Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on March 25, 2008 (73 FR 15681). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comment received.

Northwest Airlines (NWA) requests that we revise the applicability of the NPRM to state that the AD applies only to those airplanes produced before February 28, 2007 that have fewer than 8,000 total flight hours and that have not had Airbus A318/A319/A320/A321 Maintenance Review Board Report (MRBR) Task 26.23.00/03 and 26.23.00/07, or Airbus Service Bulletin A320-26A1068, dated March 19, 2007, accomplished.

We disagree that the applicability needs to be clarified. Paragraph (c), “Applicability,” of the NPRM already excludes airplanes on which the MRBR tasks have been performed. Paragraph (f), “Actions and Compliance,” gives credit for airplanes on which the service bulletin has been accomplished before the effective date of this AD. These exclusions are valid no matter the number of total flight hours on the airplane. We have not changed the AD in this regard.

We have clarified the applicability to include a reference to the German standard airworthiness certificate or original German export certificate of airworthiness. The applicability of the NPRM referred only to the French standard airworthiness certificate or original French export certificate of airworthiness. Some of the airplanes affected by this AD were produced in Germany.

We have removed the reference to Airbus A318/A319/A320/A321 MRBR Task 26.23.00/03 or 26.23.00/07 in paragraph (f) of this AD to be consistent with FAA policy and Office of the Federal Register regulations. We may consider approving the use of Airbus A318/A319/A320/A321 MRBR Task 26.23.00/03 or 26.23.00/07 as an alternative method of compliance with this AD, as provided by paragraph (g)(1) of this AD.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 679 products of U.S. registry. We also estimate that it will take about 6 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $325,920, or $480 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify this AD:

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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Discussion

EASA, which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2008-0109 R1, dated June 17, 2008, to correct an unsafe condition for the specified products. The EASA AD states that for RB211 Trent 500 series turbofan engines that have not incorporated RR SB No. RB.211-72-D733, dated August 21, 2002, or Revision 1 of that SB, dated March 6, 2008, the unsafe condition is as follows:

Rolls-Royce plc has issued ASB No. RB.211-72-AF994, Revision 1, dated September 1, 2008 and SB No. RB.211-72-D733, Revision 1, dated March 6, 2008. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

Although no airplanes registered in the United States use these engines, the possibility exists that the engines could be used on airplanes registered in the United States in the future. The unsafe condition described previously is likely to exist or develop on other engines of the same type design. We are issuing this AD to prevent release of IP turbine blades and disc posts, resulting in damage to the airplane. This AD requires:

• Initial and repetitive borescope inspections for missing or lifting IP turbine blade outer shroud dust caps; and

• Installation of core restrictor plugs in the IP turbine blade roots, if 20 or more IP turbine blade outer shroud dust caps are found lifting, or if 1 or more dust caps are missing.

Since there are currently no domestic operators of this engine model, notice and opportunity for public comment before issuing this AD are unnecessary. Therefore, a situation exists that allows the immediate adoption of this regulation.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we require the initial borescope inspection to be done within 5 flight cycles, since the MCAI required the initial inspection to be done before July 1, 2008, which has already passed.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-1063; Directorate Identifier 2008-NE-32-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify this AD:

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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

On August 11, 2005, the FAA issued AD 2005-17-12, amendment 39-14223 (70 FR 49164, August 23, 2005). That AD applies to certain Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. That AD requires inspecting to identify the wing anti-ice ducts (piccolo tubes) in the wing leading edge. For airplanes with affected piccolo tubes, that AD requires revising the airplane flight manual (AFM) to introduce new procedures for operation in icing conditions. That AD provides an optional implementation of repetitive inspections for cracks of affected piccolo tubes, and corrective actions if necessary, which terminates the operational limitations. That AD also provides an optional installation of certain new piccolo tubes, which terminates both the AFM revision and the inspections. That AD resulted from reports of failed piccolo tubes. The actions specified in that AD are intended to prevent cracked piccolo tubes, which could result in air leakage, a possible adverse effect on the anti-ice air distribution pattern and anti-ice capability without annunciation to the flight crew, and consequent reduced controllability of the airplane.

Since we issued AD 2005-17-12, we received a report that faulty piccolo tubes might have been installed in a number of leading edge assemblies built as spares, and whose current locations are not specifically known. These faulty parts may have been installed on airplanes affected by that AD. Faulty piccolo tubes could crack, which could result in air leakage, a possible adverse effect on the anti-ice air distribution pattern and anti-ice capability without annunciation to the flight crew, and consequent reduced controllability of the airplane.

Bombardier has issued Canadair Temporary Revision RJ/155-6, dated September 17, 2008 (“the TR”), to the Canadair Regional Jet AFM, CSP A-012. The TR describes new procedures for operation in icing conditions and supersedes Canadair TR RJ/155, dated July 5, 2005 (which we referred to as the appropriate source of service information for doing the AFM revision required by AD 2005-17-12).

Bombardier has also issued Service Bulletin 601R-30-029, Revision B, dated August 29, 2005. We referred to Bombardier Service Bulletin 601R-30-029, Revision A, dated July 7, 2005, as the appropriate source of service information for doing certain actions required by AD 2005-17-12. Revision B contains the same procedures as Revision A but adds airplanes to the effectivity and removes certain other airplanes from the effectivity.

Bombardier has also issued Alert Service Bulletin A601R-30-032, dated September 18, 2008. This service bulletin supersedes Bombardier Service Bulletin 601R-30-029, Revision A, dated July 7, 2005. Bombardier Alert Service Bulletin A601R-30-032 describes procedures for inspecting to determine if certain anti-ice piccolo ducts are installed, and replacing or repairing the piccolo duct if necessary.

Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. Transport Canada Civil Aviation (TCCA) mandated the service information and issued Canadian airworthiness directive CF-2008-30, dated October 7, 2008 (referred to after this as “the MCAI”), to ensure the continued airworthiness of these airplanes in Canada. Canadian airworthiness directive CF-2008-30 supersedes Canadian airworthiness directive CF-2005-26R1, dated September 21, 2005, and adds airplanes to the applicability. We referred to Canadian airworthiness directive CF-2005-26, dated July 11, 2005, in our AD 2005-17-12.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

Therefore, we are issuing this AD to supersede AD 2005-17-12. This new AD retains certain requirements of the existing AD. This AD also requires accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between the AD and the Service Information.” This AD also adds airplanes to the applicability and removes certain other airplanes from the applicability.

Where Bombardier Alert Service Bulletin A601R-30-032, dated September 18, 2008, specifies that Bombardier may be contacted for information regarding repair, this AD requires repair according to a method approved by either the Manager, New York ACO, or TCCA (or its delegated agent).

We consider this AD interim action. We are currently considering requiring the replacement of all piccolo ducts that have serial numbers identified in Part A, Paragraph 2.A., of the Accomplishment Instructions of Bombardier Alert Service Bulletin A601R-30-032, dated September 18, 2008, with piccolo ducts that do not have the affected serial numbers, which will constitute terminating action for the actions required by this AD. However, the planned compliance time for the replacement would allow enough time to provide notice and opportunity for prior public comment on the merits of the replacement.

Because of our requirement to promote safe flight of civil aircraft and thus, the critical need to ensure proper functioning of the anti-ice systems during the upcoming winter season, and the short compliance time involved with this action, this AD must be issued immediately.

Because an unsafe condition exists that requires the immediate adoption of this AD, we find that notice and opportunity for prior public comment hereon are impracticable and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-1200; Directorate Identifier 2008-NM-178-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that the regulation:

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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 90-17-19, amendment 39-6705 (55 FR 33280, August 15, 1990). The existing AD applies to certain Boeing Model 747 series airplanes. That NPRM was published in the Federal Register on April 28, 2008 (73 FR 22845). That NPRM proposed to retain the requirements of the existing AD but to add a repetitive inspection to detect broken parts, and revise the overhaul threshold and repetitive intervals.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments that have been received on the NPRM.

Boeing has reviewed the NPRM and concurs with the contents of the proposed rule. Northwest Airlines (NWA) has no technical objection to the AD.

The Hong Kong Civil Aviation Department, and Air Transport Association (ATA), on behalf of its member NWA, request that we revise the inspection threshold for the inspection for broken parts proposed in paragraph (i) of the NPRM. The commenters point out that the NPRM stated the first inspection should be done at the earlier of 12 months or 400 flight cycles after the effective date of the AD; however, Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008, specifies doing that inspection at the later of those two times.

We agree with the commenters. It was our intent that the compliance threshold should match that of the Boeing Service Bulletin 747-27-2280, Revision 6. We have revised paragraph (i) of the AD as requested.

ATA on behalf of NWA, requests that we revise paragraph (j), “Repetitive Overhauls,” of the NPRM to clarify the compliance threshold for the initial overhaul for carriage assemblies previously overhauled in accordance with the requirements of AD 90-17-19. NWA requests that we specify that the compliance threshold is measured from the completion of the overhaul mandated by AD 90-17-19 for carriages/assemblies previously overhauled.

We agree that the compliance times can be clarified, although we do not agree that it is necessary to change the AD in this regard. Paragraph (j) of the NPRM specifies doing the initial overhaul at the later of the applicable thresholds specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008; or 48 months after the effective date of the AD. Paragraph 1.E. of the service bulletin includes notes (a) and (e). Note (a) states, “Compliance Time and Repeat Interval applies to each new or overhauled carriage or aft link from the time it enters service, regardless of whether the part is removed and installed on another airplane.” Note (e) states, “The initial overhaul must be accomplished prior to terminating the repetitive overhauls at the compliance times specified in FAA AD 90-17-19.” These notes provide the information requested by the commenter. It is the intent of this new AD that if the initial or repetitive overhaul required by AD 90-17-19 is due prior to “48 months after the effective date of this AD,” the compliance time for the initial carriage overhaul will not be affected by the new requirements of this AD. However, if the initial or repetitive carriage overhaul required by AD 90-17-19 is due subsequent to “48 months after the effective date of this AD,” the required carriage overhauls are governed by the new compliance times of this AD. Specifically, the compliance time for carriages with sleeved journals is to accomplish the initial overhaul within 6000 flight cycles or 8 years, whichever occurs first, since new or since completion of the overhaul mandated by AD 90-17-19; and the compliance time for carriages with chrome-plated forward and aft journals is to accomplish the initial overhaul within 9000 flight cycles or 8 years, whichever occurs first, since new or since completion of the overhaul mandated by AD 90-17-19. We have not changed the AD in this regard.

Japan Airlines (JAL) requests that we refer to the latest aft links. JAL explains that the latest aft links do not require a repeat overhaul, and points out that the latest aft links are not shown in Boeing Service Bulletin 747-27-2371, dated December 20, 2000 (we referred to this service bulletin in paragraph (k) of the NPRM as the source of service information for the optional terminating action of replacing the existing 4340M aft link with a new corrosion resistant steel (CRES) aft link). JAL states that the latest aft links are shown in paragraph 3.B.5. of Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008.

We agree that the newest aft links do not require a repeat overhaul and that a note in paragraph 3.B.5. of Boeing Service Bulletin 747-27-2280, Revision 6, refers to these links. Therefore, we have revised paragraph (k) of this AD to state that replacing the existing 4340M aft link with a new CRES aft link in accordance with the Accomplishment Instructions of Boeing Service Bulletin 747-27-2371, dated December 20, 2000, or with an aft link specified in paragraph 3.B.5. of the Accomplishment Instructions of Boeing Service Bulletin 747-27-2280, Revision 6, dated February 14, 2008, terminates the repetitive inspection requirements of paragraph (f) of this AD and the repetitive overhaul requirements of paragraphs (g) and (j) of this AD for that aft link only.

All Nippon Airways (ANA) requests that we use the results of a Boeing analysis, using ANA flight data as a basis, to change intervals in the NPRM for Boeing Model 747-400D series airplanes, or provide the intervals as an alternative method of compliance (AMOC). ANA states that it operates five Boeing Model 747-400 series airplanes, for which the maximum takeoff weight (MTOW) is 899,600 pounds, and 11 Boeing Model 747-400D series airplanes for which the MTOW is 599,600 pounds. ANA believes that the loads on the spindles must be smaller for the Model 747-400D series airplanes because of the difference between the takeoff and landing weights. ANA requests that Boeing develop for Model 747-400D series airplanes different repetitive intervals for the flap carriage overhaul and the general visual inspection. ANA makes this request because the repetitive flap carriage overhaul must be done every two to three C-checks (3 to 4.5 years) and the general visual inspection must be done every 2 months, thus requiring a lot of manpower and costs. ANA provided no analysis to justify this requested increase.

