The Occupational Safety and Health Administration (OSHA) has completed a “look back” review of its EtO Standard, 29 CFR 1910.1047, titled “Regulatory Review of the Occupational Safety and Health Administration's Ethylene Oxide Standard, March 2005.” This Federal Register document announces the availability of the Regulatory Review and briefly summarizes it. The review was undertaken pursuant to Section 610 of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) and Section 5 of Executive Order 12866 (59 FR 51739, Oct 4, 1993) and all issues raised by those provisions. The purpose of a review under section 610 of the Regulatory Flexibility Act “Shall be to determine whether such rule should be continued without change, or should be rescinded, or amended consistent with the stated objectives of applicable statutes to minimize any significant impact of the rule on a substantial number of small entities.”

“The Agency shall consider the following factors:

(1) The continued need for the rule;

(2) The nature of complaints or comments received concerning the rule from the public;

(3) The complexity of the rule;

(4) The extent to which the rule overlaps, duplicates or conflicts with other Federal rules; and, to the extent feasible, with state and local governmental rules; and

(5) The length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the areas affected by the rule.”

The review requirements of Section 5 of the Executive Order 12866 require agencies:

“To reduce the regulatory burden on the American people, their families, their communities, their state, local and tribal governments, their industries to determine whether regulations promulgated by the [Agency] have become unjustified or unnecessary as a result of changed circumstances; to confirm that regulations are both compatible with each other and not duplicative or inappropriately burdensome in the aggregate; to ensure that all regulations are consistent with the President's priorities and the principles set forth in the Executive Order, within applicable law; and to otherwise improve the effectiveness of existing regulations.”

OSHA published a Federal Register document requesting public comments on the EtO Standard and specifically all issues raised by those provisions, and held a public meeting on those matters (62 FR 28649, May 27, 1997). The Review summarizes the public comments and responds to them.

Ethylene Oxide is an industrial chemical that has high volume uses as an intermediate to produce other chemicals such as antifreeze. It is also used as a sterilant principally in the hospital, medical device and spice processing industries.

In 1984, principally based on evidence of carcinogenicity in animals, OSHA issued a standard (29 CFR 1910. 1047) lowering exposures from 50 parts per million (ppm) to 1 ppm. That standard also included requirements for monitoring, medical surveillance, training and other provisions.

OSHA has reviewed the studies, information and public comments about the standard. Based on those, it has reached the following conclusions pursuant to the section 610 review discussed in greater length in the full report.

There is a continued need for the rule. Workers exposed to EtO in a range of industries would continue to be at risk of cancer, genetic changes and other adverse health effects, without the standard. Since the standard was developed, the International Agency for Research on Cancer reclassified EtO as a known human carcinogen and the National Toxicology program reclassified EtO as a one “known to be a human carcinogen.” Based on the significant scientific information, OSHA finds that the potential carcinogenicity of EtO and the risk posed to workers continues to justify the need for the Standard.

Comprehensive studies, compliance information, and public comments indicate that the Standard has been effective in reducing exposure to EtO thereby achieving the predicted health benefits. The public comments evidenced widespread support for continuance of the EtO Standard and endorsed its effectiveness. No commenter argued that the standard should be rescinded.

The evidence indicates that the EtO Standard has not had a negative economic impact on the industries affected by the standard, generally, or on small businesses in those industries. Production of EtO has increased from 6.2 billion pounds to 8 billion pounds since the standard was issued. Most of the small businesses affected by the EtO Standard are hospitals, medical device manufacturers, and spice manufacturers. There are no indications that the regulation of occupational exposure to EtO has impaired the economic well being of businesses in any of these sectors or has disproportionately affected small businesses.

The rule is not unduly or unreasonably complex. Although most commenters did not directly address the issue of whether the standard was considered to be unduly or unreasonably complex, a few comments at the public meeting and comments submitted to the Docket requested clarification of a few requirements of the standard. OSHA intends to issue compliance assistance and outreach materials to aid employers' and employees' understanding of the standard.

The EtO Standard does not overlap with other regulations. Four major federal regulatory entities in addition to OSHA currently regulate various aspects of EtO use and transport. The only potential regulatory conflict raised by one commenter during this lookback review involved an Environmental Protection Agency standard under the Clean Air Act for EtO using commercial sterilization and fumigation operations. Commercial sterilization and fumigation operations using one ton or more of EtO per year are required to use emission control technology to comply with EPA standards. The two agencies' rules do not actually conflict and no employers have stated that they have not been able to comply with both.

Technological improvements have improved worker safety. OSHA's independent research, comments received, and the technical literature indicate that significant technological developments have occurred since the promulgation of the standard. Improvements in sterilizer technology, the growth in number and use of alternative sterilants and sterilizing processes, and use of contract sterilizers to perform EtO sterilization have contributed to an observed reduction in occupational exposure to EtO. None of the comments received by OSHA indicated that technology feasibility problems prevented affected businesses from complying with the EtO Standard.

The Standard encouraged the development of improved sterilizers, which achieved compliance with the standard and cost less than other sterilizers. The newer equipment costs about half the cost of the older equipment with add-on controls. This reduced costs for all employers including small businesses.

A 1995 Congressional Office of Technology Assessment study completed after the standard took effect concluded that the Feasibility Study, which OSHA performed before issuance of the standard, was accurate and well done.

The agency has also reviewed the record and standard pursuant to E.O. 12866. Pursuant to that review it has reached the following conclusions:

The EtO Standard remains both justified and necessary. As discussed in OSHA's Section 610 analysis, EtO poses significant health and safety risks to workers exposed to the substance. While the standard has resulted in dramatic reductions in occupational exposures to EtO, OSHA continues to document overexposures and non-compliance in the workplace. A study of Massachusetts hospitals demonstrated that enforcement actions were necessary before they came into compliance with the standard.

The EtO Standard is compatible with other OSHA standards and is not inappropriately burdensome in the aggregate. No public comment questioned the compatibility of the EtO standard with Federal OSHA or state standards.

The EtO Standard is compatible with E.O. 12866. The Executive Order essentially provides for a regulatory system that efficiently and effectively protects health and safety without imposing unacceptable or unreasonable costs on society. The regulations that are produced must be consistent, sensible, and understandable. This lookback review has received many comments supporting the standard's effectiveness in reducing occupational exposures to EtO. In addition, the industries that use EtO appear to be familiar with the standard and have adopted improved technology, use of substitutes, and other methods to improve efficiency. No evidence was submitted to the Docket or identified by OSHA in the course of this lookback review to suggest that the standard was imposing either a significant impact on a substantial number of small entities or that it was causing an excessive compliance burden. The EtO Standard is effective in achieving its mission. Uniform support for retaining the EtO standard is in the public record for this lookback review.

Therefore, based on the comments and testimony of participants in this lookback review process and the studies and other evidence submitted to the public docket, OSHA concludes, as discussed in depth in “Regulatory Review of the Occupational Safety and Health Administration's Ethylene Oxide Standard” March 2005, that the Agency's Standard should be continued without change. The evidence also demonstrates that the Standard does not need to be rescinded or substantially amended to minimize significant impacts on a substantial number of small entities.

OSHA also finds that the EtO Standard is necessary to protect employee health, is compatible with other OSHA standards, is not duplicative or in conflict with other Federal, state, or local government rules, is not inappropriately burdensome, and is consistent with the President's priorities and the principles of E.O. 12866. Further, no changes have occurred in technological, economic, or other factors that would warrant revision of the Standard at this time. No commenters recommended that the standard be repealed or made less protective.

As a result of this lookback review and the comments received from participants, OSHA will enhance some of its compliance assistance materials. The enhancements may cover emergency requirements, medical surveillance and other areas.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. This safety zone is temporary in nature and limited time existed for an NPRM. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying this rule would be impracticable and contrary to public interest as boating season is resuming and immediate action is necessary to clear the barge from the canal and perform clean up of the surrounding area; further, immediate action is necessary to ensure the safety of persons and vessels during the salvage operations and to prevent possible loss of life or property. During the enforcement of this safety zone, comments will be accepted and reviewed and may result in a modification to the rule.

On January 19, 2005, the tank barge EMC423 was involved in a marine casualty on the Chicago Sanitary and Ship Canal (CSSC) at Mile Marker 317.5. The barge sustained an explosion and partially sank with a full load of clarified slurry oil on board. Salvage and recovery operations are underway. With the change in weather and increase in recreational vessel traffic in the area, the Captain of the Port Chicago finds it necessary to implement operational restrictions and control vessel traffic through the area to protect response workers, vessels transiting the zone, and to maintain the integrity of the site.

This rule establishes a safety zone from bank-to-bank beginning at the Cicero Avenue Bridge at Mile Marker 317.3 and ending at the Belt Railroad Bridge at Mile Marker 317.5 on the Chicago Sanitary and Ship Canal.

Vessels will not be allowed to enter the safety zone, without the express permission of the Captain of the Port Chicago or the designated on-scene representative. It is anticipated that controlled passage of vessels will be possible on a case-by-case basis.

Barges transiting the area will be limited to dry cargo, 35 foot wide with drafts not exceeding 9-feet. Up bound tows are limited to one barge. Down bound tows are limited to one loaded barge or two empty barges. All down bound tows require a bow assist boat.

All commercial and recreational vessels must contact the Coast Guard Forward Command Post via VHF-FM Channel 19 or land line at 630-336-0291 to request permission to transit through the safety zone.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

This finding is based on the relatively small percentage of vessels that would fall within the applicability of the regulation, the relatively small size of the limited access area around the EMC423 tank barge, the minimal amount of time that vessels will be restricted when the zone is being enforced. In addition, vessels that will need to enter the zone may request permission on a case-by-case basis from the Captain of the Port or the designated on-scene representatives.

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

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

This rule affects the following entities, some of which might be small entities: The owners or operators of vessels intending to transit through the safety zone in and around the sunken barge.

