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Code · REGISTER · 2007-04-11 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Final rule

16,455 words·~75 min read·/register/2007/04/11/07-1801

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BILLING CODE 8120-08-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 524 Ophthalmic and Topical Dosage Form New Animal Drugs; Mupirocin Ointment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Altana, Inc. The ANADA provides for veterinary prescription use of mupirocin ointment for the treatment of bacterial skin infections in dogs. DATES: This rule is effective April 11, 2007. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: *john.harshman@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Altana, Inc., 60 Baylis Rd., Melville, NY 11747, filed ANADA 200-418 that provides for veterinary prescription use of MURICIN (mupirocin) Ointment 2% for the treatment of bacterial skin infections in dogs. Altana, Inc.'s MURICIN Ointment 2% is approved as a generic copy of Pfizer, Inc.'s BACTODERM Ointment approved under new animal drug application
(NADA)140-839. The ANADA is approved as of March 8, 2007, and the regulations are amended in 21 CFR 524.1465 to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 524 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 524 is amended as follows: PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 2. Revise § 524.1465 to read as follows: § 524.1465 Mupirocin.
(a)*Specifications* . Each gram of ointment contains 20 milligrams mupirocin.
(b)*Sponsors* . See Nos. 000069 and 025463 in § 510.600(c) of this chapter.
(c)*Conditions of use in dogs* —(1) *Amount* . Apply twice daily. Treatment should not exceed 30 days.
(2)*Indications for use* . For the topical treatment of bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of *Staphylococcus aureus* and *S. intermedius* .
(3)*Limitations* . Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: March 30, 2007. Bernadette A. Dunham, Acting Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-6828 Filed 4-10-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 AGENCY: Department of the Navy, DOD. ACTION: Final rule. SUMMARY: The Department of the Navy is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has determined that USS SAMPSON (DDG 102) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply. DATES: Effective Date: April 11, 2007. FOR FURTHER INFORMATION CONTACT: Commander Gregg A. Cervi, JAGC, U.S. Navy, Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave., SE., Suite 3000, Washington Navy Yard, DC 20374-5066, telephone 202-685-5040. SUPPLEMENTARY INFORMATION: Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR Part 706. This amendment provides notice that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS SAMPSON (DDG 102) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; Annex I, paragraph 2(f)(ii), pertaining to the vertical placement of task lights; Annex I, paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead lights; and Annex I, paragraph 3(c), pertaining to placement of task lights not less than two meters from the fore and aft centerline of the ship in the athwartship direction. The Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements. Moreover, it has been determined, in accordance with 32 CFR Parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner different from that prescribed herein will adversely affect the vessel's ability to perform its military functions. List of Subjects in 32 CFR Part 706 Marine safety, Navigation (water), and Vessels. For the reasons set forth in the preamble, amend part 706 of title 32 of the Code of Federal Regulations as follows: PART 706—CERTIFICATIONS AND EXEMPTIONS UNDER THE INTERNATIONAL REGULATIONS FOR PREVENTING COLLISIONS AT SEA, 1972 1. The authority citation for part 706 continues to read: Authority: 33 U.S.C. 1605. 2. Table Four, Paragraph 15 of § 706.2 is amended by adding, in numerical order, the following entry for USS SAMPSON: § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Vessel Number Horizontal distance from the fore and aft centerline of the vessel in the athwartship direction * * * * * * * USS SAMPSON DDG 102 1.88 meters. * * * * * * * 3. Table Four, Paragraph 16 of § 706.2 is amended by adding, in numerical order, the following entry for USS SAMPSON: § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Vessel Number Obstruction angle relative ship's headings * * * * * * * USS SAMPSON DDG 102 107.27 thru 112.50 [degrees]. * * * * * * * 4. Table Five of § 706.2 is amended by adding, in numerical order, the following entry for USS SAMPSON: § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Table Five Vessel Number Masthead lights not over all other lights and obstructions. Annex I, sec. 2(f) Forward masthead light not in forward quarter of ship. Annex I, sec. 3(a) After mast-head light less than 1/2 ship's length aft of forward masthead light. Annex I, sec. 3(a) Percentage horizontal separation attained * * * * * * * USS SAMPSON DDG 102 X X X 14.5 * * * * * * * Approved: March 27, 2007. Gregg A. Cervi, Commander, JAGC, U.S. Navy, Deputy Assistant Judge Advocate General (Admiralty and Maritime Law). [FR Doc. E7-6738 Filed 4-10-07; 8:45 am] BILLING CODE 3810-FF-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [CGD05-07-013] RIN 1625-AA08 Special Local Regulations for Marine Events; Western Branch, Elizabeth River, Portsmouth, VA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is temporarily changing the regulations for the “Virginia State Hydroplane Championship” hydroplane races held annually on the waters of the Western Branch of the Elizabeth River at Portsmouth, Virginia. This action is necessary because the event will be held on April 21 and 22, 2007, instead of on April 27 and 28, 2007 as established by permanent regulation. This special local regulation is intended to restrict vessel traffic in portions of the Elizabeth River and is necessary to provide for the safety of life on navigable waters during the event. DATES: This rule is effective from 8 a.m. to 6 p.m. on April 21 and 22, 2007. ADDRESSES: Documents indicated in this preamble as being available in the docket, are part of docket (CGD05-07-013) and are available for inspection or copying at Commander (dpi), Fifth Coast Guard District, 431 Crawford Street, Portsmouth, Virginia 23704-5004, between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Dennis M. Sens, Project Manager, Inspections and Investigations Branch, at
(757)398-6204. SUPPLEMENTARY INFORMATION: Regulatory Information On March 2, 2007, we published a notice of proposed rulemaking
(NPRM)entitled Special Local Regulations for Marine Events; Western Branch, Elizabeth River, Portsmouth, VA in the **Federal Register** (72 FR 9477). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. 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 the effective date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, support craft and other vessels transiting the event area. However, advance notifications will be made to affected waterway users via marine information broadcasts, area newspapers and local radio stations. Background and Purpose On April 21 and 22, 2007, Virginia Boat Racing Association will sponsor the “Virginia State Hydroplane Championship” hydroplane races on the waters of the Western Branch of the Elizabeth River at Portsmouth, Virginia. The event will consist of approximately 75 hydroplane powerboats conducting high-speed competitive races on the Western Branch of the Elizabeth River in the vicinity of Portsmouth City Park, Portsmouth, Virginia. A fleet of spectator vessels is expected to gather near the event site to view the competition. The regulation at 33 CFR 100.525 is effective annually for this marine event. Paragraph
