The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 2005-13-24, amendment 39-14161 (70 FR 36470, June 24, 2005). The existing AD applies to all AvCraft Dornier Model 328-100 airplanes. That NPRM was published in the Federal Register on May 22, 2008 (73 FR 29720). That NPRM proposed to continue to require modifying the electrical wiring of the fuel pumps; installing insulation at the hand flow control and shut-off valves, and other components of the environmental control system; and installing markings at fuel wiring harnesses. That NPRM also proposed to continue to require revising the Airworthiness Limitations section (ALS) of the Instructions for Continued Airworthiness to incorporate new inspections of the fuel tank system. That NPRM also proposed to replace the flight-hour-based threshold for conducting certain initial inspections, with an 8-year threshold.

We provided the public the opportunity to participate in the development of this AD. No comments have been received on the NPRM or on the determination of the cost to the public.

We removed all references to the use of “later revisions” of the applicable service information from this AD to be consistent with FAA policy. This change will not increase the economic burden on any operator, nor will it increase the scope of the AD, since we may consider approving the use of later revisions of the service bulletin as an alternative method of compliance with this AD, as provided by paragraph (j) of this AD.

We have carefully reviewed the available data, and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

This AD affects about 16 airplanes of U.S. registry. The actions that are required by AD 2005-13-24 and retained in this AD take about 70 work hours per airplane, at an average labor rate of $80 per work hour. Required parts cost about $14,118 per airplane. Based on these figures, the estimated cost of the currently required actions is $315,488, or $19,718 per airplane.

The new required action to revise the ALS takes about 1 work hour per airplane. Based on these figures, the estimated cost of the new actions specified in this AD for U.S. operators is $1,280, or $80 per airplane.

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.

We issued a supplemental notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That supplemental NPRM was published in the Federal Register on May 1, 2008 (73 FR 23995). That supplemental 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 received no comments on the NPRM or on the determination of the cost to the public.

We have clarified the identity of certain airplanes as listed in the supplemental NPRM by correctly identifying them throughout this AD as Model DHC-8-201 airplanes.

We removed the reference to “a later revision of Part 2 ‘Airworthiness Limitations List’ of the applicable de Havilland Dash 8 Series MPM” from paragraph (f)(4) of this AD and removed Table 3 of the NPRM, which listed the MPMs (and renumbered the subsequent table accordingly). We removed the reference to the use of “later revisions” of the applicable service information from this AD to be consistent with FAA policy. This change will not increase the economic burden on any operator, nor will it increase the scope of the AD, since operators may request approval to use a later revision of the referenced service information as an alternative method of compliance, under the provisions of paragraph (g) of this AD.

We reviewed the available data 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 about 122 products of U.S. registry. We also estimate that it will take about 1 work-hour 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 $9,760, or $80 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.

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 7, 2008 (73 FR 18722). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

The corrective action includes repairing or replacing MLG Rib 5, as applicable. 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 comments received.

Airbus asks that we revise paragraph (g)(2) of the NPRM to clarify the intent of Airbus Service Bulletin A310-57-2090, Revision 01, dated December 19, 2007. Airbus states that paragraph (g)(2) of the NPRM refers to that service bulletin for replacement of the MLG Rib 5. However, Airbus clarifies that the intent of Service Bulletin A310-57-2090 is not to provide instructions for the MLG Rib 5 replacement, but to introduce new bushes with increased interference fit into the aft bearing forward lug of MLG Rib 5. Airbus asks that paragraph (g)(2) of the NPRM be changed as follows, for clarification: “Replacement of the MLG Rib 5 bushes with high interference fit in accordance with the instructions defined in Airbus Service Bulletin A310-57-2090. * * *”

We agree that paragraph (g)(2) of this AD should be further clarified to address the commenter's suggestion; therefore, we have changed that paragraph accordingly.

Airbus also asks that the last sentence of paragraphs (g)(3) and (g)(4)(ii) of the NPRM be changed to remove the reference to Airbus Service Bulletin A310-57-2090, Revision 01, dated December 19, 2007, when the MLG Rib 5 replacement is in question. Airbus asks that paragraphs (g)(3) and (g)(4)(ii) of the NPRM be changed as follows, for clarification: “After MLG Rib 5 replacement, whether Airbus Service Bulletin A310-57-2090, Revision 01, dated December 19, 2007 is not accomplished: * * *”

We agree that paragraphs (g)(3) and (g)(4)(ii) of this AD should be further clarified to capture the commenter's intent; therefore, we have changed those paragraphs accordingly.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We also 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 68 products of U.S. registry. We also estimate that it will take about 5 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 $27,200, or $400 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.

The FAA issued a supplemental notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 94-15-06, amendment 39-8977 (59 FR 37659, July 25, 1994). The existing AD applies to certain Boeing Model 747 series airplanes. That supplemental NPRM was published in the Federal Register on May 7, 2008 (73 FR 25601). That supplemental NPRM proposed to continue to require inspecting to detect cracking in certain lower lobe fuselage skin lap joints, doing repetitive inspections for cracking at certain fastener locations having countersunk fasteners, and replacing countersunk fasteners with protruding head fasteners at certain fastener locations. That supplemental NPRM also proposed to require replacing a previous high-frequency eddy current (HFEC) inspection method with a new HFEC inspection method, adding a one-time inspection for cracking of certain airplanes, and terminating the adjustment factor for the inspection compliance times based on cabin differential pressure. That supplemental NPRM also proposed to require inspecting additional lap joints.

We provided the public the opportunity to participate in the development of this AD. We have considered the single comment that has been received on the supplemental NPRM. The commenter, Boeing, supports the NPRM.

We have carefully reviewed the available data, including the comment that has been received, and determined that air safety and the public interest require adopting the AD as proposed.

There are about 348 airplanes in the worldwide fleet. We estimate that this AD affects 90 airplanes of U.S. registry. The issue associated with Alodine-coated aluminum rivets occurs on 162 airplanes in the worldwide fleet and affects 24 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.

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 June 9, 2008 (73 FR 32497). 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 received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

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 FAA policies. Any such differences are highlighted in a NOTE within the AD.

Based on the service information, we estimate that this AD will affect 50 products of U.S. registry. We also estimate that it will take about 7 work-hours per product to comply with basic requirements of this AD. The average labor rate is $80 per work-hour. Required parts will cost about $310 per product.

Based on these figures, we estimate the cost of this AD to the U.S. operators to be $43,500, or $870 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 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 Management Facility 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 Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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 June 23, 2008 (73 FR 35361). 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 received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

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 FAA policies. Any such differences are highlighted in a NOTE within the AD.

Based on the service information, we estimate that this AD will affect 156 products of U.S. registry. We also estimate that it will take about 3 work-hours per product to comply with basic requirements of this AD. The average labor rate is $80 per work-hour. Required parts will cost about $0 per product (warranty credit given by manufacturer) per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $0, or $0 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 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 Management Facility 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 Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to certain McDonnell Douglas Model DC-8-61, DC-8-61F, DC-8-63, DC-8-63F, DC-8-71F, and DC-8-73F airplanes. That NPRM was published in the Federal Register on May 6, 2008 (73 FR 24887). For certain airplanes, that NPRM proposed to require non-destructive testing (NDT) to detect cracks of the door jamb corners of the forward and aft service doors, and doing applicable related investigative and corrective actions. For certain other airplanes, that NPRM proposed to require inspecting and repairing if necessary or replacing previously repaired door jamb corners with an applicable repair.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed.

There are about 299 airplanes of the affected design in the worldwide fleet. This AD affects about 55 airplanes of U.S. registry. The testing takes about 1 work hour per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is $4,400, or $80 per airplane, per testing cycle.

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.

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.

You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket.

Retirement and disability annuities under the Railroad Retirement Act are composed of independently calculated segments known as tiers. The tier I amount combines both railroad and non-railroad earnings, and is calculated using social security benefit formulas. The tier II amount is calculated under different formulas, generally representing railroad earnings alone. In addition, some annuitants receive a dual benefit component based on non-railroad wages earned through December 1974, or in some cases, through an earlier date. Finally, career railroad employees may receive a supplemental annuity ranging from $23 to $43 per month.

Under section 14(b) of the Railroad Retirement Act, the non-tier I portion of a railroad retirement annuity may be characterized as property subject to partition in a proceeding for divorce, annulment, or legal separation. Prior to August 17, 2007, the effective date of the Pension Protection Act of 2006, Public Law 109-280, a partition payment would terminate upon the death of either the railroad employee or the former spouse, whichever occurred first, unless the court order provided for termination at an earlier date. Section 1003 of Public Law 109-280 amended the Railroad Retirement Act to provide that a partition payment will only terminate upon the employee's death when the court order requires such termination. Consequently, unless the court order requires termination of payments upon the employee's death, tier II partition payments to divorced spouses may now continue beyond the employee's death. While the change in law does not allow for the reinstatement of payments terminated prior to August 17, 2007, due to the death of the employee prior to that date, the change does mean that any divorced spouse who was getting a partition payment as of that date may continue to be paid a tier II partition amount.

The Board amends Part 295 of its regulations to reflect the changes made by Public Law 109-280, to reflect changes in certain titles of agency employees, and to correct or clarify certain references. Specifically, the Board amends section 295.1, which explains the purpose of Part 295, to incorporate a reference to Public Law 109-280. Section 295.1(b)(3) is modified to clarify references to certain annuity increases under section 3(f) of the Railroad Retirement Act.

Section 295.2 is amended to include a separate new definition of former spouse and a revised separate definition of spouse.

Section 295.4(a) is amended by the addition of a new subparagraph (4) to specify that unless a court order expressly provides otherwise, a partition order will be applied to any annuity paid to an employee, whether the employee has retired based on age or based on disability.

The phrase “pertaining to the employee” is added to the end of the second sentence of section 295.4(c) and to the end of the first sentence in section 295.4(d)(2) in order to clarify that the Board's records concerning the railroad employee will be reviewed to determine the most current address for each party to a partition order.

A new subparagraph (4) is added to section 295.5(f) to reflect the amendment made by Public Law 109-280 that allows continued payment of a partition tier II to a former spouse if the railroad employee dies on or after August 17, 2007. Paragraphs 295.5(a) and 295.5(f) are amended to include a reference to the new subparagraph (4).

A new subparagraph (2) is added to section 295.7(e) to clarify that an erroneous payment to the employee may occur if the Board has all required documentation and due to clerical oversight fails to withhold the amount awarded by a court partition order.

Finally, references to “Deputy General Counsel” and to the “Associate Executive Director for Retirement Claims” throughout Part 295 are changed to “General Counsel” and “Director of Retirement Benefits” respectively in order to reflect title changes within the agency. Several minor corrections of capitalization and grammar are also made.

The Board published the proposed rule on March 6, 2008 (73 FR 12037) and invited comments by May 5, 2008. No comments were received. Accordingly, the proposed rule is being published as a final rule without change.

The proposed rule was determined to be a significant regulatory action and was reviewed by the Office of Management and Budget prior to its publication in the Federal Register . There are no changes to the information collections associated with Part 295.

On September 14, 2007, the Department, through OLMS, issued proposed revisions to the Guidelines it employs to administer the Department's program under 49 U.S.C. 5333(b), which requires the Secretary to certify that labor protections are in place for employees who may be affected by certain grants of Federal financial assistance. See Amendment to Guidelines for Processing Applications for Assistance To Conform to Sections 3013(h) and 3031 of the Safe, Accountable, Flexible, and Efficient Transportation Equity Act—A Legacy for Users and To Improve Processing for Administrative Efficiency (“NPRM”), 72 FR 52521. The Department invited written comments on the proposed revisions from interested parties. The written comment period closed on October 15, 2007, and the Department has considered all timely comments received in response to the proposed Guidelines revisions.

The Department received 10 timely comments in response to its proposed revisions, including five comments from various labor organizations (the Transportation Trades Department of the AFL-CIO; the Amalgamated Transit Union; a joint submission from the United Transportation Union and the Sheet Metal Workers International Association; the Transportation Communications International Union, and a joint submission by the American Train Dispatchers Association, the Brotherhood of Locomotive Engineers and Trainmen/IBT, the Brotherhood of Maintenance of Way Employees Division/IBT, the Brotherhood of Railroad Signalmen, the International Brotherhood of Boilermakers and Blacksmiths, the National Council of Firemen and Oilers/SEIU, the Sheet Metal Workers International Association, and the Transport Workers Union of America (rail division)); two comments from transit associations (American Public Transportation Association and Taxicab, Limousine & Paratransit Association); two public transit authorities (the Texas Department of Transportation and the Regional Transportation Commission of Southern Nevada); and one private consulting firm (Jim Seal Consulting Services).

Under 49 U.S.C. 5333(b), when Federal funds are used to acquire, improve, or operate a transit system, the Department must ensure that the recipient of those funds establishes arrangements to protect the rights of affected transit employees. Federal law requires such arrangements to be “fair and equitable,” and the Department must certify the arrangements before the U.S. Department of Transportation's Federal Transit Administration (FTA) can award certain funds to grantees. These employee protective arrangements must include provisions that may be necessary for the preservation of rights, privileges, and benefits under existing collective bargaining agreements or otherwise; the continuation of collective bargaining rights; the protection of individual employees against a worsening of their positions related to employment; assurances of employment to employees of acquired transportation systems; assurances of priority of reemployment of employees whose employment is ended or who are laid off; and paid training or retraining programs. 49 U.S.C. 5333(b)(2).

The development of these Final Guidelines has included a careful review of the public's timely comments. All timely comments received are addressed in this Section. In those cases in which comments made suggestions that, in the Department's view, improved or corrected the proposed Guidelines, such changes have been incorporated. In some cases, no change to the proposed language was deemed necessary.

In its NPRM, the Department proposed amending the guidelines to conform to section 3031 of SAFETEA-LU, which added a new subparagraph to section 5333(b) relating to grants for the purchase of “like-kind” equipment or facilities. As amended by SAFETEA-LU, section 5333(b)(4) now requires that employee protective arrangements for grants requesting assistance to purchase like-kind equipment or facilities be certified by the Department without referral to the parties. The current Guidelines, at section 215.3(b)(1), reflect this practice, except that the current provision creates an exception to non-referral if the Department determines that the grant application has a “potentially material effect on employees.” To conform the guidelines to the statutory mandate, the proposed guidelines, at section 215.3(a)(4)(iii), provided that employee protections relating to grants funding equipment and/or facilities of like-kind shall be certified without a referral, and deleted the “material effect” exception. Proposed Section 215.3(a)(4)(iii) also addressed the terms the Department will apply in like-kind grant applications. That section states that where “application of the existing protective agreement(s) or the Unified Protective Arrangement would not satisfy the requirements of the statute in the circumstances presented, the Department will make any necessary modifications to the existing protections to ensure that the requirements of the statute are satisfied.”

The Department received five comments regarding its proposed change to its processing of grant applications to replace like-kind equipment or facilities, and the comments addressed the following three issues: Whether it is appropriate for the Department to eliminate its current exception to its practice of non-referral of grant applications for like-kind purchases in those cases in which the funding would result in a “potentially material effect on employees” under the current Section 215.3(b)(1); whether the Department appropriately included new language in Section 215.3(a)(4)(iii) permitting it to make “any necessary modifications to the existing protections” when certifying grant applications for like-kind purchases; and whether the Department will notify the labor organizations representing employees who may be affected by grant applications for like-kind purchases that the Department has received such an application but has made no referral. Addressing the last issue first, the Department has included a subsection in Section 215.3(a) to confirm its current practice that the Department will “notify labor organizations representing potentially affected transit employees of the certification of grants without referral under paragraph (a)(4) and inform them of their rights under the applicable protective arrangements.” See Section 215.3(a)(5).

The Department has fully considered the first issue regarding the deletion of the current exception to the practice of non-referral of grant applications for like-kind purchases in those cases in which the funding would result in a “potentially material effect on employees,” currently found at Section 215.3(b)(1). The amendments to 49 U.S.C. 5333(b) enacted by SAFETEA-LU incorporate the following provision into the statute:

The remaining issue addressed by the comments dealing with the Department's non-referral of grants for like-kind purchases is the Department's proposal in Section 215.3(a)(4)(iii) to “make any necessary modifications to the existing [non-referred] protections to ensure that the requirements of the statute are satisfied” in those cases in which application of the existing protective agreement(s) or the Unified Protective Arrangement would not satisfy the requirements of the statute. One comment in particular noted that where changes to existing arrangements are “deemed necessary [they] should be referred to the parties for resolution or, at a minimum, such imposed changes should be made without prejudice to any future objections or proposal by the parties.” Comment submitted by Transportation Communications International Union in response to NPRM, October 15, 2007 (“TCU Comment”), page 2.

With one modification, the Department will retain the proposed language in Section 215.3(a)(4)(iii) to permit it to modify those non-referred arrangements to comply with the statute in the event that circumstances associated with a grant for a like-kind purchase indicate that application of the current protective arrangement would no longer satisfy the statute's requirements. Because referrals are not permitted for like-kind grants, and situations may arise where the existing protections are not statutorily sufficient, the Department must retain the authority to unilaterally apply protections as an alternative to referral. Situations that may give rise to the Department's need to make a unilateral change to existing protections include a change to the framework of state or local law, a court decision interpreting existing protections, or where the Department's periodic review of an agreement has disclosed that required protections are missing or inadequate based on current policies and standards. This retention of authority to unilaterally modify non-referred arrangements to ensure statutory sufficiency is consistent with the Department's treatment of other grant programs subject to non-referral, see, e.g. , 29 CFR 215.3(a)(4), 215.3(b)(3), and is necessary in order to ensure that the Department certifies only those arrangements that are statutorily sufficient. In some circumstances the Department will need to modify protections to simultaneously ensure satisfaction of the statutory requirements and to conform to the SAFETEA-LU requirement that certification be made without referral. However, in response to comments by labor organizations suggesting that the proposed language was too broad and created uncertainty, the Department will delete the word “any,” which may be broadly construed, from the proposed Section 215.3(a)(4)(iii) so that the final Guidelines limit the Department to “make necessary modifications to the existing protections to ensure that the requirements of the statute are satisfied.” See Section 215.3(a)(4)(iii).

The Department agrees with the comment, noted above, suggesting that imposed changes should be made without prejudice to any future objections or proposals by the parties. Therefore, should the Department determine unilaterally that changes are necessary to arrangements applicable to a particular like-kind grant in order to satisfy the requirements of the statute in the circumstances presented, those changes will be made without prejudice to future objections or proposals of either of the parties in response to subsequent referrals for new grants. Accordingly, where subsequent referrals contain the unilateral modifications made by the Department pursuant to Section 215.3(a)(4)(iii), parties to the referral may object at that time to the proposed terms, including any terms that had been unilaterally modified by the Department. This approach is consistent with the Department's practice, in which it fully considers any objections to referral terms, even when those terms have been previously imposed by the Department. Where objections are deemed sufficient in subsequent referred protections, the Department will require negotiations to permit the parties to develop alternative employee protections for application to the subsequently referred grant.

The Department has proposed amending section 215.5 of the guidelines to conform to section 3031 of SAFETEA-LU, which provides that “grant amendments which do not materially amend existing assistance agreements” will not be subject to the Department's referral procedures. See 49 U.S.C. 5333(b)(4). The proposed guidelines were designed to reflect this statutory provision, and to clarify the Department's treatment of grant amendments that, on the one hand, result in material changes to existing assistance agreements and those that, on the other hand, make only immaterial changes to such agreements. The proposed revision also identified as examples some types of grant amendments that would be certified without referral. As set out below, in response to certain comments from the public, the Department has made some revisions to proposed section 215.5.

As explained in the NPRM, the statutory change regarding certification of grant amendments essentially codifies the Department's current practice, and requires the Department to distinguish between “material” grant amendments that will be referred and “immaterial” grant amendments that will be certified without referral. 1 In making the distinction in the NPRM, the Department focused on what constituted “immaterial” grant amendments, in large part because this term already appears in the Guidelines, which establish that the Department will certify “immaterial” grant revisions or amendments on the basis of the previously certified terms without referral. See current 29 CFR 215.5. In responding to the statute's now explicit requirement that the Department refer only those grant amendments that are “material,” and building on the presence of the term “immaterial” in the Guidelines text, the Department proposed in the NPRM to add to the Guidelines several circumstances in which it appeared that “immaterial” changes were present. For reasons explained here, the Department has rejected this approach, and has revised Section 215.5 accordingly.

Several comments raised concerns about the Department's distinction between grant amendments that make material changes and those that make immaterial changes to existing assistance agreements. Two comments objected to the Department's description of the nature of an immaterial grant amendment. Comments submitted by the Amalgamated Transit Union (ATU) in response to the NPRM, October 15, 2007 (“ATU Comment”), page 3; United Transportation Union, October 11, 2007 (“UTU Comment”), page 2. Additionally, one comment noted concern that “the NPRM does not appropriately define the line between material and immaterial grant amendments” and that “the NPRM would actually allow material amendments without referral, which clearly violates the intent of Section 3031 of SAFETEA-LU.” Comment submitted by Transportation Trades Department, AFL-CIO, October 15, 2007 (“TTD Comment”), page 2.

As is the Department's current practice, Section 5333(b)(4) now explicitly requires the Department to review and assess the potential impact on employees and existing protections in order to distinguish between those grant amendments that may “materially revise or amend existing assistance agreements,” which will be referred, and those that do not. In order to clearly incorporate the statutory mandate into the Guidelines, the Department has revised proposed Section 215.5(a)(2) (now Section 215.5(a)(1) in the final Guidelines) to indicate that material changes are those that “make changes to a project that may necessitate alternative employee protections.” If a grant amendment makes changes to a project that may necessitate alternative employee protections in the circumstances presented, a new referral will be made. Conversely, those grant amendments that do not materially revise a grant in such a way that they would potentially affect employees will not be referred. The Department's past practice and administrative experience, upon which the Department will rely to administer certification of grant amendments, suggests generally that material changes that may necessitate alternative employee protections include those that constitute a significant, important or sizeable change to items or elements in the federally funded project.

The Department agrees with those comments suggesting that the specific examples of “immaterial changes” included in the proposed guidelines did not provide useful guidance for either the Department or the regulated community in determining when referral would be necessary. The examples in the NPRM largely mirrored FTA criteria for categorizing the nature and type of grant modifications for that agency's determination of whether a change was, in fact, a “grant amendment,” and did not serve to assist with the concept of “material” grant amendments as that term is used in Section 5333(b)(4). Because conclusions regarding the impact of changes may vary in differing circumstances, those examples may not universally qualify as immaterial changes for the Department's statutory purposes. Moreover, the comments regarding the NPRM's examples of “immaterial” grant amendments reinforce the conclusion that the term itself is too dependent on specific facts to be capable of a more detailed definition in the abstract. Under these circumstances, hypothetical examples are more likely to result in confusion than clarity.

Upon reconsideration of the approach to this subject in the NPRM, the Department has made three modifications to Section 215.5 (in addition to the change noted above regarding “material” amendments) to clarify the procedures under which grant revisions or amendments will be certified. First, as an organizational matter, the order of the two sub-paragraphs in subsection 215.5(a) have been switched, so that the initial subparagraph of the subsection addresses the issue of “material” revisions or amendments. Second, the term “immaterial” has been deleted from Section 215.5, and final subparagraph (a)(2) instead addresses those cases in which “an application amends in a manner that is not material” a previously certified grant. Finally, those examples of immaterial changes to a grant have been deleted, and because each grant is fact-specific, the Department has concluded that including alternate examples of “immaterial” changes in the Guidelines would not assist in the administration of the program * * * See 29 CFR 215.5(a)(1) and (a)(2). As the Department does with all non-referred grants, informational copies of those grant amendments not referred will be sent to the affected labor organizations.