This rule would not have a significant impact on a substantial number of small entities because the restrictions affect only a limited area for a brief amount of time as this safety zone is effective only when salvage operations on the tank barge EMC423 is underway. Further, transit through the zone may be permitted with proper authorization from the Captain of the Port Chicago or his designated representative. Additionally, the opportunity to engage in recreational activities outside the limits of the safety zone will not be disrupted.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact LTJG Cameron Land, Coast Guard Marine Safety Office Chicago, at (630) 986-2155.

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

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

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

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

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

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

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

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

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. Under figure 2-1, paragraph (34)(g) of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES.

On January 7, 2005, we published a notice of proposed rulemaking (NPRM) entitled “Security Zone; Port of Mobile, Mobile Ship Channel, Mobile, AL” in the Federal Register (70 FR 1400). We received no comments on the proposed rule. No public hearing was requested, and none was held.

On September 11, 2001, both towers of the World Trade Center and the Pentagon were attacked by terrorists. The President has continued the national emergencies he declared following those attacks (69 FR 55313 (Sep. 13, 2004) (continuing the emergency declared with respect to terrorist attacks); 69 FR 56923 (Sep. 22, 2004) (continuing emergency with respect to persons who commit, threaten to commit or support terrorism)). The President also has found pursuant to law, including the Magnuson Act (50 U.S.C. 191 et seq.), that the security of the United States is and continues to be endangered following the terrorist attacks (E.O. 13,273, 67 FR 56215 (Sep. 3, 2002) (security of U.S. endangered by disturbances in international relations of U.S. and such disturbances continue to endanger such relations)). In response to these terrorist acts and warnings, heightened awareness for the security and safety of all vessels, ports, and harbors is necessary.

On November 12, 2004, the Coast Guard published a temporary final rule entitled “Security Zone; Port of Mobile, Mobile Ship Channel, Mobile, AL” (69 FR 65373). This temporary final rule established temporary security zones around cruise ships when transiting the Mobile Ship Channel and Port of Mobile, as well as when moored in the Port of Mobile. This temporary final rule will expire at 6 p.m. on April 14, 2005. However, due to the increased security concerns surrounding the transit of cruise ships, the Captain of the Port Mobile is establishing permanent security zones around all cruise ships while such vessels are transiting the Mobile Ship Channel or Port of Mobile, and while moored in the Port of Mobile.

We received no comments on the proposed rule, and no changes have been made from the proposed rule.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

These security zones will only be enforced while cruise ships are located shoreward of the Mobile Sea Buoy, are transiting the Mobile Ship Channel, and are moored in the Port of Mobile. Once a cruise ship is moored in the Port of Mobile, the security zone will be reduced to 25 yards. While the cruise ship is moored, other vessels will be able to safely transit around this zone provided they approach no closer than 25 yards. Additionally, while a cruise ship is in transit on the Mobile Ship Channel or in the Port of Mobile, the Captain of the Port or a designated representative may allow other persons or vessels to enter into the security zone for the purpose of passing or overtaking a cruise ship if such persons or vessels obtain permission from the on-scene Coast Guard representative prior to initiating such action.

Notifications of the enforcement periods of this security zone will be made to the marine community through broadcast notice to mariners. The impacts on routine navigation are expected to be minimal.

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

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

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit the waters of the Port of Mobile or the Mobile Ship Channel while cruise ships are shoreward of Mobile Sea Buoy.

This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: (1) This rule will only be enforced while cruise ships are shoreward of the Mobile Sea Buoy; (2) Once a cruise ship is moored in the Port of Mobile, the security zone will be reduced to 25 yards and other vessels will be able to safely transit around this zone provided they approach no closer than 25 yards; (3) The Captain of the Port Mobile may permit vessels to transit through the security zone for the purpose of passing or overtaking a transiting cruise ship if permission is sought and obtained from the on-scene Coast Guard representative prior to initiating such action.

If you are a small business entity and are significantly affected by this regulation please contact LT Maurice York, Operations Department, Marine Safety Office Mobile, at (251) 441-5940.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation because this rule is not expected to result in any significant adverse environmental impact as described in the National Environmental Policy Act of 1969 (NEPA).

A final “Environmental Analysis Checklist” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES.

On November 12, 2004, the Coast Guard published a temporary final rule (TFR) entitled “Security Zone; Port of Mobile, Mobile Ship Channel, Mobile, AL” (69 FR 65373). This temporary final rule will expire at 6 p.m. on April 14, 2005. On January 7, 2005, we published a notice of proposed rulemaking (NPRM) entitled “Security Zone; Port of Mobile, Mobile Ship Channel, Mobile, AL” (70 FR 1400). We received no letters commenting on the proposed rule. No public hearing was requested, and none was held. That final rule is being published elsewhere in this same issue of the Federal Register and will become effective on May 23, 2005.

Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM, and under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the Federal Register. It took longer to resolve issues related to the final rule than we expected at the time we issued the last TFR. Because the current TFR expires at 6 p.m. on April 14, 2005, this new TFR is necessary because it would be contrary to public interest not to maintain a security zone around transiting cruise ships in the Mobile Ship Channel or Port of Mobile until the final rule becomes effective on May 23, 2005, at which time this temporary rule will be removed.

On September 11, 2001, both towers of the World Trade Center and the Pentagon were attacked by terrorists. The President has continued the national emergencies he declared following those attacks (69 FR 55313 (Sep. 13, 2004) (continuing the emergency declared with respect to terrorist attacks); 69 FR 56923 (Sep. 22, 2004) (continuing emergency with respect to persons who commit, threaten to commit or support terrorism)). The President also has found pursuant to law, including the Magnuson Act (50 U.S.C. 191 et seq.), that the security of the United States is and continues to be endangered following the terrorist attacks (E.O. 13,273, 67 FR 56215 (Sep. 3, 2002) (security of U.S. endangered by disturbances in international relations of U.S and such disturbances continue to endanger such relations)). In response to these terrorist acts and warnings, heightened awareness for the security and safety of all vessels, ports, and harbors is necessary. Due to the increased security concerns surrounding the transit of cruise ships, the Captain of the Port Mobile is establishing temporary security zones around all cruise ships while such vessels are transiting the Mobile Ship Channel or Port of Mobile, and while moored in the Port of Mobile.

This temporary final rule is identical to the previous rule published in the Federal Register on November 12, 2004 (69 FR 65373). The Coast Guard was unable to publish an extension to this rule. However, the practical effect of this new temporary final rule is the same and continues the security zone currently in effect.

The Coast Guard is establishing temporary security zones for the Port of Mobile and Mobile Ship channel. This rule establishes security zones that prohibits movement within 25 yards of all cruise ships while moored in the Port of Mobile, and prohibits movement within 100 yards of any cruise ship while transiting the Mobile Ship Channel or the Port of Mobile. For the purpose of this rule the term “cruise ship” is defined as a passenger vessel over 100 gross tons, carrying more than 12 passengers for hire, making a voyage lasting more than 24 hours any part of which is on the high seas, and for which passengers are embarked or disembarked in the United States or its territories. This definition covers passenger vessels that must comply with 33 CFR parts 120 and 128.

These security zones will be enforced when a cruise ship transiting inbound passes the Mobile Sea Buoy in approximate position 28°07′50″ N, 88°04′12″ W, at all times during transit through the Mobile Ship Channel and Port of Mobile, and while moored in the Port of Mobile. A security zone will exist during each cruise ship's transit outbound the Port of Mobile and the Mobile Ship Channel. Enforcement of these security zones will cease once the cruise ship passes the Mobile Sea Buoy on its outbound voyage.

These security zones are needed to protect the safety of life, property and the environment in the area. All vessels are prohibited from moving within these zones unless specifically authorized by the Captain of the Port Mobile, or a designated representative.

Persons on vessels that desire to enter into one of these security zones for the purpose of passing or overtaking a cruise ship that is in transit on the Mobile Ship Channel or in the Port of Mobile must contact the on-scene Coast Guard representative, request permission to conduct such action, and receive authorization from the on-scene Coast Guard representative prior to initiating such action. The on-scene Coast Guard representative may be contacted on VHF-FM channel 16. All persons and vessels authorized to enter into a security zone shall obey any direction or order of the Captain of the Port or designated representative.

The Captain of the Port Mobile or a designated representative will inform the public through broadcast notice to mariners of the enforcement periods for these security zones.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

These security zones will only be enforced while cruise ships are located shoreward of the Mobile Sea Buoy, are transiting the Mobile Ship Channel, and are moored in the Port of Mobile. Once a cruise ship is moored in the Port of Mobile, the security zone will be reduced to only 25 yards. While the cruise ship is moored, other vessels will be able to safely transit around this zone provided they approach no closer than 25 yards. Additionally, while a cruise ship is in transit on the Mobile Ship Channel or in the Port of Mobile, the Captain of the Port or a designated representative may allow other persons or vessels to enter into the security zone for the purpose of passing or overtaking a cruise ship if such persons or vessels obtain permission from the on-scene Coast Guard representative prior to initiating such action.

Notifications of the enforcement periods of these security zones will be made to the marine community through broadcast notice to mariners. The impacts on routine navigation are expected to be minimal.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities for the reasons enumerated under the Regulatory Evaluation section of this rule.

If you are a small business entity and are significantly affected by this regulation please contact LT Maurice York, Operations Department, Marine Safety Office Mobile, at (251) 441-5940.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so they may better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation because this rule is not expected to result in any significant adverse environmental impact as described in the National Environmental Policy Act of 1969 (NEPA).

A final “Environmental Analysis Checklist” and a final “Categorical Exclusion Determination” will be available for inspection or copying where indicated under ADDRESSES.

Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.