(c)of Section 100.525 establishes the enforcement date for the hydroplane races. This regulation temporarily changes the permanent regulation so that the event may be held on April 21 and 22, 2007 instead of the fourth Friday and following Saturday in April. The Virginia Boat Racing Association who is the sponsor for this event still intends to hold this event annually, however, this year they have requested a change in the date of the event for 2007. The change was requested to accommodate participation by all hydroplane participants. To provide for the safety of participants, spectators, support and transiting vessels, the Coast Guard will temporarily restrict vessel traffic in the event area during the hydroplane races. Discussion of Comments and Changes The Coast Guard did not receive comments in response to the notice of proposed rulemaking
(NPRM)published in the **Federal Register** . Accordingly, the Coast Guard is establishing temporary special local regulations on specified waters of the Western Branch, Elizabeth River, Portsmouth, Virginia. Regulatory Evaluation 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. The effect of this proposed action merely establishes the date on which the existing regulation would be in effect and would not impose any new restrictions on vessel traffic. Small Entities 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 would not have a significant economic impact on a substantial number of small entities. This rule would effect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of the Western Branch of the Elizabeth River during the event. This rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would merely change the date on which the existing regulations would be enforced in the regulated area and would not impose any new restrictions on vessel traffic. Assistance for Small Entities 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 this rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under ADDRESSES . 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. 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). Collection of Information This rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism 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. Unfunded Mandates Reform Act 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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule would 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. Civil Justice Reform 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. Protection of Children 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. Indian Tribal Governments 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. Energy Effects 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. Technical Standards 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. Environment We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, 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)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine event permit are specifically excluded from further analysis and documentation under that section. Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule. List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows: PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233. 2. In § 100.525: A. From 8 a.m. to 6 p.m. on April 21 and 22, 2007, suspend paragraph (c); and B. From 8 a.m. to 6 p.m. on April 21 and 22, 2007, add a new paragraph
(d)to read as follows: § 100.525 Western Branch, Elizabeth River, Portsmouth, Virginia.
(d)*Enforcement period.* This section will be enforced from 8 a.m. to 6 p.m. on April 21 and 22, 2007. A notice of enforcement of this section will be disseminated through the Fifth Coast Guard District Local Notice to Mariners announcing the specific event date and times. Notice will also be made via marine Safety Radio Broadcast on VHF-FM marine band radio channel 22 (157.1 MHz). Dated: March 26, 2007. Larry L. Hereth, Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District. [FR Doc. E7-6780 Filed 4-10-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [CGD05-07-009] RIN 1625-AA08 Special Local Regulations for Marine Events; Martin Lagoon, Middle River, MD AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing temporary special local regulations during the “Baltimore County Community Waterfront Festival”, an event to be held May 12, 2007 at Martin Lagoon, Middle River, Maryland. These special local regulations are necessary to provide for the safety of life on navigable waters during the event. This action is intended to temporarily restrict vessel traffic in a portion of the Middle River waterfront to accommodate watercraft static displays, fire-rescue demonstrations and a fireworks display. DATES: This rule is effective from 9 a.m. to 11 p.m. on May 12, 2007. If this event is postponed due to weather this temporary final rule will be effective from 9 a.m. to 11 p.m. on May 13, 2007. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket CGD05-07-009 and are available for inspection or copying at Commander (dpi), Fifth Coast Guard District, 431 Crawford Street, Portsmouth, Virginia 23704-5004, between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: D. M. Sens, Project Manager, Inspections and Investigations Branch, at
(757)398-6204. SUPPLEMENTARY INFORMATION: Regulatory Information On February 26, 2007, we published a notice of proposed rulemaking
(NPRM)entitled Special Local Regulations for Marine Events; Martin Lagoon, Middle River, MD in the **Federal Register** (72 FR 8323). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. Background and Purpose On May 12, 2007 Baltimore County will sponsor the “Baltimore County Community Waterfront Festival”. Various watercraft static displays and fire-rescue demonstrations will be staged within Martin Lagoon. The fireworks display will be launched from Wilson Point Park but the hazardous fallout area will extend over Martin Lagoon. A fleet of spectator vessels is expected to gather near the event site to view the fireworks display. Due to the need for vessel control during the event, vessel traffic will be temporarily restricted to provide for the safety of participants, spectators and transiting vessels. Discussion of Comments and Changes The Coast Guard did not receive comments in response to the notice of proposed rulemaking
(NPRM)published in the **Federal Register** . Accordingly, the Coast Guard is establishing temporary special local regulations on the specified waters of Martin Lagoon, Middle River, Maryland. Regulatory Evaluation 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. Although this regulation restricts vessel traffic from transiting Martin Lagoon during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via marine information broadcasts and area newspapers so mariners can adjust their plans accordingly. Small Entities 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 Martin Lagoon during the event. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for only a short period, from 9 a.m. to 11 p.m. on May 12, 2007. Before the enforcement period, we will issue maritime advisories so mariners can adjust their plans accordingly. Assistance for Small Entities 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 would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under ADDRESSES . 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. 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). Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism 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. Unfunded Mandates Reform Act 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. Taking of Private Property 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. Civil Justice Reform 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. Protection of Children 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. Indian Tribal Governments 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. Energy Effects 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. Technical Standards 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. Environment We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, 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)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine event permit are specifically excluded from further analysis and documentation under those sections. List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows: PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233. 2. Add temporary § 100.35-T05-009 to read as follows: § 100.35-T05-009 Martin Lagoon, Middle River, Maryland.