We disagree with the request to change the AD to include revised intervals for Boeing Model 747-400D series airplanes. The intervals for inspection proposed in the NPRM were based on analysis provided by the manufacturer. In the absence of any analysis showing the differences in landing weights for these spindles, there is no evidence that increasing the intervals would provide an acceptable level of safety. However, as ANA noted, under the provisions of paragraph (m) of the AD, we will consider requests for approval of an AMOC if sufficient data are submitted to substantiate that the change to the intervals would provide an acceptable level of safety. We have not changed the AD in this regard.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

There are about 925 airplanes of the affected design in the worldwide fleet, which includes 160 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this AD. The average labor rate is $80 per work hour.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

Discussion

On August 1, 2008, we issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Allied Ag Cat Models G-164, G-164A, and G-164B airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on August 7, 2008 (73 FR 45900). The NPRM proposed to supersede AD 78-08-09 with a new AD that would retain the actions required in AD 78-08-09 and expand the applicability to include all G-164 series airplanes.

We provided the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal and FAA's response to each comment:

Ronald I. Gustin, Craig T. Fountain, and Ken J. Kuther all state that they support the AD action as proposed in the NPRM.

Ronald Gustin states that of the 13 Ag Cat airplanes inspected by mechanics at Gustin Aviation, which was prompted by the NPRM, 4 airplanes had severe corrosion of the rudder main spar tube that required repair; 2 airplanes had light rust; and 7 airplanes were corrosion free. Craig T. Fountain and Ken J. Kuther, who collectively own four of the airplanes inspected by Gustin Aviation, confirm the reported corrosion found and also support the proposed AD action.

The commenters support the NPRM.

We are not changing the final rule AD action based on these comments.

Bryan D. Hauschild states that he is planning to recover the rudder on his airplane during the off-season, which is November through March. He states that at that time he would be able to get a good look at the area in question.

Mr. Hauschild requests to extend the comment period for the NPRM so that his airplane is not pulled from its seasonal service at this time.

We do not agree with the commenter. We believe that the fleet service history and severity of corrosion reported on Ag Cat rudders requires AD action. Extending the comment period in order to delay the effective date of this AD would create an unacceptable safety risk.

We are not changing the final rule AD action based on this comment.

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial corrections. We have determined that these minor corrections:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We estimate that this AD affects 2,700 airplanes in the U.S. registry.

We estimate the following costs to do the inspections:

We have no way of determining the cost of repairs, parts replacement, or the number of airplanes that may require repair or parts replacement based on the result of the proposed inspections.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this AD.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

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.

We prepared a summary of the costs to comply with this AD (and other information as included in the Regulatory Evaluation) and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES . Include “Docket No. FAA-2008-0854; Directorate Identifier 2008-CE-050-AD” in your request.

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on July 7, 2008 (73 FR 38346). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the single comment received.

Dassault recommends that the AD reflect the updated service information that was issued after the date of the MCAI. Dassault states that the most recent revisions of the service information are as follows:

• Dassault Mandatory Service Bulletin F900-360, Revision 1, dated February 15, 2008.

• Dassault Mandatory Service Bulletin F900EX-261, Revision 1, dated February 15, 2008.

• Dassault Mandatory Service Bulletin F2000-316, Revision 1, dated February 15, 2008.

We agree to change the AD to reflect the current service information. Revision 1 of the service information contains an editorial change that does not affect the procedures. Table 1 of paragraph (f) of the AD has been changed accordingly, and we have added new paragraph (g) and Table 2 to the AD to give credit for actions performed according to the original versions of the service information.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the change described previously. We determined that this change will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 335 products of U.S. registry. We also estimate that it will take 4 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $107,200, or $320 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify this AD:

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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on April 29, 2008 (73 FR 23134). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

The unsafe condition is that smoke in the flight deck may interfere with the flightcrew's ability to operate the airplane. Corrective actions include inspecting for damage of the Pitot 1 and 2 and TAT 1 and 2 current sensor relays and sockets; and, as applicable, replacing the A1 and C1 electrical contacts of the sockets and reidentifying the sockets, replacing the sockets, and replacing current sensor relays. Damage may include melted points or stuck material of the silicone gasket, incorrect shape of the current sensor relay/sockets, discoloration of contacts, loose pin-type contacts, cracking or loose material of the polish and sealant of the bases, contaminants of the current sensor relays/sockets, and stuck material or roughness of the surface of the current sensor relay/pin-type contact. You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We considered the comment[s]received.

ExpressJet Airlines requests that we clarify the requirements for the inspection proposed by the NPRM. Embraer Service Bulletin 145-30-0052, dated August 2, 2007 (specified in the NPRM), calls for doing a general visual inspection, reporting damage that was found, and reporting service bulletin compliance. ExpressJet states that the NPRM calls for a detailed inspection and does not omit the reporting requirements. ExpressJet notes that it is not clear if inspections accomplished before the effective date of the AD according to the service bulletin would be acceptable for compliance or if an additional inspection would need to be accomplished. ExpressJet also notes it is not clear if reporting is required.

We agree that clarification is needed. Agência Nacional de Aviação Civil (ANAC), which issued the Brazilian Airworthiness Directive referenced in the NPRM, determined that a detailed inspection is necessary, instead of the general visual inspection specified in the referenced service bulletin, to adequately detect possible damage. We concurred with that determination. Wherever the requirements of an AD and the referenced service information differ, the AD takes precedence. Therefore, an inspection for possible damage that is accomplished before the effective date of this AD must be a detailed inspection to be acceptable for compliance with the requirements of this AD.

After we published the NPRM, we received Revision 01 to Embraer Service Bulletin 145-30-0052, dated January 23, 2008; and Revision 01 to Embraer Service Bulletin 145LEG-30-0019, dated January 25, 2008 (the original issue was referred to in the NPRM). Revision 01 of each service bulletin specifies a detailed inspection. We have revised paragraph (f) of this AD to reference Revision 01 of each service bulletin and provide credit for accomplishing the original issue of the service bulletin, as long as a detailed inspection technique is used.

Additionally, although the service bulletin specifies reporting damage and service bulletin compliance, this AD does not require reporting. Our intent is to match the actions specified in the Brazilian Airworthiness Directive, which does not require the reporting. However, an operator may elect to submit such information, although not required to do so by this AD. We have not changed the AD in this regard.

Air Line Pilots Association, International (ALPA), supports the intent of the AD, but considers the proposed 2,500-flight-hours or 24-months (whichever is first) compliance time to be excessive. ALPA recommends a shorter compliance time.

We disagree with the commenter's request. While the service bulletins recommend a compliance time of 6,000 flight hours or 48 months, ANAC specified a compliance time of 2,500 flight hours or 24 months based on its engineering analysis. We concur with ANAC's engineering analysis and have determined that the compliance time, as proposed, represents an appropriate interval of time in which the required actions can be performed and provides an acceptable level of safety. We have not changed the AD in this regard.

We have revised the model designations in the applicability of this AD to match the designations as published in the most recent type certificate data sheet for the affected models.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 704 products of U.S. registry. We also estimate that it will take about 8 work- hours per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $450,560, or $640 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify this AD:

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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Discussion

The FAA issued a supplemental notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 2006-12-02, amendment 39-14626 (71 FR 34814, June 16, 2006). The existing AD applies to all Airbus Model A318, A319, A320, and A321 airplanes. That supplemental NPRM was published in the Federal Register on March 13, 2008 (73 FR 13507). That supplemental NPRM proposed to supersede an existing AD that currently requires inspecting to determine the part number and serial number of the fuel tank boost pumps and, for airplanes with affected pumps, revising the airplane flight manual (AFM) and the FAA-approved maintenance program. The existing AD also provides for optional terminating action for compliance with the revisions to the AFM and the maintenance program. That supplemental NPRM proposed to require modifying or replacing the fuel tank boost pumps, which would terminate the AFM limitations and the maintenance program revisions. That supplemental NPRM proposed to exclude certain modified airplanes from the applicability, require the AFM/maintenance program revisions on additional airplanes, and require modification or replacement of additional fuel tank boost pumps.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received on the supplemental NPRM.

Airbus states a concern that we have introduced Airbus Modification 36734/Mandatory Service Bulletin A320-28-1153, dated May 5, 2006, as terminating action to the AD. Airbus recognizes that this modification and associated service bulletin were terminating action for AD 2006-12-02, however Airbus points out that any modified pump installed according to either Airbus Modification 36734 or Airbus Mandatory Service Bulletin A320-28-1153 is two-way interchangeable with an affected pump having a part number ending in -005, -002, or -001. Airbus points out that Airbus Modification 37508 and Airbus Mandatory Service Bulletin A320-28-1159, dated January 8, 2007, are the only means to ensure that no affected pumps are on the airplanes. Further, Airbus states that operators that do not use Airbus Mandatory Service Bulletin A320-28-1159 will not be allowed to update their AFMs.

From these statements, we infer that Airbus is requesting that we remove paragraph (k) of the supplemental NPRM, which provides credit for actions done using Airbus Mandatory Service Bulletin A320-28-1153, and that we remove reference to Airbus Modification 36734 from the applicability statement of the supplemental NPRM. We do not agree. This AD requires accomplishment of Airbus Mandatory Service Bulletin A320-28-1159, which, as Airbus points out, allows operators to remove the TR from the AFM. We have determined that any affected fuel pump modified in accordance with the actions specified in Airbus Mandatory Service Bulletin A320-28-1153 (Modification 36734) will be the same as any affected fuel pump modified in accordance with Airbus Mandatory Service Bulletin A320-28-1159. Therefore, paragraph (k) of this AD merely provides credit to operators that have previously modified an affected fuel pump before the effective date of this AD using Airbus Mandatory Service Bulletin A320-28-1153 for that pump only. While we understand Airbus' concern that the modified pumps may be interchanged with unmodified pumps, we note that paragraph (j) of this AD allows removal of the AFM TR only if all pumps have been replaced or modified. Therefore, we have made no change to this AD in this regard.

Airbus notes that Airbus TR 4.03.00/28, Issue 02, dated May 18, 2007, to the Airbus A318/319/320/321 AFM has replaced Airbus TR 4.03.00/28, dated May 4, 2006. From this statement, we infer that Airbus requests that we revise this AD to refer to Airbus TR 4.03.00/28, Issue 02. Because Airbus TR 4.03.00/28, Issue 02, is already referred to in paragraph (g)(2) of this AD, we do not agree that any change to the AD is necessary in this regard.

Air Transport Association (ATA), on behalf of one of its members, Northwest Airlines (NWA), states that the proposed actions should not apply to fuel boost pumps below serial number (S/N) 6137 and that no operating restrictions should be placed on airplanes with those pumps. NWA states that there have been no definitive findings of missing or loose fasteners on pumps below S/N 6137. NWA further asserts that the fuel boost pump vendor, Eaton, has indicated the cause of the unsecured nuts was errors made by a robotic tool used during assembly, which was not used prior to S/N 6137 and not used on any older pump part numbers.

From these statements, we infer that the commenters request that we remove fuel boost pumps having S/N below S/N 6137 from the requirements of this AD. We do not agree. While it is true that there have not been any confirmed loose or missing fasteners found on the -001, -002, or -005 Eaton fuel boost pump with a serial number below S/N 6137, these pumps are vulnerable to the same unsafe condition. We, along with Airbus and the European Aviation Safety Agency (EASA), have determined that all of the subject fuel boost pumps might have had inadequate torque applied to the screws during assembly, whether hand-driven (below S/N 6137) or robotic-driven (above S/N 6137). Therefore, the operational restriction must be applied to all airplanes with the affected Eaton fuel boost pumps installed until the fuel boost pumps are modified in accordance with the AD. We have made no change to the AD in this regard.

We have carefully reviewed the available data, including the comments received on the supplemental NPRM, and determined that air safety and the public interest require adopting the AD as proposed in the supplemental NPRM.

The following table provides the estimated costs for U.S. operators to comply with this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

On June 12, 2008, we issued AD 2008-13-12, amendment 39-15575 (73 FR 38905, July 8, 2008), for certain Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. That AD requires various repetitive inspections for cracking of the upper frame to side frame splice of the fuselage, and other specified and corrective actions if necessary. That AD also provides for an optional preventive modification, which terminates the repetitive inspections. That AD resulted from a report that the upper frame of the fuselage was severed between stringers S-13L and S-14L at station 747, and the adjacent frame at station 767 had a 1.3-inch-long crack at the same stringer location. We issued that AD to detect and correct fatigue cracking of the upper frame to side frame splice of the fuselage, which could result in reduced structural integrity of the frame and adjacent lap joint. This reduced structural integrity can increase loading in the fuselage skin, which will accelerate skin crack growth and result in decompression of the airplane.

Since we issued AD 2008-13-12, we have determined that we inadvertently omitted paragraph (j)(3) from that AD. Paragraph (j)(3) provided operators with a third option for doing an optional terminating action, which terminates the repetitive inspections required by paragraph (f) of the existing AD.

