A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 2001-20-13, Amendment 39-12461 (66 FR 52023, October 12, 2001), which is applicable to Pratt & Whitney PW4000 series turbofan engines, was published in the Federal Register on January 15, 2002 (67 FR 1913). That action proposed to clarify inspection requirements for cracking of HPC front drum rotors that have fewer than 1,000 cycles-since-new (CSN), in accordance with Pratt & Whitney Alert Service Bulletin (ASB) PW4ENG A72-722, dated September 29, 2000 and ASB PW4ENG A72-722, Revision 1, dated June 7, 2001.

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

Two commenters state that in proposed paragraph (a), the inspection requirements are not clear for HPC front drum rotors with fewer than 1,000 cycles-since-new (CSN). One of the commenters states that the requirements are not clear on how to fulfill the initial inspection for HPC front drum rotors with less than 1,000 CSN. The commenter states that proposed paragraph (a)(1) refers to an HPC front drum rotor with less than 1,000 CSN, but the front drum must have accumulated at least 1,000 CSN before an initial inspection can be carried out. Therefore, it is not possible to fulfill the AD. The commenter suggests changing the wording of paragraph (a)(1) to say that HPC front drum rotors must have accumulated at least 1,000 CSN before an inspection can be carried out as an initial inspection.

The FAA does not agree. Proposed paragraph (a)(1) states that HPC front drum rotors may have fewer than 1,000 cycles-since-new on the effective date of the AD, and further states that after the front drum rotors accumulate 1,000 cycles-since-new (CSN), the initial inspection must be done within 500 cycles-in-service. This is consistent with the requirements of Pratt & Whitney ASB PW4ENG A72-722, dated September 29, 2000 and ASB PW4ENG A72-722, Revision 1, dated June 7, 2001. Proposed paragraph (a)(1) addresses front drum rotors that have fewer than 1,000 cyles-since-new on the effective date of the AD in order to include them in the inspection program. Therefore, no changes are necessary and the proposed paragraph (a) is adopted without change.

One commenter requests that the effective date of the superseding AD be the same as the effective date of ASB PW4ENG A72-722, Revision 1, dated June 7, 2001. The commenter expresses concern that the effective date of the superseding AD would require changing the operators' ongoing inspection program.

The FAA does not agree that the effective date of the superseding AD must be the same as the effective date of Revision 1 of the ASB. The actions in the AD are required unless already done. Also, the inspections are based on the number of cycles the HPC front drum rotor has accumulated since new. An on-going inspection program is not affected by a change in the effective date of the AD.

One commenter notes that the proposal differs from the ASB, by not including the off-wing repetitive inspection program. The commenter states that when an engine is removed in accordance with another AD, AD 2001-25-11, the engine may be returned to service without HPC disassembly. Therefore, the off-wing borescope inspection program is necessary in this superseding AD and the commenter requests it be incorporated in the AD.

The FAA partially agrees. The FAA does not agree that the off-wing borescope inspection program must be incorporated in the AD. In the discussion of comments section of AD 2001-20-13, published in the Federal Register on October 12, 2001, it was noted that there are differences between the manufacturer's service information and the AD. The FAA stated that ASB PW4ENG A72-722, Revision 1, dated June 7, 2001, provides procedures for operators to perform off-wing initial and repetitive HPC drum rotor inspections, and that the off-wing requirements are not mandated by AD 2001-20-13. The FAA evaluated a 20-year cumulative risk assessment and determined that an acceptable level of safety will be met by requiring the on-wing inspections at the cyclic intervals detailed in the ASB. This description was not provided in the proposal. As the commenter states, operators performing the actions of AD 2001-20-13 have access to the HPC module, and can perform the off-wing HPC front drum rotor inspections of the ASB. It is noted in the ASB that the inspection program is intended for incorporation on engines installed on aircraft but may be incorporated on engines in the shop. The FAA agrees that using the off-wing procedures satisfies the repetitive inspection requirement. Therefore, paragraph (b) of the AD now reflects that option.

One commenter expresses concern that the proposal does not address engines that have met the requirements of the ASB before the effective date of the AD. Another commenter expresses concern that the proposal does not reference engines that have complied with the ASB during a shop visit before the effective date of the AD. The commenters request that paragraph (a) of the AD reference the off-wing borescope inspection in accordance with off-wing inspection paragraphs of ASB PW4ENG A72-722. The commenters also request that a paragraph be added to the AD to state that HPC drum rotors previously inspected in accordance with the on-wing and off-wing accomplishment instructions of the ASB's before the effective date of the AD, satisy the initial inspection requirements of the AD.

The FAA partially agrees. The FAA does not agree that the off-wing borescope inspection program must be incorporated in the AD, as explained previously in the third comment response. The FAA agrees that inspection of HPC front drum rotors in accordance with the off-wing inspection instructions of the ASB before the effective date of the AD, satisfies the initial inspection requirements of the AD. Therefore, a new sub-paragraph (7) is added to paragraph (a) of the AD to allow the use of off-wing inspections of the HPC front drum rotors to satisfy the initial inspection requirement.

One commenter states that the repetitive inspection program is not at part level and requests that the repetitive inspection program be at part level.

The FAA disagrees that a part level inspection program should be added to the AD. Because the actions required by this AD are on-wing borescope inspections, the engine does not need to be disassembled to the part level in order to do the required actions.

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

The FAA estimates that this superseding AD will result in no additional costs to operators beyond those already incurred to comply with the current AD.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would 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. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

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 the 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 by contacting the Rules Docket at the location provided under the caption ADDRESSES .

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain McDonnell Douglas Model MD-90-30 airplanes was published in the Federal Register on April 5, 2002 (67 FR 16335). That action proposed to require an inspection of the galley power feeder cable above the main cabin ceiling supports for damage caused by chafing. The action also proposed to require repairing any damage on the outer cable jacket or primary insulation, installing a splice on the power feeder cable to remove damage, installing sleeving along a portion of the cable, installing standoffs for the cable, re-routing the galley power feeder cable, and testing the galley equipment, as applicable.

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

For clarification, the FAA has revised the definition of a “general visual inspection” in this final rule. We also have corrected a typographical error in the docket number specified in the proposed rule in the section containing the manufacturer's name.

The FAA has determined that air safety and the public interest require the adoption of the rule with the changes described above. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

The FAA estimates that 17 airplanes of U.S. registry will be affected by the requirement to accomplish McDonnell Douglas Alert Service Bulletin MD90-24A046, Revision 02, dated March 26, 2001. We estimate that 22 airplanes of U.S. registry will be affected by the requirement to accomplish McDonnell Douglas Alert Service Bulletin MD90-24A047, Revision 01, dated July 31, 2000.

It will take approximately 1 work hour per airplane to accomplish the required inspection, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the inspection on U.S. operators is estimated to be $1,020, or $60 per airplane.

It will take approximately 2 work hours per airplane to accomplish the required installation of sleeving along a portion of the cable, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the installation of sleeving on U.S. operators is estimated to be $2,040, or $120 per airplane.

It will take approximately 5 work hours per airplane to accomplish the required modification of the installation of the galley power feeder cables and re-routing of the cables, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the modification and re-routing of the cable on U.S. operators is estimated to be $6,600, or $300 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Boeing Model 727 series airplanes was published in the Federal Register on November 28, 2001 (66 FR 59382). That action proposed to require a review of maintenance records or a one-time test to determine if elevator hinge support ribs on the trailing edge of the horizontal stabilizer are made from a certain material, and follow-on repetitive inspections for corrosion or cracking of the elevator hinge support ribs, if necessary. For airplanes with the affected ribs installed, the action also proposed to eventually require replacement of all affected ribs with new, improved ribs.

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

One commenter, an operator, notes how the proposed AD will affect its fleet but makes no request for any change to the proposed AD.

One commenter believes that the adoption of the proposed AD at this stage would be premature. The commenter states that it is not aware of any instance of in-service or operational problems related to stress corrosion cracking in the elevator hinge support ribs. The commenter acknowledges the inherent potential for stress corrosion cracking of 7079-T6 material, as well as the potential for airframe vibration if the hinge support ribs no longer provide the required stiffness for the elevator support. However, the commenter points to the fact that, in more than 30 years of service of Model 727 series airplanes, “no major irregularities” have been found on airplanes with the subject ribs installed. The commenter states that, if the FAA determines that rulemaking is indeed necessary at this time, the proposed AD should be revised to require only repetitive inspections, with no requirement for replacement of the subject ribs with improved ribs. The commenter goes on to suggest that, if the FAA decides to require replacement of the subject ribs, the compliance time for such replacement should be extended from 48 months to 60 months after the effective date of this AD. The commenter explains that a compliance time of 60 months would be more consistent with the manufacturer's ability to deliver the necessary replacement part, and would allow the majority of operators to accomplish the rib replacement during a regularly scheduled “D” check, which would reduce the cost impact of the proposed AD on affected operators.

The FAA partially concurs. We do not concur that repetitive inspections alone will provide an acceptable level of safety for the affected airplane fleet. Mandating the replacement of subject elevator hinge support ribs is based on our determination that, in this case, long-term continued operational safety will be better assured by design changes to remove the source of the problem, rather than repetitive inspections. Repetitive inspections alone may not provide the degree of safety assurance necessary for the transport airplane fleet. This, coupled with a better understanding of the human factors associated with numerous continual inspections, has led us to consider placing less emphasis on inspections and more emphasis on design improvements. The replacement of elevator hinge support ribs required by this AD is consistent with these conditions.

However, we do concur with the commenter's request to extend the compliance time for the rib replacement from 48 months to 60 months. We find that the justification provided by the commenter is reasonable. Further, we find that repetitive inspections at the intervals required by this AD, along with adequate maintenance, will provide an acceptable level of safety over the 60-month compliance period. We have revised paragraph (d) of this final rule accordingly.

Two commenters request that we extend the 180-day compliance time for the proposed inspection for corrosion or cracking of elevator hinge support ribs made from 7079-T6 material. Both commenters request extension of the compliance time to coincide with a regularly scheduled “C” check. One commenter states that a 180-day compliance time would be appropriate for airplanes on which the subject ribs have never been inspected, but requests a compliance time of 18 months or 4,000 flight hours (which would correspond to the industry standard for “C” checks) for airplanes on which the subject ribs have been inspected previously. This commenter concludes that previous zonal inspections, which many operators have been performing at three to six year intervals, have been adequate to ensure some degree of safety. The commenter bases its conclusion on the low incidence of cracked ribs with no flight control anomalies attributed to cracked ribs. The commenter also notes that the proposed AD would mandate inspections of the subject ribs significantly more frequently than specified by current maintenance programs. The second commenter also considers the proposed 180-day compliance time unduly restrictive considering the service history of the affected airplanes. The second commenter asserts that the proposed compliance time would add a significant cost burden for operators in the form of out-of-service costs and costs associated with gaining access and closing up outside of a regularly scheduled maintenance visit.

We partially concur with the commenters' request. We do not concur that it is appropriate to extend the initial compliance time for the inspection for cracking or corrosion on all airplanes. In developing an appropriate compliance time for this AD, we considered not only the manufacturer's recommendation, as presented in the referenced service bulletin, but the degree of urgency associated with addressing the subject unsafe condition, as well as the nature of the unsafe condition. Given the potential hazards associated with stress corrosion cracking of multiple elevator hinge support ribs, we find that it is important for the subject ribs to be inspected in a timely manner, so that any cracks may be found and fixed. Therefore, for airplanes with multiple ribs made from 7079-T6 material, we find that the 180-day compliance time for the initial inspection is warranted, in that it represents an appropriate interval of time allowable for affected airplanes to continue to operate without compromising safety.

However, we find that the compliance time may be extended somewhat for the initial inspection for cracking or corrosion on airplanes with no more than one rib made of 7079-T6 material per side of the horizontal stabilizer. For these airplanes, the potential for cracking of multiple ribs is low. Thus, we have determined that the initial inspection for cracking or stress corrosion may be deferred until 18 months after the effective date of this AD without jeopardizing the continued safety of the airplane fleet. Accordingly, paragraph (b) has been revised and paragraphs (b)(1) and (b)(2) have been added in this final rule.

Two commenters request that we extend the interval for the repetitive inspections for corrosion or cracking of all elevator hinge support ribs made from 7079-T6 material from every 180 days to every “C” check (i.e., approximately every 18 months). One commenter states that a previous AD, AD 77-18-06 R1, amendment 39-3048, requires repetitive inspections every 3,200 flight hours or 18 months for parts made from 7079-T6 material on the center section of the front spar fitting of the horizontal stabilizer. The commenter also refers to AD 75-09-04 R1, amendment 39-2142, stating that it requires repetitive inspections every 3,000 flight hours of the center section of the rear spar fitting of the horizontal stabilizer (which is made from 7079-T6 material). The other commenter refers to the satisfactory service history of Model 767 series airplanes with hinge support ribs made from 7079-T6 material as justification for extending the proposed inspection interval to correspond to the “C” check interval of the majority of operators. That commenter states that the proposed 180-day repetitive interval would necessitate special maintenance visits and increase the cost impact on affected operators.

We partially concur. With regard to the ADs that the commenter refers to as justification for extending the repetitive interval of this AD, we note that the repetitive intervals to which the commenter refers are only applicable under certain conditions. In this AD, we find that the proposed repetitive interval of 180 days is important to ensure that any crack on an affected rib will be found and fixed in a timely manner. If not found and fixed in a timely manner, propagation of cracks on multiple ribs could decrease the stiffness of the elevator support, resulting in vibration of the airframe during flight and consequent damage to the elevator and horizontal stabilizer, which could result in loss of controllability of the airplane.

However, we find that the repetitive interval may be extended somewhat for airplanes with no more than one rib made of 7079-T6 per side of the horizontal stabilizer. As discussed previously, for these airplanes, the potential for cracking of multiple ribs is low. Thus, we have determined that the repetitive inspections for cracking or stress corrosion may be performed on these airplanes at 18-month intervals without jeopardizing the continued safety of the airplane fleet. Paragraphs (b), (b)(1), and (b)(2) of this final rule have been revised accordingly.

One commenter requests that we revise paragraph (c) of the proposed AD, which specifies that any discrepancy must be repaired before further flight according to a method approved by the Manager of the FAA's Seattle Aircraft Certification Office (ACO) or an authorized Boeing Designated Engineering Representative (DER). The commenter states that the current Boeing 727 Structural Repair Manual (SRM) contains appropriate repair data for certain cracks of the hinge support ribs, and requests that we clarify that applicable repairs per the SRM are acceptable for compliance with paragraph (c) of the proposed AD. The commenter also states that Boeing should provide additional repairs for small flange or web cracks that will be acceptable in the interim until subject ribs are replaced.

We partially concur with the commenter's request. The Accomplishment Instructions of Boeing Alert Service Bulletin 727-55A0091, including Appendix A, dated August 16, 2001, refer to Boeing 727 SRM Chapter 55, Subject 55-10-4, as an acceptable source of service information for repair of “some” cracks. We find that repairs included in that chapter of the SRM are acceptable for compliance with this AD. However, for necessary repairs not included in that section, the repair must be accomplished according to a method approved by the Manager, Seattle ACO, or an authorized DER. Paragraph (c) of this AD has been revised accordingly, and a new Note 3 has been added to this final rule (and subsequent notes reidentified accordingly) to specify that the service bulletin refers to Boeing 727 SRM Chapter 55, Subject 55-10-4, as an acceptable source of service information for certain repairs.

With regard to the commenter's concern about flange and web cracks, the manufacturer has not provided us with any procedures for repair of such cracks, so we cannot evaluate such repairs. If procedures for such repairs are submitted to us as provided by paragraph (f) of this AD, we will consider approving them as an alternative method of compliance for paragraph (c) of this AD. No further change to the final rule is necessary in this regard.

One commenter requests that we revise the proposed AD to make the repetitive inspection and replacement requirements applicable only to airplanes listed in Group 1 in the referenced service bulletin. The commenter notes that airplanes in Group 1, which were delivered with elevator hinge support ribs made from 7079-T6 material installed at all 14 elevator station locations, are at a significantly higher risk to have multiple cracked ribs and consequent damage than are airplanes in Groups 2 and 3, which have only one or two subject ribs. The commenter concludes that there is no airworthiness concern for airplanes in Groups 2 and 3; thus, there is no justification for including them in the proposed AD.

We do not concur. As explained in the preamble of the proposed AD, airplanes in Groups 2 and 3 may have had ribs replaced after delivery with ribs made from 7079-T6 material, so these airplanes may have more than “one or two” subject ribs. Further, even if only one subject rib is installed on each side of the horizontal stabilizer, failure of one of these ribs could lead to failure of adjacent ribs and result in the unsafe condition addressed by this AD. However, we acknowledged previously in this final rule that failure of multiple ribs is somewhat less likely on airplanes with no more than one subject rib on each side of the horizontal stabilizer. Thus, as explained above, we have extended the repetitive inspection interval to 18 months for airplanes with no more than one rib made of 7079-T6 material on each side of the horizontal stabilizer. No further change to the final rule is necessary in this regard.

For clarification, we have made minor revisions to the service information citations in paragraph (a) of this final rule. These revisions are strictly editorial; no substantive change has been made.

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

There are approximately 1,383 Model 727 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 915 airplanes of U.S. registry will be affected by this AD.

This AD offers two alternatives for compliance with the requirement for an initial inspection to determine whether elevator hinge support ribs made from 7079-T6 material are installed. Estimates of the cost of these actions are provided below.

The review of maintenance records, which is one alternative for compliance, will take approximately 1 work hour per airplane, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this review is estimated to be $60 per airplane.

In lieu of the review of maintenance records (i.e., if the review of maintenance records is not sufficient to make a determination), the inspection of the ribs to determine if they are made from 7079-T6 material will take approximately 1 work hour per airplane, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this inspection is estimated to be $60 per airplane.

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

Should an operator be required to accomplish the repetitive detailed inspections, these inspections will take approximately 13 work hours per airplane, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of this inspection, if required, will be $780 per airplane, per inspection cycle.

Should an operator be required to accomplish the replacement of the elevator hinge support ribs, it will take approximately 722 work hours per airplane for replacement of all ribs (on both the left- and right-hand sides of the airplane, excluding the time for gaining access and closing up), at an average labor rate of $60 per work hour. Required parts will cost approximately $70,000 per airplane. Based on these figures, the cost impact of the replacement, if required, will be $113,320 per airplane.

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 part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Bombardier Model DHC-8-100, -200, and -300 series airplanes was published in the Federal Register on March 21, 2002 (67 FR 13108). That action proposed to require revision of the applicable maintenance program manual; repetitive inspections for corrosion or cracking of the hook roller shafts of the flap carriage; and eventual replacement of the hook roller shafts with new or serviceable hook roller shafts, which would extend the interval for the repetitive inspections.

