We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in theFederal Registeron November 28, 2011 (76 FR 72863). For certain airplanes, that NPRM proposed to require using redefined flight cycle counts, determining the type of material of the horizontal stabilizer, rear spar, and upper and lower chords on the inboard and outboard ends of the rear spar; repetitively inspecting for cracking of the horizontal stabilizer components; and repairing or replacing the chord, or modifying the chord segments made from 7079 aluminum, if necessary. For all airplanes, that NPRM also proposed to require inspecting certain structurally significant items, and repairing discrepancies if necessary.

We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the proposal (76 FR 72863, November 28, 2011) and the FAA's response.

Boeing reported that the NPRM (76 FR 72863, November 28, 2011), in various locations, stated incorrectly that fatigue cracking occurred in rear spar chords made from 7075 aluminum. According to Boeing, fatigue cracking has been reported in spar chords made from 7079 aluminum only. Boeing requested that we revise the NPRM to remove reference to “fatigue cracking” when addressing the failure mode of the rear spar chords made from 7075 aluminum.

We partially agree with the request. Chords made from 7075 aluminum have better fatigue characteristics than those made from 7079 aluminum. But all metals fatigue to a varying degree. We have therefore revised this final rule to characterize these conditions as “potential early fatigue” to address Boeing's concern and clarify that the accelerated fatigue occurrence was a consequence of abnormal use of the airplane as used in military touch-and-go training.

Note 1 to paragraph (i) of the NPRM (76 FR 72863, November 28, 2011) defined a special detailed inspection. We have removed that note in this final rule. A special detailed inspection is defined in Boeing 707 Alert Service Bulletin A3515, dated December 19, 2007, and it is unnecessary to repeat that definition in the AD.

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting the ADwith the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (76 FR 72863, November 28, 2011) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (76 FR 72863, November 28, 2011).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We consider this AD interim action. If final action is later identified, we might consider further rulemaking then.

We estimate that this AD affects 10 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this AD.

We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

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

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

(4) 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.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD No. 2012-0086-E, dated May 18, 2012 (EASA AD 2012-0086-E), to correct an unsafe condition for Agusta Model AB412 and AB412EP helicopters. EASA advises of a report where a hoist hook separated from an AB412 helicopter. EASA states the initial investigation revealed that the nut and housing hook were not properly assembled. According to EASA, this condition could lead to separation of the hook and detachment of an external load from the hoist, resulting in personal injury or damage to property on the ground. For these reasons, EASA issued EASA AD 2012-0086-E to require inspecting the hook before the next flight, and after every subsequent reassembly of the hook.

These helicopters have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with Italy, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs.

We reviewed AgustaWestland Bollettino Tecnico (BT) No. 412-132, dated May 2, 2012, and BT No. 412-133, dated May 17, 2012, which describe procedures for inspecting the nut and housing hook to determine whether the two locking screws are inserted into the slot of the housing. Both BTs also describe procedures for assembling the hook if the nut and body are not properly aligned.

This AD requires, before further flight, and after any reassembly of the hook:

• Inspecting the nut and housing hook to determine whether the two locking screws are inserted into the slot of the housing.

• Correcting the assembly, before further flight, if the locking screws are not properly inserted in the slots of the housing.

There are no costs of compliance with this AD because there are no helicopters with this type certificate on the U.S. Registry.

There are no helicopters with this type certificate on the U.S. Registry. Therefore, we believe it is unlikely that we will receive any adverse comments or useful information about this AD from U.S. Operators.

Since an unsafe condition exists that requires the immediate adoption of this AD, we determined that notice and opportunity for public comment before issuing this AD are unnecessary because there are none of these products on the U.S. Registry.

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

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

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed, I certify that this AD:

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

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

3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

4. 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.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The Civil Aviation Safety Authority (CASA), which is the aviation authority for the Commonwealth of Australia, has issued AD AD/GA200/1, dated August 23, 2012 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

GippsAero has issued Mandatory Service Bulletin SB-GA200-2012-08, Issue 1, dated August 22, 2012. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

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

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because failure to complete the actions required by this service bulletin may result in wing strut bolt failure, resulting in wing structural failure. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under theADDRESSESsection. Include “Docket No. FAA-2012-0946; Directorate Identifier 2012-CE-037-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

We estimate that this AD will affect 3 products of U.S. registry. We also estimate that it would take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $0 per product.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $510, or $170 per product.

In addition, we estimate that any necessary follow-on actions would take about 2 work-hours and require parts costing $400 for a cost of $570 per product. We have no way of determining the number of products that may need these actions.

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

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

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

(4) 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.

History

On February 7, 2012, the FAA published in theFederal Registera notice of proposed rulemaking (NPRM) to amend controlled airspace at Boise Air Terminal (Gowan Field), Boise, ID (77 FR 6026). Interested parties were invited to participate in this rulemaking effort by submitting written commentson the proposal to the FAA. No comments were received. Subsequent to publication, the FAA found the Boise navigation aid is no longer needed and should be removed from the Class E airspace area designated as an extension.