The unsafe condition described previously is likely to exist or develop on other airplanes of the same type design. For this reason, we are issuing this AD to revise AD 2008-13-12. This new AD retains the requirements of the existing AD. This AD also adds an optional terminating action inadvertently omitted from the existing AD.

There are about 1,509 airplanes of the affected design in the worldwide fleet. This AD continues to affect about 524 airplanes of U.S. registry. The inspections currently required by AD 2008-13-12 and retained in this AD take between 18 and 38 work hours per airplane, depending on airplane configuration. The average labor rate is $80 per work hour. Based on these figures, the estimated cost of the currently required inspections required by this AD for U.S. operators is between $754,560 and $1,592,960, or $1,440 and $3,040 per airplane, per inspection cycle.

The omitted paragraph was previously published in the NPRM for the existing AD and affected operators had the opportunity to comment on that action at that time. Therefore, we have determined that notice and opportunity for public comment before issuing this AD are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-15719; Directorate Identifier 2008-NM-128-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that the regulation:

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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

The Consumer Product Safety Improvement Act of 2008 (“CPSIA”) was enacted on August 14, 2008. Public Law 110-314, 122 Stat. 3016 (August 14, 2008). The CPSIA amends statutes which the U.S. Consumer Product Safety Commission (“Commission” or “CPSC”) administers, adding requirements with broad applicability and some product-specific provisions as well. Section 232 of the CPSIA adds a new section 42 to the Consumer Product Safety Act (“CPSA”) that sets forth numerous requirements for all terrain vehicles (“ATVs”). 15 U.S.C. 42, as added by CPSIA § 232.

The Commission has been involved with ATVs since the 1980s. In 1987, the Commission filed a lawsuit to declare ATVs an imminently hazardous consumer product under section 12 of the CPSA against the five companies that were the major distributors of ATVs in the U.S. at that time. The section 12 lawsuit was settled by Consent Decrees that were filed on April 28, 1988 and remained in effect for ten years. The Consent Decrees contained provisions concerning restrictions on the distribution of three-wheel ATVs; development of a voluntary performance standard; requirements for ATV warning labels, owner's manuals, point of purchase safety materials, free rider training, and media and advertising materials. The parties also agreed to promote and sell adult-size ATVs (defined in the Consent Decrees as ATVs with engines greater than 90 cc) only for the use of riders 16 years of age and older.

In accordance with the Consent Decrees, the main distributors, working through the Specialty Vehicle Institute of America (“SVIA”), continued work on a voluntary standard for ATVs. The standard, known as ANSI/SVIA, The American National Standard for Four Wheel All-Terrain Vehicles Equipment Configuration, and Performance Requirements, was first published in 1990, was revised in 2001 and again in 2007.

While the Consent Decrees were in effect, the companies entered into monitoring agreements with the CPSC agreeing to monitor their dealers' compliance with the Consent Decrees' requirements, particularly the age restrictions.

After the Consent Decrees expired, the distributors who had been parties to the Consent Decrees (and three companies that had entered the market later) developed action plans, also known as letters of undertaking, in which the companies agreed to undertake voluntary actions to continue many of the actions that were required under the Consent Decrees and to continue monitoring their dealers. See 63 FR 48199 (1998).

Section 232 of the CPSIA (now section 42 of the CPSA) states that within 90 days of enactment of the CPSIA “the Commission shall publish in the Federal Register as a mandatory consumer product safety standard the American National Standard for Four Wheel All-Terrain Vehicles Equipment Configuration, and Performance Requirements developed by the Specialty Vehicle Institute of America (American National Standard ANSI/SVIA 1-2007).” 15 U.S.C. 42(a)(1) as added by CPSIA § 232.

The ANSI/SVIA standard specifies requirements concerning the vehicle's equipment and configuration (including requirements for owner's/operator's manuals, labels and hang tags), maximum speed capability, speed capability of youth ATVs, service and parking brakes, pitch stability, electromagnetic compatibility, and sound level limits. It also requires that ATVs have a certification label indicating that they comply with the ANSI/SVIA standard.

The CPSIA requires the Commission to publish the ANSI/SVIA standard in the Federal Register . The Commission is fulfilling this direction by incorporating the ANSI/SVIA standard by reference. Congress mandated that the ANSI/SVIA standard will go into effect as a consumer product safety standard 150 days after it is published in the Federal Register . The Freedom of Information Act states that a standard that is incorporated by reference in the Federal Register and made reasonably available is deemed to be published in the Federal Register . 5 U.S.C. 552(a)(1)(E). Because Congress mandated the standard without any changes, we believe that it is appropriate to incorporate the standard by reference.

The standard takes effect as a consumer product safety standard 150 days after this publication in the Federal Register . See 15 U.S.C. 2058(g)(1). This means that ATVs manufactured on or after the effective date must comply with the standard. They also must meet additional requirements related to action plans. See 15 U.S.C. 42(a)(2) and (e)(2), as added by CPSIA § 232. The statute provides: “After the standard takes effect, it shall be unlawful for any manufacturer or distributor to import into or distribute in commerce in the United States any new assembled or unassembled all-terrain vehicle unless” the ATV complies with the newly-mandated standard, the ATV is subject to an ATV action plan filed with and (unless the action plan was filed with the Commission before August 14, 2008) approved by the Commission, and the manufacturer or distributor is in compliance with the action plan. (CPSA § 42(a)(2) as added by CPSIA § 232). Failure to comply with these requirements is deemed to be a failure to comply with a consumer product safety standard and subjects the violator to the penalties and remedies applicable under the CPSA. Id. § 42(a)(3).

The statute requires ATV manufacturers and distributors to file with the Commission an ATV action plan. Unless the ATV action plan was filed with the Commission before August 14, 2008 the action plan must be approved by the Commission. The manufacturer or distributor must be in compliance with the action plan. CPSA § 42(a)(2), as added by CPSIA § 232.

The statute defines “ATV action plan” as a plan or letter of undertaking describing safety-related actions the manufacturer or distributor agrees to take concerning ATVs. The plan must be “substantially similar” to the action plans distributors entered into in 1998. CPSA § 42(e)(2), as added by CPSIA § 232.

The CPSIA also addresses 3-wheel ATVs. It provides that until the Commission issues a consumer product safety standard applicable to 3-wheel ATVs (and the standard goes into effect) “new 3-wheeled all terrain vehicles may not be imported into or distributed in commerce in the United States.” CPSA § 42(c), as added by CPSIA § 232. Violation of this restriction is a prohibited act under section 19(a)(1) of the CPSA.

The CPSIA provides procedures for modifying the standard in the future either if SVIA revises the underlying voluntary standard or if the Commission determines on its own to amend the standard.

The CPSIA also requires the Commission to issue a final rule in its open rulemaking concerning ATVs. (The Commission issued a notice of proposed rulemaking related to ATVs on August 10, 2006. See 73 FR 54564.) The CPSIA directs the Commission to consult with the National Highway Traffic Safety Administration (“NHTSA”) and consider whether to establish a multiple factor method of categorizing youth ATVs. Also in consultation with NHTSA, the Commission must review the mandated ANSI/SVIA standard and “establish additional safety standards for all-terrain vehicles to the extent necessary to protect the public health and safety.” The statute specifies certain provisions that the Commission is to consider adding or strengthening. CPSA § 42(d), as added by CPSIA § 232(a).

The CPSIA also requires the U.S. Government Accountability Office (“GAO”) to conduct a study of ATVs' utility, recreational and other benefits and the costs associated with ATV-related accidents and injuries. CPSIA § 232(b).

In FR Document E8-25139, published October 27, 2008 (73 FR 63770) make the following corrections to citations in Footnotes 51 and 60:

1. On page 63781, column 1, Footnote 51, second sentence, change “125 FERC ¶ 61,062.” to “125 FERC ¶ 61,064.”

2. On page 6378, column 2, footnote 60, second sentence, change “125 FERC ¶ 61,062” to “125 FERC ¶ 61,064.”

The final and temporary regulations that are the subjects of this document are under section 901 of the Internal Revenue Code.

As published, final and temporary regulations (TD 9416) contain errors that may prove to be misleading and are in need of clarification.

The final regulations that are the subjects of this document are under section 1367 of the Internal Revenue Code.

As published, final regulations (TD 9428) contain errors that may prove to be misleading and are in need of clarification.

The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets.

Three sets of interest assumptions are prescribed: (1) A set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to Part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to Part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in Appendix C to Part 4022).

This amendment (1) adds to Appendix B to Part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during December 2008, (2) adds to Appendix B to Part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during December 2008, and (3) adds to Appendix C to Part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during December 2008.

For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in Appendix B to part 4044) will be 7.92 percent for the first 20 years following the valuation date and 6.99 percent thereafter. These interest assumptions represent an increase (from those in effect for November 2008) of 0.83 percent for the first 20 years following the valuation date and 0.83 percent for all years thereafter.

The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 4.75 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. These interest assumptions represent an increase (from those in effect for November 2008) of 1.00 percent in the immediate annuity rate and are otherwise unchanged. For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022).

The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during December 2008, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

Background

On April 28, 2008, the NPS published in the Federal Register proposed regulations to revise Denali National Park and Preserve regulations in Subpart L of 36 CFR part 13. This rule implements certain decisions made in the 2006 Final Environmental Impact Statement (EIS) and Record of Decision (ROD) regarding the Denali Backcountry Management Plan (BMP) and the 2007 Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) for subsistence use of off-road vehicles in the Cantwell Traditional Use Area (TUA). The final regulations (1) establish group size limits in the backcountry, restrict the number of climbers on Mount McKinley from April 1 through August 1 to a maximum of 1500, and require camping permits (currently required through the compendium) in accordance with the 2006 BMP/EIS; and (2) restrict off-road vehicle use for subsistence purposes to designated routes and trails in Windy Creek, Cantwell Creek, and Bull River drainages in the Cantwell Traditional Use Area in accordance with the 2007 EA/FONSI. Comments received and the corresponding NPS responses are summarized below. Modifications to the proposed rule are listed under Changes to the Final Rule. As used within this document, the terms “we,” “our,” and “us” refer to the National Park Service.

The proposed rule was published for public comment on April 28, 2008 (73 FR 22890), with a 60 day comment period lasting until June 27, 2008. The National Park Service received three timely comments. Of the three comments, one was from the State of Alaska, one was from non-governmental organizations (consolidated response from two signatory groups), and one was submitted by an individual. Many proposed changes either received supporting comments or no comments. The proposed regulations are being adopted as proposed unless noted otherwise below. The proposed sections that did receive substantive comments are discussed below.

1. The NPS received three comments regarding subsistence use of off-road vehicles. The State of Alaska asked for clarification on whether any qualified subsistence users who are currently using ORVs in the Cantwell TUA would be unable to continue to do so based on the requirement that subsistence users either be residents of the Cantwell resident zone community or residents of Alaska Game Management Unit (GMU) 13E holding a permit to use ORVs issued under 36 CFR 13.440. The State also suggested providing the Superintendent discretion to authorize subsistence users to use ORVs if they move outside the boundaries of this area.

The NPS appreciates the opportunity to explain the eligibility criteria for using ORVs in the Cantwell TUA. Section 811(b) of the Alaska National Interest Lands Act authorizes the use of ORVs for subsistence purposes if such ORV use was “traditionally employed.” In 2005, the NPS reviewed information regarding historical ORV use in the Cantwell area of Denali National Park. Several individuals who reside in and around Cantwell provided information regarding ORV use that occurred before this portion of the park was established in 1980. Based on this information, the NPS determined that Cantwell area residents used ORVs for successive generations in that portion of Denali National Park prior to the park's establishment in 1980. Because only residents of the Cantwell area have demonstrated traditional ORV use, this regulation restricts ORV use in the 1980 Park additions to those residents. The 2007 FONSI specifically stated that ORV use would be limited to residents of the Cantwell resident zone community and those residents of GMU 13E holding a 13.440 permit. For this reason, the NPS declines to accept the suggestion to allow individuals who move outside the Cantwell area to continue to use of ORVs for subsistence purposes.

The State requested additional information regarding the basis for the 1,000 pound weight limit and if this proposed limit will cause hardship to any existing qualified subsistence uses that may already possess vehicles exceeding the weight limit. The State noted the weight limit for ORVs on adjacent state land is 1,500 pounds curb weight and that consistent weight limits on adjacent park land would benefit ORV operators. Consistent with a recommendation by the Denali Subsistence Resource Commission, the NPS selected the 1,000 pound curb (unloaded) vehicle weight requirement during the EA process in an effort to minimize damage to park resources while still allowing ORV access to subsistence resources. The NPS also notes ORVs are limited to 1,000 pounds in several State of Alaska Game Refuges, including Palmer Hay Flats, Yakataga, Susitna Flats, and Goose Bay State Game Refuges. The NPS does not believe that this weight limit will curtail subsistence activities and has not received any comments through either the compliance or rulemaking process from existing qualified subsistence users indicating that a 1,000 pound limit would cause hardship.

