Rules and Regulations. Final rule

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BILLING CODE 4910-13-M DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2005-22024; Airspace Docket No. 06-AAL-08] RIN-2120-AA66 Modification of Offshore Airspace Area: Control 1487L; Alaska AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action modifies Control 1487L offshore airspace area in the vicinity of the Sitka Rocky Gutierrez Airport, Sitka, AK; Merle K. Mudhole Smith Airport, Cordova, AK; and Middleton Island Airport, Middleton Island, AK, by lowering the affected airspace floors associated within Control 1487L.

The FAA is taking this action to provide additional controlled airspace for the safety of aircraft executing instrument flight rules

(IFR)operations at the Sitka Rocky Gutierrez Airport, Merle K. Mudhole Smith Airport, and Middleton Island Airport. DATES: *Effective Date:* 0901 UTC, August 3, 2006. FOR FURTHER INFORMATION CONTACT: Ken McElroy, Airspace and Rules, Office of System Operations Airspace and AIM, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone:

(202)267-8783. SUPPLEMENTARY INFORMATION: History On April 6, 2006, the FAA published in the **Federal Register** a notice of proposed rulemaking to modify the Control 1487L offshore airspace area in Alaska (71 FR 17389). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received. Offshore Airspace Areas are published in paragraph 6007 of FAA Order 7400.9N dated September 1, 2005 and effective September 15, 2005, which is incorporated by reference in 14 CFR 71.1. The Offshore Airspace Areas listed in this document will be published subsequently in the Order. The Rule This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Control 1487L offshore airspace area, AK, by lowering the floor from 5,500 feet mean sea level

(MSL)to as low as 700 feet MSL in the vicinity of the Sitka Rocky Gutierrez Airport, Merle K. Mudhole Smith Airport and Middleton Island Airport. This action will provide offshore airspace in the vicinity of Merle K. Mudhole Smith Airport, AK, by lowering the offshore airspace floor from 5,500 feet MSL to 1,200 feet MSL. Additionally, this action will re-designate the existing Class E airspace at Anchorage, AK, by extending Control 1487L airspace area westward to the 12-mile shoreline limit within the 149.5-mile radius associated with Anchorage, AK, Class E airspace, and clarify offshore airspace descriptions within already established domestic Class E airspace at Anchorage and Cordova. This action will provide additional controlled airspace for the safety of aircraft executing IFR operations at the Sitka Rocky Gutierrez, Merle K. Mudhole Smith, and Middleton Island Airports, and will correctly designate the existing Class E airspace for Anchorage and Cordova, AK. The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation:

(1)Is not a “significant regulatory action” under Executive Order 12866;

(2)is not a “significant rule” under Department of Transportation

(DOT)Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and

(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. ICAO Considerations As part of this rule relates to navigable airspace outside the United States, the notice of this action is submitted in accordance with the International Civil Aviation Organization

(ICAO)International Standards and Recommended Practices. The application of International Standards and Recommended Practices by the FAA, Office of System Operations Airspace and AIM, Airspace & Rules, in areas outside the United States domestic airspace, is governed by the Convention on International Civil Aviation. Specifically, the FAA is governed by Article 12 and Annex 11, which pertain to the establishment of necessary air navigational facilities and services to promote the safe, orderly, and expeditious flow of civil air traffic. The purpose of Article 12 and Annex 11 is to ensure that civil aircraft operations on international air routes are performed under uniform conditions. The International Standards and Recommended Practices in Annex 11 apply to airspace under the jurisdiction of a contracting state, derived from ICAO. Annex 11 provisions apply when air traffic services are provided and a contracting state accepts the responsibility of providing air traffic services over high seas or in airspace of undetermined sovereignty. A contracting state accepting this responsibility may apply the International Standards and Recommended Practices that are consistent with standards and practices utilized in its domestic jurisdiction. In accordance with Article 3 of the Convention, state-owned aircraft are exempt from the Standards and Recommended Practices of Annex 11. The United States is a contracting state to the Convention. Article 3(d) of the Convention provides that participating state aircraft will be operated in international airspace with due regard for the safety of civil aircraft. Since this action involves, in part, the designation of navigable airspace outside the United States, the Administrator is consulting with the Secretary of State and the Secretary of Defense in accordance with the provisions of Executive Order 10854. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). The Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of the FAA Order 7400.9N, Airspace Designations and Reporting Points, dated September 1, 2005, and effective September 15, 2005, is amended as follows: Paragraph 6007 Offshore airspace areas. Control 1487L [Amended] That airspace extending upward from 8,000 feet MSL within 149.5 miles of the Anchorage VOR/DME clockwise from the 090° radial to the 185° radial of the Anchorage VOR/DME; and that airspace extending upward from 5,500 feet MSL within the area bounded by a line beginning at lat. 58°19′58″ N., long. 148°55′07″ W.; to lat. 59°08′35″ N., long. 147°16′04″ W.; thence counterclockwise via the arc of a 149.5-mile radius centered on the Anchorage VOR/DME to the intersection of the 149.5-mile radius arc and a point 12 miles from and parallel to the U.S. coastline; thence southeast 12 miles from and parallel to the U.S. coastline to a point 12 miles offshore on the Vancouver FIR boundary; to lat. 54°32′57″ N., long. 133°11′29″ W.; to lat. 54°00′00″ N., long. 136°00′00″ W.; to lat. 52°43′00″ N., long. 135°00′00″ W.; to lat. 56°45′42″ N., long. 151°45′00″ W.; to the point of beginning; and that airspace extending upward from 1,200 feet MSL within the area bounded by a line beginning at lat. 59°33′25″ N., long. 141°03′22″ W.; thence southeast 12 miles from and parallel to the U.S. coastline to lat. 58°56′18″ N., long. 138°45′19″ W.; to lat. 58°40′00″ N., long. 139°30′00″ W.; to lat. 59°00′00″ N., long. 141°10′00″ W.; to the point of beginning, and that airspace within 85 miles of the Biorka Island VORTAC, and that airspace within 42 miles of the Middleton Island VOR/DME, and that airspace within 30 miles of the Glacier River NDB; and that airspace extending upward from 700 feet MSL within 14 miles of the Biorka Island VORTAC and within 4 miles west and 8 miles east of the Biorka Island VORTAC 209° radial extending to 16 miles southwest of the VORTAC. The portion within Canada is excluded. Issued in Washington, DC on May 31, 2006. Edith V. Parish, Manager, Airspace and Rules. [FR Doc. E6-8848 Filed 6-6-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2006-23708; Airspace Docket No. 06-AAL-1] RIN-2120-AA66 Modification of Control 1234L Offshore Airspace Area; AK AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action amends Control 1234L offshore airspace area in Alaska. Specifically, this action modifies Control 1234L in the immediate vicinity of the Saint Paul Island Airport, AK, by lowering the airspace floor from 2,000 feet above ground level

(AGL)to 700 AGL. Additionally, outside the vicinity of the airport this action lowers the airspace floor from 2,000 AGL to 1,200 feet AGL within a 73-mile radius of the St. Paul Island Airport. The FAA is taking this action to provide additional controlled airspace for aircraft instrument flight rules

(IFR)operations at the St. Paul Island Airport. DATES: *Effective Date:* 0901 UTC, August 3, 2006. FOR FURTHER INFORMATION CONTACT: Ken McElroy, Airspace and Rules, Office of System Operations Airspace and AIM, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone:

(202)267-8783. SUPPLEMENTARY INFORMATION: History On April 13, 2006, the FAA published in the **Federal Register** a notice of proposed rulemaking to modify the Control 1234L offshore airspace area in Alaska (71 FR 19148). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received. Offshore Airspace Areas are published in paragraph 6007 of FAA Order 7400.9N dated September 1, 2005 and effective September 15, 2005, which is incorporated by reference in 14 CFR 71.1. The Offshore Airspace Areas listed in this document will be published subsequently in the Order. The Rule This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Control 1234L Offshore Airspace Area, AK by lowering the floor to 700 feet AGL in the vicinity of the St. Paul Island Airport, AK, and 1,200 feet AGL within a 73-mile radius of the airport. The action is to establish controlled airspace to support IFR operations at the St. Paul Island Airport, Alaska. The FAA Instrument Flight Procedures Production and Maintenance Branch developed new instrument approach procedures for the St. Paul Island Airport. New controlled airspace extending upward from 700 feet AGL and 1,200 feet AGL in international airspace is created by this action. The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation:

(1)Is not a “significant regulatory action” under Executive Order 12866;

(2)is not a “significant rule” under Department of Transportation

(DOT)Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and

(ICAO)International Standards and Recommended Practices. The application of International Standards and Recommended Practices by the FAA, Office of System Operations Airspace and AIM, Airspace & Rules, in areas outside the United States domestic airspace, is governed by the Convention on International Civil Aviation. Specifically, the FAA is governed by Article 12 and Annex 11, which pertain to the establishment of necessary air navigational facilities and services to promote the safe, orderly, and expeditious flow of civil air traffic. The purpose of Article 12 and Annex 11 is to ensure that civil aircraft operations on international air routes are performed under uniform conditions. The International Standards and Recommended Practices in Annex 11 apply to airspace under the jurisdiction of a contracting state, derived from ICAO. Annex 11 provisions apply when air traffic services are provided and a contracting state accepts the responsibility of providing air traffic services over high seas or in airspace of undetermined sovereignty. A contracting state accepting this responsibility may apply the International Standards and Recommended Practices that are consistent with standards and practices utilized in its domestic jurisdiction. In accordance with Article 3 of the Convention, state-owned aircraft are exempt from the Standards and Recommended Practices of Annex 11. The United States is a contracting state to the Convention. Article 3(d) of the Convention provides that participating state aircraft will be operated in international airspace with due regard for the safety of civil aircraft. Since this action involves, in part, the designation of navigable airspace outside the United States, the Administrator is consulting with the Secretary of State and the Secretary of Defense in accordance with the provisions of Executive Order 10854. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). The Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of the FAA Order 7400.9N, Airspace Designations and Reporting Points, dated September 1, 2005, and effective September 15, 2005, is amended as follows: Paragraph 6007 Offshore airspace areas. Control 1234L [Amended] That airspace extending upward from 700 feet above the surface within 8 miles west and 6 miles east of the 360° bearing from the St. Paul Island Airport to 14 miles north of the St. Paul Island Airport, and within 6 miles west and 8 miles east of the 172° bearing from the St. Paul Island Airport to 15 miles south of the St. Paul Island Airport; and that airspace extending upward from 1,200 feet above the surface within a 73-mile radius of the St. Paul Island Airport, and the airspace extending upward from 1,200 MSL within a 72.8-mile radius of Chignik Airport, AK; and that airspace extending upward from 2,000 feet above the surface within an area bounded by a line beginning at lat. 58°06′57″ N., long. 160°00′00″ W., south along long. 160°00′00″ W. until it intersects the Anchorage Air Route Traffic Control Center boundary; thence southwest, northwest, north, and northeast along the Anchorage Air Route Traffic Control Center boundary to lat. 62°35′00″ N., long. 175°00′00″ W.; to lat. 59°59′57″ N., long. 168°00′08″ W.; to lat. 57°45′57″ N., long. 161°46′08″ W.; to the point of beginning. Issued in Washington, DC on May 31, 2006. Edith V. Parish, Manager, Airspace and Rules. [FR Doc. E6-8850 Filed 6-6-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 50 RIN 0910-AC25 [Docket No. 2003N-0355] Medical Devices; Exception From General Requirements for Informed Consent AGENCY: Food and Drug Administration, HHS. ACTION: Interim final rule. SUMMARY: The Food and Drug Administration

(FDA)is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. DATES: This rule is effective June 7, 2006. Submit written or electronic comments by August 7, 2006. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Claudia M. Gaffey, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0496, ext. 109. SUPPLEMENTARY INFORMATION: I. Background U.S. Federal, State, and local authorities have developed and are refining a comprehensive public health plan to prepare for, and respond to, the threat of terrorism and other potential public health emergencies. A critical element in responding to such emergencies is the ability to correctly and quickly identify the chemical, biological, radiological, or nuclear agents that may have caused, or may cause, human disease or injury. The devices included within the scope of this rule are those for the detection of agents that have the potential to be used in acts of chemical, biological, radiological, or nuclear terrorism, or that can lead to other potential public health emergencies. Examples of these agents include *Bacillus anthracis* (anthrax); *Yersinia pestis* (plague); ricin (a lethal chemical agent); and cobalt-60, a radiological material that could be used to build a dirty bomb. Although it is not possible to provide an all inclusive list of etiological agents that would be identified under conditions that meet the criteria described in this rule, critical biologic agents such as Category A Diseases/Agents (available at *http://www.bt.cdc.gov/agent/agentlist-category.asp* ) or specific chemical agents ( *http://www.bt.cdc.gov/chemical/* ) that are used by the federal government for regulatory and emergency planning purposes, may serve as examples of the types of agents within the scope of this rule. Select agents as defined in 42 CFR 73.1, that would suggest a terrorism event or other public health emergency, may be considered as other examples. Most in vitro diagnostic devices used to identify such agents have been developed (and more are under development) by the Centers for Disease Control and Prevention (CDC), and the Department of Defense (DOD). Some nongovernment entities are also developing such in vitro diagnostic devices. In most instances, these are the only devices available to provide timely diagnostic information on the identity of these agents, although they may not yet have been approved or cleared by FDA. Many of these devices have not yet been approved or cleared by FDA because clinical studies involving devices used for the identification of such agents frequently cannot be conducted. Studies may not be possible because natural exposure to these agents is rare or never occurs, and there may not be enough exposed subjects to enroll in a study. Studies also may not be possible because it is not ethical to expose healthy human volunteers to a life-threatening toxic substance or organism to determine the ability of the unapproved diagnostic device to correctly identify the agent. While these unapproved devices may not have been evaluated on specimens collected from human subjects, testing (procedural) validation and other analytical studies generally have been conducted (or are being conducted) by the sponsors. Some of these devices may be under clinical investigation, while others may not have reached that stage of development. For purposes of this rule we are considering the term “investigational device” to include those devices being evaluated in a clinical investigation as well as those that are undergoing preclinical and/or analytical evaluation. Given all of these facts, the agency believes that the use of these investigational diagnostic devices in limited circumstances is justified when the devices are needed to identify the causative agent in a potential public health emergency and thereby enable authorities to promptly provide appropriate care to those exposed, and to provide preventive therapies (if available) to others in the affected geographic region(s). Under FDA's regulations informed consent must be obtained before an investigational in vitro diagnostic device may be used unless an exception under part 50 (21 CFR part 50) applies. Institutional review board

(IRB)review and approval is also required, unless an exception under part 56 (21 CFR part 56) applies. Under the IRB regulations investigations may be reviewed by an IRB through a joint review process, reliance upon the review of another qualified IRB (e.g., at the research site, a central IRB, an independent or commercial IRB), or similar arrangements. (See 21 CFR 56.114.) Therefore, absent an applicable exception, investigational in vitro diagnostic devices used to identify chemical, biological, radiological, or nuclear agents in human specimens may only be used after obtaining informed consent from each subject whose specimen is tested, and with IRB review and approval. If a terrorism event (such as dissemination of *B. anthracis* spores in the mail system in 2001) or other potential public health emergency occurs (such as the multistate outbreak of monkeypox in persons exposed to pet prairie dogs in 2003), the timely identification of the etiological agent may be critical to the lives of the affected subjects as well as to the general population who may also have been exposed. The risk to subjects and others exposed could be life-threatening, and difficult to assess and address without the use of these investigational devices. Identification of the agent could be delayed significantly or precluded while the investigator seeks to obtain informed consent. Also, in some cases, storing the specimen while awaiting consent could have an adverse effect on the specimen and compromise the test results. The consequences of delay could be catastrophic for subjects and for public health in general. Consider the following possible scenario in which a terrorist event is not suspected until a public health laboratory cultures an unusual or rare organism. When a patient presents to a health care facility with symptoms suggesting a systemic microbial infection, blood and other specimens are typically collected to determine the identity of the causative organism. The clinical laboratory would determine that the specimens contain an unusual organism that cannot be identified by the tests available in that laboratory. Because many clinical laboratories do not have the capability or resources to identify unusual organisms or those to which humans are rarely exposed naturally, the organism (culture isolate) or collected specimen would be referred to a public health laboratory. The public health laboratory would use in vitro diagnostic devices, including those that are investigational, to try to identify the cultured organism or detect its presence directly in the specimen. In this scenario, the referring laboratory would not have obtained informed consent when the specimen was collected because the person directing that the specimen be collected would not have known at the time that the infecting organism could be reliably identified only by using an investigational device. To obtain informed consent would require a number of steps and introduce unacceptable delays. The public health laboratory would have to contact the referring laboratory that collected the specimen or the physician who ordered the cultures in order to locate the subject (or the subject's legally authorized representative). Once located, the subject or the subject's legally authorized representative would need to be contacted, provided the informed consent information, and given the opportunity to ask questions and sign the informed consent document. The referring laboratory or health care facility would then have to notify the public health laboratory that informed consent had been obtained. Only at that point could testing be performed. The scenario described in the previous paragraph is one example and is not the only set of circumstances in which this exception to informed consent might apply. The new exception would also apply if the event were not terrorism-related but was another type of potential public health emergency, such as sporadic outbreaks resulting from the spread of an emerging infectious agent that has the potential to cause a life-threatening situation, as in the case of Severe Acute Respiratory Syndrome

(SARS)or the potential for a pandemic influenza virus strain. This rule would not apply in a situation which is not life-threatening or where there is a cleared or approved available alternative method of diagnosis that provides an equal or greater likelihood of saving the life of the subject, such as the in vitro diagnostic devices for identifying agents causing certain known sexually transmitted diseases such as *Chlamydia trachomatis* , *Neisseria gonorrhoeae* , human papillomavirus, human immunodeficiency virus, etc. The emergency nature of the event may or may not be suspected at the time the specimen is collected, and the laboratory involved may or may not be a public health laboratory. Finally, even if the nature of the event is suspected, the person collecting the specimen may not know the investigational status of the in vitro diagnostic device and thus would not know that informed consent should be obtained from the patient. These variables are examples and are not meant to be the exclusive circumstances in which this rule might apply. The exception has been constructed in somewhat general terms because we can not anticipate the circumstances of every emergency involving a chemical, biological, radiological, or nuclear agent that may occur. The process for obtaining informed consent in the scenarios described previously would introduce dangerous delays or could compromise the effectiveness of the testing. This process would delay not only the diagnosis and possibly lifesaving treatment of the subject, but would also delay recognition of a terrorism event or other public health emergency, with serious public health consequences. To avoid potentially dangerous delays in using investigational in vitro diagnostic devices to identify these agents, FDA is creating a new limited exception, within the restrictions of section 520(g)(3)(D) of the act (21 U.S.C. 360j(g)(3)(D)), from the requirement of informed consent. The exception applies to investigational in vitro diagnostic tests used to identify agents, when a specimen is collected without the recognition that an investigational test will have to be used. II. Current Exceptions From the General Requirements for Informed Consent Two exceptions from the general requirements for informed consent are described in § 50.23. Section 50.23(a) provides that informed consent shall be deemed feasible unless, before use of the test article, both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following: The human subject is confronted by a life-threatening situation necessitating the use of the test article; informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject; time is not sufficient to obtain consent from the subject's legally authorized representative; and there is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject. An inability to communicate in the context of § 50.23(a) means that the subject is in a coma or unconscious. (See 46 FR 8942 at 8946, January 27, 1981). Section 50.23(d) states that, under 10 U.S.C. 1107(f), the President may waive the prior informed consent requirement for the administration of an investigational new drug to armed forces personnel in connection with the personnel's participation in a particular military operation. The waiver is based on a finding by the President that obtaining consent is not feasible, is contrary to the best interests of the military personnel, or is not in the interests of national security (64 FR 54180, October 5, 1999). Currently FDA is re-examining this regulation in light of the recent amendment of 10 U.S.C. 1107 by the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 which changed the criteria that may be used by the President for waiving informed consent. In addition, § 50.24 provides an exception from the informed consent requirements for emergency research. Section 50.24 is intended to permit the study of potential improvements in the treatment of life-threatening conditions where current treatment is unproven or unsatisfactory, in order to improve interventions and patient outcomes. The exception applies to limited research activities involving human subjects who are in need of emergency medical intervention, but cannot give informed consent because of their medical condition. (See 61 FR 51498 at 51499, October 2, 1996.) Section 50.24 is intended to be used in circumstances that are different than those described in this rule, i.e., planned clinical research of a specific investigational article that will be studied in a specific class of patients. The situation described in this document does not meet the requirements of the current exceptions from the general requirements for informed consent in § 50.23. It does not satisfy the requirements of § 50.23(a) because the subject may be physically able to provide informed consent. It does not satisfy the requirements of § 50.23(d) because that exception applies only to administration of investigational drugs to military personnel by DOD. In addition, Section 50.24 is generally not applicable because, in the situations addressed in that section, subjects are not able to consent because of their medical condition. In contrast, in the situations addressed in this document, it is not the condition of the subject that prevents the subject from giving informed consent, but rather the fact that, by the time it is known that the laboratory needs to use an investigational device to identify the etiological agent, the subject is physically separated from the specimen, and there is not enough time to locate the subject or the subject's legally authorized representative and obtain informed consent. III. Revisions FDA is creating a new exception from the general requirements for informed consent to address situations associated with preparing for, and responding to, chemical, biological, radiological, or nuclear terrorism or other potential public health emergencies. The exception applies when investigational in vitro diagnostic devices are used and the investigator is unable to obtain timely informed consent from subjects (or their legally authorized representatives) whose specimens are being tested. The new limited exception is applicable only when it is not feasible to obtain informed consent because, at the time the specimen is collected, it may not be known that an investigational device would need to be used on that specimen, and delay in diagnosis could be life-threatening to the subject. This exception is contingent on several determinations that must be made before using the investigational device, and later certified in writing, by both the investigator and, if time permits, by a physician who is not otherwise participating in the clinical investigation. These determinations are: • The human subject is confronted with a life-threatening situation necessitating the use of the investigational in vitro diagnostic device; • Informed consent cannot be obtained from the subject because: 1. There was no reasonable way for the person directing that the specimen be collected to know at the time the specimen was collected, that there would be a need to use the investigational device on that specimen and; 2. Time is not sufficient to obtain consent from the subject without risking the life of the subject; • Time is not sufficient to obtain consent from the subject's legally authorized representative; and • There is no available alternative approved or cleared method of diagnosis to identify the chemical, biological, radiological, or nuclear agent that provides an equal or greater likelihood of saving the life of the subject. Under this interim final rule, the investigator has 5 working days after using the investigational device to submit to the IRB these determinations as well as the review and evaluation of an independent licensed physician. However, if, in the opinion of the investigator, there is not sufficient time to obtain the determination of an independent licensed physician in advance of using the investigational device, the independent physician is required to review and evaluate the determinations of the investigator and the investigator is required to submit this documentation to the IRB within 5 working days after using the device. Until the investigational in vitro diagnostic device is used, it will not be known whether there has been actual exposure to a chemical, biological, radiological, or nuclear agent and whether that agent is life-threatening. Nonetheless, FDA believes the possibility of such exposure itself represents a life-threatening situation for the subject because, until the investigational in vitro diagnostic device is used, it is unknown to what agent, if any, the subject has been exposed or how the subject should be treated. FDA expects that in accordance with routine clinical practice, the investigator will provide the test results obtained using the investigational in vitro diagnostic device to the subject's health care provider and that the results will be used in the clinical management of the human subject. It is possible that, in certain circumstances, the test results will also be reported to the appropriate public health authorities. This reporting will occur when appropriate and/or required by State or Federal law. Under the regulation, at the time the result of the test is reported (whether to the subject's health care provider and/or to the appropriate public health officials), the investigator is required to disclose the investigational status of the device used to perform the diagnostic test. The investigator is also responsible for providing the IRB with the information required in § 50.25, the elements of informed consent, and the procedures that will be used to provide this information to each subject or to the subject's legally authorized representative. Section 50.25(a) requires that the following information be provided to each subject: • A statement that the study involves research and an explanation of its purposes and the expected duration of the subject's participation; • A description of the procedures to be followed, and identification of any procedures which are experimental; • A description of any reasonably foreseeable risks or discomforts to the subject; • A description of any benefits to the subject or others which may be reasonably expected from the research; • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; • A statement of the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that FDA may inspect the records; • For more than minimal risk research, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; and • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject. Section 50.25(b) requires this additional information when it is appropriate: • A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; • Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; • Any additional costs to the subject that may result from participation in the research; • The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; • A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation; and • The approximate number of subjects involved in the study. This information will be provided at the time the test results are sent to the subject's health care provider and to public health authorities, if public health reporting is required by Federal, State, or local law. In this rule, we are requiring investigators to provide all information described in § 50.25 except the information in § 50.25(a)(8) concerning voluntary participation. Normally under the regulations subjects voluntarily agree to participate in research before the research begins. In the circumstances covered by this rule, an individual provides a specimen for diagnostic testing without the knowledge of either the patient or the physician that an investigational in vitro diagnostic

