanying the Order and published in the September 5, 1986, Federal Register at 51 FR 31901. The weight of imported pork and pork products is converted to a carcass weight equivalent by utilizing conversion factors which are published in the USDA's Agricultural Handbook No. 697 “Conversion Factors and Weights and Measurers.” These conversion factors take into account the removal of bone, weight lost in cooking or other processing, and the nonpork components of pork products. Secondly, the carcass weight equivalent is converted to a live animal equivalent weight by dividing the carcass weight equivalent by 74 percent, which is the average dressing percentage of porcine animals in the United States as recognized by the industry. Thirdly, the equivalent value of the live porcine animals is determined by multiplying the live animal equivalent weight by an annual average market price for barrows and gilts as calculated by the USDA's, AMS, Livestock and Grain Market News (LGMN) Branch. Finally, the equivalent value is multiplied by the applicable assessment rate due on imported pork and pork products. The end result is expressed in an amount per pound for each type of pork or pork product. To determine the amount per kilogram for pork and pork products subject to assessment under the Act and Order, the cent-per-pound assessments are multiplied by a metric conversion factor 2.2046 and carried to the sixth decimal.

Since the last adjustment was made in the amount of the assessment due on live hogs and imported pork and pork products (66 FR 67071), there has been a change in the way LGMN Branch reports hog prices. Due to the implementation of the Livestock Mandatory Price Reporting Program, LGMN no longer report hogs on a live basis because most of the industry moved to buying hogs on a carcass basis. Thus, the Iowa-Southern Minnesota hog reports are now reported on a carcass basis defined by muscle and fat. Previously, these reports were quoted for 49-52 percent lean yield barrows and gilts weighing an average of 240-280 pounds live weight. Therefore, the only consistent price available for hogs for calendar year 2001 is the average base carcass price for 51-52 percent lean hogs derived from the National Base Lean Hog Carcass Slaughter Cost Report. To convert this figure to a live basis, it must be multiplied by 74 percent, the average dressing percentage of porcine animals in the United States as recognized by the industry.

The average annual market price increased from $42.70 per hundredweight in 2000 to $45.87 per hundredweight in 2001, an increase of about 7 percent. The combined effect of the assessment rate decrease and the increase in the average annual market price will result in a decrease in assessments for all HTS numbers listed in the table in § 1230.110(b), 66 FR 67071; December 28, 2001, of an amount equal to two-to four-hundredths of a cent per pound, or as expressed in cents per kilogram, four-hundredths to nine-hundredths of a cent per kilogram. Based on Department of Commerce, Bureau of Census, data on the volume of pork and pork products imported during 2001, the decreases in the assessment amounts will result in an estimated $290,000 decrease in importer assessments over a 12-month period. In addition, this rule adds a new HTS number—1602.49.9000—to the table in § 1230.110(b). This HTS number has been assigned to prepared or preserved pork. In 2001, over 2,114 metric tons of prepared or preserved pork products were imported into the United States as reported by the Department of Commerce.

On July 19, 2002, AMS published in the Federal Register (67 FR 47474) a proposed rule which would (1) decreases the current rate of assessment of 0.45 percent of the market value of porcine animals to 0.40 percent, and (2) decreases the amount of assessment per pound due on imported pork and pork products (two-to four-hundredths of a cent per pound) to reflect the combined effect of the increase in the 2001 average price for domestic barrows and gilts (about 7 percent) and the decrease in the assessment rate. The proposal was published with a request for comments by August 19, 2002. Five comments were received. All of the commenters, which included the National Pork Board, the National Pork Producers Council, and three state pork producer associations, support the decrease of assessment rate. In addition, the Board provided information regarding the timing of the decrease in order to provide the Board with ample time to communicate an assessment rate change and to minimize the burden on those responsible for remitting pork checkoff assessments.

USDA carefully considered the comments and the recommendation of the Delegate Body. This action lessens the assessment burden on producers and importers. The effective date of September 30, 2002, gives the Board ample time to communicate this change and will not burden those that remit pork checkoff assessments. Accordingly, pursuant to 5 U.S.C. 553, it is found that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register .

This final rule adopts the decrease in the assessment rate from .45 percent of market value of porcine animals to .40 percent as proposed and decreases the amount of assessment per pound due on imported pork and pork products (two-to four-hundredths of a cent per pound) to reflect the combined effect of the increase in the 2001 average price for domestic barrows and gilts (about 7 percent) and the decrease in the assessment rate.

This 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 rule is excluded from the scope of Executive Order 12372, Intergovernmental Consultation, which may require consultation with State and local officials. See the final rule related notice titled “Department Programs and Activities Excluded from Executive Order 12372” (50 FR 47034) advising that RUS loans and loan guarantees from coverage were not covered by Executive Order 12372.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. RUS has determined that this proposed rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all state and local laws and regulations that are in conflict with this rule will be preempted; no retroactive effect will be given to this rule, and, in accordance with section 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6912(e)), administrative appeals procedures, if any are required, must be exhausted before an action against the Department or its agencies.

In accordance with the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Administrator of RUS has determined that this rule will not have significant impact on a substantial number of small entities. The RUS electric loan program provides loans and loan guarantees to borrowers at interest rates and terms that are more favorable than those generally available from the private sector. Small entities are not subjected to any requirements, which are not applied equally to large entities. RUS borrowers, as a result of obtaining federal financing, receive economic benefits that exceed any direct cost associated with RUS regulations and requirements.

This rule contains no additional information collection or recordkeeping requirements under OMB control number 0572-0032 that would require approval under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

This rule contains no Federal mandates (under the regulatory provision of title II of the Unfunded Mandates Reform Act) for State, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act.

The Administrator of RUS has determined that this rule will not significantly affect the quality of human environment as defined by the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ). Therefore, this action does not require an environmental impact statement or assessment.

The program described by this rule is listed in the Catalog of Federal Domestic Assistance Programs under No. 10.850, Rural Electrification Loans and Loan Guarantees. This catalog is available on a subscription basis from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325, telephone number (202) 512-1800.

For reasons set for in the proposed rule dated November 1, 2001, 66 FR 55130, and to provide a greater opportunity to provide loans to as many borrowers as possible, the Rural Utilities Service (RUS) is amending 7 CFR part 1717, subpart D, to provide the Administrator the flexibility to limit the amount of a loan to a successor (surviving business entity) following a merger.

No comments were received by RUS as the result of the proposed rule.