(a)*Regulated area.* The regulated area includes all waters of Martin Lagoon that are north of a line drawn from latitude 39°19′34″ N, 076°25′41″ W, thence to a position located at 39°19′33″ N, 076°25′33″ W. All coordinates reference Datum NAD 1983.
(b)*Definitions.*
(1)Coast Guard Patrol Commander means a commissioned, warrant, or petty officer of the Coast Guard who has been designated by the Commander, Coast Guard Sector Baltimore.
(2)Official Patrol means any vessel assigned or approved by Commander, Coast Guard Sector Baltimore with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.
(c)*Special local regulations.*
(1)Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area.
(2)The operator of any vessel in the regulated area shall:
(i)Stop the vessel immediately when directed to do so by any Official Patrol.
(ii)Proceed as directed by any official patrol.
(d)*Enforcement period.* This section will be enforced from 9 a.m. to 11 p.m. on May 12, 2007. If the marine event is postponed due to weather, then the temporary special local regulations will be enforced during the same time period on May 13, 2007. Dated: March 29, 2007. Larry L. Hereth, Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District. [FR Doc. E7-6781 Filed 4-10-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD09-07-011] RIN 1625-AA00 Safety Zone; Michigan Aerospace Challenge, Muskegon Lake, Muskegon, MI AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Muskegon Lake near Muskegon, MI. This zone is intended to restrict vessels from a portion of the Muskegon Lake during the Michigan Aerospace Challenge Rocket Launch. This temporary safety zone is necessary to protect spectators and vessels from the hazards associated with sport rockets. DATES: This rule is effective from 8 a.m. (local) to 6 p.m. (local) on April 28, 2007. ADDRESSES: Documents indicated in this preamble as being available in the docket, are part of docket CGD09-07-011 and are available for inspection or copying at U.S. Coast Guard Sector Lake Michigan, 2420 South Lincoln Memorial Drive, Milwaukee, Wisconsin, 53207 between 8 a.m. (local) and 3 p.m. (local), Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: CWO Brad Hinken, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at
(414)747-7154. SUPPLEMENTARY INFORMATION: Regulatory Information 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. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. 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** . Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property. The Coast Guard has not received any complaints or negative comments previously with regard to this event. Background and Purpose This temporary safety zone is necessary to ensure the safety of vessels and spectators from hazards associated with a sport rocket launch. Based on the explosive and missile hazards of sport rockets, the Captain of the Port Lake Michigan has determined sport rocket launches in close proximity to watercraft pose significant risk to public safety and property. The likely combination of large numbers of recreation vessels, congested waterways, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the location of the rocket launch site will help ensure the safety of persons and property at these events and help minimize the associated risks. Discussion of Rule A temporary safety zone is necessary to ensure the safety of spectators and vessels during the setup, loading and launching of a sport rockets in conjunction with the Michigan Aerospace Challenge Rocket Launch. The rocket launch will occur between 8 a.m. (local) and 6 p.m. (local) on April 28, 2007. The safety zone for the rocket launch will encompass all waters and adjacent shoreline of Muskegon Lake and within the arc of a circle with a 1500-yard radius from the rocket launch site located at the West Michigan Dock and Market Corp facility with its center in position 43°14′21″ N, 086°15′35″ W (NAD 83). All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on-scene representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16. Regulatory Evaluation 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 determination is based on the minimal time that vessels will be restricted from the zone and the zone is an area where the Coast Guard expects insignificant adverse impact to mariners from the zone's activation. Small Entities 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 and operators of vessels intending to transit or anchor in a portion of Muskegon Lake near Muskegon, Michigan between 8 a.m. (local) and 6 p.m. (local) on April 28, 2007. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: this rule will be in effect for only ten hours for one event. Vessel traffic can safely pass outside the safety zone during the event. In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Lake Michigan to transit through the safety zone. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect. Assistance for Small Entities 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 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). Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. Unfunded Mandates Reform Act 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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property 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. Civil Justice Reform 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. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments 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. Energy Effects 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. Technical Standards 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 procedure; and related management system 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. Environment 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 made a preliminary determination 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, we believe that this rule should be categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This event establishes a safety zone therefore paragraph (34)(g) of the Instruction applies. A final “Environmental Analysis Check List” is available in the docket where indicated under ADDRESSES . Comments on this section will be considered before we make the final decision on whether the rule should be categorically excluded from further environmental review. List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. A new temporary § 165.T09-011 is added as follows: § 165.T09-011 Safety zone; Michigan Aerospace Challenge, Muskegon Lake, Muskegon, MI.