On June 28, 2012, the FAA published in theFederal Registera supplemental notice of proposed rulemaking (SNPRM) to remove reference to the navigation aid listed under Class E airspace designated as an extension at Boise Air Terminal, Boise, ID (77 FR 38552). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

The FAA's Aeronautical Products Office requested the legal description for the Class E airspace extending upward from 700 feet above the surface be rewritten for clarity. With the exception of editorial changes and the changes described above, this rule is the same as that proposed in the SNPRM.

Class E airspace designations are published in paragraph 6003 and 6005, respectively, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E airspace designated as an extension, at Boise Air Terminal (Gowan Field), Boise, ID. The legal description is rewritten to better describe the airspace area by removing reference to the Boise VORTAC. Class E airspace extending upward from 700 feet above the surface has been reconfigured due to the decommissioning of the Donnelly TACAN, and is rewritten for clarity. The geographic coordinates of the airport are adjusted in accordance with the FAA's aeronautical database. This ensures the safety and management of IFR operations within the National Airspace System.

The FAA has determined 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 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 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. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Boise Air Terminal (Gowen Field), Boise, ID.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends

14 CFR part 71 as follows:

On March 15, 2012, the FAA published in theFederal Registera notice of proposed rulemaking (NPRM) to amend Class E airspace at Dillon Airport, Dillon, MT (77 FR 15295). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. One comment was received.

The commenter recommended establishing Class E surface airspace and also expanding the Class E airspace extending upward from 700 feet above the surface for aircraft safety. The FAA found merit in this comment and proposed to further amend the NPRM.

On July 11, 2012, the FAA published in theFederal Registera supplemental notice of proposed rulemaking (SNPRM) to create Class E surface airspace and further amend existing Class E airspace at Dillon Airport, Dillon, MT (77 FR 40834). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6002 and 6005, respectively, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by creating Class E surface airspace, and further modifying Class E airspace extending upward from 700 feet above the surface, at Dillon Airport, Dillon, MT, to accommodate IFR aircraft executing new RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations. The geographic coordinates are adjusted to be in concert with the FAAs aeronautical database.

The FAA has determined 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 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 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. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes and amends controlled airspace at Dillon Airport, Dillon, MT.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

On July 5, 2012, the FAA published in theFederal Registera notice of proposed rulemaking (NPRM) to establish controlled airspace at Circle Town, MT (77 FR 39651). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. The FAA received one comment from the National Business Aviation Association (NBAA).

The NBAA recommended the FAA lower some of the adjacent Class E airspace extending upward from 14,500 feet Mean Sea Level (MSL) to the east, south and west of the airport down to 1,200 feet above the surface to accommodate orderly en route descent into the airport. The NBAA is also concerned that the Minimum Instrument Flight Rules Altitude (MIA) outside the 1,200 feet above the surface would affect air traffic services into the airport. Finally, the commenter points out that extending the Class E 1,200-foot area would provide relief to Salt Lake City Air Route Traffic Control Center (ARTCC).

The FAA believes that lowering this airspace is outside the scope of this rulemaking at this time, and would not serve the immediate purpose of establishing the airspace necessary for the safety of aircraft within the Circle Town, MT, airport area.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 feet above the surface, at Circle Town County Airport, to accommodate IFR aircraft executing new RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations.

The FAA has determined 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 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 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. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Circle Town County Airport, Circle Town, MT.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

On July 12, 2012, the FAA published in theFederal Registera notice of proposed rulemaking (NPRM) to establish controlled airspace at Fort Garland, CO (77 FR 41108). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 feet above the surface, at Trinchera Ranch Airstrip Airport, to accommodate IFR aircraft executing new RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations.

The FAA has determined 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 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 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. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Trinchera Ranch Airstrip Airport, Fort Garland, CO.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

In theFederal Registerof July 6, 2012, FDA amended the color additive regulations in §§ 74.1306 and 74.1307 (21 CFR 74.1306 and 74.1307) by replacing the current specification for “Ether-soluble matter” with a maximum limit of 0.015 percent for the recently identified impurity 1-[(4-methylphenyl)azo]-2-naphthalenol. FDA also removed Appendix A in 21 CFR part 74, which pertains to the ether-soluble matter specification. The changes to §§ 74.1306 and 74.1307 also affect the color additive regulations in §§ 74.2306 and 74.2307 (21 CFR 74.2306 and 74.2307) because the identity and specifications in §§ 74.1306 and 74.1307 are referenced by §§ 74.2306 and 74.2307.

FDA gave interested persons until August 6, 2012, to file objections or requests for a hearing. The Agency received no objections or requests for a hearing on the final rule. Therefore, FDA finds that the effective date of the final rule that published in theFederal Registerof July 6, 2012, should be confirmed.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Office of Food Additive Safety, notice is given that no objections or requests for a hearing were filed in response to the July 6, 2012, final rule. Accordingly, the amendments issued thereby became effective August 7, 2012.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule, because a safety zone was not determined to be necessary until August 1, 2012. As a result, the Coast Guard did not have sufficient time to publish an NPRM and to receive public comments prior to the Miami Paddle Challenge. Any delay in the effective date of this rule would be contrary to the public interest as immediate action is needed to minimize potential danger to the public, race participants, and spectator craft.

For the same reason discussed above, under 5 U.S.C. 553(d)(3) the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register.

The legal basis for the rule is the Coast Guard's authority to establish regulated navigation areas and otherlimited access areas: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.