A proposal to amend 14 CFR part 39 to include an AD for the specified ECF model helicopters was published in the Federal Register on June 7, 2002 (67 FR 39314). That action proposed to require inspecting the radial play and the rotational torque on the collector initially and at specified intervals. If the radial play or the rotational torque exceeds 0.1 millimeter or 3.5 daN, respectively, the AD proposed replacing the collector with an airworthy part.

The Direction Generale De L'Aviation Civile (DGAC), the airworthiness authority for France, notified the FAA that an unsafe condition may exist on ECF Model SA330 helicopters. The DGAC advises of excessive play measured on the collector.

ECF has issued AS 332 Service Bulletin No. 05.00.45, Revision 1, dated August 16, 1999, and SA 330 Alert Service Bulletin No. 05.88, dated June 8, 2001. The service bulletins specify checking the condition of the bearings and the collector-to-rotor attachment shaft at regular intervals, measuring the radial play, measuring the rotation torque of the collector, and state the acceptable radial and rotational tolerances. The DGAC classified the service bulletins as mandatory and issued AD No. 2001-317-082(A), dated July 25, 2001, to ensure the continued airworthiness of these helicopters in France.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on the proposal or the FAA's determination of the cost to the public. The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that this AD will affect 3 helicopters of U.S. registry, that it will take approximately 2 work hours per helicopter to inspect and replace the collector, and that the average labor rate is $60 per work hour. Required parts will cost approximately $300. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $1260 to replace the collectors on the entire fleet.

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

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

A proposal to amend 14 CFR part 39 by superseding AD 98-06-04, Amendment 39-10633 (63 FR 34790, June 26, 1998), which applies to ECF Model AS332C, L, and L1 and Model SA330F, G, and J helicopters, was published in the Federal Register on February 14, 2002 (67 FR 6885). That action proposed to require an inspection of the angular play of certain gearboxes and to allow more play than the current AD allows before removing the gearbox is required. For the Model SA330 helicopter, the allowable play increased from 0.51mm to 0.64mm. For the Model AS332 helicopter, the allowable play increased from 0.51mm to 0.74mm.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on the proposal or the FAA's determination of the cost to the public. The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that 4 helicopters of U.S. registry will be affected by this AD, that it will take approximately 3 work hours per helicopter to accomplish the required actions, and that the average labor rate is $60 per work hour. Creating measurement tools will cost approximately $100 per helicopter and it will cost $45,000 to replace a gearbox. Based on these figures, the total cost impact of this AD on U.S. operators is estimated to be $1,120, assuming no gearbox will need to be replaced.

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

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

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

The Rule was issued by the Commission in 1979, 44 FR 66466 (Nov. 19, 1979), in response to a directive in the Energy Policy and Conservation Act of 1975 (“EPCA”). 1 The Rule covers several categories of major household appliances including central air conditioners and heat pumps.

The Rule requires manufacturers of all covered appliances to disclose specific energy consumption or efficiency information (derived from the DOE test procedures) at the point of sale in the form of an “EnergyGuide” label, fact sheets (for some appliances), and in catalogs. The Rule requires manufacturers to include, on labels and fact sheets, an energy consumption or efficiency figure and a “range of comparability.” This range shows the highest and lowest energy consumption or efficiencies for all comparable appliance models so consumers can compare the energy consumption or efficiency of the other models (perhaps competing brands) similar to the label model. The Rule also requires manufacturers to include, on labels for some products, a secondary energy usage disclosure in the form of an estimated annual operating cost based on a specified DOE national average cost for the fuel the appliance uses.

Section 305.8(b) of the Rule requires manufacturers, after filing an initial report, to report certain information annually to the Commission by specified dates for each product type. 2 These reports, which are to assist the Commission in preparing the ranges of comparability, contain the estimated annual energy consumption or energy efficiency ratings for the appliances derived from tests performed pursuant to the DOE test procedures. Because manufacturers regularly add new models to their lines, improve existing models, and drop others, the data base from which the ranges of comparability are calculated is constantly changing. To keep the required information on labels consistent with these changes, the Commission will publish new ranges if an analysis of the new information indicates that the upper or lower limits of the ranges have changed by more than 15%. Otherwise, the Commission will publish a statement that the prior range remain in effect for the next year.

The annual submissions of data for central air conditioners, and heat pumps have been made and analyzed by the Commission. The ranges of comparability for central air conditioners and heat pumps have not changed by more than 15% from the current ranges for these products. Therefore, the current ranges for these products, which were published on September 16, 1996 (61 FR 48620), will remain in effect until further notice.

The Commission is amending the cost calculation formulas in Appendices H and I to Part 305 that manufacturers of central air conditioners and heat pumps must include on fact sheets and in directories to reflect this year's energy costs figures published by DOE. These routine amendments will become effective December 16, 2002.

The amendments published in this notice involve routine, technical and minor, or conforming changes to the Rule's disclosure requirements so that the information on fact sheets and directories is accurate and up to date. Accordingly, the Commission finds for good cause that public comment for these technical, procedural amendments is impractical and unnecessary (5 USC 553(b)(A)(B) and (d)).

The provisions of the Regulatory Flexibility Act relating to a Regulatory Flexibility Act analysis (5 U.S.C. 603-604) are not applicable to this proceeding because the amendments do not impose any new obligations on entities regulated by the Applicance Labeling Rule. These technical amendments merely provide a routine change to the range information required by the Rule. Thus, the amendments will not have a “significant economic impact on a substantial number of small entities.” 5 U.S.C. 605. The Commission has concluded, therefore, that a regulatory flexibility analysis is not necessary, and certifies, under Section 605 of the Regulatory Flexibility Act (5 U.S.C. 605(b)), that the amendments announced today will not have a significant economic impact on a substantial number of small entities.

In a June 13, 1988 notice (53 FR 22106), the Commission stated that the Rule contains disclosure and reporting requirements that constitute “information collection requirements” as defined by 5 CFR 1320.7(c), the regulation that implements the Paperwork Reduction Act. 3 The Commission noted that the Rule had been reviewed and approved in 1984 by the Office of Management and Budget (“OMB”) and assigned OMB Control No. 3084-0068. OMB has reviewed the Rule and extended its approval for its recordkeeping and reporting requirements until September 30, 2004. The amendments now being adopted do not change the substance or frequency of the recordkeeping, disclosure, or reporting requirements and therefore, do not require further OMB clearance.