Finally, the State requested clarification that this regulation does not apply to the use of snowmachines. The NPS appreciates the opportunity to clarify that this regulation does not close or restrict the use of snowmachines for subsistence purposes. The term “motor vehicle” is defined in 36 CFR 1.4 and excludes snowmobiles (which are defined to be the same as snowmachines). Accordingly, this regulation does not affect the use of snowmachines in the park.

The National Parks Conservation Association (NPCA) and Denali Citizens Council (DCC) requested that the procedure for closing and opening areas to ORV use follow a procedure similar to that outlined in 36 CFR 13.960 for snowmachine use.

The NPS agrees with NPCA and DCC that notifying the public of closures to ORV use and lifting those closures should be done via press release and other appropriate means. The NPS modified this provision to include the means of notice that we believe will be most effective for communicating closure information to qualified subsistence users in the Cantwell area. These means include issuing a press release, posting at local post offices, posting on the park website, posting signs at designated trails or areas if appropriate, use of electronic media, and via other appropriate means. We believe this modification also enables the NPS to respond more quickly to changing conditions.

A third commenter opposed permitting ORV use for subsistence uses. This comment misunderstands the effect of this regulation. Subsistence is a recognized and authorized use of the ANILCA additions of Denali National Park (Denali park additions). Section 811(b) of ANILCA provides that “the Secretary shall permit * * * appropriate use [of]* * * surface transportation traditionally employed” for subsistence uses by federally qualified local rural residents, subject to reasonable regulation.

In 2005 the NPS determined that ORVs were used by successive generations of Cantwell residents for subsistence in the Cantwell area (TUA) of the Denali National Park additions and therefore are authorized for subsistence purposes in this area under ANILCA section 811 and 36 CFR 13.460. This regulation merely implements the 2007 FONSI on subsistence ORV use in the TUA.

The State of Alaska requested clarification that the camping permit provision only applies in designated areas and not throughout the former Mount McKinley National Park. The NPS appreciates the opportunity to clarify that a camping permit is only required in designated areas of the backcountry. Camping is also allowed in the Frontcountry Developed Area in accordance with 36 CFR 13.972-13.974.

Based on the preceding comments and responses as well as internal NPS comments, the NPS has made the following changes to the proposed rule language:

• 13.903(d), Subsistence use of off-road vehicles . The NPS modified the provision specifying means of public notice for closures to subsistence ORV use. This change will provide more effective notice of closures to interested parties.

• 13.910(a), Mountain climbing . The NPS replaced the provision requiring all individuals to apply for a permit 60 days in advance of any climb on Mount McKinley or Mount Foraker with a provision that the superintendent will establish application procedures. These procedures will be published in the Superintendent's compendium. This modification will enable the superintendent to relax the 60 day advance application requirement for climbers who have previously climbed Mount McKinley or Mount Foraker under certain circumstances.

This document is not a significant rule and is not subject to review by the Office of Management and Budget under Executive Order 12866.

(1) This rule will not have an effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. A qualitative cost/benefit analysis was conducted to examine costs and benefits associated with the proposed rule. That analysis concludes that positive net benefits will be generated by each component of the proposed regulatory action, and hence by the regulatory action overall. The analysis also indicates that governmental processes in NPS-administered areas in Alaska will be improved. Therefore, it is anticipated that economic efficiency will be improved by this proposed regulatory action.

(2) This rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. This is an agency-specific rule that will not interfere with other agencies or local government plans, policies, or controls. The proposals included with this rulemaking apply to areas managed by the National Park Service and do not conflict with other federal regulations. The review process used to develop the rulemaking proposals included consultation with the State of Alaska to seek views of appropriate officials and to provide consistency with state rules on adjacent lands as well as active participation where NPS is proposing variation from similar state regulations.

(3) This rule does not alter the budgetary effects of entitlements, grants, user fees, or loan programs, or the rights and obligations of their recipients. No grants or other forms of monetary supplements are involved.

(4) This rule does not raise novel legal or policy issues.

The Department of the Interior certifies that this rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The economic effects of this rule are local in nature and positive or negligible in scope. This rule either implements rules unrelated to business activity or makes permanent various temporary and emergency rules under which area businesses have been operating. This rule will have no effect or in some cases a salutary effect by eliminating year to year uncertainty for park visitors.

A qualitative Regulatory Flexibility threshold analysis was conducted to examine potential impacts to small entities. The analysis concludes that, since no significant costs are anticipated for any component of the rule, significant economic impacts would not be imposed on a substantial number of small entities.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million or more. Expenses related to compliance with various provisions of this proposed rule are slight. No new user fees or charges are proposed. Any incidental costs from this rule would be small and generally would not be additional to those already associated with visiting park areas.

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. The provisions of this rule will generally continue existing rules and use patterns for the park areas in Alaska.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. The various provisions of this rule do not apply differently to U.S.-based enterprises and foreign-based enterprises.

This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. This rule is an agency-specific rule and imposes no other requirements on small governments.

In accordance with Executive Order 12630, the rule does not have significant takings implications. A takings implications assessment is not required because no taking of property will occur as a result of this final rule.

In accordance with Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. The rule is limited in effect to federal lands and waters administered by the NPS and does not have a substantial direct effect on state and local government in Alaska. The rule was initiated in part at the request of the State of Alaska and was developed in close consultation with the State of Alaska and, as such, promotes the principles of federalism.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.

This regulation does not require any information collection from 10 or more parties and a submission under the Paperwork Reduction Act is not required. An OMB form 83-I is not required.

We have analyzed this rule in accordance with the criteria of the National Environmental Policy Act and 516 DM. This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A Record of Decision (ROD) for the Denali National Park and Preserve Final Backcountry Management Plan Environmental Impact Statement was approved on February 21, 2006. On September 18, 2007, a Finding of No Significant Impact (FONSI) was approved for the Cantwell Subsistence ORV Management Environmental Assessment. These documents together represent the environmental analysis for this proposed rule, and are available for review at: http://www.nps.gov/dena/parkmgmt/managementdocs.htm, or http://www.regulations.gov.

In accordance with Executive Order 13175 “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249); the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951); the Department of the Interior-Alaska Policy on Government-to-Government Relations with Alaska Native Tribes dated January 18, 2001; part 512 of the Departmental Manual, Chapter 2 “Departmental Responsibilities for Indian Trust Resources”; and various park consultation agreements with tribal governments, the potential effects on Federally-recognized Indian tribes have been evaluated, and it has been determined at this time that there are no potential effects that have not been addressed in prior decision documents.

While the consultation agreements noted above have not resulted in findings of potential effects, review of this rule has been facilitated by the relationships established through government-to-government consultation.

Drafting Information: The principal contributors to this rule are: Vic Knox, Chuck Passek, Jane Hendrick, Andee Sears and Paul Hunter, Alaska Regional Office; and Jerry Case, Regulations Program Manager, NPS, Washington, DC.

Regulatory History, 73 FR 64370 (October 29, 2008).

The Postal Service seeks to add a new product identified as Parcel Return Service Contract 1 to the Competitive Product List. For the reasons discussed below, the Commission approves the request.

On October 15, 2008, the Postal Service filed a formal request pursuant to 39 U.S.C. 3642 and 39 CFR 3020.30 et seq. to add Parcel Return Service Contract 1 to the Competitive Product List. The Postal Service asserts that the Parcel Return Service Contract 1 product is a competitive product “not of general applicability” within the meaning of 39 U.S.C. 3632(b)(3). This request has been assigned Docket No. MC2009-1. 1

The Postal Service contemporaneously filed a contract related to the proposed new product pursuant to 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. The contract has been assigned Docket No. CP2009-2. The Postal Service represents that the contract fits within the proposed Mail Classification Schedule (MCS) language.

In support of its Request, the Postal Service filed the following materials: (1) A redacted version of the Governors' Decision authorizing the new product which also includes an analysis of the Parcel Return Service Contract 1;  2 (2) a redacted version of the contract, which among other things, provides that the contract will expire 2 years from the effective date which is proposed to be 1 day after the Commission issues all regulatory approvals;  3 (3) requested changes in the MCS product list;  4 (4) a Statement of Supporting Justification as required by 39 CFR 3020.32;  5 and (5) certification of compliance with 39 U.S.C. 3633(a). 6

In the Statement of Supporting Justification, Daniel J. Barrett, Acting Manager, Product & Business Development, Ground Shipping Services, asserts that the service to be provided under the contract will cover its attributable costs, make a positive contribution to coverage of institutional costs, and will increase contribution toward the requisite 5.5 percent of the Postal Service's total institutional costs. Request, Attachment D, at 1. W. Ashley Lyons, Manager, Corporate Financial Planning, Finance Department, certifies, based on the financial analysis provided by the Postal Service, that the contract complies with 39 U.S.C. 3633(a). See id., Attachment E.

The Postal Service filed much of the supporting materials, including the Governors' Decision and the specific Parcel Return Service Contract 1, under seal. In its Request, the Postal Service maintains that the contract and related financial information, including the customer's name and the accompanying analyses that provide prices, terms, conditions, and financial projections should remain under seal. Id. at 2.

In Order No. 119, the Commission gave notice of the two dockets, appointed a public representative, and provided the public with an opportunity to comment. In addition, the Commission posed questions to the Postal Service seeking supplemental information.

Comments were filed by the Public Representative. 7 No filings were submitted by other interested parties. The Public Representative's comments focus principally on confidentiality and pricing under the contract. Public Representative Comments at 2-4.

The Public Representative states that a sufficient rationale for maintaining the confidentiality of the documents under seal has been provided by the Postal Service. Also, based upon a review of materials filed by the Postal Service in this proceeding, the Public Representative concludes that the contract reduces costs for both parties. Id. at 2-3.

The Public Representative notes that the contract is intended to promote new volumes for the Postal Service and provide incentives for the shipper. He concludes, inter alia, that the contract should generate sufficient revenue to cover the product's attributable costs, and contribute to the recovery of total institutional costs assigned to competitive products. Id. at 4.

The Commission's statutory responsibilities in this instance entail assigning Parcel Service Return Contract 1 to either the Market Dominant Product List or the Competitive Product List. 39 U.S.C. 3642. As part of this responsibility, the Commission also reviews the proposals for compliance with the Postal Accountability and Enhancement Act (PAEA) requirements. This includes, for proposed competitive products, a review of the provisions applicable to rates for competitive products. 39 U.S.C. 3633.

Product list assignment. 39 U.S.C. 3642 governs the assignment of new products to the Market Dominant or Competitive Product List. In this case, Parcel Return Service Contract 1 is being proposed by the Postal Service to be added to the Competitive Product List.

The statutory standard that the Commission must consider is whether

The Commission is further required to consider the availability and nature of enterprises in the private sector engaged in the delivery of the product, the views of those that use the product, and the likely impact on small business concerns. 39 U.S.C. 3642(b)(3).

The Postal Service asserts that its bargaining position is constrained by the existence of other shippers who can provide similar services. Thus, the market precludes the Postal Service from taking unilateral action to increase prices without the risk of losing volume to private companies. Request, Attachment D, at 2-3. The Postal Service also contends that the Postal Service may not decrease quality or output without risking the loss of business to competitors that offer similar expedited delivery services. Id. at 2. It further states that the contract partner supports the addition of the contract to the product list to effectuate the negotiated contractual terms. Id. at 3. Finally, the Postal Service states that due to the fact that the market for ground shipping services requires a substantial infrastructure to support a national network, only large shippers serve the market under consideration. Accordingly, the Postal Service is unaware of any small business concerns that could offer comparable service for this customer. Id.

No commenter opposes the proposed classification of Parcel Return Service Contract 1 as competitive. Having considered the statutory requirements and the support offered by the Postal Service and the public comment, the Commission finds that Parcel Return Service Contract 1 is appropriately classified as a competitive product and should be added to the Competitive Product List.

Cost considerations. The Commission has reviewed the contract, the financial analysis provided under seal that accompanies the agreement including the responses to the questions posed in PRC Order No. 119, as well as the comments by the Public Representative. Based on an analysis of the information submitted, the cost accounting methods proposed in Docket No. RM2008-6 are to be used for updating costs for subsequent years of the contract. 8 The analysis of the Commission is included as part of the record of these proceedings in Library Reference PRC-CP2009-2-NP-LR-1.

Library Reference PRC-CP2009-2-NP-LR-1 is the analysis of the Postal Service data which updates the original data with the supplemental data filed by the Postal Service on October 27, 2008, and provides calculations for revenue per piece for each of the negotiated service agreement's rate categories. The analysis finds that the updated data do not cause financial results to vary significantly.