The purpose of the rule is to provide for the safety of life on navigable waters of the United States during the Miami Paddle Challenge.

On Sunday, September 29, 2012, Miami Children's Hospital is sponsoring the Miami Paddle Challenge. Over 150 paddle boats are expected to participate in the event. Participant paddle boats will include: kayaks, surfskis, paddleboards, outriggers, sculls, canoes, dories, and dragon boats.

The temporary safety zone encompasses certain waters of Biscayne Bay located west of Key Biscayne and south of Rickenbacker Causeway in Miami, Florida. The safety zone will be enforced from 6 a.m. until 4 p.m. on September 29, 2012.

Non-participant persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the safety zone unless authorized by the Captain of the Port Miami or a designated representative. Non-participant persons and vessels desiring to enter, transit through, anchor in, or remain within the safety zone may contact the Captain of the Port Miami by telephone at 305-535-4472, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the safety zone is granted by the Captain of the Port Miami or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Miami or a designated representative. The Coast Guard will provide notice of the safety zone by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under that Order.

The economic impact of this rule is not significant for the following reasons: (1) The safety zone will be enforced for only ten hours; (2) although persons and vessels will not be able to enter, transit through, anchor in, or remain within the event area without authorization from the Captain of the Port Miami or a designated representative, they may operate in the surrounding area during the enforcement period; (3) persons and vessels may still enter, transit through, anchor in, or remain within the event area during the enforcement period if authorized by the Captain of the Port Miami or a designated representative; and (4) the Coast Guard will provide advance notification of the safety zone to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of the Biscayne Bay encompassed within the safety zone from 6 a.m. until 4 p.m. on September 29, 2012. For the reasons discussed in the Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of 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 the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in theFOR FURTHER INFORMATION CONTACT, above.

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in theFOR FURTHER INFORMATION CONTACTsection to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it 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.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, 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 this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves the establishment of a temporary safety zone to protect the public on navigable waters of the United States. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

Throughout this document “we,” “us,” or “our” refer to EPA.

EPA is taking final action on administrative changes to the Virginia SIP. On March 16, 2012, Virginia submitted a SIP revision which revises regulatory citations found in Regulations 9VAC5 Chapter 40, Part I, Article 43 (Municipal Solid Waste Landfills) and Chapter 130, Part I (Regulation for Open Burning). The amended text changes those citations which cross-reference Virginia's current Solid Waste Management Regulations (9VAC5-20-81). The affected SIP-approved regulations are sections 5-40-5810, 5-40-5820, 5-40-5850, 5-40-5880, 5-40-5920, 5-130-20, and 5-130-40. EPA has determined that the revisions are minor SIP changes without any substantive changes, and that they comply with all applicable requirements of the CAA and EPA regulations concerning such SIP revisions. EPA approved these revisions through a Letter Notice to the Virginia Department of Environmental Quality (VADEQ) dated June 1, 2012 consistent with the procedures outlined in both EPA's Notice of Procedural Changes on SIP processing published on January 19, 1989 at 54 FR 2214 and a memorandum dated April 6, 2011 entitled “Regional Consistency for the Administrative Requirements of State Implementation Plan Submittals and the Use of Letter Notices” from Janet McCabe, Deputy Assistant Administrator for the Office of Air and Radiation to the EPA Regional Administrators.

Today's action merely codifies in 40 CFR 52.2420(c) the administrative amendments approved by EPA through its June 1, 2012 Letter Notice to VADEQ. EPA has determined that this action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act (APA). This exemption authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make an action effective immediately, thereby avoiding the 30-day delayed effective date otherwise provided for in the APA. With respect to the SIP revision described above, today's administrative action simply codifies provisions which are already in effect as a matter of law in Federal and approved state programs. Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment for this administrative action is “unnecessary” because the revisions are administrative and non-substantive in nature. Immediate notice of this action in theFederal Registerbenefits the public by providing the public notice of the updated Virginia SIP. Approval of these revisions will ensure consistency between state and Federally-approved rules. EPA has determined that these changes will not relax the SIP or adversely impact air emissions.

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information that: (1) Are generated or developed before the commencement of a voluntary environmental assessment; (2) are prepared independently of the assessment process; (3) demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege Law, Va. Code § 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts. * * *” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.” Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, orany, state audit privilege or immunity law.

Under the Clean Air Act (CAA), the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act (CRA) (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. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. 5 U.S.C. 808(2). In taking action on this SIP revision, EPA already made such a finding. Thus, the SIP revisions announced in this notice became effective upon EPA's June 1, 2012 Letter Notice to Virginia. Today's administrative action simply codifies a provision which is already in effect as a matter of law in Federal and approved state programs. EPA will submit a report containing this action and other 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 action in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 13, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action to codify in 40 CFR 52.2420(c) the administrative amendments approved by EPA through its June 1, 2012 Letter Notice to VADEQ may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR Part 52 is amended as follows:

For specific information regarding the risk modeling methodology, contact Mr. James Hirtz, Health and Environmental Impacts Division (C539-02), Office ofAir Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-0881; fax number: (919) 541-0840; and email address:hirtz.james@epa.gov.For information about the applicability of the national emission standards for hazardous air pollutants to a particular entity, contact the appropriate person listed in Table 1 to this preamble.