(a)*Location.* The following area is a temporary safety zone: All waters of Muskegon Lake and within the arc of a circle with a 1500-yard radius from the rocket launch site located at the West Michigan Dock and Market Corp facility with its center in position 43°14′21″ N, 086°15′35″ W (NAD 83).
(b)*Effective period.* This regulation is effective from 8 a.m. (local) on April 28, 2007 to 6 p.m. (local), on April 28, 2007.
(c)*Regulations.*
(1)In accordance with the general regulations in section 165.23 of this part, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan, or his designated on-scene representative.
(2)This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Lake Michigan or his designated on-scene representative.
(3)The “on-scene representative” of the Captain of the Port is any Coast Guard commissioned, warrant, or petty officer who has been designated by the Captain of the Port to act on his behalf. The on-scene representative of the Captain of the Port will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.
(4)Vessel operators desiring to enter or operate within the safety zone shall contact the Captain of the Port Lake Michigan or his on-scene representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Lake Michigan or his on-scene representative. Dated: March 31, 2007. Bruce C. Jones, Captain, U.S. Coast Guard, Commander, Coast Guard Sector Lake Michigan. [FR Doc. E7-6777 Filed 4-10-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD05-07-034] RIN 1625-AA00 Safety Zone; Fireworks Display, Potomac River, Oxon Hill, MD AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone upon certain waters of the Potomac River during a fireworks display. This action is necessary to provide for the safety of life on navigable waters during a fireworks display launched from a barge, located in a cove near Oxon Hill, Maryland. This action will restrict vessel traffic in a portion of the Potomac River. DATES: This rule is effective from 8 p.m. to 10 p.m. on May 31, 2007. ADDRESSES: Documents indicated in this preamble as being available in the docket, are part of this docket and are available for inspection or copying at Commander, U.S. Coast Guard Sector Baltimore, 2401 Hawkins Point Road, Building 70, Waterways Management Division, Baltimore, Maryland 21226-1791, between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Mr. Ronald L. Houck, at Coast Guard Sector Baltimore, Waterways Management Division, at telephone number
(410)576-2674 or
(410)576-2693. SUPPLEMENTARY INFORMATION: Regulatory Information 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. There was insufficient time to allow for the publication of an NPRM followed by a temporary final rule before the effective date. Any delay of the effective date of this rule would be contrary to the public interest by exposing the public to the known dangers associated with Fireworks Displays. Background and Purpose Each year, thousands of spectators attend outdoor fireworks displays discharged from vessels or floating platforms on or near the navigable waters of the United States. Accidental discharge of fireworks and falling hot embers are a safety concern during such events. The Coast Guard has the authority to impose appropriate controls on marine events that may pose a threat to persons, vessels and facilities under its jurisdiction. The Coast Guard is establishing a safety zone that will be enforced during a fireworks display held over the Potomac River, in a cove near Oxon Hill, Maryland. The rule is needed to control movement through a portion of the waterway that is expected to be populated by vessels seeking to view the fireworks display. Discussion of Proposed Rule On May 31, 2007, the Peterson Companies, National Harbor, will sponsor a fireworks display launched from a barge located on the Potomac River near Oxon Hill, in Prince George's County, Maryland. The planned event includes an aerial fireworks display beginning at 9 p.m. Due to the need for vessel control during the fireworks display, vessel traffic will be restricted to provide for the safety of spectators and transiting vessels. The purpose of this rule is to promote maritime safety, and to protect the environment and mariners transiting the area from the potential hazards due to falling embers or other debris associated with a fireworks display from a barge. This rule establishes a safety zone on the waters of the Potomac River, within a radius of 150 yards around a fireworks barge, which will be located at position latitude 38°47′24.2″ N, longitude 077°01′18.7″ W. The Coast Guard anticipates a spectator fleet during this event. The rule will impact the movement of all vessels operating in a specified area of the Potomac River. Interference with normal port operations is unlikely; however, if required, will be kept to the minimum considered necessary to ensure the safety of life on the navigable waters immediately before, during, and after the scheduled event. Regulatory Evaluation 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. We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. Small Entities 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: The owners or operators of vessels intending to operate, remain or anchor within certain waters of the Potomac River, within a radius of 150 yards around a fireworks barge located at position latitude 38°47′24.2″ N, longitude 077°01′18.7″ W, from 8 p.m. to 10 p.m. on May 31, 2007. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for two hours, commercial vessel traffic in this area is limited, vessels not constrained by their draft may proceed safely around the safety zone, and the Coast Guard will issue maritime advisories widely available to users of the river before the effective period. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Coast Guard Sector Baltimore, Waterways Management Division, at telephone number
(410)576-2674. 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. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.). Federalism 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. Unfunded Mandates Reform Act 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. Taking of Private Property 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. Civil Justice Reform 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. Protection of Children 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. Indian Tribal Governments 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. Energy Effects 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. Technical Standards 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. Environment We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide 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. This rule establishes a safety zone. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add temporary § 165.T05-034 to read as follows: § 165.T05-034 Safety zone; Fireworks Display, Potomac River, Oxon Hill, MD.
(a)*Location.* The following area is a safety zone: All waters of the Potomac River near Oxon Hill, Maryland, surface to bottom, within a radius of 150 yards around a fireworks barge which will be located at position latitude 38° 47′ 24.2″ N, longitude 077° 01′ 18.7″ W. All coordinates reference Datum NAD 1983.
(b)*Definition.* As used in this section the Captain of the Port Baltimore means the Commander, Coast Guard Sector Baltimore or any Coast Guard commissioned, warrant or petty officer who has been authorized by the Captain of the Port to act on his behalf.