(IVD)will be necessary. When the investigational IVD is used at a setting remote from the patient and treating physician in this case, it is not practicable (because of the time and distance involved to contact the patient or the patient's legally authorized representative) to obtain consent for the use of the device. Under this rule, by the time the patient is informed that an investigational device has been used to test his/her specimen, the investigation is already underway, and the time at which a subject would normally consent to voluntary participation has past. Therefore, the investigator is not responsible for providing the information described in § 50.25(a)(8) concerning voluntary participation. In addition, subjects or their legally authorized representatives will not be entitled to withdraw previously collected data from the research database, because it is critical that FDA obtain and have available for review all data on the investigational in vitro diagnostic device's use in order to determine whether it is safe and effective. As a result, it is the responsibility of the IRB to ensure the adequacy of the information required in § 50.25 (except for the requirements under § 50.25(a)(8)) concerning voluntary participation) and to ensure that procedures for providing this information to the subject or the subject's legally authorized representative are in place. The IRB is responsible for this even if an exception under § 56.104(c) exists under which the emergency use of the test article would be reported to the IRB within 5 working days. We recognize that, in this situation, the IRB may be delayed in assuring that these procedures are in place. IV. Applicability of 45 CFR Part 46 and Other Legal Requirements According to the Office for Human Research Protection

(OHRP)in the Department of Health and Human Services (HHS), some of the activities described in this rule may also constitute non-exempt human subjects research within the meaning of 45 CFR part 46. In particular, the use of the investigational in vitro diagnostic device on individually identifiable human specimens as described in this rule would not be human subjects research under 45 CFR part 46, while the analysis of the individually identifiable data obtained from the use of the investigational device to determine the safety and effectiveness of the device would be considered human subject research under 45 CFR part 46. If the analysis of individually identifiable data involves non-exempt human subjects research that is conducted or supported by HHS, the institution conducting the analysis must obtain an OHRP-approved assurance. In addition, this means that this research activity, if not exempt, i.e., the analysis of the individually identifiable data, must be reviewed prospectively by an IRB and must be conducted with the informed consent of the subjects unless waived. OHRP expects that IRBs will often find that informed consent may be waived under 45 CFR 46.116(d) for the analysis of the individually identifiable data obtained through the use of the investigational device. OHRP is issuing guidance regarding this issue simultaneously with the publication of this interim final rule which can be found at *http://www.hhs.gov/ohrp/policy/index.html* . Those interested in seeking additional information concerning the application of the regulations at 45 CFR part 46 should contact OHRP. We note that research conducted or supported by another department or agency may be subject to other laws and regulations. Sponsors should check to see if they are complying with all applicable requirements. V. Legal Authority FDA believes the statutory authority provided in section 520(g)(3)(D) of the act permits this limited exception to obtaining informed consent for the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents in potential terrorism events or other potential public health emergencies. Section 520(g)(3)(D) of the act specifically states when an exception from informed consent is permissible. Under section 520(g)(3)(D) of the act, informed consent is required unless the investigator determines the following in writing:

(1)There exists a life threatening situation involving the human subject of such testing which necessitates the use of such device;

(2)it is not feasible to obtain informed consent from the subject; and

(3)there is not sufficient time to obtain such consent from the subject's legally authorized representative. Further, a licensed physician uninvolved in the testing must agree with this three-part determination in advance of using the device unless use of the device is required to save the life of the human subject of such testing, and there is not sufficient time to obtain such concurrence. As noted earlier, FDA believes that, if the presence of an agent is suspected, there exists a life-threatening situation for the subjects whose specimens have been sent to laboratories. Until the laboratory identifies the agent to which the subject has been exposed or by which the subject has been infected, specific treatment cannot be provided. However, this limited exception applies only if it is also not feasible to obtain informed consent because there is an inability to communicate, in a timely manner, with the subject or the subject's legally authorized representative, and there was no reasonable way to know, at the time the specimen was collected, that there would be a need to use the investigational device on that specimen. In such a situation, the act would permit a limited exception to obtaining informed consent. In accordance with section 521 of the act (21 U.S.C. 360k), state or local requirements that are different from, or in addition to, the requirements in this rule are expressly preempted. This rule establishes a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. Consequently, State and local laws that require that informed consent be obtained in those situations are preempted. VI. Issuance of an Interim Final Rule and Effective Date FDA is proceeding without notice and comment rulemaking because the Nation needs to have this regulation in place immediately to be prepared to deal effectively with a terrorism event or other potential public health emergency. Under the provisions of the Administrative Procedure Act at 5 U.S.C. 553(b)(B), FDA finds for good cause that prior notice and comment on this rule are impracticable and contrary to the public interest. The absence of this exception was an impediment to the most efficient and effective public health response to the SARS outbreak. We do not want the absence of such an exception to be an impediment to our response to an outbreak of Avian flu or some other public health emergency. It is critical that FDA act quickly now to ensure that, in the future, individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent have the benefit of the timely use of the most appropriate diagnostic devices, including those that are investigational. For the same reasons, the agency is making this interim final rule effective as of the date of publication. VII. Environmental Impact The agency has determined under 21 CFR 25.30(h) that this interim final rule 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. VIII. Analysis of Impacts FDA has examined the impacts of this interim final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, the rule is not an economically significant regulatory action as defined by the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this interim final rule provides an exception from an otherwise applicable requirement for investigators, FDA believes that it does not impose a significant burden. The agency therefore certifies that this rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $115 million, using the most current

(2003)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this interim final rule to result in any 1-year expenditure that would meet or exceed this amount. IX. Paperwork Reduction Act of 1995 This interim final rule contains information collection provisions that are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The information collection requirements for this interim final rule have been approved under the emergency processing provisions of the PRA. The assigned OMB approval number for this collection of information is 0910-0586. This approval expires on November 30, 2006. A description of these provisions is given in the following paragraphs with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. FDA invites comments on the following topics:

(1)Whether the collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility:

(2)the accuracy of FDA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Medical Devices: Informed Consent: Investigational In Vitro Diagnostic Device To Identify a Chemical, Biological, Radiological, or Nuclear Threat Agent *Description* : This interim final rule amends FDA's informed consent regulation to provide an exception from the general requirement to obtain informed consent from the subject of an investigation involving an unapproved or not cleared in vitro diagnostic device intended to identify a chemical, biological, radiological, or nuclear agent. For the exception to apply, it is necessary for the investigator and an independent licensed physician to make the determination and certify in writing certain facts concerning the need for use of the investigational in vitro diagnostic device without informed consent. The investigator submits this written certification to the IRB. When reporting the test results to the subject's health care provider and, possibly, to the appropriate public health authorities, the investigator must disclose the investigational status of the in vitro diagnostic device. The investigator must also provide the IRB with the information required in § 50.25 and the procedures that will be used to provide this information to each subject or the subject's legally authorized representative at the time the test results are provided to the subject's health care provider and possibly to the public health authorities. *Description of Respondents* : Clinical laboratories, physicians. FDA estimates the burden of the collection of information as follows: **Table 1.—Estimated Average Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 50.23(e)(1) and (e)(2) 150 3 450 2 900 50.23(e)(4) 150 3 450 1 450 Total Hours 1,350 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA is adding § 50.23(e)(1) to provide an exception to the general rule that informed consent is required for the use of an investigational in vitro diagnostic device for the purpose of preparing for and responding to a chemical, biological, radiological, or nuclear terrorism event or other public health emergency, if the investigator and an independent licensed physician make the determination and later certify in writing that:

(1)There is a life-threatening situation necessitating the use of the investigational device;

(2)obtaining informed consent from the subject is not feasible because there was no way to predict the need to use the investigational device when the specimen was collected, and there is not sufficient time to obtain consent from the subject or the subject's legally authorized representative; and

(3)no satisfactory alternative device is available. Under this interim final rule these determinations are made before the device is used, and the written certifications are made within 5 working days after the use of the device. If use of the device is necessary to preserve the life of the subject and there is not sufficient time to obtain the determination of the independent licensed physician in advance of using the investigational device, § 50.23(e)(2) provides that the certifications must be made within 5 working days of use of the device. In either case, the certifications are submitted to the IRB within 5 working days of the use of the device. From its knowledge of the industry, FDA estimates that there are approximately 150 laboratories that could perform this type of testing. FDA estimates that in the United States each year there are approximately 450 naturally occurring cases of diseases or conditions that are identified in CDC's list of category ‘A’ biological threat agents. The number of cases that would result from a terrorist event or other public health emergency is uncertain. Based on its knowledge of similar types of submissions, FDA estimates that it will take about 2 hours to prepare each certification. Section 50.23(e)(4) provides that an investigator must disclose the investigational status of the device and what is known about the performance characteristics of the device at the time test results are reported to the subject's health care provider and public health authorities. Under this interim final rule, the investigator provides the IRB with the information required by § 50.25 and the procedures that will be used to provide this information to each subject or the subject's legally authorized representative. Based on its knowledge of similar types of submissions, FDA estimates that it will take about 1 hour to prepare this information and submit it to the health care provider and, where appropriate, to public health authorities. X. Federalism FDA has analyzed this interim final rule in accordance with the principles set forth in Executive Order 13132 on Federalism (64 FR 43255, August 10, 1999). FDA has concluded that the rule raises federalism implications because, in accordance with section 521 of the act, this rule preempts State and local laws that require that informed consent be obtained before an investigational in vitro diagnostic device may be used to identify a chemical, biological, radiological, or nuclear agent in suspected terrorism events and other potential public health emergencies that are different from, or in addition to, the requirements of this regulation. In accordance with the Executive order, preemption of State law is restricted to the minimum level necessary to achieve the objective of the statute to protect the public health by ensuring that individuals who may have been exposed to such an agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. Also in accordance with the Executive order, officials at FDA consulted with the States on the effect of this rule on State law. The new exception from informed consent is available in a very narrowly defined set of circumstances. Under these circumstances, a specimen already would have been taken from the individual. The individual would not be subjected to any further specimen collection or other procedure in order for the investigational device to be used on the specimen. In addition, in the circumstances in which the exception would apply, it is not only the health of the individual from whom the specimen was taken that would be at risk. It is possible that other people, perhaps many other people, would have been exposed to the chemical, biological, radiological, or nuclear agent as well. In conclusion, the agency believes that it has complied with all of the applicable requirements under Executive Order 13132 and has determined that this final rule is consistent with the Executive order. XI. Civil Justice Reform This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988. XII. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this interim final rule. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects in 21 CFR Part 50 Human research subjects, Prisoners, Reporting and recordkeeping requirements, Safety. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 50 is amended as follows: PART 50—PROTECTION OF HUMAN SUBJECTS 1. The authority citation for 21 CFR part 50 continues to read as follows: Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n. 2. Section 50.23 is amended by adding paragraph

(e)to read as follows: § 50.23 Exception from general requirements. (e)(1) Obtaining informed consent for investigational in vitro diagnostic devices used to identify chemical, biological, radiological, or nuclear agents will be deemed feasible unless, before use of the test article, both the investigator (e.g., clinical laboratory director or other responsible individual) and a physician who is not otherwise participating in the clinical investigation make the determinations and later certify in writing all of the following:

(i)The human subject is confronted by a life-threatening situation necessitating the use of the investigational in vitro diagnostic device to identify a chemical, biological, radiological, or nuclear agent that would suggest a terrorism event or other public health emergency.

(ii)Informed consent cannot be obtained from the subject because:

(A)There was no reasonable way for the person directing that the specimen be collected to know, at the time the specimen was collected, that there would be a need to use the investigational in vitro diagnostic device on that subject's specimen; and

(B)Time is not sufficient to obtain consent from the subject without risking the life of the subject.

(iii)Time is not sufficient to obtain consent from the subject's legally authorized representative.

(iv)There is no cleared or approved available alternative method of diagnosis, to identify the chemical, biological, radiological, or nuclear agent that provides an equal or greater likelihood of saving the life of the subject.

(2)If use of the investigational device is, in the opinion of the investigator (e.g., clinical laboratory director or other responsible person), required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required in paragraph (e)(1) of this section in advance of using the investigational device, the determinations of the investigator shall be made and, within 5 working days after the use of the device, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.

(3)The investigator must submit the documentation required in paragraph (e)(1) or (e)(2) of this section to the IRB within 5 working days after the use of the device.

(4)An investigator must disclose the investigational status of the in vitro diagnostic device and what is known about the performance characteristics of the device in the report to the subject's health care provider and in any report to public health authorities. The investigator must provide the IRB with the information required in § 50.25 (except for the information described in § 50.25(a)(8)) and the procedures that will be used to provide this information to each subject or the subject's legally authorized representative at the time the test results are provided to the subject's health care provider and public health authorities.

(5)The IRB is responsible for ensuring the adequacy of the information required in section 50.25 (except for the information described in § 50.25(a)(8)) and for ensuring that procedures are in place to provide this information to each subject or the subject's legally authorized representative.

(6)No State or political subdivision of a State may establish or continue in effect any law, rule, regulation or other requirement that informed consent be obtained before an investigational in vitro diagnostic device may be used to identify chemical, biological, radiological, or nuclear agent in suspected terrorism events and other potential public health emergencies that is different from, or in addition to, the requirements of this regulation. Dated: May 31, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8790 Filed 6-6-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 874 [Docket No. 2006N-0182] Medical Devices; Ear, Nose, and Throat Devices; Classification of Olfactory Test Device AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is classifying the olfactory test device into class II (special controls). The special control that will apply to the device is the guidance document entitled “Class II Special Controls Guidance Document: Olfactory Test Device.” The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of the guidance document that is the special control for the device. DATES: This final rule becomes effective July 7, 2006. The classification was effective March 27, 2006. FOR FURTHER INFORMATION CONTACT: Eric A. Mann, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2080. SUPPLEMENTARY INFORMATION: I. What is the Background of This Rulemaking? In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976 (the amendments), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless the device is classified or reclassified into class I or class II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the **Federal Register** announcing such classification (section 513(f)(2) of the act). In accordance with section 513(f)(1) of the act, FDA issued an order on May 27, 2004, classifying the HealthCheck TM Home Test for Loss of the Sense of Smell into class III, because it was not substantially equivalent to a class I or class II device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On July 28, 2004, FMG Innovations, Inc., submitted a request for classification of the HealthCheck TM Home Test for Loss of the Sense of Smell under section 513(f)(2) of the act (Ref. 1). The manufacturer recommended that the device be classified into class I. In accordance with section 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the act. In general, devices are to be classified into class I if general controls, by themselves are sufficient to provide reasonable assurance of safety and effectiveness. Devices are to be classified into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the HealthCheck TM Home Test for Loss of the Sense of Smell should be classified into class II with the establishment of special controls. FDA believes that special controls, in addition to general controls, are necessary to provide reasonable assurance of safety and effectiveness of the device, and there is sufficient information to establish special controls to provide such assurance. The device is assigned the generic name “olfactory test device,” and it is identified as a device used to determine whether a loss of olfactory function is present. The device includes one or more odorants that are presented to the patient's nose to subjectively assess olfactory function (i.e., the patient's ability to perceive odors). This device is not intended for the screening or diagnosis of diseases or conditions other than the loss of olfactory function. FDA has identified the risks to health associated with this type of device as failure to detect olfactory sensory loss and user error. FDA believes that the class II special controls guidance document will aid in mitigating the potential risks to health by providing recommendations for the validation of performance characteristics and labeling. FDA believes that the special controls guidance document, in addition to general controls, addresses the risks to health identified previously and provides reasonable assurance of the safety and effectiveness of the device. Therefore, on March 27, 2006, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying this classification at § 874.1600. Following the effective date of the final classification rule, manufacturers will need to address the issues covered in this special control guidance. However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is not necessary to assure the safety and effectiveness of olfactory test devices when intended to determine whether an olfactory loss is present. II. What Is the Environmental Impact of This Rule? The agency has determined under 21 CFR 25.34(b) 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. III. What Is the Economic Impact of This Rule? FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because classification of this device into class II will relieve manufacturers of the cost of complying with the premarket approval requirements of section 515 of the act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ``any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $115 million, using the most current

(2003)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. IV. Does This Final Rule Have Federalism Implications? FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. V. How Does This Rule Comply with the Paperwork Reduction Act of 1995? This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995

(PRA)is not required. FDA concludes that the special controls guidance document contains information collection provisions that are subject to review and clearance by OMB under the PRA. Elsewhere in this issue of the **Federal Register** , FDA is publishing a notice announcing the availability of the guidance document entitled “Class II Special Controls Guidance Document Olfactory Test Device.” The notice contains an analysis of the paperwork burden for the guidance. VI. What References are on Display? The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Petition from FMG Innovations, Inc., for classification of the HealthCheck TM Home Test for Loss of the Sense of Smell submitted July 28, 2004. List of Subjects in 21 CFR Part 874 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 874 is amended as follows: PART 874—EAR, NOSE, AND THROAT DEVICES 1. The authority citation for 21 CFR part 874 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Add § 874.1600 to subpart B to read as follows: § 874.1600 Olfactory test device.

(a)*Identification* . An olfactory test device is used to determine whether an olfactory loss is present. The device includes one or more odorants that are presented to the patient's nose to subjectively assess the patient's ability to perceive odors.

(b)*Classification* . Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Olfactory Test Device.” For the availability of this guidance document, see § 874.1(e). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. When indicated for the screening or diagnosis of diseases or conditions other than the loss of olfactory function, the device is not exempt from premarket notification procedures. Dated: May 24, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-8791 Filed 6-6-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [CGD05-06-015] RIN 1625-AA08 Special Local Regulations for Marine Events; Onslow Bay, Beaufort Inlet, Morehead City State Port, Beaufort Harbor and Taylor Creek, NC AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing special local regulations during the “Pepsi Americas’ Sail 2006”, tall ships parade and race to be held on Onslow Bay, Beaufort Inlet, inland waters of the Morehead City State Port and Beaufort Waterfront. This special local regulation is necessary to provide for the safety of life on navigable waters during the event. This action is intended to restrict vessel traffic in segments of coastal North Carolina in the vicinity of Onslow Bay, Beaufort Inlet, inland waters of Morehead City State Port and Beaufort Harbor during the parade of sail and tall ship race. DATES: This rule is effective from July 1, 2006 through July 5, 2006. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, are part of docket (CGD05-06-015) and are available for inspection or copying at Commander (dpi), Fifth Coast Guard District, 431 Crawford Street, Portsmouth, Virginia 23704-5004, Room 119, between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: CWO C.D. Humphrey, U.S. Coast Guard Sector North Carolina, at

(252)247-4525. SUPPLEMENTARY INFORMATION: Regulatory Information On March 22, 2006, we published a notice of proposed rulemaking

(NPRM)entitled Special Local Regulations for Marine Events; Onslow Bay, Beaufort Inlet, Morehead City State Port, Beaufort Harbor and Taylor Creek, NC in the **Federal Register** (71 FR 14428). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. Background and Purpose During the period 30 June to July 5, 2006, Pepsi Americas' Sail 2006 LLC will host the North Carolina port call of the “Pepsi Americas” Sail 2006”. A parade of sails and tall ships racing event are planned during this period to be conducted on the waters adjacent to Onslow Bay, Beaufort Inlet and the inland waters of Morehead City State Port and Beaufort Harbor, North Carolina. The first event will be the “Tall Ships Parade of Sails” on July 1, 2006 that will commence in Anchorage Area “ALFA” as depicted on NOAA Chart 11545 “Beaufort Inlet and Part of Core Sound”, and will enter Beaufort Inlet Channel at Beaufort Inlet Channel Lighted Buoy 7 and Beaufort Inlet Channel Lighted Buoy 8, and will proceed inbound to the Morehead City State Port turning basin thence to Beaufort Harbor Channel to Beaufort Harbor waterfront. The second event will be the “Tall Ships Race”, on July 3, 2006 that will take place on Onslow Bay from Beaufort Inlet Channel and continuing west approximately 11 nautical miles to a line drawn along longitude 076-54′ W. Because of the danger posed by numerous sailing vessels maneuvering in close proximity of each other during the proposed parade and race, special local regulations are necessary. For the safety concerns noted and to address the need for vessel control and vessel security, 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 specified waters of Onslow Bay, Beaufort Inlet, Morehead City State Port, Beaufort Harbor and Taylor Creek, North Carolina. Regulatory Evaluation This temporary 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 temporary regulation will prevent traffic from transiting a segment of the Onslow Bay, Beaufort Inlet, Morehead City State Port and Beaufort Harbor during these events, the effect of this regulation will not be significant due to the limited duration that the regulated area will be enforced. Extensive advance notifications will be made to the maritime community via Local Notice to Mariners, marine information broadcasts, area newspapers and local radio stations, 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 temporary 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 temporary rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit these sections of the Onslow Bay, Beaufort Inlet, Morehead City State Port, Beaufort Harbor Channel and Taylor Creek during these events. This temporary rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would be in effect for only a limited period. Although the regulated area will apply to two separate segments within and around the waters of Onslow Bay, Beaufort Inlet, Morehead City State Port and Beaufort Harbor, traffic may be allowed to pass through the regulated areas with the permission of the Coast Guard Patrol Commander. In the case where the Patrol Commander authorizes passage through a regulated area during an event, vessels shall proceed at the minimum speed necessary to maintain a safe course that minimizes wake near the event. Although this regulation prevents traffic from transiting the Onslow Bay, Beaufort Inlet, Morehead City State port and Beaufort Harbor Bay during these event, the effect of this regulation will not be significant because of its limited duration. Before the enforcement period, the Coast Guard will issue maritime advisories so mariners can adjust their plans accordingly. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this temporary 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. Collection of Information This temporary 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 temporary 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 temporary 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 temporary rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children. Indian Tribal Governments This temporary rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this temporary 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 temporary rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969

(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine parade 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 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; Department of Homeland Security Delegation No. 0170.1. 2. Add a temporary *§ 100.35-T06-015* to read as follows: § 100.35-T06-015 Onslow Bay, Beaufort Inlet, Morehead City State Port, Beaufort Harbor and Taylor Creek near Morehead City NC.