On January 14, 2004, TCEQ adopted a Memorandum of Agreement (MOA) between TCEQ and NCTCOG's Regional Transportation Council (RTC). At the same time, TCEQ adopted a revision to the Texas SIP to incorporate this MOA into it, and has since submitted this SIP revision to EPA for approval. This MOA commits the RTC to provide the DWFIA with emissions offsets in the amount of 0.18 tpd of NOX and 0.04 tpd of VOCs in 2007 and to adjust the modeled 2015 on-road mobile source emissions estimates by an increase of 1.17 tpd and 0.26 tpd of NOX and VOCs, respectively, in future transportation conformity demonstrations by the FAA.

EPA is approving the incorporation of this MOA into the DFW SIP. This action by EPA will ensure that the MOA, and the resulting emission offsets, are enforceable at both the federal and state levels.

The DFW area is a nonattainment area for the air pollutant ozone, and is operating under a SIP to control the emissions of NOX and VOCs, which are ozone precursor pollutants. Under the Texas general conformity rules (30 TAC 101.30), which implement the general conformity requirements of section 176(c) of the Clean Air Act, certain types of Federal actions, such as FAA approval of environmental documents developed in accordance with the National Environmental Policy Act (NEPA), require a determination as to whether the total emissions from the action conform with the applicable SIP, unless the resultant emissions are expected to be below the de minimis levels identified in these regulations (30 TAC 101.30(c)(2); see 40 CFR 51.853(b)(1)). The de minimis level for the DFW one-hour nonattainment area is 50 tons per year. The applicable SIP, in this case, is the Post 1996 Rate of Progress (ROP) SIP approved by EPA on March 28, 2005 (70 FR 15592, effective April 27, 2005).

The DFWIA notified TCEQ and EPA of upcoming aviation projects that would trigger the need for a general conformity determination by the FAA. These projects include construction of a new terminal (Terminal F), addition of a new cargo complex, improvement of airport parking, changes to current operating restrictions of existing terminal facilities, and other related projects included in the DFW Airport Master Plan.

Based on submitted estimates of direct and indirect NOX and VOC emissions resulting from these projects, emissions are expected to exceed the de minimis level of 50 tons per year during some of the project years. As evaluated in 2007, only NOX estimates exceed this level (0.18 NOX tpd or 65.7 NOX tpy), but in the peak operation year of 2015 both precursor pollutants are expected to exceed the de minimis level (1.16 NOX tpd and 0.26 tpd VOC). As a result a general conformity determination by the FAA is required.

The conformity regulations provide several options to show that an action conforms to an applicable implementation plan. One option is to establish enforceable measures that offset the expected emissions from the project. 30 TAC 101.30(h)(1)(B); see 40 CFR 51.858(a)(2). The DFWIA worked with the Regional Transportation Council in 2002 to identify emission reduction measures to be used to offset the emissions associated with these airport expansion projects. On December 12, 2002, the RTC resolved to implement emission reduction measures to provide offsets for use by the DFWIA to meet general conformity requirements for the year 2007. At a minimum, these measures will offset the 0.18 tpd of NOX and 0.04 tpd of VOCs that are expected to be generated in 2007 by the Terminal F projects. In addition, the RTC resolved to provide emission reductions in the amount of 1.17 tpd of NOX and 0.26 tpd of VOCs for the year 2015. This will be accomplished by incorporating these expected emissions into the Metropolitan Transportation Plan for the year 2015, for which the total estimated emissions cannot exceed the emissions cap set by the motor vehicle emissions budget for that year. Provisions in the general conformity regulations allow for such an interaction between the general conformity and transportation conformity processes. The general conformity regulations specifically state that a federal agency can demonstrate general conformity, in part, by showing that “the action or portion thereof, as determined by the MPO, is specifically included in a current transportation plan and transportation improvement program which have been found to conform to the applicable SIP [under the transportation conformity regulations].” 30 TAC 101.30(h)(1)(E)(ii); 40 CFR 51.858(a)(v)(ii). See also Question 1 on p. 30 of the General Conformity Guidance Questions and Answers, issued by EPA on July 13, 1994. Details on the emission reduction measures are available in the Technical Support Document associated with this action. These emission reduction commitments are intended to assist the FAA in making a general conformity determination for the planned airport expansion projects associated with construction of Terminal F.

The general conformity rules require these measures to be enforceable under both state and Federal law (30 TAC 101.30(h)(1)(B); see 40 CFR 51.858(a)(2)). Upon the effective date of our action, these measures will be federally enforceable. The MOA between TCEQ and the RTC was adopted by the state on January 14, 2004, and was incorporated into the State Implementation Plan for the DFW ozone nonattainment area on that same day. Thus, these measures are already enforceable by state law.

It is important to note that EPA is not making a general conformity determination itself nor are we approving a general conformity determination for this FAA action. Under the conformity regulations, each Federal agency must make its own conformity determination (30 TAC 101.30(d); see 40 CFR 51.854). With this approval action, EPA is simply approving into the SIP an MOU that will provide a means for the FAA to make future general conformity determinations for the DFWIA.

On October 29, 2004, EPA published a direct final rule approving a revision to incorporate the MOA into the Texas SIP for the DFW ozone nonattainment area. This rule contained the condition that if any adverse comments were received by the end of the public comment period on November 29, 2004, the direct final rule would be withdrawn and we would respond to the comments in a subsequent final action. One consolidated set of comments was received from a representative of Blue Skies Alliance, Downwinders at Risk, Public Citizen and Sierra Club. The following summarizes the comments and EPA's response to these comments.

Comment 1: The action allows Texas to avoid Clean Air Act obligations under the 1-hour ozone standard by allowing emission reduction measures to offset airport emissions. Any reductions from these measures should be included in the area's SIP to meet its outstanding 1-hour obligation.

Response: EPA action on the 1-hour ozone attainment demonstration SIP submitted by TCEQ to EPA on April 25, 2000, is outside the scope of this Federal Register action. The general conformity regulations authorize the use of emission offsets in conformity determinations (30 TAC 101.30(h)(1)(B); see 40 CFR 51.858(a)(2)). This provision states that emission offsets may be implemented through a revision to the SIP or a similarly enforceable measure so that sufficient emission reductions are achieved that there is no net increase in emissions of the criteria pollutant. The incorporation of this MOA into the Texas SIP is not specifically related to the attainment demonstration SIP. EPA action to incorporate this MOA into the general Texas SIP will render the provisions of the MOA federally enforceable as required by the general conformity regulations discussed above. Although there is currently not an approved 1-hour ozone attainment demonstration SIP for the DFW area, EPA has outlined several options that will allow States to fulfill unmet 1-hour obligations in the recent rulemaking related to promulgation of the 8-hour ozone NAAQS (69 FR 23951).

Comment 2: Comment questions the ability of 2015 MVEBs to accommodate emissions from the airport project and states that the proposed action blurs the distinction between the conformity rules that allow conformity to be determined by either inclusion of the emissions in the SIP or by providing separate offsets.

Response: EPA disagrees with this comment. The MOA commits the North Central Texas Council of Governments to accommodate expected emissions from the airport project by adjusting (i.e., increasing) the modeled regional mobile emissions estimates for 2015. EPA action to incorporate this MOA into the general Texas SIP will render the provisions of the MOA federally enforceable as required by the general conformity regulations. Therefore, any failure by the NCTCOG to adjust the regional emissions estimates in 2015 could result in a finding by EPA of a failure to implement the SIP and could jeopardize future transportation conformity determinations required for the area's Metropolitan Transportation Plan and Transportation Improvement Program. Further, the conformity rule provisions for demonstrating conformity allow a combination of approaches to be used. 30 TAC 101.30(h); see 40 CFR 51.858(a). The FAA has decided to demonstrate conformity by implementing emissions offsets and by ensuring that the 2015 emissions estimates will be included in a conforming Transportation Improvement Program as authorized by 30 TAC 101.30(h)(1)(E)(ii). See 40 CFR 51. 858(a)(5)(ii); Question 39 of General Conformity Guidance for Airports Questions and Answers (published jointly by EPA and FAA on September 25, 2002). The NCTCOG must continue to adjust the regional emissions analysis to accommodate this airport project in any transportation conformity determination undertaken prior to the MOA expiration date of December 31, 2015.

Comment 3: The general conformity determination would rely on inclusion of 2015 emissions in a future 1-hour SIP.

Response: EPA disagrees. Any conformity determination made by the FAA or other Federal agency is not dependent upon submission or approval of a 1-hour ozone attainment demonstration SIP. The conformity regulations provide several mechanisms to demonstrate conformity that are unrelated to whether an approved SIP is in place, including the provision related to emissions offsets (30 TAC 101.30(h)(1)(B); 40 CFR 51.858(a)(2)).

Comment 4: EPA should treat the 1999 [sic] attainment demonstration SIP as disapproved and find that no projects may proceed until current inventories are developed and an attainment demonstration is made.

Response: EPA believes the commenters are referring to the attainment demonstration SIP submitted in 2000, because EPA has taken final action on the 1999 attainment demonstration SIP. On June 2, 1999, EPA published a final rule finding that the 1999 SIP submitted by TCEQ was incomplete (64 FR 29570). To date, EPA has taken no action on the 2000 attainment demonstration SIP. Action on this SIP is outside the scope of this notice. The conformity regulations provide several mechanisms to demonstrate conformity that are unrelated to whether an approved SIP is in place, including the provision related to emissions offsets (30 TAC 101.30(h)(1)(B); 40 CFR 51.858(a)(2)).

Comment 5: Construction emissions in the SIP should first be mitigated to as low a level as possible, and then offset with emission reduction measures.

Response: Although EPA supports and encourages air quality mitigation measures and use of Best Management Practices in construction operations, mitigation is not required prior to determination of emission offsets.

Comment 6: Offset requirements are underestimated because the 90% NOX emission reduction controls on airport Ground Support Equipment (GSE) are not part of an approved SIP. Agreed Orders do not assure that all future airport activity will be controlled to the assumed level.