In the Federal Register of February 21, 2002 (67 FR 7982), FDA published a proposed rule to reclassify cyclosporine and tacrolimus assays after reviewing information contained in reclassification petitions submitted by Dade Behring, Inc., and Microgenics, Inc. FDA identified the guidance document entitled “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Draft Guidance for Industry and FDA” as the special control capable of providing reasonable assurance of safety and effectiveness for these devices. These assays are used as an aid in the management of transplant patients receiving these drugs. Interested persons were invited to comment on the proposed rule by April 22, 2002. FDA received two comments that were supportive of its proposed reclassification, but the comments suggested specific recommendations for changes to the guidance.

Based on a review of the available information referenced in the preamble to the proposed rule and placed on file in FDA's Dockets Management Branch, FDA concludes that the special controls, in conjunction with general controls, provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register , FDA is announcing the availability of the guidance document. The guidance document was revised to reflect consideration of the comments received. Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a cyclosporine or tacrolimus test system will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

FDA is now codifying the classification and the special control guidance document for cyclosporine and tacrolimus test systems by adding new §§ 862.1235 and 862.1678. For the convenience of the reader, FDA is also adding a new § 862.1(d) to inform the reader where to find guidance documents referenced in part 862.

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

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (Public Law 96-354) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4)). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages, distributive impacts, and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, the final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of cyclosporine and tacrolimus assays from class III to class II will relieve manufacturers of the cost of complying with the premarket approval requirements in section 515 of the act. Furthermore, the special controls guidance document does not impose any new burdens on manufacturers; it advises manufacturers about ways to comply with the special controls that allow the agency to down classify these devices. By eliminating the need for premarket approval applications, reclassification will reduce regulatory costs with respect to these devices, impose no significant economic impact on any small entities, and may permit small potential competitors to enter the marketplace by lowering their costs. The agency therefore certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In addition, this final rule will not impose costs of $100 million or more on either the private sector or State, local, and tribal governments in the aggregate, and therefore a summary statement of analysis under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

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

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

The Coast Guard believes notice and comment are unnecessary because the only vessel operator upstream from the bridge can pass under the bridge without a bridge opening. In view of the historic absence of bridge opening requests and the demonstrated need to complete structural work at the bridge, any delay encountered in this regulation's effective date would be unnecessary and contrary to the public interest.

The Route 7 Bridge has been replaced with a new Route 7 Bridge. The final phase of the new bridge construction involves the installation of the roadway deck, during which, the bridge will not be able to open for vessel traffic.

The bridge owner, New Jersey Department of Transportation, requested a change to the temporary regulation to facilitate the remaining construction. On June 26, 2002, we published a temporary final rule (67 FR 42997) for the Route 7 (Rutgers Street) Bridge. That temporary final rule allowed the bridge to remain in the closed position from June 15, 2002 through September 3, 2002, to facilitate the installation of the roadway deck.

Subsequent to publication of the above temporary final rule, the Coast Guard was notified by the owner of the bridge that the June 15, 2002, start date for the repair work and bridge closure would be postponed because of a delay in the delivery of materials required for the project.

The commencement of repair work and the bridge closure did not actually begin until July 24, 2002. As a result of the above delay in the commencement of the bridge construction, the end date for the temporary final rule must be extended.

The Coast Guard believes this temporary final rule is reasonable because no vessel traffic will be precluded from transiting this bridge as a result of the bridge closure. Presently there is only one vessel operator upstream from the bridge and that vessel can pass under the bridge without a bridge opening.

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

This conclusion is based on the fact that no known vessel traffic will be prevented from transiting the bridge as a result of this closure.

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

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

This conclusion is based on the fact that no known vessels will be prevented from transiting the bridge as a result of this bridge closure.

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

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

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

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

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

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

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

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

We have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (32)(e), of Commandant Instruction M16475.1d, this rule is categorically excluded from further environmental documentation because promulgation of changes to drawbridge regulations have been found to not have a significant effect on the environment. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES .

We did not publish a notice of proposed rulemaking (NPRM) for this rule. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM, and, under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

National security and intelligence officials warn that future terrorist attacks against United States interests are likely. Current advisories of terrorist threats, a history of violence directed towards this facility, and the nature of material handled at Pittsburgh Plate Glass Industries (PPG) make this rulemaking necessary for the protection of national security interests. Any delay in making this regulation effective would be contrary to the public interest because action is necessary to protect against the possible loss of life, injury, or damage to property.

The Coast Guard will, during the effective period of this temporary final rule, complete notice and comment rulemaking for a proposed permanent regulation.

A temporary security zone for this area expired on June 15, 2002 (67 FR 9589, March 4, 2002). We received no comments or objections regarding this zone. Advisories regarding continued threats of terrorism have revealed the need for another security zone to protect PPG, persons, and vessels from subversive or terrorist acts. To enhance security the Captain of the Port is establishing a temporary security zone.

This security zone includes all water extending 200 feet from the water's edge of the left descending bank on the Ohio River beginning from mile marker 119.0 and ending at mile marker 119.8. All persons and vessels are prohibited from entering the zone without the permission of the Captain of the Port Pittsburgh or designated representative.

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

The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary. This rule does not obstruct the regular flow of vessel traffic and will allow vessel traffic to pass safely around the security zone. Vessels may be permitted to enter the security zone on a case-by-case basis.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. The Coast Guard is unaware of any small entities that would be impacted by this rule. The navigable channel remains open to all vessel traffic. We received no comments or objections regarding the previous security zone covering the same area.

If you are a small business entity and are significantly affected by this regulation please contact Petty Officer Michael Marsula, U.S. Coast Guard Marine Safety Pittsburgh, Suite 1150 Kossman Bldg., 100 Forbes Ave., Pittsburgh, PA at (412) 644-5808 x114.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

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

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

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

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

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

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

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

We have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph 34(g), of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation because this rule is not expected to result in any significant adverse environmental impact as described in the National Environmental Policy Act of 1969 (NEPA). A “Categorical Exclusion Determination” is available for inspection or copying where indicated under ADDRESSES.

We did not publish a notice of proposed rulemaking (NPRM) for this temporary rule. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. While the Navy has been implementing many force protection measures since the attack on the U.S.S. Cole and the attacks of September 11, 2001, the Chief of Naval Operations has recently emphasized the need for the expanded use of an anti-small boat barrier boom around Navy vessels in U.S. ports to protect against attacks similar to the one launched against the U.S.S. Cole. In addition, the Office of Homeland Security through its web site has described the current nationwide threat level as “Elevated.” According to the Office of Homeland Security, an Elevated Condition is declared when there is a significant risk of terrorist attacks. The Coast Guard believes that issuing an NPRM for this temporary rule and thereby delaying implementation of the expanded security zone would be against the public interest during this elevated state of alert.