(a)*Regulated area* includes two segments within and around the waters of the Onslow Bay, Beaufort Inlet, Morehead City Turning Basin, Beaufort Harbor and Taylor Creek North Carolina.

(1)The first segment for the “Parade of Sail” is bounded by a line drawn from a position at latitude 34°39′36″ N, longitude 076°37′52″ W, thence southerly to a position at latitude 34°37′52″ N, longitude 076°37′52″ W, thence westerly to a position at latitude 34°37′36″ N, longitude 076°40′17″ W, thence southerly to a position at latitude 34°36′50″ N, longitude 076°40′42″ W, thence westerly to a position at latitude 34°36′57″ N, longitude 076°41′25″ W, thence northerly parallel to Beaufort Inlet Channel to latitude 34°40′37″ N, longitude 076°40′32″ W, thence northeasterly to latitude 34°41′21″ N longitude 076°40′11″ W, thence northwesterly parallel to Cutoff Channel to latitude 34°41′43″ N, longitude 076°40′21″ W, thence northwesterly parallel to Morehead City Channel to latitude 34°42′46″ N, longitude 076°42′02″ W, thence westerly to latitude 34°42′46″ N, longitude 076°42′12″ W, thence northerly to latitude 34°42′54″ N, longitude 076°42′13″ W, thence easterly along Morehead City State Port berth seven, six, five and four to latitude 34°42′52″ N, longitude 076°41′33″ W, thence southeasterly to latitude 34°42′35″ N, longitude 076°41′20″ W, thence southeasterly parallel to Morehead City Channel to latitude 34°42′19″ N, longitude 076°40′49″ W at the entrance to Beaufort Harbor Channel, thence along the western bank of Beaufort Harbor Channel to latitude 34°42′54″ W, longitude 076°40′44″ W, thence easterly to the southern tip of Pivers Island, latitude 34°42′54″ N, longitude 076°40′24″ W, thence northerly along the shoreline of Pivers Island to latitude 34°43′08″ N, longitude 076°40′19″ W, thence northerly to intersection of the Beaufort Bascule Bridge and the shoreline at latitude 34°43′21″ N, longitude 076°40′12″ W, thence northerly along the shoreline to latitude 34°43′38″ N, longitude 076°40′17″ W, thence northwesterly to latitude 34°43′47″ N longitude 076°40′22″ W, thence northeasterly to latitude 34°43′55″ N, longitude 076°40′15″ W, thence southerly along then shoreline to latitude 34°43′42″ N, longitude 076°40′04″ W, thence southerly parallel to Gallants Channel to the intersection of the Beaufort Bascule Bridge and the shoreline at latitude 34°43′21″ N, longitude 076°40′05″ W, thence southerly to Beaufort Waterfront at latitude 34°43′07″ N, longitude 076°40′10″ W, thence southeasterly along Beaufort waterfront to latitude 34°42′57″ N, longitude 076°39′55″ W, thence south to Carrot Island latitude 34°42′45″ N, longitude 076°39′55″ W, thence westerly following the shore line of Carrot Island to latitude 34°42′31″ W, longitude 076°40′44″ W, thence southeasterly to latitude 34°41′50″ N, longitude 076°40′08″ W, thence southerly to the western tip of Shackleford Banks at latitude 34°41′18″ N, longitude 076°39′57″ W, thence southerly to latitude 34°40′30″ N, longitude 076°39′50″ W, thence southerly parallel to Beaufort Inlet Channel to latitude 34°39′35″ N, longitude 076°40′00″ W, thence east to the point of origin.

(2)The second segment for the “Tall Ships Race” is bounded by a line drawn from a position at latitude 34°40′36″ N, longitude 076°41′00″ W, thence westerly parallel to Bogue Banks to latitude 34°40′21″ N, longitude 076°52′12″ W, thence southwesterly to latitude 34°39′00″ N 076°53′06″ W, thence southeasterly to latitude 34°33′18″ N, longitude 076°42′33″ W, thence northeasterly to latitude 34°34′18″ N, longitude 076°41′27″ W, thence northerly to the point of origin.

(3)All coordinates reference Datum NAD 1983.

(b)*Definitions.*

(1)Coast Guard Patrol Commander means any commissioned, warrant, or petty officer of the Coast Guard who has been designated by the Commander, Coast Guard Sector North Carolina.

(2)Official Patrol means any person or vessel authorized by the Coast Guard Patrol Commander or approved by Commander, Coast Guard Sector North Carolina.

(3)Participant includes all vessels participating in the Pepsi Americas' Sail 2006 under the auspices of the Marine Event Permit issued to the event sponsor and approved by Commander, Coast Guard Sector North Carolina.

(c)*Special local regulations.*

(1)Except for the Official Patrol, participants, and persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area.

(2)Any person in the regulated area must stop immediately when directed to do so by any Official Patrol and then proceed only as directed.

(3)The operator of any vessel in the regulated area must stop the vessel immediately when directed to do so by any Official Patrol and then proceed only as directed.

(4)All persons and vessels shall comply with the instructions of the Official Patrol.

(5)When authorized to transit within the regulated area, all vessels shall proceed at the minimum speed necessary to maintain a safe course that minimizes wake near the parade, race course and near other persons and vessels.

(d)*Enforcement period.* This section will be enforced from 6:30 a.m. to 1 p.m. on July 1, 2006, for the “Parade of Sails”; and from 10:30 a.m. to 5:30 p.m. on July 3, 2006 for the “Tall Ships Race”. If the “Tall Ships Race” is postponed due to inclement weather, then these temporary special local regulations will be enforced the same time period during one of the next two days, July 4, 2006 through July 5, 2006. Dated: May 19, 2006. Larry L. Hereth, Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District. [FR Doc. E6-8857 Filed 6-6-06; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD09-06-027] Safety Zone: Captain of the Port Detroit Zone AGENCY: Coast Guard, DHS. ACTION: Notice of Implementation of final rule. SUMMARY: The Coast Guard is implementing safety zones for annual fireworks displays in the Captain of the Port Detroit Zone during June 2006. This action is necessary to provide for the safety of life and property on navigable waters during these events. These safety zones will restrict vessel traffic from a portion of the Captain of the Port Detroit Zone. DATES: The safety zones will be effective from 12:01 a.m. (local) on June 7, 2006 to 11:59 p.m. (local) on June 30, 2006. FOR FURTHER INFORMATION CONTACT: LTJG Cynthia Channell, Chief of Waterways Management, Sector Detroit, 110 Mt. Elliott Ave., Detroit, MI at

(313)568-9580. SUPPLEMENTARY INFORMATION: The Coast Guard is implementing certain permanent safety zones in 33 CFR 165.907 (published May 21, 2001, in the **Federal Register** , 66 FR 27868), for fireworks displays in the Captain of the Port Detroit Zone during June 2006. The following safety zones will be enforced during the times indicated below:

(1)*Bay-Rama Fishfly Festival,* New Baltimore, MI. Location: All waters off New Baltimore City Park, Lake St. Clair-Anchor Bay bounded by the arc of a circle with a 300-yard radius with its center located at approximate position 42°41′ N, 082°44′ W, on June 22, 2006, from 9 p.m. to 11 p.m.

(2)*St. Clair Shores Fireworks,* St. Clair Shores, MI. Location: All waters of Lake St. Clair within a 300-yard radius of the fireworks barge in approximate position 42°32′ N, 082°51′ W, about 1000 yards east of Veterans Memorial Park (off Masonic Rd.), St. Clair Shores, MI on June 30, 2006, from 10:00 p.m. to 10:30 p.m.

(3)*Sigma Gamma Assoc.,* Grosse Pointe Farms, MI. Location: The waters off Ford's Cove, Lake St. Clair bounded by the arc of a circle with a 300-yard radius with its center in approximate position 42°27′ N, 082°52′ W on June 26, 2003 from 9 p.m. to 11 p.m. In order to ensure the safety of spectators and transiting vessels, these safety zones will be in effect for the duration of the events. In the event that these safety zones affect shipping, commercial vessels may request permission from the Captain of the Port Detroit to transit through the safety zone. Requests must be made in advance and approved by the Captain of Port before transits will be authorized. The Captain of the Port may be contacted via U.S. Coast Guard Group Detroit on channel 16, VHF-FM. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect. Dated: May 18, 2006. P. W. Brennan, Captain, U.S. Coast Guard, Captain of the Port Detroit. [FR Doc. E6-8783 Filed 6-6-06; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [COTP Charleston 06-003] RIN 1625-AA00 Safety Zone; Cooper River, Hog Island Channel, Charleston SC AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: The Coast Guard is removing one of two duplicate temporary rules that establish safety zones on the navigable waters of Hog Island Reach on the Cooper River, for demolition of the Grace Memorial and Silas Pearman Bridges and associated recovery operations. DATES: This rule is effective June 7, 2006. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket are part of docket [COTP Charleston 06-003] and are available for inspection or copying at Coast Guard Sector Charleston (WWM), 196 Tradd Street, Charleston, South Carolina 29401 between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Chief Warrant Officer James J. McHugh, Sector Charleston Office of Waterways Management, at

(843)724-7647. SUPPLEMENTARY INFORMATION: On January 19, 2006, we published a temporary final rule that created a temporary safety zone around the Grace Memorial and Silas Pearman Bridges on Hog Island Reach. (71 FR 3005) This safety zone includes all waters within the area bounded by the following coordinates: 32°48.566′ N, 079°55.211′ W to 32°48.389′ N, 079°54.256′ W to 32°47.824′ N, 079°54.401′ W thence to 32°47.994′ N, 079°55.359′ W. Due to an administrative error, we published a second temporary safety zone for this location on May 25, 2006, at 71 FR 30062. This second temporary final rule has the same section number and establishes a safety zone at the same coordinates as the temporary final rule that published in January; however it has a different effective date and a slightly different title. In order to avoid confusion and maintain the January effective date of the safe zone, we are removing the second temporary rule that published on May 25, 2006, at 71 FR 30062 and is entitled “Safety Zone; Cooper River, Hog Island Channel, Charleston, SC.” 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. This rule is not a significant regulatory action because it removes a second temporary final rule has the same section number and establishes a safety zone at the same coordinates as the temporary final rule that published in January. 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, because it removes one of two duplicate temporary rules that establish safety zones on the navigable waters of Hog Island Reach on the Cooper River, for demolition of the Grace Memorial and Silas Pearman Bridges and associated recovery operations. 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 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. Under figure 2-1, paragraph (34)(g), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule, because this rule removes a duplicate temporary rule from the Code of Federal Regulations. 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, subpart C 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. § 165.T07-003 [Removed] 2. Remove § 165.T07-003 entitled “Safety Zone, Hog Island Channel, Grace Memorial and Silas Pearman Bridges, Charleston, SC.” Dated: May 31, 2006. Stefan G. Venckus, Chief, Office of Regulations and Administrative Law, United States Coast Guard. [FR Doc. E6-8853 Filed 6-6-06; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 82 [EPA-HQ-OA-2005-0131; FRL-8181-2] Protection of Stratospheric Ozone: Recordkeeping and Reporting Requirements for the Import of Halon-1301 Aircraft Fire Extinguishing Vessels AGENCY: Environmental Protection Agency (EPA). ACTION: Withdrawal of direct final rule. SUMMARY: In response to adverse comment, EPA is withdrawing the direct final rule published in the **Federal Register** on April 11, 2006 (71 FR 18219). This direct final rule sought to exempt importers of aircraft fire extinguishing vessels containing halon-1301 (“aircraft halon bottles”) from the import petition process in order to facilitate the routine hydrostatic testing of these bottles for environmental and safety purposes. In the direct final rule, the Agency indicated that should we receive adverse comment by May 11, 2006, we would publish a timely withdrawal notice in the **Federal Register** . We received adverse comment on the direct final rule from one commenter and we will address this comment in a subsequent final action based on the parallel proposal also published on April 11, 2006 (71 FR 18259). As stated in the parallel proposal, we will not institute a second comment period on this action. DATES: Effective June 7, 2006, EPA withdraws the direct final rule published at 71 FR 18219 on April 11, 2006. ADDRESSES: EPA has established a docket for this action under Docket ID No. OAR 2005-0131. All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, *e.g.* , CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http:// www.regulations.gov* or in hard copy at the Air Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. This docket facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is

(202)566-1744, and the telephone number for the Air Docket is

(202)566-1742. FOR FURTHER INFORMATION CONTACT: For further information about this action, contact Hodayah Finman by telephone at

(202)343-9246, or by e-mail at *finman.hodayah@epa.gov* , or by mail at Hodayah Finman, U.S. Environmental Protection Agency, Stratospheric Protection Division (6205J), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Overnight or courier deliveries should be sent to 1310 L St., NW., Room 827M, Washington, DC 20005; att: Hodayah Finman. You may also visit the Ozone Depletion web site of EPA's Stratospheric Protection Division at *http://www.epa.gov/ozone/index.html* for further information about EPA's Stratospheric Ozone Protection regulations, the science of ozone layer depletion, and other topics. List of Subjects in 40 CFR Part 82 Environmental protection, Chemicals, Halon, Ozone, Reporting and recordkeeping requirements, Treaties. Dated: June 1, 2006 William L. Wehrum, Acting Assistant Administrator for the Office of Air and Radiation. [FR Doc. E6-8831 Filed 6-6-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0297; FRL-8061-4] Fenarimol; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for residues of fenarimol in or on filbert. Interregional Research Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). Fenarimol was reassessed and approved by the Agency effective August 1, 2002. To view the Tolerance Reassessment Progress and Risk Management Decision

(TRED)and related supporting documents, please refer to docket number (EPA-HQ-OPP-2002-0250-0001) at *www.regulations.gov* . DATES: This regulation is effective June 7, 2006. Objections and requests for hearings must be received on or before August 7, 2006, 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-2005-0297. All documents in the docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, 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: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-3194; e-mail address: *brothers.shaja@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: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . 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 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0297 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 7, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0297, 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 Building), 2777 S. Crystal Drive, 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. Background and Statutory Findings In the **Federal Register** of August 31, 2005 (70 FR 51802) (FRL-7733-1), 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 5E4573) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.421 be amended by establishing a tolerance for residues of the fungicide fenarimol [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol] in or on filbert at 0.02 parts per million (ppm). That notice included a summary of the petition prepared by Gowan Company, the registrant. There were no comments received in response to the notice of filing. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.” III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of fenarimol on filbert at 0.02 ppm. 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 toxic effects caused by fenarimol as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies can be found at *http://www.epa.gov/EPA-PEST/2002/December/Day-04/p30471.htm* . B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for fenarimol used for human risk assessment is shown in Table 1 of this unit: **Table 1.— Summary of Toxicological Dose and Endpoints for Fenarimol for Use in Human Risk Assessment** Exposure/Scenario Dose Used in Risk Assessment, Interspecies and Intraspecies and any Traditional UF Special FQPA SF and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary (Females 13-50 years of age) NA NA Rat Developmental and Multi-generation Reproductive Toxicity Study Acute Dietary (General population including infants and children) NA NA No appropriate endpoint was available to quantitate risk. Chronic Dietary (All populations) NOAEL = 0.6 mg/kg/day UF = 100 X Chronic RfD = 0.006 mg/kg/day Special FQPA SF = 3X cPAD = chronic RfD/Special FQPA SF = 0.002 mg/kg/day Multi-generation Reproduction Study LOAEL = 1.2 mg/kg/day based on decreased live born litter size in the F 1 and F 2 generations. Short-Term Incidental Oral, Dermal, and Inhalation (1 to 30 days) (Residential) Dermal/oral study LOAEL = 35 mg/kg/day LOC for MOE = 900 (Residential) FQPA factor = 3X UF= 300 Special Reproduction Study LOAEL = 35 mg/kg/day based on decreased fertility and dystocia, an indicator of hormonal effects, observed in a special non-guideline cross breeding reproduction/developmental toxicity study in rats Intermediate-Term Incidental Oral, Dermal, and Inhalation (1- 6 months) (Residential) Dermal/oral study NOAEL = 0.6 mg/kg/day LOC for MOE = 100 (Residential) FQPA factor = 3X Multi-generation Reproduction Study LOAEL = 0.6 mg/kg/day based on decreased live born litter size in the F 1 and F 2 generations Cancer (oral, dermal, inhalation) NA NA Fenarimol has been classified as a “not likely” human carcinogen (Group E). C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.421)(a)(1) for the residues of fenarimol, [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol] for the following raw agricultural commodities (RACs): Apple at 0.1; apple, dry pomace at 2.0; apple, wet pomace at 2.0; cattle, fat at 0.1; cattle, kidney at 0.1; cattle, meat at 0.01; cattle, meat byproducts, except kidney at 0.05; goat, fat at 0.1; goat, kidney at 0.1; goat, meat at 0.01; goat, meat byproducts, except kidney at 0.05; horse, fat at 0.1; horse, kidney at 0.1; horse, meat at 0.01; horse, meat byproducts, except kidney at 0.05; pear at 0.1; pecan at 0.1; sheep, fat at 0.1; sheep, kidney at 0.1; sheep, meat at 0.01; and sheep, meat byproducts, except kidney at 0.05. Tolerances have also been established (40 CFR 180.421)(a)(2) for the combined residues of fenarimol [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol] and its metabolites [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-1,4-dihydro-5-pyrimidinemethanol and 5-[(2-chlorophenyl) (4-chlorophenyl)methyl]-3,4-dihydro-4-pyrimidinol measured as the total of fenarimol and 5-[(2-chlorophenyl)-(4-chlorophenyl)methyl]pyrimidine (calculated as fenarimol) for the following RACs: Banana (import) at 0.5; cherry at 1.0; grape, juice at 0.6; grape pomace (wet and dry) at 2.0; grape at 0.2; grape, raisin, waste at 3.0; grape, raisin at 0.6. Risk assessments were conducted by EPA to assess dietary exposures from fenarimol 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. No such effects were identified in the toxicological studies for fenarimol, therefore a quantitative acute dietary exposure assessment is unnecessary. ii. *Chronic exposure* . The chronic dietary exposure assessment for fenarimol is highly refined using anticipated residues based on 1996-1999 Food and Drug Administration

(FDA)monitoring data for apples, bananas, cherries, grapes and pears. Field trial residue data were used for pecans and filberts. Percent crop treated (%CT) information and processing factors, where available, were used in the assessment. There were no PDP monitoring data available for fenarimol. iii. *Anticipated residue and percent crop treated

(PCT)information* . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals 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. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins 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 the Agency can make the following findings: Condition 1, that 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; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: Almonds 0.1%; apples 25%; bananas < 1%; cherries, sweet 13%; cherries, tart 9%; grapes, raisin 21%; grapes, table 8%; grapes wine 9%; hazelnuts 9%; pecans 1%; and pears 10%. These PCT figures were derived from a quantitative usage analysis

(QUA)for fenarimol by the Agency based on data years 1990-1999. The weighted average of percent crop treated (%CT) was used for estimating chronic dietary exposure. Additional information on imported bananas was obtained indicating that less than 1% of bananas consumed in the United States are treated with fenarimol. For pecans, a default 1% crop treated was assumed (0% CT reported in QUA). The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 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 fenarimol may be applied in a particular area. iv. *Cancer* . Fenarimol has been classified as a “not likely” human carcinogen (Group E) and thus a quantitative exposure assessment as to cancer risk is unnecessary. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for fenarimol 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 physical characteristics of fenarimol. Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Groundwater models, the estimated environmental concentrations

(EECs)of fenarimol chronic exposures are estimated to be 26 ppb for surface water and 16 ppb for ground 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). Fenarimol is not registered for use on any sites that would result in exposure in or around the home. Fenarimol is registered for use on turf however,. Applications to turf are limited to golf courses, and stadium fields or professional athletic fields only. Therefore, the Agency has determined that the only potential non-occupational postapplication exposure is short-term dermal exposure to adult golfers. EPA's “Standard Operating Procedures

(SOPs)for Residential Exposure Assessments” at *(http://www.epa.gov/fedrgstr/EPA-PEST/1999/January/Day-04/o-p34736.htm)* were used to estimate the exposures of adult golfers contacting treated turf. The SOPs for turf use transfer coefficients based on mowing studies. Chemical specific data from a turf transferable residue