Response: Agreed Orders and Memoranda of Agreement (MOAs) concerning emission reductions in Ground Support Equipment at DFW area airports were signed by the parties involved in 2001 and approved into the SIP by EPA on April 22, 2002 (67 FR 19515). Therefore, as measures approved into the Texas SIP, the Agreed Orders and MOAs are federally enforceable and subject to the enforcement provisions generally applicable to SIPs, including potential sanctions that could be triggered if EPA finds that TCEQ has failed to implement the SIP.

Comment 7: Emission estimates are likely erroneous. The commenters reference a Texas Transportation Institute (TTI) Airport Emissions Inventory study.

Response: The emissions estimates were based on inventories, emission factors and emission models that were available at the time the analysis was started. While emission inventories and models are updated periodically, EPA believes that the initial estimates provided by the DFWIA are reasonable and appropriate. The revised 2007 NOX inventory, upon which the Agreed Orders and MOAs are based, is the result of a more refined survey of the GSE population in actual use at the affected airports. This inventory revision went through the State's administrative process for adoption and was subsequently accepted by EPA. The TTI study referenced by the commenters was cited in the DFW 5% Increment-of-Progress SIP, which is still under consideration by TCEQ. This study was not available at the time the GSE Agreed Orders were developed.

Please note that EPA is not making a general conformity determination itself; we are solely approving a mechanism that the FAA may use for a future general conformity determination for the DFWIA. Each Federal agency must make an independent conformity determination for its action. Prior to making conformity determination the FAA must evaluate the emission estimate methodology and inventory. Any conformity determination made by the FAA is subject to the public notice and involvement provisions of the general conformity regulations.

Comment 8: Current controls on existing sources expire and are not enforceable because the MOU containing the DFWIA emission reduction commitments expires in 2007.

Response: The GSE Agreed Orders and MOAs (among which is presumably the MOU referenced in the comment) have been signed and incorporated into the Texas SIP. Therefore, because EPA has already approved the orders and MOAs into the SIP in a separate final action (see 67 FR 19515), this comment is outside the scope of this action. Nonetheless, airport operators and major carriers in the affected areas have already made the required conversions of GSE to electric. Although the GSE MOA expires in 2007, it is unreasonable to expect that airport operators and carriers would then convert this equipment back to diesel.

Comment 9: The Technical Support Document must address the effectiveness of various elements of the SIP that generate the basis of the GSE emission factors.

Response: This request is beyond the scope of this action. EPA is not acting on the 2000 attainment demonstration SIP with this notice. The GSE emission factors used mirror those used to develop the Agreed Orders with DFWIA, the Cities of Dallas and Fort Worth and the GSE owners/operators at DFWIA. These Agreed Orders were approved by EPA and incorporated into the general Texas SIP on April 22, 2002 (67 FR 19515).

Comment 10: General conformity regulations require the use of the latest and most accurate emission estimation techniques available per 40 CFR 93.160(b), but MOA activity is based on 1996 data.

Response: The emissions inventory was prepared in accordance with methods and models approved by EPA and FAA, and used the latest available inventory at the time the analysis was begun. Please note that this Federal Register action is not a conformity determination and the FAA may require additional analyses with updated inventories and currently available models prior to any future conformity determination it may undertake.

Comment 11: The general conformity determination does not reference FAA's Emissions and Dispersion Modeling system (EDMS).

Response: This is not a general conformity determination but simply a mechanism by which to make available emission reduction credits or offsets for possible use by a Federal agency in making a conformity determination. Emission estimates for the Terminal F projects provided by DFWIA included use of the FAA's EDMS model, among others (see the Technical Support Document associated with the proposal for this action.)

Comment 12: The analysis is proposed using MOBILE5 and should be reevaluated using MOBILE6.

Response: At the time the analysis was developed, MOBILE5 was the latest EPA-approved model for estimating on-road mobile source emissions. EPA released a later version of the MOBILE model, MOBILE6, on January 29, 2002 (67 FR 4254). EPA regulations allow a grace period for emission analysis begun prior to the issuance of a new emissions model. In accordance with 30 TAC 101.30(i)(2)(A)(ii) and 40 CFR 58.859(b)(1)(ii), general conformity analyses for which the analysis was begun during the grace period or no more than three years before the Federal Register notice of availability of the latest emissions model may continue to use the previous version of the model specified by EPA. The initial emissions estimate prepared by DFWIA was submitted in January 2003, well within the three-year window of model acceptability. Depending on the timing of any conformity determination by FAA based on the submitted emissions estimates, that agency may choose to require an updated emissions analysis using MOBILE6. However, that decision is outside the scope of this action.

Comment 13: The FAA/EPA general conformity guidance for airports requires incorporation of mitigation measures into the project.

Response: The FAA is not making a general conformity determination at this time, and this comment is outside the scope of this action. Any conformity determination made by FAA will be subject to the mitigation and public notice and involvement provisions of the general conformity regulation.

Comment 14: The mitigation measures are ill-defined per 40 CFR 93.160 requirements.

Response: DFWIA is proposing to use offsets rather than mitigation to demonstrate conformity in this case. Although a draft list of candidate projects that could be used as offsets was provided by the NCTCOG, specific projects to be used as offsets have not been identified. We agree with the commenters that these measures must be specifically identified, along with a timeline for implementation, and included in a conformity determination if the FAA intends to use such measures as offsets. This action supports the requirements of 30 TAC 101.30(h)(1)(B) and 40 CFR 51.858(a)(2) by making use of any such measures federally enforceable. For further discussion of mitigation and offsets, please see Question 38 in the General Conformity Guidance for Airports: Questions and Answers jointly issued by EPA and FAA on September 25, 2002.

Comment 15: “Signal improvement” is not a sufficient description of the emission reduction measures.

Response: The list of emission reduction measures proposed by the NCTCOG and provided in the Technical Support Document of EPA's proposed approval of the MOA is draft and therefore subject to change. With this action, EPA is merely approving the mechanism to commit to use such measures in general conformity determinations. The appropriateness of individual measures is outside the scope of this action and will be addressed by the FAA if a conformity determination is conducted for the Terminal F project. The term “signal improvement” is a recognized term used in professional practice and with generally agreed upon methodologies to calculate emission reduction benefits from such measures.

Comment 16: Emission offsets are Reasonably Available Control Measures and should not be used to permit emissions growth.

Response: Under 30 TAC 101.30(b)(1) and 40 CFR 58.852, emissions reductions can be considered surplus when they are not required for use by or credited to other applicable SIP provisions. The applicable SIP (i.e., the most recently approved SIP) is the Post 1996 ROP SIP, approved by EPA on March 28, 2005 (70 FR 15592, effective April 27, 2005). The emission offsets memorialized by this MOA are not part of the 15% ROP SIP, nor are they reserved for use elsewhere. The 15% ROP SIP does not contain an airport emission budget, so conformity may be demonstrated by one of the other means available under 30 TAC 101.30(h) and 40 CFR 51.858, including offsetting the expected emissions from the project so that no net increase in emissions occurs.

Comment 17: Minutes from TCEQ's modeling meetings disclose projections that enormous additional emission reduction measures will be needed for DFW to attain the 1-hour or 8-hour ozone standards. These offsets are not surplus reductions.

Response: As a result of recent promulgation of a new ozone standard, the 8-hour ozone standard, TCEQ must submit a SIP demonstrating that this standard can be attained in the DFW 8-hour nonattainment area no later than the statutory attainment date (69 FR 23951). As a result of the MOA signed between TCEQ and NCTCOG, the emission reductions identified to offset the expected increase in emissions due to construction and operation of Terminal F at DFWIA would not be available for use in demonstrating attainment of the 8-hour standard. TCEQ may include an airport emissions budget in the 8-hour attainment demonstration SIP for the DFW area. If so and if approved by EPA, this would offer the FAA another means to demonstrate conformity of airport projects to the SIP.

Comment 18: Deferring analysis of a project's conformity by assigning project emissions to a future MVEB is improper.

Response: The conformity regulations intend for federal agencies to be accountable for emissions resultant from their actions. In fact, the general conformity regulations specifically state that a federal agency can demonstrate general conformity, in part, by showing that “the action or portion thereof, as determined by the MPO, is specifically included in a current transportation plan and transportation improvement program which have been found to conform to the applicable SIP [under the transportation conformity regulations].” 30 TAC 101.30(h)(1)(E)(ii); 40 CFR 51.858(a)(v)(ii). See also, Question 1 on p. 30 of the General Conformity Guidance Questions and Answers, issued by EPA on July 13, 1994.

Comment 19: A finding of conformity does not meet § 93.160 mitigation requirements and does not constitute a finding that emissions in interim years will actually be achieved.

Response: Mitigation measures were not specifically included in the emission estimates for Terminal F provided by DWIA, but may be required by FAA prior to any conformity determination on this project. Any such requirement is outside the scope of this Federal Register action. The general conformity regulations do not require emissions offsets and/or mitigation for every year of a project. Specific analysis years are defined at 30 TAC 101.30(i)(4) and 40 CFR 51.859(d) and include the area's attainment year (currently 2007 for the DFW area under the 1-hour standard) and the year emissions from the action are expected to be at their greatest, and any year in which the applicable SIP includes an emission budget.

Comment 20: The 2015 MVEBs have little relevance to future SIP goals, as future conformity determinations will be based on the DFW 5% Increment-of-Progress SIP.

Response: TCEQ has proposed a 5% Increment-of-Progress (IOP) SIP as a transition SIP between the 1-hour and 8-hour ozone standards in accordance with the 8-hour ozone rules promulgated at 69 FR 23951. However, this SIP has not yet been adopted nor submitted to EPA for approval. Until EPA approves of the proposed 5% IOP SIP, it is not considered the applicable SIP for general conformity demonstrations. As a result of the incorporation of the MOA into the general Texas SIP, the amount of emission reductions necessary to satisfy the terms of the MOA will need to be subtracted from any 2015 MVEB in effect at the time, regardless of which SIP they come from.

Comment 21: The general conformity determination calculates project emissions with MOBILE5.