Under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Any delay in implementing this rule would be contrary to the public interest since immediate action is necessary to ensure the protection of the Naval vessels, their crew, and national security.

Furthermore, in order to protect the interests of national security, the Coast Guard is promulgating this temporary regulation to provide for the safety and security of U.S. Naval vessels in the navigable waters of the United States. As a result, the establishment and enforcement of this security zone is a function directly involved in and necessary to military operations. Accordingly, based on the military function exception set forth in the Administrative Procedure Act, 5 U.S.C. 553(a)(1), notice and comment rule-making and advance publication, pursuant to 5 U.S.C. 553(b) and (d), are not required for this regulation.

The Coast Guard has plans to make the expansion of the security zone permanent. Towards that end, the Coast Guard will initiate notice and comment rulemaking before issuing any permanent rule.

The Coast Guard is expanding the security zone (33 CFR 165.1101) by temporarily extending it approximately 80 feet seaward of the pier heads to allow the U.S. Navy to deploy an anti-small boat barrier boom perpendicular to the piers. The expansion of this security zone is needed to ensure the physical protection of naval vessels moored in the area by providing adequate standoff distance. It will also prevent recreational and commercial craft from interfering with military operations involving all naval vessels home-ported at Naval Base San Diego and it will protect transiting recreational and commercial vessels and their respective crews from the navigational hazards posed by such military operations. In addition, the Navy has been reviewing all aspects of its anti-terrorism and force protection posture in response to the attack on the USS COLE and the terrorist attacks of September 11, 2001. The expansion of this security zone will safeguard vessels and waterside facilities from destruction, loss, or injury from sabotage or other subversive acts, accidents, or other causes of a similar nature. Entry into, transit through, or anchoring within this security zone is prohibited unless authorized by the Captain of the Port or Commander, Navy Region Southwest. Vessels or persons violating this section would be subject to the penalties set forth in 50 U.S.C. 192 and 18 U.S.C. 3571: Seizure and forfeiture of the vessel, a monetary penalty of not more than $250,000, and imprisonment for not more than 10 years. The U.S. Coast Guard may be assisted in the patrol and enforcement of this security zone by the U.S. Navy.

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

The implementation of this security zone is necessary for the protection of the United States' national security interests. The size of the zone is the minimum necessary to allow for safe placement of the anti-small boat boom while providing adequate protection for U.S. Naval vessels, their crews, adjoining areas, and the public. The entities most likely to be affected, if any, are pleasure craft engaged in recreational activities and sightseeing in close proximity to the Naval Base. Any hardships experienced by persons or vessels wishing to approach the Naval Base are considered minimal compared to the national interest in protecting U.S. Naval vessels, their crews, and the public. The expansion of the security zone will not impact navigation in the shipping channel.

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

This security zone will not have a significant impact on a substantial number of small entities because these security zones are only closing small portions of the navigable waters adjacent to Naval Base, San Diego, California. In addition, there are no small entities shoreward of the security zone. For these reasons, and the ones discussed in the previous section, the Coast Guard certifies, under 5 U.S.C. 605(b), that this temporary final rule will not have a significant economic impact on a substantial number of small entities.

In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), the Coast Guard offers to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If your small business or organization is affected by this rule and you have questions concerning its provisions or options for compliance, please contact Lieutenant Commander Rick Sorrell, Chief of Port Operations, Marine Safety Office San Diego, at (619) 683-6495.

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

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

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

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

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

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

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

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

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

We have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.lD, this rule, which temporarily modifies an existing security zone, is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES .

On May 23, 2002, EPA published a notice of proposed rulemaking (NPR) for approval of the redesignation of the Denver PM 10 nonattainment area to attainment (67 FR 36124). Throughout this document, wherever “we,” “us,” or “our” are used, we mean the Environmental Protection Agency (EPA).

We are approving the Governor of Colorado's submittal of July 30, 2001, that requests a redesignation for the Denver nonattainment area to attainment for the 1987 PM 10 standards. We are using 1999-2001 ambient air quality data from the Denver PM 10 nonattainment area as the basis for our decision. We are also approving the maintenance plan for the Denver PM 10 nonattainment area, which was submitted with Colorado's July 30, 2001 redesignation request. In conjunction with the maintenance plan, the Governor also submitted revisions to Colorado's Regulation No. 1, “Emission Control For Particulates, Smokes, Carbon Monoxide, & Sulfur Oxides,” and Colorado's Regulation No. 16, “Street Sanding Emissions.” With their submittal, Colorado also requested that we remove Regulation No. 12, the “Diesel Inspection/Maintenance Program” and the stationary source construction permits that we had incorporated by reference into our April 17, 1997 approval of the PM 10 SIP (62 FR 18716). Thus, Regulation No. 12 and the permits for Public Service Company of Colorado's Cherokee Electric Generating Station, Purina Mills, Electron Corporation, Trigen-Colorado Energy Corporation, Rocky Mountain Bottle Company (which includes earlier permits that were issued in 1993 under the former name of Coors Brewing Company), and Conoco Refinery are being removed from the SIP with this action. We are approving this request, the maintenance plan and its accompanying regulation revisions because the Colorado Air Pollution Control Division (Colorado) has adequately addressed all of the requirements of the Act for redesignation to attainment applicable to the Denver PM 10 nonattainment area. Upon the effective date of this final action, the Denver area's designation status under 40 CFR part 81 will be revised to attainment. By using “Denver” or the “Denver area,” we mean Denver, Jefferson, and Douglas Counties, as well as part of Boulder, Adams and Arapahoe Counties. Please refer to our proposed action published on May 23, 2002 at 67 FR 36124 for a more detailed explanation of the redesignation requirements and analysis of how the Denver area has met those requirements.

Whether an area has attained the PM 10 NAAQS is based exclusively upon measured air quality levels over the most recent and complete three calendar year period. See 40 CFR part 50 and 40 CFR part 50, appendix K. A State must demonstrate that an area has attained the PM 10 NAAQS through submittal of ambient air quality data from an ambient air monitoring network representing maximum PM 10 concentrations. The data, which must be quality assured and recorded in the Aerometric Information Retrieval System (AIRS), must show that the average annual number of expected exceedances for the area is less than or equal to 1.0, pursuant to 40 CFR 50.6. In making this showing, three consecutive years of complete air quality data must be used.