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

The FAA has revised paragraph (a) of the final rule to clarify that the maintenance manual revision must be accomplished according to the applicable temporary revision listed in paragraph (a)(1), (a)(2), or (a)(3) of the AD.

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

The FAA estimates that 183 airplanes of U.S. registry will be affected by this AD.

It will take approximately 4 work hours per airplane to accomplish the required inspection, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the required inspection on U.S. operators is estimated to be $43,920, or $240 per airplane, per inspection cycle.

It will take approximately 4 work hours per airplane to accomplish the required replacement, at an average labor rate of $60 per work hour. Required parts will cost approximately $460 per airplane. Based on these figures, the cost impact of the required replacement on U.S. operators is estimated to be $128,100, or $700 per airplane.

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

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

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

In the Federal Register of November 24, 2000 (65 FR 70538), FDA proposed to revoke § 310.500 (21 CFR 310.500), which established conditions for marketing digoxin products for oral use (tablets and elixir). The regulation: (1) Declared all digoxin products for oral use (tablets and elixir) to be new drugs, (2) required submission of ANDAs and bioavailability tests for all oral digoxin products (the requirement for the submission of ANDAs was stayed indefinitely (41 FR 43135, September 30, 1976)), (3) required a mandatory FDA certification program for digoxin tablets based on dissolution testing by the National Center for Drug Analysis, (4) required a recall of any previously marketed batch of digoxin tablets found to fail United States Pharmacopeia (USP) dissolution specifications, and (5) set forth a labeling requirement for all oral digoxin products.

In the preamble to the proposed rule, FDA described actions that have occurred since § 310.500 was published that render the regulation unnecessary. The agency discussed the 1997 approval of NDA 20-405 for Lanoxin (digoxin) Tablets and described the indications for the tablets, which differ from the indications for oral digoxin drug products set forth in § 310.500. The agency explained that because of the approval of NDA 20-405, digoxin tablets are now eligible for ANDAs under section 505 of the act (21 U.S.C. 355).

The agency also noted that the dissolution requirements specified in § 310.500 are no longer used as standards in the certification program and are therefore obsolete. The agency concluded that regulation of these products under batch certification was no longer warranted.

The proposed rule referenced a companion notice published elsewhere in the Federal Register of November 24, 2000 (65 FR 70573), reaffirming the new drug status of oral digoxin products and requiring approved applications for marketing. In that notice, FDA lifted the stay for submitting ANDAs for digoxin products for oral use.

Interested persons were given until February 22, 2001, to submit comments on the proposal. FDA received comments from four manufacturers of drug products subject to the proposal.

(Comment 1) Three of the four submitted comments agreed that the agency should revoke § 310.500. One comment identified several public health reasons to revoke § 310.500. Those reasons are described in section II of this document and incorporated into the agency's response to the one comment that opposed revocation of § 310.500.

(Comment 2) One comment opposed the agency's proposed rule to revoke § 310.500, contending that the batch certification procedure is sufficient for FDA to regulate digoxin tablets and that the proposed rule is inadequate because FDA failed to identify a public health reason or change of facts or circumstances to justify revoking its regulation of digoxin tablets under batch certification.

FDA disagrees with this comment. The integrity of the batch certification process, the principal concern of the comment, is not the relevant issue. The relevant issue is whether the certification procedure is still warranted in light of new information or changing circumstances. FDA concludes it is not warranted and, as explained in section II of this document, has determined that revocation of § 310.500 is rationally related to FDA's statutory obligation to ensure that marketed oral digoxin drug products are safe, effective, and properly labeled as reflected by current scientific knowledge and information.

In its November 2000 proposed rule and a companion notice published in the same issue of the Federal Register , FDA described the reasons for the agency's plan to revoke § 310.500. As discussed in section II of this document, the agency believes those reasons are still valid and that revocation of the regulation is appropriate and required under the circumstances.

As noted in the proposed rule and companion notice, along with other prior notices referenced in the proposed rule, in 1974 FDA established the conditions for marketing oral digoxin drug products in § 310.500 because of safety concerns with digoxin products on the market. Studies had shown clinically significant differences in bioavailability of certain oral digoxin products. This variability was a major concern because of the drug's narrow therapeutic index and the potential risk presented to patients using digoxin products of varying bioavailability. Therefore, FDA established the regulations to provide a systematic regulatory approach to ensure uniformity of marketed oral digoxin products.

The conditions for marketing included, among other things, requirements for submission of ANDAs, a batch certification program for digoxin tablets based on dissolution testing, and labeling requirements for all oral digoxin drug products. The requirement for ANDAs was later stayed pending resolution of the agency's ANDA policy. Absent submission of ANDAs, the batch certification program was the only preclearance requirement for digoxin tablets. The batch certification program was not intended to be a permanent solution to the problem of digoxin variability, but a stopgap measure to bring the potential for a serious health problem under control.

In that 1974 regulation, the agency also announced its determination that digoxin products for oral use are new drugs within the meaning of section 201(p) of the act (21 U.S.C. 321(p)). Because of the need for an optimal regulatory program to ensure the uniformity of oral digoxin drug products, FDA has, over the years, considered various approaches to bring digoxin into the new drug approval system.

The approval of NDA 20-405 for Lanoxin Tablets represented the first step in regulating all oral digoxin products under the requirements of section 505 of the act and the corresponding regulations. Approval of that NDA was also important because it provided data to help establish in vivo bioavailability and bioequivalence standards for oral digoxin drug products.

The approval of NDA 20-405 and the new information that emerged from the agency's review of the NDA provide a rational basis for the agency's actions to revoke § 310.500. Because the agency has approved an NDA for digoxin tablets, oral digoxin drug products are no longer covered by the exemptions set forth in Compliance Policy Guide (CPG) 7132c.02. That CPG provides priorities for regulating marketed new drugs without approved NDAs or ANDAs, such as oral digoxin products regulated under § 310.500.

As noted in one comment, FDA's decision to revoke § 310.500 is also supported by safety concerns related to the differences in labeling of the Lanoxin drug product and the labeling required under § 310.500. FDA approved NDA 20-405 for treatment of mild to moderate heart failure and for atrial fibrillation. The labeling of § 310.500 provides for use of digoxin in congestive heart failure (all degrees), atrial fibrillation, atrial flutter, paroxysmal atrial tachycardia, and cardiogenic shock.

The labeled indications for new drugs, such as oral digoxin drug products, must be supported by substantial evidence derived from adequate and well-controlled investigations, including clinical investigations. (See section 505(d) of the act (21 U.S.C. 355(d) and §§ 314.126, 201.56, and 201.57 (21 CFR 314.126, 201.56, and 201.57).) Labeling indications that are not supported by adequate and well-controlled studies are false and misleading, in violation of section 502(a) of the act (21 U.S.C. 352(a)).

Except for the data to support the two indications approved in NDA 20-405, the agency is not aware of any adequate and well-controlled studies to support the indications for use in § 310.500. Thus, the labeling of oral digoxin as set forth in § 310.500 is outdated and does not reflect current scientific and medical information about oral digoxin. Moreover, marketing of oral digoxin drug products with labeling described in § 310.500 could present a risk to patients because substantial scientific evidence to establish the safety and effectiveness of all of the indications in that labeling has not been established.

In addition, the criteria in § 310.500 are not current because the dissolution requirements specified in that regulation are no longer used as standards in the certification program. The dissolution requirements in § 310.500 differ from those in the current official U.S.P. monograph for oral digoxin tablets that FDA considers scientifically appropriate. Therefore, the dissolution requirements specified in § 310.500 for digoxin tablets are obsolete.

Furthermore, as described in a comment, § 310.500 lacks the uniform standards of the new drug approval system that ensure predictable bioavailability for oral digoxin products. Digoxin is a potent drug with a narrow therapeutic index. Slight variations in bioavailability can result in toxicity or loss of effect. Formulation and manufacturing controls are critical to the safe and effective use of oral digoxin drug products. Review of oral digoxin through the new drug approval process is necessary to provide adequate evidence of safety and substantial evidence of effectiveness, as well as adequate information about formulation and manufacturing procedures.

In addition to approval requirements under the new drug approval system, all oral digoxin products must be subject to the same postmarketing requirements so that changes that may affect the safety or effectiveness of the products can be monitored. Sponsors of products not approved through the new drug approval process, such as oral digoxin products under § 310.500, may reformulate their products or make manufacturing changes without seeking FDA approval. Such changes may affect bioavailability and hence may affect the safety or effectiveness of the products.

Additionally, although manufacturers of such unapproved products are required under 21 CFR 310.305 to report adverse events that are serious and unexpected, they are not required to report all adverse events associated with drug use. In contrast, manufacturers of approved new drug products are required to report all adverse events under 21 CFR 314.80. Consequently, adverse drug events that may reflect problems with the safety or effectiveness of oral digoxin products may not be reported.

Moreover, allowing oral digoxin products to be marketed under § 310.500 and the new drug approval process creates confusion in the marketplace regarding the substitutability or interchangeability of the drug products. Products marketed under § 310.500 and those approved under the new drug approval system may have differences in bioavailability. Furthermore, marketed oral digoxin products cannot be considered to be therapeutically equivalent, and therefore substitutable, unless equivalence is demonstrated through appropriate bioequivalence studies. Regulating all oral digoxin drug products under the same approval process would eliminate those safety concerns.

As discussed in section I of this document and in the November 24, 2000, proposed rule and its companion notice published in the same issue of the Federal Register , the conditions established in § 310.500 for marketing oral digoxin products either are obsolete or no longer warranted. Because of the approval of the NDA for digoxin tablets and the new drug status of oral digoxin drug products, all oral digoxin products can and must be regulated under the new drug approval process for NDAs and ANDAs as set forth in section 505 of the act. Regulation through this process protects the public health by ensuring the safety and efficacy of each oral digoxin drug product. Therefore, the agency is revoking that regulation.

As proposed, the final rule would become effective 30 days after its date of publication in the Federal Register .

(Comment 3) Three comments stated that additional time is needed to prepare, submit, and obtain approval of an NDA.

Two comments from manufacturers of digoxin elixir requested a 2-year compliance period. One comment, characterizing digoxin elixir as medically necessary, noted that there are only two manufacturers of digoxin elixir drug products and expressed concern that a shortage of digoxin elixir drug products may occur if such products were removed from the market 30 days after publication of the final rule in the Federal Register . The comment further indicated that preparation of an application for digoxin elixir is complicated by the fact that there is no reference listed drug for digoxin elixir in FDA's “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book), and therefore, no guidance is currently available from the agency on which to base a submission for digoxin elixir drug products.

Digoxin elixir is a medically necessary dosage form. It is used primarily in the pediatric population for the treatment of atrial fibrillation and congestive heart failure, both serious and potentially life-threatening diseases/conditions. Available alternative therapies are not approved for treating atrial fibrillation and congestive heart failure in the pediatric population. Such therapies are limited in their use because of toxicities, lack of safety and efficacy data in the pediatric population, and/or lack of a pediatric formulation allowing for consistent administration to children. There should not be a disruption in the marketplace for patients who need digoxin elixir. In order to protect the public health, FDA plans to exercise its enforcement discretion and not take regulatory action against currently marketed unapproved digoxin elixir products before June 28, 2004. This should allow sufficient time for a manufacturer to conduct the required tests, evaluate the data, and prepare and submit a new drug application to FDA. After that date, any digoxin elixir drug product on the market without an approved NDA or ANDA will be subject to regulatory action.

A manufacturer of digoxin tablets contends that FDA must extend the effective date of the final rule for at least 2 years to allow current producers and marketers of the drug products subject to the certification program to prepare, submit, and obtain an approved new drug application.

a. Lack of notice . In its comments, the manufacturer implies that the firm was not aware of FDA's intent to revoke § 310.500. (The comment's allegation that the proposed rule was issued to settle a lawsuit is spurious. The agency was preparing the proposed rule long before the party to that suit even approached the agency.)

The proposed rule itself provides reasonable notice of the agency's intent. The manufacturer has had more than a year in which to continue marketing under § 310.500 and, at the same time, pursue approval of an ANDA.

Moreover, a reasonably observant member of the drug industry would have known for a number of years that FDA intended to revoke § 310.500 and that applications approved through the new drug approval process would be required. For example, articles in the trade press have announced the agency's intention to require approval of oral digoxin through the new drug approval process. (See e.g., F-D-C Reports, July 6, 1992 at 7.) NDA 20-405 for Lanoxin (digoxin) Tablets was approved in September 1997. The approval was published in FDA's “Approved Drug Products with Therapeutic Equivalence Evaluations,” and also was reported in the trade press. (See e.g., F-D-C Reports , October 6, 1997 at T&G-2.) Certainly since that time, if not many years before, the drug industry has known that FDA would change its approach for regulating oral digoxin products and that the agency would take action to revoke § 310.500.

b. Takings under the fifth amendment . The manufacturer argues that if its digoxin drug product is removed from the market 30 days after publication of the final rule in the Federal Register , the potential loss to its company would be substantial and could constitute a “taking” for which the Federal Government could be financially liable. The manufacturer did not submit any evidence or analysis to support its views.

FDA disagrees that this final rule effects a taking in violation of the fifth amendment of the United States Constitution. The Supreme Court has developed three factors to consider in assessing whether a regulatory taking has occurred: (1) The character of the governmental action, (2) its economic impact, and (3) its interference with reasonable investment-backed expectations. (See Ruckelshaus v. Monsanto Co. , 467 U.S. 986, 1005 (1984).)

The force of any one of these factors may be “so overwhelming * * * that it disposes of the taking question” ( Ruckelshaus , 467 U.S. at 1005) (finding interference with reasonable investment-backed expectations by use of trade secret information in pesticide approval process to be decisive). So, for example, if the economic impact is to rob real property of “all economically beneficial uses,” the regulation effects a taking ( Lucas v. South Carolina Coastal Council , 112 S. Ct. 2886, 2899 (1992) emphasis in original). Regulations that cause a temporary denial of property use, however, are not subject to such “per se” rules but entail complex factual assessments of the purposes and economic effects of government actions. See Tahoe-Sierra Preservation Council v. Tahoe Regional Planning Agency , No. 00-1167, 2002 WL 654431 (U.S. April 23, 2002). When examined in light of these three factors, FDA's revocation of § 310.500 clearly does not effect a compensable taking under the fifth amendment of the Constitution.

i. Character of the governmental action. With respect to the first factor, courts are more likely to find a taking when the interference with property can be characterized as a physical invasion by the Government (e.g. United States v. Causby , 328 U.S. 256, 261-62 (1946) (characterizing Government's use of flight path just over property as physical invasion)) than when the interference is caused by a regulatory program that “adjust[s] the benefits and burdens of economic life to promote the common good.” ( See Penn Central Transp. Co. v. City of New York , 438 U.S. 104, 124 (1978).) Courts have accorded particular deference to governmental action taken to protect the public interest in health, safety, and welfare. (See Keystone Bituminous Coal Ass'n v. DeBenedictis , 480 U.S. 470, 488 (1987).)

In this case the governmental action is associated with a regulatory program designed to protect the health and safety of the public. Revocation of § 310.500 is intended to ensure that digoxin drug products on the market meet the current safety and efficacy product approval standards and are regulated in the same manner as other drug products under the act. As such, it does not constitute governmental action that would be considered a taking.

ii. Economic impact. The second factor to consider is the economic impact of the governmental action. “There is no fixed formula to determine how much diminution in market value is allowable without the fifth amendment coming into play” ( Florida Rock Indus., Inc. v. United States , 791 F.2d 893, 901 (Fed. Cir. 1986), cert. denied, 479 U.S. 1053 (1987)). It is clear, however, that a regulation's economic impact may be great without rising to the level of a taking. ( See Pace Resources Inc. v. Shrewsbury Township , 808 F.2d 1023, 1031 (3d Cir.), cert. denied, 482 U.S. 906 (1987) (no taking even given reduction in value from $800,000 to $60,000); Village of Euclid v. Ambler Realty Co. , 272 U.S. 365 (1926) (no taking despite 75 percent diminution in value).) Mere denial of the most profitable or beneficial use of property does not require a finding that a taking has occurred. ( See Florida Rock Indus., Inc. v. United States , 791 F.2d 893, 901 (Fed. Cir. 1986), cert. denied 479 U.S. 1053 (1987); see also Andrus v. Allard , 444 U.S. 51, 66 (1979).)

In assessing whether a regulation effects a taking, the Supreme Court has considered whether the regulation denies an owner the “economically viable” use of its property. See, e.g., Keystone , 480 U.S. at 499. This analysis involves looking not just at what has been lost, but at the whole “bundle” of property rights. Andrus v. Allard , 444 U.S. at 65-66. Courts focus on the remaining uses permitted and the residual value of the property. Pace Resources , 808 F.2d at 1031. Although it is undeniable that compliance with these regulations will cost money and may mean that certain product names must be altered, companies will not be denied the economically viable use of their property.

By revoking the regulation, the agency is not taking away the ability of manufacturers to market digoxin drug products. The one manufacturer that might be affected does not complain in its comments that it would be unable to produce digoxin, but that it would face “severe difficulty re-entering the market and re-establishing its position after an absence which could span a year or more while waiting for FDA to approve an NDA or ANDA.” The manufacturer may submit an NDA or ANDA and then market its digoxin drug product after approval. It is possible that this could be done with little or no interruption in marketing. Therefore, the manufacturer has “remaining uses” of its property and does not suffer loss of “economically viable use” of property. ( See Pace Resources , 808 F. 2d at 1031; and Keystone, 480 U.S. at 499.) Consequently, this factor also does not support a conclusion that revocation of the regulatory provision is a taking.

iii. Investment-backed expectation. The final factor to consider is whether a company has a reasonable investment-backed expectation in continuing to use the property at issue. To be reasonable, expectations must take into account the power of the State to regulate in the public interest. ( See Pace Resources , 808 F.2d at 1033.) Reasonable expectations must also take into account the regulatory environment, including the foreseeability of changes in the regulatory scheme. “In an industry that long has been the focus of great public concern and significant government regulation,” Monsanto , 467 U.S. at 1008, the possibility is substantial that there will be additional regulatory requirements. “Those who do business in the regulated field cannot object if the legislative scheme is buttressed by subsequent amendments to achieve the legislative end.” ( See Connolly v. Pension Benefit Guarantee Corp. , 475 U.S. 211, 227 (1986).)

The manufacturer is a regulated body and, as such, has been aware from the time it began manufacturing digoxin that the regulatory scheme could be modified. As described in section II.B.2.a of this document, the manufacturer has had notice for many years that the regulatory scheme in § 310.500 would be changed. As with the other factors, analysis of this factor establishes that revoking § 310.500 is not a taking under the fifth amendment.