Response: Please see response to Comment 12 above.

Comment 22: The project will cause or contribute to future ozone violations.

Response: The purpose of the criteria to demonstrate conformity found at 30 TAC 101.30(h) and 40 CFR 51.858 is to ensure that the actions of Federal agencies conform to the State's air quality plan. One way to demonstrate conformity is by committing to offset or mitigate any expected emissions increases that are not otherwise exempted from conformity. This action memorializes the commitment of the NCTCOG to work with the FAA in determining appropriate emission reduction measures that may be used to offset emission increases associated with specific projects at the DFWIA. The FAA may require other mitigation deemed necessary for a positive conformity determination. Offsetting the expected emissions by implementation of emission reduction measures elsewhere in the DFW nonattainment area and demonstrating conformity in this manner will, by law, result in a finding that any increases in emissions associated with the Terminal F suite of projects will not cause or contribute to future ozone violations. As noted previously, the FAA has the ultimate responsibility for making the general conformity determination for the Terminal F projects.

Comment 23: The DFW Rate of Progress SIP is no longer accurate or current enough to support a conformity finding.

Response: Incorporation of the MOA into the general Texas SIP by this Federal Register action will enable the FAA to demonstrate conformity by a means other than reliance on the ROP SIP and still meet the general conformity requirements of section 176 (c) of the Clean Air Act.

Comment 24: The risk from toxic emissions upon downwind communities must be identified.

Response: General conformity regulations apply only to the criteria pollutants defined at 40 CFR 51,853(b). For further information on mobile source air toxics, please see 66 FR 17229.

EPA is approving the revision to the DFW ozone SIP providing emission reduction offsets to DFW International Airport for the year 2007 and a commitment that the NCTCOG will account for expected emissions from certain improvement projects planned for DFWIA in 2015 as part of its transportation conformity determination for the Metropolitan Transportation Plan.

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 21, 2005. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS code 311),, e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

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

In addition to using EDOCKET (http://www.epa.gov/edocket/), you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two 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/.

In the Federal Register of October 14, 1999 (64 FR 55714) (FRL-6382-7), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of three pesticide petitions (9F5066, 9F6023 and 7E4830) by Sipcam Agro, USA, Inc., 300 Colonial Center Parkway, Roswell, GA 30076, formerly of 70 Mansell Court, Suite 230, Rosewell, GA 30076. The petitions requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide tetraconazole, in or on the following raw agricultural commodities: beets, sugar at 0.01 ppm, beets, sugar, roots at 0.1 ppm, beets, sugar, tops at 7.0 ppm, beets, sugar, pulp, dried at 0.3 ppm, and beets, sugar, molasses at 0.3 ppm, cattle, meat at 0.01 ppm, cattle meat byproducts at 2.0 ppm, cattle fat at 0.1 ppm, and milk at 0.02 ppm (9F5066); peanuts meat (hulls removed) at 0.03 ppm, peanuts meal at 0.03 ppm, and peanuts oil at 0.1 ppm (9F6023); and imported bananas at 0.2 ppm (7E4830). Petition 7E4830 was later withdrawn. Petition 9F6023 was placed in abeyance by the petitioner. There were no comments received in response to the notice of filing. The tolerances will expire on February 28, 2009.

Section 408(b)(2)(A)(i) of the 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 the 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 the 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. * * *”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances of November 26, 1997 (62 FR 62961) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of the 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, consistent with section 408(b)(2) of the FFDCA, for tolerances for residues of tetraconazole 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1H-1,2,4-triazole in or on sugarbeet roots at 0.05 ppm; sugarbeet tops at 3.0 ppm; sugarbeet dried pulp at 0.15 ppm; sugarbeet molasses at 0.15 ppm; meat of cattle, goat, horse, and sheep at 0.05 ppm; liver of cattle, goat, horse, and sheep at 4.0 ppm; fat of cattle, goat, horse, and sheep at 0.30 ppm; meat byproducts except liver of cattle, goat, horse and sheep at 0.10 ppm; and milk at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance 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. The nature of the toxic effects caused by tetraconazole are discussed below. Table 1 of this unit presents the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

1. Acute toxicity. Acute toxicity data were as follows: Acute oral lethal dose (LD)50 = 1,031 milligrams/kilogram (mg/kg) (toxicity category III); acute dermal LD50 < 2,000 mg/kg (toxicity category III); acute inhalation lethal concentration (LC)50 = 3.66 mg/liter (L) (toxicity category IV); primary eye irritation - clear by 72 hours (toxicity category III); primary skin irritation - slight irritation (toxicity category IV); and dermal sensitization - negative.

2. Developmental toxicity in rats. A developmental toxicity study was conducted using rats gavaged with doses of 0, 5, 22.5, 100 mg/kg/day from days 2 through 15 of gestation. The maternal toxicity LOAEL is 100 mg/kg/day based on decreased body weight gain, and food consumption and increased liver and kidney weights. The maternal toxicity NOAEL is 22.5 mg/kg/day. Developmental toxicity was noted at 100 mg/kg/day and consisted of an increased incidence of small fetuses, and supernumerary ribs. The LOAEL and NOAEL for developmental toxicity were 100 and 22.5 mg/kg/day, respectively.

3. Development toxicity study in rabbits. A developmental toxicity study was conducted using rabbits gavaged with doses of 0, 7.5, 15, and 30 mg/kg/day from days 6 through 18 of gestation. Compound-related maternal toxicity was limited to depressed body weight gain during the dosing period. No treatment-related effects occurred in maternal mortality, clinical signs, food consumption, or cesarean parameters. The maternal LOAEL is 30 mg/kg/day based on decreased body weight gain. The maternal NOAEL is 15 mg/kg/day. No treatment-related effects in developmental parameters were noted. The developmental LOAEL is greater than 30 mg/kg/day. The developmental NOAEL is 30 mg/kg/day, the highest dose tested (HDT).

4. Two-generation reproduction study. A two-generation reproduction study was conducted using rats fed diets with dose levels of 0, 10, 70, or 490 ppm (0, 0.7, 4.9, and 35.5 mg/kg/day for males or 0, 0.8, 5.9, and 40.6 mg/kg/day for females). The LOAEL for parental toxicity was 70 ppm (4.9 mg/kg/day in males and 5.9 mg/kg/day in females) based on increased mortality in P generation females. The NOAEL was 10 ppm (0.7 mg/kg/day in males and 0.8 mg/kg/day in females). The LOAEL for offspring toxicity was 490 ppm (40.6 mg/kg/day from the P generation female intake) based on decreased litter weight and mean pup weight in litters of all generations before weaning and increased relative liver weights at weaning in both sexes of all litters. The NOAEL was 70 ppm (5.9 mg/kg/day). The LOAEL for reproductive toxicity was 70 ppm (4.9 mg/kg/day for males and 5.9 mg/kg/day for females) based on increased mean gestation duration in P generation parental females and related evidence of compound toxicity in the parturition process. The NOAEL was 10 ppm (0.7 mg/kg/day for males and 0.8 for females).

5. Chronic toxicity. A chronic toxicity study was conducted using dogs fed diets containing 0, 22.5, 90, or 360 ppm for 52 weeks. Treatment-related effects at the high dose included slight but nonsignificant body weight reductions in both sexes from study week 3 to termination; significantly increased alkaline phosphatase, gamma-glutamyltransferase, alanine aminotransferase and ornithine carbamoyl transferase in both sexes from study week 13 to 52, increased absolute and relative liver and kidney weights for both sexes, and histopathological changes in both organs. In the mid-dose group, effects were manifested as increased absolute and relative kidney weights for males correlated with histopathological findings in the males (apparent hypertrophy in cortical tubules of the kidneys in one male). No adverse effects were seen at the low dose. The NOAEL is 22.5 ppm (equivalent to achieved intakes of 0.73 mg/kg/day for males or 0.82 mg/kg/day for females) and the LOAEL is 90 ppm (equivalent to achieved intakes of 2.95 mg/kg/day for males or 3.33 mg/kg/day for females) based on increased absolute and relative kidney weights and histopathological changes in the male kidney.

6. Carcinogenicity study—i. Rats. A 2-year carcinogenicity study was conducted using rats fed diets containing 0, 10, 80, 640 and 1,280 ppm for males and 0, 10, 80, and 640 ppm for females. The LOAEL is 640 ppm (27.7/39.4 mg/kg/day in male/female) based on histopathology of the bone (osseous hypertrophy of the cranium/parietal bone), pale and thickened incisors, and decreased absolute and relative adrenal and pituitary weights in males; decreased body weight (at terminal sacrifice) in females. The NOAEL is 80 ppm (3.4/4.4 mg/kg/day in male/female). Under the conditions of this study, there was no evidence of a treatment-related increase in tumor incidence when compared to controls. Therefore, tetraconazole is not a carcinogen in this study.

ii. Mice. An 80-week carcinogenicity study was conducted using mice fed diets containing 0, 10, 90, 800, or 1,250 ppm (0, 1.4, 12, 118, or 217 mg/kg/day for males; 0, 1.6, 14.8, 140, or 224 mg/kg/day for females). The systemic toxicity LOAEL is 90 ppm (12 and 14.8 mg/kg/day for males and females, respectively), based on increased liver weight and hepatocyte vacuolation in both sexes and increased kidney weights in males. The NOAEL is 10 ppm (1.4 and 1.6 mg/kg/day for males and females, respectively). There was evidence of increased incidence of combined benign and malignant liver tumors in mice of both sexes treated with 95.05% tetraconazole at 800 ppm (48% for males and 22% for females) and 1,250 ppm (84% for males and 64% for females) compared to the control (20% for males and 0% for females). The doses were found to be adequate to test the carcinogenic potential based on the reduction of body weight gain and increased mortality at the highest dose.