Our proposed approval of the Denver redesignation to attainment was based on 1998 through 2000 air quality monitoring data, however, we now have a more recent year of data available to use for the final redesignation. Thus, we are using 1999 through 2001 data for the basis of this final rulemaking. Between 1999 and 2001, Colorado operated thirteen PM 10 monitors, which were either State and Local Air Monitoring Stations (SLAMS) or National Air Monitoring Sites (NAMS), in the Denver PM 10 nonattainment area. Data from these monitors have been quality-assured and placed in AIRS on a quarterly basis. Only one exceedance of the 24-hour PM 10 NAAQS was measured between 1999 and 2001. In 1999, the Adams City monitor recorded a 24-hour value of 160 μg/m 3 (the 24-hour PM 10 NAAQS is 150 μg/m 3 ). Because data collection was less than 100% at this monitoring site, the expected exceedance rate for 1999 at this site was 1.16, (as calculated according to 40 CFR part 50, appendix K). For 2000 and 2001, the expected exceedance rate was 0.0. Thus, the three-year average was less than 1.0, which indicates the Denver area attained the 24-hour PM 10 NAAQS. All other sites had expected exceedance rates of 0.0 for this three-year period. Review of the annual standard for calendar years 1999, 2000 and 2001 reveals that the Denver area has also attained the annual PM 10 NAAQS. There was no violation of the annual standard for the three year period from 1999 through 2001. Further information on PM 10 monitoring is presented in Chapter 3, section B of the redesignation request and maintenance plan. We have evaluated the ambient air quality data and believe that Colorado has adequately demonstrated that the PM 10 NAAQS have been attained in the Denver area.

In the proposed approval of the redesignation request and maintenance plan, we explained that we were relying on a proposed federal consent decree that would require significant emission reductions at the Conoco facility before 2015. On December 20, 2001, a proposed Complaint and Consent Decree in United States v. Conoco Inc. was lodged with the United States District Court for the Southern District of Texas. ( See 67 FR 107 for the notice of lodged consent decree.) That consent decree was entered by the Court on April 29, 2002. Under the consent decree, Conoco Denver Refinery's fluid catalytic cracking unit (FCCU) is required to comply with a New Source Performance Standard (NSPS), subpart J, emissions limit for PM of 1 pound per 1000 pounds of coke burned by no later than June 30, 2006. This restriction will limit Conoco to approximately 67 tons per year of primary PM 10 , which is far less than the 1233 tons per year which Colorado used to re-model Conoco's emissions and less than the 185 tons per year Colorado used in the maintenance plan; this new limit will more than offset the 0.3 μg/m 3 increase that Colorado projected based on the 1233 tons per year value and that would have affected the year 2015 “safety margin” allocation for mobile sources. Because it is based on an NSPS requirement, this new PM limit at Conoco will be permanent.

(1) Comment: One commentor expressed concern that it was unclear whether the commitment that Colorado has made in the PM 10 maintenance plan to revise the maintenance demonstration using the new mobile source emissions model (MOBILE6) is enforceable. The commentor believes that it is important that mobile source modeling uses MOBILE6 when emission reduction credits are taken for the federal Tier II emission standards and pointed out that EPA has acknowledged that Tier II assumptions may not be as accurate when MOBILE5 is used instead of MOBILE6.

Response: Colorado's commitment was adopted through Colorado's SIP process and is part of the maintenance plan. With the effective date of this final action, this commitment will be an enforceable part of Colorado's SIP. In addition, the SIP doesn't take credit for the Tier II program until 2004, and we expect Colorado to have fulfilled their commitment to revise the maintenance plan using MOBILE6 by that time.

(2) Comment: One commentor expressed concern that the recent EPA announcement of future revisions to the new source review (NSR) program may have implications for this redesignation and maintenance plan. The commentor also stated that in taking final action on the Denver PM 10 redesignation and maintenance plan, we should clarify that any SIP revision implementing the federal NSR changes must analyze the suite of air quality implications associated with such changes.

Response: To the extent these comments on the possible NSR program revisions pertain to NSR under Part D of the CAA, they are irrelevant to the Denver PM 10 redesignation because the area will be subject to the prevention of significant deterioration requirements (PSD) under Part C of the Clean Air Act upon redesignation to attainment. The Denver PM 10 maintenance plan is premised upon PSD applying to the area rather than the NSR requirements under Part D of the Act. To the extent the comments pertain to PSD, EPA has not yet taken final action regarding the changes to the NSR program; thus, the effect of any possible changes to the PSD program is speculative. Furthermore, Colorado's existing PSD regulations will remain part of the SIP until EPA approves a change to those regulations following notice and comment rulemaking. Thus, if EPA were to take final action on changes to the PSD program, Colorado would then have to revise their State PSD regulations and submit those revisions to us for approval. Any PSD program change that would affect Denver's continued maintenance of the PM 10 standard, or any other NAAQS, would be evaluated at that time.

(3) Comment: One commentor asked why there were significant and inexplicable differences between the onroad NO X mobile source emissions budgets in the ozone maintenance plan and the PM 10 maintenance plan. The commentor noted that the differences between the NO X budgets in the ozone maintenance plan and the NO X budgets in the PM 10 maintenance plan may be based on seasonality.

Response: The commentor is correct in pointing out that one reason for the difference between the NO X emission inventories in the PM 10 maintenance plan and the ozone maintenance plan is that the ozone plan uses a summertime inventory, whereas the PM 10 maintenance plan uses a wintertime inventory. Aside from this seasonal variation, we believe that the differences between the NO X emissions in the two maintenance plans result from the following: (1) While the nonattainment areas for both pollutants were the same, the emissions inventory domains differ. The ozone emissions inventory includes the entire nonattainment area while the PM 10 maintenance plan covers a smaller area than the actual nonattainment area, although all areas with the expected maximum PM 10 concentrations are included in the domain; (2) The PM 10 maintenance plan takes emission reduction credit from EPA's Tier 2 Motor Vehicle Emissions Standards and Gasoline Sulfur Control Requirements , which take effect in 2004, and EPA's Heavy Duty Engines and Vehicle Standards and Highway Diesel Sulfur Control Requirements , which take effect in 2007. The ozone maintenance plan does not take emission reduction credit from these control programs; (3) The vehicle miles traveled (VMT) is higher in the summertime versus the wintertime; and (4) The mobile source emission modeling inputs for the ozone plan came from the Denver Regional Council of Government's (DRCOG) 1999 through 2004 Transportation Improvement Program (TIP) while the modeling inputs for the PM 10 maintenance plan are based on DRCOG's more recent 2001 through 2006 TIP. We believe that the difference in the NO X inventories between the ozone and PM 10 maintenance plans is reasonable and that these numbers are accurate.