When examined in light of these three factors, FDA's revocation of § 310.500 clearly does not effect a compensable taking under the fifth amendment of the Constitution.

c. Market disruption . Contrary to the comment's assertion, FDA does not believe that a disruption in the marketplace of digoxin tablets will occur if, should it be necessary, an unapproved digoxin tablet product supplying from 15 to 20 percent of the market is taken off the market. As the comment recognizes, there are two other manufacturers of digoxin tablets, holders of approved NDAs. FDA believes that these manufacturers are capable of satisfying an increased demand for digoxin tablets.

d. Levothyroxine sodium . In further support of its contention that FDA extend the effective date of the final rule, the comment alleges that the digoxin tablet drug products are in a situation similar to that in which sponsors of levothyroxine sodium were allowed a minimum of 3 years to obtain approved NDAs. The comment contends that FDA should accord comparable time for completion and review of digoxin NDAs.

The agency's handling of levothyroxine sodium does not provide a necessary precedent for setting an effective date for approval of digoxin tablet drug products. The facts involving digoxin tablets and levothyroxine sodium differ in at least two significant ways. First, the Federal Register notice of August 14, 1997 (62 FR 43535) (announced that orally administered drug products containing levothyroxine sodium are new drugs and announced the conditions for marketing the products), was the first time FDA issued any public announcement of the new drug status of levothyroxine sodium products. By contrast, in the Federal Register of November 24, 2000 (65 FR 70573), FDA reaffirmed the agency's 1974 determination that digoxin products for oral use are new drugs requiring approved NDAs. Second, and most importantly, when FDA published the notice on levothyroxine sodium drug products, there were no approved NDAs for the products. When FDA published the proposed rule on digoxin, on the other hand, there were two approved products on the market for digoxin tablets under NDA 20-405 and ANDA 40-282. Because FDA determined that levothyroxine sodium drug products are medically necessary, sponsors of the products were allowed 3 years to obtain approved NDAs. In contrast, while digoxin tablets may be medically necessary, there is no medical necessity for unapproved digoxin tablets. Unapproved digoxin tablets may be indicated for serious cardiac conditions, as the comment claims, but there are approved digoxin tablets in sufficient quantity to meet the market demand.

To summarize, the comment has set forth no sufficient reason to justify an extension. Industry has been on notice for a number of years that § 310.500 would be revoked and that applications approved through the new drug procedures would be required. It is the manufacturer's responsibility to prove the safety and effectiveness of its product(s).

In order to protect the public health, FDA plans to exercise its enforcement discretion and not take regulatory action against currently marketed unapproved digoxin elixir products before June 28, 2004. Any unapproved digoxin elixir introduced after June 26, 2002, will be subject to regulatory action when this rule becomes effective on July 26, 2002.

Any unapproved digoxin tablet will be subject to regulatory action when this rule becomes effective on July 26, 2002.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (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 the benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year (adjusted annually for inflation). Under the Regulatory Flexibility Act, unless an agency certifies that a rule will not have a significant economic impact on a substantial number of small entities, the agency must analyze regulatory options that would minimize any significant impact of a rule on small entities.

The agency has reviewed this final rule and determined that it is consistent with the regulatory philosophy and principles identified in the Executive order and these two statutes. The Unfunded Mandates Reform Act of 1995 does not require FDA to prepare a statement of costs and benefits for the final rule because the final rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation-adjusted statutory threshold is $110 million. No further analysis is required under the Regulatory Flexibility Act because the agency has determined that this final rule will not have a significant effect on a substantial number of small entities.

As mentioned in the proposed rule, several studies have indicated a significant variation in the bioavailability of digoxin products for oral use. FDA published the January 1974 regulation that established conditions for marketing such products, including a mandatory batch certification program for digoxin tablets. In the proposed rule, FDA described actions that have occurred since that regulation was published that render the January 1974 regulation unnecessary. Therefore, under this final rule, manufacturers of digoxin products will be required to obtain an approved marketing application to enter or remain on the market.

In the proposed rule, FDA noted that one of the manufacturers of digoxin tablets had not already obtained an NDA or ANDA and would need to obtain an ANDA to remain on the market. In addition, the two manufacturers of digoxin elixir would need to obtain approved applications. In the proposed rule, the agency calculated a cost of submitting either an ANDA or 505(b)(2) application, based on an estimate of 480 hours to complete the necessary paperwork.

One comment disagreed with the estimate of 480 hours, contending it to be a gross underestimate of the actual time required. The comment did not provide an alternate estimate. It should be noted that the estimate in the proposed rule considered that the three manufacturers in question would be submitting an application to market a dosage form they were already producing. Nevertheless, the agency acknowledges that the 480-hour figure may underestimate the actual time required. Accordingly, for this final rule, the agency estimates the time to complete an ANDA or 505(b)(2) application to be between 480 and 720 hours.

Using a 2001 labor rate of $49 per hour 1 , and assuming 480 to 720 hours to complete the required application, the one-time cost is between $23,500 and $35,300 ($49/hour x 480 to 720 hours). The one-time cost to all three firms is between $70,600 and $105,800 (3 x $23,500 to $35,300).

As stated in the proposed rule, FDA recognizes there will be future submission costs for new manufacturers of digoxin for oral use, and estimates two manufacturers will enter the market per decade. Some additional annual costs may also be incurred over the life of the application. While there may be some cost savings from the elimination of the batch certification requirement, the savings will be negligible.

According to the Small Business Administration, manufacturers of pharmaceutical preparations with 750 or fewer employees are considered small entities. Applying this definition, only one of the four current manufacturers that will incur submission costs is a small entity. In addition, these costs are likely to represent less than 1 percent of gross revenue. Therefore, the agency certifies that this action will not have a significant economic effect on a substantial number of small entities.

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

This final rule does not require information collection subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (Public Law 104-13). The information collection consists of the submission of NDAs or ANDAs for digoxin products for oral use. The information collection requirements for the submission of NDAs and ANDAs are contained in 21 CFR part 314 and have been approved under OMB control number 0910-0001, which expires on March 31, 2005.

MoorMan's, Inc., 1000 North 30th St., Quincy, IL 62305-3115, has informed FDA of a change of sponsor's name to ADM Alliance Nutrition, Inc. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect the change of sponsor's name.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for “MoorMan's, Inc.” and by alphabetically adding an entry for “ADM Alliance Nutrition, Inc.”; and in the table in paragraph (c)(2) by revising the entry for “021930” to read as follows.

(c) * * *

(1) * * *

(2) * * *

The Coast Guard has determined that good cause exists under the Administrative Procedure Act (5 U.S.C. 553) for not publishing a NPRM with comment and for making this rule effective in less than thirty 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 (Rutgers Street) Bridge, at mile 8.9, across the Passaic River, has a vertical clearance of 8 feet at mean high water, and 13 feet at mean low water in the closed position. The existing drawbridge operating regulations are listed at 33 CFR 117.739(k) require the bridge to open on signal if at least four-hours notice is given.

The Route 7 Bridge has been replaced with a new Route 7 Bridge located at the same alignment on the waterway and with the same vertical clearance as the old structure. The final phase of bridge construction involves installation of the roadway deck. During this installation the bridge will not be able to open for vessel traffic. Presently there is only one vessel operator upstream from this bridge and that vessel can pass under the bridge without a bridge opening.

The bridge owner, New Jersey Department of Transportation, requested a temporary regulation to facilitate final structural work at the bridge. The Coast Guard believes this rule is reasonable because no vessel traffic will be precluded from transiting this bridge as a result of this bridge closure.

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

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).

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

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

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

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

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

The Coast Guard considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (32)(e) of Commandant Instruction M16475.1C, 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 written “Categorical Exclusion Determination” is not required for the temporary final rule.

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.

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

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

On March 15, 2002, these rule submittals were found to meet the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

We approved earlier versions of the above listed rules into the SIP on the following dates: Rule 4602, November 13, 1998; Rule 4604, November 18, 1994; Rule 4606, March 22, 2000; Rule 4607, November 13, 1998; and, Rule 4684, June 13, 1995. Between these SIP incorporations and today, CARB made no intervening submittals of these rules.

The majority of changes to these rules result from adding organic solvent use, disposal, and storage requirements. The changes related to these additions are listed below. Other individual rule changes are discussed following this review.

Rule 4602 included the following significant changes to its 1998 SIP approved version.

Rule 4604 included the following significant changes to its 1994 SIP-approved version.

SJVUAPCD's December 20, 2001 amendments to Rule 4606 included the following significant changes to its 2000 SIP approved version.

SJVUAPCD's December 20, 2001 amendments to Rule 4607 included the following significant changes to its 1998 SIP approved version.

SJVUAPCD's December 20, 2001 amendments to Rule 4684 included the following significant changes to its 1995 SIP approved version.

The TSD for a given rule has more information about these rule revisions.

Generally, SIP rules must be enforceable ( see section 110(a) of the Act), must require Reasonably Available Control Technology (RACT) for major sources in nonattainment areas ( see section 182(a)(2)(A)), and must not relax existing requirements ( see sections 110(l) and 193). The SJVUAPCD regulates an ozone nonattainment area ( see 40 CFR part 81), so these rules must fulfill RACT.

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

“Guideline Series, Control of Volatile Organic Compound Emissions from Offset Lithographic Printing,” Draft. USEPA, OAQPS, September 1993; and “Alternative Control Techniques Document: Offset Lithographic Printing,” USEPA, OAQPS, June 1994, EPA 453/R-94-054.

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

For Rules 4602, 4606, and 4607, the respective TSD describes additional rule revisions that do not affect EPA's current action but are recommended for the next time the local agency modifies the rules.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by July 26, 2002, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on August 26, 2002. This will incorporate these rules into the federally enforceable SIP.

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

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Table 2 lists some of the national milestones leading to the submittal of these local agency VOC rules.

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 26, 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).)

Pursuant to sections 182(b)(2) and 182(f) of the Clean Air Act (CAA), the Commonwealth of Pennsylvania (the Commonwealth or Pennsylvania) is required to establish and implement RACT for all major VOC and NO X sources. The major source size is determined by its location, the classification of that area and whether it is located in the ozone transport region (OTR). Under section 184 of the CAA, RACT as specified in sections 182(b)(2) and 182(f) applies throughout the OTR. The entire Commonwealth is located within the OTR. Therefore, RACT is applicable statewide in Pennsylvania.

On December 21, 2001, PADEP submitted formal revisions to its SIP to establish and impose RACT for several major sources of VOC and NO X . This rulemaking pertains to two of those sources. The other sources are the subject of separate rulemaking actions. The RACT determinations and requirements are included in plan approvals or operating permits issued by PADEP.

(1) Hershey Chocolate USA (Hershey) is a chocolate candy and confectionery manufacturing facility. This facility is located in Dauphin County, Pennsylvania and is a major NO X emitting facility. In this instance, RACT has been established and imposed by PADEP in an operating permit. On December 21, 2001, PADEP submitted Operating Permit No. OP 22-02004A to EPA as a SIP revision. This permit requires Hershey to ensure that all combustion units subject to monitoring, recordkeeping and reporting requirements comply with RACT. In addition, all facility units must be operated and maintained in a manner consistent with good operating and management practices. Operating Permit No. OP 22-02004A also requires Hershey NO X emissions limit of 100 tons per year. NO X emissions from Hershey's Boilers Nos. 5 and 7 shall not exceed 0.54 lb/mmBtu when firing natural gas and 0.45 lb/mmBtu when firing No. 6 fuel oil. Combined NO X emissions from Boilers Nos. 5 and 7 shall not exceed 14 tons per consecutive 12 month period. This limit represents an annual capacity factor of less than two percent which satisfies the presumptive RACT requirements specified under 25 PA Code section 129.93 (c)(5) of the SIP. NO X emissions from Boilers Nos. 2 and 3 shall not exceed 0.04 lb/mmBtu when firing natural gas and 0.40 lb/mmBtu when firing No. 6 fuel oil. These emission rates must be verified annually by stack testing or other means approved by PADEP. Records must be maintained in accordance with 25 Pa Code, section 129.95 requirements.

(2) Pennsylvania Power Company (PPC), New Castle Plant, is a utility facility. This facility is located in Lawrence County, Pennsylvania and is a major VOC and NO X emitting facility. There are several large combustion units at this facility, and they include five medium bituminous coal-fired steam electric generating units and two oil-fired diesel generators. RACT has been established and imposed by PADEP in an operating permit issued by the state. On December 21, 2001, PADEP submitted Operating Permit No. OP 37-0023 to EPA as a SIP revision. This permit requires that NO X emission rates for PPC Boilers Nos. 3, 4 and 5 shall not exceed 0.50 lb/mmBtu on a 30-day rolling average. The NO X emission rates for PPC Boilers Nos. 1 and 2 shall not exceed 0.50 lb/mmBtu on an annual basis. PPC's Electron Diesel units A and B shall have an annual capacity factor for each diesel unit at less than 5 percent as required under 25 PA Code section 129.93 (c)(5) of the SIP. All combustion units are subject to monitoring, recordkeeping and reporting requirements, and must comply with RACT. PPC must maintain all records in accordance with the recordkeeping requirements of 25 PA Code section 129.95. All units must be operated and maintained in a manner consistent with good air pollution control practices and manufacturer's specifications as identified in PPC's operating permit. These records shall be retained for two years, and made available to PADEP upon request.

EPA is approving these SIP submittals because the Commonwealth established and imposed requirements in accordance with the criteria set forth in SIP-approved regulations for imposing RACT or for limiting a source's potential to emit. The Commonwealth has also imposed recordkeeping, monitoring, and testing requirements on these sources sufficient to determine compliance with these requirements.

EPA is approving revisions to the Commonwealth of Pennsylvania's SIP which establishes and requires RACT for Hershey Chocolate USA located in Dauphin County, Pennsylvania and Pennsylvania Power Company's New Castle Plant, located in Lawrence County, Pennsylvania. EPA is publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comment. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This direct final rule will be effective on August 26, 2002, without further notice unless we receive adverse comment by July 26, 2002. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment for a specific source or subset of sources covered by an amendment, paragraph, or section of this rule, only that amendment, paragraph, or section of that source or subset of sources will be withdrawn.

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

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

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 804 exempts from section 801 the following types of rules: (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability establishing source-specific requirements for Hershey Chocolate USA and Pennsylvania Power Company, New Castle Plant.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 26, 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 approving the Commonwealth's source-specific RACT requirements to control VOC and NO X from Hershey Chocolate USA and Pennsylvania Power Company, New Castle Plant, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

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

On February 25, 2002 (67 FR 8493), EPA proposed a limited approval and limited disapproval of the following rule that was submitted for incorporation into the California SIP.

Throughout this document, the words “we,” “us,” or “our” mean the Environmental Protection Agency (EPA). Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this action, we are approving the Sandpoint SIP revision submitted by the State of Idaho, Department of Health and Welfare, Division of Environmental Quality (IDEQ, Idaho, or State) on August 16, 1996. 1 We are approving this revision because we believe the State adequately demonstrates that the control measures being implemented in Sandpoint result in attainment of the National Ambient Air Quality Standards (NAAQS) for PM 10 promulgated on July 1, 1987, 2 as required by the Clean Air Act Amendments of 1990.

Idaho began monitoring PM 10 in the Sandpoint area in 1986. Data collected between 1986 and 1990 showed the Sandpoint area violated the NAAQS for PM 10 . In the 1990 Amendments to the Clean Air Act, areas that violated the PM 10 NAAQS prior to 1989 were, by law, designated nonattainment for PM 10 and classified as moderate under sections 107(d)(4)(B) and 188(a). 3 Because Sandpoint was one of those areas (see 56 FR 56694 (November 6, 1991) and 40 CFR 81.313), Idaho was required to adopt and submit a PM 10 SIP that addressed the requirements of section 189 of the Act.

Idaho initially submitted a PM 10 SIP for the Sandpoint area in May of 1993. Our initial review found it complete, but our technical review uncovered deficiencies in the plan. Over the next 3 years, Idaho, the local agencies and community in Sandpoint worked to develop a new PM 10 SIP that addressed the deficiencies of the 1993 submittal.

On August 16, 1996, the State of Idaho submitted a revised PM 10 SIP for the Sandpoint nonattainment area, replacing and addressing the deficiencies in the 1993 submittal. We have completed a review of the technical and administrative adequacy of this plan and presented the results in a Technical Support Document (TSD). The TSD provides the basis for our approval of the plan and discusses in more detail the air quality planning requirements for moderate PM 10 nonattainment areas in subparts 1 and 4 of title I of the Act. 4 Based on our review, we believe the plan brings the area into attainment and, therefore, are approving it in this notice.

EPA's approval of this SIP revision brings Sandpoint a step closer to becoming an attainment area for PM 10 . A redesignation to attainment would relieve the Sandpoint area of certain obligations currently in place because of its nonattainment status.

Although the SIP revision contains emission reduction control measures that impact residential wood combustion, roadways, and industrial facilities, these control measures have been in place and have been enforceable by the State since 1996. Therefore, our approval of these measures now has little or no additional impact on the Sandpoint community.

Section 172(c)(3) of the Act requires that a nonattainment plan include a comprehensive, accurate, and current inventory of actual emissions from all sources of relevant pollutants in the nonattainment area. The emissions inventory should also include a comprehensive, accurate, and current inventory of allowable emissions in the area.

An emissions inventory provides information about the relative contribution of pollution sources within an airshed. It forms the basis for evaluating control strategies, tracking emission reductions, and measuring growth. Because this information is required for an area's attainment demonstration (or its demonstration that it cannot practicably attain) an accurate emissions inventory must accompany each attainment plan submission (57 FR 13539).

The emissions inventory for the 1996 Sandpoint SIP consists of the actual emissions from industrial sources in 1993 and the projected emissions from area sources in 1994. The reason the inventory covers two different years is because it uses some, but not all, of the inventory prepared for the SIP originally submitted by Idaho in 1993. For the 1993 SIP, emissions inventories were developed for two separate time periods: 1990 (actual emissions) and 1994 (projected emissions). When the State began preparing the 1996 SIP using the same data, concerns were raised about using the values in the 1990 inventory for industrial sources because they might not accurately reflect projected growth at the sources. To address these concerns, the State updated the base-year inventory to reflect actual emissions from industry in 1993. It did not, however, update the area source inventory because there was no indication that the area source inventories were not representative. In order to work with an area source inventory that covered a similar time period as the industrial inventory, the State used the 1994 projected area source inventory instead of the 1990 actual area source inventory for its baseline area source inventory.

As shown below in Table I, the three largest daily wintertime PM 10 emissions sources in 1993/4 were residential wood combustion, fugitive road dust, and industrial processes. The total maximum daily wintertime PM 10 emissions were 6364 lb/day, and the annual PM 10 emissions were 577 tons/year. The term “Before Control Strategy” in Table I means before the control measures described in the following section, “What is the Sandpoint area doing to cut emissions?,” were in place.