Based on the data submitted, the Commission finds that Parcel Return Service Contract 1 should cover its attributable costs (39 U.S.C. 3633(a)(2)); should not lead to the subsidization of competitive products by market dominant products (39 U.S.C. 3633(a)(1)), and should have a positive effect on competitive products' contribution to institutional costs (39 U.S.C. 3633(a)(3)). Thus, a preliminary review of the proposed Parcel Return Service Contract 1 indicates that it comports with the provisions applicable to rates for competitive products.

The Postal Service shall promptly notify the Commission when the contract terminates, but no later than the actual termination date. The Commission will then remove the contract from the Mail Classification Schedule at the earliest possible opportunity.

In conclusion, the Commission approves Parcel Return Service Contract 1 as a new product. The revision to the Competitive Product List is shown below the signature of this Order and is effective upon issuance of this Order.

It is ordered:

1. Parcel Return Service Contract 1 (MC2009-1 and CP2009-2) is added to the Competitive Product List as a new product under Negotiated Service Agreement, Domestic.

2. The Postal Service shall notify the Commission of the termination date of the contract as discussed in this Order.

3. The Secretary shall arrange for the publication of this Order in the Federal Register .

Citizens concerned with water quality in Pennsylvania may be interested in this rulemaking. Entities discharging pollutants to the surface waters of Pennsylvania could be indirectly affected by this rulemaking since water quality standards are used in determining National Pollutant Discharge Elimination System (NPDES) permit limits.

Categories and entities which may ultimately be affected include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding NPDES-regulated entities likely to be affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action.

As EPA explained in its September 15, 2008 notices (73 FR 53140 and 73 FR 53178), EPA proposed to remove the federal regulation that made provisions of the federal antidegradation policy directly applicable in Pennsylvania. EPA proposed to remove the federal rule because Pennsylvania now has an EPA-approved antidegradation policy meeting the federal requirements at 40 CFR 131.12. Therefore, the federal antidegradation regulation promulgated by EPA for Pennsylvania is no longer needed. On September 15, EPA also published a direct final rule to remove the federal regulation at 40 CFR 131.32.

EPA has determined that additional opportunity for public comment would be beneficial. Therefore, EPA is withdrawing the direct final rule (73 FR 53140).

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

•Crop production (NAICS code 111).

•Animal production (NAICS code 112).

•Food manufacturing (NAICS code 311).

•Pesticide manufacturing (NAICS code 32532).

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

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2008-0250 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before January 13, 2009.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2008-0250, by one of the following methods:

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of January 19, 2005 (70 FR 3026) (FRL-7690-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 4E6818) by Associated Octel Company, Limited, P.O. Box 17, Oil Sites Road, Ellesmere Port, South Wirral L65 4HF, United Kingdom. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of (S,S)-Ethylenediaminedisuccinic acid (CAS Reg. No. 20846-91-7) when used as an inert ingredient sequestrant or chelating agent in pesticide formulations. That notice provided a summary of studies summated by the petitioner, Associated Octel Company, Limited. There were no comments received in response to the notice of filing. For ease of reading in this document, (S,S)-Ethylenediaminedisuccinic acid is referred to as (S,S)-EDDS.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

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

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

The following provides a brief summary of the risk assessment and conclusions for the Agency’s review of (S,S)-EDDS. The Agency’s full decision document for this action is available in EPA’s Electronic Docket at http://www.regulations.gov under docket number EPA-HQ-OPP-2007-0250.

Studies show that (S,S)-EDDS has low acute and subchronic toxicity, is a mild eye irritant, and is not a dermal irritant or skin sensitizer. Based on the results of submitted mutagenicity studies, (S,S)-EDDS is not likely to be mutagenic. No carcinogenicity studies are available on (S,S)-EDDS, however, NTP tested trisodium EDTA in mice and rats showed no carcinogenic potential. Based on its similarity with EDTA and lack of mutagenicity, (S,S)-EDDS is not likely to be carcinogenic to humans at low doses. In addition, metabolism studies show that (S,S)-EDDS is poorly absorbed but rapidly excreted within 72 hours.

The (S,S)-EDDS studies indicate developmental toxicity only at high dosage levels that resulted in maternal toxicity (limit dose levels). In a developmental toxicity study in rats, the maternal toxicity LOAEL is 944.1 milligrams/kilograms, body weight/day (mg/kg bw/day) (16,000 ppm) (limit dose) based on reductions in body weight, body weight gain, feed consumption, and blood levels of zinc, iron, and copper, and the NOAEL is 551.1 mg/kg bw/day (8,000 ppm). The developmental toxicity LOAEL is 944.1 mg/kg bw/day (16,000 ppm) (limit dose) was manifested as an increase in fetal death, reduced fetal growth, and multiple developmental malformations and variations affecting almost all major organ systems and skeletal structures, and the NOAEL is 551.1 mg/kg bw/day (8,000 ppm). Therefore, the maternal and developmental NOAEL are both 551.1 mg/kg bw/day (8,000 ppm). The results of this dietary study indicate qualitative evidence of increased susceptibility, however, the concern for this increased susceptibility is low for the reasons discussed in Unit VII.

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

There are no data provided on (S,S)-EDDS residues in food or on non-occupational exposures to (S,S)-EDDS. In the absence of actual residue data for (S,S)-EDDS, the Agency performed a dietary (food and drinking water) exposure assessment for (S,S)-EDDS in which it was assumed that (a) (S,S)-EDDS would be used as an inert ingredient in all food use pesticide formulations, applied to all crops; (b) one hundred percent of all food crops would be treated with pesticides containing (S,S)-EDDS; (c) (S,S)-EDDS residues would be present in all crops at levels equal to or exceeding the highest established tolerance levels for any pesticide active ingredient, and (d) (S,S)-EDDS would be present in all sources of drinking water at concentrations equal to the highest established standards for drinking water contaminants established by EPA.

This approach is highly conservative as it is extremely unlikely that (S,S)-EDDS would have such use as a pesticide product inert ingredient and be present in food commodities and drinking water at such high levels. In addition, this highly conservative exposure assessment is protective of any possible non-occupational exposures to (S,S)-EDDS as it results in exposure estimates orders of magnitude greater than the high-end exposure estimates for residential uses of pesticides routinely used by EPA.

Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide’s residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to (S,S)-EDDS and any other substances, and the chemical does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that (S,S)-EDDS has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at http://www.epa.gov/pesticides/cumulative .

Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for pre-natal and post-natal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. EPA concluded that the FQPA safety factor could be removed for (S,S)-EDDS for the following reasons:

1. EPA has sufficient data to assess the toxicity of (S,S)-EDDS. Although the toxicological database on (S,S)-EDDS is limited, adequate long term studies are available on structurally related compounds such as calcium disodium EDTA, and trisodium EDTA. Based on the structural similarities in these compounds, EPA concluded the database for (S,S)-EDDS is adequate.

2. EPA has low concern regarding the potential developmental effects of (S,S)-EDDS. The (S,S)-EDDS studies indicate developmental toxicity only at high dosage levels that resulted in maternal toxicity (limit dose levels). In a developmental toxicity study in rats, the maternal toxicity LOAEL is 944.1 mg/kg bw/day (16,000 ppm) (limit dose) based on reductions in body weight, body weight gain, feed consumption, and blood levels of zinc, iron, and copper, and the NOAEL is 551.1 mg/kg bw/day (8,000 ppm). The developmental toxicity LOAEL is 944.1 mg/kg bw/day (16,000 ppm) (limit dose) was manifested as an increase in fetal death, reduced fetal growth, and multiple developmental malformations and variations affecting almost all major organ systems and skeletal structures, and the NOAEL is 551.1 mg/kg bw/day (8,000 ppm). Therefore, the maternal and developmental NOAEL are both 551.1 mg/kg bw/day (8,000 ppm). The results of this dietary study indicate qualitative evidence of increased susceptibility, however, the concern for this increased susceptibility is low because:

i. Effects were seen only at the limit dose and in the presence of maternal toxicity.

ii. There is a well characterized NOAEL (551.1 mg/kg/day) protecting from these effects.

iii. The presence of zinc, iron and copper may have contributed to the observed developmental toxicity, since other chelating agents (such as EDTA) have been shown to impact zinc, iron, and copper levels and some of the developmental toxicity.

iv. The results were not reproduced in a concurrently conducted gavage study in rats at doses up to 1,000 mg/kg/day.

3. In the absence of actual exposure data on (S,S)-EDDS, a highly conservative exposure estimate was utilized thereby reducing uncertainty associated with exposures by infants and children to (S,S)- EDDS.

EPA determines whether pesticide chemical exposures are safe by comparing aggregate exposure estimates to the dose at which no adverse effects were seen in the most sensitive animal studies. In the case of (S,S)-EDDS, the estimated exposures are compared to a dose level equal of 551.1 mg/kg/day derived from the rat developmental toxicity study. Utilizing the highly conservative aggregate exposure assessment discussed in Unit IV of this document, EPA has concluded that aggregate exposures to (S,S)-EDDS are more than three orders of magnitude less than the dose at which no adverse effects were seen in the most sensitive animal study, and therefore, are below the level of concern for the entire U.S. population, including infants and children.

Based on this risk assessment, EPA concludes that there is a reasonable certainty of no harm to the general population, including infants and children, from aggregate exposure to residues of (S,S)-EDDS. Accordingly, EPA finds that the tolerance exemption under 40 CFR 180.920 for residues of (S,S)-EDDS will be safe and is granting the requested tolerance exemption.

An analytical method is not required for enforcement purposes because the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

There are no known international tolerances for residues of (S,S)-EDDS in food or animal feed.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

In addition to accessing electronically available documents at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-1161 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before January 13, 2009.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-1161, by one of the following methods:

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of January 23, 2008 (73 FR 3964) (FRL-8345-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7E7273) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.557 be amended by establishing a tolerance for residues of the fungicide tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1 H -1,2,4-triazole, in or on grape at 0.15 parts per million (ppm). That notice referenced a summary of the petition prepared on behalf of IR-4 by Isagro, S.p.A, the registrant, which is available to the public in the docket, at http://www.regulations.gov . There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the tolerance level for grape from 0.15 ppm to 0.20 ppm. The reason for this change is explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of tetraconazole on grape at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Tetraconazole has low acute toxicity via the oral, dermal and inhalation routes. It is a slight eye irritant but not a dermal irritant or a dermal sensitizer. The liver and kidney are the primary target organs of tetraconazole. In the subchronic, chronic and reproduction rat studies, subchronic and carcinogenicity mouse studies, and the chronic dog study, increases in liver weight, increases in liver serum enzymes or gross and microscopic liver pathology were noted at various doses, providing evidence of liver toxicity. There is no evidence in the toxicity database that tetraconazole is an immuno- or neurotoxicant.

Tetraconazole is classified as “likely to be carcinogenic to humans” by the oral route of exposure, based on the occurrence of liver tumors in male and female mice. Cancer risk is assessed by EPA using the linear low dose extrapolation approach with a potency factor (Q 1 *) of 2.3 x 10 -2 milligrams/kilograms/day (mg/kg/day) -1 .

Oral rat and rabbit developmental toxicity studies showed no increased susceptibility of fetuses to tetraconazole. Maternal toxicity (decreased body weight gain and food consumption, increased water intake and increased liver and kidney weights) and developmental toxicity (increased incidence of small fetuses, supranumerary ribs and hydroureter and hydronephrosis) occurred at the same dose level in the rat study. No developmental toxicity was seen in the rabbit study, whereas maternal toxicity (decreased body weight gain) was noted at the highest dose tested. Similarly, there was no evidence of increased susceptibility of offspring in the 2-generation rat reproduction study. Parental toxicity (increased mortality in parental females) was observed at a lower dose (4.9 mg/kg/day) than the dose (35.5 mg/kg/day) resulting in pup effects (decreased litter weight and mean pup weight in litters of all generations before weaning and increased relative liver weight at weaning in both sexes of all litters).

Specific information on the studies received and the nature of the adverse effects caused by tetraconazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document Tetraconazole: Human-Health Risk Assessment for New Use on Grapes and a Label Amendment for Pecans , page 34 in docket ID number EPA-HQ-OPP-2007-1161.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm .

A summary of the toxicological endpoints for tetraconazole used for human risk assessment can be found at http://www.regulations.gov in the document Tetraconazole: Human-Health Risk Assessment for New Use on Grapes and a Label Amendment for Pecans , page 12 in docket ID number EPA-HQ-OPP-2007-1161.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to tetraconazole, EPA considered exposure under the petitioned-for tolerance as well as all existing tetraconazole tolerances in 40 CFR 180.557. Additional metabolites of toxicological concern (M14360-alcohol (free and conjugated), M14360-acid, M14360-DFA, and M14360-hydroxydetriazolyl-O-malonyldiglucoside) that are not included in the tolerance expression were included in the dietary exposure assessments based on the ratio of metabolite to parent found in metabolism studies. EPA assessed dietary exposures from tetraconazole in food as follows:

i. Acute exposure . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. EPA identified such effects (increased incidence of small fetuses and supernumerary ribs) for the population subgroup, females 13 years and older; however, no such effects were identified for the general population, including infants and children.

In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 Nationwide Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, EPA assumed tolerance-level residues of tetraconazole and 100 percent crop treated (PCT) for all existing and new uses.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. The assessment was refined through the incorporation of empirical processing factors, average field trial residues, average residues from the feeding studies and projected percent crop treated (PPCT) estimates for the feed commodities. 100 PCT was assumed for all food commodities.

iii. Cancer . Tetraconazole is classified as “likely to be carcinogenic to humans” by the oral route of exposure. Cancer risk from tetraconazole exposure is assessed by EPA using the linear low dose extrapolation approach with a potency factor (Q 1 *) of 2.3 x 10 -2 (mg/kg/day) -1 . EPA used the same food residue estimates as discussed in Unit III.C.1.ii., chronic exposure.

iv. Anticipated residue and PCT information . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to section 408(f)(1) of FFDCA that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data Call-Ins as are required by section 408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.

The Agency used projected percent crop treated (PPCT) information as follows:

In the chronic and cancer dietary assessments, EPA used PPCT for the feed commodities derived from peanuts (77%), soybeans (27%) and sugar beets (70%). Since tetraconazole was registered for use on these crops recently (2007 and 2008), PCT estimates based on actual usage data are not sufficient indicators of potential usage on these crops.

EPA estimates PPCT for a new pesticide use by assuming that the PCT during the pesticide's initial 5 years of use on a specific use site will not exceed the average PCT of the market leader (i.e., the one with the greatest PCT) on that site. Typically, EPA uses USDA/National Agriculture Statistic Service (NASS) as the primary source for PCT data. When a specific use site is not surveyed by USDA/NASS, EPA uses other sources, including proprietary data, and calculates the PCT. Comparisons are only made among pesticides of the same pesticide types (i.e., the leading fungicide on the use site is selected for comparison with the new fungicide). The PCTs included in the average may be for the same pesticide, or for different pesticides, since the same, or different pesticides, may dominate for each year selected. This PPCT, based on the average PCT of the market leader, is appropriate for use in chronic dietary risk assessment. The method of estimating a PPCT for a new use of a registered pesticide or a new pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial 5 years of actual use. The predominant factors that bear on whether the estimated PPCT could be exceeded are whether a new pesticide use or new pesticide is more efficacious or controls a broader spectrum of pests than the dominant pesticide; and/or whether there are concerns with pest pressures as indicated in emergency exemption requests or other readily available information; and/or other factors based on analysis of additional information, such as the total crop acreage and the geographical distribution of the crops and pests. All information currently available for the predominant factors mentioned above or relevant to the case in question have been considered for this chemical, and EPA has determined that it is unlikely that actual PCT for tetraconazole will exceed the PPCT during the next 5 years.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which tetraconazole may be applied in a particular area.

2. Dietary exposure from drinking water . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for tetraconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of tetraconazole. Further information regarding EPA's drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of tetraconazole for acute exposures are estimated to be 10.45 parts per billion (ppb) for surface water and 0.40 ppb for ground water. For chronic exposures for non-cancer assessments, EDWCs are estimated to be 4.68 ppb for surface water and 0.40 ppb for ground water. For chronic exposures for cancer assessments, EDWCs are estimated to be 3.29 ppb for surface water and 0.40 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 10.45 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 4.68 ppb was used to assess the contribution to drinking water. For cancer dietary risk assessment, the water concentration of value 3.29 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Tetraconazole is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Tetraconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in fungi by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not necessarily constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found; some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

Tetraconazole is a triazole-derived pesticide. This class of compounds can form the common metabolite, 1,2,4-triazole (T), and several triazole conjugates, including triazole alanine (TA) and triazole acetic acid (TAA). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including tetraconazole, EPA conducted a human health risk assessment for exposure to T, TA, and TAA resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment was a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment included evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment is found in the propiconazole reregistration docket at http://www.regulations.gov (Docket ID EPA-HQ-OPP-2005-0497). In March of 2008, EPA updated the triazole risk assessment to include new uses of fenbuconazole, ipconazole, metconazole, tebuconazole and uniconazole. The updated risk assessment can be found at http://www.regulations.gov in the document Dietary Exposure Assessments for the Common Triazole Metabolites 1,2,4-Triazole, Triazolylalanine, Triazolylacetic Acid, and Triazolylypyruvic Acid; Updated to Include New Uses of Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and Uniconazole; and a Change in Plant-back Restriction for Tetraconazole in docket ID number EPA-HQ-OPP-2007-1199. When EPA updated the triazole risk assessment, it considered triazole residues on grapes, because other triazole fungicides are already registered for this use site. Triazole residues on grapes from the use of tetraconazole are not expected to exceed those from the use of other triazole fungicides on grapes; therefore, establishing this tolerance for tetraconazole on grape will not increase aggregate exposure to the triazole metabolites, and an updated triazole risk assessment is unnecessary.

1. In general . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity . The pre- and postnatal toxicology database for tetraconazole includes rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. As discussed in section III.A, Toxicological Profile, there was no evidence of increased susceptability to tetraconazole of in utero rats or rabbits or offspring in these studies. In the rat developmental toxicity study, maternal and developmental toxicity occurred at the same dose, and in the rabbit study, no developmental toxicity was seen at doses that resulted in maternal toxicity. In the rat reproduction study, parental toxicity was observed at a lower dose than that which resulted in pup effects.

3. Conclusion . EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for tetraconazole is complete, except for immunotoxicity testing. EPA began requiring functional immunotoxicity testing of all food and non-food use pesticides on December 26, 2007. Since this requirement went into effect well after the tolerance petition was submitted, these studies are not yet available for tetraconazole. In the absence of specific immunotoxicity studies, EPA has evaluated the available tetraconazole toxicity data to determine whether an additional database uncertainty factor is needed to account for potential immunotoxicity. There was no evidence of adverse effects on the organs of the immune system at the LOAEL in any study with tetraconazole. In addition, tetraconazole does not belong to a class of chemicals (e.g., the organotins, heavy metals, or halogenated aromatic hydrocarbons) that would be expected to be immunotoxic. Based on these considerations, EPA does not believe that conducting a special series 870.7800 immunotoxicity study will result in a point of departure less than the NOAEL of 0.73 mg/kg/day used in calculating the cPAD for tetraconazole; therefore, an additional database uncertainty factor is not needed to account for potential immunotoxicity.

ii. There is no indication that tetraconazole is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that tetraconazole results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary food exposure assessment assumed tolerance-level residues and 100 PCT. The chronic and cancer dietary food exposure assessments were refined using reliable PPCT information and anticipated residue values calculated from valid field trial results. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to tetraconazole in drinking water. Residential exposure to tetraconazole is not expected. These assessments will not underestimate the exposure and risks posed by tetraconazole.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to tetraconazole will occupy < 1% of the aPAD for females, 13 to 49 years old, the only population group for which an acute toxicity endpoint of concern was identified.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to tetraconazole from food and water will utilize 7.7% of the cPAD for infants less than 1 year old, the population group receiving the greatest exposure. There are no residential uses for tetraconazole.

3. Short-/intermediate-term risk . Short- and intermediate term aggregate exposures take into account short- and intermediate-term residential exposure plus chronic exposure from food and water (considered to be a background exposure level). Tetraconazole is not registered for any use patterns that would result in residential exposure. Therefore, the short- and intermediate-term aggregate risk is the sum of the risk from exposure to tetraconazole through food and water and will not be greater than the chronic aggregate risk.

4. Aggregate cancer risk for U.S. population . Using the exposure assumptions described in this unit for the cancer risk assessment, EPA has concluded that exposure to tetraconazole from food and water will result in a lifetime cancer risk of 3 x 10 -6 for the U.S. population. EPA generally considers cancer risks in the range of 10 -6 or less to be negligible. The precision which can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the log scale; for example, risks falling between 3.16 x 10 -7 and 3.16 x 10 -6 are expressed as risks in the range of 10 -6 . Considering the precision with which cancer hazard can be estimated, the conservativeness of low-dose linear extrapolation, and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark level of concern of the range of 10 -6 until the calculated risk exceeds approximately 3 x 10 -6 . Since the calculated cancer risk for tetraconazole falls within this range, estimated cancer risk is considered to be negligible.

5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to tetraconazole residues.

Adequate enforcement methodology (gas chromatography with electron capture detection (GC/ECD)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no CODEX, Canadian or Mexican maximum residues levels established for tetraconazole.

Based upon review of the data supporting the petition, EPA has revised the tolerance level for grape from 0.15 ppm to 0.20 ppm. EPA revised the tolerance level based on analysis of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data . The recommended value differs from the value proposed by IR-4, because only data from field plots harvested at the proposed pre-harvest interval (PHI) were used in calculating the tolerance level.

Therefore, a tolerance is established for residues of tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1 H -1,2,4-triazole, in or on grape at 0.20 ppm.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://regulations.gov. Follow the search instructions on that Web site to view public comments.

Comments received timely will be also available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) was enacted on December 8, 2003. The MMA established the Medicare prescription drug benefit program (Part D) and made revisions to the provisions in Medicare Part C, governing what is now called the Medicare Advantage (MA) program (formerly Medicare+Choice). The MMA directed that important aspects of the new Medicare prescription drug benefit program under Part D be similar to, and coordinated with, regulations for the MA program.

The MMA also directed implementation of the prescription drug benefit and revised MA program provisions by January 1, 2006. The final rules for the MA and Part D prescription drug programs appeared in the Federal Register on January 28, 2005 (70 FR 4588 and 70 FR 4194, respectively). Many of the provisions relating to applications, marketing, contracts, and the new bidding process, for the MA program, became effective on March 22, 2005, 60 days after publication of the rule, so that the requirements for both programs could be implemented by January 1, 2006. All of the provisions regarding the new Part D prescription drug program became effective on March 22, 2005.

As we gained more experience with the MA program and the prescription drug benefit program, we proposed to revise areas of both programs and issued a proposed rule on May 16, 2008 (73 FR 28556) that would have clarified existing policies or codified current guidance for both programs. Several of these proposed regulatory revisions were overtaken by statutory provisions enacted in the Medicare Improvements for Patients and Providers Act (MIPPA) (Pub. L. 110-275), enacted on July 15, 2008. These MIPPA provisions directly address in statute several issues we proposed to address through rulemaking, and thus superseded our rulemaking in these areas.

The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) established a new “Part C” in the Medicare statute (sections 1851 through 1859 of the Social Security Act (the Act)) which provided for a Medicare+Choice (M+C) program. Under section 1851(a)(1) of the Act, every individual entitled to Medicare Part A and enrolled under Medicare Part B, except for most individuals with end-stage renal disease (ESRD), could elect to receive benefits either through the original Medicare program or an M+C plan, if one was offered where he or she lived.

The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), Public Law 106-111, amended the M+C provisions of the BBA. Further amendments were made to the M+C program by the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554), enacted December 21, 2000.

As noted above, the MMA was enacted on December 8, 2003. Title I of the MMA added a new “Part D” to the Medicare statute (sections 1860D-1 through 1860D-42) creating the Medicare Prescription Drug Benefit Program, the most significant change to the Medicare program since its inception in 1965.

Sections 201 through 241 of title II of the MMA made significant changes to the Part C program. Title II of the MMA renamed the M+C program the MA program and included new payment and bidding provisions, new regional MA plans and special needs plans, reestablished authority for medical savings account (MSA) plans that had been provided in the BBA on a temporary basis, and made other changes. Title I of the MMA created prescription drug benefits under Medicare Part D, and a new retiree drug subsidy program.

Both the MA and prescription drug benefit regulations were published separately, as proposed and final rules, though their development and publication were closely coordinated. On August 3, 2004, we published in the Federal Register proposed rules for the MA program (69 FR 46866) and the prescription drug benefit program (69 FR 46632). In response to public comments on the proposed rules, we made several revisions to the proposed policies for both programs. For further discussion of these revisions, see the respective final rules (70 FR 4588) and (70 FR 4194).

As noted above, on July 15, 2008, the Medicare Improvements for Patients and Providers Act became law, making several significant new revisions to the MA and Part D prescription drug benefit programs.