Preamble Acronyms and Abbreviations.Several acronyms and terms used to describe industrial processes, data inventories and risk modeling are included in this preamble. While this may not be an exhaustive list, to ease the reading of this preamble and for reference purposes, the following terms and acronyms are defined here:

Background Information Document.On December 27, 2011 (76 FR 81328), the EPA proposed revisions to the pulp and paper industry NESHAP based on evaluations performed by the EPA in order to conduct our RTR. In this action, we are finalizing decisions and revisions for the rule. A summary of the public comments on the proposal and the EPA's responses to those comments is available in Docket ID Number EPA-HQ-OAR-2007-0544.Organization of this Document.The following outline is provided to aid in locating information in the preamble.

Section 112(f)(2) of the CAA requires us to determine for source categories subject to MACT standards, whether the MACT emissions standards provide an ample margin of safety to protect public health. This review, known as the residual risk review—is a one-time review that must occur within 8 years of issuance of the MACT standard. Section 112(d)(6) of the CAA requires the EPA to review and revise section 112 emissions standards, as necessary, taking into account developments in practices, processes and control technologies, emission standards promulgated under section 112 no less often than every 8 years. We issued the NESHAP for the pulp and paper industry (40 CFR part 63, subpart S) in 1998 and are due for review under CAA sections 112(d)(6) and 112(f)(2). In addition to conducting the RTR for subpart S, we are evaluating the SSMprovisions in the rule in light of the D.C. Circuit Court of Appeals decision inSierra Clubv.EPA,551 F.3d 1019 (D.C. Cir. 2008). As explained below, in theSierra Clubcase, the D.C. Circuit vacated the SSM exemption provisions in the General Provisions for non-opacity and opacity standards.

To address the RTR assessments and SSM exemptions, proposed amendments to subpart S were developed, signed by the EPA Administrator on December 15, 2011, and published in theFederal Registeron December 27, 2011. A 60-day period ending February 27, 2012, was provided for the public to submit comments on the proposal to the EPA. This action addresses the public comments on the proposal and finalizes the amendments to subpart S. The amendments are expected to ensure that control systems are properly maintained over time, ensure continuous compliance with standards and improve data accessibility.

As part of an ongoing effort to improve compliance with various federal air emission regulations, we are requiring repeat air emissions performance testing once every 5 years for facilities complying with the standards for kraft, soda and semi-chemical pulping vent gases; sulfite pulping processes; and bleaching systems. We are also finalizing changes to the subpart S NESHAP and the General Provisions applicability table to eliminate the SSM exemption. To increase the ease and efficiency of data submittal and improve data accessibility, we are requiring mills to submit electronic copies of performance test reports to the EPA's WebFIRE database. To allow mills greater flexibility in demonstrating compliance with emission limits for total HAP measured as methanol, we are including four additional test methods for measuring methanol emissions from pulp and paper processes, as alternatives to EPA Method 308. We are also making a number of technical and editorial changes, including clarifying the location in the CFR of applicable test methods, incorporating by reference several non-EPA test methods and revising the General Provisions applicability table to align with those sections of the General Provisions that have been amended or reserved over time.

Table 2 summarizes the costs and benefits of this action. See section V of this preamble for further discussion.

Regulated Entities.Categories and entities potentially regulated by this action are shown in Table 3 of this preamble.

Table 3 of this preamble is not intended to be exhaustive but rather provides a guide for readers regarding entities likely to be affected by the final action for the source category listed. To determine whether your facility would be affected, you should examine the applicability criteria in the appropriate NESHAP. As defined in the Source Category Listing Report published by the EPA in 1992, the pulp and paper production source category includes any facility engaged in the production of pulp and/or paper.1 This category includes, but is not limited to, integrated mills (where pulp and paper or paperboard are manufactured on-site), non-integrated mills (where either pulp or paper/paperboard are manufactured on-site, but not both), and secondary fiber mills (where waste paper is used as the primary raw material). Examples of pulping methods include kraft, soda, sulfite, semi-chemical and mechanical.

If you have any questions regarding the applicability of this NESHAP, please contact the appropriate person listed in the precedingFOR FURTHER INFORMATION CONTACTsection.

In addition to being available in the docket, an electronic copy of this final action will also be available on the WWW through the TTN. Following signature, a copy of the final action will be posted on the TTN's policy and guidance page for newly proposed and promulgated rules at the following address:http://www.epa.gov/ttn/caaa/new.html.The TTN provides information and technology exchange in various areas of air pollution control.

Additional information is available on the RTR Web page athttp://www.epa.gov/ttn/atw/rrisk/rtrpg.html.This information includes source category descriptions and detailed emissions and other data that were used as inputs to the risk assessments.

Under section 307(b)(1) of the CAA, judicial review of this final action is available only by filing a petition for review in the Court by November 13, 2012. Under section 307(b)(2) of the CAA, the requirements established by these final rules may not be challenged separately in any civil or criminal proceedings brought by the EPA to enforce the requirements.