Table II shows the State projects the three largest daily wintertime PM 10 emissions sources—before control strategy or after control strategy—in the 1997 attainment year to remain the same ( i.e., residential wood combustion, fugitive road dust, and industrial process). The term “After Control Strategy” in Table II means after the control measures described in the following section, “What is the Sandpoint area doing to cut emissions?,” were in place. The SIP projects the peak daily wintertime PM 10 emissions in 1997—after control—to be 3926 lb/day. This is in contrast to 6364 lbs/day PM 10 emitted during the 1993/4 baseline year before the control strategy was in place (see Table I).

EPA is approving the emissions inventory in the Sandpoint SIP revision because it generally appears to be accurate and comprehensive, and provides a sufficient basis for determining the adequacy of the attainment demonstration for this area consistent with the requirements of section 172(c)(3) of the Clean Air Act.

For approval, the Sandpoint SIP revision must assure that Reasonably Available Control Measures (RACM) to reduce PM 10 are being implemented in the Sandpoint nonattainment area. 5 There are three main sources of PM 10 emissions in the Sandpoint nonattainment area: residential wood combustion, fugitive road dust, and industrial processes. The SIP uses the following control strategy to reduce emissions from these sources. Overall, the control strategy provides for a reduction of 2442 pounds of PM 10 per day.

a. Public Awareness Program. Sandpoint's public awareness program informs and educates citizens about stove sizing, installation, proper operation and maintenance, general health risks of wood smoke, new technology stoves, and alternatives to wood heating. It uses a wide variety of media, including brochures, radio advisories, newspaper advertisements, TV PSA's, TV advertisements, pay stub inserts, and utility inserts, to educate citizens on these topics. In addition, the Greater Sandpoint Chamber of Commerce developed and implemented an aggressive public awareness campaign in 1995 to initially kick-off its wood smoke reduction efforts. Appendix F-3 of the SIP contains an outline of this campaign.

Sandpoint's public awareness program qualifies as a RACM because it falls within the description of a qualifying public awareness program, as described in Appendix C2 of the General Preamble. 57 FR 18072. (See List of Available Control Measures no. 2.)

b. Uncertified Wood Stove Replacement Program. Sandpoint's uncertified woodstove replacement program is a temporary program that offered homeowners incentive grants to replace their old wood stoves with cleaner burning heating systems. By the time it ended in September 1995, the replacement program had resulted in the removal of 84 wood stoves. These were replaced by 64 natural gas devices, 18 new wood stoves and 2 pellet stoves.

Sandpoint's uncertified wood stove replacement program meets the requirements of RACM because it encourages improved performance of woodburning devices by subsidizing stove purchases. ( See Appendix C2 of the General Preamble, List of Available Control Measures no. 3.)

c. Tax Reduction Program. Idaho revised its State tax code to allow taxpayers to receive a tax reduction if they replace their uncertified wood stoves with cleaner burning units. As of September 1999, 90 taxpayers in the Sandpoint NAA qualified for this tax deduction.

This program meets the requirements of RACM because it gives a financial incentive for replacing old, uncertified wood stoves with cleaner burning heating units. ( See Appendix C2 of the General Preamble, List of Available Control Measures no. 3).

d. Limits on Growth of Uncertified Wood Stoves. In 1995, the City of Sandpoint adopted Ordinance No. 965, which, among other things, restricts the sale and installation of uncertified solid fuel heating appliances in the City of Sandpoint. More specifically, the ordinance prohibits any person in the City to advertise for sale, offer for sale, sell, or install in any new or existing building a solid fuel heating device that has not been certified by EPA. The ordinance also prohibits any person in the City of Sandpoint from installing a solid fuel heating appliance in any new or existing structure before first procuring a permit from the building department, which requires payment of a fee.

Because these measures slow the growth of non-certified woodburning devices by restricting their sale and the growth of all woodburning devices by imposing installation permit fees, the measures qualify as RACM. ( See Appendix C2 of the General Preamble, List of Available Control Measures no. 4.)

e. Episodic Curtailment Program. In 1995, the City of Sandpoint passed Ordinance No. 965, which, among other things, lays out a two-stage approach for wood smoke curtailment. The first stage calls for voluntary curtailment of the use of woodburning appliances if the PM 10 concentration reaches 70 micrograms per cubic meter (ug/m3). The second stage calls for mandatory curtailment if the concentration reaches 100 ug/m3. Violation of the mandatory curtailment requirements is a misdemeanor offense, and violators are subject to a monetary fine.

IDEQ provides the City of Sandpoint with the daily air quality advisory status. Notification of a voluntary or mandatory curtailment is announced during regularly scheduled broadcasts on radio and television. There is also a toll-free hotline and a phone tree run by the Sandpoint Chamber of Commerce to spread the notification throughout the community.

Because this measure establishes a mandatory episode curtailment program, includes a plan, a communication strategy, a trigger level, and is enforceable, the measure qualifies as a RACM. ( See Appendix C2 of the General Preamble, List of Available Control Measures no. 1.)

Winter road sanding has been shown to adversely affect PM 10 levels throughout the western United States, including Sandpoint. The silt-laden, friable sand is placed on roads by local and state highway departments to provide vehicles with better traction on snow and ice. However, once the snow has melted and the roads have dried out, the remaining dry road sand is easily resuspended by moving vehicular traffic as fugitive dust.

a. Improved quality of anti-skid materials. In 1994, the City of Sandpoint adopted Ordinance 939:

Material Specifications for Street Sanding Material. This measure requires applicators of anti-skid materials to use only materials that meet certain standards for fines and durability. Historically, road maintenance departments in the Sandpoint area used anti-skid material that had a fine content ranging from 5-10 percent. The new measure allows a maximum of 2-5 percent fines, depending on the durability index. Lowering the percent of fines improves the abrasiveness of the material and, thus, results in lower silt loadings and, consequently, emissions.

While this ordinance technically only applies to city-maintained roads in Sandpoint, it also impacts State highways that are under the Idaho Transportation Department's (ITD's) jurisdiction as well. ITD, in order to avoid having to maintain separate stockpiles of anti-skid materials, has agreed to adhere to the City's standard on all its highways within the nonattainment area boundaries.

Ordinance 939 qualifies as RACM because it requires improved material specification requirements for skid control materials. ( See Appendix C1 of the General Preamble (57 FR 18072), List of Available Control Measures no. 8.)

b. Reduced volume of anti-skid materials. Compared to the baseline year, both the ITD and Sandpoint Independent Highway District (SIHD) are using less anti-skid material on State highways and roadways in the City of Sandpoint. There are a number of reasons for this change. First, the adoption of sanding material specifications has increased the cost of material from $0.50/yard to approximately $12.00/yard. This gives ITD and SIHD a strong incentive to apply the materials as efficiently as possible. The regional ITD office has also developed a policy to establish portions of state highways in downtown Sandpoint as an “anti-skid free zone.” In this zone, a liquid de-icer is used instead of sand when weather conditions are appropriate. Finally, ITD has made improvements in the application of sand by installing ground speed control sensors that vary the application rate based on vehicle speed, preventing unnecessary deposition of material that could later become entrained as fugitive dust.

These measures qualify as RACM because they result in a reduction of usage of skid control sand or salt. (See Appendix C1 of the General Preamble, List of Available Control Measures no. 8.)

c. Use of alternative materials—liquid de-icer. SIHD and ITD have acquired equipment to apply liquid de-icer as an alternative to anti-skid material. Between November 1994 and January 1995, SIHD used 8750 gallons of liquid de-icer. Use of a combination of liquid de-icer and anti-skid material also proved effective, with the de-icer acting as a binder and dust suppressant.

This measure qualifies as RACM because it results in a reduction of usage of skid control sand or salt. ( See Appendix C1 in the General Preamble, List of Available Control Measures no. 8.)

d. Increased frequency of street sweeping. Vacuum sweeping streets reduces the silt loading on vehicle travel lanes and reduces re-entrained road dust. This practice is particularly important after there is no longer a need for sanding material, such as after the snow melts. SIHD purchased and is using a new regenerative air vacuum sweeper, which has a higher collection efficiency than the vacuum sweeper it used previously. Approximately 20% of the local and highway lane miles and approximately 40% of the collector lane miles are swept. In addition, re-surfacing projects are planned to provide uniform road surfaces so that the effectiveness of the new vacuum sweeper is maintained.

This measure qualifies as RACM because it provides for rapid clean up of temporary sources of dust, such as skid control sand, on paved roads. ( See Appendix C1 of the General Preamble, List of Available Control Measures no. 4.)

In the inventory, IDEQ identified five industrial facilities in the Sandpoint nonattainment area that had the potential to emit over 1 ton/year of PM 10 : Interstate Concrete & Asphalt, L.D. McFarland Pole Co., Lake Pre-Mix Concrete, Lignetics of Idaho, and Louisiana-Pacific Corp. IDEQ modeled the emissions from each source using EPA's Guideline Model ISCSTDFT. Based on the modeling results and emissions inventory, IDEQ determined the emissions reduction that was necessary at each source in order to ensure attainment with the standard. The necessary reductions for each source were then converted into emission limits and control measures and incorporated into each source's State-issued operating permit. Control measures included the paving of haul roads, installing baghouses and dust collections systems, and improving dust enclosures. Some of the measures required at the Interstate Concrete & Asphalt and Louisiana Pacific sites were required to be implemented in the future. According to certifications submitted by the facilities and inspections by the State, these measures have been successfully implemented.

Table III below shows the reductions that resulted from this control strategy. In particular, it shows that, in 1997, the amount of PM 10 emissions that industrial sources were allowed to emit was capped at 679 lb/day due to new emissions limitations in the permits. That is 7 lb/day fewer emissions than were actually emitted by industrial sources on a worst-case day in 1993, and 191 lb/day fewer emissions than would have been allowed to be emitted by industrial sources in 1997 if the permits had not been revised.

EPA has defined RACT for PM 10 planning purposes as the lowest emission rate that a particular source is capable of meeting by application of control technology that is reasonably available considering technological and economic feasibility. 57 FR 13541. The attainment needs of the area are also considered in determining RACT. Additional controls that might otherwise constitute RACT may not be required if the additional controls would not expedite attainment. 57 FR 13540-13541 and fn. 18 and 20. Because the industrial sources have implemented the emission limits and control requirements of the permits, the permits implement emission limits and control requirements that are technologically and economically feasible. Because the Sandpoint area has not had an exceedance of the PM 10 standard since January 1994 and because the area appears to have attained the standard, additional controls would not expedite attainment. Therefore, EPA believes that the permits issued by IDEQ to these sources represent RACT in light of the attainment needs of the area.

To demonstrate attainment of the 24-hour PM 10 standard, IDEQ ran an air quality dispersion model that predicted the ambient concentrations of PM 10 in the Sandpoint area in the baseline year and 1997. Among the inputs into the model, IDEQ used five years of Spokane meteorological data and 1997 projected inventory data. Consistent with EPA policy, IDEQ identified the sixth highest 24-hour PM 10 concentration at each modeling receptor, then used the highest of the sixth highest values to determine whether or not a violation of the standard occurred. (PM 10 SIP Development Guideline, June 1987, pg 6-4). This value was 133 μg/m 3 (110 μg/m 3 from area and industrial sources and 23 μg/m 3 from background level). Because 133 μg/m 3 is below the 24-hour PM 10 standard of 150 μg/m 3 , the SIP demonstrates attainment of the standard.

Supporting these results, monitoring data for Sandpoint show no exceedences of the standard since January 26, 1994. Based on these data, Sandpoint is attaining the 24-hour PM 10 standard. To demonstrate attainment of the annual PM 10 NAAQS, IDEQ relied on the area's historic monitoring data, in lieu of a modeling demonstration. We believe this approach is appropriate for two reasons. First, Sandpoint has never violated the annual PM 10 NAAQS since monitoring began in 1986. Second, the annual arithmetic mean concentration reported for Sandpoint has been at least 15 percent below the standard since monitoring began and at least 45 percent below the standard since 1995. In light of this historic evidence of clean annual data for the area, in combination with our expectations that control measures implemented to reduce 24-hour levels will also aid in reducing annual levels, we believe it is very unlikely that Sandpoint will exceed the annual standard in the future. Consequently, we believe that IDEQ has demonstrated attainment of the annual standard.

As provided in section 172(c)(9) of the Act, all moderate nonattainment area SIP's that demonstrate attainment must include contingency measures (see generally 57 FR 13510-13512 and 13543-13544). Contingency measures must provide for additional emissions reductions beyond the control strategy that is used to attain the ambient standard. A State may rely on “over control” as a contingency measure, that is, rely on control measures that are part of the core control strategy in the SIP. EPA has stated that, in general, reductions equal to at least 25 percent of the total reductions for the control strategy would be appropriate for a moderate nonattainment area. See 57 FR 13544.

The Sandpoint SIP revision uses over control to meet the contingency requirements. Emissions reductions from over control are achieved primarily by the mandatory residential wood burning curtailment program adopted by the City of Sandpoint in February 1995. Modeling of the core control measures in the SIP for the Sandpoint nonattainiment area indicates a 63 μg/m 3 reduction in the 24-hour standard (from 196 μg/m 3 to 133 ug/m 3 )and a 17 ug/m 3 over control reduction in the 24-hour standard (from 150 μg/m 3 to 133 μg/m 3 ). This means that the core control measures in the SIP result in over control of 27% (the ratio of 17 μg/m 3 to 63 μg/m 3 ). Since these measures result in at least 25 percent more reductions than were needed to attain the standard, EPA approves the contingency measures submitted in the Sandpoint SIP.

The control requirements which are applicable to major stationary sources of PM 10 also apply to major stationary source of PM 10 precursors unless EPA determines such sources do not contribute significantly to PM 10 levels in excess of the NAAQS in that area ( see section 189(e) of the Act). The General Preamble contains guidance addressing how EPA intends to implement section 189(e) ( see 57 FR 13539-13540 and 13541-13542).

Because the emission inventory for the Sandpoint nonattainment area did not reveal any major stationary sources, including any major stationary sources of PM 10 precursors, EPA is granting the exclusion from control requirements authorized under section 189(e) for major stationary sources of PM 10 precursors.

The Sandpoint SIP revision must contain quantitative milestones that demonstrate RFP in maintaining the standard. These must be met until the area is redesignated attainment.

RFP is demonstrated in the Sandpoint nonattainment area by programs in the Sandpoint nonattainment area that continue to reduce PM 10 emissions. For instance, the tax deduction program has resulted in at least 16 replacements of uncertified wood stoves in the nonattainment area during 1998 and 1999. Another step taken to further reduce emissions is the SIHD's recent purchase of a new high-efficiency street sweeper to improve the effectiveness of the street cleaning program. Steps like these and continued operation of the reduction programs, in combination with monitoring data showing that the Sandpoint NAA has not exceeded the 24-hour standard since early 1994, satisfy the RFP and demonstration of maintenance requirements.

All measures and other elements in the SIP must be enforceable by IDEQ and EPA (see section 172(c)(6) and 110(a)(2)(A) of the Act and 57 FR 13556). Our criteria addressing the enforceability of SIP's and SIP revisions are set forth in a September 23, 1987 memorandum (with attachments) from J. Craig Potter, Assistant Administrator for Air and Radiation, et al. ( see 57 FR 13541). Nonattainment area plan provisions must also contain a program that provides for enforcement of the control measures and other elements in the SIP ( see section 110(a)(2)(C)).

The State submitted to EPA documentation that describes, for each control measure implemented in Sandpoint, how compliance will be assured, the frequency of the assurance, and the enforcement mechanisms to be used. IDEQ's role, as well as other entities' roles in assuring adequate implementation of the RACT/RACM attainment strategy in the Sandpoint SIP, are also identified.

Based on the ordinances IDEQ submitted (City of Sandpoint Ordinances Nos. 965 and 939) and IDEQ's explanation of how those ordinances and other control measures will be tracked and enforced, EPA believes that the enforceability requirements are met. This is consistent with section 110(a)(2)(A) of the Act which requires all emission limits, control measures and other elements of the SIP to be enforceable.

States with initial moderate PM 10 nonattainment areas were required to submit a permit program for the construction and operation of new and modified stationary sources of PM 10 by June 30, 1992. See section 189(a) of the Clean Air Act.

The Clean Air Act Amendments of 1990 included revisions to the new source review (NSR) program requirements of the construction and operation of new and modified major stationary sources located in nonattainment areas. The Act requires states to amend their SIPs to reflect these revisions, but it did not require submittal of this element along with the other SIP elements. The Act established June 30, 1992 as the submittal date for the revised NSR programs. See section 189(a) of the Act.

In the “General Preamble,” EPA issued guidance for states to follow in the development of revised NSR programs to meet the requirements of the 1990 Amendments. 57 FR 13552-13556. EPA guidance calls for states to implement their existing NSR programs during the interval preceding EPA's formal approval of their revised NSR program.

Idaho did not submit a permit program for the construction and operation of new and modified major stationary sources of PM 10 by the June 30, 1992 deadline. On January 15, 1993, we mailed a findings letter to the Governor of Idaho explaining that this element was missing. The State had until July 15, 1994 to submit the NSR program or sanctions would have been imposed under the provisions of the Act. IDEQ submitted its NSR program on May 17, 1994, and we informed Idaho that the NSR program was complete in a June 10, 1994 letter to the IDEQ Administrator. Upon further review, we uncovered a number of deficiencies in the submitted program. In 1999, IDEQ submitted revisions to its NSR program addressing these deficiencies. We will take action on IDEQ's NSR submittal in a separate FR document when we have completed our review of the 1999 revisions.

The Act requires states to observe certain procedural requirements in developing implementation plans and plan revisions for submission to EPA. Section 110(a)(2) of the Act provides that each implementation plan submitted by a state must be adopted after reasonable notice and public hearing. 6 Section 110(l) of the Act similarly provides that each revision to an implementation plan submitted by a state under the Act must be adopted by the state after reasonable notice and public hearing.

IDEQ held a public hearing on the SIP revision on June 13, 1995 and, after IDEQ reviewed the oral testimony, the IDEQ Administrator adopted the final plan and submitted it to EPA on August 16, 1996 as a proposed revision to the SIP.

EPA reviewed the SIP revision to determine completeness in accordance with the completeness criteria set out at 40 CFR part 51, appendix V. We sent a letter dated December 8, 1997 to the Administrator of the Idaho Division of Environmental Quality indicating the submittal was complete and the next steps to be taken in the review process.

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 26, 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).)

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

We are approving the moderate area plan and the maintenance plan for the Payson PM 10 nonattainment area (“Payson”)  1 and redesignating the area to attainment for the 24-hour and annual PM 10 NAAQS.

On March 29, 2002, the Arizona Department of Environmental Quality (ADEQ) submitted the plan for the Payson PM 10 nonattainment area as well as a request for redesignation of the area from nonattainment to attainment. On May 31, 2002, we found that the submittal met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

Particulate matter with an aerodynamic diameter of less than 10 micrometers (PM 10 ) is the pollutant that is the subject of this action. The NAAQS are safety thresholds for certain ambient air pollutants set to protect public health and welfare. PM 10 is among the ambient air pollutants for which we have established such a health-based standard.