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 15, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

This Supplementary Information is organized as follows:

Under CAA section 112(l), EPA may approve state or local rules or programs to be implemented and enforced in place of certain otherwise applicable Federal rules, emissions standards, or requirements. The Federal regulations governing EPA's approval of state and local rules or programs under section 112(l) are located at 40 CFR part 63, subpart E ( see 58 FR 62262, November 26, 1993) and the subsequently amended regulations ( see 65 FR 55810, September 14, 2000). Under these regulations, a state air pollution control agency has the option to request EPA's approval to substitute a state rule for the applicable Federal rule ( e.g. the Federal National Emission Standards for Hazardous Air Pollutants (NESHAP)). Upon approval, the state agency is given the authority to implement and enforce its rule in place of the NESHAP.

This “rule substitution” option requires EPA to “make a detailed and thorough evaluation of the State's submittal to ensure that it meets the stringency and other requirements” of 40 CFR 63.93 ( see 58 FR 62274). A rule will be approved if EPA finds: (1) The State, local and territorial agencies and Indian tribes (S/L/T) are “no less stringent” than the corresponding Federal regulation, (2) adequate authorities exist, (3) the schedule for implementation and compliance is “no less stringent”, and (4) the S/L/T program is otherwise in compliance with Federal guidance.

On September 22, 1993, the Environmental Protection Agency (EPA) promulgated the NESHAP for perchloroethylene dry cleaning facilities ( see 58 FR 49354), which has been codified in 40 CFR part 63, subpart M, “National Perchloroethylene Air Emission Standards for Dry Cleaning Facilities” (dry cleaning NESHAP). On October 24, 2001, EPA received Massachusetts Department of Environmental Protection's (MA DEP) request to implement and enforce its 310 CMR 7.26(10)-(16) Perchloroethylene Air Emissions Standards for Dry Cleaning Facilities and 310 CMR 70.01-04 Environmental Results Program (ERP) Certification known as the “ERP for dry cleaning facilities in lieu of the dry cleaning NESHAP rule. MA DEP's request for approval was submitted pursuant to the provisions of 40 CFR part 63, subpart E and was found to be complete on January 8, 2002.

The ERP is a multimedia compliance program which requires self certification regarding air, water and hazardous waste requirements while providing extensive compliance assistance to dry cleaners through training programs and workbooks. Inspections and enforcement are part of the air program. Only the air portion of the ERP for dry cleaning facilities is evaluated by this EPA action.

The MA DEP's dry cleaning and certification program rules differ in several ways from the Federal dry cleaning NESHAP. Most of these differences make the MA DEP dry cleaning regulations more stringent than the Federal NESHAP. However, some of the provisions of the State's dry cleaning regulations require further clarification to explain how they are no less stringent than the Federal dry cleaning NESHAP.

In a letter and supplemental material dated October 22, 2001, the MA DEP submitted its application for substitution of its dry cleaning rules with an equivalency demonstration table, narrative, and a summary of its enforcement and compliance measures under its Environmental Results Program. Extracts of the equivalency table and narrative are presented here to provide explanation that provisions in the Massachusetts rules are no less stringent than the Federal dry cleaning NESHAPS. The places where the Massachusetts rules are identical are not cited in this section. The state provided a summary of the status of its enforcement and compliance program for dry cleaners as well as its training and outreach program for dry cleaners. This additional information is available upon request or for public inspection at EPA's Region I Office at the address listed above.

In 40 CFR 63.320(g), the Federal NESHAP classifies dry cleaning sources as major sources based on either annual perchloroethylene (perc) emissions or annual perc consumption. Major sources are those sources with either 10 tons per year perc emissions or perc consumption greater than 8000 liters (2100 gallons) for dry-to-dry machines or greater than 6800 liters (1800 gallons) for transfer or transfer and dry-to-dry machines. These major sources will remain subject to the Federal dry cleaning NESHAPS.

Under 40 CFR 63.320(d) and (e), the Federal NESHAP provides partial exemptions for certain area sources based on perc consumption. Depending on the types of dry cleaning equipment at the area sources, exemption thresholds are 140 or 200 gallons of perc per year. Additionally, both the Federal NESHAP and the ERP exempt coin-operated machines. The MA DEP applicability provisions for dry cleaners as established in 310 CMR, 7.26 (10)-(16) and the certification requirements of 310 CMR 70.00 do not provide partial exemptions for area sources based on consumption of perc. Therefore, the full ERP applies to more area sources than the area source provisions of the Federal NESHAP.

The Federal regulations required compliance by September 22, 1993 or immediately upon startup. The MA DEP regulations provide that the compliance date begins at promulgation of the rules or at start up of new dry cleaners in 310CMR 7.26 (10)(b). The state compliance dates have been passed because the state regulations have been in place since 1997. Hence for this rulemaking, the compliance dates are identical to Federal requirements.

In 40 CFR 63.322(a) and 63.323(a)(1), there are Federal requirements for operating and maintaining refrigerated condensers on a dry-to-dry machine, dryer, or reclaimer. Similar requirements for washers are in 40 CFR 63.322(f) and 63.323(a)(2). Federal rules require a sensor to monitor its gas stream to determine if it is equal to or less than 45 °F. The ERP has an identical monitoring provision. In addition, the ERP includes in the operation and maintenance requirements a temperature limit that makes the standard clearer. See 310 CMR 7.26(13)(c) and (d).

In 40 CFR 63.322(k), there is a Federal work practice requirement for leak detection of large area sources and biweekly leak detection for small area sources. In the MA DEP regulations, there is no distinction between large or small area sources. Leak detection is required weekly for all sources and the use of a leak detection device is required in contrast to the Federal requirement that relied on perceptible detection of leaks. The MA DEP requirements are more stringent in requiring a measuring device rather than just the senses. Further, if perceptible leaks are detected, the Federal regulation 40 CFR 63.322, requires that all leaks be repaired. The MA DEP requirements regulates that both perceptible leaks and leaks detected by monitoring devices be repaired.

The Federal NESHAP requires the owner or operator of a dry cleaning facility constructed or reconstructed after September 22, 1993, to file a compliance certification notification within 30 days of startup. See 40 CFR 63.320(b) and 63.324(b). This certification is a one time only requirement for the Federal standard. The MA DEP requirements require not only an initial compliance certification within 60 days of start up but also an additional annual certification of compliance for area source dry cleaners. This annual self certification requirement of the ERP is more stringent than the Federal requirements. While the initial compliance certification for a new source may be filed up to 30 days later than under the Federal NESHAP, on balance the compliance certification requirements of the ERP are at least as stringent as the Federal NESHAP. EPA notes that new sources must be in compliance with the control requirements upon start-up under both rules.