(TTR)study were available; however, these TTR data were unacceptable for use in postapplication exposure assessment. Therefore, default assumptions from the SOPs were used. Exposures were estimated for short-term dermal contact with treated turf during the low contact activity of golfing. The exposure estimates generated for the golfing turf use is based on some upper-percentile assumptions (i.e., duration of exposure and maximum application rate for this short-term assessment) and is considered to be representative of high end exposures. The uncertainties associated with this assessment stem from the use of an assumed amount of pesticide retained on turf, and assumptions regarding the transfer of fenarimol residues. The turf risk estimate is believed to be a reasonable and protective estimate. Therefore, the level of confidence is fairly high, and does not under estimate risk. 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.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fenarimol and any other substances and fenarimol does not appear to produce a toxic metabolite produced by other substances. EPA has also evaluated comments submitted that suggested there might be a common mechanism among fenarimol and other named pesticides that cause brain effects. EPA concluded that the evidence did not support a finding of common mechanism for fenarimol and the named pesticides. For the purposes of this tolerance action, therefore, EPA has not assumed that fenarimol has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for 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. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 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 safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . The developmental and reproductive toxicity studies showed no evidence of increased sensitivity or susceptibility of young rats or rabbits following prenatal or postnatal exposure to fenarimol. However, the studies demonstrated that fenarimol is associated with hydronephrosis that is reversible. 3. *Conclusion* . The data base for prenatal developmental and reproductive toxicity is considered complete. Based upon the RED completed June 2002, the Agency reduced the FQPA Safety factor from 10X to 3X. It was determined that the 3X would be retained until a special developmental toxicity study was received and reviewed to confirm if the potential hormonal effects elicited by inhibition of aromatase would result in effects in the rat pups. However more recently, fenarimol has been evaluated in studies considered in EPA's Endocrine Disruptor Screening Program including the Pubertal Female and Uterotrophic Assays. The Pubertal Female Assay involves the use of rats to screen for estrogenic and thyroid activity in females during sexual maturation, and examines abnormalities associated with sex organs and puberty markers, as well as thyroid tissue. The Uterotrophic assay involves the use of female rats to screen for estrogenic effects. In this *in vivo* assay, uterine weight changes are measured in ovariectomised or immature female rats. No adverse effects were found in the female pubertal assay when SD rats were treated at 50 and 250 milligram/kilogram (mg/kg) day for 21 days, except for a decrease in T4 and an increase in circulating TSH levels. In the Uterotrophic assay, a dose of 200 mg/kg day results in a significant increase of uterine weights which were accompanied by an increase in serum FSH levels and a decrease in serum T3 levels. The uterotrophic response and the effects found on thyroid hormone levels are found at much higher doses than the regulatory endpoints based on the rat multi-generation study where fenarimol reduced fertility of males at 1.2 mg/kg per day with a NOAEL of 0.6 mg/kg per day. The 0.6 mg/kg NOAEL is over 300-fold lower than the uterotrophic response found in rats at 200 mg/kg. In conclusion, there is greater confidence in the current NOAEL of 0.6 mg/kg per day given these recent studies on the reproductive, developmental and endocrine effects of fenarimol. It is therefore recommended that the 3X FQPA safety factor be removed because there are adequate data evaluating the potential endocrine effects of fenarimol during development and in the young animal. As a result, the Agency no longer requires a special developmental study. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . No acute risk is expected from exposure to fenarimol since no acute endpoints were identified for the general U.S. population (including infants and children) or the females 13-50 years old population subgroup. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fenarimol from food will utilize < 1% of the cPAD for the U.S. population, < 1% of the cPAD for all infants < 1 year old, and < 1% of the cPAD for children 1-6 years old. There are no residential uses for fenarimol that result in chronic residential exposure to fenarimol. In addition, there is potential for chronic dietary exposure to fenarimol in drinking water. After calculating Drinking Water Level of Comparison (DWLOCs) and comparing them to the EECs for surface water and ground water, infants and children, the most sensitive population subgroups slightly exceed the chronic DWLOC of 20. However, the chronic EECs were estimated using Tier I modeling and only slightly exceed the DWLOC. Additional data are being required that will provide important information on the mobility of fenarimol and its degradates. These studies will help to refine the chronic surface and ground water drinking water risk assessments. The EECs are based on a Tier 1 model FIRST for a turf use scenario with maximum application rates. The estimated EEC for surface water is a very conservative estimate. It represents the 1-in-10 year mean yearly surface water concentration. The Agency's surface water modeling for drinking water uses a default percent cropped area factor

(PCA)for turf, which represents the fraction of the watershed that is cropped and treated with the pesticide being modeled. In the absence of a crop-specific PCA factor, a default PCA of 0.87 is used. The 0.87 factor represents the maximum fraction of a watershed in the US that is agriculturally cropped. This default PCA was used for fenarimol modeling on turf. The Agency is currently attempting to develop PCA factors specific for turf scenarios, and recognizes that it is unlikely that 87% of a watershed used for drinking water would be grown to turf and treated with fenarimol at the maximum rate allowed only for turf applications especially since applications to turf are limited to golf courses, and stadium fields or professional athletic fields only. The default PCA factor assumed and used in fenarimol modeling is most likely overestimated and adds to the conservatism of the assessment. Given the relatively low usage of fenarimol across the country it is highly unlikely that the amount applied to the watershed in the model will be concentrated in any real watershed used to derive drinking water. Therefore, the EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit. The results indicated in the table below are based upon the RED, and are considered over estimates. Therefore, the risk estimates shown below are actually lower than what the table reports. **Table 2.—Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fenarimol** Population/Subgroup cPAD/mg/kg/day %/cPAD

(Food)Surface Water EEC

(ppb)Ground Water EEC

(ppb)Chronic DWLOC

(ppb)U.S. population 0.002 < 1% 26 16 70 All Infants < 1 year old 0.002 < 1% 26 16 20 Children (1-6 years old) 0.002 < 1% 26 16 20 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fenarimol is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for fenarimol. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOE of 1,400 for adult golfers. This aggregate MOE does not exceed the Agency's level of concern for aggregate exposure to food and residential uses. 4. *Aggregate cancer risk for U.S. population* . Fenarimol has been classified as a “not likely” human carcinogen (Group E). 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, and to infants and children from aggregate exposure to fenarimol residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate methods are available for data collection and enforcement of tolerances for residues of fenarimol per se in/on plants and livestock. Adequate methods are also available for determination of residues of fenarimol and Metabolites B and C in plants Pesticide Analytical Manual

(PAM)Volume II, Methods I (AM-AA-CA-R039-AB-755), II (AM-AA-CA-R072-AA-755), and III (AM-AA-CA-R124-AA-755. B. International Residue Limits There is no CODEX maximum residue limit for filbert. V. Conclusion Therefore, the tolerance is established for residues of fenarimol, [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol], in or on filbert at 0.02 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 due to its lack of significance, 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). 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.* , or 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). 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); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of 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: May 22, 2006. 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 180.421 is amended by alphabetically adding a commodity to the table in paragraph (a)(1) to read as follows: § 180.421 Fenarimol; tolerances for residues.

(a)*General* .

(1)* * * Commodity Parts per million * * * * * Filbert 0.02 * * * * * [FR Doc. E6-8659 Filed 6-6-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0056; FRL-8070-2] Pendimethalin; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for combined residues of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl alcohol in or on pistachio. Interregional Research Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective June 7, 2006. Objections and requests for hearings must be received on or before August 7, 2006, 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-2005-0056. All documents in the docket are listed in the index for the docket. 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 availablein hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 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: Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-6463; e-mail address: *Madden.Barbara@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: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . 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 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2005-0056 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 7, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2005-0056, 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

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of March 19, 2001 (66 FR 15459) (FRL-6766-8), 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 0E6083) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.361 be amended by establishing a tolerance for combined residues of the herbicide pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, and its metabolite 4-[(1-ethylpropyl)amino-2-methyl-3,5-dinitrobenyzl alcohol, in or on pistachio at 0.1 parts per million (ppm). That notice included a summary of the petition prepared by FMC Corporation, the registrant. There were no comments received in response to the notice of filing. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined residues of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl alcohol in or on pistachio at 0.1 ppm. On April 12, 2006 the Agency published a Final Rule (71 FR 18628, FRL-7770-4) establishing tolerances for combined residues of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl alcohol in or on almond, hulls; carrots; citrus, oil; Fruit, citrus, group 10; Nut, tree, group 14; peppermint, oil; peppermint, tops; spearmint, oil; and spearmint, tops. When the Agency conducted the risk assessments in support of this tolerance action it assumed that pendimethalin residues would be present on pistachio as well as on all foods covered by the proposed and established tolerances. Residues on pistachio were included because there was a pending application under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 *et seq* ., to register pendimethalin on pistachio. Therefore, establishing the pistachio tolerance will not change the most recent estimated aggregate risks resulting from use of pendimethalin, as discussed in the April 12, 2006 **Federal Register** . Refer to the April 12, 2006 **Federal Register** document for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the **Federal Register** document in support of this action. Based on the risk assessments discussed in the final rule published in the **Federal Register** of April 12, 2006, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to pendimethalin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate methods are available for data collection and tolerance enforcement for existing and proposed uses of pendimethalin. Methods I through IV in the Pesticide Analytical Manuel

(PAM)Vol. II are gas chromatography/electron capture (GC/ECD) methods. Methods used for data collection are essentially the same as the PAM Vol. II methods, and have been adequately validated. The Food and Drug Administrations's PESTDATA data base (PAM Volume I, Appendix I) indicates that pendimethalin is completely recovered (<80%) by Multiresidue Methods Section 302 (Luke method; Protocol D) and 303 (Mills, Onley, Gaither method; Protocol E, nonfatty), and partially recovered (50-80%) by Multiresidue Method Section 304 (Mills fatty food method; Protocol E, fatty). The method maybe 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 or proposed Codex Maximum Residue Levels

(MRLs)for pendimethalin residues. Therefore, there are no issues of compatibility with respect to Codex MRLs and U.S. tolerances. V. Conclusion Therefore, the tolerance is established for combined residues of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl alcohol in or on pistachio at 0.1 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

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of 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: May 24, 2006. 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 180.361 is amended by alphabetically adding a commodity to the table in paragraph

(a)to read as follows: § 180.361 Pendimethalin; tolerances for residues.

(a)* * * Commodity Parts per million * * * * * Pistachio 0.1 * * * * * [FR Doc. E6-8830 Filed 6-6-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0404; FRL-8069-5] Methoxyfenozide; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for residues of methoxyfenozide in or on soybean aspirated grain fractions, soybean forage, soybean hay, soybean hulls, and soybean seed. Dow AgroSciences requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective June 7, 2006. Objections and requests for hearings must be received on or before August 7, 2006, 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-2006-0404. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Mark Suarez, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-0120; e-mail address: *suarez.mark@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: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . 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 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0404 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 7, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0404, 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

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of August 13, 2004 (69 FR 50192) (FRL-7364-9), 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 3F6794) by DowAgroSciences, 9330 Zionsville Road 308-2E225, Indianapolis, IN 46268-1054. The petition requested that 40 CFR 180.544 be amended by establishing a tolerance for residues of the insecticide methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on soybean aspirated grain at 200 parts per million (ppm), soybean forage at 45 ppm, soybean hay at 65 ppm, soybean hulls at 3.0 ppm, soybean meal at 0.1 ppm, soybean oil at 1.0 ppm, and soybean seed at 2.0 ppm. That notice included a summary of the petition prepared by Dow AgroSciences, the registrant. There were no comments received in response to the notice of filing. The registrant subsequently revised Section F of the petition to concur with the tolerances found to be supported by the Agency based on the available data used for the risk assessment. In the revised Section F, Dow AgroSciences requested that 40 CFR 180.544 be amended by establishing a tolerance for residues of the insecticide methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on soybean aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean hay at 80 ppm, soybean hulls at 2.0 ppm, and soybean seed at 1.0 ppm. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of methoxyfenozide on soybean aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean hay at 80 ppm, soybean hulls at 2.0 ppm, and soybean seed at 1.0 ppm. 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 toxic effects caused by methoxyfenozide as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies can be found at *http://www.epa.gov/EPA-PEST/2002/September/Day-20/p23996.htm* . B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(cPAD)= 0.10 mg/kg/day This cPAD applies to All population subgroups. Short-Term, Intermediate- Term, and Long-Term (Dermal) None No systemic toxicity was seen at the limit dose following repeated dermal application to rats None Short-Term, Intermediate-Term, and Long-Term (Inhalation) None Based on low vapor pressure, the low acute toxicity of both the technical and formulated products as well as the application rate and application method, there is minimal concern for inhalation exposure. None Cancer None Methoxyfenozide has been classified as “not likely to be a human carcinogen.” The classification is based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice and on the lack of genotoxicity in an acceptable battery of mutagenicity studies None C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.544) for the residues of methoxyfenozide, in or on a variety of raw agricultural commodities, animal (cattle, goat, hog, horse, poultry, and sheep) meats and fats, and milk. Risk assessments were conducted by EPA to assess dietary exposures from methoxyfenozide 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. No appropriate endpoint was identified in the oral toxicity studies including the acute neurotoxicity study in rats and the developmental toxicity studies in rats and rabbits. Therefore, acute dietary exposure assessments were not conducted. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Drinking water will contain the highest estimate drinking water concentration (EDWC), 100% of all existing and proposed crops are treated, and all resulting residues are at tolerance levels. iii. *Cancer* . Because methoxyfenozide has been classified as “not likely to be a human carcenogen,” an exposure assessment for the purpose of assessing cancer risk is not needed. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for methoxyfenozide 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 physical characteristics of methoxyfenozide. Further information regarding EPA drinking water models used in pesticide exposure assessment is discussed in Unit III.C.2 of the final rule previously published in the **Federal Register** of July 5, 2000 (65 FR 41355) (FRL-6496-5). Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System and Screening Concentrations in Groundwater models, the estimated environmental concentrations

(EECs)of methoxyfenozide for acute exposures are estimated to be 43 parts per billion

(ppb)for surface water and 3.5 ppb for ground water. The EECs for chronic exposures are estimated to be 30 ppb, based on surface 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). Methoxyfenozide 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.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to methoxyfenozide and any other substances and methoxyfenozide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that methoxyfenozide has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for 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. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 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 safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There is no evidence of prenatal or postnatal sensitivity, as discussed in Unit IV.C. of the final rule previously published in the **Federal Register** of August 31, 2005 (70 FR 51597) (FRL-7732-3). 3. *Conclusion* . There is a complete toxicity data base for methoxyfenozide and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The Agency has determined that the FQPA Safety Factor can be reduced to 1X in assessing the risk posed by this chemical. The basis for this determination is discussed in Unit IV.C.5 of the final rule previously published in the **Federal Register** of August 31, 2005. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . No appropriate endpoint was identified in the oral toxicity studies including the acute neurotoxicity study in rats and the developmental toxicity studies in rats and rabbits. Therefore, no acute dietary risk is expected. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to methoxyfenozide from food and drinking water will utilize 23% of the cPAD for the U.S. population, 32% of the cPAD for all infants < 1-year old, and 56% of the cPAD for children 1-2 years old, the highest exposed subgroup. There are no residential uses for methoxyfenozide that result in chronic residential exposure to methoxyfenozide. 3. *Short-term and Intermediate-term risk* . Short-term and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Methoxyfenozide 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, which does not exceed the Agency's level of concern. 4. *Aggregate cancer risk for U.S. population* . Methoxyfenozide has been classified as “not likely” to be a human carcinogen. The classification is based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice and on the lack of genotoxicity in an acceptable battery of mutagenicity studies. Therefore, methoxyfenozide is not expected to pose a cancer risk. 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, and to infants and children from aggregate exposure to methoxyfenozide residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (TR 34-00-28) was previously developed by Rohm and Haas; high performance liquid chromatography

(HPLC)with positive ion electrospray (E.I.) tandem mass spectrometry (LC/MS/MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no established or proposed Codex, Canadian, or Mexican limits for residues of methoxyfenozide in or on plant or animal commodities. Therefore, no compatibility issues exist regarding the proposed U.S. tolerances. V. Conclusion Therefore, the tolerance is established for residues of methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-2-(3,5- dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide, in or on soybean aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean hay at 80 ppm, soybean hulls at 2.0 ppm, and soybean seeds at 1.0 ppm. The original petition (PP 3F6794) and notice of filing (Docket identification number OPP-2004-0184) contained additional proposed tolerances for soybean, oil and soybean, meal. Dow AgroSciences the registrant submitted a revised Section F of the petition for the removal of soybean, oil and soybean, meal from the tolerance expression. 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

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of 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: May 22, 2006. 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 180.544 is amended by alphabetically adding commodities to the table in paragraph (a)(1) to read as follows: § 180.544 Methoxyfenozide; tolerances for residues.

(a)*General* .

(1)* * * Commodity Parts per million * * * * * Soybean, aspirated grain fractions 160 Soybean, forage 30 Soybean, hay 80 Soybean, hulls 2.0 Soybean, seed 1.0 * * * * * [FR Doc. E6-8828 Filed 6-6-06; 8:45 am] BILLING CODE 6560-50-S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 06-1051; MB Docket No. 05-108; RM-11178] Radio Broadcasting Services; Andover and Haverhill, MA AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: The Audio Division, at the request of Beanpot Broadcasting Corp., licensee of Station WXRV(FM), Channel 223B, Haverhill, Massachusetts, deletes Channel 223B at Haverhill, Massachusetts, from the FM Table of Allotments, allots Channel 223B at Andover, Massachusetts, as the community's first local FM service, and modifies the license of Station WXRV(FM) to specify operation on Channel 223B at Andover. Channel 223B can be allotted to Andover, Massachusetts, in compliance with the Commission's minimum distance separation requirements at WXRV(FM)'s existing transmitter site. The coordinates for Channel 223B at Andover, Massachusetts, are 42-46-23 North Latitude and 71-06-01 West Longitude, with a site restriction of 13.1 km (8.1 miles) north of Andover. DATES: Effective July 3, 2006. FOR FURTHER INFORMATION CONTACT: Deborah Dupont, Media Bureau,

(202)418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's *Report and Order,* MB Docket No. 05-108, adopted May 17, 2006, and released May 19, 2006. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW, Room CY-A257, Washington, DC 20554. The complete text of this decision also may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW, Room CY-B402, Washington, DC, 20554,

(800)378-3160, or via the company's Web site, *http://www.bcpiweb.com.* The Commission will send a copy of this *Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR part 73 Radio, Radio broadcasting. For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Massachusetts is amended by adding Andover, Channel 223B, and by removing Haverhill, Channel 223B. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E6-8846 Filed 6-6-06; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 06-1053; MB Docket No. 06-19; RM-11288] Radio Broadcasting Services; Hattiesburg and Sumrall, MS AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: In response to a *Notice of Proposed Rule Making,* this *Report and Order* upgrades Channel 226A, FM Station WGDQ, Hattiesburg, Mississippi, to Channel 226C3, reallotts Channel 226C3 from Hattiesburg to Sumrall, Mississippi, and modifies Station WGDQ's license accordingly. The coordinates for Channel 226C3 at Sumrall, Mississippi, are 31-33-15 NL and 89-24-50 WL, with a site restriction of 19.5 kilometers (12.1 miles) northeast of Sumrall. DATES: Effective July 3, 2006. ADDRESSES: Federal Communications Commission, 445 12th Street, S.W., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: R. Barthen Gorman, Media Bureau,

(202)418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's *Report and Order,* MB Docket No. 06-19, adopted May 17, 2006, and released May 19, 2006. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, 445 12th Street, SW, Room CY-A257, Washington, DC, 20554. The document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW, Room CY-B402, Washington, DC, 20554, telephone 1-800-378-3160 or *http://www.BCPIWEB.com.* The Commission will send a copy of this *Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 reads as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Mississippi is amended by removing Channel 226A at Hattiesburg, and by adding Channel 226C3 at Sumrall. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E6-8862 Filed 6-6-06; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 06-1049; MB Docket No. 05-104; RM-10837, RM-10838] Radio Broadcasting Services; Black Rock, Cave City and Cherokee Village, AR and Thayer, MO AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: This document substitutes Channel 252C2 for Channel 252C3 at Cherokee Village, Arkansas, reallots Channel 252C2 to Black Rock, Arkansas, and modifies the Station KFCM license to specify operation on Channel 252C2 at Cherokee Village. To replace the loss of the sole local service at Cherokee Village, this document also reallots Channel 222C2 from Thayer, Missouri, and modifies the Station KSAR license to specify Cherokee Village as the community of license. This document also reclassifies the Channel 253C allotment at Little Rock, Arkansas, to Channel 253C0, and modifies the Station KURB license at Little Rock, Arkansas, to specify operation on Channel 253C0. The reference coordinates for the Channel 252C2 allotment at Black Rock, Arkansas, are 36-05-25 and 91-08-55. The reference coordinates for the Channel 222C2 allotment at Cherokee Village, Arkansas, are 36-21-58 and 91-28-35. The reference coordinates for the Channel 253C0 allotment at Little rock, Arkansas, are 34-47-56 and 92-29-44. With this action, the proceeding is terminated. DATES: Effective July 3, 2006. FOR FURTHER INFORMATION CONTACT: Robert Hayne, Media Bureau,