Section 307(d)(7)(B) of the CAA further provides that “[o]nly an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review.” This section also provides a mechanism for us to convene a proceeding for reconsideration, “[i]f the person raising an objection can demonstrate to EPA that it was impracticable to raise such objection within [the period for public comment] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” Any person seeking to make such a demonstration to us should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave. NW., Washington, DC 20460, with a copy to both the person(s) listed in the precedingFOR FURTHER INFORMATION CONTACTsection and the Associate General Counsel for the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA,1200 Pennsylvania Ave. NW., Washington, DC 20460.

Section 112 of the CAA establishes a two-stage regulatory process to address emissions of HAP from stationary sources. In the first stage, after the EPA has identified categories of sources emitting one or more of the HAP listed in CAA section 112(b), CAA section 112(d) calls for the EPA to promulgate NESHAP for those sources. “Major sources” are those that emit or have the potential to emit 10 tpy or more of a single HAP or 25 tpy or more of any combination of HAP. For major sources, these technology-based standards must reflect the maximum degree of emissions reductions of HAP achievable (after considering cost, energy requirements and nonair quality health and environmental impacts) and are commonly referred to as MACT standards.

For MACT standards, the statute specifies certain minimum stringency requirements, which are referred to as floor requirements and may not be based on cost considerations. See CAA section 112(d)(3). For new sources, the MACT floor cannot be less stringent than the emission control that is achieved in practice by the best controlled similar source. The MACT standards for existing sources can be less stringent than floors for new sources but they cannot be less stringent than the average emission limitation achieved by the best-performing 12 percent of existing sources in the category or subcategory (or the best-performing five sources for categories or subcategories with fewer than 30 sources). In developing MACT, we must also consider control options that are more stringent than the floor under CAA section 112(d)(2). We may establish standards more stringent than the floor, based on the consideration of the cost of achieving the emissions reductions, any nonair quality health and environmental impacts and energy requirements. In promulgating MACT standards, CAA section 112(d)(2) directs us to consider the application of measures, processes, methods, systems or techniques that reduce the volume of or eliminate HAP emissions through process changes, substitution of materials or other modifications; enclose systems or processes to eliminate emissions; collect, capture or treat HAP when released from a process, stack, storage or fugitive emissions point; and/or are design, equipment, work practice or operational standards.

In the second stage of the regulatory process, we undertake two different analyses, as required by the CAA. First, section 112(d)(6) of the CAA calls for us to review the technology-based standards and to revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less frequently than every 8 years. Second, within 8 years after promulgation of the MACT standards, CAA section 112(f) calls for us to evaluate the risk to public health remaining after application of the standards and to revise the standards, if necessary, to provide an ample margin of safety to protect public health or to prevent, taking into consideration costs, energy, safety and other relevant factors, an adverse environmental effect. Under section 112(f)(2), the EPA may re-adopt the existing MACT standards if the EPA determines that those standards are sufficiently protective.Natural Resources Defense Council (NRDC)v.EPA,529 F.3d 1077, 1083 (DC Cir. 2008).

On December 27, 2011, the EPA published a proposed rule in theFederal Registerfor the pulp and paper industry NESHAP, 40 CFR part 63, subpart S based on the RTR analyses that the EPA conducted under CAA sections 112(d)(6) and 112(f)(2) (76 FR 81328). Today's action provides the EPA's final determinations and regulatory amendments pursuant to the RTR provisions of CAA section 112.

In addition, several other aspects of the subpart S MACT rule were reviewed and considered for revision at proposal, and after review of the public comment received, we are taking the following actions:

• Finalizing the requirement for 5-year repeat emissions testing for selected process equipment.

• Revising the requirements in the NESHAP related to emissions during periods of SSM.

• Finalizing the requirement for electronic reporting of performance test data.

• Adding test methods for measuring methanol emissions.

• Finalizing changes to address technical and editorial corrections in the rule.

The NESHAP for the pulp and paper industry was promulgated on April 15, 1998 (63 FR 18504). The standards are codified at 40 CFR part 63, subpart S. The pulp and paper industry consists of facilities engaged in the production of pulp and/or paper/paperboard. This category includes, but is not limited to, integrated mills (where pulp and paper or paperboard are manufactured on-site), non-integrated mills (where paper/paperboard or pulp are manufactured, but not both), and secondary fiber mills (where waste paper is used as the primary raw material). The subpart S MACT standard applies to major sources of HAP emissions from the pulp production areas (e.g., pulping system vents, pulping process condensates) at chemical, mechanical, secondary fiber and non-wood pulp mills; bleaching operations; and papermaking systems. A separate NESHAP (40 CFR part 63, subpart MM) applicable to chemical recovery processes at kraft, soda, sulfite and stand-alone semi-chemical pulp mills was promulgated on January 12, 2001 (66 FR 3180). Today's rule takes final action only with respect to the RTR for subpart S. The source category covered by subpart S includes 171 facilities. As explained below, we are re-adopting the MACT standards pursuant to section 112(f)(2). We also conducted a section 112(d)(6) review and evaluated developments in practices, processes and control technologies applicable to all the emission sources subject to the pulp and paper MACT. After reviewing the comments provided at proposal, we have determined that our conclusion that there have been no developments in practices, processes and control technologies since the subpart S standard was originally promulgated was correct. Although we proposed revisions to the kraft pulping process condensate standards based on our conclusion at proposal that existing technologies were achieving greater than the 92 percent minimum level of control, we re-analyzed the performance data and impacts of revising the kraft condensate standards in response to public comments and have decided not to promulgate amendments to those standards because we found that the costs and impacts associated with the HAP reduction were not reasonable. Consequently, we are not revising the MACT standards for subpart S pursuant to our 112(d)(6) review as explained further below.