7. Mutagenicity studies. A battery of mutagenicity studies yielded negative results in Salmonella typhimurium, cultured Chinese hamster ovary (CHO) cells, and mouse lymphoma cells. There was no evidence of clastogenicity in vitro or in vivo and tetraconazole did not induce unscheduled DNA synthesis in human HeLa cells.

The dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (aRfD or cRfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic population adjusted dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor (SF).

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10-6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for tetraconazole used for human risk assessment is shown in the following Table 1.

DoD published an interim rule at 68 FR 75196 on December 30, 2003, containing policy that requires contractors to provide unique item identification (UID) and the Government's unit acquisition cost for items delivered under DoD contracts. Thirteen sources submitted comments on the interim rule. The following is a discussion of the comments and the changes made to the rule as a result of those comments:

1. Comment: A respondent stated that the implementation date of January 1, 2004, was too aggressive. The respondent recommended a later implementation date that would allow time in which to alert both Federal agencies and Federal contractors about the specifics of the new rule.

DoD Response: DoD agrees that the implementation schedule was aggressive. However, the rule is considered to be a strategic imperative. The implementation schedule could not be slipped.

2. Comment: We have been instructed to identify “to be determined” in the clause fill-in. We have also been instructed to contact our requirements (logistics) counterparts for their determination if this clause applies. According to our counterparts, they don't have the technical training or knowledge to make that determination. Also, there is currently no training or knowledge in the contracting world on a realistic cost for this information.

DoD Response: The clause must go into all contracts that require the delivery of “items” as defined in the clause, unless an exception applies. Items valued at or above $5,000 must be marked with UID. The fill-ins are for items that meet other specified conditions, as well as embedded items that meet specified conditions. The implementing guidance in section 211.274 has been reworded for clarity to specify that the requiring activity determines what embedded items, subassemblies, or components require UID. There is less technical training or knowledge required than the interim rule implied; however, additional information is available at http://www.acq.osd.mil/dpap/uid.

3. Comment: DoD should give special consideration to communicating, aiding, and making available, training to all suppliers that will need to comply with this requirement—whether as prime contractors, or as subcontractors at any tier.

DoD Response: Concur. DoD is engaged in a large communication effort through its UID Program Office. The UID Web site at http://www.acq.osd.mil/dpap/uid should be consulted for information and resources that are available.

4. Comment: Both government buying offices and prime contractors should be encouraged to make special efforts to assist small and small disadvantaged, minority- or women-owned firms and make accommodations as needed to help them achieve the goals of this new requirement.

DoD Response: Concur. Small businesses will find that there are a number of vendors, many of which are small businesses themselves, that can provide UID marking assistance. Additionally, the final rule permits exceptions to marking requirements for items acquired from small business concerns when it is more cost effective for the Government requiring activity to assign, mark, and register the UID after delivery.

5. Comment: Not all requirements are generated from DoD. How does this requirement apply when a foreign government is the customer? A related comment was whether UID is applicable to Foreign Military Sales (FMS) contracts and whether our FMS customers were consulted about UID applicability and advised of potential cost impacts.

DoD Response: Items valued at or above $5,000, or items delivered to DoD that meet other specified conditions, must be marked with UID. There is no exception for FMS contracts. This rule has been developed with assistance from our allies and in consideration of international standards.

6. Comment: Does UID apply to items that we lease but of which we never take ownership?

DoD Response: Yes. Items valued at or above $5,000, or items delivered to DoD that meet other specified conditions, must be marked with UID.

7. Comment: Two respondents asked whether UID and valuation apply to classified or COMSEC contracts. One respondent suggested that the final rule include instructions to require that all such issues be directed to the contracting officer for resolution.

DoD Response: Yes, the UID and valuation apply to classified contracts, unless there is an exemption cited in program directives.

8. Comment: Does UID apply to furniture that has an acquisition cost of $5,000 and above?

DoD Response: Yes, all items over $5,000 in value require unique identification.

9. Comment: The clause should include a statement that the contractor must comply with the most current version of MIL-STD-130.

DoD Response: Concur. After much consideration, it was considered best to refer to the version of MIL-STD-130 that is cited in the contract Schedule. This allows for updating, if necessary, at the time of award.

10. Comment: Is UID really appropriate when, in all likelihood, it probably will not survive the manufacturing process?

DoD Response: If an item is valued at or above $5,000, and it is delivered to DoD, it must be marked with UID. One of the purposes of UID is to be able to track items that may be warehoused for a period of time prior to being incorporated into a manufactured end item. The property record that was created when the item was delivered should be annotated with the item's disposition when it is incorporated into a manufactured item.

11. Comment: One respondent believes that, in an effort to save taxpayer dollars, items required for their own base operations, that are never used/received by the warfighter (i.e., is not a spare part), should be excluded.

DoD Response: Do not concur. Items valued at or above $5,000, or items meeting other specified conditions that are delivered to DoD, must be marked with UID. Although our primary mission is the warfighter, sound property management and accountability are integral to our responsibilities to the taxpayer.

12. Comment: Paragraph (c)(3) of clause at 252.211-7003 states, “The contractor shall (i) mark the encoded data elements (except issuing agency code) on the item using any of the following three types of data qualifiers as specified elsewhere in the contract.” Where in the contract did you intend this to be specified?

DoD Response: The phrase “as specified elsewhere in the contract” has been excluded from the final rule.

13. Comment: The DoD Guide to Uniquely Identifying Items, Version 1.3, Nov 25, 2003, p. 18, indicates that the enterprise assigning serialization to an item makes the decision regarding which construct to use to uniquely identify items, as well as use of the associated business rules. The guide also suggests that it should not matter which of the three constructs the contractor uses because DoD should be able to read any of them. If that is the case, is it necessary to specify which type must be used in the contract?

DoD Response: The final rule clarifies that the determination of which construct to use is made by the contractor.

14. Comment: In the solicitation phase, would it not be better to allow contractors to propose which data qualifier they prefer to use rather than specifying one in the solicitation?

DoD Response: The phrase “as specified elsewhere in the contract” has been excluded from the final rule.

15. Comment: What “Data Item Description” covers UID? Further, is a new Data Item Description for UID being developed, or which existing one should we use?

DoD Response: The Data Item Description can be found under “References” on the UID Web site at http://www.acq.osd.mil/uid.

16. Comment: With regard to DFARS 211.274-2, it is not clear from the interim rule when the contract line items/subline items (CLINs/SLINs) or contract data requirements list (CDRL) will be updated to reflect the delivered items that require UID.

DoD Response: The intent is that the CLIN/SLIN structure should reflect the UID requirements at contract award. This may be the result of the procurement request and solicitation CLIN/SLIN structure, or it may be the result of information provided in the contractor's proposal in response to the solicitation. However, if this is not the case, the contract should be modified to reflect the CLIN/SLIN structure as necessary prior to delivery of the items requiring UID.

17. Comment: A respondent requested that DoD policy on applying UID to existing contracts remain as currently stated to apply UID to existing contracts “where it makes business sense.”

DoD Response: Concur. This policy has not changed.

18. Comment: Considering that the new UID labeling requirement allows for the use of commonly accepted commercial marks for items that are not required to have unique identification, will DoD reconsider the application of the UID labeling requirement to contracts for commercial items under FAR Part 12?

DoD Response: The requirement for commonly accepted commercial marks for items that are not required to have unique identification has been deleted from the rule. Additionally, the final rule permits exceptions from UID requirements for commercial items when it is more cost effective for the Government requiring activity to assign, mark, and register the UID after delivery.

19. Comment: Is it DoD's intention to apply the UID labeling requirement to product orders placed under another agency's contract vehicle, such as GSA's Federal Supply Schedule or another agency's multiple award indefinite-delivery indefinite-quantity contract?

DoD Response: Yes. The final rule makes the clause at DFARS 252.211-7003 mandatory for all solicitations, contracts, and delivery orders. DoD believes that inclusion of the clause in delivery orders under Federal Supply Schedule (FSS) contracts is consistent with the provision at 252.211-7003, Marking, that is currently in FSS contracts allowing ordering activities to specify marking requirements in delivery orders.

20. Comment: Does the UID labeling requirement apply to entities that resell a manufacturer's product to DoD?

DoD Response: Yes.

21. Comment: Does DoD recognize Telcordia as an issuing agency?

DoD Response: Yes, DoD recognizes IAC “LB” for Telcordia.

22. Comment: Will DoD accept the UID in a MicroPDF417 symbol? The majority of North American Telecommunications Service Providers require equipment manufacturers to CLEI Code their products. Telcordia GR-383-CORE identifies MicroPDF417 as the required symbology for CLEI Coded product. We currently use MicroPDF417 in our designs and would require significant changes to implement Data Matrix 200. There is not sufficient space for two symbols, particularly when both will have the same information. The MH10.8.3 and MH10.8.2 data syntax will be the same for both symbologies. Further, MicroPDF417 has the benefit of being either square or rectangular in shape depending on how it is specified. This provides increased flexibility when working with space-constrained product. Scanners capable of reading Data Matrix 200 are also capable of reading MicroPDF417, but scanners capable of reading MicroPDF417 are not always capable of reading Data Matrix 200.

DoD Response: No decision has been made as to DoD acceptance of the MicroPDF417 symbol.

23. Comment: Is the part number required in the 2D symbol if we use serialization within the enterprise identifier? The examples we see for serialization within the enterprise are not clear. We will be using data identifier 18V, ANSIT1.220 issuing agency “LB”, an enterprise identifier of “WECO”. The serial number will use the data identifier “S” to define our unique serial number to form the UID. Do the data strings shown below meet the UID requirement?

DoD Response: No. The only data identifier available for use in Construct #1 in this case is “25S”, which is defined as “18V” + unique serial number (unique within the enterprise). The syntax would be:

24. Comment: Does the order of the data fields matter? Telcordia has defined the CLEI Code as the first data field within the data symbol, and that is our current data format. Is the use of data identifiers sufficient to assemble the UID from the data string regardless of order?