PM 10 causes adverse health effects by penetrating deep in the lung, aggravating the cardiopulmonary system. Children, the elderly, and people with asthma and heart conditions are the most vulnerable.

On July 1, 1987 (52 FR 24634), we revised the NAAQS for particulate matter with an indicator that includes only those particles with an aerodynamic diameter less than or equal to a nominal 10 micrometers. ( See 40 CFR 50.6).

The annual primary PM 10 standard is 50 ug/m 3 as an annual arithmetic mean. The 24-hour PM 10 standard is 150 ug/m 3 with no more than one expected exceedance per year. The secondary PM 10 standards, promulgated to protect against adverse welfare effects, are identical to the primary standards.

The Clean Air Act requires States to attain and maintain ambient air quality equal to or better than the NAAQS. The State's commitments for attaining and maintaining the NAAQS are outlined in the State Implementation Plan (or SIP) for that State. The SIP is a planning document that, when implemented, is designed to ensure the achievement of the NAAQS. Each State currently has a SIP in place, and the Act requires that SIP revisions be made periodically as necessary to provide continued compliance with the standards.

SIPs include, among other things, the following: (1) An inventory of emission sources; (2) statutes and regulations adopted by the State legislature and executive agencies; (3) air quality analyses that include demonstrations that adequate controls are in place to meet the NAAQS; and (4) contingency measures to be undertaken if an area fails to attain the standard or make reasonable progress toward attainment by the required date.

The State must make the SIP available for public review and comment through a public hearing, it must be adopted by the State, and submitted to EPA by the Governor or her designee. EPA takes Federal action on the SIP submittal thus rendering the rules and regulations Federally enforceable. The approved SIP serves as the State's commitment to take actions that will reduce or eliminate air quality problems. Any subsequent revisions to the SIP must go through the formal SIP revision process specified in the Act.

Upon enactment of the 1990 Clean Air Act Amendments (Act), PM 10 areas meeting the requirements of either (i) or (ii) of section 107(d)(4)(B) of the Act were designated nonattainment for PM 10 by operation of law and classified “moderate.” See generally, 42 U.S.C. 7407(d)(4)(B). These areas included all former Group I PM 10 planning areas identified in 52 FR 29383 (August 7, 1987) and further clarified in 55 FR 45799 (October 31, 1990), and any other areas violating the NAAQS for PM 10 prior to January 1, 1989 (many of these areas were identified by footnote 4 in the October 31, 1990 Federal Register document). A Federal Register notice announcing the areas designated nonattainment for PM 10 upon enactment of the 1990 Amendments, known as “initial” PM 10 nonattainment areas, was published on March 15, 1991 (56 FR 11101). A subsequent Federal Register document correcting some of these areas was published on August 8, 1991 (56 FR 37654). These nonattainment designations and moderate area classifications were codified in 40 CFR part 81 in a Federal Register document published on November 6, 1991 (56 FR 56694). All other areas in the nation not designated nonattainment at enactment were designated unclassifiable (see section 107(d)(4)(B)(iii) of the Act).

In January and February of 1991, we notified the Governors of those States which recorded violations of the PM 10 standard after January 1, 1989 that EPA believed that those areas should be redesignated as nonattainment for PM 10 . In September 1992 we proposed that several areas be redesignated nonattainment for PM 10 and took final action on December 21, 1993 (58 FR 67335). Payson was among those areas listed. The effective date of the final action redesignating this area as nonattainment for the PM 10 NAAQS was January 20, 1994.

The air quality planning requirements for moderate PM 10 nonattainment areas are set out in subparts 1 and 4 of title I of the Act. We have issued guidance in a General Preamble describing our views on how we will review SIPs and SIP revisions submitted under title I of the Act, including those containing moderate PM 10 nonattainment area SIP provisions. 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992). The General Preamble provides a detailed discussion of our interpretation of the Title I requirements.

States with initial moderate PM 10 nonattainment areas were required to submit, among other things, the following provisions by November 15, 1991:

(a) Provisions to assure that reasonably available control measures (RACM) (including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology (RACT)) shall be implemented no later than December 10, 1993;

(b) Either a demonstration (including air quality modeling) that the plan will provide for attainment as expeditiously as practicable but no later than December 31, 1994, or a demonstration that attainment by that date is impracticable;

(c) Pursuant to section 189(c)(1), for plan revisions demonstrating attainment, quantitative milestones which are to be achieved every 3 years and which demonstrate reasonable further progress (RFP) toward attainment by December 31, 1994; and

(d) Provisions to assure that the control requirements applicable to major stationary sources of PM 10 also apply to major stationary sources of PM 10 precursors, except where the Administrator determines that such sources do not contribute significantly to PM 10 levels which exceed the NAAQS in the area.

In addition, States must submit a permit program for the construction of new and modified major stationary sources in 1992 and contingency measures in 1993. See sections 189(a) and 172(c)(9).

The clean data areas approach applies the clean data policy concept already in place for ozone to selected PM 10 nonattainment areas in order to approve control measures for these areas into the SIP. The approach only applies to PM 10 areas with simple PM 10 source problems, such as residential wood combustion and fugitive dust problems. If an area meets the following requirements, the State will no longer be required to develop an attainment demonstration. The requirements for the approach are:

(a) The area must be attaining the PM 10 NAAQS with the three most recent years of quality assured air quality data.

(b) The State must continue to operate an appropriate PM 10 air quality monitoring network, in accordance with 40 CFR part 58, in order to verify the attainment status of the area.

(c) The control measures for the area, which were responsible for bringing the area into attainment, must be approved by EPA. EPA would also need to find that the area has adopted RACM/RACT, and make a finding that the area attained the 24-hour and annual PM 10 NAAQS.

(d) An emissions inventory must be completed for the area. In addition to the above requirements for the use of the clean data areas approach, any requirements that are connected solely to designation or classification, such as new source review (NSR) and RACM/RACT, will remain in effect. However, the requirements under CAA section 172(c) for developing attainment demonstrations, RFP demonstrations and contingency measures are waived due to the fact that the areas which are eligible under this approach have already attained the PM 10 NAAQS and have met RFP.

Any sanctions clocks that may be running for an area due to failure to submit, or disapproval of any attainment demonstration, RFP or contingency measure requirements, are stopped. In addition, areas are still required to demonstrate transportation conformity using the build/no-build test, or the no-greater-than-1990 test. 40 CFR 93.119. The emissions budget test would not be required, because the requirements for an attainment demonstration and RFP, which establish the budgets, no longer apply. The applicable tests for general conformity still apply. The use of the clean data areas approach does not constitute a CAA section 107(d) redesignation, but only serves to approve nonattainment area SIPs required under Part D of the CAA.

CAA section 175A provides the general framework for maintenance plans. The maintenance plan must provide for maintenance of the NAAQS for at least 10 years after redesignation, and must include any additional control measures as may be necessary to ensure such maintenance. In addition, maintenance plans are to contain such contingency provisions as we deem necessary to assure the prompt correction of a violation of the NAAQS that occurs after redesignation. The contingency measures must include, at a minimum, a requirement that the State will implement all control measures contained in the nonattainment SIP prior to redesignation. Beyond these provisions, however, CAA section 175A does not define the content of a maintenance plan. Our primary guidance on maintenance plans and redesignation requests is a September 4, 1992 memo from John Calcagni, entitled “Procedures for Processing Requests to Redesignate Areas to Attainment” (“Calcagni memo”).

On August 9, 2001, EPA issued new guidance on streamlined maintenance plan provisions for certain moderate PM 10 nonattainment areas seeking redesignation to attainment (Memo from Lydia Wegman entitled “Limited Maintenance Plan Option for Moderate PM 10 Nonattainment Areas”). This policy allows maintenance plans for areas having a low risk of future exceedances to omit air quality modeling, future year emission inventories, and some of the standard analyses to determine transportation conformity with the SIP.

To qualify for the LMP option, the area should be maintaining the NAAQS, and the average PM 10 design value for the area, based upon the most recent 5 years of air quality data at all monitors in the area, should be at or below 40 ug/m 3 for the annual and 98 ug/m 3 for the 24 hour PM 10 NAAQS with no violations at any monitor in the nonattainment area. See section IV of the LMP Option memo cited above. The 40 and 98 ug/m 3 limits are margin of safety (MOS) limits for the relevant PM 10 standard for a given area. In addition, the area should expect only limited growth in on-road motor vehicle PM 10 emissions (including fugitive dust) and should have passed a motor vehicle regional emissions analysis test.

As discussed below in Section III.B.1, the State has demonstrated that the LMP option is appropriate for the Payson nonattainment area.

The 1990 CAA Amendments revised section 107(d)(3)(E) to provide five specific requirements that an area must meet in order to be redesignated from nonattainment to attainment:

(1) the area must have attained the applicable NAAQS;

(2) the area has met all relevant requirements under section 110 and Part D of the Act;

(3) the area has a fully approved SIP under section 110(k) of the Act;

(4) the air quality improvement must be due to permanent and enforceable reductions; and,

(5) the area must have a fully approved maintenance plan pursuant to section 175A of the Act.

Prior to adoption by the State, the plan received proper public notice and was the subject of a public hearing in Payson on February 19, 2002. 2

a. Based on the past 3 years of air quality data, is the area attaining both the 24-hour and annual PM 10 NAAQS? An area has attained the 24-hour standard when the average number of expected exceedances per year is less than or equal to one, when averaged over a three-year period. (40 CFR 50.6) To make this determination, three consecutive years of complete ambient air quality data were collected in accordance with Federal requirements (40 CFR part 58, including appendices). On February 15, 2002, EPA issued a determination that the Payson area had attained the PM-10 NAAQS. 67 FR 7082.

The Payson area has one PM 10 monitoring site, currently located at the Payson water treatment plant at 204 W. Aero Drive. Street. The area has attained both the annual and 24-hour PM 10 NAAQS for the past 3 years; indeed, the area has not exceeded either NAAQS since 1990. Thus, the submittal demonstrates that the area has met the ambient attainment requirements for both the 24-hour and annual PM 10 NAAQS.

b. Is the State continuing to operate an appropriate PM 10 air quality monitoring network? Demonstrating that an area has attained the PM 10 NAAQS involves submittal of ambient air quality data from an ambient air monitoring network representing peak PM 10 concentrations, which should be stored in the EPA Aerometric Information Retrieval System (AIRS). Once the area has been redesignated, the State will continue to operate an appropriate air quality monitoring network, in accordance with 40 CFR part 58, to verify the attainment status of the area. The maintenance plan contains provisions for continued operation of air quality monitors that provide such verification. ADEQ has committed to continue operating an appropriate air quality monitoring network, in accordance with 40 CFR part 58, to verify the attainment status of the area. This commitment satisfies the obligation to maintain an adequate monitoring program in the area.

c. Has EPA approved the control measures responsible for bringing the areas into attainment? The measures implemented in Payson beginning in 1990 and used for the attainment demonstration are listed below. These measures address the source categories responsible for the exceedances recorded in the Payson area: reentrained dust from paved and unpaved roads and wood smoke.

1. Arizona Department of Transportation (ADOT) installed 2 miles of curbs and gutters on Arizona State Highway 87 from the intersection of Highways 87 and 260 to Roundup Road in 1992.

2. ADOT installed 5 miles of paved shoulders on Highway 87 North and Highway 260 East when those stretches were widened to 4 lanes in 1992.

3. The Town of Payson paved 4 miles of unpaved roads that were unpaved in 1990.

4. Gila County paved nearly 18 miles of previously unpaved roads starting in 1989.

5. ADEQ implemented Arizona Administrative Code R18-2-607 that requires control of storage piles to minimize fugitive emissions.

6. In 1988, EPA implemented New Source Performance Standards for woodstoves.

Implementation of these measures helped bring the area into timely attainment of both the 24-hour and annual PM 10 NAAQS, and the measures thus meet the CAA requirement for RACM. Measures 1-4 are fully constructed and are permanent by their very nature. Measure 5 has previously been approved by EPA and remains a Federally enforceable component of the SIP. Therefore, we conclude that the submittal demonstrates that the controls responsible for bringing the area into attainment have been fully carried out or are fully approved SIP regulations.

In addition to these permanent or SIP enforceable controls, the Town of Payson implemented an ordinance requiring the paving of commercial parking facilities and the paving of unpaved roads as condition of minor land divisions. Kaibab Industries' lumber and sawmill operation closed and the facility was dismantled in June 1993, and the Lewis M. Pyle Memorial Hospital's medical waste incinerator was shutdown and removed in 1993. Smoke management plan requirements were implemented by the Forest Service, Bureau of Land Management, and Arizona Department of State Lands, in cooperation with ADEQ. These supplemental strategies contributed still further PM-10 emission reductions and public health protection. Continued implementation of the measures will help ensure that the Payson area maintains the 24-hour and annual PM 10 NAAQS.

The Payson plan includes emission inventories for 1999 to show emission levels in a recent, representative year during which there were no violations of the PM 10 standards. This inventory is summarized in Table IV-1, while Table IV-3 presents an inventory of industrial sources, all of which emit less than 3 tons per year of PM 10 . This inventory is consistent with our most recent guidance on emission inventories for nonattainment areas, and reflects the latest information available, including 2000 census data. 3 We approve the emissions inventory under CAA section 172(c)(3) as current, accurate, and complete.

The measures listed above in Section III.A.2.c. reflect effective control for an important emissions category in the Payson area: Reentrained dust from traffic on paved and unpaved roads. These measures were implemented expeditiously and have proven sufficient to prevent violations of the NAAQS over the past 10 years. We therefore conclude that the controls reflect RACM and we approve the plan as meeting the RACM provisions of CAA Section 189(a)(1)(C).

CAA Section 189(e) requires RACT provisions for gaseous precursors of PM 10 except where EPA determines that such sources do not contribute significantly to PM 10 levels exceeding the standard. There are no major stationary sources in the nonattainment area, and total emissions associated with all industrial sources account for only 0.93 percent of PM 10 emissions in 1999. For this reason and because the historic violations of the PM 10 NAAQS were the direct result of reentrained dust and wood smoke emissions in the late 1980's, no sources within the Payson area are subject to the RACT requirement, either with respect to primary or secondary PM 10 emissions.

For the Payson nonattainment area, ADEQ administers the preconstruction review and permitting provisions of Arizona Administrative Code, Title 18, Chapter 2, Articles 1, 3, 4, and 5. All new major sources and modifications to existing major sources are subject to the new source review (NSR) and prevention of significant deterioration (PSD) requirements of these rules. We have not yet fully approved the State's NSR rules but, for major sources and modifications of PM 10 emissions, we have delegated to Arizona the authority to administer the PSD program.

Section 172(c)(5) requires NSR permits for the construction and operation of new and modified major stationary sources anywhere in nonattainment areas. We have determined that areas being redesignated from nonattainment to attainment do not need to comply with the requirement that an NSR program be approved prior to redesignation provided that the area demonstrates maintenance of the standard without part D nonattainment NSR in effect. The rationale for this decision is described in a memorandum from Mary Nichols dated October 14, 1994 (“Part D New Source Review (part D NSR) Requirements for Areas Requesting Redesignation to Attainment”). We have determined that the ADEQ maintenance demonstration for Payson does not rely on nonattainment NSR and, therefore, the State need not have a fully approved nonattainment NSR program prior to approval of the redesignation request. The ADEQ's PSD program at 40 CFR 52.21 will become effective in the area with respect to PM-10 upon redesignation of the area to attainment, pursuant to the delegation agreement between EPA and ADEQ dated March 12, 1999.

Section II.E. of the plan discusses how the area meets each of the LMP option criteria for use of this option.

First, the area should be attaining the NAAQS. Table III-3 of the plan summarizes quality assured ambient data showing that the Payson area has continued to meet both the 24-hour and annual PM 10 NAAQS for the period 1996-2000.

Second, the design values for the past 5 years must be at or below the margin of safety levels identified in the LMP option. The annual average PM 10 design value for the area from 1996 through 2000 data is 26 ug/m 3 , and the 24-hour average design value is 88 ug/m 3 , both of which are below the MOS limits of 40 and 98 ug/m 3 , respectively.

Third, the area must meet the motor vehicle regional emissions analysis test in the LMP option. The calculated value is 28.3 ug/m 3 for the annual average PM 10 standard, which is less than the 40 ug/m 3 MOS limit for annual, and the calculated value is 95.7 ug/m 3 for the 24-hour average PM 10 standard, which is less than the 98 ug/m 3 MOS limit.

Therefore, the State has shown that the area qualifies for the streamlined maintenance plan provisions under the LMP option. We have concluded in Section III.A. that the plan submittal meets the moderate area plan provisions for emissions inventories, permanent and enforceable control measures, and maintenance of adequate monitoring. There is one remaining maintenance plan provision under the LMP option not previously discussed: contingency measures.

The maintenance plan must include contingency control measures which will go into effect automatically to correct any future violation of the NAAQS. These provisions must include a requirement that the State will implement all measures contained in the nonattainment area SIP. The August 9, 2000 LMP option memo states that the contingency measures do not have to be fully adopted at the time of redesignation.

ADEQ has included 6 contingency measures in the maintenance plan (see table below entitled “Payson Area Contingency Measures”).

The State also committed to determine whether or not violations have been recorded within 6 months of the close of each calendar year, and to review and determine the appropriate contingency measure(s) by the end of the same calendar year. Finally, the State committed to implement the selected contingency measure(s) within 1 year of determining that a violation has occurred. We conclude that these measures and commitments meet the contingency measure provision of CAA Section 175A(d).

The area has attained the 24-hour standard when the average number of expected exceedances per year is less than or equal to one, when averaged over a three-year period. (40 CFR 50.6) To make this determination, three consecutive years of complete ambient air quality data were collected in accordance with Federal requirements (40 CFR part 58, including appendices).

As discussed above, there have been no recorded exceedances of either the annual or 24-hour PM 10 NAAQS in the area in the past 3 years. The area has attained both the annual and 24-hour PM 10 NAAQS for the past 3 years.

The Calcagni memo directs States to meet all of the applicable section 110 and part D planning requirements for redesignation purposes. EPA interprets the Act to require State adoption and EPA approval of the applicable programs under section 110 and part D that were due prior to the submittal of a redesignation request, before EPA may approve a redesignation request.

Section 110(a)(2) of the Act contains general requirements for nonattainment plans. These requirements include, but are not limited to, submittal of a SIP that has been adopted by the State after reasonable notice and public hearing, provisions for establishment and operation of appropriate apparatus, methods, systems, and procedures necessary to monitor ambient air quality, implementation of a permit program, provisions for Part C—Prevention of Significant Deterioration (PSD) and Part D—New Source Review (NSR) permit programs, criteria for stationary source emission control measures, monitoring and reporting, provisions for modeling, and provisions for public and local agency participation.