In addition, this section describes the other final rule amendments to the pulp and paper industry NESHAP. These revisions include the addition of repeat emissions testing for selected process equipment; changes to the requirements that apply during periods of SSM; the addition of electronic reporting requirements; and various minor changes to address technical and editorial corrections.

As part of an ongoing effort to improve compliance with the standard, we are adding 40 CFR 63.457(a)(2) to require repeat air emissions performance testing once every 5 years for facilities complying with the standards for kraft, soda and semi-chemical pulping vent gases (40 CFR 63.443(a)); sulfite processes (40 CFR 63.444); and bleaching systems (40 CFR 63.445). Repeat performance tests are already required by permitting authorities for some facilities.2 Requiring periodic repeat performance tests will help to ensure that control systems are maintained properly over time and a more rigorous testing requirement will better assure compliance with the standard.3

In this action, repeat air emissions testing will be required for mills complying with the kraft pulping process condensate standards in 40 CFR 63.446 using a steam stripper since stripper off-gases are, by definition, part of the LVHC system. We are clarifying that repeat air emissions testing will not be required for: (1) Knotter or screen systems with HAP emission rates below the criteria specified in 40 CFR 63.443(a)(1)(ii); or (2) decker systems using fresh water or paper machine white water, or decker systems using process water with a total HAP concentration less than 400 ppmw as specified in 40 CFR 63.443(a)(1)(iv).

We are also finalizing changes to the subpart S NESHAP to eliminate the SSM exemption, as discussed further in section III.B below. The changes include:

(1) Revising 40 CFR 63.443(e), 63.446(g) and 63.459(b)(11)(ii) to eliminate reference to periods of SSM;

(2) Revising 40 CFR 63.453(q) to incorporate the general duty from 40 CFR 63.6(e)(1)(i) to minimize emissions;

(3) Adding 40 CFR 63.454(g), and 40 CFR 63.455(g) to require reporting and recordkeeping requirements associated with periods of malfunction;

(4) Adding 40 CFR 63.456 (formerly reserved) to include an affirmative defense to civil penalties for violations of emissions limits caused by malfunctions that meet the criteria for establishing the affirmative defense;

(5) Adding 40 CFR 63.457(o) to specify the conditions for performance tests; and

(6) Revising Table 1 to specify that 40 CFR 63.6(e)(1)(i) and (ii), 40 CFR 63.6(e)(3), 40 CFR 63.6(f)(1); 40 CFR 63.7(e)(1), 40 CFR 63.8(c)(1)(i) and (iii), and the last sentence of 40 CFR 63.8(d)(3); 40 CFR 63.10(b)(2)(i), (ii), (iv) and (v); 40 CFR 63.10(c)(10), (11) and (15); and, 40 CFR 63.10(d)(5) of the General Provisions do not apply.

To increase the ease and efficiency of data submittal and improve data accessibility, we are requiring mills to submit electronic copies of performance test reports to the EPA's WebFIRE database, as discussed in section III.D below. The electronic reporting requirement is being added under 40 CFR 63.455(h).

To allow mills greater flexibility in demonstrating compliance with emission limits for total HAP measured as methanol, we are revising 40 CFR 63.457(b)(5)(i) to include four additional test methods for measuring methanol emissions from pulp and paper processes, as alternatives to EPA Method 308 of part 63, appendix A. The four additional test methods are:

(1) Method 18 of part 60, appendix A-6;

(2) Method 320 of part 63, appendix A;

(3) ASTM D6420-99, determined to be an acceptable alternative to EPA Method 18; and

(4) ASTM D6348-03, determined to be an acceptable alternative to EPA Method 320.

We are also revising 40 CFR 63.14(b)(28) and (b)(54) to IBR ASTM D6420-99 and ASTM D6348-03, respectively.

We are also finalizing the following minor changes to the subpart S NESHAP and part 63 General Provisions to address technical and editorial corrections:

(1) Revising 40 CFR 63.457(b)(1) to specify part 60, appendix A-1 for Method 1 or 1A;

(2) Revising 40 CFR 63.457(b)(3) to specify part 60, appendix A-1 for Method 2, 2A, 2C or 2D;

(3) Revising 40 CFR 63.457(b)(5)(ii) to specify part 60, appendix A-8 for Method 26A;

(4) Revising 40 CFR 63.457(d) to specify part 60, appendix A-7 for Method 21;

(5) Revising 40 CFR 63.457(k)(1) to specify part 60, appendix A-2 for Method 3A or 3B, and include ASME PTC 19.10—part 10 as an alternative to Method 3B;

(6) Revising 40 CFR 63.457(c)(3)(ii) to replace NCASI Method DI/MEOH-94.02 with the more recent version of this method, NCASI Method DI/MEOH-94.03;

(7) Revising 40 CFR 63.14(f)(1) to incorporate by reference NCASI Method DI/MEOH-94.03;

(8) Redesignating 40 CFR 63.14(f)(3) and (f)(4) as 40 CFR 63.14(f)(4) and (f)(5) and adding 40 CFR 63.14(f)(3) to incorporate by reference NCASI Method DI/HAPS-99.01;

(9) Revising 40 CFR 63.14(i)(1) to incorporate by reference ANSI/ASME PTC 19.10-1981; and

(10) Revising Table 1 so it aligns more closely to the sections in subpart A which have been amended or reserved over time.