In 40 CFR 63.324(d), the Federal requirement for retaining records of perchloroethylene purchases is five years on-site. The MA DEP provisions require record retention for a three year period. Although there is a difference in the record retention time, EPA does not consider the ERP to be, on balance, less stringent given the ERP annual certification requirements. The MA DEP provisions impose an annual certification requirement on all dry cleaners, which does not exist under the Federal requirements. Under the MA DEP provisions, a responsible official must sign the certification form, certifying under penalties of perjury that the facility is in compliance with all requirements. By requiring annual certification, the MA DEP can maintain a dry cleaner database containing historical and current information, and measure environmental performance, which meets the needs of the recordkeeping requirements.

After reviewing the request for approval of the Massachusetts Department of Environmental Protection Environmental Results Program Certification and Perchloroethylene Air Emissions Standards for Dry Cleaning Facilities, EPA has determined that this request meets all of the requirements necessary to qualify for approval under CAA section 112(l) and 40 CFR 63.91 and 63.93. EPA has determined that the MA DEP's dry cleaning rule is equivalent to or not less stringent than the Federal dry cleaning NESHAP. Therefore, EPA hereby approves MA DEP dry cleaning rules to be implemented and enforced in place of the Federal dry cleaning NESHAP, as it applies to only area sources in Massachusetts. As of the effective date of this action, MA DEP's dry cleaning rule is enforceable by the EPA and citizens under the CAA. Although the MA DEP has primary implementation and enforcement responsibility, EPA retains the right, pursuant to CAA section 112(l)(7), to enforce any applicable emission standard or requirement under CAA, section 112.

Under 40 CFR 63.91(d), the MA DEP must demonstrate that it meets all 112(l) approval criteria and under 63.91(d)(3), final Title V program approval satisfies this approval criteria. On September 28, 2001 EPA granted MA DEP final Title V operating permit approval which became effective November 27, 2001.

EPA views the approval of the MA DEP request to use its ERP for dry cleaning facilities as a substitute for the Federal dry cleaning NESHAP as a noncontroversial action, since the state program has been in operation for several years and is more stringent then the NESHAP. EPA anticipates no adverse comments. Therefore, EPA is publishing this direct final rule without prior proposal. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal for this action should relevant adverse comments be filed. This action will be effective on November 15, 2002, without further notice, unless EPA receives relevant adverse comments by October 16, 2002.

If EPA receives such comments, then it will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this rule. Any parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on November 15, 2002, and no further action will be taken on the proposed rule.

Pursuant to section 112(l) of the CAA and 40 CFR 63.91 and 63.93, EPA is approving the Massachusetts Department of Environmental Protection request to implement and enforce its Regulations 310 CMR, Sections 7.26 (10)-(16) Perchloroethylene Air Emissions Standards for Dry Cleaning Facilities and Sections 70.01-04 Environmental Results Program Certification pertaining to dry cleaning facilities in place of 40 CFR part 63, subpart M, National Perchloroethylene Air Emissions Standards for Dry Cleaning Facilities, as it applies to area sources. This approval makes the Massachusetts Department of Environmental Protection rules federally enforceable and reduces the burden on area sources within Massachusetts' jurisdiction such that they only have one rule with which they must comply. Major sources remain subject to 40 CFR part 63, subpart M.

The Office of Management and Budget has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.” This rule is not subject to Executive Order 13045, entitled, “Protection of Children from Environmental Health Risks and Safety Risks,” because it is not an “economically significant” action under Executive Order 12866.

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.

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.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”

This final rule does not have tribal implications. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. This Federal action allows the Commonwealth of Massachusetts to implement an equivalent regulation to replace pre-existing requirements under Federal law and does not have tribal implications. Thus, Executive Order 13175 does not apply to this rule.

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

This 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. This action simply allows Massachusetts to implement equivalent alternative requirements to replace a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, Executive Order 13132 does not apply to this rule.

The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental entities with jurisdiction over populations of less than 50,000. This final rule will not have a significant impact on a substantial number of small entities because approvals under 40 CFR 63.93 do not create any new requirements, but simply allows the state to implement and enforce equivalent requirements in place of the Federal requirements that EPA is already imposing. Therefore, because this approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

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 annual costs to state, local, or tribal governments in the aggregate, or to private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated annual costs of $100 million or more to either state, local, or tribal governments in the aggregate, or to the private sector.

This Federal action allows Massachusetts to implement equivalent alternative requirements to replace pre-existing requirements under Federal law, and imposes no new requirements. Accordingly, no additional costs to state, local, or tribal governments, or to the private sector, result from this action.

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

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

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 November 15, 2002. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements ( see section 307(b)(2)).

Since 1992, RSPA has conducted a national registration program of persons who offer for transportation or transport hazardous materials in intrastate, interstate, or foreign commerce, under the mandate in 49 U.S.C. 5108. The purposes of the registration program are to (1) gather information about the transportation of hazardous material and (2) fund the Hazardous Materials Emergency Preparedness (HMEP) grants program which supports hazardous material emergency response planning and training activities by States, local governments, and Indian tribes and related activities. See sections 5108(b), 5116. The law gives RSPA discretion to require additional persons to register, beyond those offerors and transporters of the categories and quantities of hazardous materials listed in § 5108(a)(1), and to set the annual registration fee between $250 and $5,000. See sections 5108(a)(2), 5108(g)(2)(A).

Until 2000, only those persons who offer or transport the categories and quantities of hazardous materials set forth in section 5108(a)(1) were required to register, and the annual registration fee was set at the minimum level of $250 (plus a processing fee of $50). In each year through the July 1, 1999-June 30, 2000 registration year, the total registration fees collected by RSPA amounted to less than one-half of the total $14.3 million intended by Congress for training and planning grants and grant-related activities.

In a final rule published in the Federal Register on February 14, 2000, RSPA applied the requirement to register to additional persons, and we adopted a two-tiered fee under which the registration fee was set at $275 for a person meeting the Small Business Administration (SBA) criteria for a small business, and $1,975 for other persons (plus a $25 processing fee in all cases). 65 FR 7297. However, a much greater than anticipated number of persons have paid the higher registration fee applicable to a larger business, and RSPA has collected more than $21 million each registration year starting with 2000-2001. Because Section 5108(g)(2)(C) requires RSPA to adjust the registration fee “to reflect any unexpended balance” in the HMEP Fund, on December 7, 2000, we published a notice of proposed rulemaking (NPRM) under Docket No. RSPA-00-8439 (HM-208D) proposing to: (1) Temporarily lower registration fees for all registrants for six registration years; (2) specify that a not-for-profit organization (regardless of its size) would pay the same fee as a small business; (3) replace the Standard Industrial Classification (SIC) code system with the North American Industry Classification System (NAICS), consistent with SBA actions; and, (4) allow payment by credit cards not previously authorized.