(202)418-2177. SUPPLEMENTARY INFORMATION: This is a synopsis of the *Report and Order* in MB Docket No. 05-104, adopted May 17, 2006, and released May 19, 2006. The full text of this decision is available for inspection and copying during normal business hours in the FCC Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or *http://www.BCPIWEB.com.* The Commission will send a copy of this *Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR Part 73 Radio, Radio Broadcasting. For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments, under Arkansas, is amended by removing Channel 252A and adding Channel 222C2 at Cherokee Village. 3. Section 73.202(b), the Table of FM Allotments, under Missouri, is amended by removing Thayer, Channel 222C2. 4. Section 73.202(b), the Table of FM Allotments under Arkansas, is amended by adding Black Rock, Channel 252C2. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E6-8863 Filed 6-6-06; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 571 [Docket No. NHTSA-2006-24980] RIN 2127-AI66 Federal Motor Vehicle Safety Standards; Child Restraint Systems AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: This final rule establishes breaking strength requirements for child restraint webbing. Under today's final rule, new webbing that attaches a restraint to a vehicle is required to have a minimum breaking strength of 15,000 N. New restraint webbing used to restrain a child in a restraint is required to have a minimum breaking strength of 11,000 N. Today's final rule maintains the percent-of-strength requirements for webbing after it is exposed to specific environmental conditions that have been required under the child restraint system standard. Today's final rule also clarifies the weights used in the webbing abrasion test procedure. The requirements of this final rule increase the likelihood that the webbing of child restraint systems will sufficiently perform throughout the life of a child restraint. DATES: The effective date of this final rule ( *i.e.* , the date that the rule amends the Code of Federal Regulations) is August 7, 2006. The compliance date of this rule is September 1, 2007 (all child restraints manufactured on or after this date must meet the requirements of this final rule). Petitions for reconsideration must be received not later than July 24, 2006. ADDRESSES: Petitions must be submitted to: Administrator, 400 Seventh Street, SW., Washington, DC 20590. FOR FURTHER INFORMATION CONTACT: For technical issues, you may contact Mr. Tewabe Asebe, Office of Rulemaking (Telephone: 202-366-2365) (Fax: 202-366-7002). For legal issues, you may contact Mr. Chris Calamita, Office of Chief Counsel (Telephone: 202-366-2992) (Fax: 202-366-3820). You may send mail to these officials at the National Highway Traffic Safety Administration, 400 Seventh Street, SW., Washington, DC 20590. SUPPLEMENTARY INFORMATION: Table of Contents I. Strength Requirements a. Background and the NPRM b. Summary of Public Comments c. Response to the Comments 1. What should be the minimum strength requirements for new webbing? i. Are the proposed limits too low? ii. Are the proposed limits too high? 2. Need to retain percent-of-strength requirement for exposed webbing 3. Artifacts of component testing of webbing d. Conclusions II. Weight Used to Abrade III. Compliance Date IV. Rulemaking Analyses and Notices I. Strength Requirements a. Background and the NPRM Federal Motor Vehicle Safety Standard (FMVSS) No. 213, *Child restraint systems* , regulates child restraint systems used in motor vehicles and aircraft (49 CFR 571.213). Among other things, this standard specifies requirements for the webbing material used in child restraint systems, including requirements for the strength of the webbing after the webbing is subjected to abrasion (S5.4.1(a)), light exposure (S5.4.1(b)), and micro-organisms (S5.4.1(b)). 1 These specified conditions simulate the conditions that webbing will likely encounter through normal use. Evaluating the performance of the webbing after subjecting the webbing to those conditions better ensures the long-term integrity of the webbing. 1 S5.4.1(a) and

(b)reference FMVSS No. 209, 49 CFR 571.209, *Seat belt assemblies* , which specifies requirements and the associated test procedures for seat belt assemblies. Each of the requirements for exposed webbing is expressed in the form of a percent-of-strength of the webbing measured before exposure. S5.4.1(a) specifies that, after being subjected to abrasion as specified in certain sections of FMVSS No. 209, the webbing must have a breaking strength of not less than 75 percent of the strength of the unabraded webbing. S5.4.1(b) of FMVSS No. 213, referring to S4.2(e) in FMVSS No. 209, specifies that after being exposed to light, the webbing shall have a breaking strength of not less than 60 percent of the strength before exposure. The same section of FMVSS No. 213 also refers to S4.2(f) of FMVSS No. 209, which specifies that after being exposed to micro-organisms, the webbing shall have a breaking strength of not less than 85 percent of the strength before exposure to micro-organisms. However, FMVSS No. 213 does not currently specify a minimum breaking strength for new webbing against which the percentages would be measured. Addressing this aspect of the standard, on June 30, 2005, we published the notice of proposed rulemaking (NPRM)(70 FR 37731; Docket No. NHTSA-2005-21243) preceding this final rule. In the NPRM, we expressed concern that because there is no specified minimum breaking strength for new webbing, manufacturers could use webbing of inferior strength to meet the standard's requirements. The exposed webbing might have a breaking strength that is within the specified percentage of the strength of the new webbing, but the webbing might not have an absolute strength high enough to provide a margin of safety for use throughout the life of a child restraint. The NPRM sought to achieve three goals (70 FR at 37732). First was to specify a minimum breaking strength for unabraded webbing or webbing that has not been exposed to light or micro-organisms (hereinafter referred to as “new webbing”), to address the concern about a lack of a minimum breaking strength requirement for new webbing. Second was to affirm that a purpose of S5.4.1(a) and

(b)of FMVSS No. 213 was to limit the degradation rate of the webbing. We stated that limiting degradation was done by having a minimum breaking strength requirement that applies to webbing that has been exposed to mechanical or environmental conditions in the test laboratory that accelerate the aging of the webbing. (Webbing that has been abraded or exposed to the accelerated conditions is referred to as “exposed webbing.”) We tentatively concluded that specifying minimum breaking strength requirements for new and exposed webbing would eliminate the need for the current percent-of-strength degradation requirements. Third was to clarify the weight used in the abrasion test to abrade the webbing used to attach child restraint systems to the child restraint anchorages located in a vehicle. Table 1, below, summarizes the NPRM's proposed minimum breaking strength requirements for new and exposed webbing:

(a)Used to attach the child restraint system to the vehicle (hereinafter “tether webbing”) 2 , and

(b)used to restrain the child in the child restraint (hereinafter “harness webbing”). We proposed a more stringent requirement for tether webbing because tether webbing secures the mass of a child restraint and child, whereas harness webbing is limited to securing the mass of a child occupant. 2 As used in this preamble, the term “tether webbing” includes webbing used to attach a child restraint to all three anchorages of a LATCH system. The agency explained in the NPRM (70 FR at 37734) that the 15,000 N value for new tether webbing was based on a calculation of the loads imposed by the mass of a child and child restraint together, and on a consideration of the breaking strength previously required for seat belt assembly restraints for persons not weighing more than 50 pounds (Type 3 seat belt assemblies) 3 (70 FR at 37734). Type 3 webbing was required to meet a breaking strength in the range of approximately 13,000-18,000 N, depending on the number of webbing connections to attachment hardware. The agency believed that a 15,000 N requirement has a margin of safety above the minimum 13,000 N lower limit previously established for Type 3 webbing. We also noted that of 20 child restraint systems tested, 17 had tether webbing with a breaking strength of 15,000 N or greater, indicating that a 15,000 N requirement would be feasible. We further stated that we are unaware of real-world data that would indicate the presence of a safety problem associated with the strength levels of current webbing. 3 As explained in the NPRM (70 FR 37732), prior to 1979 FMVSS No. 209, *Seat belt assemblies,* had requirements for Type 3 seat belts. In December 1979, the Type 3 requirements were removed from FMVSS No. 209 and incorporated into an updated FMVSS No. 213 (44 FR 72131). The NPRM proposed a minimum breaking strength of 11,000 N for new harness webbing. The 11,000 N proposal was based in part on the breaking strength requirements for Type 3 belt assemblies prior to 1979, which ranged from 1,500 pounds (6,670 N) for webbing in pelvic and upper torso restrains to 4,000 pounds ( 17,793 N) for webbing in seat back retainers. The proposal was also based on a consideration of compliance data for 109 child restraint systems collected from 2000-2002. Ninety-two percent (100 out of 109) of the harness webbing had a breaking strength above 11,000 N. Given also that there have been no real-world reports of harness webbing failures, the agency tentatively determined that the proposed requirement was reasonable. The NPRM proposed to require tether and harness webbing to meet minimum strength requirements after abrasion, exposure to light, and exposure to micro-organisms, the same test conditions to which child restraint webbing is currently exposed. Currently in FMVSS No. 213, each of the post-exposure strength requirements is calculated from percentages of the strength of the original

(new)webbing. The NPRM proposed not changing the percentages now used to calculate the post-exposure strength requirements (75 percent—abrasion, 60 percent—exposure to light, and 85 percent—exposure to micro-organisms). The proposed minimum strength requirements for the exposed webbing were calculated using those percentages, which were determined by the Society of Automotive Engineers

(SAE)and incorporated into SAE Standard SAE J4c, Motor Vehicle Seat Belt Assemblies. The agency incorporated the SAE percentages and procedures into FMVSS No. 209 and FMVSS No. 213. Table 1.—Proposed Breaking Strength Requirements Type of webbing Type of exposure Proposed breaking strength requirement New tether webbing 15,000 N. Exposed tether webbing Abrasion 11,200 N. Exposure to light 9,000 N. Exposure to micro-organisms 12,700 N. New harness webbing 11,000 N. Exposed harness webbing Abrasion 8,200 N. Exposure to light 6,600 N. Exposure to micro-organisms 9,300 N. b. Summary of Public Comments In response to the NPRM, the agency received comments from Advocates for Highway and Auto Safety (Advocates), a consumer group, and Britax Child Safety, Inc. (Britax), a child restraint manufacturer. Both commenters generally supported the establishment of minimum breaking strength requirements for child restraint system webbing, but Advocates believed that a 15,000 N requirement for new tether webbing may be too low, while Britax questioned whether a 15,000 N requirement was too high. 4 The comments generally centered on:

(a)What the strength requirements should be; and

(b)artifacts of component testing of webbing. 4 No commenter directly addressed the proposal for a 11,000 N strength requirement for new harness webbing. c. Response to the Comments 1. What should be the minimum strength requirements for new webbing? The NPRM proposed that the minimum breaking strength should be 15,000 N for new tether webbing and 11,000 N for new harness webbing. i. Are the proposed limits too low? A. In its comments to the NPRM, Advocates supported establishing specific strength requirements, but questioned whether a 15,000 N requirement would be sufficient. Advocates suggested that the agency consider the breaking strength requirements of FMVSS No. 209, “Seat belt assemblies,” because the tether webbing attaches child restraints to a vehicle and takes the place of the vehicle's belts in fulfilling this function. Advocates recommended that the minimum breaking strength for new tether webbing should be 22,241 N, the breaking strength requirement for the lap belt portion of a lap/shoulder seat belt (Type 2 seat belt) under FMVSS No. 209. *Response:* The agency believes that a 15,000 N requirement is sufficient. The requirement is based on an analysis of the force generated by a 50 pound

(lb)child that is secured in a 15-lb child restraint system (the average weight of a toddler restraint) in a 48 kilometer per hour (km/h) (30 mile per hour (mph)) crash. As explained in the NPRM, the resulting dynamic force from such a crash is less than 15,000 N. There are child restraints for children weighing more than 50 lb, but those restraints are typically booster seats which do not use webbing to attach the child restraint to the vehicle. We disagree that there is a safety need to adopt FMVSS No. 209 webbing strength requirements. FMVSS No. 209 establishes requirements for vehicle seat belts to ensure that seat belt assemblies are suitable for restraining occupants as large as a 95th percentile male (223 lb). Child restraint system webbing does not need to be as strong, since the loads generated in that application are much less. B. Advocates stated in its arguments that the minimum breaking strengths for exposed webbing should at least be comparable to the LATCH 5 anchorage strength requirements. Advocates stated that such a requirement would ensure that the webbing provided adequate strength for the life of a child restraint, and that the webbing would not be a “weak link” in the LATCH system, *i.e.* , webbing would not fail at force levels lower than those that would result in a failure of the LATCH anchorages. 5 “LATCH” stands for “Lower Anchors and Tethers for Children,” a term that was developed by manufacturers and retailers to refer to the standardized child restraint anchorage system required by FMVSS No. 225, “Child restraint anchorage systems.” This preamble uses the term to describe either an FMVSS No. 225 anchorage system in a vehicle or a child restraint that attaches to an FMVSS No. 225 child restraint anchorage system. Child restraints have been required by FMVSS No. 213 to have components enabling attachment to the lower anchors of a vehicle's LATCH system since September 1, 2002. Child restraints have had top tethers that attach to the tether anchor of a LATCH system since 1999. *Response:* The strength requirements established today are component requirements. Each webbing component must meet the requirement. The strength requirements for LATCH anchorages under FMVSS No. 225 apply to the anchorages when the system is tested, *i.e.* the anchorages must be able to endure a 15,000 N force applied to all three anchorages simultaneously, and a separate 11,000 N force applied to just the lower anchorages simultaneously. The minimum strength requirements for exposed webbing as tested on the component level are comparable to or more than the loads generated on the anchorages as a system in the test, ensuring an adequate margin of safety over the life time of a restraint while keeping the requirements within reason. C. Advocates also suggested that webbing that secures a child restraint to the lower LATCH anchorage points should have a more stringent strength requirement than that for tether webbing which secures a child restraint to the upper LATCH anchorage. Advocates stated that the webbing associated with the lower anchorages will “bear the brunt of the forces exerted on the child restraint in the event of a crash.” *Response:* S9.4 of FMVSS No. 225 requires that the lower anchorages withstand an 11,000 N force applied to both anchorages simultaneously. Today's final rule requires that the webbing have a minimum breaking strength of 15,000 N at the component level. Child restraint systems typically are secured to the LATCH attachments with more than one piece of webbing. The combined strength of the webbing attaching the child restraint to the lower LATCH anchors is sufficiently strong, provides an adequate margin of safety, and does not need to be increased. D. In setting the proposed strength requirements for new webbing, NHTSA evaluated compliance data from the FMVSS No. 213 compliance program in 2000-2002. We determined that a certain portion of the tested webbing would pass a higher limit (17,000 N), and a certain portion would pass a lower limit (13,000 N) (70 FR at 37734). Advocates stated that the agency “should not be seeking to ‘grandfather’ a majority of current products. * * *” *Response:* The agency's evaluation of compliance data was to demonstrate that the proposed requirements, and ultimately those adopted today, are feasible to achieve. Additionally, as stated in the NPRM, the agency wanted to point out that current webbing meeting a 15,000 N requirement has not been breaking in normal use. Advocates commented that this lack of data may be a result of the LATCH requirements being relatively new. The LATCH top tether anchorage has been used in the United States since 1999. Moreover, tethers have been used in Canada, which has comparable strength requirements to those adopted today, since the 1970's without an indication of an issue with webbing strength. Thus, for the reasons explained in the NPRM, we conclude that a 15,000 N strength requirement for new tether webbing meets the need for safety, improves the enforceability of the standard, and is practicable. ii. Are the proposed limits too high? A. Noting that the NPRM had discussed NHTSA's compliance test of a Britax tether webbing specimen that had an unabraded breaking strength of only 5,385 N, Britax stated that it has seen no real-world experiences related to webbing failures. Britax believed that the proposed webbing strength values are more stringent than necessary, and that overly stringent requirements for tether webbing may result in an increase in recorded injury criteria. Britax stated that excessive webbing strength may negatively affect other characteristics of webbing material such as elongation, and suggested that further evaluation by NHTSA and the industry is needed to determine the affect the proposed webbing strength requirements will have on dynamic performance. *Response:* The lack of a minimum breaking strength requirement for new webbing prompted the agency to undertake this rulemaking. NHTSA was concerned that where there is no specified minimum breaking strength for new webbing, manufacturers could use webbing of inferior strength to meet the standard's requirements. Without a specified initial breaking strength requirement, the percentage-of-strength requirement alone did not provide an effective floor for acceptable performance. The exposed webbing might have a breaking strength that is within the specified percentage of the strength of the new webbing, but the webbing might not have an absolute strength high enough to provide a margin of safety for use throughout the life of a child restraint (70 FR at 37732). The agency also determined that a minimum strength requirement should be based on an analysis of the forces likely to be imposed on the webbing. Our calculation of those forces led us to determine that a 15,000 N requirement would be high enough to withstand such forces, and would be high enough such that exposed webbing could degrade in strength yet would maintain sufficient strength to perform as needed for as long as the restraint is used. Related to its comment that its 5,385 N webbing is satisfactory, Britax stated that its webbing maintained in some cases up to 100 percent of the original webbing strength. Britax believed that the webbing maintains an acceptable strength following the specified testing and meets the agency's intent of the rulemaking. (Britax states, and we concur, that our intent “is to ensure that the webbing strength will as satisfactorily protect the life of the occupant at the end of the product life, as it did in the beginning.”) The agency concurs that keeping the current requirement that exposed webbing must retain a specified percentage of the original strength of the webbing is preferable to the approach proposed in the NPRM. This point is discussed in the next section. However, for the reasons given above, the agency believes that there should also be a component in FMVSS No. 213 that specifies the minimum strength of the new webbing. The 15,000 N and 11,000 N breaking strength requirements for new tether and harness webbing, respectively, serve a safety need and are reasonable. Further, Britax did not provide any data to show that the minimum breaking strength adopted today is “excessive.” The compliance data relied upon by the agency in the NPRM demonstrated that current child restraint systems are equipped with webbing that exceeds the minimum requirements adopted today 6 while being compliant with all of the injury criteria requirements of FMVSS No. 213. 6 The mean breaking strength for new tether webbing was over 17,000 N (NHTSA Docket No. 2005-21243-2). B. Advocates also raised a concern related to elongation of the webbing. The commenter recommended that the agency establish a requirement for the elongation characteristics of webbing, stating that elongation leads to fatigued material strength and can dramatically reduce webbing tensile strength during sudden dynamic loading. *Response:* An elongation requirement would be outside of the scope of the NPRM. Moreover, the agency disagrees that there is a demonstrated need to establish elongation requirements for webbing at the component level. The effect of webbing elongation is already addressed in the excursion limit requirements in the dynamic testing specified in FMVSS No. 213. S5.1.3.1 of FMVSS No. 213 limits the amount of excursion that can be experienced by a test dummy's head and knees during a 48 km/h (30 mile per hour) crash test. As such, the requirements for child restraint systems, when tested dynamically, place practical limits on the elongation characteristics of webbing. Advocates did not provide any data to indicate that the elongation limitation inherent to the dynamic requirements of FMVSS No. 213 is insufficient. 2. Need to retain percent-of-strength requirement for exposed webbing The NPRM proposed to establish minimum breaking strength requirements for exposed webbing. The minimum breaking strength requirements were calculated from the proposed strength requirements for new webbing, using the existing percent-of-strength requirements in the current rule. We proposed that abraded tether webbing would be required to have a minimum breaking strength of 11,200 N (which is 75 percent of 15,000 N), tether webbing exposed to the light degradation procedure would be required to have a breaking strength of 9,000 N (60 percent of 15,000 N), and tether webbing exposed to the micro-organism test procedure would be required to have a minimum breaking strength of 12,700 N (85 percent of 15,000 N). Comparable limits were proposed for exposed harness webbing. A. Britax suggested that “As the agency only tests new child restraint systems, with the proposed webbing breaking strength there is a wider window of degradability that may create an adverse condition in the field not detectable by the agency.” Britax stated that “the wider the window of degradability, the increase on the risk of adverse affect [sic] on child safety. * * * The proposed rule potentially permits a greater percentage of degradation.” Britax suggested that the minimum strength requirements for exposed webbing “must reflect the degradation percentages.” As stated by Britax: Under the proposed requirement, the minimum breaking strength of unabraded tether webbing is 15,000 N, 75% of which is 11,200 N—the minimum breaking strength of abraded tether webbing. As the proposed rule is written, the ‘minimum’ requirement allows the manufacturer to provide webbing with a higher breaking strength. Notwithstanding the potential result the higher breaking strength may have on the overall performance of the child restraint, the abraded webbing strength may be as low as 11,200 N, potential[ly] more than the 25% reduction in breaking strength now permitted under 49 CFR § 571.213 and 209. *Response:* After considering Britax's comment, we conclude that the NPRM did not sufficiently limit the degradation rate of webbing material and thus did not adequately fulfill the second of the agency's goals for the rulemaking. The agency agrees with the commenter that exposed webbing should be required to maintain a minimum percentage of its strength as new webbing, as a means of limiting the degradation rate of the webbing. The rate of degradation is preferable to specifying an absolute minimum strength for exposed webbing because limiting a rate of degradation insures proper webbing material selection. An excessive degradation rate ( *e.g.* , over 25% when subjected to the abrasion test) indicates a problem with the quality and/or durability of the selected material. Our review of general engineering literature indicates that specifying strength requirements by limiting degradation rates is standard industry practice for proper material selection. The degradation rate will not be limited by having only a minimum breaking strength applying to new and exposed webbing. We believe that Britax is correct that the approach of the NPRM created a potential loophole whereby webbing that degraded in the laboratory tests more than 25 percent when abraded, 40 percent when exposed to light, or 15 percent when exposed to micro-organisms could be used in the manufacture of child restraints. We want to prevent the use of such webbing because it may not last as long as necessary to protect children using the restraint (including for second-hand restraint use). The laboratory tests are accelerated aging tests which provide a snapshot of the webbing over prolonged exposure to environmental conditions. The tests are not intended to and do not assess how strong a particular tested specimen will be at the end of its life. The tests do not replicate the lifetime use of the webbing. 7 If a child restraint webbing sample lost more than 25 percent of its strength when abraded in the test, the webbing will have abraded so much during that snapshot assessment that we question its ability to last the lifetime of the restraint, 8 especially when exposed year after year to the cumulative effects of light, micro-organisms and other conditions. Thus, today's final rule maintains the current percent-of-strength requirements for exposed webbing. Exposed tether webbing must maintain 75 percent, 60 percent, and 85 percent of the new webbing strength when exposed to abrasion testing, light degradation testing, and micro-organism degradation testing, respectively. 7 “The primary purposes of laboratory tests are merely to save valuable time and to serve as controls in the manufacture of basic materials.” Plastics Engineering Handbook of the Society of the Plastics Industry, Inc., Third Ed., Van Nostrand Reinhold Company, 1960. 8 The same concerns apply to webbing that lost more than 40% or 15% of its strength after exposure to light and micro-organisms, respectively. NHTSA emphasizes that as a result of retaining the percent-of-strength breaking strength requirements for exposed webbing, if new webbing has a breaking strength higher than the minimum required (15,000 N for new tether webbing or 11,000 N for new harness webbing), the exposed webbing breaking strengths must be higher than the minimum values listed for exposed webbing in proposed Table 1 of the NPRM (for the convenience of the reader, that table was set forth in this preamble, *supra* ). Exceeding the degradation rates of the standard indicates a quality problem with the webbing material selection and raises concern that the webbing may not satisfactorily perform at the end of its product life as it did at the beginning, even if the exposed webbing has a breaking strength that is higher in magnitude than a competitor's webbing that met the percent-of-strength requirement. B. The agency proposed specific minimum strength requirements for exposed harness webbing that were based on the percent-of-strength requirements of the current standard; *i.e.* , 8,200 N (75 percent of 11,000 N) for abraded harness webbing, 6,600 N (60 percent of 11,000 N) for harness webbing exposed to light degradation, and 9,300 N (85 percent of 11,000 N) for harness webbing exposed to micro-organism degradation. Today's final rule does not establish absolute minimum strength values for exposed harness webbing, but instead retains the percent-of-strength requirements of the current regulation. Again, as the webbing requirements apply at a component level, the minimums established today ensure that child restraint webbing will perform adequately and will continue to do so as it ages. 3. Artifacts of component testing of webbing A. The webbing requirements adopted today apply to webbing at the component level, *i.e.* , child restraint webbing must comply with the requirements when tested independently from the child restraint system. Britax wanted the agency to consider child restraint requirements in terms of the interaction of the restraint with a vehicle on a system level. The commenter was concerned that establishing minimum breaking strength requirements for multiple child restraint components would hinder a manufacturer's ability to “optimize” a design to maximize safety. *Response:* Today's requirements apply to the component level to the same extent as currently required under the standard. The component requirements enable the agency to conduct accelerated aging tests. The breaking strength requirements ensure that the performance of webbing over the lifetime of a child restraint system is sufficient to provide the necessary protection. Requirements that apply to new child restraints only, such as the dynamic sled test conducted on the child restraint as a system, do not provide comparable assurances, particularly for components such as webbing that are likely to experience extraordinary “wear and tear” and exposure to elements that can degrade the webbing strength in the course of normal use. B. With regard to the specific percent-of-strength requirements, Advocates asked why different exposure paths have different percent requirements. *Response:* As explained in the NPRM, the percent-of-strength values and the corresponding test procedures were determined by the Society of Automotive Engineers