In addition, one comment notes that the proposed guidelines did not include a provision in this section for the Department to “make any minimal modifications necessary to the protective terms where application of existing protective agreements would not satisfy the requirements of the statute in the circumstances presented.” ATU Comment, page 3. Similar authority has been adopted for like-kind grants certified without referral, and comments suggested that such language would be appropriate in any instance where protections would be applied without referral. The Department has determined that such language is not necessary to ensure satisfaction of the requirements of the statute when grant amendments are processed by the Department. As noted above, where grants materially revise existing assistance agreements by making changes that may necessitate alternative employee protections in the circumstances presented, the Department will refer the grant amendment, and the parties will have the opportunity to address employee protective provisions that may not satisfy the statute in the circumstances presented. Where grant amendments make changes that require no alternate employee protections, then the Department need not retain authority to make unilateral modifications to employee protections. Under either process, the requirements of the statute will be assured, and there is no need for the Department's retention of this authority with regard to grant amendments.

Finally, several comments indicated that a copy of applications for grant amendments that result in no referral must be provided to labor organizations. Consistent with the proposed guidelines, the Department confirms that its “processing of these applications will be expedited and copies will be forwarded to interested parties.” See 215.5(a)(2). In addition, the Department will forward to service area unions any informational copies of budget revisions received from the Federal Transit Administration.

For grant applications under 49 U.S.C. 5311 for funding of transit operations in Other Than Urbanized areas, SAFETEA-LU now requires the use of a warranty as the sole mechanism for certification of employee protections, and eliminates the Secretary of Labor's option to waive the required certification. See 49 U.S.C. 5311(i). 2 Prior to the enactment of SAFETEA-LU, the Department followed procedures contained in a “Guidebook” published in September 1979 governing the processing of small urban and rural grants. The Department is discontinuing use of the 1979 Guidebook, and has included in sections 215.3(a)(4)(i) and 215.7 procedures to be used for the application of a warranty without referral when processing Other Than Urbanized and Over-the-Road Bus (OTRB) grants. 3 The comments received by the Department raised several issues, and particularly addressed two primary issues concerning procedures used to bind State's subrecipients to terms of the Special Warranty and the application of alternative comparable arrangements when necessitated by requirements of the statute.

Regarding the subrecipients issue, the Department indicated in the NPRM that it will include a requirement in the new Special Warranty that the protective arrangements are binding upon any subrecipients assisted under the grant. Three comments expressed concern that the Department had eliminated the requirement contained in the Guidebook to have State agencies provide copies of assurances to the Department indicating each recipient had signed and understood the Special Warranty. One comment in particular noted that “[e]nforcement of employee protections under such a provision would * * * be problematic at best and more likely a practical, or even legal, impossibility.” ATU Comment, page 5. Another comment indicated that “transportation labor urges the Department to establish procedures to guarantee that sub-recipients are bound to the protective arrangements, perhaps by continuing to require written assurances.” TTD Comment, page 2. Still another comment indicated that the Department cannot “bind third parties to arrangements simply by proclaiming they are bound in a Special Warranty that will be incorporated into the contract of assistance * * *.” UTU Comment, page 3.

In response to these comments, the Department notes that the former Special Warranty procedures required only that a State agency “certify to the Department of Labor that each Recipient designated to receive transportation assistance under the Project has indicated in writing acceptance of the terms and conditions of the Warranty.” Rural Transportation Employee Protection Guidebook, September 1979, page 13. Thus, the Department did not require fully executed copies of the Special Warranty from each subrecipient, but instead required only that a State agency submit certified lists of recipients that it indicated had signed the Warranty. Accordingly, the obligation to ensure that recipients had signed and were thus bound by the Special Warranty has long rested with the State agencies. The Department has not altered the State agencies' responsibility to ensure that its subrecipients are equally bound to the terms of the Special Warranty.

In response to concerns noted above regarding a State's obligation to ensure that its subrecipients are bound to the terms of the Special Warranty, the Department clarifies its proposal in the NPRM that it will include language in the Special Warranty requiring the State agency (Grantee), which signs the contract of assistance, to obligate its subrecipients to the required protections as a condition precedent to the subrecipient's receipt of any funds under the contract of assistance. Thus, the requirement remains that a State agency must ensure that sub-recipients have agreed to be bound by the protective arrangements. That requirement will now be an explicit part of the Special Warranty, and the failure to comply with this provision may impact the State's eligibility for such funds. In addition, should a Grantee fail to bind a subrecipient, the alleged breach can be pursued in a state court. Therefore, the new procedure is an adequate, effective alternative to assuring that subrecipients are bound and their employees are aware that the protections of the Special Warranty are fully applicable.

Regarding the “alternative comparable arrangement procedures” issue, the Department stated in the NPRM that “as required under SAFETEA-LU, the Department will eliminate waivers and procedures to request alternative comparable arrangements.” This statement raised concerns among several commenters. Some noted that although SAFETEA-LU eliminated procedures to waive application of the Special Warranty, the amendment did not require that the alternative comparable arrangements provision be removed. In addition, comments noted, some State agencies and subrecipients may be deemed ineligible for assistance if alternative warranty arrangements were not available.

SAFETEA-LU specifies that employee protections will be applicable to Other Than Urbanized grants “if the Secretary of Labor utilizes a special warranty that provides a fair and equitable arrangement to protect the interests of employees.” 49 U.S.C. 5311(i). To clarify our statement in the NPRM, the Department interprets this statutory provision to preclude the development of alternate arrangements through special procedures established in the Guidelines. However, after considering comments, the Department has concluded that where a recipient is unable to satisfy the specific provisions in the Special Warranty because of a conflict with State or local law, the Department will make every effort to develop modifications to the Warranty that are necessary to ensure that the requirements of the statute are satisfied.

This approach is consistent with the Department's residual authority, noted above in reference to like-kind grants, to make modifications to non-referred arrangements where necessary. Therefore, as with all non-referred arrangements that present compliance problems for grantees as the result of conflict with State or local law, parties must notify the Department in writing in advance of the Department's certification that modification to the terms of the Special Warranty may be necessary. In instances in which the Department makes necessary modifications to the Special Warranty for specific recipients or subrecipients, a supplementary certification letter will be sent to the FTA setting forth the alternative provisions to be included in the contract of assistance between the recipient and FTA, by reference.

Other comments concerning the new Special Warranty procedures addressed the omission of a provision in the proposed guidelines to ensure that potentially affected transit employees in the service area of Other Than Urbanized grants, in addition to those employees who may be affected by Over-the-Road Bus grants, are notified of their rights under the Special Warranty and receive copies of grant applications to facilitate the unions' administration of protections. This inadvertent oversight has been corrected in the final guidelines, which now state that the “Department will notify labor organizations representing potentially affected transit employees of the approval of Other Than Urbanized and OTRB grants and inform them of their rights under the Special Warranty Arrangement.” See Section 215.7(d)(2).

Two comments note that proposed Section 215.7 states that the revised Special Warranty will be “derived from the terms and conditions of the May 1979 Special Section 13(c) Warranty, and the Department's subsequent experience under 49 U.S.C. 5333(b).” NPRM Section 215.7. These comments request that the Department clarify what it means to “derive” protections from the current Special Warranty, and that it also specify that the terms and conditions of any new Warranty Arrangement will be “no less protective” and “offer no less protection” than the version currently in place. ATU Comment, page 5; UTU Comment, page 3. While the terms and conditions of the Special Warranty will adopt much of the May 1979 Special Section 13(c) Warranty, some additional changes are needed to reflect processing differences under the new Guidelines, to create a self-contained document, and to update the language. Most of the planned changes are largely procedural and were previously described in the NPRM, such as the establishment of procedures necessary to bind subrecipients, the elimination of the need for unions to become a party to the Special Warranty, the elimination of the Department's finding of noncompliance in the Other Than Urbanized program, and the adoption of a dispute resolution procedure that ends the Department's involvement in claims arbitration. In response to concerns that the new Special Warranty must not be less protective than its predecessor, the Department will ensure that the provisions of the new Special Warranty provide appropriate protections for Other Than Urbanized and OTRB grants and continue to satisfy all the requirements of the statute.

Two comments note that the Department has indicated that it will no longer make findings of non-compliance and will instead include a dispute resolution procedure to address compliance issues that arise under the Special Warranty. One comment indicates that “provisions must be made for the Department to honor an arbitrator's ruling of non-compliance and refuse further certifications to stop new funding from flowing to the recipient until evidence of compliance is presented to the arbitrator.” ATU Comment, page 5. In the absence of such provisions, the commenter suggests that violators would be free of consequences resulting from the failure to abide by the Warranty. The Department has concluded that the inclusion of a standard labor arbitration dispute resolution procedure in the Special Warranty will ensure that there is a process in place to resolve disputes, and the arbitrator may direct compliance with the terms of the Warranty. A prevailing party to an arbitrator's ruling directing compliance with the terms of the Warranty can seek enforcement of that ruling in the appropriate state court.

Three comments indicate that it is unclear how the Special Warranty is to be included in the contract of assistance. The proposed guidelines specified in section 215.7(c) that “[t]he Federal Transit Administration will include the current version of the Special Warranty, through reference in its Master Agreement.” The Master Agreement is included in each contract of assistance with a Grantee receiving Federal assistance and the reference in the Master Agreement will include language which specifies that the recipient agrees to comply with the terms and conditions of the Special Warranty Arrangement which is most current as of the date of execution of the contract of assistance, and any alternative comparable arrangements specified by the Department of Labor for application to the recipient's grants.. Inclusion of this language in the Master Agreement will ensure that the protections are binding on the Grantee and the specific reference to Special Warranty Arrangement that is most current as of the date of the execution of the contract of assistance will eliminate confusion about which terms and conditions were applied if changes to the Warranty are made in the future.

Several comments raised concerns regarding the procedures the Department will use to identify relevant labor organizations as a result of the Department's notification provision in Section 215.7(d)(2) of the proposed guidelines (now Section 215.7(c)(2) of the final guidelines). In the past, the Department has relied on information contained in the grant applications to identify labor organizations that may be affected by grants and should be notified of Federal funding of projects, and such information has generally proven sufficient to make such identification. Accordingly, this information will be employed to make the notifications required in Section 215.7(c)(2). Other comments expressed doubt that, as asserted in the NPRM, the changes to the Special Warranty procedures will advance administrative efficiency. In response, the Department notes a variety of changes that it believes will improve the efficiency of the Special Warranty program and streamline the Department's processes: the provision establishing that the FTA will incorporate required employee protections into the contract of assistance through the Master Agreement and proceed with funding of Other Than Urbanized and Over the Road Bus grants without awaiting the Department's prior approval; the elimination of procedures to request to become a party to the warranty; the elimination of waiver procedures; and establishment of third-party neutral arbitration of disputes involving labor organizations, among others.

In the NPRM, the Department proposed amending section 215.3(b)(1) and (2) of the guidelines to implement use of a unified protective arrangement (UPA) for both operating and capital grants except in certain situations set forth in the guidelines. 4 The use of the UPA was primarily proposed because, over the past 12 years, administrative modifications to the Department's Operating and Capital Assistance Arrangements have rendered the two documents virtually identical to each other. As a result, the Department determined that two separate arrangements were no longer necessary, and administrative efficiency would be improved through the application of a single arrangement applicable to both operating and capital assistance. Application of a single UPA to future grants will simplify the preparation of referrals, expedite processing of grant applications, and, most importantly, continue to satisfy the requirements of the statute.

To clarify those circumstances in which previously certified arrangements will continue to be referred, and those circumstances in which the UPA will be referred, the Department has made organizational and substantive revisions to Sections 215.3(b)(1) and (b)(2). Section 215.3(b)(1) now sets forth the general proposition that the Department will refer to applicants with previously certified arrangements, and new applicants that develop and submit protections to the Department before applying for assistance, those protective terms and conditions that are appropriate to the new grant and are set by:

(1) A negotiated agreement developed and executed by the parties or the parties' adoption of the Model Agreement;

(2) Terms adopted by a state or local government based on agreement between the grantee and affected employees, where the grantee is a state or political subdivision subject to legal restrictions on bargaining collectively with employee organizations;

(3) A determination of protective terms by the Department that modifies in whole or in part negotiated or adopted protections; or

(4) A standardized arrangement (either the Operating or Capital Arrangement) that has been modified through agreement or determination to include provisions that are more protective than the UPA.

In addition to the organizational change, the Department has concluded that a substantive revision was required to Section 215.3(b)(1) (formerly proposed 215.3(b)(2)) because the standard originally proposed— i.e. , whether a provision in an arrangement modified by negotiation or Department determination, was “addressed by” the UPA—was ambiguous and would permit the substitution of the UPA in those cases in which the parties' may have adopted unique provisions that may be “more protective than” the UPA. Similarly, the language may have permitted the substitution of the UPA for a negotiated agreement or adopted instrument where the Department had made a determination addressing one issue in that otherwise unique agreed upon document. This result was not intended, and so the standard for the use of the UPA in those cases in which the applicant has protective terms described in Section 215.3(b)(1)(iii) and (iv) has been modified accordingly.

A number of comments raised concerns regarding the continued application of previously certified arrangements, and whether they would be replaced in new grants by new arrangements. With the implementation of these guidelines revisions, in those cases in which the applicant has been previously certified on the basis of the Operating or Capital Arrangements, and there has been no modification to that previously certified arrangement through negotiation or Departmental determination, the UPA will be referred to the parties for the next grant. Section 215.3(b)(2). In those cases in which the applicant has been previously certified on the basis of the Operating or Capital Arrangement that has been modified either through negotiation or Departmental determination, and that modification contains a protective provision with an equivalent level of protection as a provision in the UPA, then the UPA will form the basis of the referral for the next grant. Section 215.3(b)(2). If the applicant has been previously certified on the basis of the Operating or Capital Arrangement, and any negotiated or Department-imposed modification thereto contains a protective provision that exceeds the level of protection established by a similar provision in the UPA, then the previously certified arrangement and not the UPA will be referred for the next grant because that arrangement is unique to those parties. Section 215.3(b)(1)(iv). The Department considers to be relatively rare those cases in which a grantee has been previously certified on the basis of Operating or Capital arrangement with more protective negotiated or Departmentally determined modifications. If the grantee has been previously certified based on protective terms and conditions that include, in whole or in part, a Departmental determination, then the previously certified terms and conditions and not the UPA will be referred for the next grant, again because those protections are unique to those parties. Section 215.3(b)(1)(iii). Finally, if the grantee's previous certifications are based on either a negotiated agreement, adoption of the Model Agreement, or adoption through resolution or other means by a state or local government of protective terms agreed to by the parties, those protections are unique to the parties and will form the basis of the Department's referral for the grantee's next grant. Section 215.3(b)(1)(i) and (ii). The same is true for new applicants that present to the Department proposed terms for certification based on either a negotiated agreement, adoption of the Model Agreement, or adoption through resolution or other means by a state or local government of protective terms agreed to by the parties—the Department's referral in those cases will be based on those proposed terms and not the UPA. Section 215.3(b)(1).

Three comments indicated that there was support for a UPA, and for elimination of the sole provider clause from the terms and conditions to be applied. The Department received no explicit objections to elimination of the sole provider clause, but we presume that labor organizations that objected to the development of the UPA in general objected sub silentio to the elimination of the sole provider clause. The primary goal addressed by the use of the UPA is to substitute one instrument in place of the two instruments previously used. In addition, the terms of the UPA are intended to uniformly apply statutorily sufficient terms and conditions to future grants, where warranted. As a result, the UPA will exclude the “sole provider” clause, which has been determined by the Department to be unnecessary in ensuring compliance with the statute.

Some comments indicated that certifying new arrangements for grant applicants that are already a party to Department of Labor-crafted arrangements would not create efficiencies in administration of the employee protections and would add to the number of arrangements to be administered, not reduce their proliferation. Currently, each time a new union is recognized, service is expanded to areas involving new unions, or a new project is proposed, additional operating and/or capital arrangements are put in place to accommodate the new unions or new service. Applying the UPA will reduce this proliferation of operating and capital arrangements through application of the same arrangement to all those unions that are using standard Department of Labor-crafted arrangements. As new grant applications are submitted, the Department will refer the UPA rather than the various post-1996 Operating and Capital Arrangements. As a result, the administrative burden for the regulated community, as well as the Department, will decrease over time.

Several comments expressed concerns that the Department's proposed adoption of the UPA is not consistent with the policy that the Department adopted when it revised the guidelines in 1996. One comment indicated that the earlier guidelines “sought to preserve all terms, including those never negotiated or in bilateral agreements.” ATU Comment, page 7. Another comment indicated “it is improper to unilaterally negate arrangements that were negotiated in good faith or developed by DOL determination following briefing by the parties.” Comment submitted jointly by the American Train Dispatchers Association, et al. (“ATDA, et al. comment”) in response to NPRM, October 15, 2007, page 3. The Department recognizes that the approach of applying the UPA in lieu of previously certified standard protective arrangements, i.e. , the Operating or Capital Arrangements, departs from the practice established under the 1996 guidelines. Pursuant to the 1996 guidelines revisions, new applicants and applicants for which previously certified arrangements were not appropriate to the pending project received a referral based on either the Operating Arrangement or the Capital Arrangement, and that arrangement would continue to be applied to subsequent grants unless the parties objected and the provisions were renegotiated. This system led to the proliferation of multiple arrangements and created a system that is currently difficult to administer. The UPA was developed in order to consolidate protections into one document that satisfies all of the statutory requirements. This will eventually reduce the grantees' need to administer multiple sets of standard arrangements for unions representing affected employees in the service area of a project. Use of the UPA will also benefit International Unions, because their oversight of protections applied for their local unions should be substantially more uniform. Moreover, application of the UPA in lieu of existing standard arrangements does not “unilaterally negate” the existing protective arrangements, because those arrangements will continue to be in force for the projects for which they were certified. Only grantees with previous certifications that do not fall into one of the categories contained in Section 215.3(b)(1) will have the UPA referred as a standard protective arrangement.

The Department's administration of the program will also be improved using the UPA. Initially, as one comment suggested, the Department's decisions regarding referrals based on the UPA will “call for a level of discretion in individual cases that will render the process more, rather than less complex.” ATDA, et al. comment, p. 3. However, once the exceptions have been identified, processing of future grants will be expedited considerably. It will be easier to keep track of the appropriate protections to be included in future referrals and the parties to those protections. In the long run, there will be fewer arrangements for the Department and the regulated community to administer, and it will be easier to change a standard arrangement such as the UPA to reflect current program policies and statutory standards applicable to grants whenever necessary. As the Department previously indicated, it will also provide administrative certainty for the applicant and union because, with the exception of existing negotiated agreements and certain arrangements which are the product of negotiations or determinations, only the UPA will be applied to any particular grant.

Finally, one comment expressed concern about the referral of the UPA should one or more provisions within it conflict with State law. The Department has determined that a State law conflict with one or more provisions of the UPA's protective terms and conditions will not render the entire document “inappropriate” for referral. In the event that a State law conflict is raised in connection with the provisions in the UPA, the Department will resolve such a conflict in the same manner that it currently does—by negotiation or Departmental determination of a substitute term required as the result of a sufficient objection raised under Section 215.3(d)(3).

The Department proposed amending Section 215.3(a)(4) of the guidelines to specify that OTRB grants will no longer be subject to its referral process, but instead will be certified on the basis of the Special Warranty. The NPRM indicated that by eliminating referrals for OTRB grants and using the Special Warranty for certification, the Department intended to fully implement a requirement in the legislation establishing the OTRB program (Transportation Equity Act for the 21st Century “TEA-21”, Public Law 105-178 (1998)) that OTRB grants “shall be subject to all of the terms and conditions applicable to subrecipients who provide intercity bus transportation under section 5311(f) of title 49.” Section 3038(f) of TEA-21. The Department reasoned that because grants under 49 U.S.C. 5311(f) are certified on the basis of the Special Warranty without referral to the parties, TEA-21 contemplated that OTRB grants would be certified on the basis of the Special Warranty without referral.

Three comments challenged the Department's stated interpretation of TEA-21. Commenters suggested that in the absence of specific exclusionary language, TEA-21 cannot be read to preclude the use of the referral process for OTRB grants, particularly in light of the fact that Congress subsequently employed specific exclusionary language in SAFETEA-LU with regard to the Other Than Urbanized grant program.

Upon reconsideration, the Department agrees with those comments stating that TEA-21 does not require OTRB grants to be certified without referral. Indeed, in 1999, when finalizing revisions to the Guidelines following the passage of TEA-21, the Department concluded that TEA-21 requires only that OTRB grants be subject to certification by the Secretary under Section 5333(b), and that “neither th[at] statute nor [its] legislative history specify the procedures for processing these grants.” See 64 FR 40,990, 40,992 (July 28, 1999). Accordingly, “the Department has flexibility to develop and implement procedures appropriate to carry out its section 5333(b) responsibilities” as to these grants. Ibid. In employing its administrative discretion under TEA-21, the Department at that time decided to employ the use of its referral procedures to OTRB grants.

Although the Department agrees that TEA-21 does not require OTRB grants to be certified without referral, the Department nevertheless adheres to its proposal in the NPRM that such grants will be processed in that manner. While one comment appears to argue that TEA-21 mandates the use of referral (ATU Comment, page 7), such an argument is premised on the incorrect assumption, which the Department rejected in 1999, that the “terms and conditions” guaranteed by TEA-21 include the referral procedure. Thus, the comment has provided no basis for concluding that referral is required. As a result, in employing its discretion, the Department now concludes that use of the Special Warranty without referral is the preferred policy in the OTRB context. As explained in the NPRM, the Department's experience with the OTRB program has led to the conclusion that use of the Special Warranty will improve administration of the program. See 72 FR at 52,522. Use of the Warranty streamlines the Department's processing of grants that have limited potential for adversely affecting employees and historically have been the subject of very few objections, while continuing to ensure that the requirements of the statute are satisfied through application of a Special Warranty. Accordingly, the Department will administer grants under the OTRB program through application of the warranty arrangement set forth in Section 215.7, which also provides procedures to be followed for the Other Than Urbanized program. See Section 215.7.

Several adjustments were proposed in the NPRM to reflect current administrative practices.

First, the Department has eliminated language contained in Section 215.2 of the guidelines indicating that it will process applications that are in “preliminary” form. This section now requires that applications “be in final form,” based on the Department's determination that its administrative processes should not be engaged until the grant application reflects the actual project activities to be undertaken. Although all project activities must be firmly established, it is not necessary that project funding be available for the entire grant before the Department processes its certification of the grant. In addition, Section 215.8 will be modified to add an e-mail address and correct the room number of the Division of Statutory Programs office. Finally, the text of Section 5333(b) of the Federal transit law, which was set out in its entirety in Section 215.1 of the current Guidelines, has been removed from that section in the Final Guidelines so that modifications of the Guidelines will not be necessary each time statutory changes are enacted. The Department received no comments addressing these proposed administrative changes. As a result, the Final Guidelines will incorporate these revisions as proposed in the NPRM.

As part of its administrative changes, the Department proposed to amend Section 215.6 to further explain how interested parties may utilize the July 23, 1975 National (Model) Agreement. In particular, the Department proposed to add procedures in Section 215.6, comparable to those in paragraphs 26, 27, and 28 of the Model Agreement itself, by which applicants and unions may become a party to or withdraw from the Model Agreement. One comment objected to the inclusion of these National Agreement paragraphs as untimely and unnecessary, indicating that they provide an “incomplete explanation containing only a fraction of the procedures under the National Agreement.” ATU Comment, page 8. Furthermore, it was indicated that additional parties no longer sign on to the National Agreement, and that those that are a party require no additional explanation and have access to the National Agreement itself or can access it through the Department's Web site.

The Department's proposed guidelines were intended to increase awareness that the Model Agreement remains an appropriate instrument for the parties to agree to and apply to operating assistance projects. If grant recipients choose to do so, they, along with labor organizations representing employees in the service area, may continue to sign on to the Model Agreement and the Department will utilize this as a basis for referral of operating grants. Upon reconsideration, the Department concludes that it is not necessary to include in the Final Guidelines procedures regarding becoming a party to or withdrawing from the Model Agreement, particularly because the entire Model Agreement is available on the Department's Web site . Accordingly, section 215.6 of the guidelines will remain unchanged from its current version, except to make a technical correction so that this section accurately refers back to a revised portion of Section 215.3, and to reflect the current name of the American Public Transportation Association. See 29 CFR 215.6.