(c)*Regulations.* The general regulations governing safety zones, found in § 165.23, apply to the safety zone described in paragraph
(a)of this section.
(1)All vessels and persons are prohibited from entering this zone, except as authorized by the Captain of the Port, Baltimore, Maryland.
(2)Persons or vessels requiring entry into or passage within the zone must request authorization from the Captain of the Port or his designated representative by telephone at
(410)576-2693 or by marine band radio on VHF channel 16 (156.8 MHz).
(3)All Coast Guard vessels enforcing this safety zone can be contacted on marine band radio VHF channel 16 (156.8 MHz).
(4)The operator of any vessel within or in the immediate vicinity of this safety zone shall:
(i)Stop the vessel immediately upon being directed to do so by any commissioned, warrant or petty officer on board a vessel displaying a Coast Guard Ensign, and
(ii)Proceed as directed by any commissioned, warrant or petty officer on board a vessel displaying a Coast Guard Ensign.
(d)*Enforcement.* The U.S. Coast Guard may be assisted in the patrol and enforcement of the zone by Federal, State and local agencies.
(e)*Enforcement period.* This section will be enforced from 8 p.m. to 10 p.m. on May 31, 2007. Dated: April 2, 2007. Jonathan C. Burton, Commander, U.S. Coast Guard, Acting Captain of the Port, Baltimore, Maryland. [FR Doc. E7-6784 Filed 4-10-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900-AE87 Per Diem for Nursing Home Care of Veterans in State Homes; Correction AGENCY: Department of Veterans Affairs. ACTION: Correcting amendment. SUMMARY: This document contains a minor correction to the final regulation that the Department of Veterans Affairs
(VA)published in 65 FR 23412 on January 6, 2000. The regulation relates to the payment of per diem to State homes that provide nursing home care to eligible veterans. DATES: *Effective date:* April 11. 2007. FOR FURTHER INFORMATION CONTACT: Candice Cornish, Office of Regulation Policy and Management (00REG), Department of Veterans Affairs, 810 Vermont Ave., NW., Washington, DC 20420,
(202)273-9957. SUPPLEMENTARY INFORMATION: The VA published a document in the **Federal Register** on January 6, 2000, 65 FR 23412, revising its medical regulations concerning payment of per diem to State homes that provide nursing home care to eligible veterans. In that document, we failed to properly punctuate the end of § 17.190(c). This document corrects that error by removing “, and” and adding, in its place, a period. List of Subjects in 38 CFR Part 17 Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Radioactive materials, Veterans, Vietnam. Robert C. McFetridge, Assistant to the Secretary for Regulation Policy and Management. For the reason set out in the preamble, VA is correcting 38 CFR part 17 as follows. PART 17—MEDICAL 1. The authority citation for part 17 continues to read as follows: Authority: 38 U.S.C. 501, 1721, and as stated in specific sections. § 17.190 [Corrected] 2. In § 17.190, paragraph
(c)is amended by removing “, and” and adding, in its place, a period at the end of the paragraph. [FR Doc. E7-6762 Filed 4-10-07; 8:45 am] BILLING CODE 8320-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0576; FRL-8121-3] Tetraconazole; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of tetraconazole in or on peanut, pecan, sugarbeet and soybean. Sipcam Agro USA, Inc. and Isagro S.p.A. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective April 11, 2007. Objections and requests for hearings must be received on or before June 11, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ- OPP-2006-0576. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Lisa Jones, Fungicide Branch, Registration Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-9424; e-mail address: *jones.lisa@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), 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 to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0576 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before June 11, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0576, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of July 26, 2006 (71 FR 42392) (FRL-8074-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F6971) by Isagro S.p.A., 430 Davis Dr., Suite 240, Morrisville, NC 27560. The petition requested that 40 CFR 180.557 be amended by establishing a tolerance for residues of the fungicide, tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1H-1,2,4-triazole] in or on soybean, seed at 0.1 parts per million (ppm), soybean, aspirated grain fractions/soybean, refined oil at 0.5 ppm, poultry, fat at 0.05 ppm, and poultry, egg/liver/meat/meat byproducts at 0.01 ppm. That notice referenced a summary of the petition prepared by Isagro S.p.A., the registrant, which is available to the public in the docket, *http://www.regulations.gov* . One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C. below. In the **Federal Register** of December 20, 2006 (71 FR 76321) (FRL-8104-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 6F7084, 9F6023, 9F5066) by Sipcam Agro USA, Inc., Colonial Center Parkway, # 230, Roswell, GA 30076. Petition 6F7084 requested that 40 CFR 180.557 be amended by establishing tolerances for residues of the fungicide tetraconazole in or on pecan at 0.05 ppm. Petition 9F6023 requested that 40 CFR 180.557 be amended by establishing tolerances for residues of the fungicide tetraconazole in or on the food commodities peanut, nutmeat at 0.05 ppm, and peanut, refined oil at 0.15 ppm. Petition 9F5066 requested that 40 CFR 180.557 be amended by revising the existing tolerances for residues of the fungicide tetraconazole in or on sugarbeet roots at 0.05 ppm, sugarbeet top 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. That notice referenced a summary of the petition prepared by Sipcam Agro USA, Inc., the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. III. Aggregate Risk Assessment and Determination of Safety 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. . . .” These provisions were added to the FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of tetraconazole. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile 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. Specific information on the studies received and the nature of the adverse effects caused by as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the **Federal Register** of April 22, 2005 (70 FR 20821), (FRL-7702-4). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern
(LOC)is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors
(UF)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable uncertainty/safety factors is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . A summary of the toxicological endpoints for tetraconazole used for human risk assessment is discussed in Unit III.B. of the final rule published in the **Federal Register** of April 22, 2005 (70 FR 20821) (FRL-7702-4). C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to, EPA considered exposure under the petitioned-for tolerances as well as all existing tolerances in (40 CFR 180.557). EPA assessed dietary exposures from tetraconazole in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. An acute endpoint was not identified for the general population. In estimating acute dietary exposure for females aged 13 to 49, EPA used food consumption information from the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that all food and feed commodities with established and proposed tolerances contain tolerance-level residues and that 100% of crops were treated. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Nationwide CSFII. As to residue levels in food, EPA relied upon empirical processing factors, average field trial residues for all crops and average residues in meat and meat by-products derived from feeding studies. Percent crop treated information was not used. iii. *Cancer* . In conducting the cancer dietary risk assessment, EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. The refined dietary cancer risk assessment used empirical processing factors, average field trial residues for all crops, average residues in meat and meat by-products derived from feeding studies and projected percent crop treated estimates for peanuts, soybean and sugarbeets. iv. *Anticipated residue and percent crop treated
(PCT)information* . Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data Call-Ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: a. The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; b. The exposure estimate does not underestimate exposure for any significant subpopulation group; and c. Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. EPA estimates projected percent crop treated
(PPCT)for a new pesticide use by initially assuming that the percent crop treated
(PCT)during the pesticide's initial 5 years of use on a specific use site will not exceed the average PCT of the market leader (i.e., the one with the greatest PCT) on that site. EPA also examines all other available data to determine if this method of projecting percent crop treated produces a reliable estimate. The Agency used PPCT information for the cancer dietary exposure assessment as follows: Peanuts - 77%; sugar beets - 70%; and soybeans - 27%. The PPCT for peanuts was determined by averaging the PCTs of the leading fungicide, in this case, chlorothalonil, for the three most recent available years (1991, 1999 and 2004). These data show 77% PPCT based on average market leader values. The PPCT for sugar beets was determined as the PCT of the leading fungicide, in this case, tetraconazole itself, for the year 2000, based on its use on sugar beets following registration under Section 18 of FIFRA for use in seven states (Colorado, Michigan, Minnesota, Montana, Nebraska, North Dakota, and Wyoming). Tetraconazole is the current market leader (55%) in those seven states where it is currently used. However, the acreage potentially treated by tetraconazole rises by 18% when four other sugarbeet growing states (California, Idaho, Oregon and Washington) are also considered. Treating all the planted acreage in these four additional states with tetraconazole could bring the PPCT up to 70%. The PPCT for soybeans was determined using a modified approach. Due to the discovery of a new and important disease on soybeans (Asian soybean rust), historical information was not considered useful for estimating PCT for soybeans. PCT estimates were obtained for future market leaders from soybean crop specialists. For a conservative estimate EPA utilized only the maximum projected values provided by each respondent, which ranged from 15 to 38%. These values translated into average and maximum PPCT values of 27 and 38%, respectively. EPA's evaluation of the basis for these estimates and other factors bearing on the potential use of tetraconazole show that it is unlikely that these estimates will be exceeded. The Agency believes that the three conditions listed in the second paragraph of Unit III.C.1.iv have been met. With respect to Condition 1, the data relied upon is discussed above. Where EPA relies on PCT data on existing uses, EPA typically uses the United States Department of Agriculture, National Agricultural Statistical Service (USDA/NASS) as the primary source for PCT data. When a specific use site is not surveyed by USDA/NASS, EPA uses other sources including proprietary data and calculates the PCT. Comparisons are only made among pesticides of the same pesticide types (i.e., the leading fungicide on the use site is selected for comparison with the new fungicide). The PCTs included in the average may be for the same pesticide, or for different pesticides, since the same, or different pesticides, may dominate for each year selected. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which tetraconazole may be applied in a particular area. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for tetraconazole in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of tetraconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-GROW) models, the estimated environmental concentrations
(EECs)for acute exposures are estimated to be 20.01 parts per billion
(ppb)for surface water. The EECs for chronic exposures are estimated to be a yearly average of 7.26 ppb for surface water and 1.79 ppb for ground water and a 30-year annual average of 4.97 for surface water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 20.01 ppb was used to access the contribution to drinking water. For chronic and cancer dietary risk assessment, the water concentration of value 4.97 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Tetraconazole is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Tetraconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . Triazole-derived pesticides can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including tetraconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazolylalanine and triazolylacetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide as of September 1, 2005. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment is found in the propiconazole reregistration docket at *http://www.regulations.gov* , Docket Identification
(ID)Number EPA-HQ-OPP-2005-0497. For tetraconazole, the new use on pecans was not received by the Agency prior to September 1, 2005, and therefore, was not included in the human health risk assessment for exposure to 1,2,4-triazole, triazolylalanine and triazolylacetic acid. The Agency has evaluated the additional dietary risk from 1,2,4-triazole and the two conjugates resulting from the use of tetraconazole on pecans in the Agency's human health risk assessment for tetraconazole. The Agency has determined that dietary exposure to 1,2,4-triazole, triazolylalanine and triazolylacetic acid does not exceed the Agency's level of concern. D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional
(10X)tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There is no evidence of increased susceptibility of rat or rabbit fetuses to *in utero* exposure to tetraconazole. In the developmental toxicity study in rats, developmental effects were seen at the same dose that induced maternal toxicity. In the developmental toxicity study in rabbits, no developmental toxicity was seen at the highest dose tested. In the 2-generation reproduction study, offspring toxicity occurred at doses higher than the dose that induced parental/systemic toxicity. There are no concerns or residual uncertainties for prenatal and/or postnatal toxicity. Additionally, there is no concern for neurotoxicity resulting from exposure to tetraconazole since there was no evidence of neurotoxicity in short-term studies in rats, mice and dogs; and a long-term toxicity study in dogs. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for tetraconazole is complete. ii. There is no indication that tetraconazole is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity. iii. There is no evidence that tetraconazole results in increased susceptibility in *in utero* rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The assumptions and estimates used to model ground and surface water concentrations are discussed in Unit III.C.2 and the assumptions and estimations underlying the dietary food exposure assessments are discussed in Unit III.C.1. These assessments will not underestimate the exposure and risks posed by tetraconazole. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to tetraconazole will occupy <1.0% of the aPAD for the population group (females 13-49 years old) receiving the greatest exposure. No acute toxicity endpoint was identified for the remaining population subgroups. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to tetraconazole from food and water will utilize ≤10.1% of the cPAD for the population group all infants < 1 year old. There are no residential uses for tetraconazole that result in chronic residential exposure to tetraconazole. Based on the use pattern, chronic residential exposure to residues of tetraconazole is not expected. 3. *Short-term and intermediate-term risk* . Short-term and intermediate-term aggregate exposure take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Tetraconazole is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water. 4. *Aggregate cancer risk for U.S. population* . The estimated cancer risk for the proposed use of tetraconazole on sugarbeets, peanuts, pecans and soybeans is 3 x 10 -6 . EPA considers risk estimates as high as 3 x 10 -6 to be within the negligible risk range of 1 x 10 -6 . This aggregate risk is the sum of the risk from food and water. 5. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to tetraconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (capillary gas chromatography withelectron capture detector (GC/ECD)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no established Codex, Canadian, or Mexican Maximum Residue Limits
(MRLs)established for tetraconazole in or on the relevant crops and commodities. C. Response to Comments One comment was received from a private citizen objecting to the establishment of tolerances for tetraconazole. The Agency has received similar comments from this commenter on numerous previous occasions. Refer to **Federal Register** 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), 69 FR 63096-63098 (October 29, 2004) for the Agency's response to these objections. In addition, the commenter noted several adverse effects seen in animal toxicology studies with tetraconazole and claims because of these effects no tolerance should be approved. However, EPA found in its tetraconazole risk assessment that there is a reasonable certainty of no harm to humans after considering the toxicological studies (and the adverse effects seen therein) and the exposure levels of humans to tetraconazole. The commenter did not provide any information that questioned EPA's risk assessment. V. Conclusion Upon completing the review of the current tetraconazole database, the Agency concluded that tolerances for hog meat commodities are necessary as a result of concern for secondary residues, and a sugar beet top tolerance is unnecessary since it is not a human food commodity and is being eliminated as a feed commodity from OPPTS 860.1000. The Agency concluded that the appropriate tolerance levels and preferred commodity terms for tetraconazole residues in or on pending crops and livestock commodities should be established as follows: Tolerances are established for residues of tetraconazole in or on beet, sugar, root at 0.05 ppm; beet, sugar, dried pulp at 0.15 ppm; beet, sugar, molasses at 0.15 ppm; peanut at 0.03 ppm; peanut, oil at 0.10 ppm; pecan at 0.04 ppm; soybean, seed at 0.15 ppm; soybean, refined oil at 0.80 ppm; aspirated grain fractions at 1.0 ppm; poultry, meat at 0.01 ppm; poultry, fat at 0.05 ppm; poultry, meat byproducts at 0.01 ppm; eggs at 0.02 ppm; cattle, meat at 0.01 ppm; cattle, liver at 0.20 ppm; cattle, fat at 0.02 ppm; cattle, meat byproducts (except liver) at 0.01 ppm; milk at 0.01 ppm; milk, fat at 0.25 ppm; goat, meat at 0.01 ppm; goat, liver at 0.20 ppm; goat, fat at 0.02 ppm; goat, meat, byproducts (except liver) at 0.01 ppm; hog, meat at 0.01 ppm; hog, liver at 0.05 ppm; hog, fat at 0.01 ppm; hog, meat byproducts (except liver) at 0.01 ppm; horse, meat at 0.01 ppm; horse, liver at 0.20 ppm; horse, fat at 0.02 ppm; horse, meat, byproducts (except liver) at 0.01 ppm; sheep, meat at 0.01 ppm; sheep, liver at 0.20 ppm; sheep, fat at 0.02 ppm; sheep, meat, byproducts (except liver) at 0.01 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 2, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.557 is amended by revising paragraph (a), and removing and reserving paragraphs
(b)and
(c)to read as follows. § 180.557 Tetraconazole; tolerances for residues.
(a)*General* . Tolerances are established for residues of the fungicide, tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1 *H* -1,2,4-triazole in or on the following commodities: Commodity Parts per million Aspirated grain fractions 1.0 Beet sugar, dried pulp 0.15 Beet sugar, molasses 0.15 Beet sugar, root 0.05 Cattle, fat 0.02 Cattle, liver 0.20 Cattle, meat 0.01 Cattle, meat byproducts (except liver) 0.01 Eggs 0.02 Goat, fat 0.02 Goat, liver 0.20 Goat, meat 0.01 Goat, meat byproducts (except liver) 0.01 Hog, fat 0.01 Hog, liver 0.05 Hog, meat 0.01 Hog, meat byproducts (except liver) 0.01 Horse, fat 0.02 Horse, liver 0.20 Horse, meat 0.01 Horse, meat byproducts (except liver) 0.01 Milk 0.01 Milk, fat 0.25 Peanut 0.03 Peanut, oil 0.10 Pecan 0.04 Poultry, fat 0.05 Poultry, meat 0.01 Poultry meat byproducts 0.01 Sheep, fat 0.02 Sheep, liver 0.20 Sheep, meat 0.01 Sheep, meat byproducts (except liver) 0.01 Soybean, refined oil 0.80 Soybean, seed 0.15
(b)*Section 18 emergency exemptions* . [Reserved].