Part D includes additional provisions for nonattainment areas, listed generally in CAA section 172(c) and specifically for PM 10 in sections 188-9. These additional Part D provisions include: implementation of RACM as expeditiously as practicable, reasonable further progress, emissions inventories, and quantification of growth allowances (if the State elects to establish such allowances). See the General Preamble for further explanation of these requirements.

For purposes of redesignation, the Arizona SIP was reviewed to ensure that all requirements under the Act were satisfied. The Arizona SIP was approved under section 110 of the Act as satisfying all applicable section 110 and Part D provisions. These approvals are codified in 40 CFR 52.123. We are approving the SIP with respect to the special Part D provisions for PM 10 nonattainment areas (CAA sections 188-9) in Section III.A. above.

We are approving in today's action the moderate area and maintenance plan for the Payson Area, and confirming that the SIP meets other applicable provisions of the CAA.

The submittal shows that the improvements in air quality were not due to temporary economic downturn or unusually favorable meteorology (p. 12). On the contrary, economic growth has continued over the past 10 years since the area attained the NAAQS, and the area has experienced the full range of weather conditions in that period. As discussed above, attainment is the result of the establishment of permanent and enforceable controls on fugitive dust emissions.

We are fully approving the maintenance plan, as allowed by the LMP guidance, in Section III.B. above.

The transportation conformity rule and the general conformity rule apply to nonattainment areas and attainment areas with maintenance plans. Both rules provide that conformity can be demonstrated by showing that the expected emissions from planned actions are consistent with the emissions budget for the area.

Under the limited maintenance plan option, emissions budgets are treated as essentially not constraining for the length of the maintenance period because it is unreasonable to expect that qualifying areas would experience so much growth in that period that a NAAQS violation would result.

While areas with maintenance plans approved under the limited maintenance plan option are not subject to the budget test, the areas remain subject to other transportation conformity requirements of 40 CFR Part 93, Subpart A. Thus, the metropolitan planning organization (MPO) in the area or the State will still need to document and ensure that: (1) Transportation plans and projects provide for timely implementation of SIP transportation control measures (TCMs) in accordance with 40 CFR 93.113; (2) transportation plans and projects comply with the fiscal constraint element per 40 CFR 93.108; (3) the MPO's interagency consultation procedures meet applicable requirements of 40 CFR 93.105; (4) conformity of transportation plans is determined no less frequently than every three years, and conformity of plan amendments and transportation projects is demonstrated in accordance with the timing requirements specified in 40 CFR 93.104; (5) the latest planning assumptions and emissions model are used as set forth in 40 CFR 93.110 and 40 CFR 93.111; (6) projects do not cause or contribute to any new localized carbon monoxide or particulate matter violations, in accordance with procedures specified in 40 CFR 93.123; and (7) project sponsors and/or operators provide written commitments as specified in 40 CFR 93.125.

The adequacy review period for these SIP submissions is concurrent with the public comment period on this direct final rule. Because limited maintenance plans do not contain budgets, the adequacy review period for these maintenance plans serves to allow the public to comment on whether limited maintenance is appropriate for these areas. Interested parties may comment on the adequacy and approval of the limited maintenance plans by submitting their comments on the proposed rule published concurrently with this direct final rule.

Our action on the limited maintenance plans for these areas has been announced on EPA's conformity Web site: http://www.epa.gov/oms/traq. Once there, click on the “Conformity” button, then look for “Adequacy Review of SIP Submissions for Conformity.”

For Federal actions which are required to address the specific requirements of the general conformity rule, one set of requirements applies particularly to ensuring that emissions from the action will not cause or contribute to new violations of the NAAQS, exacerbate current violations, or delay timely attainment. One way that this requirement can be met is to demonstrate that “the total of direct and indirect emissions from the action (or portion thereof) is determined and documented by the State agency primarily responsible for the applicable SIP to result in a level of emissions which, together with all other emissions in the nonattainment area, would not exceed the emissions budgets specified in the applicable SIP.” 40 CFR 93.158(a)(5)(i)(A).

The decision about whether to include specific allocations of allowable emissions increases to sources is one made by the State and local air quality agencies. Such emissions budgets are unlike and not to be confused with those used in transportation conformity. Emissions budgets in transportation conformity are required to limit and restrain emissions. Emissions budgets in general conformity allow increases in emissions up to specified levels.

ADEQ has not chosen to include any specific emissions allocations for Federal projects that would be subject to the provisions of general conformity.

We are approving the moderate area plan, and the maintenance plan for the Payson Area, and we are redesignating the area from nonattainment to attainment for the 24-hour and annual PM 10 NAAQS. We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the State plan and redesignate the area if relevant adverse comments are filed. This rule will be effective August 26, 2002, without further notice unless relevant adverse comments are received by July 26, 2002. If we receive such comments, this action will be withdrawn before the effective date. All public comments received will then be addressed in a subsequent final rule based on the proposed action. We will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. If no such comments are received, the public is advised that this action will be effective August 26, 2002.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves State law as meeting Federal requirements and imposes no additional requirements beyond those imposed by State law.

Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

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

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

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

We are approving the moderate area plan and the maintenance plan for the Bullhead City PM 10 nonattainment area (“Bullhead City”) 1 and redesignating the area to attainment for the 24-hour and annual PM 10 NAAQS. We are also approving the State of Arizona's request to revise the boundaries of the Bullhead City area by excluding 3 townships. As a result of the redesignation, the excluded townships become part of the State's unclassifiable area for PM 10 , and are not subject to the provisions of the PM 10 maintenance plan for Bullhead City.

On February 7, 2002, the Arizona Department of Environmental Quality (ADEQ) submitted the plan for the Bullhead City PM 10 nonattainment area as well as a request for a boundary change and redesignation of the area from nonattainment to attainment. On May 31, 2002, we found that the submittal met the completeness criteria in 40 CFR part 51, Appendix V, which must be met before formal EPA review.

Particulate matter with an aerodynamic diameter of less than 10 micrometers (PM 10 ) is the pollutant that is the subject of this action. The NAAQS are safety thresholds for certain ambient air pollutants set to protect public health and welfare. PM 10 is among the ambient air pollutants for which we have established such a health-based standard.

PM 10 causes adverse health effects by penetrating deep in the lung, aggravating the cardiopulmonary system. Children, the elderly, and people with asthma and heart conditions are the most vulnerable.

On July 1, 1987 (52 FR 24634), we revised the NAAQS for particulate matter with an indicator that includes only those particles with an aerodynamic diameter less than or equal to a nominal 10 micrometers. ( See 40 CFR 50.6).

The annual primary PM 10 standard is 50 ug/m 3 as an annual arithmetic mean. The 24-hour PM 10 standard is 150 ug/m 3 with no more than one expected exceedance per year. The secondary PM 10 standards, promulgated to protect against adverse welfare effects, are identical to the primary standards.

The Clean Air Act requires States to attain and maintain ambient air quality equal to or better than the NAAQS. The State's commitments for attaining and maintaining the NAAQS are outlined in the State Implementation Plan (or SIP) for that State. The SIP is a planning document that, when implemented, is designed to ensure the achievement of the NAAQS. Each State currently has a SIP in place, and the Act requires that SIP revisions be made periodically as necessary to provide continued compliance with the standards.

SIPs include, among other things, the following: (1) An inventory of emission sources; (2) statutes and regulations adopted by the State legislature and executive agencies; (3) air quality analyses that include demonstrations that adequate controls are in place to meet the NAAQS; and (4) contingency measures to be undertaken if an area fails to attain the standard or make reasonable progress toward attainment by the required date.

The State must make the SIP available for public review and comment through a public hearing, it must be adopted by the State, and submitted to EPA by the Governor or her designee. EPA takes Federal action on the SIP submittal thus rendering the rules and regulations Federally enforceable. The approved SIP serves as the State's commitment to take actions that will reduce or eliminate air quality problems. Any subsequent revisions to the SIP must go through the formal SIP revision process specified in the Act.

Upon enactment of the 1990 Clean Air Act Amendments (Act), PM 10 areas meeting the requirements of either (i) or (ii) of section 107(d)(4)(B) of the Act were designated nonattainment for PM 10 by operation of law and classified “moderate.” See generally, 42 U.S.C. 7407(d)(4)(B). These areas included all former Group I PM 10 planning areas identified in 52 FR 29383 (August 7, 1987) and further clarified in 55 FR 45799 (October 31, 1990), and any other areas violating the NAAQS for PM 10 prior to January 1, 1989 (many of these areas were identified by footnote 4 in the October 31, 1990 Federal Register document). A Federal Register notice announcing the areas designated nonattainment for PM 10 upon enactment of the 1990 Amendments, known as “initial” PM 10 nonattainment areas, was published on March 15, 1991 (56 FR 11101). A subsequent Federal Register document correcting some of these areas was published on August 8, 1991 (56 FR 37654). These nonattainment designations and moderate area classifications were codified in 40 CFR part 81 in a Federal Register document published on November 6, 1991 (56 FR 56694). All other areas in the nation not designated nonattainment at enactment were designated unclassifiable (see section 107(d)(4)(B)(iii) of the Act).

In January and February of 1991, we notified the Governors of those States which recorded violations of the PM 10 standard after January 1, 1989 that EPA believed that those areas should be redesignated as nonattainment for PM 10 . In September 1992 we proposed that several areas be redesignated nonattainment for PM 10 and took final action on December 21, 1993 (58 FR 67335). Bullhead City was among those areas listed. The effective date of the final action redesignating this area as nonattainment for the PM 10 NAAQS was January 20, 1994.

The air quality planning requirements for moderate PM 10 nonattainment areas are set out in subparts 1 and 4 of title I of the Act. We have issued guidance in a General Preamble describing our views on how we will review SIPs and SIP revisions submitted under title I of the Act, including those containing moderate PM 10 nonattainment area SIP provisions. 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992). The General Preamble provides a detailed discussion of our interpretation of the Title I requirements.

States with initial moderate PM 10 nonattainment areas were required to submit, among other things, the following provisions by November 15, 1991:

(a) Provisions to assure that reasonably available control measures (RACM) (including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology (RACT)) shall be implemented no later than December 10, 1993;

(b) Either a demonstration (including air quality modeling) that the plan will provide for attainment as expeditiously as practicable but no later than December 31, 1994, or a demonstration that attainment by that date is impracticable;

(c) Pursuant to section 189(c)(1), for plan revisions demonstrating attainment, quantitative milestones which are to be achieved every 3 years and which demonstrate reasonable further progress (RFP) toward attainment by December 31, 1994; and

(d) Provisions to assure that the control requirements applicable to major stationary sources of PM 10 also apply to major stationary sources of PM 10 precursors, except where the Administrator determines that such sources do not contribute significantly to PM 10 levels which exceed the NAAQS in the area.

In addition, States must submit a permit program for the construction of new and modified major stationary sources in 1992 and contingency measures in 1993. See sections 189(a) and 172(c)(9).

The clean data areas approach applies the clean data policy concept already in place for ozone to selected PM 10 nonattainment areas in order to approve control measures for these areas into the SIP. The approach only applies to PM 10 areas with simple PM 10 source problems, such as residential wood combustion and fugitive dust problems. If an area meets the following requirements, the State will no longer be required to develop an attainment demonstration. The requirements for the approach are:

(a) The area must be attaining the PM 10 NAAQS with the three most recent years of quality assured air quality data.

(b) The State must continue to operate an appropriate PM 10 air quality monitoring network, in accordance with 40 CFR part 58, in order to verify the attainment status of the area.

(c) The control measures for the area, which were responsible for bringing the area into attainment, must be approved by EPA. EPA would also need to find that the area has adopted RACM/RACT, and make a finding that the area attained the 24-hour and annual PM 10 NAAQS.

(d) An emissions inventory must be completed for the area. In addition to the above requirements for the use of the clean data areas approach, any requirements that are connected solely to designation or classification, such as new source review (NSR) and RACM/RACT, will remain in effect. However, the requirements under CAA section 172(c) for developing attainment demonstrations, RFP demonstrations and contingency measures are waived due to the fact that the areas which are eligible under this approach have already attained the PM 10 NAAQS and have met RFP.

Any sanctions clocks that may be running for an area due to failure to submit, or disapproval of any attainment demonstration, RFP or contingency measure requirements, are stopped. In addition, areas are still required to demonstrate transportation conformity using the build/no-build test, or the no-greater-than-1990 test. 40 CFR 93.119. The emissions budget test would not be required, because the requirements for an attainment demonstration and RFP, which establish the budgets, no longer apply. The applicable tests for general conformity still apply. The use of the clean data areas approach does not constitute a CAA section 107(d) redesignation, but only serves to approve nonattainment area SIPs required under Part D of the CAA.

CAA section 175A provides the general framework for maintenance plans. The maintenance plan must provide for maintenance of the NAAQS for at least 10 years after redesignation, and must include any additional control measures as may be necessary to ensure such maintenance. In addition, maintenance plans are to contain such contingency provisions as we deem necessary to assure the prompt correction of a violation of the NAAQS that occurs after redesignation. The contingency measures must include, at a minimum, a requirement that the State will implement all control measures contained in the nonattainment SIP prior to redesignation. Beyond these provisions, however, CAA section 175A does not define the content of a maintenance plan. Our primary guidance on maintenance plans and redesignation requests is a September 4, 1992 memo from John Calcagni, entitled “Procedures for Processing Requests to Redesignate Areas to Attainment” (“Calcagni memo”).

On August 9, 2001, EPA issued new guidance on streamlined maintenance plan provisions for certain moderate PM 10 nonattainment areas seeking redesignation to attainment (Memo from Lydia Wegman entitled “Limited Maintenance Plan Option for Moderate PM 10 Nonattainment Areas”). This policy allows maintenance plans for areas having a low risk of future exceedances to omit air quality modeling, future year emission inventories, and some of the standard analyses to determine transportation conformity with the SIP.

To qualify for the LMP option, the area should be maintaining the NAAQS, and the average PM 10 design value for the area, based upon the most recent 5 years of air quality data at all monitors in the area, should be at or below 40 ug/m 3 for the annual and 98 ug/m 3 for the 24 hour PM 10 NAAQS with no violations at any monitor in the nonattainment area. See section IV of the LMP Option memo cited above. The 40 and 98 ug/m 3 limits are margin of safety (MOS) limits for the relevant PM 10 standard for a given area. In addition, the area should expect only limited growth in on-road motor vehicle PM 10 emissions (including fugitive dust) and should have passed a motor vehicle regional emissions analysis test.

As discussed below in Section IV.B.1, the State has demonstrated that the LMP option is appropriate for the Bullhead City nonattainment area.

The 1990 CAA Amendments revised section 107(d)(3)(E) to provide five specific requirements that an area must meet in order to be redesignated from nonattainment to attainment:

(1) The area must have attained the applicable NAAQS;

(2) The area has met all relevant requirements under section 110 and Part D of the Act;

(3) The area has a fully approved SIP under section 110(k) of the Act;

(4) The air quality improvement must be due to permanent and enforceable reductions; and,

(5) The area must have a fully approved maintenance plan pursuant to section 175A of the Act.

The Bullhead City nonattainment area contains the equivalent of about six townships within more than 200 square miles (40 CFR 81.303). Bullhead City is located in the east-central part. The existing Bullhead City nonattainment area is defined by the following townships:

Although the modeling domain of the nonattainment area extends into eastern portions of Clark County, Nevada, the actual nonattainment area only includes portions of Mohave County, Arizona.

The ADEQ has proposed shrinking the area to exclude the following 3 townships (108 square miles) in the east and south of the nonattainment area as defined in 40 CFR 81.303: T21N, R20W; T20N, R20W; and T19N, R21W. As a result, the nonattainment and maintenance area would be:

The State's rationale for shrinking the nonattainment area is that the land proposed for exclusion is undisturbed desert terrain, without industrial or commercial activity. A July 2001 field study confirmed this to be the case, and no development is anticipated in the foreseeable future. The majority of the three townships is Federal land managed by the Bureau of Land Management and State land managed by the Arizona State Land Department.

CAA Section 107(d)(3)(D) authorizes states to submit revised designations, and gives us authority to approve such redesignations if they do not interfere with the effectiveness or enforceability of the applicable SIP. Since the State has provided evidence that the excluded area will remain undisturbed desert for the foreseeable future, EPA approves the boundary revision.

Prior to adoption by the State, the plan received proper public notice and was the subject of a public hearing in Bullhead City on December 18, 2001. 2

a. Based on the past 3 years of air quality data, is the area attaining both the 24-hour and annual PM 10 NAAQS? An area has attained the 24-hour standard when the average number of expected exceedances per year is less than or equal to one, when averaged over a three-year period. (40 CFR 50.6) To make this determination, three consecutive years of complete ambient air quality data were collected in accordance with Federal requirements (40 CFR part 58, including appendices). On February 15, 2002, EPA issued a determination that the Bullhead City area had attained the PM 10 NAAQS. 67 FR 7082.

The Bullhead City area has one PM 10 monitoring site located at the United States Post Office building at the northeast corner of State Route 95 and 7th Street. There have been no recorded exceedances of either the annual or 24-hour PM 10 NAAQS in the area. The area has attained both the annual and 24-hour PM 10 NAAQS for the past 3 years. Indeed, the last exceedance of the 24-hour NAAQS occurred on May 30, 1991, and the last exceedance of the annual NAAQS was a 52 ug/m 3 concentration for 1989. Thus, the submittal demonstrates that the area has met the ambient attainment requirements for both the 24-hour and annual PM 10 NAAQS.

b. Is the State continuing to operate an appropriate PM 10 air quality monitoring network? Demonstrating that an area has attained the PM 10 NAAQS involves submittal of ambient air quality data from an ambient air monitoring network representing peak PM 10 concentrations, which should be stored in the EPA Aerometric Information Retrieval System (AIRS). Once the area has been redesignated, the State will continue to operate an appropriate air quality monitoring network, in accordance with 40 CFR part 58, to verify the attainment status of the area. The maintenance plan contains provisions for continued operation of air quality monitors that provide such verification. ADEQ has committed to continue operating an appropriate air quality monitoring network, in accordance with 40 CFR part 58, to verify the attainment status of the area. This commitment satisfies the obligation to maintain an adequate monitoring program in the area.

c. Has EPA approved the control measures responsible for bringing the areas into attainment? The measures implemented in Bullhead City beginning in 1990 and used for the attainment demonstration are listed below:

1. During active construction projects on State roads, the Arizona Department of Transportation (ADOT) paved intersecting unpaved roads up to the State road alignment.

2. Mohave County paved unpaved parking areas and roadways, and added sidewalks, curbs, and gutters in Davis Camp Park.

3. ADOT paved shoulders and installed curbs along Arizona State Highway 95.

4. Mohave County paved 8.85 miles of roads that were unpaved in 1989. Bullhead City paved more than 12 miles of roads that were unpaved in 1989.