Several comments addressed the Department's discussion of Section 3031 of SAFETEA-LU, which directs the Department to follow certain substantive principles enunciated in the Department's decisions for grant NV-90-X021 (decision of September 21, 1994, supplemented by decision of November 7, 1994, also called the “Las Vegas decisions”) when making determinations involving assurances of employment when one private transit bus service contractor replaces another through competitive bidding. See 49 U.S.C. 5333(b)(5). The Department stated in the NPRM that because the Guidelines are procedural in nature, and do not encompass discussion governing the adjudication of substantive rights of parties, this provision of SAFETEA-LU would not be addressed in the revisions of the Guidelines.

In response to the NPRM, two comments requested that the Department address the Las Vegas decisions in its final rule, one suggested that the Department use only the precise language of the decisions, and the other suggested that the Department fully analyze and explain those decisions in the final rule. One comment in particular, submitted on behalf of the Regional Transportation Commission of Southern Nevada (“RTC”), took issue with the Department's very limited description of the Las Vegas decision in the NPRM and asserted that the Department had “mischaracterized” and “fail[ed] to fairly and honestly explain the principles” of the Las Vegas decisions. Comment of RTC submitted in Response to NPRM, Oct. 15, 2007, at 4. Although the RTC comment urges the Department to set forth a substantive interpretation of the Las Vegas decisions, the comment does not discuss the Department's primary justification for not addressing the decisions' principles in the guidelines— i.e., the Department's guidelines have, since 1978, been intended only to establish procedures governing the efficient certification of transit grants and not substantive interpretation of 49 U.S.C. 5333(b) guarantees. Moreover, the Department's brief discussion of the Las Vegas decisions, in the context of explaining why the Department would not address them in its procedural guidelines, was not intended to constitute complete guidance on, or interpretation of, the principles articulated in those decisions. Thus, it is unnecessary to join issue on the question whether the Department mischaracterized those principles in the NPRM. Parties to Departmental determinations, in which the Las Vegas principles are relevant, will be free to present argument about the principles' meaning and application, and those arguments will be considered and resolved with reference to specific facts presented by that existing case or controversy. Thus, the Department adheres to its conclusion in the NPRM that these procedural guidelines should not address the Las Vegas decisions, and that application of the Las Vegas principles is better carried out on a case by case basis. Although not incorporated in these Guidelines, the Department, of course, will adhere to the statutory mandate contained in 49 U.S.C. 5333(b)(5). The Department's Las Vegas determinations, and subsequent determinations made based on principles set forth in the Las Vegas determinations, will be available for review on the Department's Web site.

The Department received comments on issues that exceed the scope and nature of the revisions made to the Guidelines in the NPRM. For instance, one commenter suggested that the Department revise the criteria used for the determination of sufficiency of objections under Section 215.3(d)(3), and include in those criteria “court decisions, state law, or age of the referred protective arrangement.” Comment submitted by Jim Seals Consulting Services in response to the NPRM, October 15, 2007, page 1.

Another comment requested that the Special Warranty be applied to Job Access and Reverse Commute (“JARC”) grants serving populations under 200,000 to expedite processing of these grants because of their similarity to grants under the Other than Urbanized program. The rural JARC program is processed by the Department under Section 215.3(a)(4)(ii) without referral to affected labor organizations on the basis of existing agreements or Department of Labor-crafted protective arrangements, as appropriate.

The Department appreciates guidance offered by these comments, but because no proposals were made regarding these topics, they are beyond the scope of the revisions contemplated by the NPRM, and will not be considered at this time.

This final rule has been drafted and reviewed in accordance with Executive Order 12866, section 1(b), Principles of Regulation. The Department has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. The Department has also determined that this rule is not “economically significant” as defined in Section 3(f)(1) of Executive Order 12866. Therefore, the information enumerated in section 6(a)(3)(C) of the order is not required.

Under the Regulatory Flexibility Act (“RFA”), 5 U.S.C. 601, et seq., federal agencies must consider the impact of their rules on small entities. However, the requirements of the RFA apply only to rules that must be promulgated pursuant to notice and comment procedures under Section 553(b) of the Administrative Procedure Act (“APA”), 5 U.S.C. 553(b). 5 U.S.C. 603(a). Section 553(a) of the APA exempts from notice and comment rulemaking interpretative rules, general statements of policy, or rules of agency organization, procedure or practice. 5 U.S.C. 553(a).

Under the Federal transit law, the Department is charged with the duty to administer the statutory grant certification process, and therefore must issue procedural rules to establish standards to effectuate this Congressionally delegated authority. This final rule establishes such procedural standards, and therefore is exempt from notice and comment rulemaking under Section 553(a) of the APA. 5 As a result, this rule is also exempt from the requirements of the RFA. The Assistant Secretary for Employment Standards has certified this conclusion to the Chief Counsel for Advocacy of the Small Business Administration.

Executive Order 12875—This rule will not create an unfunded Federal mandate upon any State, local or tribal government.

Unfunded Mandates Reform Act of 1995—This rule will not include any Federal mandate that may result in increased expenditures by State, local, and tribal governments, in the aggregate, of $100 million or more, or in increased expenditures by the private sector of $100 million or more.

These Guidelines contain no new information collection requirements for purposes of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

A. This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based companies to compete with foreign-based companies in domestic and export markets.

B. Consistent with the Small Business Regulatory Enforcement Fairness Act of 1996, the Department will, prior to the rule's Effective Date, submit to Congress a report regarding the issuance of today's final rule. The report will note the Office of Management and Budget's determination that this rule does not constitute a “major rule” under the Act. 5 U.S.C. 801, 805.

Consistent with the Congressional Review Act, 5 U.S.C. 801, et seq., the Department will submit to Congress and the Comptroller General of the United States a report regarding the issuance of this Final Rule prior to the effective date set forth at the outset of this document.

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 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 EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm .

Under section 408(g) of FFDCA, 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-2007-0099 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 October 14, 2008.

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-2007-0099, 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 Avenue, NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Room S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA 22202-4501. 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 February 28, 2007 (72 FR 9000) (FRL-8115-2), 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 6F7065) by Bayer CropScience, LP in c/o Nichino America, Inc. (U.S. subsidiary of Nihon Nohyaku Co., Ltd.), P.O. Box 12014, Research Triangle Park, NC 27709-2014. The petition requested that 40 CFR part 180 be amended by establishing permanent tolerances in primary crops for residues of the insecticide flubendiamide, N 2 -[1,1-Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N 1 -[2-methyl-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide, in or on the following raw agricultural and processed commodities: Almond, hulls at 9.0 parts per million (ppm); brassica , head and stem subgroup at 0.60 ppm; brassica , leafy greens subgroup at 6.0 ppm; corn, field, forage at 8.0 ppm; corn, corn, field, grain at 0.02 ppm; field, stover at 15.0 ppm; corn, pop, grain at 0.02 ppm; corn, pop, stover at 15.0 ppm; corn, sweet, forage at 9.0 ppm; corn, sweet, kernel plus cob with husks removed at 0.02 ppm; corn, sweet, stover at 25.0 ppm; cottonseed at 2.0 ppm; cotton, gin byproduct at 60.0 ppm; fruit, pome group at 0.7 ppm; fruit, stone group at 1.6 ppm; grape at 1.4 ppm; nut, tree group at 0.06 ppm; okra at 0.30 ppm; vegetable, cucurbit group at 0.20 ppm; vegetable, fruiting group at 0.30 ppm and vegetable, leafy, except brassica at 11.0 ppm; in or on the following rotational crop commodities: Alfalfa, forage at 0.15 ppm; alfalfa, hay at 0.04 ppm; barley, hay at 0.04 ppm; barley, straw at 0.07 ppm; buckwheat at 0.07 ppm; clover, forage at 0.15 ppm; clover, hay at 0.04 ppm; grass, forage at 0.15 ppm; grass, hay at 0.04 ppm; grass, silage at 0.27 ppm; millet, pearl, forage at 0.15 ppm; millet, pearl hay at 0.04 ppm; millet, proso, forage at 0.15 ppm; millet, proso, hay at 0.04 ppm; millet, proso, straw at 0.07 ppm; oats, forage at 0.15 ppm; oats, hay at 0.04 ppm; oats, straw at 0.07 ppm; rye, forage at 0.15 ppm; rye, straw at 0.07 ppm; sorghum, grain, forage at 0.03 ppm; sorghum, grain, stover at 0.06 ppm; soybean, forage at 0.02 ppm; soybean, hay at 0.04 ppm; teosinte, forage at 0.15 ppm; teosinte, hay at 0.04 ppm; teosinte, straw at 0.07 ppm; triticale, forage at 0.15 ppm; triticale, hay at 0.04 ppm; triticale, straw at 0.07 ppm; wheat, forage at 0.15 ppm; wheat, hay at 0.03 ppm and wheat, straw at 0.03 ppm; and in the following livestock commodities: Cattle, fat at 0.80 ppm; cattle, kidney at 0.60 ppm; cattle, liver at 0.60 ppm; cattle, muscle at 0.10 ppm; eggs at 0.03 ppm; goat, fat at 0.80 ppm; goat, kidney at 0.60 ppm; goat, liver at 0.60 ppm; goat, muscle at 0.10 ppm; hog, fat at 0.80 ppm; hog, kidney at 0.60 ppm; hog, liver at 0.60 ppm; hog, muscle at 0.10 ppm; horse, fat at 0.80 ppm; horse, kidney at 0.60 ppm; horse, liver at 0.60 ppm; horse, muscle at 0.10 ppm; milk at 0.20 ppm; poultry, fat at 0.08 ppm; poultry, liver at 0.03 ppm; poultry, muscle at 0.01 ppm; sheep, fat at 0.80 ppm; sheep, kidney at 0.60 ppm; sheep, liver at 0.60 ppm; and sheep, muscle at 0.10 ppm. That notice referenced a summary of the petition prepared by Bayer CropScience, LP in c/o Nichino America, Inc. (U.S. subsidiary of Nihon Nohyaku Co., Ltd.), the registrant, which is available to the public in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

Based upon review of the data supporting this petition and EPA policy, the Agency has revised commodity definitions and/or some of the proposed tolerances and concludes that the establishment of the following tolerance is appropriate for the insecticide flubendiamide per se in or on the following food commodities: Almond, hulls at 9.0 ppm; apple, wet pomace at 2.0 ppm; brassica , head and stem, subgroup 5A at 0.60 ppm; brassica , leafy greens, subgroup 5B at 5.0 ppm; cattle, fat at 0.30 ppm; cattle, kidney at 0.30 ppm; cattle, liver at 0.30 ppm; cattle, muscle at 0.05 ppm; corn, field, forage at 8.0 ppm; corn, field, grain at 0.02 ppm; corn, field, stover at 15 ppm; corn, pop, grain at 0.02 ppm; corn, pop, stover at 15 ppm; corn, sweet, forage at 9.0 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 25 ppm; cotton gin byproducts at 60 ppm; cotton, undelinted seed at 0.90 ppm; egg at 0.01 ppm; fruit, pome, group 11 at 0.70 ppm; fruit, stone, group 12 at 1.6 ppm; goat, fat at 0.30 ppm; goat, kidney at 0.30 ppm; goat, liver at 0.30 ppm; goat, muscle at 0.05 ppm; grain, aspirated fractions at 5.0 ppm; grape at 1.4 ppm; horse, fat at 0.30 ppm; horse, kidney at 0.30 ppm; horse, liver at 0.30 ppm; horse, muscle at 0.05 ppm; milk at 0.04 ppm; milk, fat at 0.30 ppm; nut, tree, group 14 at 0.06 ppm; okra at 0.30 ppm; poultry, fat at 0.02 ppm; poultry, liver at 0.01 ppm; poultry, muscle at 0.01 ppm; sheep, fat at 0.30 ppm; sheep, kidney at 0.30 ppm; sheep, liver at 0.30 ppm; sheep, muscle at 0.05 ppm; vegetable, cucurbit, group 9 at 0.20 ppm; vegetable, fruiting, group 8 at 0.60 ppm and vegetable, leafy, except brassica , group 4 at 11 ppm; and in or on the following raw agricultural commodities: Alfalfa, forage at 0.15 ppm; alfalfa, hay at 0.04 ppm; barley, hay at 0.04 ppm; barley, straw at 0.07 ppm; buckwheat at 0.07 ppm; clover, forage at 0.15 ppm; clover, hay at 0.04 ppm; grass, forage at 0.15 ppm; grass, hay at 0.04 ppm; millet, pearl, forage at 0.15 ppm; millet, pearl, hay at 0.04 ppm; millet, proso, forage at 0.15 ppm; millet, proso, hay at 0.04 ppm; millet, proso, straw at 0.07 ppm; oats, forage at 0.15 ppm; oats, hay at 0.04 ppm; oats, straw at 0.07 ppm; rye, forage at 0.15 ppm; rye, straw at 0.07 ppm; sorghum, grain, forage at 0.03 ppm; sorghum, grain, stover at 0.06 ppm; soybean, forage at 0.02 ppm; soybean, hay at 0.04 ppm; teosinte, forage at 0.15 ppm; teosinte, hay at 0.04 ppm; teosinte, straw at 0.07 ppm; triticale, forage at 0.15 ppm; triticale, hay at 0.04 ppm; triticale, straw at 0.07 ppm; wheat, forage at 0.15 ppm; wheat, hay at 0.03 ppm and wheat, straw at 0.03 ppm.

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 submitted 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 tolerances for residues of the insecticide flubendiamide. 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.

Flubendiamide has low acute toxicity via the oral and dermal routes, is only a slight eye irritant, is non-irritating to the dermis and tests negative for skin sensitization. In the longer-term studies in the flubendiamide mammalian toxicology database, the primary target organs identified were the liver, thyroid, kidney and eyes. Liver effects reported in rats, mice and/or dogs include organ weight increase, periportal fatty change, hypertrophy and minimal foci of cellular alteration. Thyroid effects include organ weight increase, follicular cell hypertrophy and slight perturbations of triiodothyronine (TC) and thyroid stimulating hormone (TSH) in the rat and mouse. Kidney effects include increases in absolute and/or relative to body kidney weights and chronic nephropathy in the rat. Eye effects include eye enlargement, opacity and exophthalmus with hemorrhage and appear only in rat pups. Other changes include mild microcytic anemia, decreased serum triglycerides and cholesterol in female rat, increased gamma glutamyl peptidase, alkaline phosphatase and shortened activated prothrombin time in dogs, and adrenal weight increase and an increase in adrenal cortical cell hypertrophy in dogs.

The hazard assessment indicated potential toxicity resulting from exposure to flubendiamide via different routes over different durations. The observed eye effects were selected as a critical effect for the acute dietary exposure scenario; whereas liver and thyroid effects were determined critical for the chronic dietary exposure scenario. Short-term and intermediate-term dermal risks were also based on liver and thyroid effects as well as blood effects. Short-term and intermediate-term inhalation risks are based on liver toxicity as well as adrenal weight increase and an increase in adrenal cortical cell hypertrophy.

There was no evidence of carcinogenicity in rats and mice up to the limit dose at 24- and 18-months, respectively. Flubendiamide was determined to be non-mutagenic in bacteria, negative in an in vivo mammalian cytogenetics assay and did not cause unscheduled DNA synthesis (repair of DNA damage) in mammalian cells in vitro . Overall, there was no clear evidence that flubendiamide was either mutagenic or clastogenic in either in vivo or in vitro assays. The cancer classification is “Not Likely to be Carcinogenic to Humans.”

More detailed information on the studies received and the nature of the adverse effects caused by flubendiamide 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 in the document entitled, “Flubendiamide: Human Health Risk Assessment for Proposed Uses on Corn, Cotton, Tobacco, Tree fruit, Tree nuts, Vine crops and Vegetable crops,” dated April 3, 2008, by going to http://www.regulations.gov . The referenced document is available in the docket established by this action, which is described under ADDRESSES , and is identified as EPA-HQ-OPP-2007-0099-0005 in that docket. Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0099. Double-click on the document to view the referenced information on pages 65-70 of 105.

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-term, intermediate-term 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, refer to http://www.epa.gov/pesticides/factsheets/riskassess.htm .

A summary of the toxicological endpoints for flubendiamide used for human risk assessment can be found in the document entitled, “Flubendiamide: Human Health Risk Assessment for Proposed Uses on Corn, Cotton, Tobacco, Tree fruit, Tree nuts, Vine crops and Vegetable crops,” dated April 3, 2008, by going to http://www.regulations.gov . The referenced document is available in the docket established by this action, which is described under ADDRESSES , and is identified as EPA-HQ-OPP-2007-0099-0005 in that docket. Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0099. Double-click on the document to view the referenced information on pages 37-38 of 105.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to flubendiamide, EPA considered exposure under the petitioned-for tolerances and assessed dietary exposures from flubendiamide 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. In estimating acute dietary exposure, EPA used food consumption information from the Dietary Exposure Evaluation Model-Food Commodity Intake Database (DEEM-FCID TM , Version 2.03), which incorporates food consumption data from the U.S. Department of Agriculture's (USDA's) Nationwide Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. The acute assessments assumed that 100% of crops with requested uses of flubendiamide are treated and that all treated crops contain residues at tolerance-level. In addition, tolerance-level residues for livestock commodities were included in these analyses to account for the potential transfer of plant residues to livestock tissues.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment, EPA used DEEM-FCID TM , Version 2.03, which incorporates food consumption data from the USDA's CSFII from 1994-1996 and 1998. The chronic assessments assumed that 100% of crops with requested uses of flubendiamide are treated and that all treated crops contain residues at the average residue levels found in the crop field trials and experimentally-determined processing factors where available. In addition, average-level residues for livestock commodities were also included in these analyses to account for the potential transfer of plant residues to livestock tissues.

iii. Cancer . As explained in Unit III.A., flubendiamide is considered to be “Not Likely to be Carcinogenic to Humans.” As a result, cancer exposure assessment is not needed for flubendiamide.

iv. Anticipated residue 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 FFDCA section 408(f)(1) 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 FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

2. Dietary exposure from drinking water . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for flubendiamide in drinking water. These simulation models take into account data on the physical, chemical and fate/transport characteristics of flubendiamide.

Flubendiamide is persistent and potentially mobile in terrestrial and aquatic environments. These fate properties suggest that it has a potential to move into surface and ground water. The Agency lacks sufficient monitoring exposure data for use in risk assessments, as flubendiamide is a new active ingredient. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling, taking into account data on the physical and fate characteristics of flubendiamide. Further information regarding EPA 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 the Screening Concentration in Ground Water (SCI-GROW) model, the estimated drinking water concerns (EDWCs) of flubendiamide for acute exposures are estimated to be 12.93 parts per billion (ppb) for surface water and 0.06 ppb for ground water. For chronic exposures for non-cancer assessments, the EDWCs are estimated to be 11.95 ppb for surface water and 0.06 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 12.93 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 11.95 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). Flubendiamide is not registered for any specific use patterns that would result in residential exposure. That is, no residential uses are being requested for flubendiamide at this time; therefore, no residential risk assessment has been conducted.

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.”

EPA has not found flubendiamide to share a common mechanism of toxicity with any other substances, and flubendiamide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action; therefore, EPA has assumed that flubendiamide does not have 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 .

1. In general . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional ten-fold (10x) margin of safety for infants and children in the case of threshold effects to account for pre-natal and/or post-natal 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 Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10x or uses a different additional SF when reliable data available to EPA support the choice of a different factor.

2. Pre-natal and post-natal sensitivity . While both the rat and rabbit developmental studies did not identify teratogenic effects and showed no evidence of increased pre-natal susceptibility, adverse eye effects (eye enlargement) were noted in post-natal rat pups older than 14 days in multiple studies (the 2-generation reproduction and 1-generation supplemental studies) and the developmental neurotoxicity (DNT) study reported eye effects appearing in some offspring between lactation days 14 and 42, even though exposure stopped at lactation day 21, indicating a possible delay (a latent response) from the time of last exposure to onset of bupthalmos. These eye effects did not occur in adult rats. Since the iris and chamber angle are differentiating and specializing into definite structures during post-natal days 5-20, neonatal rats appear to have an increased susceptibility to flubendiamide exposure as compared to adults. The DNT study also reported that pre-mating exposures are not required to elicit the eye effect in pups. In addition to the reported eye effects in the DNT study, there was also a balano-preputial separation (separation of the prepuce (foreskin) from the glans penis (balanus)) delay. While these effects are considered adverse, they are not assumed to be developmental effects from in utero exposure. Even though the delay in balanopreputial separation may be a result of post-natal exposure (sensitivity of the young), and the effect is adverse, it is considered reversible and not an indication of perinatal sensitivity/susceptibility.

Human microsomes have been shown to be capable of approximately 4 times higher hydroxylation rates of flubendiamide as compared to female mouse microsomes and may be able to efficiently metabolize and excrete flubendiamide, preventing accumulation of the parent compound. It remains unclear whether the ability to metabolize and clear the parent compound is the only requirement to avoid ocular toxicity. Due to the potential concern for increased susceptibility of the human neonate as compared to adults, this perinatal ocular effect is considered in the human health risk assessment for flubendiamide.

3. Conclusion . EPA evaluated the quality of the toxicity and exposure data and, based on these data, has determined that 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 toxicology database for flubendiamide is complete for purposes of this risk assessment and the characterization of potential pre-natal and/or post-natal risks to infants and children. Although susceptibility was identified in the toxicological database (eye effects), the selected regulatory PODs (which are based on clear NOAELs) are protective of these effects; therefore, the human health risk assessment is protective.

ii. There are no treatment-related neurotoxic findings in the acute neurotoxicity and DNT studies in rats; although eye effects were observed in the DNT study. As noted in the previous paragraph, the PODs employed in the risk assessment are protective of this effect.

iii. There are no residual uncertainties identified in the exposure databases and the exposure assessment is protective. The acute dietary food exposure assessment utilizes tolerance-level residues, the chronic dietary food exposure assessment utilizes average residue levels found in the crop field trials/livestock commodities and both assume 100% of crops with requested uses of flubendiamide are treated. The drinking water assessment generated EDWCs using models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. The highest relevant EDWCs were used in the dietary (food and drinking water) exposure assessment. By using these screening-level exposure assessments in the acute and chronic dietary (food and drinking water) assessments, risk is not underestimated for flubendiamide.

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-term, intermediate-term 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.

For flubendiamide, there is potential exposure from food and drinking water, but not from residential use sites (as there are no proposed residential uses for flubendiamide). Since hazard was identified via the oral route over both the acute and chronic duration, the aggregate risk assessment considers exposures from food and drinking water consumed over the acute and chronic durations.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to flubendiamide will occupy less than 8% of the aPAD for the mostly highly exposed population subgroup, children aged 1-2 years old.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to flubendiamide from food and water will utilize less than 15% of the cPAD for the mostly highly exposed population subgroup, children aged 1-2 years old. There are no residential uses for flubendiamide.

3. Aggregate cancer risk for U.S. population . Flubendiamide has been classified as “Not Likely to be Carcinogenic to Humans” and is not expected to pose a cancer risk.

4. 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 flubendiamide residues.

Adequate enforcement methodology (LC/MS/MS, Methods 00816/M002 and 00912) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are currently no established CODEX, Canadian or Mexican maximum residue limits (MRLs) for residues of flubendiamide in or on various crop or livestock commodities.

Based upon review of the data submitted in support of this tolerance petition for flubendiamide and EPA policy, the Agency has revised commodity definitions and/or some of the proposed tolerances. No residue data were submitted to support the proposed uses on okra and popcorn. The available field trial data for fruiting vegetables may be translated to okra, and the submitted data for field corn may also be translated to popcorn. The proposed uses on all types of corn (field, pop and sweet) are identical.