DoD Response: The data fields should appear at the beginning of the syntax in order of concatenation: Construct #1: 25S, Construct #2: 18V+11P+S.

25. Comment: Must the UID label be scannable in service? If so, what exceptions would be considered?

DoD Response: Yes. The UID label must be scannable in service. There are no exceptions.

26. Comment: What is the labeling requirement for the first level product package label (P2 label)? Will this label require that the UID be encoded in a 2D symbol? If so, would this be a PDF417 symbol, Data Matrix 200, or other?

DoD Response: The labeling requirements are those specified in MIL-STD-129P.

27. Comment: What is the minimum data set for the UID on the shipping label, and is a 2D symbol required? We currently do not include product serial number information on our shipping labels. Adding UID information to the shipping label would require significant IT system changes.

DoD Response: The labeling requirements are those specified in MIL-STD-129P.

28. Comment: Several comments were received regarding the use of radio frequency identification (RFID) technology.

DoD Response: RFID technology is being addressed in separate DoD policy. The RFID policy, which addresses the labeling for shipping and packaging, is being developed in close coordination with the UID Program Office. RFID requirements will not replace or supersede UID requirements.

29. Comment: Is it DoD's understanding that the Christian Doctrine may apply, or will the requirement to mark items over $5,000 be applicable only to those contracts in which DFARS 252.211-7003 is cited?

DoD Response: DoD does not believe the Christian Doctrine would apply in the case of a contract that failed to include the clause at 252.211-7003.

30. Comment: Will drawings have to be changed prior to adding the physical UID marking to items? If not, will items be rejected for not conforming to the drawing? If so, are drawing changes to be bid the first time a solicitation is received for a particular item?

DoD Response: Defining the set of parts to mark, the method in which to mark them, the associated engineering analysis required, in addition to the process/program documentation, is a coordinated concert of activities that must occur simultaneously and with fluidity. The involvement of all entities is crucial as each lends a viewpoint to marking from different technological, logistical, and supply perspectives.

There must be close coordination with the DoD requiring activities, original equipment manufacturers, and vendors in order to minimize the manpower burden to accomplish the required changes on engineering documentation and to initiate the necessary changes to existing manufacturing and maintenance processes. This is true for a marking program on either a new end item or on a legacy end item.

Collaborative methods, or best practices that could be considered and are being prototyped today include the following: (1) Replacing existing data plates with UID labels; (2) Issuing a global engineering change notice; (3) Issuing part marking work orders into the existing manufacturing process; and (4) When the necessary marking information and criteria do not change the form, fit, or function of the part, the change does not require an immediate drawing update but rather can be accomplished by a coversheet with the marking instructions, thus permitting consolidation of drawing requirements.

31. Comment: Section 211.274-1(a)(3) is worded such that all lower-level assemblies of an item on a CDRL require UID marking. The respondent suggests rewording the section to “Subassemblies, components, and embedded parts identified on a Contract Data Requirements List or other exhibit.”

DoD Response: Section 211.274-1(a)(3) of the interim rule contained guidance to the contracting officer. Paragraph (c)(1)(iii) of the clause at 252.211-7003 identifies the marking requirement for subassemblies, components, and embedded parts. It reads:

“(iii) Subassemblies, components, and parts embedded within delivered items as specified in Attachment Number ___.”

32. Comment: Even though the rule has been revised to clarify the responsibility of the vendor, it is our interpretation that DoD must assume the primary responsibility for communicating the unique identification at time of contract.

DoD Response: Concur. This should be accomplished through the clause at 252.211-7003.

33. Comment: Electronic invoicing, mandated by DFARS clause 252.232-7003, will be delayed to accommodate the UID requirements. Since many companies now are changing their accounting systems in order to be compliant with Wide Area WorkFlow, an additional requirement that UID's are included on invoices clearly will cause delays in the electronic billing system.

DoD Response: Do not concur. Currently contractors can separately invoice and report UID.

34. Comment: Small business suppliers may be required to create new systems for identification and marking of their products. This will result in increased costs to small businesses.

DoD Response: Small businesses will find there are a number of vendors, many of which are small businesses, that can provide UID marking assistance at low cost. In addition, the final rule permits exceptions to marking requirements for items acquired from small business concerns, when it is more cost effective for the Government requiring activity to assign, mark, and register the UID after delivery.

35. Comment: Extension of the UID requirement to the building trade industry, including electrical and mechanical products, will impose a severe business and economic hardship on large and small businesses alike to implement the marking and identification requirement on products, plus the supporting documentation to shipping documents and invoices.

DoD Response: As stated in the DoD response to Comment 34 above, there are a number of vendors that can provide UID assistance at low cost. The final rule permits exceptions to UID requirements for commercial items and for items acquired from small business concerns, when it is more cost effective for the Government requiring activity to assign, mark, and register the UID after delivery. The required supporting shipping documentation represents only a minimal increase in current DoD requirements for completion of DD Form 250, Material Inspection and Receiving Report.

36. Comment: One respondent suggested that DoD include “Consumer Electronics Alliance” in the examples of commonly accepted commercial marks.

DoD Response: The requirement for commonly accepted commercial marks for items that are not required to have unique identification has been deleted from the rule.

37. Comment: Please clarify that the “Issuing Agency Code” is derived and not “marked” on the item.

DoD Response: A change is included in the final rule to clarify that Issuing Agency Code is not marked.

38. Comment: One respondent noted that “AIT” means automatic identification technology.

DoD Response: Concur. The change is included in the final rule.

39. Comment: Please add “Department of Defense Address Activity Code (DoDAAC)” to registration (or controlling) authority.

DoD Response: Do not concur. An Issuing Agency Code (IAC) is being requested for DoDAAC. DoDAAC should not be added until the IAC is approved.

40. Comment: One respondent suggests rewording Section 252.211-7003(c)(3)(1)(A) as follows: “Data Identifiers (DIs) (Format 06), in accordance with ISO/IEC International Standard 15418, Information Technology—EAN/UCC Application Identifiers and ASC MH 10 Data Identifiers and ASC MH 10 Data Identifiers and Maintenance.”

DoD Response: Concur. The change is included in the final rule.

41. Comment: A respondent suggests rewording Section 252.211-7003(c)(3)(1)(C) as follows: “Text Element Identifiers (TEIs), in accordance with the DoD collaborative solution “DD” format for use until the final solution is approved by ISO JTC1/SC 31. The DoD collaborative solution is described in Appendix D of the DoD Guide to Uniquely Identifying Items, available at http://www.acq.osd.mil/uid, and:”

DoD Response: Concur. DFARS 252.211-7003(c)(3)(i)(C) has been revised to essentially capture the comment.

42. Comment: The rule poses a substantial problem for commercial suppliers and service providers. The problem is that many commercial companies use item identification markings that differ significantly from the Department's prescribed unique identification markings.

For these companies to continue to do business with the Department, they will either need to establish separate assembly lines and procedures to process DoD orders using the Department's unique markings, or overhaul and convert their existing systems to meet the Department's requirements. For existing DoD suppliers and service providers, either of these approaches would pose a very expensive proposition. For potential new entrants to the Defense market, the requirements may pose a prohibitive barrier.

DoD Response: This rule is considered to be a strategic imperative. DoD acquires a large number of items from commercial suppliers and these items can not be excluded from the UID requirements. However, the final rule permits exceptions to marking requirements for commercial items when it is more cost effective for the Government requiring activity to assign, mark, and register the UID after delivery.

43. Comment: The interim rule may be read as burdensome and otherwise inconsistent with commercial practice to require vendors to change their delivery processes to accommodate Government-unique acquisition cost requirements. Some Department personnel have publicly stated that existing practices for completing DD 250 acceptance forms would suffice to support the acquisition unit cost requirement imposed by the interim rule. But that is not clear in the rule itself. We request that the rule be clarified to clearly read that vendors' existing DD 250 practices that currently meet DD 250 requirements will satisfy the interim rule's unit acquisition cost requirements.

DoD Response: Do not concur. There are no new or additional burdens imposed on vendors as a result of the “Government's unit acquisition cost” requirements. Currently, vendors are required to put a “price” on the DD 250. There is nothing in the rule to suggest that existing DD 250 practices would change.

44. Comment: Two respondents stated that imposing the interim rule's requirements in commercial acquisitions at this time is inconsistent with the Federal Acquisition Streamlining Act of 1994 (“FASA”), which mandates that Government agencies rely to the maximum extent practicable on commercial products and services to fill the Government's needs. In our view, imposition of the interim rule at this time in commercial acquisitions is neither required by statute nor consistent with customary commercial practice.

DoD Response: DoD does not concur that UID requirements are inconsistent with FASA. FASA does not restrict DoD's ability to define its needs and requirements for supporting the warfighter. However, the final rule permits exceptions to marking requirements for commercial items when it is more cost effective for the Government requiring activity to assign, mark, and register the UID after delivery of the item.

45. Comment: One respondent suggested that implementation of the rule for purposes of commercial item acquisitions be changed from January 1, 2004, to March 1, 2005. The respondent further recommended that, prior to the implementation date, the Department establish a working group that will include participants from commercial industry to determine what methods would be least intrusive to commercial practice, while operating to satisfy the Department's needs. The current interim rule seems to impose most of the burden, if not all, on the vendor, and may result in vendors having to adopt a “Government only” line of products at significant expense to both the vendor and the Government.

DoD Response: Do not concur. DoD acquires a large number of commercial items, and these items cannot be excluded from UID requirements. However, the final rule permits exceptions to marking requirements for commercial items when it is more cost effective for the Government requiring activity to assign, mark, and register the UID after delivery.

46. Comment: Does the rule apply to real property in DoD buildings and facilities?

DoD Response: Yes. Items valued at or above $5,000, or items that are delivered to DoD meeting other specified conditions, must be marked with UID.

47. Comment: Does the rule apply to electrical and mechanical equipment and building components making up a building and building systems?