RSPA has delayed taking final action on the proposals in the December 7, 2000, NPRM because our budget requests to Congress for FY 2002 and FY 2003 have proposed to fund a portion of RSPA's hazardous materials safety program from excess registration fees ( i.e. , those exceeding the $14.3 million specified to be used for training and planning grants and grant-related activities). See the status documents we published in the Federal Register on May 2, 2001 (66 FR 22080), and March 14, 2002 (67 FR 11456). This proposal was not adopted by Congress in the FY 2002 DOT appropriations and, as soon as Congress acts on the FY 2003 budget request, we intend to take appropriate action on the proposals to temporarily reduce registration fees and charge not-for-profit organizations the same registration fee as a small business. In the meantime, however, we consider that it is appropriate to adopt those proposals that are unrelated to reducing registration fees.

RSPA received 19 written comments to the NPRM from emergency response organizations; industry associations representing a broad spectrum of businesses that offer or transport hazardous materials; and individuals engaged in agricultural retailing, petroleum distribution, farming, convenience store operations, and all modes of transportation. In this rule, we discuss only the comments unrelated to the fee reduction proposals in the December 7, 2000, NPRM.

At the present time, the “small business” criteria used to determine the amount of the registration fees are found in the Standard Industrial Classification (SIC) code for the registrant's primary industry group. These codes were adopted and used by SBA until two years ago. In our February 14, 2000, final rule, we discussed the likelihood that SBA would change from SIC codes to the NAICS, and SBA's estimation that this change should not result in many instances in which an entity would lose its status as a small business. 65 FR at 7304. After SBA adopted the NAICS in a final rule published on May 15, 2000 (65 FR 30836), we proposed to make a similar change in § 107.612.

Commenters supported this proposal. The Petroleum Marketers Association of America (PMAA) stated that RSPA should join other “administrative agencies [that] have begun using NAICS [which] will promote uniformity throughout the regulations.” PMAA stated that there would be “no detrimental effect on our members in changing from SIC system to the NAICS.”

The Agricultural Retailers Association (ARA) “supports the change with the proviso that the agency include NAICS information in all future registration correspondence with the regulated community.” It stated that “there remains a definite lack of knowledge of the current SIC Code system among ARA's members and the changeover to NAICS will only further cloud the issue.”

The Petroleum Transportation and Storage Association (PTSA) stated that;

Our further review of SIC and NAICS codes confirms our earlier conclusion that very few entities would lose status as a small business. Based on that review and the comments received in response to the NPRM, we are adopting the proposal to use the NAICS for size standards.

A list of size criteria by NAICS codes is provided on the SBA Internet site at: http://www.sba.gov/size/sizetable.html .

A list by SIC code with the corresponding NAICS code and size standard is provided at: http://www.sba.gov/size/SIC2NAICSmain.html .

A search engine for the SIC and NAICS systems is provided by the SBA at its Internet site at: https://eweb1.sba.gov/naics/dsp_naicssearch2.cfm . Additional information on NAICS, including tables showing the correspondences between the two numbering systems is provided at: http://www.census.gov/epcd/www/naics.html . Registrants unfamiliar with NAICS should find these sites useful in determining the appropriate code.

Within a few months after issuing the February 14, 2000, final rule, we realized that we should allow persons to register and pay the registration fee over the Internet, even though the registration procedures contained in the regulations do not specifically discuss that method. We are amending § 107.616 to specifically permit a person to use the Internet to submit its registration statement and pay the registration fee with a credit card or by other means of electronic payment.

In the NPRM, we proposed to authorize persons to use additional credit cards (besides Visa and MasterCard) to pay registration fees. The only commenter on this proposal was the American Trucking Associations (ATA), which supported the “expanded payment methods.” To allow greater flexibility, we are providing in § 107.616(b) that a person may use any “credit card or other electronic means of payment acceptable to the Department.”

This final rule is not considered a significant regulatory action under section 3(f) of Executive Order 12866. Therefore, it was not reviewed by the Office of Management and Budget (OMB), and a regulatory assessment was not required for OMB. This rule is not considered significant under the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034). Due to minimal economic impact of this final rule, preparation of a regulatory impact analysis or regulatory evaluation is not warranted.

This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). The registration requirements do not impair the ability of States, local governments, or Indian tribes to impose their own fees or registration or permit requirements on persons who offer or transport hazardous materials in commerce. RSPA encourages States, local governments, and Indian tribes to adopt and enforce requirements in the Hazardous Materials Regulations and the Federal registration requirement, in order to enhance compliance with a nationally uniform set of regulations on the transportation of hazardous materials.

The consultation and funding requirements of Executive Order 13132 do not apply because this final rule does not adopt any regulation that:

(1) has substantial direct effects on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government;

(2) imposes substantial direct compliance costs on State and local governments; or

(3) preempts state law.

This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this rule does not have tribal implications, does not impose substantial direct compliance costs and is required by statute, the funding and consultation requirements of Executive Order 13175 do not apply.

The Regulatory Flexibility Act (5 U.S.C. 601-611) requires each agency to analyze regulations and assess their impact on small businesses and other small entities to determine whether the rule is expected to have a significant impact on a substantial number of small entities.

In the February 14, 2000, final rule in Docket No. HM-208C, RSPA certified that that final rule did affect a significant number of small entities, but that the economic impact on these small entities will not be significant. 65 FR at 7308-09. This final rule affects the same small entities that Docket HM-208C did and, therefore, this final rule affects a significant number of small entities. See 65 FR at 7307 through 7309. However, this final rule addresses editorial and other minor changes that have no economic impact on small businesses. Therefore, I certify that this final rule does not have a significant economic impact on a substantial number of small entities.

This final rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $100 million or more, in the aggregate, to any of the following: State, local, or Native American tribal governments, or the private sector.

Under 49 U.S.C. 5108(i), reporting and recordkeeping requirements pertaining to the registration rule are specifically excepted from the information management requirements of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document may be used to cross-reference this action with the Unified Agenda. To distinguish this final rule from the continuing rulemaking action concerning fee reductions we have created a new RIN number, 2137-AD74, and Docket No. RSPA-02-13328 (HM-208E) for this final rule. The fee-reduction related proposals will remain under RIN 2137-AD53 and Docket No. RSPA-00-8439 (HM-208D).