Parent residue levels vary based on crop (for edible commodities, residues ranging from 0.018 ppm, corn, field, grain to 6.7 ppm, spinach). Most crops indicated parent residues declined with successive sampling dates and were determined to be available on the surface of plants/RACs. The Agency will allow translation of residue data from trials conducted on rotated barley, sorghum and wheat to support the proposed rotational crop tolerances for the forages, hay and straw of other types of cereal grains and grasses. The Agency will also allow translation of residue data from trials conducted on rotated soybean to support the proposed rotational crop tolerances for the forages, fodder, hay and straw on alfalfa and clover to support the rotational plant-back intervals. Based on the transfer coefficients for livestock tissues and the relatively low dietary burden for swine of 0.02 ppm for flubendiamide, tolerances for hogs are not needed.

Therefore, tolerances are established for residues of the insecticide flubendiamide per se , N 2 -[1,1-Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N 1 -[2-methyl-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide.

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 rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) 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 tolerances 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 rule. In addition, this 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 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 EPA’s tolerance regulations at 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, 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-2007-0565 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 October 14, 2008.

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-2007-0565, 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 September 19, 2007 (72 FR 53577) (FRL-8144-3), 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 7F7220) by E. I. DuPont de Nemours and Company, DuPont Crop Protection, P.O. Box 80038, Wilmington, DE 19880-0038. The petition requested that 40 CFR 180.451(a) be amended by establishing tolerances for residues of the herbicide, tribenuron methyl, methyl-2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)methylamino]carbonyl]amino]sulfonyl]benzoate, in or on wheat, forage at 0.3 part per million (ppm); wheat, hay at 0.3 ppm; barley, hay at 0.3 ppm; oat, forage at 0.3 ppm; and oat, hay at 0.8 ppm. That notice referenced a summary of the petition prepared by E. I. DuPont de Nemours and Company, the registrant, which is available to the public in the docket, http://www.regulations.gov . One comment was received on the notice of filing. EPA’s response to this comment is discussed in Unit IV.C.

Tribenuron methyl currently has tolerances for grain and straw from barley, oats, and wheat. No tolerances have been established for hay and forage of these commodities because tribenuron methyl’s registration under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq., restricts the feeding of hay and forage from treated barley, oats, and wheat to livestock. DuPont has applied to EPA to lift the feeding restriction in its FIFRA registration, and this petition for hay and forage tolerances was filed in connection with that requested change.

Based upon review of the field trial data supporting the petition, EPA is revising the tolerance levels for pending commodities as follows: barley, hay at 0.4 ppm; oat, forage at 0.05 ppm; oat, hay at 0.05 ppm; and wheat, hay at 0.5 ppm.

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 tolerances for residues of the herbicide, tribenuron methyl, methyl-2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)methylamino]carbonyl]amino]sulfonyl]benzoate on barley, hay at 0.4 ppm; oat, forage at 0.05 ppm; oat, hay at 0.05 ppm; wheat, forage at 0.3 ppm; and wheat, hay at 0.5 ppm.

EPA has previously concluded that aggregate exposure to tribenuron methyl from tolerances for tribenuron methyl on grain and straw of barley, oats, and wheat as well as other commodities is safe (72 FR 11784, March 14, 2007). Establishment of requested tribenuron methyl tolerances on hay and forage of oats and wheat, and on barley, hay will not change the exposure or risk estimates from this prior action because:

1. The requested change in the FIFRA registration for tribenuron methyl is only for the lifting of the feeding restriction on barley, oats, and wheat. There are no requested changes, such as application rates that could affect residue levels on human food items. No changes in existing tolerances are necessary.

2. The Agency has determined that there will not be finite residues of tribenuron methyl in animal commodities as a result of animals consuming tribenuron methyl treated barley, oats, or wheat.

3. Since tribenuron methyl is not being registered on any additional crops and the application rates to the registered crops are not increasing, there is no change in estimated drinking water estimates.

4. No residential uses are being proposed.

The toxicological profile, endpoints and current risk assessments are discussed in the final rule published in the Federal Register of March 14, 2007 (72 FR 11784)(FRL-8117-2) which established tolerances for residues of tribenuron methyl in corn, field, forage at 0.05 ppm; corn, field, grain at 0.05 ppm; corn, field, stover at 0.05 ppm in rice, grain at 0.05 ppm; rice, straw at 0.05 ppm; sorghum, grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm; and sorghum, grain, stover at 0.05 ppm, soybean seed at 0.05 ppm and sunflower, seed at 0.05 ppm. These previous risk assessments and the reasons that the current action does not change that risk assessment are discussed in the document entitled “ Ingredient: Tribenuron Methyl Title: Label Amendments and Petition for Tolerances on Barley Hay, Oat, Forage and Hay, and Wheat Forage and Hay. ” This document can be found at http://www.regulations.gov. in docket EPA-HQ-OPP-2007-0565 and is identified as document 005. Based on risk assessments and the findings presented in the Federal Register notice above, EPA concludes that there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to tribenuron methyl residues.

Adequate enforcement methodology (liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS)) 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 established or proposed Codex Maximum residue limits (MRLs) for residues of tribenuron methyl. Canada and Mexico have established MRLs for tribenuron methyl on several plant commodities. However, no Canadian or Mexican MRLs for tribenuron methyl have been proposed or established for barley, hay; oat, forage; oat, hay; wheat, forage; or wheat, hay.

A comment was received from a private citizen supporting the Agency’s updating of pesticide regulations.

Therefore, tolerances are established for residues of tribenuron methyl, methyl-2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)methylamino]carbonyl]amino]sulfonyl]benzoate on barley, hay at 0.4 ppm; oat, forage at 0.05 ppm; oat, hay at 0.05 ppm; wheat, forage at 0.3 ppm; and wheat, hay at 0.5 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, 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 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 EPA's tolerance regulations at 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, 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-2005-0097 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 October 14, 2008.

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-2005-0097, 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 May 18, 2005 (70 FR 28527) (FRL-7708-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP) 6F4668, 0F6086, 0E6091, 0F6129, 1F6289, 4E6842, and 4F6854 by Bayer CropScience LP, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petitions requested that 40 CFR 180.474 be amended by establishing tolerances for residues of the fungicide tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on food commodities: Fruit, pome, group 11 at 0.05 parts per million (ppm) (PP 6F4668); bean, succulent at 0.1 ppm (PP 0F6086); bean, dry seed at 0.1 ppm (PP 0F6086); cotton, undelinted seed at 2.0 ppm (PP 0F6086); cotton, gin byproducts at 16 ppm (PP 0F6086); asparagus at 0.01 ppm (PP 0E6091); coffee, green bean, at 0.1 ppm (PP 0E6091); coffee, roasted bean, at 0.2 ppm (PP 0E6091); garlic, dry bulb at 0.1 ppm (PP 0E6091); onion, dry bulb at 0.1 ppm (PP 0E6091); corn, field, grain at 0.01 ppm (PP 0F6129); corn, field, forage at 3.0 ppm (PP 0F6129); corn, field, stover at 3.0 ppm (PP 0F6129); corn, pop, grain at 0.01 ppm (PP 0F6129); corn, pop, stover at 3.0 ppm (PP 0F6129) corn, sweet, kernel plus cob with husks removed at 0.5 ppm (PP 0F6129); corn, sweet, forage at 6.0 ppm (PP 0F6129); corn, sweet, stover at 5.0 ppm (PP 0F6129); soybean, seed at 0.01 ppm (PP 0F6129); soybean, forage at 0.01 ppm (PP 0F6129); soybean, hay at 0.05 ppm (PP 0F6129); fruit, stone, group 12, except cherry at 1.0 ppm (PP 1F6289); hop, dried cones at 30.0 ppm (PP 4E6842); soybean, seed at 0.06 ppm (PP 4F6854); soybean, forage at 17 ppm (PP 4F6854); soybean, hay at 45 ppm (PP 4F6854); soybean, hulls at 0.06 ppm (PP 4F6854); and grain, aspirated fractions at 15 ppm (PP 4F6854). Bayer CropScience also proposed to add a postharvest use on cherries at the current 0-day pre-harvest tolerance level of 4.0 ppm. That notice referenced a summary of the petitions prepared by Bayer CropScience LP, the registrant, which is available to the public in the docket, http://www.regulations.gov . Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C. Note that the tolerances proposed for the food commodities listed under PP 0E6091 were import tolerances.

Additionally, in the same Notice of filing, EPA announced the filing of PPs 9E6045, 9E6046, 9E6048, 0E6103, 0E6117, 0E6153, 0E6158, and 0E6212 from Interregional Research Project No. 4 (IR4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. The petitions requested that 40 CFR 180.474 be amended by establishing tolerances for residues of the fungicide tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on food commodities: Turnip, tops at 8.0 ppm (PP 9E6045); turnip, roots at 0.4 ppm (PP 9E6045); hops at 5.0 ppm (9E6046); vegetable, cucurbit, group 9 at 0.1 ppm (PP 9E6048); mango, postharvest at 0.2 ppm (PP 0E6103); fruit, stone, group 12, except cherry at 1.0 ppm (PP 0E6117); sunflower, seed at 0.05 ppm (PP 0E6153); sunflower, refined oil at 0.2 ppm (PP 0E6153); sunflower, meal at 0.2 ppm (PP 0E6153); okra at 1.0 ppm (PP 0E6158); and lychee at 1.5 ppm (PP 0E6212). That notice referenced a summary of the petitions prepared by the IR-4, which is available to the public in the docket, http://www.regulations.gov . Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

In the Federal Register of April 12, 2006 (71 FR 18746) (FRL-7773-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of PPs 6E7036 by Interregional Research Project No. 4 (IR4), 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.474 be amended by establishing tolerances for residues of the fungicide tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on the food commodity asparagus at 0.05 ppm. That notice referenced a summary of the petition prepared by IR-4, which is available to the public in the docket, http://www.regulations.gov . No comments were received in response to this Notice of Filing.

In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of PP 6E7097 by Interregional Research Project No. 4 (IR4), 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.474 be amended by establishing tolerances for residues of the fungicide tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on food commodities vegetable, bulb, group 3 at 1.3 ppm; Brassica, leafy greens, subgroup 5B at 2.5 ppm; beet, garden, roots at 0.7 ppm; and beet, garden, leaves at 5.0 ppm. That notice referenced a summary of the petition prepared by IR-4, which is available to the public in the docket, http://www.regulations.gov . No comments were received in response to this Notice of Filing.

Based upon review of the data supporting the petitions, EPA has modified the level and/or the tolerance expression for all commodities except the following: Pome fruit; bean succulent, cotton, undelinted seed; corn, sweet kernel plus cob with husks removed; sunflower, seed; sunflower, meal; sunflower, oil; brassica, leafy greens subgroup 5B; and beet, garden root. The reason for these changes is explained in Unit IV.D.

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 tolerances for residues of tebuconazole.

The toxicological profile for tebuconazole can be found in the final rule published in the Federal Register of May 14, 2008 (73 FR 27748-27756, FRL-8364-6). Refer to this Federal Register document, available at http://www.regulations.gov for a detailed discussion of the toxicological profile of tebuconazole.

The toxicological endpoints for tebuconazole can be found in the final rule published in the Federal Register of May 14, 2008 (73 FR 27748-27756, FRL-8364-6). Refer to this Federal Register document, available at http://www.regulations.gov , for a detailed discussion of the toxicological endpoint selection for tebuconazole.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to tebuconazole, EPA considered exposure under the petitioned-for tolerances, including other pending petitions, as well as all existing tebuconazole tolerances in (40 CFR 180.474). EPA assessed dietary exposures from tebuconazole 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.

In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, anticipated residues for bananas, grapes, raisins, nectarines, peaches and peanut butter were derived using the latest USDA Pesticide Data Program (PDP) monitoring data from 2002-2006. Anticipated residues for all other registered and proposed food commodities were based on field trial data. Projected percent crop treated estimates were used for apples, apricots, cherries, hops, plums and sweet corn. For the remaining crops, 100% crop treated was assumed. Available processing data were used to refine anticipated residues for apples/pears (dried and juice), apricots (dried), cherry (juice), coffee (roasted bean), grapes (juice), plums (prunes/prune juice) and peanut (oil). For all other processed commodities, DEEM (ver. 7.81) default processing factors were assumed.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the same assumptions as stated above for acute exposure (Unit III.C.1.i).

iii. Cancer . As explained in the Federal Register of May 14, 2008 (73 FR 27748-27756, FRL-8364-6), the chronic risk assessment is considered to be protective of any cancer effects; therefore, a separate quantitative cancer dietary risk assessment was not conducted.

iv. Anticipated residue and percent crop treated (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 FFDCA section 408(f)(1) 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 FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). 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 FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency assumed PCT for grapes; grape, raisins; nectarines; oats; peaches; and peanuts. The PCT for each crop is as follows: Grapes: 25%; grape, raisin: 25%; nectarine: 25%; oats: 2.5%; peach: 20%; and peanuts: 45%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency used projected percent crop treated (PPCT) information for tebuconazole on apple (44% acute assessment, 41% chronic assessment); apricot (56% acute assessment, 43% chronic assessment); cherry (pre-harvest: 42% acute assessment, 37% chronic assessment); cherry (post-harvest: 100% acute assessment, 66% chronic assessment); corn, sweet (22% acute assessment, 14% chronic assessment); hop (64% acute assessment, 64% chronic assessment); plum, pre- and post-harvest (26% acute assessment, 24% chronic assessment); and turnip tops (68% acute assessment, 44% chronic assessment).

EPA estimates PPCT for a new pesticide use by assuming that its actual PCT during the initial 5 years of use on a specific use site will not exceed the recent PCT of the market leader (i.e., the one with the greatest PCT) on that site. An average market leader PCT, based on three recent surveys of pesticide usage, if available, is used for chronic risk assessment, while the maximum PCT from the same three recent surveys, if available, is used for acute risk assessment. The average and maximum market leader PCTs may each be based on one or two surveys if three are not available. 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 market leader PCTs used to determine the average and the maximum may be each for the same pesticide or for different pesticides since the same or different pesticides may dominate for each year. Typically, EPA uses USDA/NASS as the source for raw PCT data because it is publicly available. When a specific use site is not surveyed by USDA/NASS, EPA uses other sources including proprietary data.

An estimated PPCT, based on the average PCT of the market leaders, is appropriate for use in chronic dietary risk assessment, and an estimated PPCT, based on the maximum PCT of the market leaders, is appropriate for use in acute dietary risk assessment. This method of estimating PPCTs for a new use of a registered pesticide or a new pesticide produces high-end estimates that are unlikely, in most cases, to be exceeded during the initial 5 years of actual use. Predominant factors that bear on whether the PPCTs could be exceeded may include PCTs of similar chemistries, pests controlled by alternatives, pest prevalence in the market and other factors. All relevant information currently available for predominant factors have been considered for tebuconazole on the seven crops, resulting in adjustments to the initial estimates for three crops to account for lack of confidence in projections based on less than three observations, old data and/or data based on expert opinion.

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, or conservative estimates based on information from agricultural experts. 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 tebuconazole 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 tebuconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of tebuconazole. Further information regarding EPA 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 tebuconazole for acute exposures are estimated to be 78.5 parts per billion (ppb) for surface water and 1.56 ppb for ground water. The EDWCs for chronic, non-cancer are estimated to be 44.9 ppb for surface water and 1.56 ppb for ground water. The EDWCs for chronic, cancer exposures are estimated to be 32.3 ppb for surface water and 1.56 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 78.5 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment (which is protective of any possible cancer effects), the water concentration value of 44.9 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).

Tebuconazole is currently registered for uses that could result in residential exposures. Short-term dermal and inhalation exposures are possible for residential adult handlers mixing, loading, and applying tebuconazole products outdoors to ornamental plants. Short- and intermediate-term dermal post application exposures to adults during golfing and children playing on treated wood structures are also possible. Children may also be exposed via the incidental oral route when playing on treated wood structures. Long-term exposure is not expected. As a result, risk assessments have been completed for residential handler scenarios as well as residential post application scenarios.

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.”

Tebuconazole is a member of the triazole-containing class of pesticides. Triazole-derived pesticides can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazole alanine and triazole acetic acid). Refer to EPA's recent tolerance rulemaking on tebuconazole in the Federal Register of May 14, 2008 (73 FR 27748-27756, FRL-8364-6), for more information on this risk assessment.

In the Federal Register of May 14, 2008 (73 FR 27748-27756, FRL-8364-6) the Agency published a Final rule establishing tolerances for residues of tebuconazole in or on various food commodities. When the Agency conducted the risk assessments in support of that tolerance action, it also assessed dietary exposure to tebuconazole assuming that all of the tolerances in this action were in place. Accordingly, EPA relies on the decision on the FQPA safety factor for infants and children as set out in that action. Refer to EPA's recent tolerance rulemaking on tebuconazole, available at http://www.regulations.gov , for a detailed discussion and selection of a safety factor for infants and children for tebuconazole. For the reasons explained there, EPA reduced the FQPA safety factor to 3X for all potential exposure scenarios.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate safety factors (SFs). EPA calculates the aPAD and cPAD by dividing the point of departure (POD) by all applicable uncertainty factors (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.

Below, EPA has summarized the conclusions from its recent tolerance rulemaking on tebuconazole which took into account exposure to tebuconazole from the food commodities covered by the tolerances in this action. Refer to EPA's recent tolerance rulemaking on tebuconazole, available at http://www.regulations.gov , for a detailed discussion of EPA's safety determinations.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to tebuconazole will occupy 53% of the aPAD for the population group (all infants less than 1 year old) receiving the greatest exposure.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to tebuconazole from food and water will utilize 4% of the cPAD for the U.S. population and 11% of the cPAD for the most highly exposed population group (infants less than 1 year old).

3. Short-term risk . Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Tebuconazole is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to tebuconazole.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that the short-term aggregate MOE from dietary exposure (food + drinking water) and non-occupational/residential handler exposure for adults using a hose-end sprayer on ornamentals is 400. The short-term aggregate MOE from dietary exposure and exposure from golfing is 1,800. The short-term aggregate MOE to children from dietary exposure and exposure from wood surfaces treated at the above ground use rate is 530. The short-term aggregate MOE to children from dietary exposure and exposure to wood surfaces treated at the below ground use rate is 230. The combined and aggregate MOEs for wood treated for below ground uses exceed the Agency's LOC of 300, and indicate a potential risk of concern. However, the MOE of 230 is based on unrealistic assumptions and EPA has concluded that aggregate exposure does not pose a risk of concern.

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Tebuconazole is currently registered for uses that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to tebuconazole.

Since the POD, relevant exposure scenarios and exposure assumptions used for intermediate-term aggregate risk assessments are the same as those used for short-term aggregate risk assessments, the short-term aggregate risk assessments represent and are protective of both short- and intermediate-term exposure durations.

5. Aggregate cancer risk for U.S. population . Although tebuconazole is classified as a Group C Carcinogen-Possible Human Carcinogen, the Agency has concluded that the chronic RfD is protective of the cancer effects.

6. 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 tebuconazole residues.

Adequate gas chromatography/nitrogen phosphorus detection and liquid chromatography/mass spectrometry/mass spectrometry (GC/NPD and LC/MS/MS) methods are available for enforcing tolerances for tebuconazole and its metabolites in plant commodities, livestock matrices and processing studies. The methods have been adequately validated by an independent laboratory in conjunction with a previous petition. 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 currently Codex, Canadian and Mexican maximum residue limits (MRLs) for residues of tebuconazole in or on a variety of plant and livestock commodities. The tolerance definition for residues in plants is tebuconazole, per se, for Codex, Canada, and Mexico. For livestock commodities, the tolerance expression is for the combined residues of tebuconazole and HWG 2061 in the United States and Canada, and tebuconazole, per se, for Codex. Where possible, the proposed tolerance levels have been harmonized with the MRLs from Canada, Mexico, and Codex. With regard to the pome fruit tolerance, the Agency recommended tolerance of 0.05 ppm differs from the Codex MRL of 0.5 mg/kg. Harmonization of the pome fruit tolerances is not possible because U.S. data were derived using long pre-harvest intervals (PHIs) of 75-129 days while Italian data were derived using maximum PHIs of 14 days. With regard to the cucurbit vegetable tolerance, the Agency recommended tolerance of 0.09 ppm for vegetable, cucurbit, group 9, differs from the Codex MRL of 0.2 mg/kg on cucumber and 0.02 mg/kg on summer squash. The Agency notes that some of the cucumber data from Spain were derived from trials conducted in greenhouses. Although the application rate used for the Spanish trials was similar to the trials conducted in the United States, it is quite normal for greenhouse trials to give higher residues. If the greenhouse trials are ignored, then the remaining Codex data are in the 0.02 - 0.04 range, consistent with the U.S. data and tolerance. In short, the higher Codex MRL for cucumber accommodates the greenhouse use.

The Agency received a comment from a citizen of New Jersey. The commenter questioned the necessity of using taxpayer money through the agency of the Interregional Research Project No. 4 to develop pesticides, challenged the appropriateness of conducting some of the tebuconazole field trials outside of the United States, expressed concern over whether specific warnings were given to residents of New Jersey prior to conducting field trials in that State, and worried that students at Rutgers University may have been injured in the tebuconazole toxicological tests on animals that were performed at that facility.

In response, as to the commenter's concern with field trials that were conducted in countries other than the United States, EPA notes that frequently field trials are conducted in other countries as well as in the United States so that EPA can understand the range of pesticide residues that may be present on a food. EPA received several applications for tebuconazole import tolerances and it is appropriate that the field trials would be conducted in the countries where the pesticide was to be used. Additionally, some tebuconazole import tolerances were proposed with foreign data, and then a U.S. use was proposed and U.S. data submitted. None of the other comments address the findings made in this action regarding the establishment of a tolerance. Nonetheless, EPA provides the following information regarding the comments. IR-4 was established by the USDA to help minor acreage; specialty crop producers obtain EPA tolerances and new registered uses of pesticides. As to whether warnings were given to residents of New Jersey regarding field trials, EPA would point out that experimental field trials are subject to EPA regulations at 40 CFR part 172. EPA also has regulations governing the toxicological data testing laboratories that are designed to insure data quality (40 CFR part 160). Federal jurisdiction concerning the safety of workers in testing laboratories would be under the Occupational Safety and Health Administration in the U.S. Department of Labor. EPA has responded to similar comments from this commenter on previous occasions. Refer to 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), and 69 FR 63083 (October 29, 2004).

Based upon review of the data supporting the petitions, EPA determined that the proposed tolerances should be revised as follows: Cotton, gin byproducts at 25.0 ppm; asparagus at 0.05 ppm; coffee, green bean at 0.15 ppm; coffee, roasted bean, at 0.3 ppm; onion, bulb, subgroup 3-07A at 0.2 ppm; corn, field, grain at 0.05 ppm; corn, field, forage at 4.0 ppm; corn, field, stover at 3.5 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 3.5 ppm; corn, sweet, forage at 7.0 ppm; corn, sweet, stover at 6.0 ppm; turnip, tops (limited to east of the Rockies) at 7.0 ppm; turnip, roots at 0.5 ppm; beet, garden, tops at 7.0 ppm; beet, garden, root at 0.70; hop, dried cones at 35.0 ppm; vegetable, cucurbit, group 9 at 0.09 ppm; mango, postharvest at 0.15 ppm; plum, pre- and post-harvest at 1.0 ppm; okra at 1.2 ppm; lychee at 1.6 ppm; soybean, seed at 0.08 ppm; soybean, forage at 25 ppm; soybean, hay at 50 ppm; and grain, aspirated fractions 16.0 ppm. A separate tolerance is required for apple, wet pomace at 0.1 ppm. No tolerance is required for soybean hulls. A tolerance of 1.3 ppm is required for onion, green, subgroup 3-07B. The tolerance proposed by IR-4 for hops (PP 9E6046) is covered by the registrant proposed tolerance for hops, dried cones (PP 4E6842). EPA revised most of these tolerance levels 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 Standard Operating Procedure (SOP). For the proposed tolerances on asparagus; corn, field, grain; and by translation corn, pop grain the tolerance could not be set lower than the limit of quantitation (LOQ) of the enforcement analytical method, which was 0.05 ppm for tebuconazole. For corn, field, forage, the proposed tolerance was raised to 4.0 ppm based on the maximum residue level in the field trials.