(SAE)and incorporated into SAE standard SAE J4c, *Motor Vehicle Seat Belt Assemblies.* The agency incorporated the SAE percentages and procedures into FMVSS Nos. 209 and 213. The differences in percentage degradation levels for abrasion, exposure to light, and exposure to micro-organisms are due to differences in the accelerated laboratory test procedures used to predict long-term exposure. That is, the degradation percentage requirements are dependant on the procedures for the individual tests. For example, the resistance-to-abrasion test specifies a 2,500 cycle procedure at a specific weight and cycle rate. The resistance-to-light test specifies 100 hours of exposure to carbon-arc light. The variations in the types of environmental tests the webbing is exposed to are reflected in the differences in the percent degradation requirements. d. Conclusions Today's final rule adopts the proposed minimum breaking strength requirements for new webbing, but does not adopt the proposal to specify minimum breaking strength requirements for exposed webbing. Instead, the final rule retains, for exposed webbing, the current percent-of-strength requirements. Under today's final rule, new tether webbing must have a minimum breaking strength of 15,000 N, and new harness webbing must have a minimum breaking strength of 11,000 N. For exposed webbing, rather than adopting specific strength requirements for the webbing, we are retaining the current percent-of-strength requirement. That is, exposed webbing, whether it is tether webbing or harness webbing, must maintain 75 percent, 60 percent, and 85 percent of the new webbing strength when exposed to abrasion testing, light degradation testing, and micro-organism degradation testing, respectively. The requirements adopted today increase the likelihood that the webbing material of child restraints maintains its integrity for the lifetime of the restraint. The degradation rate of the webbing, as measured in the “snapshot” of the performance of the webbing obtained in the accelerated aging tests, indicates the quality of the material in withstanding long-term exposure. The ability of the webbing to maintain its integrity is especially important now that child restraints are required by FMVSS No. 213 to have components that attach to the LATCH system on vehicles. Child restraint manufacturers have predominately chosen to connect these components to the child restraint by use of webbing material. Requiring the webbing material to meet a minimum strength requirement when new, and not exceed a specified rate of degradation when exposed to environmental conditions, will better ensure that child restraints will be able to be securely attached to the vehicle in a crash, even when the restraint is passed down to second-hand users. II. Weight Used to Abrade S5.4.1(a) of FMVSS No. 213 requires that child restraint belt webbing must meet breaking strength requirements after being abraded pursuant to a procedure specified in S5.1(d) of FMVSS No. 209. S5.1(d)'s abrasion procedure requires that belt webbing be drawn across two edges of a hexagonal steel bar by an oscillating drum, with one end of the webbing sample attached to the drum and the other attached to a weight with a specified mass. Two different weights are specified: One end of the webbing

(A)shall be attached to a mass

(B)of 2.35 [kilogram (kg)] ± .05 kg, except that a mass of 1.5 kg ± .05 kg shall be used for webbing in pelvic and upper torso restraints of a belt assembly used in a child restraint system. A tether strap used to attach a child restraint to the vehicle is neither a pelvic nor upper torso restraint, and therefore does not fall within the exclusion allowing for use of the 1.5 kg mass. Thus, the 2.35 kg mass should be used to abrade tether webbing. To make the wording clearer, the NPRM proposed to amend S5.4.1 by adding a reference to the 2.35 kg mass as the mass used in the abrasion test to abrade webbing used to attach a child restraint to a vehicle's LATCH system (tether webbing). The agency wanted to clarify the language because it believed it was important that the 2.35 kg mass be used to abrade this webbing. The heavier weight should be used because installation and removal of the child seat exposes the webbing to greater potential for abrasion, and because the webbing used for the LATCH attachments must restrain the mass of both the child and the child restraint system. No comments were received on this issue and the agency reiterates that the heavier mass should be used in the test of tether straps (i.e., any strap used to attach the child restraint to LATCH anchorages). However, as we were reviewing the proposed S5.4.1 regulatory text, we determined that the proposed language was in need of correction, as it was not equivalent to nor did it entirely clarify the language of S5.1(d) of FMVSS No. 209. We concluded that it was unnecessary to limit the text specifically to webbing used to secure a child restraint system to the LATCH anchorages, and that doing so could give rise to questions of interpretation about which weight to use for webbing that was neither used in pelvic and upper torso restraints of a child restraint belt assembly nor used to attach the restraint to a LATCH system. Accordingly, this final rule generally uses the language of S5.1(d) of FMVSS No. 209 in clarifying FMVSS No. 213 regarding the mass used to test the webbing of child restraints, but specifies that the heavier mass (2.35 kg) must be used for webbing including but not limited to webbing used to secure child restraint systems to LATCH anchorages and that the lighter mass (1.5 kg) shall be used for webbing in pelvic and upper torso restraints of a belt assembly used in a child restraint system. III. Compliance Date The compliance date of this rule is September 1, 2007 (all child restraints manufactured on or after this date must meet the requirements of this final rule). A majority of the child restraint systems surveyed for the NPRM would comply with the requirements adopted today. However, the agency is aware that manufacturers may purchase webbing for production of a child restraint model in advance of production. Today's final rule provides manufacturers with over a year of lead time, which should minimize the need for manufacturers to replace existing stock and will provide adequate time for manufacturers to secure compliant webbing for future production. IV. Rulemaking Analyses and Notices Executive Order 12866 and DOT Regulatory Policies and Procedures NHTSA has considered the impact of this rulemaking action under E.O. 12866 and the Department of Transportation's regulatory policies and procedures. This rulemaking was not reviewed by the Office of Management and Budget. The rulemaking action is also not considered to be significant under the Department of Transportation's Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). The agency concludes that this rulemaking action will not have an annual effect on the economy of $100 million. The agency is establishing minimum breaking strength requirements for webbing used in child restraint systems. The agency estimates that most child restraint systems meet these requirements. NHTSA estimates that the cost of webbing material that meets the requirements adopted today is only about $.10 per foot. Thus, the impacts of this rulemaking are so minor so as not to warrant the preparation of a full regulatory evaluation. Regulatory Flexibility Act Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), the agency must determine the impact of its proposal or final rule on small businesses. The Small Business Administration's regulations at 13 CFR Part 121 define a small business, in part, as a business entity “which operates primarily within the United States.” (13 CFR 121.105(a)). No regulatory flexibility analysis is required if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. NHTSA has considered the effects of this final rule under the Regulatory Flexibility Act. I certify that this rule would not have a significant economic impact on a substantial number of small entities. The rational for this certification is that most child restraint systems meet the requirements. For manufacturers producing child restraints that do not meet the minimum strength requirements, it will not be difficult for these manufacturers to obtain and use complying webbing on their child restraints. Further, the agency is providing more than a year for manufacturers that do not comply to obtain and incorporate compliant webbing. National Environmental Policy Act NHTSA has analyzed this rulemaking action for the purposes of the National Environmental Policy Act. The agency has determined that implementation of this rule will not have any significant impact on the quality of the human environment. Executive Order 13132 (Federalism) NHTSA has analyzed this rule in accordance with the principles and criteria set forth in Executive Order 13132 and has determined that the rule will not have sufficient Federalism implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement. The rule will not have any substantial effects on the States, the current Federal-State relationship, or the current distribution of power and responsibilities among the various local officials. Civil Justice Reform (E.O. 12988) Today's final rule will not have any retroactive effect. Under 49 U.S.C. 30103, whenever a Federal motor vehicle safety standard is in effect, a State may not adopt or maintain a safety standard applicable to the same aspect of performance which is not identical to the Federal standard, except to the extent that the State requirement imposes a higher level of performance and applies only to vehicles procured for the State's use. 49 U.S.C. 30161 sets forth a procedure for judicial review of final rules establishing, amending, or revoking Federal motor vehicle safety standards. That section does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court. Paperwork Reduction Act Under the Paperwork Reduction Act of 1995, a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. This rule does not require any collections of information as defined by the OMB in 5 CFR Part 1320. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) directs NHTSA to use voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law or otherwise impractical (Pub. L. 104-113, codified at 15 U.S.C. 272). Voluntary consensus standards are technical standards ( *e.g.* , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies, such as the Society of Automotive Engineers (SAE). The NTTAA directs NHTSA to provide Congress, through the OMB, explanations when the agency decides not to use available and applicable voluntary consensus standards. Today's final rule continues to rely on SAE J4c with regard to the exposed webbing requirements. There are no other relevant voluntary consensus standards available at this time. However, the agency will consider any such standards when they become available. Unfunded Mandates Reform Act Section 202 of the Unfunded Mandates Reform Act of 1995

(UMRA)requires Federal agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million in any one year (adjusted for inflation with a base year of 1995). Adjusting this amount by the gross domestic product price deflator for the year 2004 results in about $118 million (115.5 ÷ 98.11 × $100 million). The agency has concluded that this rule will not result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $118 million annually. Accordingly, no Unfunded Mandates assessment has been prepared. Regulation Identifier Number

(RIN)The Department of Transportation assigns a regulation identifier number

(RIN)to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda. Privacy Act Anyone is able to search the electronic form of all submissions received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit *http://dms.dot.gov.* List of Subjects in 49 CFR Part 571 Motor vehicle safety, Reporting and recordkeeping requirements, Tires. In consideration of the foregoing, NHTSA amends 49 CFR part 571 as follows: PART 571—[AMENDED] 1. The authority citation for part 571 continues to read as follows: Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30166; delegation of authority at 49 CFR 1.50. 2. S5.4.1 of Section 571.213 is amended by revising S5.4.1 and S5.4.1.1, and by adding S5.4.1.2 and S5.4.1.3, to read as follows: § 571.213 Standard No. 213; Child restraint systems. S5.4.1 *Performance requirements.* S5.4.1.1 *Child restraint systems manufactured before September 1, 2007.* The webbing of belts provided with a child restraint system and used to attach the system to the vehicle or to restrain the child within the system shall—

(a)After being subjected to abrasion as specified in S5.1(d) or S5.3(c) of FMVSS 209 (§ 571.209), have a breaking strength of not less than 75 percent of the strength of the unabraded webbing when tested in accordance with S5.1(b) of FMVSS 209. A mass of 2.35 ± .05 kg shall be used in the test procedure in S5.1(d) of FMVSS 209 for webbing, including webbing used to secure a child restraint system to the tether and lower anchorages of a child restraint anchorage system, except that a mass of 1.5 +/−.05 kg shall be used for webbing in pelvic and upper torso restraints of a belt assembly used in a child restraint system. The mass is shown as

(B)in Figure 2 of FMVSS 209.

(b)Meet the requirements of S4.2

(e)and

(f)of FMVSS No. 209 (§ 571.209); and

(c)If contactable by the test dummy torso when the system is tested in accordance with S6.1, have a width of not less than 1 1/2 inches when measured in accordance with S5.4.1.3. S5.4.1.2 *Child restraint systems manufactured on or after September 1, 2007.* The webbing of belts provided with a child restraint system and used to attach the system to the vehicle or to restrain the child within the system shall—

(a)Have a minimum breaking strength for new webbing of not less than 15,000 N in the case of webbing used to secure a child restraint system to the vehicle, including the tether and lower anchorages of a child restraint anchorage system, and not less than 11,000 N in the case of the webbing used to secure a child to a child restraint system when tested in accordance with S5.1 of FMVSS No. 209. Each value shall be not less than the 15,000 N and 11,000 N applicable breaking strength requirements, but the median value shall be used for determining the retention of breaking strength in paragraphs (b)(1), (c)(1), and (c)(2) of this section S5.4.1.2. “New webbing” means webbing that has not been exposed to abrasion, light or micro-organisms as specified elsewhere in this section. (b)(1) After being subjected to abrasion as specified in S5.1(d) or S5.3(c) of FMVSS 209 (§ 571.209), have a breaking strength of not less than 75 percent of the new webbing strength, when tested in accordance with S5.1(b) of FMVSS 209.

(2)A mass of 2.35 ± .05 kg shall be used in the test procedure in S5.1(d) of FMVSS 209 for webbing, including webbing to secure a child restraint system to the tether and lower anchorages of a child restraint anchorage system, except that a mass of 1.5 ± .05 kg shall be used for webbing in pelvic and upper torso restraints of a belt assembly used in a child restraint system. The mass is shown as

(B)in Figure 2 of FMVSS 209. (c)(1) After exposure to the light of a carbon arc and tested by the procedure specified in S5.1(e) of FMVSS 209 (§ 571.209), have a breaking strength of not less than 60 percent of the new webbing, and shall have a color retention not less than No. 2 on the Geometric Gray Scale published by the American Association of Textile Chemists and Colorists, Post Office Box 886, Durham, NC.

(2)After being subjected to micro-organisms and tested by the procedures specified in S5.1(f) of FMVSS 209 (§ 571.209), shall have a breaking strength not less than 85 percent of the new webbing.

(d)If contactable by the test dummy torso when the system is tested in accordance with S6.1, have a width of not less than 1 1/2 inches when measured in accordance with S5.4.1.3. S5.4.1.3 *Width test procedure.* Condition the webbing for 24 hours in an atmosphere of any relative humidity between 48 and 67 percent, and any ambient temperature between 70° and 77 °F. Measure belt webbing width under a tension of 5 pounds applied lengthwise. Issued: May 31, 2006. Jacqueline Glassman, Deputy Administrator. [FR Doc. E6-8727 Filed 6-6-06; 8:45 am] BILLING CODE 4910-59-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 680 [Docket No. 060227052-6139-02; I.D. 021606B] RIN 0648-AU06 Fisheries of the Exclusive Economic Zone Off Alaska; Allocating Bering Sea and Aleutian Islands King and Tanner Crab Fishery Resources AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. SUMMARY: NMFS issues a final rule implementing Amendment 20 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner crabs (FMP). This action amends the Crab Rationalization Program (hereinafter referred to as the Program) to modify the allocation of harvesting shares and processing shares for Bering Sea Tanner crab *Chionoecetes bairdi* (Tanner crab) to allow this species to be managed as two separate stocks. This action is necessary to increase resource conservation and economic efficiency in the crab fisheries that are subject to the Program. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the FMP, and other applicable law. DATES: Effective on July 7, 2006. ADDRESSES: Copies of Amendment 20, the Final Regulatory Flexibility Analysis (FRFA), and the Environmental Assessment (EA), Regulatory Impact Review (RIR), and Initial Regulatory Flexibility Analysis

(IRFA)prepared for this action may be obtained from the NMFS Alaska Region, P.O. Box 21668, Juneau, AK 99802, Attn: Records Office, and on the Alaska Region, NMFS, website at *http://www.fakr.noaa.gov/sustainablefisheries/crab/eis/default.htm* . FOR FURTHER INFORMATION CONTACT: Glenn Merrill, 907-586-7228 or *glenn.merrill@noaa.gov* . SUPPLEMENTARY INFORMATION: The king and Tanner crab fisheries in the exclusive economic zone of the Bering Sea and Aleutian Islands

(BSAI)are managed under the FMP. The FMP was prepared by the North Pacific Fishery Management Council (Council) under the Magnuson-Stevens Act as amended by the Consolidated Appropriations Act of 2004 (Public Law 108-199, section 801). Amendments 18 and 19 to the FMP to implement the Program. A final rule implementing these amendments was published on March 2, 2005 (70 FR 10174). NMFS also published three corrections to the final rule (70 FR 13097; March 18, 2005), (70 FR 33390; June 8, 2005) and (70 FR 75419; December 20, 2005). In October 2005, the Council adopted Amendment 20 to the FMP. The Notice of Availability for Amendment 20 was published in the **Federal Register** on February 27, 2006 (71 FR 9770). NMFS approved Amendment 20 on May 25, 2006. NMFS published a proposed rule to implement Amendment 20 in the **Federal Register** on March 21, 2006 (71 FR 14153). Public comments on the proposed rule were solicited through May 5, 2006. No public comments were received and therefore, no changes were made from the proposed to final rule. A description of this action is provided in the preamble to the proposed rule (March 21, 2006, 71 FR 14153) and is briefly summarized here. Under the Program, harvester quota share (QS), processor quota share (PQS), individual fishing quota (IFQ), and individual processing quota

(IPQ)currently are issued for one Tanner crab fishery. The State of Alaska (State), however, has determined that eastern Bering Sea Tanner crab should be separated into two stocks and managed as two separate fisheries to avoid localized depletion by the commercial fishery, particularly of legal-sized males in the Pribilof Islands area. The Program and the final rule implementing it allocated shares of the Tanner crab fishery in the Bering Sea, but did not separately distinguish the management of these two stocks. Amendment 20 to the FMP modifies the allocation of harvesting shares and processing shares for Bering Sea Tanner crab to accommodate management of geographically separate Tanner crab fisheries. This action allocates QS and PQS and the resulting IFQ and IPQ for two Tanner crab fisheries, one east of 166° W. longitude and the other west of 166° W. longitude. Revision of the QS and PQS allocations resolves the current inconsistency between current allocations and management of the Tanner crab species as two stocks. This change will reduce administrative costs for managers and the operational costs of harvesters and processors while increasing their flexibility. This action does not alter the basic structure or management of the Program. Reporting, monitoring, fee collection, and other requirements to participate in the Tanner crab fishery are unchanged. This action does not increase the number of harvesters or processors in the Tanner crab fisheries or the amount of crab that may be harvested currently. This action does not affect regional delivery requirements or other restrictions on harvesting and processing Tanner crab that currently apply. NMFS will reissue Tanner crab QS and PQS. Currently, Tanner crab is issued as Bering Sea Tanner

(BST)QS and BST PQS. For each share of BST QS held, a person will be issued one share of eastern Bering Sea Tanner crab

(EBT)QS, and one share of western Bering Sea Tanner crab

(WBT)QS. Similarly, for each BST PQS held, a person will be issued one share of EBT PQS, and one share of WBT PQS. EBT QS and PQS would result in IFQ and IPQ that could be used for the Tanner crab fishery occurring east of 166° W. longitude; WBT QS and PQS would result in IFQ and IPQ that could be used for the Tanner crab fishery occurring west of 166° W. longitude. This reissuance of Tanner crab QS and PQS will not increase the number of initially issued Tanner crab quota holders. Tanner crab QS and PQS holders will receive IFQ and IPQ in a specific fishery only if that specific Tanner crab fishery has a harvestable surplus and a total allowable catch

(TAC)assigned by the State. NMFS will reissue Tanner crab QS and PQS after the end of the current Tanner crab fishing season (March 31, 2006), and prior to the date when the State announces the TACs for the 2006/2007 crab fishing seasons (October 1, 2006). This will reduce any potential conflict with the current Tanner crab fishery. Classification The Regional Administrator determined that Amendment 20 is necessary for the conservation and management of the Bering Sea crab fisheries and that it is consistent with the Magnuson-Stevens Act and other applicable laws. NMFS prepared an FRFA which incorporates the IRFA, a summary of the analyses completed to support the action, and public comments received on the IRFA. A copy of this analysis is available from NMFS (see ADDRESSES ). The following summarizes the FRFA. The FRFA evaluates the impacts of this rule. The FRFA addresses the statutory requirements of the Regulatory Flexibility Act

(RFA)of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 (5 U.S.C. 601-612). It specifically addresses the requirements at section 604(a). Issues Raised by Public Comments on the IRFA The proposed rule was published in the **Federal Register** on March 21, 2006 (71 FR 14153). An IRFA was prepared for the proposed rule, and described in the classifications section of the preamble to the rule. The public comment period ended on May 5, 2006. No public comment were received on the IRFA. No changes were made to the final rule from the proposed rule. Need for and Objectives of This Action The reasons for this action and the objectives and legal basis for the rule are discussed in the preamble to this rule and are not repeated here. Number and Description of Small Entities Affected by the Rule The FRFA contains a description and estimate of the number of directly affected small entities. Estimates of the number of small harvesting entities under the Program are complicated by several factors. Each eligible captain will receive an allocation of QS under the Program. A total of 186 captains received allocations of Tanner crab QS for the 2005-2006 fishery. In addition, 269 allocations of QS to Limited License Program