On September 18, 2008, we published an interim final rule with comment period, Revisions to the Medicare Advantage and Prescription Drug Benefit Programs (73 FR 54226), that revised the regulations governing the MA program, prescription drug benefit program, and section 1876 cost plans to reflect new statutory requirements enacted in MIPPA. This included new requirements governing the marketing of Part C and Part D plans. Specifically, among other things, the September 18, 2008 regulations established requirements governing MA plan and prescription drug plan (PDP) compensation structures designed to ensure that agents and brokers enroll individuals in the MA plan or PDP that best meets their health care needs. The provisions regarding compensation structures in the September 18, 2008 rule were effective upon publication, and public comments are being accepted until November 17, 2008.

In the section that follows, we discuss the revisions made in this interim final rule with comment period to the regulations in 42 CFR parts 422 and 423 governing, respectively, the MA and prescription drug benefit programs.

Section 103(b)(1)(B) of MIPPA charged the Secretary with establishing guidelines to “ensure that the use of compensation creates incentives for agents and brokers to enroll individuals in the Medicare Advantage plan that is intended to best meet their health care needs.” Section 103(b)(2) of MIPPA applies these same guidelines to PDP sponsors.

On September 18, 2008 we published the new Medicare regulations, Medicare Advantage and Prescription Drug Benefit Programs; Final Marketing Provisions (73 FR 54208) and Revisions to the Medicare Advantage and Prescription Drug Benefit Programs (73 FR 54226), and a guidance document to assist plans in implementing these new regulations. Among other things, these new rules were intended to implement the MIPAA requirement to ensure that agents or brokers enroll beneficiaries based on the plan that “best meet[s]their health care needs” by imposing requirements pertaining to agent and broker compensation designed to reduce existing financial incentives to enroll a beneficiary in a new plan based on the agent or broker's financial interests rather than the beneficiary's health care needs. These rules provided that, after a beneficiary is enrolled in an MA plan or PDP by an agent or broker, a renewal compensation would be paid for five years after the initial compensation, and that if any agent or broker enrolls the beneficiary in a different plan of a “like plan type” during this five-year period, renewal compensation would be paid. A “like plan type” refers to PDP, MA or MA-PD, or cost plan (as defined in 422.2274(a)(3)(i) and 423.2274(a)(3)(i)). This renewal compensation will apply whether or not the new enrollment is in the same or a new (receiving) organization. The renewal compensation will be paid by the organization offering the plan into which the enrollment occurs, and the amount of the renewal compensation will be based on that organization's compensation structure. That organization will pay renewal compensation for the remainder of the cycle provided that the enrollment remains with that organization. Thus, the agent or broker will receive compensation at the renewal rate, as described above, whether the enrollee stays in the same plan, or moves to a different plan of a like type, regardless of whether the move is within the existing organization or to a different organization. However, if an enrollee moves to a plan of a different plan type (as defined in 422.2274(a)(3)(ii) and 423.2274(a)(3)(ii)) within the existing organization, the agent or broker may receive compensation at the initial rate. This is designed to ensure that recommendations will be based on the best interests of the beneficiary as MIPPA required.

Under the September 18th regulations, compensation in the initial year in this six-year cycle could not exceed 200 percent of the amount paid for renewal years. We released additional guidance on October 8 and 17, 2008 to further clarify the marketing requirements contained in these new rules. On October 24, 2008, we rescinded the October 8, 2008 guidance memorandum in light of concerns about how the compensation guidance was being interpreted. Based on comments and complaints about how the September 18, 2008 regulations were being implemented, we became concerned that MA and Part D plans were misinterpreting our intent in the compensation structure requirements in § 422.2274(a) and § 423.2274(a) by proposing structures under which compensation in the initial year in the cycle was less than the renewal years and renewal compensation varied from year to year.

First, in limiting the amount by which the initial year compensation can exceed the compensation paid for the five renewal years in the six-year cycle, the regulations clearly contemplated that the initial year compensation would be higher than the renewal compensation level. The very purpose of the regulatory scheme, ensuring that an entity does not get the benefit of a initial year level of compensation for moving a member to another plan after the first year, is clearly premised on this assumption.

In addition, we believed that the words of the regulation text made clear that, once a plan chooses an appropriate renewal amount, this fixed renewal amount would be paid for all five renewal years of the six-year cycle in question. Sections 422.2274(a)(1) and 423.2274(a)(1) refer to the “first year compensation” amount being “no more than 200 percent of the compensation paid for selling or servicing the enrollee in each individual subsequent renewal year * * *.” (Emphasis added). Thus, we believed that the current regulations made clear that the renewal “compensation paid” for a renewal year, whatever that amount is, be paid for “each” of the five “individual” renewal years of the six-year cycle.

Because, as noted, we have received reports of compensation structures that are inconsistent with the intent of the September 18 interim final rule with comment period, we are revising the regulations to expressly specify in §§ 422.2274(a)(1) and 423.2274(a)(1) that the aggregate (commissions, bonuses, etc.) of the compensation amount paid for selling or servicing an enrollee during each of the 5 individual renewal years of a six-year cycle must be fair-market value for the work performed and no more, and no less, than 50 percent of the aggregate (commissions, bonuses, etc.) of the compensation amount paid for that beneficiary in the initial year of the six-year cycle. These new regulations are necessary to achieve the original intent of the September 18, 2008 regulations. We recognize this is a significant change in approach to a compensation structure from September 18, 2008, interim final rule with comment period, where the first year in the six-year cycle could not exceed 200 percent of the amount paid for renewal years, which was modeled after the National Association of Insurance Commissioner's compensation requirements for Medicare supplemental policies. We are making this change, however, to modify the difference between initial year compensation rates and renewal rates to better ensure that agents and brokers enroll beneficiaries in a plan that is intended to best meet the beneficiaries' health care needs.

We do not currently have the administrative capability to communicate to plans as part of our enrollment acceptance process whether an individual enrolling in a plan in 2009 is a new enrollee to Part C or Part D, or an individual who, under the compensation structure provided for in this interim final rule, is subject to the renewal compensation level rather than the initial compensation level. Thus, we are in this interim final rule, for 2009 only, initially deeming all individuals enrolling in a plan to be in the first year of the five renewal years in the six-year cycle provided for under these regulations.

This means that for enrollments with effective dates in 2009, the MA or PDP plan initially pays the renewal compensation amount to the broker or agent enrolling an individual. Several times in 2009, we will run a report identifying those beneficiaries enrolled in an MA plan or PDP who were newly entitled or enrolled from original Medicare. We will sort the report by plan and send each organization the list of enrollees in a plan offered by that organization, for which, if an agent or broker wrote the policy, that agent or broker would be entitled to an initial compensation amount. Organizations can use the report to identify the agents or brokers who are entitled to an initial compensation amount.

Under this interim final rule, organizations will be required to adjust the compensation from renewal compensation in these cases only to the amount that would have been paid in compensation for an initial enrollment under the six year cycle in question. For the remainder of 2009, this interim final rule requires that organizations pay agents and brokers an initial compensation when a beneficiary enrolls in an MA plan during the beneficiary's Initial Coverage Election Period (ICEP) or in a PDP during the Initial Enrollment Period (IEP). This approach enables organizations to compensate agents and brokers for the additional work involved in explaining all of the attributes of an MA plan (and the Part C program generally) or a PDP (and the Part D program generally) to a beneficiary who has had no prior experience with Part C or Part D, while at the same time reducing the financial incentive for moving a beneficiary who is in a renewal cycle (and is thus already familiar with these types of products) to a new plan that may be contrary to his or her health care needs.

In addition to the above changes to the September 18, 2008 regulations, we are also in this interim final rule addressing the amount paid in agent and broker compensation for 2009 and beyond. We have received information that some organizations are proposing to offer extremely generous compensation in 2009 far in excess of amounts paid for the previous three years by the organization in question, or substantially in excess of the amounts paid generally in the area for the plan type involved. We are concerned about the financial incentive to enroll beneficiaries in a new plan that is created by the potential for an agent or broker to receive such a substantial increase in compensation relative to the amount he or she would be paid for a renewal in the beneficiary's current plan. We also believe that these excessive compensation structures are detrimental to sustaining an enrollee's long term relationship with the plan in which he or she is enrolled.

In order to protect against the incentive that such a substantially higher compensation level may create to enroll beneficiaries in a different plan even when doing so might not be in their best interest, and to ensure that beneficiaries' long term relationships with their plans are preserved for as long as they are in the beneficiary's interest, we are also in this interim final rule establishing a requirement that compensation levels under the new regulatory scheme must satisfy one of two regulatory standards. For an organization that offered plans in 2006, and used agents and brokers to sell its Medicare products, the MA organization or PDP sponsor offering the plan can comply with our new rules if the “initial year” compensation under the six-year cycle provided for under this rule is the same, adjusted for inflation, that was paid for the same plan type in the same area by the MA or PDP organization, as applicable, in 2006, and the MA or PDP organization certifies to that effect. The inflation adjustment will be based on the average change in MA plan growth rates for MA organizations and Part D growth rates for Part D organizations, as published in the MA and Part D rate announcements published on the first Monday in April. Because 2009 is initially deemed to be the first renewal year in the six-year cycle, this means that the organization will initially pay 50 percent of the inflation adjusted amount of the initial enrollment compensation it paid in 2006 for the plan type in question. Unless the 2009 compensation amount is adjusted to be changed to an initial enrollment compensation amount as discussed above, this renewal amount will also be paid by the current organization for the remainder of the renewal years in the six-year cycle (for example, 2010 through 2013), assuming that the enrollee remained enrolled in the current organization in the same plan type. If an agent or broker moves the enrollee to a like-plan type in a different organization, the new organization will pay renewal compensation for the remainder of the cycle at the new (receiving) organization's renewal compensation amount.

Organizations that offered plans in an area in 2006 will also have another option, which will be the only option for organizations that did not offer a plan of the type in question in the area involved in 2006 or did offer a plan of the type in question in 2006, but did not use agents and brokers to sell that product. Under this alternate test, renewal compensation initially paid in 2009 must be 50 percent of an initial rate that was determined, based on market analysis to be commensurate with the “market” rates paid by all organizations in the geographic area for an initial enrollment in the plan type in question during 2006 and 2007, also adjusted for inflation based on changes in MA and Part D growth rates. Essentially, any rates in excess of what was paid by organizations in the area must be justified. We will reserve the right to determine, based on data we receive from MA and Part D contractors, whether the compensation amount proposed meets this test. See the chart below for a reference regarding the required six-year compensation cycle. We note that for purposes of both of the foregoing tests, the “area” in which the plan is offered corresponds to the area the organization uses to determine any geographic adjustments to the amount of compensation paid. If the organization pays the same amount in each county, or MSA, or Statewide, that would be the area in question.

For 2010 and subsequent years, the compensation amount paid to an agent or broker for an initial enrollment of a Medicare beneficiary into an MA or PDP plan is the prior year's compensation adjusted by the change in MA rates for MA plans as published in the MA rate announcement and the change in the Part D rates for PDP plans as published in the Part D rate announcement. CMS releases annually the rate announcements for MA and Part D to publish on the first Monday in April.

We have removed and reserved § 422.2274(a)(2) and § 423.2274(a)(2) as it is redundant to § 422.2274(a)(1)(iii) and § 423.2274(a)(1)(iii) in this rule.

We invite comment on the extent to which the compensation structure, or some alternative compensation structure, will promote long-term relationships (that are based on the beneficiaries' interests) between beneficiaries and the plans in which they are enrolled. We are particularly interested in comments on whether this goal would be served (1) by providing for higher levels of compensation for an initial enrollment in Part C or Part D (given the added costs of explaining how the programs work) than for a change in enrollment from one Part C plan or Part D plan to another, (2) by establishing a flat fee schedule, or (3) by providing for lower payments in early years and higher payments in the renewal years, or in later renewal years, to incentivize agents or brokers to keep enrollees in the same plan rather than giving them an incentive to move enrollees.

We note that, to the extent that the high levels of agent or broker compensation that have been reported are already in place for 2008, and were not included in bids for 2008, we intend to ensure in our review of bids for 2010 that these additional uncovered costs are not included in 2010 bid amounts. Similarly, if the compensation paid for 2009, even under this new interim final rule, exceeds the amount assumed in the bids submitted this spring for 2009, we will similarly ensure in our bid review that these 2009 costs are not built into bids for 2010.

These new requirements will apply to the compensation paid to the agent or broker who actually enrolls the beneficiary, whether that agent or broker is paid directly by the MA organization or PDP sponsor, or by an intermediate entity, such as a “Field Marketing Organization” (FMO) or similar type entity that has been retained to sell a plan's Medicare products on its behalf.