In 2008, the Court vacated portions of two provisions in the EPA's CAA section 112 regulations governing the emissions of HAP during periods of SSM.Sierra Clubv.EPA,551 F.3d 1019 (D.C. Cir. 2008),cert.denied, 130 S. Ct. 1735 (U.S. 2010). Specifically, the Court vacated the SSM exemption contained in 40 CFR 63.6(f)(1) and 40 CFR 63.6(h)(1), that are part of a regulation, commonly referred to as the “General Provisions Rule,” that the EPA promulgated under section 112 of the CAA. When incorporated into CAA section 112(d) regulations for specific source categories, these two provisions exempt sources from the requirement to comply with the otherwise applicable CAA section 112(d) emission standard during periods of SSM.

Consistent withSierra Clubv.EPA,we have eliminated the SSM exemption in this rule. We have also revised Table 1 (the General Provisions table) in several respects. For example, we have eliminated the General Provisions' requirement that the source develop a SSM plan. We have also eliminated or revised certain recordkeeping and reporting that related to the SSM exemption. The EPA has attempted to ensure that we have not included in the regulatory language any provisions that are inappropriate, unnecessary or redundant in the absence of the SSM exemption.

In establishing the standards for startup and shutdown, we reviewed the information available to us from the 2011 pulp and paper ICR pertaining to equipment and control and compliance demonstration methods during startup and shutdown. Some commenterssuggested that we establish different standards for periods of startup and shutdown. However, the information available to us regarding startup and shutdown does not show that emissions are higher during startup or shutdown or indicate a need for alternate standards for these periods. Further, the commenters have not shown that sources cannot comply with the standards as proposed and have not provided information to support development of alternative standards that would apply during startup and shutdown periods.

Our findings relative to startup and shutdown for the universe of pulp and paper processes regulated under subpart S (which offers a variety of compliance options) are discussed in detail in the response-to-comments document and in a memorandum in the docket.4 Based upon these findings, and consistent with our proposal, the EPA has not established different standards for startup and shutdown periods.

Periods of startup, normal operations and shutdown are all predictable and routine aspects of a source's operations. However, by contrast, malfunction is defined as a “sudden, infrequent, and not reasonably preventable failure of air pollution control and monitoring equipment, process equipment or a process to operate in a normal or usual manner * * *” (40 CFR 63.2). The EPA has determined that CAA section 112 does not require that emissions that occur during periods of malfunction be factored into development of CAA section 112 standards. Under section 112, emissions standards for new sources must be no less stringent than the level “achieved” by the best controlled similar source and for existing sources generally must be no less stringent than the average emission limitation “achieved” by the best performing 12 percent of sources in the category. There is nothing in section 112 that directs the agency to consider malfunctions in determining the level “achieved” by the best performing or best controlled sources when setting emission standards. Moreover, while the EPA accounts for variability in setting emissions standards consistent with the section 112 case law, nothing in that case law requires the agency to consider malfunctions as part of that analysis. Section 112 uses the concept of “best controlled” and “best performing” unit in defining the level of stringency that section 112 performance standards must meet. Applying the concept of “best controlled” or “best performing” to a unit that is malfunctioning presents significant difficulties as malfunctions are sudden and unexpected events.

Further, accounting for malfunctions would be difficult, if not impossible, given the myriad different types of malfunctions that can occur across all sources in the category and given the difficulties associated with predicting or accounting for the frequency, degree and duration of various malfunctions that might occur. As such, the performance of units that are malfunctioning is not “reasonably” foreseeable. See, e.g.,Sierra Clubv.EPA,167 F. 3d 658, 662 (D.C. Cir. 1999) (the EPA typically has wide latitude in determining the extent of data-gathering necessary to solve a problem. We generally defer to an agency's decision to proceed on the basis of imperfect scientific information, rather than to “invest the resources to conduct the perfect study.”). See also,Weyerhaeuserv.Costle,590 F.2d 1011, 1058 (D.C. Cir. 1978) (“In the nature of things, no general limit, individual permit, or even any upset provision can anticipate all upset situations. After a certain point, the transgression of regulatory limits caused by `uncontrollable acts of third parties,' such as strikes, sabotage, operator intoxication or insanity, and a variety of other eventualities, must be a matter for the administrative exercise of case-by-case enforcement discretion, not for specification in advance by regulation.”). In addition, the goal of a best controlled or best performing source is to operate in such a way as to avoid malfunctions of the source and accounting for malfunctions could lead to standards that are significantly less stringent than levels that are achieved by a well-performing non-malfunctioning source. The EPA's approach to malfunctions is consistent with section 112 and is a reasonable interpretation of the statute.