DoD Response: Yes. Items valued at or above $5,000, or items that are delivered to DoD meeting other specified conditions, must be marked with UID.

48. Comment: In our February 27, 2004, letter to the Director of Defense Procurement, we expressed our concern that not all UID implementation costs may be recovered under existing accounting procedures. We encourage the Department to give early consideration to addressing this issue. We stand ready to meet with your representatives at your convenience.

49. DoD Response: DoD is willing to further discuss and examine whether all UID implementation costs may be recovered under existing accounting procedures.

50. Comment: In section 211.274-2(b)(2), Government's unit acquisition cost for cost type line, subline, or exhibit line items is the contractor's estimated fully burdened unit cost. In informal discussions with the Department's staff, we understand that this is intended to include a representative element of profit or fee. We suggest that this be clarified in the List of Frequently Asked Questions or in the Guide to Uniquely Identifying Items.

DoD Response: Concur. DoD will add to the List of Frequently Asked Questions an item that indicates that “fully burdened unit cost to the Government” would include all direct, indirect, G&A costs, and an appropriate portion of fee.

51. Comment: With regard to section 211.274-3, Contract clause, one respondent noted that this section has been improved for both industry and the government. It addresses “items” requiring UID and clarifies application where a CDRL/Exhibit is required for subassemblies, components, or embedded items. The respondent recommends that, in order to strengthen this principle, several illustrative examples be included in the DoD Guide to Uniquely Identified Items.

DoD Response: Concur. Examples will be included in the next version of the DoD Guide to Uniquely Identified Items.

52. Comment: In the clause at 252.211-7003(c)(1)(iii), there are requirements regarding subassemblies, components, and parts embedded within items specified in Exhibits or CDRLs. It should be noted that not all embedded items fit the category of subassemblies, components, or parts. As a hypothetical example, a latch that is permanently attached to a watertight door may be purchased but is not carried as a spare part, subassembly, or component. Once attached, it is embedded as a permanent part of the door and not replaceable. There needs to be clarification that such hardware is not to be subject to the requirements for assignment of a UID, and the clause need not be flowed down to the supplier.

DoD Response: Concur. This paragraph of the final rule was rewritten to clarify that only subassemblies, components, or parts embedded within an item that are serially managed, mission essential, or controlled inventory item, as determined by the requiring activity, may require UID.

53. Comment: In the clause at 252.211-7003(c)(3), Data syntax and semantics, the enterprise responsible for assigning the UID should determine the type of data qualifiers to use instead of this information being specified on a contract-by-contract basis.

DoD Response: Concur. The language was changed to avoid requiring a subcontractor that produces a common subassembly for use in three unique weapon systems to use a different type data qualifier depending on the end item application or service agency buying the item.

54. Comment: We believe that DoD should issue instructions to all of its organizations that failure to comply with the DFARS UID requirement in the first contract upon which it is imposed shall not be reason for refusing delivery or assessing withholds, provided the company has a plan in place for compliance and is proceeding in accordance with this plan. For example, we understand June 2004 is the earliest that Wide Area WorkFlow will be modified to accept DD Form 250 transactions that include required UID data, and then only for fixed-price contracts. Current contracts should not be rigidly enforced when the system for accepting the data for all contracts is not yet available to all suppliers.

DoD Response: Do not concur. Problems with compliance with the DFARS UID requirement should be addressed prior to award of the contract. After award, the contractor should be expected to comply with contract requirements.

55. Comment: We believe that special tooling and special test equipment and other items of Government property, created and used during the course of contracts during 2004, should be exempt from any UID marking or evaluation requirements until such items are delivered to the Government, or one of its suppliers, on or after January 1, 2005. Policy and procedure for this class of assets should be published as soon as possible.

DoD Response: Do not concur. Marking is only required when items, including special tooling and special test equipment, are delivered to the Government. Generally, it is unlikely that special tooling and special test equipment used in production under a contract requiring UID would have been delivered before January 1, 2005, due to the applicability of the rule (contracts resulting from solicitations that were issued on or after January 1, 2004).

56. Comment: The DoD UID policy should be coordinated and consistent with all other aspects of DoD acquisition policy. DoD should ensure that, as this and the RFID policies evolve, care is taken to reconcile the RFID and UID policies, DFARS rule, military standards, solicitation instructions, training, and other aspects to ensure uniform interpretation and avoid mis-steps on the part of Government or industry.

DoD Response: Concur. RFID policies, military standards related to RFID and UID, solicitation instructions, training, and other aspects of the policies are being closely coordinated with the UID Program Office.

57. Comment: Individual program offices should have the flexibility to designate which parts should be marked; however, they should not dictate the process and procedure for actual marking of parts. Individual program offices should be encouraged to work with their contractors to identify what parts are to be marked, but a program office should not normally tell a contractor what marking construct to use, since the contractor's plant, and its supply chain, may already be keyed to use of a certain approach, and may incur considerable cost and disruption to alter that for a single contract.

DoD Response: The phrase “as specified elsewhere in the contact” which permitted specifying the process and procedure for actual marking of parts has not been included in the final rule.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD has prepared a final regulatory flexibility analysis consistent with 5 U.S.C. 604. The analysis is summarized as follows:

This rule establishes DoD policy for marking and valuation of items delivered under DoD contracts. The objective of the rule is to improve the management of DoD assets. DoD believes that the small businesses in the manufacturing categories subject to the rule normally use some form of product identification already, i.e., bar coding, as part of their commercial business practices. DoD is unaware of any small business that cannot comply with the UID policy. In fact, there is an increase in the number of small businesses providing marking/UID data services to industry and DoD. DoD anticipates that most small vendors will be able to comply using labels and data plates readily and inexpensively available in the commercial market. A small business can order labels and data plates from a wide array of vendors at a cost of $0.10 to $3.00 per item. No specific investment need be made by a small business.

A copy of the analysis may be obtained from the point of contact specified herein.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

DFARS Transformation is a major DoD initiative to dramatically change the purpose and content of the DFARS. The objective is to improve the efficiency and effectiveness of the acquisition process, while allowing the acquisition workforce the flexibility to innovate. The transformed DFARS will contain only requirements of law, DoD-wide policies, delegations of FAR authorities, deviations from FAR requirements, and policies/procedures that have a significant effect beyond the internal operating procedures of DoD or a significant cost or administrative impact on contractors or offerors. Additional information on the DFARS Transformation initiative is available at http://www.acq.osd.mil/dp/dars/transf.htm.

DFARS Subpart 225.72, Reporting Contract Performance Outside the United States, implements: (1) DoD policy for contractor reporting of performance outside the United States under contracts exceeding $500,000; and (2) requirements of 10 U.S.C. 2410g for offerors and contractors to notify DoD of any intention to perform a DoD contract outside the United States and Canada, when the contract exceeds $10 million and could be performed inside the United States or Canada.

This final rule revises DFARS Subpart 225.72, and the corresponding solicitation provision and contract clause, to clarify the two separate reporting requirements. In addition, the rule removes DFARS text (previously at 225.7202) related to contracting officer distribution of reports. This text has been relocated to the new DFARS companion resource, Procedures, Guidance, and Information (PGI), available at http://www.acq.osd.mil/dpap/dars/pgi.

DoD published a proposed rule at 69 FR 31939 on June 8, 2004. DoD received comments from one industry association. The comments are summarized as follows:

1. Comment: The quarterly reporting requirement, which is not based on a statutory requirement, should be eliminated.

DoD Response: Do not concur. The quarterly report provides information that DoD uses in the assessment of bilateral defense trade with allied countries. The information is also of significant interest to Congress.

2. Comment: The reporting requirements should apply only to subcontracts that are awarded directly as a result of the award of the prime contract.

DoD Response: Do not concur. The purpose of the reporting requirements is to determine the portion of total contract dollars spent on performance outside the United States, regardless of whether the dollars are spent as a result of a preexisting contractual arrangement or as a result of a subcontract awarded directly under the prime contract.

3. Comment: The clause titles and text should be revised to clarify the nature and timing of the reporting requirements.

DoD Response: The final rule incorporates most of the recommended clarifying changes. In particular, the final rule—

• Revises the titles of the clauses at (252) 225-7004 and (252) 225-7006 to make a distinction between requirements for reporting of intended and actual contract performance;

• Revises paragraph (b) of the clause at (252) 225-7004 to require reporting “as soon as practical after the information is known,” rather than “as soon as the information is known.”

• Revises paragraph (b), and adds a new paragraph (e)(3), in the clause at (252) 225-7006 to further clarify reporting requirements for contractors and subcontractors.

4. Comment: Contracting officers should be authorized to substitute the new clauses for prior versions of the clauses that are in existing contracts, to simplify administration and improve compliance with clause requirements.

DoD Response: In accordance with FAR 1.108, the new clauses apply to solicitations issued on or after the effective date of this DFARS rule. Contracting officers may, at their discretion, include the clauses in any existing contract with appropriate consideration.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the rule clarifies existing requirements for reporting contract performance outside the United States, with no substantive change to those requirements.

The rule does not contain any new information collection requirements that require the approval of the Office of Management and Budget (OMB) under 44 U.S.C. 3501, et seq. The existing information collection requirements in DFARS Subpart 225.72 have been approved by OMB under Control Number 0704-0229 for use through March 31, 2007.

NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2005 Pacific cod TAC specified for catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI is 2,504 metric tons (mt) as established by the 2005 and 2006 final harvest specifications for groundfish in the BSAI (70 FR 8979, February 24, 2005) and the reallocation on April 13, 2005 (70 FR 19708, April 14, 2005). See §§ 679.20(a)(7)(i)(A), (a)(7)(i)(C), (c)(3)(iii), and (c)(5).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS, has determined that the 2005 Pacific cod TAC specified for catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 1,300 mt, and is setting aside the remaining 54 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI.

After the effective date of this closure the maximum retainable amounts at §§ 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific cod by catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.