5. Bullhead City paved more than 12 miles of previously unpaved roads in 1989.

6. ADEQ implemented Arizona Administrative Code R18-2-607 that requires control of storage piles to minimize fugitive emissions.

Implementation of these measures helped bring the area into timely attainment of both the 24-hour and annual PM 10 NAAQS, and the measures thus meet the CAA requirement for RACM. Measures 1-5 are fully constructed and are permanent by their very nature. Measure 6 has previously been approved by EPA and remains a Federally enforceable component of the SIP. Therefore, we conclude that the submittal demonstrates that the controls responsible for bringing the area into attainment have been fully carried out or are fully approved SIP regulations.

In addition to these permanent or SIP enforceable controls, the following strategies are also employed in the Bullhead City area: ADOT established contract specifications requiring erosion control plans for State construction projects in PM 10 nonattainment areas per standard specification 104.9; ADOT implemented Encroachments in Highway Rights-of-Way, Rule No. R17-3-712, which authorizes ADOT to issue permits to allow private landowners and tenants egress onto the State Highway System (in 1988, the section was renumbered, without change, as R17-3-702) but directs mitigation of trackout nuisances; Bullhead City implemented a grading ordinance requiring control of dust during grading and excavation and requiring that property be left in a condition that prevents dust from arising; and smoke management plan requirements were implemented by the Forest Service, Bureau of Land Management, and Arizona Department of State Lands, in cooperation with ADEQ. These supplemental strategies contributed still further fugitive dust emission reductions and public health protection. Continued implementation of the measures will help ensure that the Bullhead City area maintains the 24-hour and annual PM 10 NAAQS.

The Bullhead City plan includes emission inventories for 1999 to show emission levels in a recent, representative year during which there were no violations of the PM 10 standards. This inventory is summarized in Table IV-1, while Table IV-4 presents an inventory of industrial sources, all of which emit less than 3 tons per year of PM 10 . This inventory is consistent with our most recent guidance on emission inventories for nonattainment areas, and reflects the latest information available, including 2000 census data. 3 We approve the emissions inventory under CAA section 172(c)(3) as current, accurate, and complete.

The measures listed above in Section IV.A.2.c. reflect effective control for an important emissions category in the Bullhead City area: reentrained dust from traffic on paved and unpaved roads. These measures, along with the cessation of a singular construction project more than 10 years ago, were implemented expeditiously and have proven sufficient to prevent violations of the NAAQS over the past 10 years. We therefore conclude that the controls reflect RACM and we approve the plan as meeting the RACM provisions of CAA Section 189(a)(1)(C).

CAA Section 189(e) requires RACT provisions for gaseous precursors of PM 10 except where EPA determines that such sources do not contribute significantly to PM 10 levels exceeding the standard. There are no major stationary sources in the nonattainment area, and total emissions associated with all industrial sources account for only 0.18 percent of PM 10 emissions in 1999. For this reason and because the historic violations of the PM 10 NAAQS were the direct result of massive highway construction activities in the late 1980's, no sources within the Bullhead City area are subject to the RACT requirement, either with respect to primary or secondary PM 10 emissions.

For the Bullhead City nonattainment area, ADEQ administers the preconstruction review and permitting provisions of Arizona Administrative Code, Title 18, Chapter 2, Articles 1, 3, 4, and 5. All new major sources and modifications to existing major sources are subject to the new source review (NSR) and prevention of significant deterioration (PSD) requirements of these rules. We have not yet fully approved the State's NSR rules but, for major sources and modifications of PM 10 emissions, we have delegated to Arizona the authority to administer the PSD program.

Section 172(c)(5) requires NSR permits for the construction and operation of new and modified major stationary sources anywhere in nonattainment areas. We have determined that areas being redesignated from nonattainment to attainment do not need to comply with the requirement that an NSR program be approved prior to redesignation provided that the area demonstrates maintenance of the standard without part D nonattainment NSR in effect. The rationale for this decision is described in a memorandum from Mary Nichols dated October 14, 1994 (“Part D New Source Review (part D NSR) Requirements for Areas Requesting Redesignation to Attainment”). We have determined that the ADEQ maintenance demonstration for Bullhead City does not rely on nonattainment NSR and, therefore, the State need not have a fully approved nonattainment NSR program prior to approval of the redesignation request. The ADEQ's PSD program at 40 CFR 52.21 will become effective in the area with respect to PM 10 upon redesignation of the area to attainment, pursuant to the delegation agreement between EPA and ADEQ dated March 12, 1999.

Section II.E. of the plan discusses how the area meets each of the LMP option criteria for use of this option.

First, the area should be attaining the NAAQS. Table III-2 of the plan summarizes quality assured ambient data showing that the Bullhead City area has continued to meet both the 24-hour and annual PM 10 NAAQS for the period 1996-2000.

Second, the design values for the past 5 years must be at or below the margin of safety levels identified in the LMP option. The annual average PM 10 design value for the area from 1996 through 2000 data is 17 ug/m 3 , and the 24-hour average design value is 79 ug/m 3 , both of which are below the MOS limits of 40 and 98 ug/m 3 , respectively.

Third, the area must meet the motor vehicle regional emissions analysis test in the LMP option. The calculated value is 18 ug/m 3 for the annual average PM 10 standard, which is less than the 40 ug/m 3 MOS limit for annual, and the calculated value is 84 ug/m 3 for the 24-hour average PM 10 standard, which is less than the 98 ug/m 3 MOS limit.

Therefore, the State has shown that the area qualifies for the streamlined maintenance plan provisions under the LMP option. We have concluded in Sections IV.A. that the plan submittal meets the moderate area plan provisions for emissions inventories, permanent and enforceable control measures, and maintenance of adequate monitoring. There is one remaining maintenance plan provision under the LMP option not previously discussed: contingency measures.

The maintenance plan must include contingency control measures which will go into effect automatically to correct any future violation of the NAAQS. These provisions must include a requirement that the State will implement all measures contained in the nonattainment area SIP. The August 9, 2000 LMP option memo states that the contingency measures do not have to be fully adopted at the time of redesignation.

ADEQ has included 9 contingency measures in the maintenance plan ( see table below entitled “Bullhead City Area Contingency Measures”).

The State also committed to determine whether or not violations have been recorded within 6 months of the close of each calendar year, and to review and determine the appropriate contingency measure(s) by the end of the same calendar year. Finally, the State committed to implement the selected contingency measure(s) within 1 year of determining that a violation has occurred. We conclude that these measures and commitments meet the contingency measure provision of CAA Section 175A(d).

The area has attained the 24-hour standard when the average number of expected exceedances per year is less than or equal to one, when averaged over a three-year period. (40 CFR 50.6) To make this determination, three consecutive years of complete ambient air quality data were collected in accordance with Federal requirements (40 CFR part 58, including appendices).

As discussed above, there have been no recorded exceedances of either the annual or 24-hour PM 10 NAAQS in the area in the past 3 years. The area has attained both the annual and 24-hour PM 10 NAAQS for the past 3 years.

The Calcagni memo directs States to meet all of the applicable section 110 and part D planning requirements for redesignation purposes. EPA interprets the Act to require State adoption and EPA approval of the applicable programs under section 110 and part D that were due prior to the submittal of a redesignation request, before EPA may approve a redesignation request.

Section 110(a)(2) of the Act contains general requirements for nonattainment plans. These requirements include, but are not limited to, submittal of a SIP that has been adopted by the State after reasonable notice and public hearing, provisions for establishment and operation of appropriate apparatus, methods, systems, and procedures necessary to monitor ambient air quality, implementation of a permit program, provisions for Part C—Prevention of Significant Deterioration (PSD) and Part D—New Source Review (NSR) permit programs, criteria for stationary source emission control measures, monitoring and reporting, provisions for modeling, and provisions for public and local agency participation.

Part D includes additional provisions for nonattainment areas, listed generally in CAA section 172(c) and specifically for PM 10 in sections 188-9. These additional Part D provisions include: implementation of RACM as expeditiously as practicable, reasonable further progress, emissions inventories, and quantification of growth allowances (if the State elects to establish such allowances). See the General Preamble for further explanation of these requirements.

For purposes of redesignation, the Arizona SIP was reviewed to ensure that all requirements under the Act were satisfied. The Arizona SIP was approved under section 110 of the Act as satisfying all applicable section 110 and Part D provisions. These approvals are codified in 40 CFR 52.123. We are approving the SIP with respect to the special Part D provisions for PM 10 nonattainment areas (CAA sections 188-9) in Section IV.A. above.

We are approving in today's action the moderate area and maintenance plan for the Bullhead City Area, and confirming that the SIP meets other applicable provisions of the CAA.

The submittal shows that the improvements in air quality were not due to temporary economic downturn or unusually favorable meteorology (p. 14). On the contrary, economic growth has continued over the past 10 years since the area attained the NAAQS, and the area has experienced the full range of weather conditions in that period. As discussed above, attainment is the result of the cessation of unusual construction activities and the establishment of permanent and enforceable controls on fugitive dust emissions.

We are fully approving the maintenance plan, as allowed by the LMP guidance, in Section IV.B. above.

The transportation conformity rule and the general conformity rule apply to nonattainment areas and attainment areas with maintenance plans. Both rules provide that conformity can be demonstrated by showing that the expected emissions from planned actions are consistent with the emissions budget for the area.

Under the limited maintenance plan option, emissions budgets are treated as essentially not constraining for the length of the maintenance period because it is unreasonable to expect that qualifying areas would experience so much growth in that period that a NAAQS violation would result.

While areas with maintenance plans approved under the limited maintenance plan option are not subject to the budget test, the areas remain subject to other transportation conformity requirements of 40 CFR part 93, subpart A. Thus, the metropolitan planning organization (MPO) in the area or the State will still need to document and ensure that: (1) Transportation plans and projects provide for timely implementation of SIP transportation control measures (TCMs) in accordance with 40 CFR 93.113; (2) transportation plans and projects comply with the fiscal constraint element per 40 CFR 93.108; (3) the MPO's interagency consultation procedures meet applicable requirements of 40 CFR 93.105; (4) conformity of transportation plans is determined no less frequently than every three years, and conformity of plan amendments and transportation projects is demonstrated in accordance with the timing requirements specified in 40 CFR 93.104; (5) the latest planning assumptions and emissions model are used as set forth in 40 CFR 93.110 and 40 CFR 93.111; (6) projects do not cause or contribute to any new localized carbon monoxide or particulate matter violations, in accordance with procedures specified in 40 CFR 93.123; and (7) project sponsors and/or operators provide written commitments as specified in 40 CFR 93.125.

The adequacy review period for these SIP submissions is concurrent with the public comment period on this direct final rule. Because limited maintenance plans do not contain budgets, the adequacy review period for these maintenance plans serves to allow the public to comment on whether limited maintenance is appropriate for these areas. Interested parties may comment on the adequacy and approval of the limited maintenance plans by submitting their comments on the proposed rule published concurrently with this direct final rule.

Our action on the limited maintenance plans for these areas will also be announced on EPA's conformity Web site: http://www.epa.gov/oms/traq . Once there, click on the “Conformity” button, then look for “Adequacy Review of SIP Submissions for Conformity.”

For Federal actions which are required to address the specific requirements of the general conformity rule, one set of requirements applies particularly to ensuring that emissions from the action will not cause or contribute to new violations of the NAAQS, exacerbate current violations, or delay timely attainment. One way that this requirement can be met is to demonstrate that “the total of direct and indirect emissions from the action (or portion thereof) is determined and documented by the State agency primarily responsible for the applicable SIP to result in a level of emissions which, together with all other emissions in the nonattainment area, would not exceed the emissions budgets specified in the applicable SIP.” 40 CFR 93.158(a)(5)(i)(A).

The decision about whether to include specific allocations of allowable emissions increases to sources is one made by the State and local air quality agencies. Such emissions budgets are unlike and not to be confused with those used in transportation conformity. Emissions budgets in transportation conformity are required to limit and restrain emissions. Emissions budgets in general conformity allow increases in emissions up to specified levels.

ADEQ has not chosen to include any specific emissions allocations for Federal projects that would be subject to the provisions of general conformity.

We are approving the boundary revision, the moderate area plan, and the maintenance plan for the Bullhead City Area, and we are redesignating the area from nonattainment to attainment for the 24-hour and annual PM 10 NAAQS. We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the State plan and redesignate the area if relevant adverse comments are filed. This rule will be effective August 26, 2002, without further notice unless relevant adverse comments are received by July 26, 2002. If we receive such comments, this action will be withdrawn before the effective date. All public comments received will then be addressed in a subsequent final rule based on the proposed action. We will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. If no such comments are received, the public is advised that this action will be effective August 26, 2002.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves State law as meeting Federal requirements and imposes no additional requirements beyond those imposed by State law.

Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 26, 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 is a summary of the Federal Communications Commission's Memorandum Opinion and Order and Second Report and Order, FCC 02-116, adopted on April 11, 2002, and released on May 23, 2002. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, Room CY-A257, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the Commission's copy contractor, Qualex International, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at: www.fcc.gov. Alternative formats are available to persons with disabilities by contacting Brian Millin at (202) 418-7426 or TTY (202) 418-7365.

1. This Second Report and Order contains either a new or modified information collection. As part of the Commission's continuing effort to reduce paperwork burdens, we invite the general public and the Office of Management and Budget (OMB) to take this opportunity to comment on revision to the information collections contained in the Second Report and Order as required by the Paperwork Reduction Act of 1995. Public and agency comments are due August 26, 2002. Comments should address:

• Whether the new or modified collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility.

• The accuracy of the Commission's burden estimates.

• Ways to enhance the quality, utility, and clarity of the information collected.

• Ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

Written comments by the public on the new or modified information collections are due August 26, 2002. Written comments must be submitted by the OMB on the new or modified information collections on or before October 25, 2002. In addition to filing comments with the Secretary, a copy of any comments on the information collections contained herein should be submitted to Judith B. Herman, Federal Communications Commission, Room 1-C804, 445 12th Street, SW., Washington, DC 20554, or via the Internet to jboley@fcc.gov, and to Jeanette Thornton, OMB Desk Officer, Room 10236 New Executive Office Building, 725 Seventeenth Street, NW., Washington, DC 20503, or via the Internet to JThornto@omb.eop.gov.

OMB Control No.: 3060-xxxx

Title: 25.139 NGSO FSS coordination and information sharing between MVDDS licensees in the 12.2 GHz to 12.7 GHz band.

Form No: N/A.

Type of Review: New.

Number of Respondents: 6.

Frequency of Response: On occasion.

Total Annual Burden: 6.

Total Annual Cost: 0.

Needs and Uses: This rule is needed for NGSO FSS licensees to maintain a subscriber database in a format that can be readily shared with MVDDS licensees for the purpose of determining compliance with the MVDDS transmitting antenna spacing requirement relating to qualifying existing NGSO FSS subscriber receivers set forth in § 101.129 of this chapter.

OMB Control No.: 3060-xxxx.

Title: 101.103 Frequency coordination procedures.

Form No: N/A.

Type of Review: New collection.

Frequency of Response: On occasion.

Total Annual Burden: 177 hours.

Total Annual Cost: 0.

Needs and Uses: This rule is necessary to require MVDDS licensees to provide notice of intent of construct a proposed antenna to NGSO FSS licensees.

OMB Control No.: 3060-xxxx.

Title: 101.1403 Broadcast Carriage Requirements.

Form No: N/A.

Type of Review: New.

Frequency of Response: On occasion.

Number of Respondents: 354.

Total Annual Burden: 354.

Total Annual Cost: 0.

Needs and Uses: This rule is needed for the purpose of coming into compliance with the broadcast carriage requirements.

OMB Control No.: 3060-xxxx.

Title: 101.1413 License term and renewal expectancy.

Form No: N/A.

Type of Review: New collection.

Frequency of Response: On occasion.

Total Annual Burden: 7080 hours.

Total Annual Cost: 0.

Needs and Uses: The information required in § 101.1413 is used to determine whether a renewal applicant of a MVDDS has complied with the requirements to provide substantial service by the end of the ten-year initial license term. The FCC uses the information to determine whether an applicant's license will be renewed at the end of the license period.

OMB Control No.: 3060-xxxx.

Title: 101.1417 Annual Report.

Form No: N/A.

Type of Review: New.

Frequency of Response: Annually.

Total Annual Burden: 354.

Total Annual Cost: 0.

Needs and Uses: This rule requires MVDDS licensees to file two copies of a report by March 1 of each year for the preceding calendar year. This report must include name and address of licensee; station(s) call letters and primary geographic service area(s); and statistical information for the licensee's station.

OMB Control No.: 3060-xxxx.

Title: 101.1440 MVDDS protection of DBS.

Form No: N/A.

Type of Review: New.

Frequency of Response: On occasion.

Total Annual Burden: 14,522.

Total Annual Cost: 0.

Needs and Uses: This rule requires MVDDS licensees conduct a survey to determine the location of all DBS customers of record and obtain a signed written agreement from the DBS customers of record agreeing to their DBS system receiving MVDSS signal in excess of appropriate EFPD.

1. In this Memorandum Opinion and Order and Second Report and Order, we make the following major determinations regarding the licensing of MVDDS in the 12 GHz band:

• We find that the Commission provided clear notice that the Commission was considering authorizing MVDDS in the 12 GHz band in the November 24, 1998 Notice of Proposed Rulemaking, 64 FR 7565 (January 12, 1999) (Amendment of Parts 2 and 25 of the Commission's Rules to Permit Operation of NGSO FSS Systems Co-Frequency with GSO and Terrestrial Systems in the Ku-Band Frequency Range; Amendment of the Commission's Rules to authorize subsidiary Terrestrial Use of the12.2-12.7 GHz Band by Direct Broadcast Satellite Licensees and Their Affiliates, ET Docket No. 98-206, ET Docket No. 98-206, 14 FCC Rcd 1131 (1998)), as required by the Administrative Procedure Act (5 U.S.C. Chapter 5, et. seq. ).

• The MVDDS authorization complies with the provisions, and fosters the goals, of the Satellite Home Viewer Improvement Act of 1999 (SHVIA) and the Rural Local Broadcast Signal Act (RLBSA) (Public Law 106-113 Stat. 1501 (enacting S. 1948, including the SHVIA and the RLBSA, Titles I and II of the Intellectual Property and Communications Omnibus Reform Act of 1999)).

• The technical rules and regulatory safeguards we are adopting in the Second Report and Order will protect the primary allocation status of incumbent DBS/Broadcast Satellite Service (BSS) and the co-primary NGSO FSS operators in the 12 GHz band.

• The Commission's decision to authorize MVDDS in the 12 GHz band was carefully considered and rationally explained based upon all of the available information in the record.