Additionally, IR-4 petitioned for a tolerance on bulb vegetables group 3 as that crop group was defined at the time of the petition (6E7097). In the Federal Register of December 7, 2007 (72 FR 69150-69158) (FRL-8340-6), EPA issued a final rule that revised the crop grouping regulations. EPA indicated in the December 7, 2007 final rule as well as the earlier May 23, 2007 proposed rule (72 FR 28920-28930) that, for existing petitions for which a Notice of Filing had been published, the Agency would attempt to conform these petitions to the rule. As part of this action, EPA expanded and revised bulb vegetables group 3. Changes to crop group 3 (bulb vegetables) included adding new commodities, creating subgroups for bulb and green onions, and changing the name of one of the representative commodities from “onion, dry bulb” to “onion, bulb”. The Bayer proposed tolerance for garlic (bulb) and onion (bulb) with no U. S. registration was superseded by the proposed tolerance for bulb vegetables. The proposed tolerance on bulb vegetables group 3 was determined to be inappropriate because the residues were found to be more than a factor of 5x. Thus, separate tolerances were set for the crop subgroups, onion, bulb, subgroup 3-07A at 0.2 ppm, and onion, green, subgroup 3-07B at 1.3 ppm.

EPA concludes it is reasonable to revise the petitioned-for tolerance so that they agree with the recent crop grouping revisions because (1) although the new crop groups/subgroups include several new commodities, the added commodities are closely related minor crops which contribute little to overall dietary or aggregate exposure and risk; and tebuconazole exposure from these added commodities was considered when EPA conducted the dietary and aggregate risk assessments supporting this action; and (2) the representative commodities for the revised crop groups/subgroups have not changed.

Finally, the proposed tolerance for hops, domestically grown, in PP 4E6046, was superseded by the proposed tolerance for hops, dry cone (based on data for imported hops) in PP 4E6842, since the latter proposed tolerance is higher, 30.0 ppm. The proposed tolerance for asparagus (domestic) at 0.2 ppm, in PP 6E7036, superseded the proposed tolerance for imported asparagus at 0.1 ppm, in PP 0E6091. The tolerances for inadvertent residues of tebuconazole in soybeans planted in rotation with treated wheat in PP 0F6129, were superseded by the proposed tolerance for soybean following a direct treatment of tebuconazole in PP 4F6854.

Therefore, tolerances are established for residues of the fungicide tebuconazole, alpha-[2-(4-Chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on food commodities apple, wet pomace at 0.1 ppm; asparagus at 0.05 ppm; bean, succulent at 0.1 ppm; bean, dry seed at 0.1 ppm; beet, garden, tops at 7.0 ppm; beet, garden, roots at 0.70 ppm; brassica, leafy greens, subgroup 5B at 2.5 ppm; coffee, green bean at 0.15 ppm; coffee, roasted bean at 0.3 ppm; corn, field, grain at 0.05 ppm; corn, field, forage at 4.0 ppm; corn, field, stover at 3.5 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 3.5 ppm; corn, sweet, kernel plus cob with husks removed at 0.5 ppm; corn, sweet, forage at 7.0 ppm; corn, sweet, stover at 6.0 ppm; cotton, undelinted seed at 2.0 ppm; cotton, gin byproducts at 25.0 ppm; Fruit, pome, group 11 at 0.05 ppm; fruit, stone, group 12, except cherry at 1.0 ppm; grain, aspirated fractions at 16.0 ppm; hop, dried cones at 35.0 ppm; lychee at 1.6 ppm; mango, postharvest at 0.15 ppm; okra at 1.2 ppm; onion, bulb, subgroup 3-07A at 0.2 ppm; onion, green, subgroup 3-07B at 1.3 ppm; plum, pre- and post-harvest at 1.0 ppm; soybean, forage at 25 ppm; soybean, hay at 50 ppm; soybean, seed at 0.08 ppm; sunflower, seed at 0.05 ppm; sunflower, meal at 0.2 ppm; sunflower, refined oil at 0.2 ppm; vegetable, cucurbit, group 9 at 0.09 ppm; turnip, roots at 0.5 ppm; and turnip, tops at 7.0 ppm.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petitions 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 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 EPA's tolerance regulations at 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, 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-2007-0564 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 October 14, 2008.

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-2007-0564, 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 September 19, 2007 (72 FR 53577) (FRL-8144-3), 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 7F7219) by E.I. DuPont de Nemours and Company, DuPont Crop Protection, P.O. Box 80038, Wilmington, DE 19880-0038. The petition requested that 40 CFR 180.439(a) be amended by establishing tolerances for residues of the herbicide, thifensulfuron methyl, methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate, in or on barley, hay at 0.7 part per million (ppm), oat, forage at 0.2 ppm; oat, hay at 2.0 ppm; wheat, forage at 1.0 ppm; and wheat, hay at 0.8 ppm. That notice referenced a summary of the petition prepared by E. I. DuPont de Nemours and Company, the registrant, which is available to the public in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

Thifensulfuron methyl currently has tolerances for grain and straw from barley, oats, and wheat. No tolerances have been established for hay and forage of these commodities because thifensulfuron methyl's registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), U.S.C. 136 et seq., restricts the feeding of hay and forage from treated barley, oats, and wheat to livestock. DuPont has applied to EPA to lift the feeding restriction in its FIFRA registration and this petition for hay and forage was filed in conjunction with that requested change.

Based upon review of the field trial data supporting the petition, EPA is revising the tolerance levels for pending commodities as follows: barley, hay at 0.8 ppm; oat, hay at 0.05 ppm; wheat, forage at 2.5 ppm; and wheat, hay at 0.7 ppm.

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 tolerances for residues of thifensulfuron methyl, methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate, on barley, hay at 0.8 ppm; oat, forage at 0.2 ppm; oat, hay at 0.05 ppm; wheat, forage at 2.5 ppm and wheat, hay at 0.7 ppm.

EPA has previously concluded that aggregate exposure to thifensulfuron methyl on the grain and straw of barley, oats, and wheat as well as other commodities is safe. (72FR13179 (March 21, 2007)). Establishment of the requested thifensulfuron methyl tolerances on hay and forage of barley, oats, and hay will not change the exposure or risk estimates from this prior tolerance action because:

1. The requested change in FIFRA registration for thifensulfuron methyl is only for the lifting of the feeding restriction on treated barley, oats, and wheat. There are no requested changes, such as to application rates that could affect residue levels on human food items. No changes in existing tolerances are necessary.

2. The Agency has determined that there will not be finite residues of thifensulfuron methyl in animal commodities as a result of animals consuming thifensulfuron methyl-treated barley, oats or wheat.

3. Since thifensulfuron methyl is not being registered on any additional crops and the application rates to the registered crops are not increasing, there is no change in estimated drinking water estimates.

4. No residential uses are being proposed.

The toxicological profile, endpoints and current risk assessments are discussed in the final rule published in the Federal Register of March 21, 2007 (72FR13179)(FRL-8117-1) which established tolerances for residues of thifensulfuron methyl in rice, grain at 0.05 ppm; rice, straw at 0.05 ppm; sorghum, grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm; and sorghum, grain, stover at 0.05 ppm. These previous risk assessments and the reasons that the current action does not change that risk assessment are discussed in the document entitled “Ingredient: Thifensulfuron Methyl Title: Label Amendments and Petition for Tolerances on Wheat Forage and Hay, Oat Forage and Hay, and Barley, Hay.” This document can be found at http://www.regulations.gov. in docket EPA-HQ-OPP-2007-0564 and is identified as document 004. Based on risk assessments and the findings presented in the Federal Register notice above, EPA concludes that there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to thifensulfuron methyl residues.

Adequate enforcement methodology ((liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS)) 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 established or proposed Codex Maximum residue limits (MRLs) for residues of thifensulfuron methyl. Canada and Mexico have established MRLs for thifensulfuron methyl on several plant commodities. However, no Canadian or Mexican MRLs for thifensulfuron methyl have been proposed or established for barley, hay; oat, forage; oat, hay; wheat, forage; or wheat, hay.

Therefore, tolerances are established for residues of thifensulfuron methyl, methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate, on barley, hay at 0.8 ppm; oat, forage at 0.2 ppm; oat, hay at 0.05 ppm; wheat, forage at 2.5 ppm and wheat, hay at 0.7 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, 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).

The Life Safety Code (LSC), published by the National Fire Protection Association (NFPA), a private, nonprofit organization dedicated to reducing loss of life due to fire, is a compilation of fire safety requirements. The LSC contains fire safety requirements for both new and existing buildings. It is updated through a consensus process and generally published every 3 years. Sections 1819(d)(2)(B) and 1919(d)(2)(B) of the Social Security Act (the Act) require that long term care facilities participating in the Medicare and Medicaid programs generally meet the applicable provisions of the edition of the LSC that is adopted by the Secretary.

Beginning with the adoption of the 1967 edition of the LSC in 1971, Medicare and Medicaid regulations have historically incorporated the LSC requirements by reference for all long term care facilities as well as other providers, while providing the opportunity for a Secretarial waiver of a requirement under certain circumstances. The statutory basis for incorporating NFPA's LSC for our other providers is under the Secretary's general rulemaking authority at sections 1102 and 1871 of the Act, and under provider-specific provisions of title XVIII that permit us to issue regulations to protect the health and safety of participants in Medicare and Medicaid.

We adopted the LSC to ensure that patients and residents are consistently protected from fire, regardless of the location in which they receive care. Since adopting and enforcing the 1967 and subsequent editions of the LSC, there has been a significant decline in the number of multiple death fires, indicating that the LSC has been effective in improving fire safety in health care facilities.

On October 26, 2001, we published a proposed rule (66 FR 54179), and on January 10, 2003, we published a final rule in the Federal Register , entitled “Fire Safety Requirements for Certain Health Care Facilities” (68 FR 1374). In that final rule, we adopted the 2000 edition of the LSC provisions as the standard governing Medicare and Medicaid health care facilities, including long term care facilities. The final rule required all existing long term care facilities to comply with the 2000 edition of the LSC.

The 2000 edition of the LSC required all newly constructed buildings containing health care facilities to have an automatic sprinkler system installed throughout the building. However, like all previous editions, the LSC did not require existing buildings to install automatic sprinkler systems throughout if they met certain construction standards, ranging from the size of the buildings to the types of material used in their construction.

In accordance with the 2000 edition of the LSC, an existing building that meets the above-mentioned construction standards must install sprinklers if it undergoes a major renovation. However, in such cases, it is required to install sprinklers only in the renovated section(s). Therefore, a building may have sprinklers only on one floor or in one wing. We did not receive any timely public comments in response to the October 2001 proposed rule that addressed the issue of installing automatic sprinkler systems in buildings not undergoing major renovations. That is to say, no public comments supported, questioned or challenged our proposal to incorporate this LSC provision by reference.

In the 2006 edition of the LSC, the NFPA decided to include an automatic sprinkler system requirement for all long term care facilities. We support the NFPA in its decision. We decided to proceed with this rule, without proposing adoption of the NFPA 2006 edition of the LSC, because we want to avoid further delay in requiring an automatic sprinkler system in long term care facilities. As stated in the October 27, 2006 proposed rule (71 FR 62957, 62960), given the large scope of the LSC, we would not be able to adopt and enforce compliance with the 2006 edition of the LSC until 2009 or 2010. Therefore, we decided at this time to proceed with rulemaking that does not include adoption of the NFPA 2006 LSC.

We will continue to work with the NFPA to revise and refine each edition of the LSC. We are currently working with the NFPA through its consensus process to revise and refine the 2009 edition of the LSC. Once the 2009 edition is issued, we will review the code in its entirety and explore the possibility of adopting it for all Medicare and Medicaid-participating health care facilities.

A Government Accountability Office (GAO) report entitled “Nursing Home Fire Safety: Recent Fires Highlight Weaknesses in Federal Standards and Oversight” (GAO-04-660, July 16, 2004, http://www.gao.gov/new.items/d04660.pdf ) examined two long term care facility fires (Hartford and Nashville) in 2003 that resulted in 31 total resident deaths. The report examined Federal fire safety standards and enforcement procedures, as well as results from the fire investigations of these two incidents. The report recommended that fire safety standards for unsprinklered facilities be strengthened and the report cited the effectiveness of smoke detectors' and sprinklers' fire protection features for long term care facilities.

In response to a recommendation made in the GAO report, on March 25, 2005, we published an interim final rule with comment period in the Federal Register entitled, “Fire Safety Requirements for Certain Health Care Facilities; Amendment” (70 FR 15229). This interim final rule added paragraph (a)(7) to § 483.70, to require long term care facilities, at minimum, to install battery-operated smoke detectors in resident sleeping rooms and public areas, unless they had a hard-wired smoke detector system in resident rooms and public areas or a sprinkler system installed throughout the facility. This IFC was finalized September 22, 2006 (71 FR 55326).

Structural fires in long term care facilities are relatively common events. From 1994 to 1999, an average of 2,300 long term care facilities reported a structural fire each year (2004 GAO Report). Although approximately 2,300 facilities per year reported fires, those fires resulted in an average of only 5 fatalities nationwide per year (2004 GAO Report). The likelihood of a fatality occurring due to a long term care facility fire was quite low.

From 1990 to 2002, there were no fires in long term care facilities that resulted in more than one or two fatalities. During that time period there were no fires in long term care facilities that resulted in a loss of life comparable to that of the Hartford and Nashville fires.

We believe the low number of fire-related fatalities each year is attributable, in part, to the increasing use of automatic sprinkler systems in long term care facilities as a fire protection method. State and local jurisdictions often adopt an edition of the LSC or a comparable fire safety code shortly after it is published. Therefore, a building constructed in the early 1990s likely met the requirements of the 1991 edition of the LSC or another comparable code. Beginning with the 1991 edition of the LSC, all newly built facilities were required to have automatic sprinkler systems. In addition, beginning with the 1991 edition of the LSC, all facilities undergoing major renovations were also required by the LSC to install automatic sprinkler systems at least in those renovated areas. Therefore, as new facilities have replaced old facilities, and as facilities have been renovated, the number of residents protected by automatic sprinkler systems has increased. The increase in the number of automatic sprinkler systems and the number of residents residing in sprinklered buildings has decreased significantly the likelihood of a fatality occurring due to fire.

According to NFPA data cited in the 2004 GAO report, there is an 82 percent reduction in the chance of death occurring in a sprinklered building when compared to the chance of death occurring in an unsprinklered building. In addition, we note that there has never been a multiple death fire in a long term care facility that had an automatic sprinkler system installed throughout the facility.

Automatic sprinkler systems are effective in reducing the risk of fatalities due to fire because they limit the size of a developing fire and prevent the fire from growing and spreading beyond the area where the fire ignited. In addition, impeding the fire's growth gives the facility staff and residents and the local fire department more time to respond to the situation.

Automatic fire suppression through sprinklers also alleviates some of the current heavy reliance on facility staff to implement the facility's emergency plan. Fires often occur at night, as both the Hartford and Tennessee fires did, when staffing levels are lowest. Investigators of the Hartford fire determined that the facility's staff did not fully implement the facility's emergency plan, which may have contributed to the number of fatalities in that fire. The 2004 GAO report concluded that “reliance on staff response as a key component of fire protection may not always be realistic, particularly in an unsprinklered facility.” Limiting the area of a building affected by a fire may result in less of a need to evacuate or relocate residents.

The effectiveness of automatic sprinkler systems has prompted some States, including Virginia, Connecticut, and Tennessee, to require that all long term care facilities have sprinklers. The NFPA also requires all long term care facilities to have automatic sprinkler systems as part of the 2006 edition of the LSC.

We published a proposed rule in the Federal Register on October 27, 2006 (71 FR 62957) that would require all long term care facilities to be equipped with sprinkler systems. That proposed rule also requested public comments on the duration of a phase-in period to allow such facilities to install such systems.

For the reasons described in section I of this preamble, we proposed a rule with three main components. First, the regulation proposed to add a sunset provision to paragraph (a)(7) in § 483.70 that would correspond to the phase-in date of the sprinkler requirement. This sunset provision would provide that, as of the phase-in date, we would no longer enforce the requirement that facilities have and maintain at least battery-operated smoke alarms. We proposed to add the sunset date because the requirements of § 483.70(a)(7) apply only to unsprinklered and partially sprinklered long term care facilities. Once all long term care facilities are fully sprinklered, there would not be any unsprinklered or partially sprinklered facilities to which § 483.70(a)(7) would apply.

Second, we proposed to require every long term care facility to install an approved, supervised automatic sprinkler system in accordance with the 1999 edition of NFPA 13, Standard for the Installation of Sprinkler Systems , throughout the facility if it did not have such a system already. If a long term care facility was part of another building, such as a hospital, then the building would be required to have sprinklers only in the long term care facility section. The NFPA 13 specifies how to properly design and install sprinkler systems using the proper components. The standards of NFPA 13 cover a wide variety of factors that are involved in designing and installing sprinkler systems. The NFPA 13 is divided into 10 main chapters governing the design and installation phases of automatic sprinkler systems, and the October 2006 proposed rule summarized the content of these chapters.

The NFPA 13 is a very detailed document, with a wide variety of standards and exceptions to those standards. The document provides many options for the design and installation of sprinkler systems so that each system may be tailored to the building in which it is installed.

Third, the regulation proposed to require every long term care facility to test, inspect, and maintain an approved, supervised automatic sprinkler system in accordance with the 1998 edition of NFPA 25, Standard for the Inspection, Testing and Maintenance of Water-Based Fire Protection Systems . Proper inspections, tests, and maintenance of sprinkler systems are critical to ensuring that sprinkler systems function properly on a continuous basis. Fires are, by nature, unpredictable, and sprinkler systems must be operable at all times to ensure that buildings are protected whenever and wherever fires occur. NFPA 25 covers a wide variety of testing, inspection, and maintenance requirements for the numerous types of sprinkler systems that facilities may install and the auxiliary equipment that may be necessary for some facilities. We summarized the content of NFPA 25 in the proposed rule.

The proposed requirements of this regulation include three technical terms: “approved,” “automatic,” and “supervised.” These terms are terms of art in the fire safety community and are included in NFPA 101, Life Safety Code, with which long term care facilities must already comply. There may be, however, individuals who are not familiar with the terms. Their definitions, as used in the fire safety community, are as follows:

• Approved means acceptable to the authority having jurisdiction (from 2000 edition of NFPA 101, the LSC).

• Automatic means that which provides a function without the necessity of human intervention (from 2000 edition of NFPA 101, the LSC).

• Supervised means that the system and particular components of the system are monitored by a device with auditory and visual signals that are capable of alerting facility staff should the system or one of its components become inoperable for any reason (adapted from 1999 edition of NFPA 13, Standard for the Installation of Sprinkler Systems ).

We received 107 comments from the public on the October 27, 2006 proposed rule. The comments received and our responses to those comments are discussed below.

Comment: The vast majority of commenters strongly supported our intent to require automatic sprinkler systems throughout all long term care facilities. Conversely, a small minority of commenters disagreed with the proposed rule, citing the expense of purchasing and installing sprinklers and the availability of other fire safety features such as water-based fire-proof coatings and fire walls as reasons for not requiring sprinklers in all long term care facilities.

Response: We appreciate the strong support expressed by most commenters. While we agree that there are other methods for improving fire safety in long term care facilities, these other methods do not achieve the same high level of fire safety as automatic sprinkler systems. We are proceeding with this final rule requiring all long term care facilities to install and maintain automatic sprinkler systems because we agree with the GAO that such systems are the single most effective fire safety method currently available and that the presence of such systems will help save lives and property.

Comment: Several commenters submitted comments related to the specific facilities that are, or should be, affected by this final rule. One commenter explicitly supported our decision to apply the proposed sprinkler requirements to all affected long term care facilities, regardless of their size. Some commenters requested that this rule be expanded to apply to any residential facility that cares for individuals on a 24-hour basis. One commenter suggested that the rule should apply to federally operated nursing homes as well, such as those operated by the U.S. Department of Veterans Affairs. Another commenter suggested that the rule should apply to inpatient facilities such as hospitals and critical access hospitals with swing beds. Still other commenters asked whether the requirements of the final rule will affect adult day care centers.

Response: We proposed to require all long term care facilities to install automatic sprinkler systems regardless of their size because their recent fire history and current staffing levels indicated the need for additional fire safety features. We do not believe it is necessary for us to require sprinkler systems in other facility types, such as intermediate care facilities, adult day care facilities, or critical access hospitals at this time because there is no demonstrated need for such regulation. While we agree that it may be appropriate for federally operated nursing homes, such as those operated by the U.S. Department of Veterans Affairs, to install automatic sprinkler systems, we do not have regulatory authority over these facilities. Therefore, we are unable to promulgate a regulation applying to them.

Comment: Numerous commenters discussed the financial impact that the proposed rule will have on long term care facilities, and suggested a variety of methods to offset the expected impact. Of these commenters, several suggested that CMS should support legislation in the Congress that will provide financial incentives for long term care facilities to install sprinkler systems. A few commenters indicated that they are actively working with the Congress to obtain financial assistance for long term care facilities in implementing the requirements of this final rule. Other commenters suggested that CMS should make financial assistance available to facilities, with some suggesting that such assistance should be limited to those facilities with not-for-profit status or those that are not profitable. Still another commenter suggested that CMS should compel State Medicaid programs to increase reimbursement rates to fund capital improvements in long term care facilities.

Response: We recognize that purchasing and installing an automatic sprinkler system throughout a long term care facility requires a substantial capital investment. We defer to the Congress and States to provide financial assistance to long term care facilities to complete the purchase and installation process, whether such assistance comes in the form of loans, grants, tax relief, and/or increased reimbursement rates.

We have included a 5 year phase-in period in this final rule. This phase-in period allows facilities the time and flexibility to install sprinkler systems in a manner that is sensitive to the individual circumstances of each facility. We believe this phase-in period will help mitigate the financial impact of this final rule.

Comment: Numerous commenters stated that this final rule should provide additional discussion of the role that State and locally imposed building and fire safety codes play in protecting long term care facility residents.

Response: We acknowledge that State and local authorities use their authority to require long term care facilities to meet building and fire safety codes independent of the codes applied to facilities through Federal regulations. State and local authorities often adopt more recent editions of such codes than those required by Federal rules. Until 2003, Federal fire safety regulations referenced simultaneously Life Safety Code provisions from several editions including the editions of 1967, 1973, and 1985. However, health care facilities were not being built to these older standards because State and local jurisdictions adopted and enforced far more recent editions of building and fire safety codes. Such prompt adoption of updated codes by State and local jurisdictions likely has led to the large number of long term care facilities that currently have automatic sprinkler systems throughout their facilities. We continue to support the right of State and local authorities to impose building and fire safety codes independent of these Federal requirements and will continue to monitor all efforts to improve safety for long term care facility residents.

Comment: Some commenters expressed concern that this final rule will preempt State and local fire safety requirements. Of these commenters, a few expressed concern that this Federal rulemaking preempted State and local efforts and did not respond to the unique needs of different localities. Furthermore, some of these commenters requested a more detailed discussion of Executive Order 13132 (Federalism) as it relates to this rulemaking action. Conversely, several commenters indicated that they agreed with our conclusion that this rule is in accordance with the actions of State and local governments, and that it is appropriate for the Federal government to require automatic sprinkler systems in Medicare and Medicaid-participating long term care facilities.