(LLP)license holders were made under the Program, for a total of 455 QS allocations in the Tanner crab fisheries. Because some persons participated as LLP holders and captains and others received allocations from the activities of multiple vessels, only 294 unique persons received QS. Of those entities receiving QS, 287 are small entities because they either generated $4.0 million or less in gross revenue, or they are independent entities not affiliated with a processor. Estimates of gross revenues for purposes of determining the number of small entities relied on the low estimates of prices from the arbitration reports based on the 2005/2006 fishing season. Allocations of Tanner crab PQS under the Program were made to 20 processors. Of these PQS recipients, nine are estimated to be large entities, and 11 are small entities. Estimates of large entities were made based on available records of employment and the analysts' knowledge of foreign ownership of processing companies. These totals exclude catcher/processors, which are included in the LLP holder discussion. Recordkeeping and Reporting Requirements The reporting, recordkeeping, and other compliance requirements of the final rule will not change from those of the Program with respect to QS, IFQ, PQS, and IPQ. As such, this action requires no additional reporting, recordkeeping, or other compliance requirements. Description of Significant Alternatives and Description of Steps Taken to Minimize the Significant Economic Impacts on Small Entities The EA/RIR/FRFA prepared for this action analyzed a suite of three alternatives for harvesters, and a separate suite of three alternatives for processors. Alternative 1 for harvesters and processors, the no action alternative, would maintain the existing inconsistency between Federal allocations supporting a single Tanner crab fishery and State management of two stocks of Tanner crab. For harvesters, the difference in effects of the revised allocation alternatives on the social and economic environment is primarily distributional. Under the preferred harvester alternative (Alternative 2), an eligible participant receives an allocation in both fisheries based on all qualifying catches regardless of where that catch occurred. Under harvester Alternative 3, a harvester would receive an allocation in each fishery based on historic catch from the area of the fishery. Under this alternative, a person's allocation would be skewed toward the area in which the person had greater catch relative to other participants. For processors, the choice of revised allocation alternatives would have operational and efficiency effects. Under the preferred processor alternative (Alternative 2), PQS and IPQ pools are created for the two fisheries. Share holders can trade shares in the fisheries independently to establish long-term relationships in each fishery. Under processor Alternative 3, PQS would generate an annual allocation of IPQ that could be used in either fishery. Since TACs in the fisheries may fluctuate independently, harvesters that do not hold equal percentages of the pools in both fisheries will be unable to establish fixed long-term relationships with a processor for all their shares. Instead, these participants would need to modify their relationships if TACs change independently in the different Tanner crab fisheries. This restructuring of relationships could reduce efficiency in the Tanner crab fisheries by adding to transaction costs of participants. Although the different allocations under consideration in this action would have distributional and efficiency impacts for individual participants, in no case are these aggregated impacts expected to be substantial. In all instances, similar numbers of participants would receive allocations. Alternative 1 for harvesters would create inefficiencies for harvesters by failing to provide a mechanism to ensure that quota is managed for each stock separately in accordance with biomass distribution. Preferred Alternative 2 provides additional flexibility to industry participants to hold quota to fish specific Tanner crab fisheries and reduce potential conflicts among participants that may occur if one quota is used to provide harvesting privileges to two distinct stocks. Alternative 3 would skew the allocation of a harvesters QS to a specific region based on historic catch that may not be reflective of current fishing practices, and could result in increased transaction costs for harvesters to transfer QS or IFQ to fit their current fishing practices. Alternative 1 for processors would fail to provide an opportunity for processors to establish long term relationships with specific harvesters for specific Tanner crab deliveries. This could increase operational costs. Although none of the alternatives has substantial negative impacts on small entities, preferred Alternative 2 for processors minimizes the potential negative impacts that could arise under Alternatives 1 and 3 for processors by increasing their ability to establish fixed long-term relationships with a harvester for delivery of their IFQ. Differences in efficiency that could arise among the harvester and processor alternatives are likely to affect most participants in a minor way having an overall insubstantial impact. As a consequence, none of the alternatives is expected to have any significant economic or socioeconomic impacts. This final rule has been determined to be not significant for purposes of Executive Order 12866. Small Entity Compliance Guide NMFS has posted a small entity compliance guide on the Internet at *http://www.fakr.noaa.gov/sustainablefisheries/crab/crfaq.htm* to satisfy the Small Business Regulatory Enforcement Fairness Act of 1996, which requires a plain language guide to assist small entities in complying with this rule. Contact NMFS to request a hard copy of the guide (see ADDRESSES ). List of Subjects in 50 CFR Part 680 Alaska, Fisheries, Reporting and recordkeeping requirements. Dated: June 1, 2006. James W. Balsiger, Acting Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. For the reasons set out in the preamble, 50 CFR part 680 is amended as follows: PART 680—SHELLFISH FISHERIES OF THE EXCLUSIVE ECONOMIC ZONE OFF ALASKA 1. The authority citation for part 680 continues to read as follows: Authority: 16 U.S.C. 1862. 2. In § 680.4, revise paragraphs

(b)and

(c)to read as follows: § 680.4 Permits.

(b)*Crab QS permit.*

(1)Crab QS is issued by the Regional Administrator to persons who successfully apply for an initial allocation under § 680.40 or receive QS by transfer under § 680.41. Once issued, a crab QS permit is valid until modified under paragraph (b)(2) of this section, or by transfer under § 680.41; or until the permit is revoked, suspended, or modified pursuant to § 679.43 of this chapter or under 15 CFR part 904. To qualify for a crab QS permit, the applicant must be a U.S. Citizen.

(2)Each unit of Crab QS initially issued under § 680.40 for the Bering Sea Tanner crab ( *Chionoecetes bairdi* ) CR fishery shall be reissued as one unit of Eastern Bering Sea Tanner crab

(EBT)QS and one unit of Western Bering Sea Tanner crab

(WBT)QS.

(c)*Crab PQS permit.*

(1)Crab PQS is issued by the Regional Administrator to persons who successfully apply for an initial allocation under § 680.40 or receive PQS by transfer under § 680.41. Once issued, a crab PQS permit is valid until modified under paragraph (c)(2) of this section, or by transfer under § 680.41; or until the permit is revoked, suspended, or modified pursuant to § 679.43 of this chapter or under 15 CFR part 904.

(2)Each unit of Crab PQS initially issued under § 680.40 for the Bering Sea Tanner crab ( *Chionoecetes bairdi* ) CR fishery shall be reissued as one unit of Eastern Bering Sea Tanner crab

(EBT)PQS and one unit of Western Bering Sea Tanner crab

(WBT)PQS. §§ 680.40 and 680.41 [Amended] 3. In the table below, at each of the locations shown in the “LOCATION” column, remove the phrase indicated in the “REMOVE” column and replace it with the phrase indicated in the “ADD” column: LOCATION REMOVE ADD § 680.40(b)(2)(ii)(A) BST EBT or WBT § 680.40(d)(2)(iv)(B) BST EBT or WBT § 680.41(l)(1)(i) BST EBT, WBT, 4. In § 680.40, revise paragraph (b)(2)(iii) to read as follows: § 680.40 Quota Share (QS), Processor QS (PQS), Individual Fishing Quota (IFQ), and Individual Processor Quota

(IPQ)issuance.

(b)* * *

(2)* * *

(iii)The regional designations that apply to each of the crab QS fisheries are specified in the following table: Crab QS Fishery North Region South Region West Region Undesignated Region

(A)EAG X X

(B)WAG X X

(C)EBT X

(D)WBT X

(E)BSS X X

(F)BBR X X

(G)PIK X X

(H)SMB X X

(I)WAI X 5. In § 680.42, revise paragraph (a)(2)(i), (a)(3)(i), (a)(4)(i), and (c)(1) to read as follows: § 680.42 Limitations on use of QS, PQS, IFQ and IPQ.

(a)* * *

(2)* * *

(i)Hold QS in amounts in excess of the amounts specified in the following table, unless that person's QS was received in the initial allocation: Fishery CVO/CPO Use Cap in QS Units CVC/CPC Use Cap in QS Units

(A)Percent of the initial QS pool for BBR 1.0% = 3,880,000 2.0% = 240,000

(B)Percent of the initial QS pool for BSS 1.0% = 9,700,000 2.0% = 600,000

(C)Percent of the initial QS pool for EBT 1.0% = 1,940,000 2.0% = 120,000

(D)Percent of the initial QS pool for WBT 1.0% = 1,940,000 2.0% = 120,000

(E)Percent of the initial QS pool for PIK 2.0% = 582,000 4.0% = 36,000

(F)Percent of the initial QS pool for SMB 2.0% = 582,000 4.0% = 36,000

(G)Percent of the initial QS pool for EAG 10.0% = 970,000 20.0% = 60,000

(H)Percent of the initial QS pool for WAG 10.0% = 3,880,000 20.0% = 240,000

(I)Percent of the initial QS pool for WAI 10.0% = 5,820,000 20.0% = 360,000

(3)* * *

(i)Hold QS in excess of more than the amounts of QS specified in the following table: Fishery CDQ CVO/CPO Use Cap in QS Units

(A)5.0 percent of the initial QS pool for BBR 19,400,000

(B)5.0 percent of the initial QS pool for BSS 48,500,000

(D)5.0 percent of the initial QS pool for WBT 9,700,000

(E)10.0 percent of the initial QS pool for PIK 2,910,000

(F)10.0 percent of the initial QS pool for SMB 2,910,000

(G)20.0 percent of the initial QS pool for EAG 1,940,000

(H)20.0 percent of the initial QS pool for WAG 7,760,000

(I)20.0 percent of the initial QS pool for WAI 11,640,000

(4)* * *

(i)Hold QS in excess of the amounts specified in the following table: Fishery CVO/CPO Use Cap in QS Units

(A)5.0 percent of the initial QS pool for BBR 19,400,000

(B)5.0 percent of the initial QS pool for BSS 48,500,000

(D)5.0 percent of the initial QS pool for WBT 9,700,000

(E)5.0 percent of the initial QS pool for PIK 1,455,000

(F)5.0 percent of the initial QS pool for SMB 1,455,000

(G)5.0 percent of the initial QS pool for EAG 485,000

(H)5.0 percent of the initial QS pool for WAG 1,940,000

(I)5.0 percent of the initial QS pool for WAI 2,910,000

(c)* * *

(1)Except for vessels that participate solely in a crab harvesting cooperative as described under § 680.21 and under the provisions described in paragraph (c)(4) of this section, no vessel may be used to harvest CVO or CPO IFQ in excess of the following percentages of the TAC for that crab QS fishery for that crab fishing year:

(i)2.0 percent for BSS;

(ii)2.0 percent for BBR;

(iii)2.0 percent for EBT;

(iv)2.0 percent for WBT;

(v)4.0 percent for PIK;

(vi)4.0 percent for SMB;

(vii)20.0 percent for EAG;

(viii)20.0 percent for WAG; or

(ix)20.0 percent for the WAI crab QS fishery west of 179° W. long. 6. Revise Table 1, to part 680 to read as follows: Table 1 to Part 680—Crab Rationalization

(CR)Fisheries Fishery Code CR Fishery Geographic Area BBR Bristol Bay red king crab ( *Paralithodes camtshaticus* ) In waters of the EEZ with:

(1)*A northern boundary* of 58°30′ N. lat.,

(2)*A southern boundary* of 54°36′ N. lat., and

(3)*A western boundary* of 168° W. long. and including all waters of Bristol Bay. BSS Bering Sea Snow crab ( *Chionoecetes opilio* ) In waters of the EEZ with:

(1)*A northern and western boundary* of the Maritime Boundary Agreement Line as that line is described in the text of and depicted in the annex to the Maritime Boundary Agreement between the United States and the Union of Soviet Socialist Republics signed in Washington, June 1, 1990, and as the Maritime Boundary Agreement Line as depicted on NOAA Chart No. 513 (6th edition, February 23, 1991) and NOAA Chart No. 514 (6th edition, February 16, 1991), and

(2)*A southern boundary* of 54°30′ N. lat. to 171° W. long., and then south to 54°36′ N. lat. EAG Eastern Aleutian Islands golden king crab ( *Lithodes aequispinus* ) In waters of the EEZ with:

(1)*An eastern boundary* the longitude of Scotch Cap Light (164°44′ W. long.) to 53°30′ N. lat., then West to 165° W. long.,

(2)*A western boundary* of 174° W. long., and

(3)*A northern boundary* of a line from the latitude of Cape Sarichef (54°36′ N. lat.) westward to 171° W. long., then north to 55°30′ N. lat., then west to 174° W. long. EBT Eastern Bering Sea Tanner crab ( *Chionoecetes bairdi* ) In waters of the EEZ with:

(1)*A western boundary* the longitude of 166° W. long.,

(2)*A northern boundary* of the Maritime Boundary Agreement Line as that line is described in the text of and depicted in the annex to the Maritime Boundary Agreement between the United States and the Union of Soviet Socialist Republics signed in Washington, June 1, 1990, and as the Maritime Boundary Agreement Line as depicted on NOAA Chart No. 513 (6th edition, February 23, 1991) and NOAA Chart No. 514 (6th edition, February 16, 1991), and

(3)*A southern boundary* of 54°30'N. lat. PIK Pribilof red king and blue king crab ( *Paralithodes camtshaticus* and *P. platypus* ) In waters of the EEZ with:

(1)*A northern boundary* of 58°30′ N. lat.,

(2)*An eastern boundary* of 168° W. long., and

(3)*A southern boundary* line from 54°36′ N. lat., 168° W. long., to 54°36′ N. lat., 171° W. long., to 55°30′ N. lat., 171° W. long., to 55°30′ N. lat., 173°30′ E. lat., and then westward to the Maritime Boundary Agreement Line as that line is described in the text of and depicted in the annex to the Maritime Boundary Agreement between the United States and the Union of Soviet Socialist Republics signed in Washington, June 1, 1990, and as the Maritime Boundary Agreement Line as depicted on NOAA Chart No. 513 (6th edition, February 23, 1991) and NOAA Chart No. 514 (6th edition, February 16, 1991). SMB St. Matthew blue king crab ( *Paralithodes platypus* ) In waters of the EEZ with:

(1)*A northern boundary* of 62° N. lat.,

(2)*A southern boundary* of 58°30′ N. lat., and

(3)*A western boundary* of the Maritime Boundary Agreement Line as that line is described in the text of and depicted in the annex to the Maritime Boundary Agreement between the United States and the Union of Soviet Socialist Republics signed in Washington, June 1, 1990, and as the Maritime Boundary Agreement Line as depicted on NOAA Chart No. 513 (6th edition, February 23, 1991) and NOAA Chart No. 514 (6th edition, February 16, 1991). WAG Western Aleutian Islands golden king crab ( *Lithodes aequispinus* ) In waters of the EEZ with:

(1)*An eastern boundary* the longitude 174° W. long.,

(2)*A western boundary* the Maritime Boundary Agreement Line as that line is described in the text of and depicted in the annex to the Maritime Boundary Agreement between the United States and the Union of Soviet Socialist Republics signed in Washington, June 1, 1990, and as the Maritime Boundary Agreement Line as depicted on NOAA Chart No. 513 (6th edition, February 23, 1991) and NOAA Chart No. 514 (6th edition, February 16, 1991), and

(3)*A northern boundary* of a line from the latitude of 55°30′ N. lat., then west to the U.S.-Russian Convention line of 1867. WAI Western Aleutian Islands red king crab ( *Paralithodes camtshaticus* ) In waters of the EEZ with:

(1)*An eastern boundary* the longitude 179° W. long.,

(2)*A western boundary* of the Maritime Boundary Agreement Line as that line is described in the text of and depicted in the annex to the Maritime Boundary Agreement between the United States and the Union of Soviet Socialist Republics signed in Washington, June 1, 1990, and as the Maritime Boundary Agreement Line as depicted on NOAA Chart No. 513 (6th edition, February 23, 1991) and NOAA Chart No. 514 (6th edition, February 16, 1991), and

(3)*A northern boundary* of a line from the latitude of 55°30′ N. lat., then west to the Maritime Boundary Agreement Line as that line is described in the text of and depicted in the annex to the Maritime Boundary Agreement between the United States and the Union of Soviet Socialist Republics signed in Washington, June 1, 1990, and as the Maritime Boundary Agreement Line as depicted on NOAA Chart No. 513 (6th edition, February 23, 1991) and NOAA Chart No. 514 (6th edition, February 16, 1991). WBT Western Bering Sea Tanner crab ( *Chionoecetes bairdi* ) In waters of the EEZ with:

(1)*An eastern boundary* the longitude of 166° W. long.,

(2)*A northern and western boundary* of the Maritime Boundary Agreement Line as that line is described in the text of and depicted in the annex to the Maritime Boundary Agreement between the United States and the Union of Soviet Socialist Republics signed in Washington, June 1, 1990, and as the Maritime Boundary Agreement Line as depicted on NOAA Chart No. 513 (6th edition, February 23, 1991) and NOAA Chart No. 514 (6th edition, February 16, 1991), and

(3)*A southern boundary* of 54°30′ N. lat. to 171° W. long., and then south to 54°36′ N. lat. 7. Revise Tables 7,8, and 9 to part 680 to read as follows: Table 7 to Part 680—Initial Issuance of Crab QS by Crab QS Fishery Column A: Crab QS Fisheries Column B: Qualifying Years for QS Column C: Eligibility Years for CVC and CPC QS Column D: Recent Participation Seasons for CVC and CPC QS Column E: Subset of Qualifying Years For each crab QS fishery the Regional Administrator shall calculate (see § 680.40(c)(2): QS for any qualified person based on that person's total legal landings of crab in each of the crab QS fisheries for any: In addition, each person receiving CVC and CPC QS must have made at least one landing per year, as recorded on a State of Alaska fish ticket, in any three years during the base period described below: In addition, each person receiving CVC or CPC QS, must have made at least one landing, as recorded on a State of Alaska fish ticket, in at least 2 of the last 3 fishing seasons in each of the crab QS fisheries as those seasons are described below: The maximum number of qualifying years that can be used to calculate QS for each QS fishery is: 1. Bristol Bay red king crab

(BBR)4 years of the 5-year QS base period beginning on:

(1)November 1-5, 1996;

(2)November 1-5, 1997;

(3)November 1-6, 1998;

(4)October 15-20, 1999;

(5)October 16-20, 2000. 3 years of the 5-year QS base period beginning on:

(1)November 1-5, 1996;

(2)November 1-5, 1997;

(3)November 1-6, 1998;

(4)October 15-20, 1999;

(5)October 16-20, 2000.

(1)October 15-20, 1999.

(2)October 16-20, 2000.

(3)October 15-18, 2001. 4 years 2. Bering Sea snow crab

(BSS)4 years of the 5-year period beginning on:

(1)January 15, 1996 through February 29, 1996;

(2)January 15, 1997 through March 21, 1997;

(3)January 15, 1998 through March 20, 1998;

(4)January 15, 1999 through March 22, 1999;

(5)April 1-8, 2000. 3 years of the 5-year period beginning on:

(1)January 15, 1996 through February 29, 1996;

(2)January 15, 1997 through March 21, 1997;

(3)January 15, 1998 through March 20, 1998;

(4)January 15, 1999 through March 22, 1999;

(5)April 1-8, 2000.

(1)April 1-8, 2000.

(2)January 15, 2001 through February 14, 2001.

(3)January 15, 2002 through February 8, 2002. 4 years 3. Eastern Aleutian Islands golden king crab

(EAG)5 years of the 5-year base period beginning on:

(1)September 1, 1996 through December 25, 1996;

(2)September 1, 1997 though November 24, 1997;

(3)September 1, 1998 through November 7, 1998;

(4)September 1, 1999 through October 25, 1999;

(5)August 15, 2000 through September 24, 2000. 3 years of the 5-year base period beginning on:

(1)September 1, 1996 through December 25, 1996;

(2)September 1, 1997 though November 24, 1997;

(3)September 1, 1998 through November 7, 1998;

(4)September 1, 1999 through October 25, 1999;

(5)August 15, 2000 through September 25, 2000.

(1)September 1 1999 through October 25, 1999.

(2)August 15, 2000 through September 24, 2000.

(3)August 15, 2001 through September 10, 2001. 5 years 4. Eastern Bering Sea Tanner crab

(EBT)4 of the 6 seasons beginning on:

(1)November 15, 1991 through March 31, 1992;

(2)November 15, 1992 through March 31, 1993;

(3)November 1-10, 1993, and November 20, 1993 through January 1, 1994;

(4)November 1-21, 1994;

(5)November 1-16, 1995;

(6)November 1-5, 1996 and November 15-27, 1996. 3 of the 6 seasons beginning on:

(1)November 15, 1991 through March 31, 1992;

(2)November 15, 1992 through March 31, 1993;

(3)November 1-10, 1993, and November 20, 1993 through January 1, 1994;

(4)November 1-21, 1994;

(5)November 1-16, 1995;

(PIK)4 years of the 5-year period beginning on:

(1)September 15-21, 1994;

(2)September 15-22, 1995;

(3)September 15-26, 1996;

(4)September 15-29, 1997;

(5)September 1-28, 1998. 3 years of the 5-year period beginning on:

(1)September 15-21, 1994;

(2)September 15-22, 1995;

(3)September 15-26, 1996;

(4)September 15-29, 1997;

(5)September 15-28, 1998. In any 2 of the last 3 seasons prior to June 10, 2002 in the Eastern Aleutian Island golden (brown) king crab, Western Aleutian Island golden (brown) king crab, Bering Sea snow crab, or Bristol Bay red king crab fisheries, except that persons applying for an allocation to receive QS based on legal landings made aboard a vessel less than 60 feet (18.3 m) LOA at the time of harvest are exempt from this requirement. 4 years 6. St. Matthew blue king crab

(SMB)4 years of the 5-year period beginning on:

(1)September 15-22, 1994;

(2)September 15-20, 1995;

(3)September 15-23, 1996;

(4)September 15-22, 1997;

(5)September 15-26, 1998. 3 years of the 5-year period beginning on:

(1)September 15-22, 1994;

(2)September 15-20, 1995;

(3)September 15-23, 1996;

(4)September 15-22, 1997; and

(5)September 15-26, 1998. In any 2 of the last 3 seasons prior to June 10, 2002 in the Eastern Aleutian Island golden (brown) king crab, Western Aleutian Island golden (brown) king crab, Bering Sea snow crab, or Bristol Bay red king crab fisheries. 4 years 7. Western Aleutian Islands brown king crab

(WAG)5 of the 5 seasons beginning on:

(1)September 1, 1996 through August 31, 1997;

(2)September 1, 1997 though August 21, 1998;

(3)September 1, 1998 through August 31, 1999;

(4)September 1, 1999 through August 14, 2000;

(5)August 15, 2000 through March 28, 2001. 3 of the 5 seasons beginning on:

(1)September 1, 1996 through August 31, 1997;

(2)September 1, 1997 though August 31, 1998;

(3)September 1, 1998 through August 31, 1999;

(4)September 1, 1999 through August 14, 2000;

(5)August 15, 2000 through March 28, 2001.

(1)September 1, 1999 through August 14, 2000.

(2)August 15, 2000 through March 28, 2001.