We are also concerned about amounts paid to FMOs or other similar type entities for their services that do not necessarily flow down to the agent or broker who deals with the beneficiary. Examples of such services are training, material development, customer service, direct mail, and agent recruitment. Specifically, we are concerned that these FMOs or other similar entities could engage in a “bidding war” with respect to payments they retain, agree to contract to recruit agents, or perform other services only for MA and PDP organizations that are the “highest bidders” for their services. Thus, in this interim final rule, in addition to limiting the compensation that is ultimately paid to agents or brokers as set forth above, we are requiring that, for organizations that contract with FMOs or pay other similar type entities, any amount paid to such a third party must be fair-market value and may not exceed an amount that is commensurate with the amount that organization paid to a third party for similar services in each of the prior two years.

Finally, we have learned that some organizations did not post their compensation structures by October 15, 2008, but instead posted them after they had the opportunity to review competitors' compensation structure postings. In fact, it appears that some organizations have yet to post their compensation levels. In light of the new requirements set forth in this interim final rule with comment period, MA and PDP organizations must submit compensation structures paid for the 3 previous years, and the compensation structures for the upcoming plan year in accordance with our instructions. This information must be submitted to the following mailbox: MA_PDPSalesCompensation@cms.hhs.gov (there is an underscore between “MA_PDP”) no later than the date we specify. For MA and PDP organizations that did not sell products through agents and brokers in any of these years, they would not be required to provide information for those years. Nevertheless, all MA and PDP organizations must respond to the data requests in accordance with our instructions. In addition, if the MA and PDP organization contracts with an FMO or other third party, the compensation structure paid to each third party in each of the past three years, and the compensation structure for 2009, should be reported.

We will consider an organization that does not submit compensation structure information for the appropriate years to us by the date indicated to be out of compliance with our marketing requirements and the organization will face potential sanctions and/or other penalties. An organization's submission must include a signed certification from its CEO or CFO (or other authorized senior official). MA and PDP organizations must distribute their rates by November 15, 2008 to agents, brokers, and other third parties under contract to sell Medicare Advantage and Part D plans. Once plans distribute their 2009 compensation rates and submit that information to CMS, they cannot change the rate without prior CMS approval.

Based on public comments and discussions with the industry, we realize that while our current compensation regulations are relevant to the way independent agents and brokers are compensated, the relationship and compensation arrangements between MA and Part D organizations and employed agents is very different. As a result, the new compensation requirements in this interim final rule will not apply to employed agents. CMS considers agents employed if the employed agent sells exclusively for one organization and receives a set salary in addition to any compensation tied to volume of sales. We are interested in receiving public comments on what, if any, compensation requirements should apply to employed agents.

In accordance with the above new requirements, we will investigate outliers whose current compensation is not reasonable in light of the compensation paid during the previous three years and compensation paid in that geographic area by similar plan types to ensure that organizations are in compliance with our requirements and take enforcement action as appropriate, including requiring organizations to be prepared to adjust the compensation rates submitted to CMS, or to take other steps to ensure that beneficiaries' interests are not harmed by the excessive compensation paid. In addition, as noted in the preamble to the September 18, 2008 interim final rule (73 FR 54239), all parties should be mindful that their compensation arrangements including arrangements with FMOs and other similar type entities must comply with the fraud and abuse laws, including the anti-kickback statute.

Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

We ordinarily publish a notice of proposed rulemaking in the Federal Register and allow a 60-day public comment on the proposed rule. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. In addition, under section 1871(b)(1)(B) of the Act, prior notice and comment are not required when “a statute establishes a specific deadline for the implementation of a provision and the deadline is less than 150 days after the date of the enactment” of the statute in which the deadline is contained. The MIPPA was enacted on July 15, 2008. The deadline for issuing the compensation rules included in this interim final rule with comment period are required by MIPPA to be in effect on a date specified by the Secretary, but no later than November 15, 2008, which is less than 150 days after enactment of MIPPA. For this reason, we find good cause to waive the proposed rulemaking requirement and to shorten the customary 60-day comment period to 30 days.

In addition, since the provision discussed above which is required by statute to be in effect by a date specified by the Secretary, but in no case later than November 15, 2008, we find good cause to waive the 30-day delay in effective date that would otherwise apply under section 1871(e)(1)(B)(i) of the Act and section 553(d) of the Administrative Procedure Act (APA).

Section 553(d) of the APA and section 1871(e)(1)(B)(i) of the Act ordinarily require that a regulation be effective no earlier than 30 days after publication. Under section 553(d)(3) this requirement can be waived for good cause, and under section 1871(e)(1)(B)(ii) this requirement can be waived if necessary to comply with statutory requirements, or if a delay is contrary to the public interest.

As noted above, Congress enacted MIPPA on July 15, 2008 and directed that many of the marketing provisions including the provision related to agent/broker compensation in this rule be effective on a date specified by the Secretary, but in no event later than November 15, 2008, so that they could be implemented in time for this fall's marketing for the 2009 plan year. As a result, we find good cause to waive the APA delay of effective date, and find that a delay under section 1871 is contrary to the public interest.

In addition, 5 U.S.C. section 801 generally requires that agencies submit major rules to the Congress 60 days before the rules are scheduled to become effective. This delay does not apply, however, when there has been a finding of good cause for waiver of prior notice and comment as set forth above.

Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs).

Section 422.2274(d) states that upon CMS' request, the organization must provide to CMS the information necessary for it to conduct oversight of marketing activities. Specifically, we are requiring all Medicare Advantage plans to post revised compensation structures to brokers or agents that conform precisely to our regulations and guidance (for 2009, these rates must be posted by November 15, 2008). We are further requiring organizations to submit their compensation structures for the previous years plus the current year to CMS (for example, 2009 plans must submit 2006 through 2009). In addition to the compensation structures, every complete submission must include a signed certification from the organization's CEO or CFO (or other authorized senior official). The burden associated with this requirement is the time and effort put forth by the organization to post the compensation structures and to provide the structures and certification to CMS.

We anticipate it would take 1 organization 56 hours to fulfill this requirement. We estimate 670 MA organizations would be affected annually by this requirement. Therefore, the total annual burden associated with this requirement is 37,520 hours.

In this interim final rule with comment period, we are collecting additional information to implement § 422.2274(d). We submitted a revision of the currently approved information collection request assigned to OMB control number 0938-0753. The information collection requirements contained in § 422.2274(d) will be included in the revised information collection request.

Section 423.2274(d) states that the Part D sponsor provide information for it to conduct oversight of marketing activities upon CMS' request. Specifically, we are requiring all Medicare Prescription Drug Plans to post revised compensation structures to brokers or agents that conform precisely to our regulations and guidance (for 2009, these rates must be posted by November 15, 2008). We are further requiring organizations to submit their compensation structures for the 3 previous years plus the current year to CMS (for example, 2009 plans must submit 2006 through 2009). In addition to the compensation structures, every complete submission must include a signed certification from the organization's CEO or CFO (or other authorized senior official). The burden associated with this requirement is the time and effort put forth by the organization to post the compensation structures and to provide the structures and certification to CMS.

We anticipate it would take 1 Part D sponsor 49 hours to fulfill this requirement. We estimate 87 Part D sponsors would be affected annually by this requirement. Therefore, the total annual burden associated with this requirement is 4,263 hours.

The information collection requirements contained in § 423.2274 were submitted to OMB for approval as part of an emergency revision of the currently approved information collection request assigned to OMB Control Number 0938-0964.

As reflected in the table that follows, the aggregate annual burden associated with the collection of information section for this rule totals 41,783 hours.

If you comment on these information collection and recordkeeping requirements, please do either of the following:

1. Submit your comments electronically as specified in the ADDRESSES section of this rule; or

2. Mail copies to the address specified in the ADDRESSES section of this rule and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: CMS Desk Officer, CMS-4138-IFC2, Fax (202) 395-6974.

We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993, as further amended), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Order 12866 (as amended by Executive Order 13258) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). As a result of our analysis, this interim final rule does not meet the threshold of being economically significant and is consequently not a major rule.

The RFA requires agencies to analyze options for regulatory relief of small businesses, if a rule has significant impact on a substantial number of small entities. Under the RFA, we are not required to conduct an initial regulatory flexibility analysis for interim final rules. However, it is our longstanding policy to provide an analysis when we believe it would aid understanding of the effects of the interim final rule. We are providing a summary of the minimal costs associated with this interim final rule. Costs for preparing and reporting compensation structures to CMS are as follows: MA program $54.98 × 37,520 hours = $2,062,849. Costs for the PDP program are $54.98 × 4,263 hours = $234,379. The aggregate new burden costs are estimated to be $2,297,228.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditure in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. That threshold level is currently approximately $130 million. We anticipate that this interim final rule would not impose costs above the $130 million UMRA threshold on State, local, tribal governments, in the aggregate or by the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it issues a final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. The changes and additions contained in this interim final rule do not impose new costs on states or local governments. Thus, there are no anticipated Federalism implications.

Given that we expect the cost of implementing this provision to be minimal and under the $100 million threshold; we did not conduct a full economic impact analysis with regard to those entities potentially impacted by these provisions, as outlined by the regulatory flexibility analysis or Section 1102(b) of the Act.

In accordance with the provisions of Executive Order 12866, this final rule was reviewed by the Office of Management and Budget.

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001 et seq. ; unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the Federal Register .

Previously, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below of the modified BFEs for each community listed. These modified BFEs have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of FEMA resolved any appeals resulting from this notification.

The modified BFEs are not listed for each community in this notice. However, this final rule includes the address of the Chief Executive Officer of the community where the modified BFEs determinations are available for inspection.

The modified BFEs are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.

These modified BFEs are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings. The changes in BFEs are in accordance with 44 CFR 65.4.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132, Federalism.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

This document announces that, on October 31, 2008, OMB approved, for a period of three years, the information collection requirements contained in the Commission's DNC Report and Order , FCC 08-147, published at 73 FR 40183, July 14, 2008. The OMB Control Number is 3060-0519. The Commission publishes this notice as an announcement of the effective date of the rule. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street, SW., Washington, DC 20554. Please include the OMB Control Number, 3060-0519, in your correspondence. The Commission will also accept your comments via the Internet if you send them to PRA@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail to f cc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on October 31, 2008, for the information collection requirements contained in the Commission's rules at 47 CFR 64.1200(c)(2). The OMB Control Number is 3060-0519. The total annual reporting burden for respondents for these collections of information, including the time for gathering and maintaining the collection of information, is estimated to be: 49,397 respondents, 135,607,383 responses, total annual burden hours of 625,406 hours, and $4,590,000 in total annual costs. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act, which does not display a current, valid OMB Control Number.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

This is a synopsis of the Commission's Report and Order , MB Docket No. 08-108, adopted October 7, 2008, and released October 17, 2008. The full text of this document is available for public inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC 20554. This document will also be available via ECFS ( http://www.fcc.gov/cgb/ecfs/ ). (Documents will be available electronically in ASCII, Word 97, and/or Adobe Acrobat.) This document may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-478-3160 or via e-mail http://www.BCPIWEB.com . To request this document in accessible formats (computer diskettes, large print, audio recording, and Braille), send an e-mail to fcc504@fcc.gov or call the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This is a synopsis of the Commission's Report and Order, MB Docket No. 08-105, adopted October 7, 2008, and released October 17, 2008. The full text of this document is available for public inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC 20554. This document will also be available via ECFS ( http://www.fcc.gov/cgb/ecfs/ ). (Documents will be available electronically in ASCII, Word 97, and/or Adobe Acrobat.) This document may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-478-3160 or via e-mail http://www.BCPIWEB.com. To request this document in accessible formats (computer diskettes, large print, audio recording, and Braille), send an e-mail to fcc504@fcc.gov or call the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This is a synopsis of the Commission's Report and Order, MB Docket No. 08-109, adopted October 7, 2008, and released October 17, 2008. The full text of this document is available for public inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC 20554. This document will also be available via ECFS ( http://www.fcc.gov/cgb/ecfs/ ). (Documents will be available electronically in ASCII, Word 97, and/or Adobe Acrobat.) This document may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-478-3160 or via e-mail, http://www.BCPIWEB.com . To request this document in accessible formats (computer diskettes, large print, audio recording, and Braille), send an e-mail to fcc504@fcc.gov or call the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This is a synopsis of the Commission's Report and Order, MB Docket No. 08-111, adopted October 7, 2008, and released October 17, 2008. The full text of this document is available for public inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC, 20554. This document will also be available via ECFS ( http://www.fcc.gov/cgb/ecfs/ ). (Documents will be available electronically in ASCII, Word 97, and/or Adobe Acrobat.) This document may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-478-3160 or via e-mail http://www.BCPIWEB.com . To request this document in accessible formats (computer diskettes, large print, audio recording, and Braille), send an e-mail to fcc504@fcc.gov or call the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional review Act, see 5 U.S.C. 801(a)(1)(A).