Response: The Federal regulations for long term care facilities are considered to be the minimum standards that a facility must meet in order to participate in the Medicare and Medicaid programs. As such, they will not preempt more stringent State and local requirements. For example, if a State or local authority requires a long term care facility to install an automatic sprinkler system within 3 years after adoption of a law requiring it, then a facility must comply with that shorter time frame, even though this Federal regulation allows a facility up to 5 years to install an automatic sprinkler system. However, if a State or local authority requires a long term care facility to install an automatic sprinkler system only in hazardous areas, then a facility must go beyond the State or local requirement and install an automatic sprinkler system throughout its building in order to participate in Medicare or Medicaid. We believe that all facilities must install an automatic sprinkler system throughout a facility by 2013, regardless of the State or locality where a facility is located. In order to achieve this goal, it is necessary to promulgate a Federal regulation. State and local jurisdictions have always had the authority to require automatic sprinkler systems in existing long term care facilities. However, few States have taken action to require existing long term care facilities to retrofit their buildings with such systems. Thus, we believe it is necessary to take this Federal action.

In addition, this rule adopts the sprinkler installation and maintenance requirements established by the NFPA. The NFPA is a national standard setting body with representatives from all members of the fire safety community, including State and local jurisdictions. As such, these representatives had active input in the content and framework of the NFPA sprinkler standards. The standards allow flexibility in the design, installation, and maintenance of sprinkler systems to adapt to the needs of individual facilities as well as jurisdictions. Facilities are required by the NFPA standards to submit their design and installation plans to the appropriate authorities having jurisdiction. This allows local and State authorities the opportunity to ensure that such plans meet their individual needs. Since this action does not impinge upon a State or local jurisdiction's authority to impose more stringent fire safety requirements upon long term care facilities in response to the unique needs and concerns of the particular area, and gives State and local authorities the opportunity to provide further input into individual sprinkler planning activities, we do not believe this final rule has Federalism implications as described in Executive Order 13132.

Furthermore, we regularly communicate with State and local officials and with the long term care provider community through Open Door Forums, as well as through responses to letters, informal phone calls, and informal e-mails. Through these communications, as well as through the public comment process for this proposed rule, we believe we have sufficiently consulted with all affected parties, including State and local jurisdictions, as is required by Executive Order 13132.

Comment: Several commenters submitted views regarding the assumptions and estimates we used in the impact analysis for the proposed rule. Commenters questioned our estimates of the cost per square foot, the projected number of facilities affected, and the projected number of lives saved.

Response: We appreciate the suggestions that we received, and we considered them as we revised the impact analysis for this final rule. The final impact analysis reflects an increase in our estimate of the cost per square foot, from a high of $6.10 to a high of $7.95, to reflect inflation since the publication of the proposed rule. The final analysis also revises the number of facilities that are affected by this rule by replacing projections of future sprinkler system installations with the actual number of facilities lacking automatic sprinkler systems as of December 2007. The final impact analysis does not revise the method for estimating future lives saved by this rule. Although a commenter questioned this methodology, the commenter did not offer an alternative methodology that would more accurately estimate this number. Since we are not aware of an alternative method to estimate the number of lives that will be saved, we have retained the method used in the proposed rule.

Comment: Some commenters agreed with our proposal to require automatic sprinkler systems in all facilities, while a small number of commenters requested that certain long term care facilities be exempt from the requirements of this final rule.

Response: Automatic sprinkler systems are generally considered to be the single most effective fire protection feature in a building. As such, we believe all long term care facilities, regardless of their size or location in relationship to another type of health care facility, should be required to have sprinklers. Exempting a particular class of long term care facilities, regardless of the criteria used, will not provide a consistent level of fire safety across the country.

Comment: Several commenters submitted comments regarding CMS enforcement of this final rule. Some of these commenters sought assurance that surveyors would be appropriately trained to enforce the new sprinkler requirement. One commenter suggested that we should survey each facility annually to ensure compliance with this rule. Other commenters asked about the enforcement remedies that would be available if a facility was non-compliant with the requirements of this final rule, going so far as to suggest that non-compliant facilities should receive reduced payments from Medicare and Medicaid. Still other commenters requested that additional information about the sprinkler status of particular facilities and facilities as a whole be included on CMS' Nursing Home Compare Web site.

Response: We agree that it is essential to ensure that surveyors are appropriately trained to survey facilities for compliance with all fire safety requirements, including automatic sprinkler systems. To that end, we conduct annual training sessions for surveyors to educate them on, among other things, fire safety requirements and appropriate survey procedures. This training ensures surveyor competency in this area. We also agree that frequent surveys of long term care facilities are key to ensuring continued compliance with these requirements. By law, we are required to survey long term care facilities every 15 months to ensure compliance with all health and safety requirements, and we will incorporate this new requirement into the existing survey process. If a facility is found to be non-compliant with the provisions of this final rule, we have the full complement of enforcement remedies available to ensure that a facility comes into compliance. In addition to termination of the provider agreement, available remedies include the following: (1) Temporary management (that is, the temporary appointment by CMS or the State of a temporary director or administrator of a facility); (2) denial of payment, including denial of payment for all individuals, imposed by CMS upon a skilled nursing facility for Medicare payments, by a State for Medicaid payments, or denial of payment for all new admissions; (3) civil money penalties; (4) State monitoring; (5) transfer of residents; or (6) transfer of residents and closure of the facility. CMS currently includes information about a facility's sprinkler status on the Nursing Home Compare Web site to enable consumers to make an informed decision.

Comment: A commenter suggested that installation of sprinkler systems should be limited to pre-approved companies with proven fire safety records. Another commenter suggested that we should create a special task force in each State to visit each facility and examine the information used to design the facility's sprinkler system.

Response: While we agree that long term care facilities should look for qualified contractors to design and install their sprinkler systems, we do not believe it is appropriate to, nor do we have the authority to, select or approve such contractors. In addition, we do not believe it is appropriate for us to develop task forces in each State to review a facility's research and design plan. There are numerous qualified designers who are capable of designing sprinkler systems that fulfill facility-specific specifications. It is incumbent upon facilities to assure that their automatic sprinkler systems meet their specific facility needs as identified during a thorough review of their current fire and building safety features and various other factors.

Comment: A few commenters submitted additional information on their own fire safety features and requirements (for example State sprinkler requirements and facility-specific fire safety plans).

Response: We appreciate the additional information provided by the commenters. It validates our understanding of current fire safety efforts, both on the facility and State levels.

Comment: A commenter suggested that staffing levels may also impact facility fire safety, and that we should require additional staffing during the phase-in period to ensure that facility residents are protected from fire.

Response: We agree that sufficient staffing is necessary to ensure resident health and safety, including fire safety. Ensuring resident health and safety, which is closely tied to facility staffing, is already required in § 483.15, “Quality of life,” § 483.30, “Nursing services,” and § 483.70, “Physical environment.” We believe these regulations ensure sufficient staffing levels in long term care facilities to promote and protect resident health and safety in all circumstances.

Comment: A commenter questioned the conclusions of the GAO report regarding the two multiple death fires in Connecticut and Tennessee. The commenter stated that the GAO report did not demonstrate the superiority of sprinklers over smoke alarms. The commenter also stated that the number of multiple death fires before 1990 was zero, and that the installation of sprinklers in new facilities after 1990 thus had no bearing on the number of fires between 1990 and 1992.

Response: While we recognize that the commenter disagrees with the data analysis of current fire safety levels in long term care facilities presented by the GAO, we continue to support the GAO's data, collection methodology, analytic methodology, and conclusions. We concur with the GAO that smoke alarms are necessary in unsprinklered facilities; we now require unsprinklered facilities to have such alarms in accordance with the requirements of § 483.70(a)(7). We also concur with the GAO that before 1990, multiple death fires occurred on a more frequent basis. As stated in the GAO report, “When the federal government first adopted the NFPA fire safety standards in 1971, the number of multiple-death fires in nursing homes was about 15 to 18 per year. With the adoption and enforcement of these standards, including the requirement for sprinklers in homes that were not highly fire resistant, the number of fire-related nursing home fatalities dropped dramatically.” (p. 14; we note that the average annual number of long term care facility fire fatalities, according to the GAO report, is now 5.) Furthermore, we concur with the GAO that sprinklers improve the level of fire safety beyond that which is provided by smoke alarms, and we are implementing this final rule to require sprinklers in all long term care facilities.

Comment: A commenter suggested that all facilities that currently have automatic sprinkler systems throughout their buildings be required to maintain those systems in accordance with the requirements of NFPA 25.

Response: Long term care facilities are required to meet the standards of the LSC, which requires facilities with existing sprinklers to maintain those sprinklers in accordance with the requirements of NFPA 25. We agree with the commenter and are adopting NFPA 25 by reference at § 483.70(a)(8)(ii).

Comment: A commenter stated that NFPA 101, NFPA 13, and NFPA 25 can all be viewed without charge at http://www.nfpa.org/freecodes/free_access_document.asp .

Response: We thank the commenter for providing this Web site citation. Unfortunately, the citation provided does not link to the documents that a long term care facility will need to comply with this final rule. Instead, an alternative, free Web site for this information is http://www.nfpa.org/aboutthecodes/list_of_codes_and_standards.asp .

Comment: A few commenters suggested that facilities be permitted to have a reduced water supply that does not meet the specifications of the NFPA requirements for health care facilities when an adequate level of safety can be assured with less water.

Response: The NFPA uses a consensus process to establish the requirements of its sprinkler installation and maintenance codes. It would not be in the best interests of long term care facilities and their residents to reduce the NFPA standards. We believe that the NFPA standards represent the absolute minimum standards that long term care facilities must meet, and that lowering the standards below those of the NFPA would jeopardize long term care facility resident and staff safety.

Comment: A commenter requested a 90-day extension of the public comment period.

Response: We do not believe it is necessary to extend the standard comment period. We received 107 unique comments, as well as numerous duplicate comments, from interested parties during the comment period, and we believe these comments adequately reflect public sentiment on this matter.

Comment: A few commenters suggested additional requirements to which long term care facilities should be held. One commenter suggested that, in addition to installing and maintaining automatic sprinkler systems, long term care facilities should be required to install and maintain automatic fire alarm systems incorporating commercial smoke detectors that comply with the audio and visual notification standards of the Americans with Disabilities Act. Another commenter suggested that long term care facilities should be required to have mattresses that comply with certain fire safety standards.

Response: We agree with the commenters that numerous additional options are available to long term care facilities that wish to further enhance their fire safety levels. Long term care facilities may explore these options in addition to meeting all requirements of the LSC and this final rule.

Comment: A small number of commenters submitted comments on the existing provision that a State may apply to CMS to use its own alternative fire safety code imposed by State law if that code adequately protects patients. The commenters inquired as to the status of their own particular applications for a waiver under this provision.

Response: CMS actively considers any application submitted by a State regarding the use of an alternate fire safety code in health care facilities. However, these applications have no bearing on the requirements of this final rule because this final rule requires automatic sprinklers independent of the requirements of the LSC.

Comment: A commenter asked us to present a list of those States in the early 1990s that adopted the 1991 or later edition of the LSC or another code requiring newly constructed long term care facilities to install automatic sprinkler systems.

Response: We do not believe it is necessary to present such a list of information regarding the requirements of individual States. While such a list may provide additional historic background on fire safety requirements in the United States, all unsprinklered long term care facilities must install and maintain automatic sprinkler systems.

Comment: A commenter suggested that, instead of requiring all long term care facilities to install an automatic sprinkler system, we should permit such facilities an exemption if they have all of the following features: Smoke detectors, mattresses that meet certain fire safety requirements, and upholstered furniture that meets certain fire safety requirements.

Response: The fire safety measures noted above are valuable tools for enhancing fire safety in long term care facilities. However, none of these features serve the same purpose as an automatic sprinkler system, which is to actively suppress a fire once it is ignited. Thus, we do not believe the suggested options achieve the same level of fire safety as automatic sprinklers.

Comment: A commenter suggested that we should include regulatory language that endorses standardization and provides for system interconnectivity.

Response: We are not clear regarding the commenter's suggestion. If the commenter is referring to the standardization of installation and maintenance requirements, we believe that referencing the NFPA installation and maintenance standards does endorse standardization of fire safety across long term care facilities.

Comment: Many commenters submitted comments regarding the placement of smoke alarms in long term care facilities. In September 2006 we published a final rule requiring all unsprinklered long term care facilities to, at minimum, install and maintain battery-operated smoke alarms in all resident rooms and common areas. In the October 2006 proposed sprinkler rule, we proposed to add a sunset date to this smoke alarm requirement. The smoke alarm requirement would, according to our proposal, cease to be effective on the phase-in date of the sprinkler requirement. Many commenters disagreed with our proposal to add a sunset date to the smoke alarm requirement. Furthermore, many of these commenters stated that all long term care facilities should be required to have both automatic sprinkler systems throughout their buildings and smoke alarms in resident rooms and common areas. Conversely, several commenters agreed with our proposal to add a sunset provision to the smoke alarm requirement. Of these commenters, many requested that the sunset date be flexible for individual long term care facilities. These commenters suggested that, rather than having a single sunset date, the final rule should state that a long term care facility is no longer required to meet the smoke alarm provision as soon as it installs and begins using an automatic sprinkler system. Additionally, one commenter sought clarification of the relationship between the CMS smoke alarm requirement and the smoke alarm requirement of the 2000 edition of the Life Safety Code that long term care facilities are required to meet.

Response: The proposed smoke alarm sunset provision appears to have caused significant confusion and concern, and we thank the commenters for the opportunity to clarify our intent. The smoke alarm requirements of paragraph (a)(7) apply only to unsprinklered or partially sprinklered long term care facilities. This final rule will require all facilities to be fully sprinklered. Thus, there will no longer be any facilities that are unsprinklered or partially sprinklered. Since (a)(7) applies only to unsprinklered or partially sprinklered facilities, it will be a moot requirement. Nonetheless, we believe that it is appropriate to retain the requirements of paragraph (a)(7) until the end of the 5-year phase-in period. At the end of this period we will consider proposing a rule which would delete both this provision and reference to the phase-in period.

Moreover, facilities that are required to have smoke alarms or smoke detection systems in accordance with the requirements of the 2000 edition of the LSC as incorporated by reference in paragraph § 483.70(a)(1) must continue to comply with those existing LSC standards.

A significant number of commenters advocated for smoke alarms and/or smoke detection systems in all long term care facilities, even those that have automatic sprinkler systems throughout their buildings. All long term care facilities may consider installing smoke detection systems in their facilities in addition to installing automatic sprinkler systems. We may consider the appropriateness of such a requirement in future rulemaking.

Comment: We received a large number of public comments regarding the appropriate length of a phase-in period for the sprinkler installation requirement. Commenter suggestions for the length of the phase-in period ranged from as little as 18 months to as long as 15 years. The most frequently suggested phase-in period was 3-5 years. Other commenters made more general recommendations such as “the sooner the better” and “sooner rather than later.” Additionally, many commenters suggested that nursing homes should be allowed phase-in waivers on a case-by-case basis to provide additional time to those nursing homes who make a good faith effort to comply within the stated timeframe, but who do not do so. One commenter suggested that we include an additional requirement that long term care facility owners file a statement with CMS detailing their intent to comply with the final rule within 180 days of publication of the final rule.

Response: We agree with commenters that a phase-in period is necessary to allow long term care facilities sufficient time to purchase and install automatic sprinkler systems throughout their buildings. While we recognize that a relatively short phase-in period (such as 18 months-3 years) will rapidly increase the level of fire safety in long term care facilities, we believe such a short time frame will not allow facilities enough time to comply with the provisions of this final rule. Re-allocating and/or securing financial resources, securing the services of a system designer and installation contractor, purchasing system components, securing any necessary permits, completing ancillary projects, and completing the actual installation process can take a substantial amount of time. We do not believe an 18-month to 3-year phase-in period allows enough time for all of these tasks to be completed in all affected facilities. Furthermore, we do not believe it is appropriate to allow waivers of this important requirement. Likewise, we do not believe it will be appropriate to allow long term care facilities 7 or more years to install automatic sprinkler systems, as some commenters suggested. While such a lengthy phase-in period will allow more than ample time for facilities to complete the installation process, it may also unnecessarily encourage facilities to postpone this much-needed fire safety improvement. In light of these considerations, we are finalizing a 5-year phase-in period. A long term care facility has 5 years from the date of publication of this final rule to purchase and install a fully-operational automatic sprinkler system throughout its building. A 5-year phase-in period balances our dual goals of improved fire safety and feasibility. It ensures that facilities begin planning for installation within a short period of time from the publication of this final rule and allows sufficient time for all facilities to complete the full installation process.

Comment: Numerous commenters submitted comments regarding the exact fire safety codes that should be used in long term care facilities. Many of these commenters supported our proposal to require facilities to meet the requirements of the 1999 edition of NFPA 13 and the 1998 edition of NFPA 25. Some of the commenters suggested that we require facilities to meet more recent editions of the NFPA standards. Other commenters questioned the role of the building codes issued by the International Code Council (ICC). Of these commenters, some suggested that we require facilities to meet the ICC codes in place of the NFPA codes. Others suggested that States, local jurisdictions, and/or facilities be given the option to meet either the NFPA or ICC codes.

Response: While we agree that more recent editions of NFPA sprinkler codes or sprinkler codes issued by other code-setting bodies may include appropriate installation and maintenance requirements for automatic sprinkler systems in long term care facilities, we believe it is most appropriate to require long term care facilities to comply with the 1998 and 1999 editions of the NFPA sprinkler codes. If we require facilities to meet more recent editions of the sprinkler codes, we could be placing them out of compliance with the provisions of the 2000 edition of the LSC. Similarly, if we were to require or permit facilities to meet another sprinkler code issued by a separate code-setting body, the standards could be incompatible with the 2000 edition of the LSC. We do not believe this will be in the best interest of facilities and their residents.

Comment: A substantial number of commenters submitted thoughts in response to our discussion of potentially adopting the 2006 edition of the LSC, which requires existing long term care facilities to install automatic sprinkler systems. Commenters were nearly evenly divided in their support of or opposition to adopting the 2006 LSC. The commenters who supported adopting the 2006 LSC stressed that this edition is the most recent version and has the potential to increase fire safety levels in all health care facilities. The commenters who did not support adopting the 2006 LSC cited potential delays in implementing the automatic sprinkler requirement and overall facility burden as key factors in their recommendation.

Response: The 2006 edition of the LSC made numerous changes to the requirements applicable to long term care facilities. The most substantial change in the 2006 LSC is the requirement that all long term care facilities must have automatic sprinkler systems. However, since we are addressing that issue in this rulemaking, we do not believe it should affect our evaluation of the overall merits of the 2006 LSC. We do not believe that the other changes in the 2006 edition of the LSC offers substantial improvements in the level of fire safety in long term care facilities that outweigh the additional burden to facilities of complying with the requirements of a newer edition of the LSC at this time. Therefore, we are not adopting the 2006 edition of the LSC at this time. We will continue to participate in the NFPA consensus process as the NFPA revises and refines subsequent editions of the LSC. Additionally, we will carefully examine the 2009 edition of the LSC when it is published for possible incorporation by reference in our regulations governing long term care facilities and a variety of other health care provider types.

In this final rule we are adopting the provisions as set forth in the October 27, 2006 proposed rule with the following revisions:

• Deleted proposed § 483.70(a)(7)(iv), the sunset provision.

• Added a 5-year phase-in date to § 483.70(2)(8)(i).

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 solicited public comment on each of these issues for the following sections of this document that contain information collection requirements:

In summary, § 483.70(a)(8)(ii) requires that all long term care facilities test, inspect, and maintain an approved, supervised automatic sprinkler system in accordance with the 1998 edition of NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems . This section states that facilities will be required by this proposed rule to comply with all applicable chapters of NFPA 25 once they have installed their sprinkler systems in accordance with the requirements of NFPA 13.

We believe facilities will utilize the services of a contractor for all inspection, testing, and maintenance activities, including documentation of those activities. Therefore, no burden will be associated with the development of the documentation. The burden associated with this requirement, is the time and effort necessary for facilities to maintain documentation of inspections, tests, and maintenance activities in accordance with the standards outlined in the NFPA 25.

The burden associated with these requirements is estimated to be 1 hour per long term care facility. Therefore, we estimate it will take 2,446 total annual hours (1 hour × 2,446 estimated affected long term care facilities) to satisfy this burden.

These requirements are not effective until they are approved by OMB.

We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Order 12866 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). We have examined this rule, and we have determined that this rule would meet the criteria to be considered economically significant, and it would meet the criteria for a major rule. This determination is based on 2,446 long term care facilities being required to install automatic sprinkler systems at an estimated cost of $7.95 per square foot, for a total cost of about $847 million over the 5-year phase-in period. Hence, in any one year costs in excess of $100 million will be incurred regardless of the decisions of individual facilities as to when to make the investment.

The estimated cost for installing a sprinkler system throughout an existing average size unsprinklered facility (50,000 square feet to be sprinklered at $7.95 per square foot) will be $397,500. Because these systems are capital investments, their costs are properly amortized over time in estimating their impact on facility finances. We believe that a reasonable estimate of the useful life of a sprinkler system is 20 years. The projected installation cost of this requirement will account for approximately one fourth of one percent of an average unsprinklered facility's actual revenue over a 20-year period. The estimated cost for installing a sprinkler system throughout an existing average size partially sprinklered facility (37,125 square feet to be sprinklered at $7.95 per square foot) will be $295,143. The projected installation cost of this requirement will account for approximately one fifth of one percent of an average partially sprinklered facility's actual revenue over a 20-year period.

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small government jurisdictions (including tribal governments). Individuals and States are not included in the definition of a small entity. For purposes of the RFA, most long term care facilities are considered to be small entities, either by virtue of their nonprofit or government status or by having revenues of less than $12.5 million in any one year. The latest SBA size standards classify a “Nursing Care Facility” under North American Industry Classification System (NAICS) as code 623110, and as “small” if its annual revenues fall below $12.5 million (for details, see the Small Business Administration's Table of Small Business Size Standards at http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf. ) According to our statistics, long term care facilities, all of which will be required to have sprinkler systems throughout their buildings, received a total of $124.9 billion in revenue in 2006 (National Health Expenditures Accounts, http://www.cms.hhs.gov/NationalHealthExpendData/02_NationalHealth AccountsHistorical.asp ). Also according to CMS data, there were 15,941 nursing facilities in operation at that time. The average facility therefore had annual revenue of $7.8 million and thus fell well below the SBA size threshold. Taking into account both typical revenue, and that non-profit facilities of any size are “small entities” within the meaning of the RFA, we assume for purposes of our analysis that all LTC facilities are “small entities” for purposes of the RFA. Although the average LTC facility has revenues well below the SBA size threshold, we have, as described in what follows, also analyzed impacts on entities that fall even farther below the size threshold. ( Note: In the following paragraphs the terms “average facility” and “smaller facility” are strictly based on a revenue metric, just as are most of the SBA size thresholds, including that for NAICS code 623110. That is, the terms only describe facilities in terms of the amount of annual revenue.)

Long term care facilities vary in a number of ways, ranging from the number of residents to the predominant source of payment for those residences. For the purposes of our analysis, we chose to assess the financial impact of this final rule on a facility with average revenue and a facility with a much smaller revenue (50 percent below the mean). An average facility had approximately $7,837,714 in revenue in 2006. A facility with revenue 50 percent below this average received $3,918,857, or less than one third of the amount set by SBA to define “small.” Over the 20-year amortization period revenues of an average facility will be about $157 million. The “smaller” facility will have revenues of about $78 million over the same 20-year amortization period. We calculate that the projected cost of this requirement will account for about one fourth of one percent of an average unsprinklered “smaller” facility's actual revenue over the 20-year period. Taking into account their smaller size and lower investment cost, the projected cost of this requirement will account about one fifth of one percent of a partially sprinklered “smaller” facility's actual revenue over the 20-year period. We are assuming that a smaller facility's square footage and number of beds are 50 percent less than an average facility's square footage because there is a strong correlation between the size of a facility, as reflected by the number of resident beds it has, and the facility's revenue level. According to CMS data from December 2007, there (see Table 3 later in this analysis) the median bed size of LTC facilities is about 100 beds, and there are 433 unsprinklered or partially sprinklered long term care facilities that have fewer than 50 beds and presumably meet our revenue definition of a “smaller facility.” Hence, there are relatively few very small (“smaller”) facilities that will be affected by this rule. That said, a total of about 2,446 unsprinklered or partially sprinklered facilites will be affected, and the great majority of these (we assume all) are “small entities” under the RFA (again, see Table 3 for the size distribution of affected entities).