(3)August 15 2001 through March 30, 2002. 5 years 8. Western Aleutian Islands red king crab

(WAI)3 of the 4 seasons beginning on:

(1)November 1, 1992 through January 15, 1993;

(2)November 1, 1993 through February 15, 1994;

(3)November 1-28, 1994;

(4)November 1, 1995 through February 13, 1996. 3 of the 4 seasons beginning on:

(1)November 1, 1992 through January 15, 1993;

(2)November 1, 1993 through February 15, 1994;

(3)November 1-28, 1994;

(4)November 1, 1995 through February 13, 1996. In any 2 of the last 3 seasons prior to June 10, 2002 in the Eastern Aleutian Island golden (brown) king crab, Western Aleutian Island golden (brown) king crab, Bering Sea snow crab, or Bristol Bay red king crab fisheries. 3 years 9. Western Bering Sea Tanner crab

(WBT)4 of the 6 seasons beginning on:

(1)November 15, 1991 through March 31, 1992;

(2)November 15, 1992 through March 31, 1993;

(3)November 1-10, 1993, and November 20, 1993 through January 1, 1994;

(4)November 1-21, 1994;

(5)November 1-16, 1995;

(6)November 1-5, 1996 and November 15-27, 1996. 3 of the 6 seasons beginning on:

(1)November 15, 1991 through March 31, 1992;

(2)November 15, 1992 through March 31, 1993;

(3)November 1-10, 1993, and November 20, 1993 through January 1, 1994;

(4)November 1-21, 1994;

(5)November 1-16, 1995;

(6)November 1-5, 1996 and November 15-27, 1996. In any 2 of the last 3 seasons prior to June 10, 2002 in the Eastern Aleutian Island golden (brown) king crab, Western Aleutian Island golden (brown) king crab, Bering Sea snow crab, or Bristol Bay red king crab fisheries. 4 years Table 8 to Part 680—Initial QS and PQS Pool for Each Crab QS Fishery Crab QS Fishery Initial QS Pool Initial PQS Pool BBR - Bristol Bay red king crab 400,000,000 400,000,000 BSS - Bering Sea snow crab ( *C. opilio* ) 1,000,000,000 1,000,000,000 EAG - Eastern Aleutian Islands golden king crab 10,000,000 10,000,000 EBT - Eastern Bering Sea Tanner crab ( *C. bairdi* ) 200,000,000 200,000,000 PIK - Pribilof Islands red and blue king crab 30,000,000 30,000,000 SMB - St. Matthew blue king crab 30,000,000 30,000,000 WAG - Western Aleutian Islands golden king crab 40,000,000 40,000,000 WAI - Western Aleutian Islands red king crab 60,000,000 60,000,000 WBT - Western Bering Sea Tanner crab ( *C. bairdi* ) 200,000,000 200,000,000 Table 9 to Part 680—Initial Issuance of Crab PQS by Crab QS Fishery Column A: For each crab QS fishery: Column B: The Regional Administrator shall calculate PQS for any qualified person based on that person's total legal purchase of crab in each of the crab QS fisheries for any... Bristol Bay red king crab

(BBR)*3 years of the 3-year QS base period beginning on:*

(1)November 1-5, 1997;

(2)November 1-6, 1998; and

(3)October 15-20, 1999. Bering Sea snow crab

(BSS)*3 years of the 3-year period beginning on:*

(1)January 15, 1997 through March 21, 1997;

(2)January 15, 1998 through March 20, 1998; and

(3)January 15, 1999 through March 22, 1999. Eastern Aleutian Island golden king crab

(EAG)*4 years of the 4-year base period beginning on:*

(1)September 1, 1996 through December 25, 1996;

(2)September 1, 1997 though November 24, 1997;

(3)September 1, 1998 through November 7, 1998; and

(4)September 1, 1999 through October 25, 1999. Eastern Bering Sea Tanner crab

(EBT)Equivalent to 50 percent of the total legally processed crab in the Bering Sea snow crab fishery during the qualifying years established for that fishery, and 50 percent of the total legally processed crab in the Bristol Bay red king crab fishery during the qualifying years established for that fishery. Pribilof Islands red and blue king crab

(PIK)*3 years of the 3-year period beginning on:*

(1)September 15-26, 1996;

(2)September 15-29, 1997; and

(3)September 15-28, 1998. St. Matthew blue king crab

(SMB)*3 years of the 3-year period beginning on:*

(1)September 15-23, 1996;

(2)September 15-22, 1997; and

(3)September 15-26, 1998. Western Aleutian Island golden king crab

(WAG)*4 years of the 4-year base period beginning on:*

(1)September 1, 1996 through August 31, 1997;

(2)September 1, 1997 though August 31, 1998;

(3)September 1, 1998 through August 31, 1999; and

(4)September 1, 1999 through August 14, 2000. Western Aleutian Islands red king crab

(WAI)Equivalent to the total legally processed crab in the Western Aleutian Islands golden (brown) king crab fishery during the qualifying years established for that fishery. Western Bering Sea Tanner crab

(WBT)Equivalent to 50 percent of the total legally processed crab in the Bering Sea snow crab fishery during the qualifying years established for that fishery, and 50 percent of the total legally processed crab in the Bristol Bay red king crab fishery during the qualifying years established for that fishery. [FR Doc. E6-8861 Filed 6-6-06; 8:45 am] BILLING CODE 3510-22-S 71 109 Wednesday, June 7, 2006 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2005-21748; Directorate Identifier 2005-NM-071-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 767-200 and -300 Series Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of comment period. SUMMARY: The FAA is revising an earlier proposed airworthiness directive

(AD)for certain Boeing Model 767-200 and -300 series airplanes. For certain airplanes, the original NPRM would have required repetitive inspections for discrepancies of the tube assemblies and insulation of the metered fire extinguisher system and the bleed air duct couplings of the auxiliary power unit

(APU)located in the aft cargo compartment; and corrective actions if necessary. For certain other airplanes, the original NPRM would have required a one-time inspection for sufficient clearance between the fire extinguishing tube and the APU bleed air duct in the aft cargo compartment, and modification if necessary. The original NPRM resulted from one report indicating that an operator found a hole in the discharge tube assembly for the metered fire extinguishing system; and another report indicating that an operator found chafing of the fire extinguishing tube against the APU duct that resulted in a crack in the tube. This action revises the original NPRM by expanding the applicability and adding an inspection for signs of chafing and to verify sufficient clearance between the fire extinguisher system and the bleed air duct couplings of the APU. We are proposing this supplemental NPRM to prevent fire extinguishing agent from leaking out of the tube assembly in the aft cargo compartment which, in the event of a fire in the aft cargo compartment, could result in an insufficient concentration of fire extinguishing agent, and consequent inability of the fire extinguishing system to suppress the fire. DATES: We must receive comments on this supplemental NPRM by July 3, 2006. ADDRESSES: Use one of the following addresses to submit comments on this supplemental NPRM. • DOT Docket Web site: Go to *http:// dms.dot.gov* and follow the instructions for sending your comments electronically. • Government-wide rulemaking Web site: Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street SW., Nassif Building, Room PL-401, Washington, DC 20590. • Fax:

(202)493-2251. • Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207, for service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Marcia Smith, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone

(425)917-6484; fax

(425)917-6590. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this supplemental NPRM. Send your comments to an address listed in the ADDRESSES section. Include the docket number “Docket No. FAA-2005-21748; Directorate Identifier 2005-NM-071-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this supplemental NPRM. We will consider all comments received by the closing date and may amend this supplemental NPRM in light of those comments. We will post all comments submitted, without change, to *http://dms.dot.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this supplemental NPRM. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or you may visit *http://dms.dot.gov.* Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov,* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone

(800)647-5227) is located on the plaza level in the Nassif Building at the DOT street address stated in ADDRESSES . Comments will be available in the AD docket shortly after the Docket Management System receives them. Discussion We proposed to amend 14 CFR part 39 with a notice of proposed rulemaking

(NPRM)for an AD (the “original NPRM”) for certain Boeing Model 767-200 and -300 series airplanes. The original NPRM was published in the **Federal Register** on July 8, 2005 (70 FR 39433). For certain airplanes, the original NPRM proposed to require repetitive inspections for discrepancies of the tube assemblies and insulation of the metered fire extinguisher system and the bleed air duct couplings of the auxiliary power unit

(APU)located in the aft cargo compartment; and corrective actions if necessary. For certain other airplanes, the original NPRM proposed to require a one-time inspection for sufficient clearance between the fire extinguishing tube and the APU bleed air duct in the aft cargo compartment, and modification if necessary. Actions Since Original NPRM was Issued Since we issued the original NPRM, Boeing has published Boeing Alert Service Bulletin 767-26A0130, Revision 1, dated December 15, 2005. (The original issue, dated December 2, 2004, was referenced in the original NPRM as the appropriate source of service information for accomplishing certain actions.) Revision 1 includes the following changes to the Accomplishment Instructions of the original issue: • Adds airplanes to the effectivity and divides affected airplanes into Groups 1 through 7. • Adds concurrent requirements for Group 3 through 7 airplanes. • Adds an inspection for signs of chafing and to verify that there is sufficient clearance between the fire extinguisher system and the bleed air duct couplings of the APU. The corrective action includes the following: • If the clearance between the fire extinguisher tube assembly and the couplings is insufficient, either repeat the inspection or move the assembly so there is a minimum clearance of 0.75 inch. • If the fire extinguisher tube assembly shows signs of chafing or contact with the couplings, repair or replace any damaged tube assembly with a new assembly; and move the tube assemblies and/or duct couplings to allow for a minimum clearance of 0.75 inch, if clearance is insufficient. The installation of tube assemblies to allow minimum clearance eliminates the need for the repetitive inspections, provided initial inspections and any necessary corrective action have been done. • If the insulation shows signs of chafing or contact with the couplings, replace any damaged insulation with new insulation. • We have revised paragraph

(f)of the supplemental NPRM to refer to Revision 1 of the service bulletin, and we have added a new paragraph

(g)to give credit for actions done before the effective date of the AD per the original service bulletin. Comments We have considered the following comments on the original NPRM. Support for the Original NPRM Boeing concurs with the contents of the original NPRM. Request To Add Revised Service Bulletin Japan Airlines states that, according to Boeing, Revision 1 of Boeing Alert Service Bulletin 767-26A0130 will be issued on September 22, 2005, and it wants to make sure that Revision 1 will be referenced in the supplemental NPRM. Japan Airlines has confirmed with Boeing that, in certain locations, the clearance between the couplings of the APU bleed air duct and the fire extinguisher tube, as specified in the original issue of the service bulletin, does not completely satisfy the requirements in the original NPRM. We agree with the commenter and, as noted above, we have added Boeing Alert Service Bulletin 767-26A0130, Revision 1, dated December 15, 2005, to this supplemental NPRM. Request To Add Certain Requirements Air Transport Association (ATA), on behalf of Delta Airlines, requests that the original NPRM specify that Boeing Service Bulletin 767-26-0118, Revision 2, dated December 21, 2004, provides terminating action for the actions in Boeing Alert Service Bulletin 767-26A0123, dated August 22, 2002. Delta states that the “Relevant Service Information” paragraph specifies that Alert Service Bulletin 767-26A0123, refers to Service Bulletin 767-26-0118, Revision 2, as the appropriate source of service information for accomplishing the modification of the fire extinguishing tube assembly. Delta adds that the “Applicability” and “Repetitive Inspections” paragraphs do not address Service Bulletin 767-26-0118. Delta notes that they have scheduled modification of its airplanes per Service Bulletin 767-26-0118, rather than accomplishing the inspections per Service Bulletin 767-26A0123, and then addressing potential rework. Delta recommends that we add notes after paragraph

(f)of the supplemental NPRM which specify that Service Bulletin 767-26-0118 constitutes terminating action for Service Bulletin 767-26A0123. We partially agree. We agree that the modification specified in Service Bulletin 767-26-0118 constitutes terminating action for the inspections specified in Service Bulletin 767-26A0123; however, we do not agree to include a note adding that action to the supplemental NPRM. Accomplishing the modification is an on-condition action and is not required if there is sufficient clearance between the APU duct and the fire extinguisher tube. We do agree to add a note after paragraph

(f)which specifies that Service Bulletin 767-26-0118 is the appropriate source of service information for accomplishing the modification of the fire extinguishing tube assembly. We have added Note 1 to this supplemental NPRM accordingly. Request To Clarify Repetitive Inspections ATA, on behalf of Delta, requests that we clarify the repetitive inspections and explain why they are necessary. Delta states that the inspections specified in paragraph (f)(1) of the original NPRM are to be repeated per Boeing Alert Service Bulletin 767-26A0130; however, the inspection specified in paragraph (f)(2) of the NPRM, which is to be done per Boeing Alert Service Bulletin 767-26A0123, does not specify repeating. Delta adds that neither Service Bulletin 767-26A0130 or 767-26A0123 recommend accomplishing the inspections on a repetitive basis. Delta notes that both service bulletins address a potential contact or chafing condition that appears to be related to relative installations, and would not be expected to change; therefore, repetitive inspections are not warranted. Delta adds that the title above paragraph

(f)is “Repetitive Inspections,” which would imply that both paragraphs (f)(1) and (f)(2) have repetitive inspection requirements, but only paragraph (f)(1) requires repetitive inspections. Delta does not consider this a condition where repetitive inspections are required; however, if repetitive inspections are warranted, Delta asks for clarification of when and why repetitive inspections are required. We agree that Service Bulletin 767-26A0123 does not specify repetitive inspections; however, Service Bulletin 767-26A0130 does include repetitive inspections as an option if no chafing or contact with the couplings of the APU bleed air duct is found, and support provisions are not in the correct location. The other option is to correct the location as a terminating action. If the couplings of the APU bleed air duct and support provisions are correctly installed (installation of the tube assembly in the correct location), and no contact or chafing is found, no further action is required by paragraph (f)(1). We also agree that to better clarify the header preceding paragraph

(f)“Repetitive Inspections” it should be changed to “Inspections and Corrective Actions.” We have changed the header preceding paragraph

(f)of this supplemental NPRM accordingly. Request To Change Work Hours ATA, on behalf of US Airways, requests that the work hour estimate be revised and notes that the cost does not include potentially significant costs that are dependent on the findings of the proposed inspection. US Airways does not agree with the work hour assessment in the original NPRM. US Airways states that the required work hours for the inspections and testing specified in the NPRM would take a total of 8 work hours, per the referenced service bulletins, amounting to a total of $520 per airplane, not $260 per airplane. US Airways notes that the proposed cost of compliance does not address the cost of damage findings from the inspections, which could add up to 23.5 additional work hours per airplane, increasing the cost up to $1,527 per airplane. We acknowledge the commenters' concerns, but don't agree to change the supplemental NPRM. The cost estimate specified in the original NPRM reflects the work hour estimate provided by the manufacturer for the inspections and varies according to the applicable model or group. Further, we do not agree to include the cost of repairing damage findings. Corrective actions are conditional based on the inspection findings. The information in the Costs of Compliance section in an AD action is limited to the cost of actions actually required by the AD. That section does not consider the costs of conditional actions (e.g., “repair, if necessary”). Regardless of AD direction, those actions would be required to correct an unsafe condition identified in an airplane and ensure operation of that airplane in an airworthy condition, as required by the Federal Aviation Regulations. In addition, we have removed the cost estimate for the functional test because that test is only accomplished as part of the corrective actions. After the original NPRM was issued, we reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we found it necessary to increase the labor rate used in these calculations from $65 per work hour to $80 per work hour. The Costs of Compliance section, below, reflects this increase in the specified hourly labor rate. Clarification of Alternative Method of Compliance

(AMOC)Paragraph We have revised this action to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies. FAA's Determination and Proposed Requirements of the Supplemental NPRM The changes discussed above expand the scope of the original NPRM; therefore, we have determined that it is necessary to reopen the comment period to provide additional opportunity for public comment on this supplemental NPRM. Differences Between the Supplemental NPRM and New Service Information Boeing Alert Service Bulletin 767-26A0130, Revision 1, recommends concurrently accomplishing the service bulletins specified in the table below; however, this supplemental NPRM would not include that requirement. The concurrent service bulletins describe procedures for installing a metered fire extinguishing system, but this proposed AD is only applicable to airplanes that already have that system installed. Concurrent Service Bulletins Group Boeing service bulletin 3 767-26-0016 4 767-26-0027 5 767-26-0034 6 767-26-0058 7 767-26-0070 Costs of Compliance There are about 749 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this supplemental NPRM. Estimated Costs Action Work hours Average labor rate per hour Parts Cost per airplane Number of U.S.-registered airplanes Fleet cost Inspection in Service Bulletin 767-26A0123 1 $80 None $80 292 $23,360 Inspection in Service Bulletin 767-26A0130, Revision 1 5 80 None 400 292 116,800 Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have Federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this supplemental NPRM and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration

(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **Boeing:** Docket No. FAA-2005-21748; Directorate Identifier 2005-NM-071-AD. Comments Due Date

(a)The FAA must receive comments on this AD action by July 3, 2006. Affected ADs

(b)None. Applicability

(c)This AD applies to Boeing Model 767-200 and -300 series airplanes; certificated in any category; with a metered fire extinguisher system in the aft cargo compartment. Unsafe Condition

(d)This AD was prompted by one report indicating that an operator found a hole in the discharge tube assembly for the metered fire extinguishing system; and another report indicating that an operator found chafing of the fire extinguishing tube against the auxiliary power unit

(APU)duct that resulted in a crack in the tube. We are issuing this AD to prevent fire extinguishing agent from leaking out of the tube assembly in the aft cargo compartment which, in the event of a fire in the aft cargo compartment, could result in an insufficient concentration of fire extinguishing agent, and consequent inability of the fire extinguishing system to suppress the fire. Compliance

(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Inspections and Corrective Actions

(f)Within 24 months or 8,000 flight hours after the effective date of this AD, whichever is first: Accomplish the actions required by paragraphs (f)(1) and (f)(2) of this AD, as applicable.

(1)For airplanes identified in Boeing Alert Service Bulletin 767-26A0130, Revision 1, dated December 15, 2005: Perform detailed and general visual inspections for discrepancies of the fire extinguishing tube assemblies between STA 1197 and STA 1340, and the insulation of the metered fire extinguisher system and the bleed air duct couplings of the APU located in the aft cargo compartment, and any applicable corrective actions, by doing all the applicable actions specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 767-26A0130, Revision 1, dated December 15, 2005. Do all applicable corrective actions before further flight in accordance with the service bulletin. Repeat the inspections thereafter at intervals not to exceed 24 months or 8,000 flight hours, whichever is first. Installation of the tube assembly in the correct location, in accordance with the service bulletin, terminates the repetitive inspections for that assembly only.

(2)For airplanes identified in Boeing Alert Service Bulletin 767-26A0123, dated August 22, 2002: Perform a general visual inspection for sufficient clearance between the fire extinguishing tube and the APU duct on the left sidewall from station 1355 through 1365 inclusive, and do all applicable modifications, by doing all the actions specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 767-26A0123, dated August 22, 2002. Do all applicable modifications before further flight. Note 1: Boeing Alert Service Bulletin 767-26A0123 refers to Boeing Service Bulletin 767-26-0118, Revision 2, dated December 21, 2004, as the appropriate source of service information for accomplishing the modification of the fire extinguishing tube assembly. Credit for Actions Accomplished Previously

(g)Accomplishing the inspections and corrective actions required by paragraph (f)(1) of this AD before the effective date of this AD, in accordance with Boeing Alert Service Bulletin 767-26A0130, dated December 2, 2004, is considered acceptable for compliance with the corresponding actions in paragraph (f)(1). Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, Seattle Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.

(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Issued in Renton, Washington, on May 26, 2006. Jeffrey E. Duven, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6-8823 Filed 6-6-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2006-24858; Airspace Docket 06-ASO-8] Proposed Establishment of Class E Airspace; Mooresville, NC AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking. SUMMARY: Proposed Establishment of Class E airspace at Mooresville, NC. An Area Navigation

(RNAV)Global Positioning System

(GPS)Standard Instrument Approach Procedure

(SIAP)Runway

(RWY)14 has been developed for Lake Norman Airpark, As a result, controlled airspace extending upward from 700 feet Above Ground Level

(AGL)is needed to contain the SIAP and for Instrument Flight Rules

(IFR)operations at Lake Norman Airpark. The operating status of the airport will change from Visual Flight Rules

(VFR)to include IFR operations concurrent with the publication of the SIAP. DATES: Comments must be received on or before July 7, 2006. ADDRESSES: Send comments on this proposal to the Docket Management System, U.S. Department of Transportation, Room Plaza 401, 400 Seventh Street, SW., Washington, DC 2590-0001. You must identify the docket number FAA-2005-23075; Airspace Docket 05-ASO-12, at the beginning of your comments. You may also submit comments on the Internet at *http://dms.dot.gov.* You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket office (telephone 1-800-647-5527) is on the plaza level of the Department of Transportation NASSIF Building at the above address. Any informal docket may also be examined during normal business hours at the office of the Regional Air Traffic Division, Federal Aviation Administration, Room 550, 1701 Columbia Avenue, College Park, Georgia 30337. FOR FURTHER INFORMATION CONTACT: Mark D. Ward, Manager, Airspace and Operations Branch, Eastern En Route and Oceanic Service Area, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone

(404)305-5627. SUPPLEMENTARY INFORMATION: Comments Invited Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2006-24858/Airspace Docket No. 06-ASO-8.” The postcard will be date/time stamped and returned to the commenter. All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket. Availability of NRPMs An electronic copy of this document may be downloaded through the Internet at *http://dms.dot.gov.* Recently published rulemaking documents can also be accessed through the FAA's Web page at *http://www.faa.gov* or the Superintendent of Document's Web page at *http://www.access.gpo.gov/nara.* Additionally, any person may obtain a copy of this notice by submitting a request to the Federal Aviation Administration, Office of Air Traffic Airspace Management, ATA-400, 800 Independence Avenue, SW., Washington, DC 20591, or by calling

(202)267-8783. Communications must identify both docket numbers for this notice Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking,

(202)267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure. The Proposal The FAA is considering an amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) to establish Class E airspace at Mooresville, NC. Class E airspace designations for airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9N, dated September 1, 2005, and effective September 16, 2005, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order. The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore,

(1)is not a “significant regulatory action” under Executive Order 12866;

(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and

(3)does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). The Proposed Amendment In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9N, Airspace Designations and Reporting Points, dated September 1, 2005, and effective September 16, 2005, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO NC E5 Mooresville, NC [NEW] Lake Norman Airpark, NC (Lat. 35°36′50″ N, long. 80°53′58″ W) That airspace extending upward from 700 feet above the surface within a 6.3—radius of Lake Norman Airpark; excluding that airspace within the Statesville, NC, Class E airspace area. Issued in College Park, Georgia, on May 31, 2006. Mark D. Ward, Acting Area Director, Air Traffic Division, Southern Region. [FR Doc. 06-5183 Filed 6-6-06; 8:45 am]

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