• The technical rules we are establishing for MVDDS operation are technologically neutral because they do not specify a particular equipment configuration or methodology, proprietary or not, that must be used within the fixed terrestrial MVDDS service.

• The Commission's decision to authorize MVDDS in the 12 GHz band does not violate International Telecommunication Union (ITU) recommendations and constitutes an appropriate exercise of domestic regulatory authority.

• We deny the petitions for reconsideration with respect to the Commission's decision to authorize MVDDS in the 12 GHz band.

• We find to be substantively without merit, and dismiss on our own motion as procedurally untimely, a “Petition for Consolidation of Rulemaking Proceedings and for a Declaration that Alternative Spectrum is Suitable for the Proposed Multichannel Video Distribution and Data Service,” which seeks to disallow MVDDS operation in the 12.2-12.7 GHz band and instead seeks consideration of alternative spectrum in the 12.7-13.25 GHz Cable Television Relay Service (CARS) band or the 2500-2690 MHz Multichannel Multipoint Distribution Service (MMDS) in the context of two other rule making proceedings.

• We will require an MVDDS operator to operate with a maximum power limit of 14 dBm per 24 megahertz Effective Isotropic Radiated Power (EIRP).

• We specify an equivalent power flux density (EPFD) limit for each of four regions across the United States. The regions and corresponding EPFD limits are: East: -168.4 dBW/m 2 /4kHz, Midwest: -169.8 dBW/m 2 /4kHz, Southwest: -171.0 dBW/m 2 /4kHz, and Northwest: -172.1 dBW/m 2 /4kHz.

• Using a prescribed methodology and a predictive model to calculate EPFD values, we used a criterion that would limit the amount of increased BSS unavailability due to the presence of MVDDS to ten percent over a baseline level of BSS unavailability. The unavailability allowance ascribed to MVDDS is in addition to the unavailability allowance ascribed to NGSO FSS operations in the 12.2-12.7 GHz band.

• MVDDS must site and design its transmitting antennas to avoid causing harmful interference to existing DBS customers.

• We will require the MVDDS operator to ensure that the prescribed EPFD limits are not exceeded at any DBS customer of record location. If the EPFD limits are exceeded, the MVDDS operator will be required to discontinue service until such time that the limits can be met.

• To promote MVDDS and NGSO FSS band sharing, MVDDS signals shall not exceed a power flux density (PFD) of −135dBW/m 2 /4kHz measured and/or calculated at the surface of the earth at distances greater than 3 km from the MVDDS transmitting site.

• We adopt a minimum MVDDS transmitting antenna spacing of 10 km from pre-existing NGSO FSS receive antennas with the option for NGSO FSS licensee agreement to accept shorter spacing. We also conclude that NGSO FSS receivers must accept any interference from pre-existing MVDDS transmitting antennas.

• We adopt basic information sharing and coordination requirements that MVDDS and NGSO FSS operators must follow to facilitate mutual sharing of the 12 GHz band as co-primary services.

• We adopt MVDDS emission mask values for protecting NGSO FSS operations in the adjacent 11.7-12.2 GHz band and CARS and Broadcast Auxiliary Service (BAS) operations in the adjacent 12.7-13.25 GHz band from out-of-band MVDDS emissions.

• We adopt low elevation angle PFD radiation limits on NGSO FSS operations that will afford protection to MVDDS receivers from NGSO FSS interference for the portion of the non-geostationary orbital path near the horizon.

• We dismiss, without prejudice, all applications for terrestrial use of the 12 GHz band. All interested parties may reapply under the new licensing rules established in this proceeding.

• We adopt a geographic area licensing scheme that permits the filing of mutually exclusive applications. Consistent with our statutory mandate to resolve such applications through the use of auctions, any mutually exclusive initial applications for the MVDDS service will be resolved by competitive bidding.

• We find that the ORBIT Act does not bar the assignment of licenses for MVDDS in the 12.2-12.7 GHz band by competitive bidding.

• We adopt our proposal to auction MVDDS licenses in conformity with the general competitive bidding rules set forth in Part 1, Subpart Q, of the Commission's Rules.

• We adopt three small business definitions and three levels of bidding credits for MVDDS. We define a very small business as an entity with average annual gross revenues not exceeding $3 million for the preceding three years; a small business as an entity with average annual gross revenues not exceeding $15 million for the preceding three years; and an entrepreneur as an entity with average annual gross revenues not exceeding $40 million for the preceding three years. Very small businesses will receive a bidding credit of 35 percent, small businesses will receive a bidding credit of 25 percent, and entrepreneurs will receive a bidding credit of 15 percent.

• We decline to adopt a set-aside of MVDDS spectrum or special bidding credits for DBS licensees.

• We decline to adopt a prohibition against transfers of MVDDS licenses.

• We adopt geographic license service areas for MVDDS on the basis of Component Economic Areas (CEAs).

• We adopt a channel plan consisting of one spectrum block of 500 megahertz per service area.

• We permit fixed one-way operations, but exclude mobile and aeronautical operations. Permissible operations include the flexibility for two-way services whereby the 12 GHz band could be used for the downstream path, and any upstream (or return) path could be located in other spectrum or over a wireline.

• We decline to adopt must-carry rules.

• We require incumbent non-public safety Private Operational Fixed Service (POFS) licensees in the 12 GHz band to protect MVDDS and NGSO FSS operations.

• We require MVDDS and NGSO FSS operations to protect incumbent traditional public safety POFS licensees in the 12 GHz band.

• We suspend the acceptance of POFS applications for new licenses, amendments to applications for new and modified licenses and major modifications to existing licenses.

• We decline to permit dominant cable operators from acquiring an attributable interest in an MVDDS license for a service area where significant overlap is present.

• We adopt a ten-year license term for MVDDS, beginning on the date of the initial authorization grant, and adopt a renewal expectancy based on the substantial service requirement.

• We restrict the placement of transmitting systems near the Canadian and Mexican borders.

2. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Amendment of Parts 2 and 25 of the Commission's Rules to Permit Operation of NGSO FSS Systems Co-Frequency with GSO and Terrestrial Systems in the Ku-Band Frequency Range; Amendment of the Commission's Rules to Authorize Subsidiary Terrestrial Use of the 12.2-12.7 GHz Band by Direct Broadcast Satellite Licensees and Their Affiliates; and Applications of Broadwave USA, PDC Broadband Corporation, and Satellite Receivers, Ltd. to Provide A Fixed Service in the 12.2-12.7 GHz Band, First Report and Order and Further Notice of Proposed Rule Making , 66 FR 30361 (June 6, 2001) ( First Report and Order and Further Notice of Proposed Rule Making ), FCC 00-418, ET Docket No. 98-206, 16 FCC Rcd 4096 (2000). The Commission sought written public comment on the proposals in the Further Notice of Proposed Rule Making including comment on the IRFA. This Final Regulatory Flexibility Analysis (FRFA) examines the possible significant economic impact of our actions on small entities and conforms to the RFA.

3. By this action, Multichannel Video Distribution and Data Service (MVDDS) providers will share the 12.2-12.7 GHz band with new NGSO FSS operators on a co-primary basis and on a non-harmful interference basis with incumbent direct broadcast satellite (DBS) providers. The objective of this Second Report and Order is to adopt licensing, service and technical rules for the MVDDS. Specifically, we seek: (1) to accommodate the introduction of innovative services; and (2) to facilitate the sharing and efficient use of spectrum. Furthermore, the rules adopted in this Second Report and Order are designed to implement Congress's goal of giving small businesses the opportunity to participate in the provision of spectrum-based services in accordance with section 309(j) of the Communications Act of 1934, as amended. Thus, we believe that this service will facilitate the delivery of communications services, such as video and broadband services, to various populations including those that are deemed to be unserved and/or underserved.

4. Although we did not receive any comments in direct response to the IRFA, commenters suggested approaches that would foster participation in the MVDDS service by smaller entities. For instance, several commenters favored allowing MVDDS licensees to partition their geographic service areas into smaller areas. In addition, the Rural Telecommunications Group (RTG) suggested the use of smaller service areas—Metropolitan Statistical Areas (MSAs), Rural Service Areas (RSAs) or Component Economic Areas (CEAs)—to facilitate opportunities for small and rural carriers to obtain MVDDS licenses and to ensure that rural regions benefit from the 12.2-12.7 GHz band. Likewise, Pegasus supported licensing MVDDS on the basis of basic trading areas (BTAs) and major trading areas (MTAs) because the population served would be smaller and the cost of licenses likely lower, thus providing greater economic opportunity for a wider variety of applicants. Thus, the need to establish opportunities for smaller entities to have access to MVDDS spectrum was a sentiment expressed by various commenters in the MVDDS rule making proceeding.

5. The RFA directs agencies to provide a description of, and, where feasible an estimate of, the number of small entities that may be affected by the rules adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

6. Small Multichannel Video Programming Distributors (MVPDs). SBA has developed a definition of small entities for cable, which includes all such companies generating $11 million or less in annual receipts. This definition includes cable system operators and DBS services. According to the Census Bureau data from 1992, there were 1,758 total cable and other pay television services and 1,423 had less than $11 million in revenue. We address each service individually to provide a more precise estimate of small entities.

7. Cable Services. The Commission has developed, with SBA's approval, our own definition of a small cable system operator for the purposes of rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers nationwide. We last estimated that there were 1439 cable operators that qualified as small cable companies. Since then, some of those companies may have grown to serve over 400,000 subscribers, and others may have been involved in transactions that caused them to be combined with other cable operators. Consequently, using this definition, we estimate that there are fewer than 1439 small entity cable system operators that may be affected by the decisions and rules adopted in this Second Report and Order.

8. The Communications Act defines a small cable system operator as “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than one percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” The Commission has determined that there are 61,700,000 subscribers in the United States. Therefore, an operator serving fewer than 617,000 subscribers shall be deemed a small operator under the Communications Act definition, if its annual revenues, when combined with the total annual revenues of all of its affiliates, do not exceed $250 million in the aggregate. Based on available data, we find that the number of cable operators serving 617,000 subscribers or less totals approximately 1450. Although it seems certain that some of these cable system operators are affiliated with entities whose gross annual revenues exceed $250,000,000, we are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act.

9. DBS Service. Because DBS provides subscription services, DBS falls within the SBA definition of Cable Networks (NAIC 513210) and Cable and Other Program Distribution (NAIC 513220). This definition provides that a small entity is expressed as one with $11 million or less in annual receipts. The operational licensees of DBS services in the United States are governed by Part 100 of the Commission's Rules. The Commission, however, does not collect annual revenue data for DBS and, therefore, is unable to ascertain the number of small DBS licensees meeting this definition that could be impacted by these rules. DBS service requires a great investment of capital for operation, and we acknowledge that there are entrants in this field that may not yet have generated $11 million in annual receipts, and therefore may be categorized as a small business by the SBA, if independently owned and operated.

10. Auxiliary, Special Broadcast and other program distribution services. This service involves a variety of transmitters, generally used to relay broadcast programming to the public (through translator and booster stations) or within the program distribution chain (from a remote news gathering unit back to the station). The Commission has not developed a definition of small entities applicable to broadcast auxiliary licensees. Therefore, the applicable definition of small entity is the definition under the SBA rules applicable to radio networks (NAICS 513111), radio stations (NAICS 513112), and television broadcasting (NAICS 513120). These definitions provide, respectively, that a small entity is one with either $5 million or less in annual receipts or $10.5 million in annual receipts. The numbers of these stations are very small. The Commission does not collect financial information on these auxiliary broadcast facilities. We believe, however, that most, if not all, of these auxiliary facilities could be classified as small businesses by themselves. We also recognize that most of these types of services are owned by a parent station which, in some cases, would be covered by the revenue definition of small business entity. These stations would likely have annual revenues that exceed the SBA maximum to be designated as a small business (as noted, either $5 million for a radio station or $10.5 million for a TV station). Furthermore, they do not meet the SBA's definition of a “small business concern” because they are not independently owned and operated.

11. Private Operational Fixed Service. Incumbent microwave services in the 12.2-12.7 GHz bands are private operational fixed (POF) services. Presently, there are approximately 22,015 common carrier licensees, and approximately 61,670 POF licensees and broadcast auxiliary radio licensees in the microwave service. Inasmuch as the Commission has not yet defined a small business with respect to these incumbent microwave services, we will utilize the SBA's definition applicable to cellular and other wireless telecommunications companies (NAICS 513322); i.e. , an entity with no more than 1500 persons. We estimate, for this purpose, that all of the Fixed Microwave licensees (excluding broadcast auxiliary licensees) would qualify as small entities under the SBA definition for radiotelephone companies.

12. The rules set forth in this Second Report and Order will affect all entities that intend to provide terrestrial MVDDS operations in the 12.2-12.7 GHz band. In this Second Report and Order, we state that licensees are permitted to use MVDDS spectrum for, among other things, fixed one-way direct-to-home/business video and data services.

13. Additionally, in the Second Report and Order, we adopt definitions for three tiers of small businesses for the purpose of providing bidding credits to small entities. Specifically, we define the three tiers of small businesses as follows: an “entrepreneur” is an entity with average annual gross revenues not exceeding $40 million for the preceding three years; a “small business” is an entity with average annual gross revenues not exceeding $15 million for the preceding three years; and a “very small business” is an entity with average annual gross revenues not exceeding $3 million for the preceding three years. We will not know how many auction participants or licensees will qualify under these definitions as entrepreneurs, small businesses, or very small businesses until an auction is held. However upon reviewing the record in the MVDDS proceeding, we assume that, for purposes of our evaluations and conclusions in the FRFA, a number of the prospective licensees will be entrepreneurs, small businesses, or very small businesses under our adopted definitions.

14. Applicants for MVDDS licenses are required to submit an FCC Form 175 short-form application prior to the auction, and auction winners will be required to file an FCC Form 601 license application. Additionally, we will apply the Part 101 rules governing reporting requirements to MVDDS systems. Specifically, each MVDDS licensee is required to file with the Commission two copies of a report no later than March 1 of each year for the preceding calendar year, which must include the following: (a) name and address of licensee; (b) station(s) call letters and primary geographic service area(s); and (c) the following statistical information for the licensee's station (and each channel thereof): (i) the total number of separate subscribers served during the calendar year; (ii) the total hours of transmission service rendered during the calendar year to all subscribers; (iii) the total hours of transmission service rendered during the calendar year involving the transmission of local broadcast signals; and (iv) a list of each period of time during the calendar year in which the station rendered no service as authorized, if the time period was a consecutive period longer than forty-eight hours. In addition, we require each MVDDS licensee to file actual data on cases of harmful interference to DBS operations and measures taken to alleviate such interference. We believe that the information compiled in this report will assist us in analyzing trends and competition in the marketplace.

15. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its approach, which may include the following four alternatives: (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.

16. We have taken significant steps to reduce burdens on small entities wherever possible. To provide opportunities for small entities to participate in any auction that is held, we provide bidding credits for entrepreneurs, small businesses, and very small businesses as defined in section C of this FRFA. The bidding credits adopted are 15 percent for entrepreneurs, 25 percent for small businesses, and 35 percent for very small businesses. Our decision to adopt CEAs as service areas for MVDDS and to permit the partitioning of these service areas is also intended to provide small entities an opportunity to acquire licenses. There are currently 348 CEAs and we believe that the use of these service areas will encourage smaller business entities to participate in the MVDDS auction. Participation in the MVDDS auction by smaller business entities would foster the buildout of services to local and/or rural areas which are traditionally deemed underserved or unserved. The regulatory burdens we have retained are necessary in order to ensure that the public receives the benefits of innovative new services in a prompt and efficient manner. We will continue to examine alternatives in the future with the objectives of eliminating unnecessary regulations and minimizing any significant economic impact on small entities.

17. None.

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

19. Authority. Accordingly, it is ordered that pursuant to the authority contained in sections 4(i), 7(a), 301, 303(c), 303(f), 303(g), 303(r), 308, and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 157(a), 301, 303(c), 303(f), 303(g), 303(r), 308, 309(j), this Memorandum Opinion and Order and Second Report and Order is adopted.

20. It is further ordered that, parts 25 and 101 of the Commission's rules ARE AMENDED as specified in rule changes, effective August 26, 2002, except for §§ 25.139, 101.103, 101.1403, 101.1413, 101.1417 and 101.1440 which contain information collection requirements that have not been approved by OMB. The Federal Communications Commission will publish a document in the Federal Register announcing the effective date. This action is taken pursuant to sections 4(i), 303(c), 303(f), 303(g), 303(r), and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(c), 303(f), 303(g), 303(r) and 309(j).

21. It is further ordered that pursuant to sections 4(i), 302, 303(e), 303(f), 303(g), 303(r) and 405 of the Communications Act of 1934, as amended, the petitions for reconsideration filed by SkyBridge, DirecTV, Inc., EchoStar Satellite Corporation, Satellite Broadcasting and Communications Association, the Boeing Company, and SkyTower, Inc. as they relate to our decision to allocate MVDDS in the 12 GHz band are denied.

22. It is further ordered that pursuant to sections 4(i), 302, 303(e), 303(f), 303(g), 303(r) and 405 of the Communications Act of 1934, as amended, the DBS Petition for Consolidation and Declaration filed by DirecTV and EchoStar is dismissed.

23. It is further ordered that pursuant to sections 4(i), 303(r) and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(r), 309(j), and section 1.934(d) of the Commission's Rules, 47 CFR 1.934(d), the Broadwave Network, LLC Applications for Licenses to Provide a New Terrestrial Transport Service in the 12 GHz band, Various DMAs, filed on January 8, 1999, are dismissed.

24. It is further ordered that pursuant to sections 4(i), 303(r) and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(r), 309(j), and section 1.934(d) of the Commission's Rules, 47 CFR 1.934(d), the PDC Broadband Corporation Applications for Licenses to Provide Terrestrial Service in the 12 GHz Band in All DMAs, filed on April 18, 2000, are dismissed.

25. It is further ordered that pursuant to sections 4(i), 303(r) and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 303(r), 309(j), and section 1.934(d) of the Commission's Rules, 47 CFR 1.934(d), the Satellite Receivers, Ltd. Applications for Licenses to Provide Terrestrial Television Broadcast and Data Services in the 12.2-12.7 GHz Band in Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin, filed on August 25, 2000, are dismissed.

26. It is further ordered that, effective as of the date of the release of this Memorandum Opinion and Order and Second Report and Order, NO NEW APPLICATIONS WILL BE ACCEPTED FOR FILING in the 12.2-12.7 GHz band for private operational fixed service, except for applications for minor modifications or for license assignment or transfer of control.

27. It is further ordered that pending applications, as of the release date of this Memorandum Opinion and Order and Second Report and Order, for Private Operational Fixed Service licenses in the 12.2-12.7 GHz band will be processed on a first-come, first-served basis.

28. It is further ordered that the Commission's Consumer Information Bureau, Reference Information Center, shall send a copy of this Memorandum Opinion and Order and Second Report and Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.