As a result of these calculations, and because we normally only regard an impact that reaches several percent of annual revenue as “significant” under the RFA, we certify that this final rule would not have a significant impact on a substantial number of small entities. However, some facilities may face financing or other problems that concentrate the impact and make its effect proportionally much larger than would otherwise be the case. While we do not believe that there would be a substantial number of facilities in this circumstance, we have prepared a voluntary regulatory flexibility analysis. This Regulatory Impact Analysis section, taken together with the remainder of the preamble, constitutes this analysis.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. We know that 8.41 percent of long term care facilities, 1,332 nationwide, are located in hospitals, but we do not know how many of those hospitals are small rural hospitals. However, it is likely that the affected number is quite small. Applying the same percentages that apply to the long term care universe to the 1,332 long term care facilities located in hospitals, we estimate that 1,125 are fully sprinklered, 176 are partially sprinklered, and only 31 are not sprinklered. Using these estimates and the preceding cost amortization calculations, we have concluded that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals and that a regulatory flexibility analysis is not required. Our voluntary analysis, however, applies equally to facilities regardless of location or affiliation and hence covers hospital-based facilities.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year by either the private sector or by State, local, and tribal governments of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $130 million. This final rule does contain mandates that will impose annual spending costs on private long term care facilities of $154 million, and on public long term care facilities of $16 million, based on an estimated cost of about $847 million distributed over a 5-year phase-in period, for an average annual cost of about $170 million for all public and private facilities. Estimated impacts on State, local, and tribal governments are well below the UMRA threshold, since over ninety percent of long term care facilities are privately owned, as shown the Federalism analysis that follows. With respect to private sector facilities, this Regulatory Impact Section, together with the remainder of the preamble, constitutes the analysis required under UMRA.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct compliance costs on State or local governments, preempts State law, or otherwise has Federalism implications. Of the 2,446 facilities that will be affected by this final rule, 216 facilities (8.83 percent of all affected facilities) are owned by State and local governments. The majority of these facilities (188) are already partially sprinklered. Of the 188 partially sprinklered facilities, 31 have less than 50 resident beds, 43 have 50-99 resident beds, 63 have 100-199 resident beds, and 49 have 200 or more resident beds. We estimate that it will cost on average about $14.24 million annually for 5 years to install sprinklers throughout the unsprinklered portions of these facilities. Of the remaining 30 completely unsprinklered facilities, 13 have less than 50 resident beds, 8 have 50-99 resident beds, 7 have 100-199 resident beds, and 2 have 200 or more resident beds. We estimate that it will cost on average about $2.12 million annually for 5 years to install sprinklers throughout these unsprinklered facilities. The total of these annual average cost estimates, about $16 million, is negligible in the context of overall State and local budgets and as a capital expense can be financed over a period of years by borrowing. Therefore, we believe that this final rule will not impose substantial direct compliance costs on State or local governments, and thus has no Federalism implications.

a. Decreasing Loss of Life

We believe that installing an approved, supervised automatic sprinkler system in accordance with NFPA 13, Standard for the Installation of Sprinkler Systems, throughout a long term care facility will have a positive impact on resident safety. According to the July 2004 GAO report discussed above, installing sprinklers decreases the chances of fire-related deaths by 82 percent. In unsprinklered facilities, there are 10.8 deaths per 1,000 fires. In sprinklered facilities, there are 1.9 deaths per 1,000 fires.

The 2003 fires in Hartford and Nashville resulted in more fire related deaths (31) than there were for several previous years combined. Both of these fires occurred in unsprinklered buildings. If sprinklers had been installed in these facilities, and if they were properly maintained, we estimate that 82 percent of those fire-related deaths may have been prevented, based on an 82 percent reduction in the chances of death occurring in a sprinklered facility. We estimate that, based on this reduction, 25 (82 percent of 31 deaths = 25) lives could have been saved by sprinklers in these two fires, or 13 lives in the Hartford fire and 12 lives in the Nashville fire.

According to the U.S. Census Bureau, in 2006, the average age of a long term care facility resident was 83.2 years. This number reflects the overall demographic trend in long term care facilities toward an older patient population. In 2003 (the most recent year of data available), the average life expectancy for an individual at age 85 was 6.6 years ( Older Americans Update 2006: Key Indicators of Well-Being. Federal Interagency Forum on Aging-Related Statistics. http://www.agingstats.gov/agingstatsdotnet/Main_Site/Data/2006_Documents/Health_Status.pdf ). This means that an 85-year-old long term care facility resident could expect to live an average of 6.6 more years. We acknowledge that the average age of a long term care facility resident (83.2 years) is slightly younger than the 85 year data point used to assess average life expectancy; however, we believe that using the life expectancy of an 85 year old is an acceptable proxy for the life expectancy of an 83.2 year old.

Based on a life expectancy at age 85 of 6.6 years, we estimate that sprinklers in these two fires would have added 165 life years (25 lives saved × 6.6 life years per life saved).

While the number of deaths in these two fires is not typical of the number of fire-related deaths in long term care facilities as a whole, we believe that they should still be taken into consideration when discussing the impact on the general long term care facility resident population.

In a typical year from 1994 through 1999, about 2,300 long term care facilities report structural fires (July 2004 GAO report). We estimate that 25 percent (575) of the 2,300 facilities that reported fires annually during the 1994-1999 time period did not have sprinklers installed throughout their buildings. This estimate is based on the results of the 2004 GAO report and a nationwide survey of long term care facilities conducted by CMS following the results of the GAO report.

Based on the rate of 10.8 deaths per 1,000 unsprinklered facility fires, we estimate that 6 deaths occurred in 575 fires in unsprinklered and partially sprinklered facilities annually. (575 facilities = 57.5 percent of 1,000 facilities; 57.5 percent of 10.8 deaths = 6 deaths). This estimate differs slightly from the average number of deaths (5) that occurred due to long term care facility fires, as presented in the July 2004 GAO report, because this estimate predicts the number of deaths that statistically would be expected to occur, based on established percentages, rather than the average number of deaths that occurred annually in the past. This estimate is prospective, whereas the 2004 GAO figure is retrospective.

If these unsprinklered or partially sprinklered facilities install sprinklers throughout their buildings and those sprinklers are properly maintained, then we estimate that there will be 1 death (57.5 percent × 1.9 deaths per 1,000 fully sprinklered facility fires according to the 2004 GAO report = 1) in those same 575 facilities. Installing sprinklers in unsprinklered and partially sprinklered buildings would, based on these estimates, save 5 lives annually.

Given the estimate described above that installing and maintaining sprinkler systems in existing long term care facilities will save 5 lives annually, we estimate that sprinklers will save 33 life years annually (5 lives saved × 6.6 years gained per life).

There are a wide variety of estimates regarding the statistical value of a life or of a quality-adjusted life year. For example, there are numerous studies that attempt to quantify how much individuals and society are willing to pay to gain a single, quality year of life, known as a quality-adjusted life year. These studies, using one or more of four different methodologies, have estimated that individuals and society are willing to pay between $50,000 and $450,000 for a quality-adjusted life year (see R.A. Hirth, et al, “Willingness to Pay for Quality-Adjusted Life Year: In Search of a Standard,” Medical Decision Making, Volume 20, Number 3, July-Sep. 2000). Due to the fact that there is no widely accepted standard value, we refrained in the proposed rule from estimating the statistical value of each life or life year that will be gained as a result of a final rule requiring sprinklers in all long term care facilities. However, a recent FDA rule used an estimate of $5 million as the value of a statistical life and derived from this figure values of between $213,000 (at a 3 percent discount rate) and $373,000 (at a 7 percent discount rate) for a quality adjusted life-year (QALY). (See the FDA Final Rule on “Medical Devices: Patient Examination and Surgeon's Gloves; Test Procedures and Acceptance Criteria,” December 19, 2006, 71 FR 75865, as corrected January 19, 2007, 72 FR 2436.) These are intended to be rough estimates of societal willingness to pay for saving a “statistical life” (not a particular person) or for adding a year of life that does not involve total disability. It is not a settled issue in the literature of valuation of life as to how well these estimates fit an elderly population, and we use them here only to provide a rough estimate as to one of the major benefits of this final rule in the same dollar metric as costs.

Applying these estimates, the life-saving benefits of this final rule once all facilities are compliant will be approximately $25 million dollars annually based on a value of $5 million per statistical life saved. These benefits accrue over the entire 20-year horizon during which automatic sprinkler systems save lives. Hence, undiscounted future benefits from life saving would be as much as $500 million ($5 million times 5 lives times 20 years).

There are additional life-year benefits, to the extent that residents who survive a fire are nonetheless physically injured in ways that that greatly reduce their future quality of life. For example, a person who spends months in the hospital recovering from burn injuries and the remainder of his life partially incapacitated by those injuries, or a person whose lungs are permanently damaged by smoke inhalation, do not have the same good health that they would have enjoyed absent the fire. We do not have at this time any basis for estimating the amount of severe morbidity caused by facility fires that sprinklers can mitigate, but it could be very substantial, likely approaching and perhaps exceeding the number of life-years lost to mortality. For purposes of this analysis, we assume that it equals the mortality QALYs, and that total benefits from morbidity reduction range from $7 to $10 million a year (33 life years times 20 years time either $213,000 or $373,000).

The FDA estimates were based on a “willingness to pay” analysis of wage differentials necessary to attract labor to riskier occupations. Such analyses have shown that people demand significantly higher wages to accept even a small additional risk of death. The estimated value of an additional year of life is based on life expectancy in the FDA analysis. However, there are other ways to create such estimates and many studies have done so. For example, an estimate using data on rural interstate highway driving speeds found that the value of a statistical life could be estimated as between $1.6 and $5.9 million (Orley Ashenfelter, “Measuring the Value of a Statistical Life: Problems and Prospects,” Working Paper 11916, National Bureau of Economic Research, January 2006). As another example, a recent study of the willingness to pay for better health care found that a reasonable estimate of the value of a QALY lies between $183,000 and $264,000 per life year (R. Scott Braithwaite, et al, “What Does the Value of Modern Medicine Say About the $50,000 per Quality-Adjusted Life-Year Decision Rule?,” Medical Care, Volume 46, Number 4, April 2008). Thus, the estimates used by the FDA, and in this CMS analysis, are broadly consistent with estimates from other sources, such as the Hirth and Braithwaite studies.

The reasonableness of applying such estimates to an elderly population is unclear, particularly when that population is, by definition, at least temporarily unable to live outside an institutional setting. However, the general approach used most often in the literature is to use the same value of a statistical life for persons of all ages. As to value of a life-year, there is considerable evidence in the literature that the kinds of disabilities most commonly found in nursing homes, such as mobility and mental impairments, do not substantially reduce the value of a life-year (see Chaim M. Bell, et al, “An Off-the-Shelf Help List: A comprehensive Catalog of Preference Scores from Published Cost-Utility Analyses,” Medical Decision Making, Volume 21, Number 4, July-August 2001). For example, on a scale of zero to 1, where zero is represented by a persistent vegetative state and 1 is best attainable health, this synthesis shows that disability after a hip fracture is rated at .8, and even after major stroke from .2 to .5. Absent a compelling rationale to the contrary, we therefore use the full values of a statistical life and a QALY in our analysis.

A few commenters questioned our methodology for assessing the potential life-saving benefits of installing and maintaining automatic sprinkler systems. However, these commenters did not suggest an alternate method for assessing these potential benefits. Therefore, we reaffirm the methodology and results described above.

As a result of installing and properly maintaining sprinklers, we anticipate that facilities that experience fires would lose less property. While the amount of property damage and loss that would be prevented by installing and maintaining sprinklers is not readily quantifiable from existing data, we believe that the amount of damage prevented will be substantial, and that this prevention will benefit affected long term care facilities.

Preventing property damage and loss may also reduce the amount of money paid by insurers to cover fire-related losses. Such reductions may help control long term care facility insurance costs and reduce any spill-over effect for other insurance markets. Again, these benefits are not easy to estimate reliably from existing data. However, we believe that they should be considered as part of the overall analysis of the benefits of purchasing, installing, and maintaining automatic sprinkler systems in long term care facilities.

For purposes of estimating overall benefits and costs, we believe that an estimate of about $26 million a year would not be unreasonable. We base this on the following calculations. First, as previously discussed there are approximately 2,300 structural fires annually in long term care facilities, a rate of about one fire per every seven facilities. However, we estimate that the number of fires in unsprinklered or partially sprinklered facilities is far higher, with these 2,446 facilities accounting for one fourth of all structural fires, or about one fire per every four such facilities (575 fires in 2,446 facilities). Assuming that the rate could be reduced to the 13 percent rate in fully sprinklered facilities (1,725 fires in 13,495 facilities), approximately 260 structural fires a year would be prevented. We have no specific data for estimating the dollar cost of fighting these fires and restoring the properties, but assuming illustratively that the average cost of a structural fire is $100,000, total annual savings would be on the order of $26 million a year.

In addition to losing less property due to fire, we anticipate that long term care facilities that experience fires will be able to recover more quickly with fewer disturbances to residents. Because sprinkler heads generally activate only in the area immediately near the fire source, the area that will be damaged by a fire will likely be much smaller in a sprinklered building than it would be in a building without sprinklers, thus reducing recovery costs. In addition, by limiting the area affected by the fire, there would be fewer disturbances to residents during the recovery time. In particular, fewer residents would be forced into a change in residence, a disruption that often affects residents' physical and mental well-being severely. Finally, by limiting the affected area and duration of disruption, an affected facility will reduce the number of paid patient-days that it loses. While we cannot quantify most of these benefits to long term care facilities and their residents, we believe that they are substantial. Assuming illustratively that they equal half the cost of a fire prevented, annual savings would be on the order of $6.5 million a year.

As a result of installing sprinklers, facilities will greatly reduce their potential exposure to legal costs and legal damages, as well as reduce their costs for liability insurance. Again, we cannot quantify these benefits but they could be very substantial. For example, were a court to find that a facility was negligent either in not installing a state-of-the-art system, or in being unable to save residents who would have been saved had such a system been in place, tort liability could be imposed. Absent any way to predict what might occur (which might depend, for example, not only on specific factual circumstances but also on the tort law in the state in which such a fire might occur), we do not estimate the dollar value of these benefits.

Fires cause morbidity as well as mortality. Not all residents who suffer deadly burns die immediately. Treatment of severely burned persons is among the most expensive kinds of medical care. Other effects of fires that require medical treatment include smoke inhalation and injuries cause by falls when fleeing from rooms affected by fire or smoke. No data are available to us on the extent of these medical costs, and hence on costs prevented by this final rule, but they are likely to be substantial. Assuming illustratively that there are ten expensive medical care cases prevented for each death prevented by this rule, and that such cases average $100,000, annual benefits would be $5 million (5 × 10 × $100,000).

This final rule requires a long term care facility to install an approved, supervised automatic sprinkler system in accordance with NFPA 13, Standard for the Installation of Sprinkler Systems , throughout the building. This final rule also allows long term care facilities to install automatic sprinkler systems over a 5-year phase-in period.

Following publication of the GAO report, CMS incorporated a data collection element on the long term care facility survey form. When completing a survey, a long term care facility surveyor must note whether the facility is fully sprinklered, partially sprinklered, or unsprinklered. Based on data collected during the survey process, we know that 13,391 facilities are fully sprinklered, 2,086 facilities are partially sprinklered, and 360 facilities are unsprinklered. The following table groups the partially and unsprinklered facilities by the number of beds.

The number of resident beds in a facility strongly corresponds to its physical size. Simply put, larger buildings have more resident beds, and smaller buildings have fewer resident beds. Therefore, based on the number of beds in a facility, we are able to estimate the square footage of a long term care facility. For purposes of our analysis, we estimate that a long term care facility has 500 total square feet for each resident bed. This estimate, which includes space for the resident's room, community spaces, and administrative spaces, is based on discussions with architects and engineers who are familiar with the design of older long term care facilities. Therefore, for purposes of our analysis, an average facility with fewer than 50 beds is 24,500 sq ft, 50-99 beds is 37,000 sq ft, 100-199 beds is 74,500 sq ft, and 200+ beds is 99,501 sq ft. When estimating the cost of installing an automatic sprinkler system in an unsprinklered facility, we use these square footage estimates.

However, these estimates do not reflect the area that must still be sprinklered in a partially sprinklered long term care facility. By definition, a partially sprinklered facility already has an automatic sprinkler system in one or more sections of the facility. For purposes of this impact analysis, we assume that a partially sprinklered building is 25 percent sprinklered, leaving 75 percent of the building to be sprinklered in accordance with this final rule. Buildings in this category may have more or less sprinkler coverage than this assumption.

For facilities with fewer than 50 resident beds, we estimate that sprinklers will be installed for 18,375 square feet (75 percent of maximum square footage in this size category). For facilities with 50 to 99 resident beds, we estimate that sprinklers will be installed for 27,750 square feet (75 percent of average square footage in this size category). For facilities with 100 to 199 resident beds, we estimate that sprinklers will be installed for 55,875 square feet (75 percent of average square footage in this size category). For facilities with more than 199 resident beds, we estimate that sprinklers will be installed for 75,000 square feet (75 percent of minimum square footage in this size category).

Purchasing and installing a sprinkler system according to the requirements of NFPA 13 encompasses a wide variety of factors, including those briefly described in section II of this final rule. Within the requirements of NFPA 13, there are numerous variables that can impact the purchase and installation costs for a facility. Each facility has different needs that must be addressed when purchasing and installing a sprinkler system, and this cost estimate cannot address each particular need or combination of needs. Therefore, we are basing our cost estimates not on the individual requirements of NFPA 13 for an individual facility, but on a bundled purchase and installation estimate for an average facility, as described below. Individual facilities may have costs above or below those of this average facility due to facility size and facility-specific sprinkler system needs. Long term care facilities that are based in other health care facilities, such as hospitals, are required by this final rule only to have sprinklers in the long term care facility section of the building. Therefore, we do not believe that facility-based long term care facilities will have different installation costs than freestanding facilities with similar resident bed and square footage numbers.

We estimate that it will cost $7.95 per square foot to purchase and install a sprinkler in an existing facility. According to the Architects, Contractors, Engineers Guide to Construction Costs, 2008 Edition by Design and Construction Resources, purchasing and installing sprinklers in new long term care facilities costs $2.65 per square foot. This cost estimate incorporates all contractor costs such as labor, materials, and a 20 percent overhead fee; 35 percent taxes and insurance on labor, equipment, and tools; and 5 percent sales tax.

Although we recognize that capital and interest costs may increase the cost of purchasing and installing automatic sprinkler systems in long term care facilities, these costs are not included in our estimates. Due to the individual circumstances of each facility, unknown future interest rates, and various other factors, we are unable to accurately estimate the capital and interest costs of installing sprinkler systems. Therefore, we have chosen to exclude these costs from our estimates while acknowledging that they do exist and will play a role to some degree in the decisions of long term care facilities that will be affected by this final rule. Note, however, that the economic costs of financing this capital investment would not be the gross cost of borrowing, but the much smaller opportunity cost of the capital devoted to sprinklers rather than some other investment. Furthermore, to the potentially substantial extent that facilities gain from this investment (reduced disruption, revenue loss, etc. as previously discussed) the opportunity cost may be very low.

Renovation costs are typically two to three times higher than new construction costs because installing the sprinkler system must be completed in a piecemeal fashion while the building remains occupied. This increases the length of the construction time and, thus, increases its costs. In addition, renovations to add sprinkler systems often require upgrading or adding related building components such as water lines and fire pumps. The upgrades and additions require more capital investment and construction time. Increased investment and construction time also increases costs.

For purposes of this impact analysis, we assume that renovating a typical facility to add sprinklers would cost three times more than purchasing and installing sprinklers in new long term care facilities. In the proposed rule, we presented a range of cost per square foot estimates from two to three times the costs of installation in a new building. Commenters indicated that the lower estimates in this range did not reflect the actual costs incurred by existing long term care facilities. Therefore, we eliminated the lower range and only use the highest estimate (three times the cost of installing sprinklers in new construction, $7.95).

The cost estimates for both unsprinklered and partially sprinklered facilities are presented in the following tables. They are based on all of the above-described estimates about the number of facilities that would be affected, the sizes of those facilities, and the installation cost per square foot. We estimate that this final rule will cost $846,680,105 over the 5-year phase-in period, or an average of $169,336,021 annually for 5 years for all affected partially sprinklered and unsprinklered long term care facilities.

We do not expect all affected long term care facilities to have all necessary resources immediately available to purchase and install automatic sprinkler systems. Therefore, we are allowing all facilities up to five years from the date of publication of this final rule to purchase and install sprinklers. While we will encourage all facilities to immediately begin the process of purchasing and installing sprinklers, we understand that some facilities will choose to wait until later in the phase-in period to begin this process. Therefore, we expect that the one-time cost of this final rule will be distributed over a period of several years as facilities nationwide will likely stagger their installation schedules to meet their individual needs and circumstances. We estimate that long term care facilities will spend, on average, $169,336,021 annually for five years to purchase and install automatic sprinkler systems throughout their facilities.

After installing an approved, supervised automatic sprinkler system in accordance with the 1999 edition of NFPA 13 throughout the building, all long term care facilities must test, inspect, and maintain their sprinkler systems in accordance with the 1998 edition NFPA 25. We estimate that long term care facilities will conduct quarterly inspections of their sprinkler systems and annual trip tests. We assume that each inspection will take 4 hours to complete, at a cost of $150 per inspection. We also assume that each trip test will take 6 hours, at a cost of $250. Based on these assumptions, we estimate that long term care facilities will spend $850 annually to test and inspect their sprinkler systems. In addition, we assume that long term care facilities will spend an additional $150 annually to perform any necessary maintenance duties.

Individuals who perform these testing, inspection, and maintenance duties will have to be properly trained and, in some States and local jurisdictions, they will have to be licensed. Generally, long term care facilities will not have enough sprinkler system work needs to directly employ someone with the necessary skills, training, and licensure. Therefore, we believe that long term care facilities will likely contract with another company to meet their testing, inspection, and maintenance needs. However, long term care facilities are not required by this rule to contract for these services. In addition to actually conducting the necessary testing, inspection, and maintenance activities, we believe that a contract will also include a provision that the contractor prepares adequate documentation of the activities conducted. We estimate that the total cost of meeting these requirements will be $1,000 ($150 × 4 quarterly inspections = $600 + $250 annual trip test + $150 general maintenance costs = $1,000). We estimate that the total maintenance cost for all affected facilities will be $2,446,000. We recognize that some commenters suggested that this estimate is not sufficient to capture the cost of maintaining an automatic sprinkler system. However, the commenters did not suggest a more suitable method for assessing the potential maintenance costs or a more suitable dollar estimate for such costs. Therefore, we reaffirm our original estimates.

In addition, all long term care facilities that will be affected by this final regulation are required to maintain documentation of all inspection, maintenance, and testing activities. The burden associated with these requirements is estimated to be 1 hour per long term care facility. Therefore, we estimate it will take 2,446 total annual hours (1 hour × 2,446 estimated affected long term care facilities) to meet this requirement. This documentation maintenance requirement will cost an affected facility $19 a year, based on an hourly rate of $19 for an office employee ($19 per hour × 1 hour). The total annual cost of this final documentation requirement will be $46,474 ($19 per facility × 2,446 facilities).