(c)*Tolerances with regional registrations* . [Reserved]. [FR Doc. E7-6837 Filed 4-10-07; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 001005281-0369-02; I.D. 040407C] Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic; Closure AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; closure. SUMMARY: NMFS closes the commercial hook-and-line fishery for king mackerel in the exclusive economic zone
(EEZ)in the southern Florida west coast subzone. This closure is necessary to protect the Gulf king mackerel resource. DATES: The closure is effective 12:01 a.m., local time, April 10, 2007, until 12:01 a.m., July 1, 2007. FOR FURTHER INFORMATION CONTACT: Steve Branstetter, telephone: 727-824-5305, fax: 727-824-5308, e-mail: *Steve.Branstetter@noaa.gov* . SUPPLEMENTARY INFORMATION: The fishery for coastal migratory pelagic fish (king mackerel, Spanish mackerel, cero, cobia, little tunny, and, in the Gulf of Mexico only, dolphin and bluefish) is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils (Councils) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. Based on the Councils' recommended total allowable catch and the allocation ratios in the FMP, on April 30, 2001 (66 FR 17368, March 30, 2001), NMFS implemented a commercial quota of 2.25 million lb (1.02 million kg) for the eastern zone (Florida) of the Gulf migratory group of king mackerel. That quota is further divided into separate quotas for the Florida east coast and west coast subzones. The Florida west coast subzone is that part of the eastern zone south and west of 25°20.4′ N. lat. (a line directly east from the Miami-Dade/Monroe County, FL, boundary) along the west coast of Florida to 87°31.1′ W. long. (a line directly south from the Alabama/Florida boundary). The Florida west coast subzone is further divided into a northern and southern subzone. The southern subzone is that part of the Florida west coast subzone, which from November 1 through March 31 extends south and west from the Miami-Dade/Monroe County boundary to 25°20.4′ N. lat. to 26°19.8′ N. lat.(a line directly west from the Lee/Collier County, FL, boundary), i.e., the area off Collier and Monroe Counties. From April 1 through October 31, the southern subzone is that part of the Florida west coast subzone which is between 26°19.8′ N. lat. and 25°48′ N. lat.(a line directly west from the Monroe/Collier County, FL, boundary), i.e., the area off Collier County. The quota implemented for the southern Florida west coast subzone is 1,040,625 lb (472,020 kg). That quota is further divided into two equal quotas of 520,312 lb (236,010 kg) for vessels in each of two groups fishing with run-around gillnets and hook-and-line gear (50 CFR 622.42(c)(1)(i)(A)( *2* )( *i* )). Under 50 CFR 622.43(a)(3), NMFS is required to close any segment of the king mackerel commercial fishery when its quota has been reached, or is projected to be reached, by filing a notification at the Office of the **Federal Register** . NMFS has determined that the commercial quota of 520,312 lb (236,010 kg) for Gulf group king mackerel for vessels using hook-and-line gear in the southern Florida west coast subzone has been met. Accordingly, the commercial fishery for king mackerel for such vessels in the southern Florida west coast subzone is closed at 12:01 a.m., local time, April 10, 2007, through 12:01 a.m., July 1, 2007, the beginning of the next (2007 - 2008) fishing season. Classification 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 prior notice and opportunity for public comment is unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself already has been subject to notice and comment, and all that remains is to notify the public of the closure. Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action in order to protect the fishery since the capacity of the fishing fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment will require time and would potentially result in a harvest well in excess of the established quota. For the aforementioned reasons, the AA also finds good cause to waive the 30 day delay in effectiveness of this action under 5 U.S.C. 553(d)(3). This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866. Authority: 16 U.S.C. 1801 *et seq.* Dated: April 6, 2007. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. 07-1801 Filed 4-6-07; 2:40 pm]
Connectionstraces to 27
Traces to 27 documents
25 references not yet in our index
  • 21 CFR 524
  • 21 CFR 20
  • 5 USC 801-808
  • 32 CFR 706
  • 33 CFR 100
  • 33 CFR 100.525
  • 5 USC 601-612
  • Pub. L. 104-121
  • 44 USC 3501-3520
  • 2 USC 1531-1538
  • 42 USC 4321-4370f
  • 33 USC 1233
  • 33 CFR 165
  • Pub. L. 107-295
  • 38 CFR 17
  • 40 CFR 180
  • 40 CFR 178
  • 40 CFR 2
  • 40 CFR 180.557
  • Pub. L. 104-4
  • Pub. L. 104-113
  • 50 CFR 622
  • 50 CFR 622.42(c)(1)(i)(A)
  • 50 CFR 622.43(a)(3)
  • 50 CFR 622.43(a)
Citation graph
cites case law
Rules and Regulations
Final rule
C.F.R.§ 524.1465
C.F.R.§ 514.11
C.F.R.§ 25.33
U.S.C.§ 804
U.S.C.§ 360b
U.S.C.§ 1605
Fed. Reg.Notices
U.S.C.§ 553
Fed. Reg.Notices
Cite21 CFR 524
Cite21 CFR 20
Cite5 USC 801-808
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