Taking into account all these categories of benefits and costs, and their timing, we believe that this final rule creates a substantial excess of benefits over costs at a social discount rate of 3 percent and a slight excess of benefits over costs at 7 percent. As shown in the table, costs are heavily concentrated in the first five years (we assume one-fifth is invested in each of the five years allowed for compliance) while benefits accrue over the entire 20-year life of these investments.

The U.S. Fish and Wildlife Service is the Federal agency that has been delegated the responsibility to carry out the Migratory Bird Treaty Act (MBTA) (16 U.S.C. 703 et seq. ), which implements conventions with Great Britain (for Canada), Mexico, Japan, and the Soviet Union (Russia). Raptors (birds of prey) are afforded Federal protection by the 1972 amendment to the Convention for the Protection of Migratory Birds and Game Animals, February 7, 1936, United States-Mexico, as amended; the Convention between the United States and Japan for the Protection of Migratory Birds in Danger of Extinction and Their Environment, September 19, 1974; and the Convention Between the United States of America and the Union of Soviet Socialist Republics (Russia) Concerning the Conservation of Migratory Birds and Their Environment, November 26, 1976.

Among other things, we manage the import and export of migratory birds and their parts, eggs, and nests. The regulations at 50 CFR 21.21 set forth the requirements for import and export permits for migratory birds and their parts, eggs, and nests, including requirements for import and export permits, application procedures for these permits, additional permit conditions, and the term for which a permit is valid. These regulations are 18 years old and are, in part, outdated. In particular, these regulations do not mention the requirements associated with CITES, addressed in part 23 of our regulations. In addition, many of the requirements currently set forth at § 21.21 simply reference another part or section of our regulations. They are therefore difficult to read and understand.

We proposed revisions to the regulations governing import and export of migratory birds on November 19, 2007 (72 FR 64981). Among other things, we wanted to: Address the export of species covered by CITES; allow the export of lawfully-acquired, captive-bred raptors without an export permit; allow the importation and possession without a migratory bird import permit of legally-acquired migratory game birds in the families Anatidae, Columbidae, Gruidae, Rallidae, and Scolopacidae that were lawfully hunted in a foreign country; extend the maximum time for which a migratory bird import and export permit is valid from 3 to 5 years; and reorganize and reword the regulations to make them easier to understand. We revised the proposed regulations to address comments we received, but we made no major changes to the proposed rule.

General requirements (§ 21.21(a)): Current § 21.21(a) provides the general requirements for import and export permits, as well as the exceptions to these requirements. We reorganize current § 21.21 to separate the general requirements (§ 21.21(a)) from the exceptions to the requirements (§ 21.21(b), (c) and (d)). In § 21.21(a), we acknowledge all of the regulations, including the CITES regulations at 50 CFR part 23, that apply to imports and exports of migratory birds and their parts, eggs, and nests. These revisions will help ensure that importers and exporters of migratory birds or their parts, eggs, or nests understand all the requirements applicable to their imports and exports.

Exceptions for import permits (§ 21.21(b)): Current § 21.21(a)(1) provides the requirements for import permits; it does not provide any exceptions to import permit requirements for migratory birds or their parts, eggs, or nests. Current § 21.21(a)(2) does have one import permit exception for raptors for falconry that will be discussed later in this document. We add, in a new § 21.21(b), a provision to allow the importation and possession without an import permit of migratory game birds in the families Anatidae, Columbidae, Gruidae, Rallidae, and Scolopacidae that were lawfully hunted in a foreign country. The imported specimens can be carcasses, skins, or mounts. They must be accompanied by evidence of lawful export from the country of origin and by any other necessary permits, such as a CITES permit. These families may be legally hunted under the provisions of the migratory bird treaties with Canada and Mexico, though hunting seasons have not been established for all of them. We will allow import of birds in these families that were legally hunted outside the United States without requiring an import permit to do so. However, should we determine that hunting of any species in these families is not consistent with the conservation of the species, we will disallow import of that species if it was originally acquired by hunting.

Exceptions for export permits (§ 21.21(c)): As stated above, current § 21.21(a) provides the requirements for import and export permits, and exceptions to these requirements. Current § 21.21(a) does provide exceptions to the export permit requirements for certain captive-bred migratory game birds exported to Canada or Mexico and for raptors used for falconry exported to or imported from Canada or Mexico. Our § 21.21(c) retains these exceptions, with changes described below.

Instead of simply directing readers to 50 CFR 21.13(b) of the regulations for the marking requirements for captive-bred migratory game birds exported to Canada or Mexico, we detail those requirements in this new paragraph. This revision will help ensure that exporters of migratory game birds understand the exceptions to our export permit requirements.

In addition, we add a provision to allow export of lawfully acquired, captive-bred raptors without an additional export permit, provided that the exporter holds both a valid raptor propagation permit and a CITES export permit, and has full documentation of the lawful origin of the raptor(s). The raptor(s) would also have to be properly identified by a captive-bred raptor band (see § 21.30 of this subpart C of part 21). This change will eliminate redundant permitting reviews for export of captive-bred raptors and help ensure that border inspectors can easily and accurately identify birds for export.

The exception to the import and export permit requirements for falconry birds under a CITES passport currently resides in § 21.21(a)(2), with the general export permit requirements for migratory birds. We moved the exception to the requirements for falconry birds into its own paragraph (new § 21.21(d)) so that it is easier to find in the regulations. For clarity, we revise the language concerning the exception and acknowledge the CITES regulations at 50 CFR part 23 that apply to exports of these birds. This revision will help ensure that importers and exporters of falconry birds understand this exception to the temporary export and import requirements for falconry birds. We believe that this change will help readers more easily find this information.

We believe it is reasonable to allow the temporary export and subsequent import of birds held for falconry out of the United States. Therefore, a provision in the regulation makes it clear that we allow this action. The provision states that unless a permittee has the necessary CITES permit or certificate to permanently export a raptor from the United States, he or she must bring any raptor transported out of the country for use in falconry back to the United States when he or she returns. However, if the raptor dies or is lost, the permittee must document the loss of the bird as required by his or her State falconry regulations and any conditions on the CITES document.

Inspection procedures (§ 21.21(e)): The current § 21.21 is silent on inspection procedures for imported and exported migratory birds and their parts, eggs, and nests, even though these inspections occur regularly. We correct language in our proposed rule, in which we stated that Customs and Border Protection (CBP) would be allowed to inspect any migratory birds brought into or out of the country. Doing so would be contrary to the provisions in 50 CFR part 14 and 23. 50 CFR § 14.54 does not authorize CBP to act on the Service's behalf for any export. In addition, CBP is not authorized under 50 CFR 23 to validate CITES documents issued for the export of CITES listed migratory birds or for migratory birds traveling on a CITES pet passport.

Application procedures (§ 21.21(f)): Current § 21.21(b) provides the application procedures for permits to import or export migratory birds or their parts, eggs, or nests. The current regulations set forth the information required on the application forms. The “additional information,” specified in current § 21.21(b)(1) through (b)(6), has been incorporated into the relevant application forms, so we remove that information requirement from the regulations. Instead, we list the specific forms required to apply for an import or export permit (FWS form 3-200-6) or a permit for scientific collecting (FWS form 3-200-7). We also add language reminding applicants of the application fee that must accompany their application to import or export migratory birds or their parts, eggs, or nests. This change helps ensure that persons interested in importing or exporting know which form to complete and its associated application fee.

Service criteria for issuing a permit (§ 21.21(g)): The current § 21.21 is silent on the criteria we consider when deciding whether or not to issue a permit to import or export migratory birds or their parts, eggs, or nests. We include the issuance criteria in this paragraph to ensure that the public understands how we make our decisions.

Standard conditions for a permit (§ 21.21(h)): The current § 21.21(c) provides information on additional permit conditions. We retain this information, but rewrite it for clarity in this paragraph. We also add a reference to 50 CFR part 14 to ensure that importers and exporters of migratory birds or their parts, eggs, or nests understand that they must also comply with the general regulations concerning the importation, exportation, and transportation of wildlife.

Term of permit (§ 21.21(i)): The current § 21.21(d) provides information on the length of time that a permit is valid. We extend the maximum time for which an import or export permit is valid from 3 to 5 years. In recent years, as we have completed regulations revisions we have extended the duration of some permit types that we believe have a limited potential effect on bird populations. This eases the burden on both permittees and our permit examiners. We believe that is also true of the import and export regulations, so this rule extends the term of an import and export permit.

Plain Language: Throughout our revisions to § 21.21, we have used short sentences and active voice to make the regulations easy to understand.

We received 58 sets of comments on the proposed rule. The following are concerns expressed about provisions of the regulations and suggestions for changes to them.

Issue: Cross-border temporary export and import of falconry birds.

• “I am concerned about the level of documentation required of falconers for a crossing and would prefer a clear definition concerning the sufficiency of documentation needed.”

• “Due to the option of Customs being able to do the inspection, please clearly state there is no fee for the inspection. Some falconers are still being charged $195 each way for both the inspection and crossing at non-designated port of entry.”

• “Please also clearly state that there is no inspection fee, because in the past some falconers have been charged exorbitant fees. If at all possible, please exempt falconers from the requirement to use only specially designated ports of entry.”

• “Almost all of the birds used in falconry are banded and/or captive bred. There will be a few wild caught birds with plastic bands and a few non banded birds but in all cases the falconer on the U.S. side will arrive with a 3-186A and a health certificate. At that point it should be up to the Canadian customs agents to accept or reject a person's entry into the country based on having the health certificate and having birds that match the description on the 3-186As (or equivalent). The same would apply to Canadians coming south. The need for an expensive U.S. Fish and Wildlife Service inspection coming and going needs to be dropped. A falconer should be able to cross at any port of entry without the need for either a U.S. or Canadian health inspector being present. Again, crossing with your dog or cat does not require such restrictions. There really can't be any legitimate health concerns as the very same falcons are flying overhead moving north and south over the borders every year.”

• “Since the USFWS proposes to allow either a Service inspector or a Customs inspector to examine the birds at the border (which I think is very appropriate and agree with) and since birds held for falconry appear to be exempt (under 21.21(d), assuming all other requirements are met) * * * is it possible that falconers could also be granted an exemption from “designated ports” and not be required to file a 3-200-2 for a Designated Port Exception? This would certainly help ease the paperwork requirements on both the falconer and the Service.”

• “Falconers meeting the documentation requirements should be exempt from specific designated ports of entry and should be able to use any legal point of entry with either customs or UFWS able to perform inspections.”

• “Concerning documentation of legally held raptors crossing borders, the CITES international authorities have accepted a “passport” system, now currently widely in use by falconers in the Middle East. Such documentation includes a microchip explicitly tying the passport to the individual bird described. It is good, I believe, for the life of the bird. Use of such a document in lieu of any import/export permitting would greatly facilitate crossing procedures and, as already accepted by CITES, should obviate any further significant governmental procedural harangues regarding adoption of its use.”

• “We also agree with proposed 21.21(e) that will allow inspections by either USFWS inspectors or Customs and Border Protection. However, we request a statement that falconers who are transporting birds for the purpose of practicing falconry are exempt from designated ports of entry and may use any legal point of entry. It is clear when the USFWS states that “We believe it is reasonable to allow temporary transport of birds held for falconry out of the United States. Therefore, a proposed provision in the regulation makes it clear that we allow this action. The provision states that unless you have the necessary CITES permit or certificate to permanently export a raptor from the United States, you must bring any raptor you transport out of the country for use in falconry back to the United States when you return. However, if the raptor dies or is lost, the permittee must document the loss of the bird as required by his or her State falconry regulations and any conditions on the CITES document.” Therefore, is it not also reasonable that falconers transporting birds for the purpose of practicing falconry, be exempt for the provision of “designated ports”?”

• “My personal recommendation includes both wild and CB [captive-bred] raptors being allowed to cross (because falconers use both CB and wild taken raptors in this sport) at any designated port of entry. The reason for this request (any port of entry) is that most border crossings will be for “hunting falconry meets” and these take place away from large cities, etc. So being able to cross the border at an entry that is close to the “hunting meet location” is critically important to the falconer.”

• “Many of the designated and non-designated ports of entry can be many miles from your intended destination, and in the case of Canada, due to the lack of an elaborate road system along the U.S. border, can force you to detour many additional miles to reach a designated or non-designated port. Even when a non-designated port of entry is reached, planning must occur to ensure that the USFWS Agent is available to review the required documentation. This is an unneeded requirement and Customs agents are amply qualified to verify the documentation against the band numbers of the raptors. Crossing the border only at a designated or non-designated port of entry is an overly burdensome requirement and currently prevents crossings after normal business hours and on weekends. Entry at any port of entry, during their normal operating hours, should be allowed. ”

• “Please consider allowing either the U.S. Fish and Wildlife Service or Customs to conduct inspections at border crossings.”

• “Service actions at the time of my 1996 crossing make any “designated port of entry” requirement ludicrous! My Canadian destination was some two hundred miles from my Montana hunting residence. To comply with your designated port requirement, however, those crossings necessitated my driving some four hundred additional miles each way. Further, in compliance with Service instructions I had made advanced appointments for the required personal Service-conducted inspection, both coming and going, with the Service resident “agent” agreeing as to both times and dates of my crossings. Despite my compliance with both agreed-upon appointments, no Service agent ever appeared, having told his Customs-inspector associates to just go ahead and pass me (and my bird) through. To add injury to insult (and I use such term explicitly), my use of the Service-designated port required me to pass through yet another province enroute where falconry was not yet legal, necessitating all the paperwork for yet another set of permits.”

• “It is possible for our raptors to unintentionally pursue game across the U.S. border which could result in needing to cross the border to retrieve the raptor. Please consider language that would specifically allow the USFWS LE authority to allow falconers to recover lost birds across the US/Canada border without the typical 30-90 day wait period for a CITES permit.”

• “[T]here should be policy that allows a falconer to recover a lost bird across the U.S./Canada border without the typical 30-90 day wait period for a CITES permit. A statement that specifically allowed USFWS LE authority and discretion in this scenario is requested.”

• Add “A statement specifically allowing USFWS LE authority to allow falconers to recover lost birds across the U.S./Canada border without the typical 30-90 day wait period for a CITES permit.”

• “I should be able to recover a lost bird without need of a CITES permit also.”

Response: These comments all address CITES-related and 50 CFR part 14 requirements that are not the subject of this rulemaking. All wildlife must pass through a Service-designated port out of or into the United States unless authorized otherwise by a designated port exception permit. We cannot make an exception for falconers. U.S. Customs and Border Protection (CBP) can only act on the Service's behalf for imports, when their role is to collect documentation for later investigation by the Service. CBP is not authorized to validate CITES documents, either upon export, or for CITES pet passports upon import. Nor is CBP authorized to operate on behalf of the Service for exports, primarily because CBP generally does not process exports.

A falconer can get a CITES Certificate of Ownership for Personally Owned Wildlife, or “pet passport” (Form 3-200-64) that facilitates temporary export and import of a falconry bird out of and into the United States. The 3-200-64 form “is used to request a passport-like certificate for a single animal (one application per pet).” A “pet passport” certificate may be valid for up to 3 years for multiple border crossings. If a falconer has more than one raptor that he or she wishes to temporarily export and import out of and back to the United States, he or she should get a CITES “pet passport” for each bird.

Issue: “If form 3-177 has not been pre-approved by USFWS, Customs should be allowed to stamp it.”

• “Review of the required supporting documentation can easily be performed by the Border or Customs agents. Review by Border agents have been utilized and accepted by the FWS at times when FWS agents have not been available. Having only FWS agents to verify documentation is an unnecessary requirement and only serves as a punitive source of revenue for the FWS ($195 each way) to have a FWS Agent review and stamp the documentation. Allowing Customs to check and stamp all documentation (CITES & 3-177 forms) is probably the most important requested change. Not only would this allow for a much more streamlined process but would allow crossing at times other than those hours when a FWS Agent is on duty.”

Response: We require a Form 3-177 for all wildlife imports and exports, regardless of whether a CITES document is required. CBP cannot stamp the Service's form. CBP may, however, collect it for later investigation by FWS, in which case CBP is conditionally allowing entry subject to FWS approval.

Fees for permits, border inspections, and other fees are not set in this regulation.

Issue: “In proposed 21.21(b), (c) and (d) there contains a section, which states in part, that compliance with parts 14, 15, 17, 21, 22 and 23 is required. While I agree, may I request that the title of each of those parts be included? (i.e.: 50 CFR part 14: Importation, Exportation, and Transportation of Wildlife)”

Response: We made this change. It adds clarity to the rule.

Issue: “Regarding permanent export, thank you for increasing the permit length to 5 years. However, this permit still seems redundant, as it could be issued automatically with each CITES permit. Even if a raptor propagator is giving a bird to a friend, they are still treated as commercial and charged extra fees in addition to the CITES permit.”

Response: If you have a CITES permit, you do not need an export permit under this rule. In paragraph (c)(2), we stated that an import/export permit is not needed for the export of live lawfully-acquired, captive-bred raptors by a raptor propagation permittee if he or she has a CITES export permit or certificate issued under part 23 for the export. The language is unchanged in this final rule.

Issue: The falconry transport provision did not allow for temporary export and import of wild-caught falconry birds without an import/export permit.

• “The first [issue] includes adding both WILD taken and captive bred birds to this exemption. We must still meet the CITES requirements to receive a Passport for both, so why not allow a falconer to take all of his/her falconry birds whether wild or captive bred?”

• “In section (d), may I request some additional clarification? It does not appear that wild caught raptors, transported for falconry are clearly being considered. I am sure this is a simple oversight and not your intention. Some wild caught birds are not required to be banded by the various states in the U.S. For those birds that are not required to be banded, would a completed 3-186A suffice for documentation?”

Response: We agree that temporary export and import of wild-caught falconry birds should be allowed. We added appropriate language to the regulations. However, a falconry raptor taken across a U.S. border will need to be banded unless it has been exempted from banding because of problems with bands placed on the bird, or if it has an implanted ISO-compliant microchip that will allow us to identify it.

Issue: “We also feel it is vital to include in 21.21(d) or a separate section, that transport across the border for falconry birds for the purpose of practicing falconry (i.e. a weekend hunt), not just at falconry meets, is allowed. The Service states this and we feel it is appropriate to place such verbiage in the regulations. We also feel it is vital that such transports also do not require an import/export permit.”

Response: The language in the proposed rule addressed the practice of falconry—not just falconry meets. No change from the proposed regulation is needed, nor do we require a migratory bird import/export permit. However, a CITES document would be required, even for a short weekend hunt.

Issue: “[T]he transport of semen should specifically be allowed without a permit due to its time sensitive nature.”

Response: The MBTA addresses migratory birds and their parts, eggs, and nests. We may not exempt semen from the provisions of the Act.

We made no major changes to the proposed rule based on comments we received.

The Office of Management and Budget (OMB) has determined that this rule is not significant and has not reviewed this rule under Executive Order 12866. OMB bases its determination upon the following four criteria:

(a) Whether the rule will have an annual effect of $100 million or more on the economy or adversely affect an economic sector, productivity, jobs, the environment, or other units of the government.

(b) Whether the rule will create inconsistencies with other Federal agencies' actions.

(c) Whether the rule will materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients.

(d) Whether the rule raises novel legal or policy issues.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 (Pub. L. 104-121)), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities.

SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide the statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We have examined this rule's potential effects on small entities as required by the Regulatory Flexibility Act, and have determined that this action will not have a significant economic impact on a substantial number of small entities, because the changes we are proposing are intended primarily to simplify export for a limited number of raptor propagators.

There are no costs associated with this regulatory change. Consequently, we certify that because this rule will not have a significant economic effect on a substantial number of small entities, a regulatory flexibility analysis is not required.

This rule is not a major rule under SBREFA (5 U.S.C. 804(2)). It will not have a significant impact on a substantial number of small entities.

a. This rule will not have an annual effect on the economy of $100 million or more.

b. This rule will not cause a major increase in costs or prices for consumers; individual industries; Federal, State, or local government agencies; or geographic regions.

c. This rule will 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.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ), we have determined the following:

a. This rule does not “significantly or uniquely” affect small governments. A small government agency plan is not required. Actions under this regulation will not affect small government activities in any significant way.

b. This rule does not produce a Federal mandate of $100 million or greater in any year; i.e., it is not a “significant regulatory action” under the Unfunded Mandates Reform Act.

In accordance with E.O. 12630, this rule does not have significant takings implications because it does not contain a provision for taking of private property. Therefore, a takings implication assessment is not required.

This rule will not have sufficient Federalism effects to warrant preparation of a Federalism assessment under E.O. 13132. It will not interfere with the States' ability to manage themselves or their funds. No significant economic impacts are expected to result from changing exemptions in migratory bird permit requirements.

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

We examined these regulations for compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ). We may not collect or sponsor, nor is a person required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number. The Office of Management and Budget approved the information collection requirements for this part, and assigned OMB Control Number 1018-0022. There are no new information collection requirements associated with this regulatory change.

We have analyzed this rule in accordance with the National Environmental Policy Act (NEPA), 42 U.S.C. 432-437(f), and Part 516 of the U.S. Department of the Interior Manual (516 DM). We have no data on the number of legally hunted birds that individuals might wish to import, though we doubt that the number will be large. Because these species are legally hunted elsewhere, we doubt that this regulations change will appreciably change the impact of hunting on these species. Therefore, we do not believe that there will be a significant environmental impact due to the regulations change.

The primary change is to allow export of lawfully-acquired, captive-bred raptors without an export permit provided that the exporter holds a valid raptor propagation permit and has been issued a Convention on International Trade in Endangered Species (CITES) export permit. This change should eliminate redundant permitting required for this activity. Another important change is to allow the import of legally-acquired migratory game birds without a permit. A permit is currently required to import such species. We believe that there are no significant environmental impacts of this action.

Socioeconomic. This rule will not have discernible socioeconomic impacts.

Migratory bird populations. This rule will not affect migratory bird populations.

Endangered and threatened species. The regulation is for migratory bird species that are not threatened or endangered. It will not affect threatened or endangered species or critical habitats.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American tribal Governments” (59 FR 22951), E.O. 13175, and 512 DM 2, we have evaluated potential effects on Federally recognized Indian Tribes and have determined that there are no potential effects. This rule will not interfere with the Tribes' ability to manage themselves or their funds or to regulate migratory bird activities on tribal lands.

On May 18, 2001, the President issued E.O. 13211 addressing regulations that significantly affect energy supply, distribution, and use. E.O. 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. Because this rule will affect only import and export of birds in limited circumstances, it is not a significant regulatory action under E.O. 12866, and will not significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required.

Section 7 of the Endangered Species Act (ESA) of 1973, as amended (16 U.S.C. 1531 et seq.), requires that “The Secretary [of the Interior] shall review other programs administered by him and utilize such programs in furtherance of the purposes of this chapter” (16 U.S.C. 1536(a)(1)). It further states that the Secretary must “insure that any action authorized, funded, or carried out * * * is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of [critical] habitat” (16 U.S.C. 1536(a)(2)). The regulations change will not affect listed species.

This final rule is accessible on the internet at: www.gpoaccess.gov/fr/ .

Since 1980, almost all of the black coral harvested around the Hawaiian Islands has been taken from the Au'au Channel Bed. The biomass of the Au'au Channel black coral population has decreased by at least 25 percent in the last 30 years, and data collected during submersible dives has shown a decline in both recruitment and relative abundance of legal-sized black coral colonies. The decline may be related to both fishing pressure and competition with the highly-invasive soft coral, Carijoa riisei , or snowflake coral, which has been found overgrowing large areas of black coral habitat. The potentially-devastating snowflake coral, combined with fishing pressure, warrants management action and further research.

This final rule designates the Au'au Channel Bed (Fig. 1) as an “Established Bed” with a harvest quota for black coral of 5,000 kg (11,023 lb) every two years. This quota applies in both Federal and State of Hawaii waters, and all other existing Federal restrictions continue to apply.