In the event that a source fails to comply with the applicable CAA section 112(d) standards as a result of a malfunction event, the EPA would determine an appropriate response based on, among other things, the good faith efforts of the source to minimize emissions during malfunction periods, including preventative and corrective actions, as well as root cause analyses to ascertain and rectify violations. The EPA would also consider whether the source's failure to comply with the CAA section 112(d) standard was, in fact, “sudden, infrequent, not reasonably preventable” and was not instead “caused in part by poor maintenance or careless operation.” 40 CFR 63.2 (definition of malfunction).

Finally, the EPA recognizes that even equipment that is properly designed and maintained can sometimes fail and that such failure can sometimes cause a violation of the relevant emission standard. (See, e.g.,State Implementation Plans: Policy Regarding Excessive Emissions During Malfunctions, Startup, and Shutdown(Sept. 20, 1999);Policy on Excess Emissions During Startup, Shutdown, Maintenance, and Malfunctions(Feb. 15, 1983)). The EPA is therefore adding to the final rule an affirmative defense to civil penalties for violations of emission standards that are caused by malfunctions. See 40 CFR 63.441 (defining “affirmative defense” to mean, in the context of an enforcement proceeding, a response or defense put forward by a defendant, regarding which the defendant has the burden of proof and the merits of which are independently and objectively evaluated in a judicial or administrative proceeding). We also have added other regulatory provisions to specify the elements that are necessary to establish this affirmative defense; the source must prove by a preponderance of the evidence that it has met all of the elements set forth in 40 CFR 63.456. (See 40 CFR 22.24). The criteria ensure that the affirmative defense is available only where the event that causes a violation of the emission standard meets certain criteria. For example, to successfully assert the affirmative defense, the source must prove by a preponderance of the evidence that the violation was “caused by a sudden, infrequent, and unavoidable failure of air pollution control equipment, process equipment, or a process to operate in a normal or usual manner * * *.” The criteria also are designed to ensure that steps are taken to correct the malfunction, to minimize emissions in accordance with 40 CFR 63.456 and to prevent future malfunctions. For example, the source must prove by a preponderance of the evidence that “[r]epairs were made as expeditiously as possible when a violation occurred * * *” and that “[a]ll possible steps were taken to minimize the impact of the violation on ambient air quality, the environment and human health * * *.” In any judicial or administrative proceeding, the Administrator may challenge the assertion of the affirmative defense and, if the respondent has not met its burden of proving all of the requirements in the affirmative defense, appropriate penalties may be assessedin accordance with section 113 of the CAA (see also 40 CFR 22.27).

The EPA is including an affirmative defense in the final rule in an attempt to balance a tension, inherent in many types of air regulation, to ensure adequate compliance while simultaneously recognizing that despite the most diligent of efforts, emission standards may be violated under circumstances beyond the control of the source. The EPA must establish emission standards that “limit the quantity, rate, or concentration of emissions of air pollutants on a continuous basis.” 42 U.S.C. 7602(k) (defining “emission limitation and emission standard”). See generallySierra Clubv.EPA,551 F.3d 1019, 1021 (D.C. Cir. 2008). Thus, the EPA is required to ensure that section 112 emissions standards are continuous. The affirmative defense for malfunction events meets this requirement by ensuring that even where there is a malfunction, the emission standard is still enforceable through injunctive relief. While “continuous” standards, on the one hand, are required, there is also case law indicating that in many situations, it is appropriate for the EPA to account for the practical realities of technology. For example, inEssex Chemicalv.Ruckelshaus,486 F.2d 427, 433 (D.C. Cir. 1973), the D.C. Circuit acknowledged that in setting standards under CAA section 111 “variant provisions” such as provisions allowing for upsets during startup, shutdown and equipment malfunction “appear necessary to preserve the reasonableness of the standards as a whole and that the record does not support the `never to be exceeded' standard currently in force.” See also,Portland Cement Associationv.Ruckelshaus, 486 F.2d 375 (D.C. Cir. 1973).Though intervening case law such asSierra Clubv.EPAand the CAA 1977 amendments call into question the relevance of these cases today, they support the EPA's view that a system that incorporates some level of flexibility is reasonable. The affirmative defense simply provides for a defense to civil penalties for violations that are proven to be beyond the control of the source. By incorporating an affirmative defense, the EPA has formalized its approach to upset events. In a CWA setting, the Ninth Circuit required this type of formalized approach when regulating “upsets beyond the control of the permit holder.”Marathon Oil Co.v.EPA,564 F.2d 1253, 1272-73 (9th Cir. 1977). See also,Mont. Sulphur & Chem. Co.v.United States EPA,2012 U.S. App. LEXIS 1056 (Jan 19, 2012) (rejecting industry argument that reliance on the affirmative defense was not adequate). But see,Weyerhaeuser Co.v.Costle,590 F.2d 1011, 1057-58 (D.C. Cir. 1978) (holding that an informal approach is adequate). The affirmative defense provisions give the EPA the flexibility to both ensure that its emission standards are “continuous” as required by 42 U.S.C. 7602(k), and account for unplanned upsets and thus support the reasonableness of the standard as a whole.

The revisions to subpart S being promulgated in this action are effective on September 11, 2012. The compliance date for the revisions we are finalizing today is September 11, 2012, with the exception of the following: (1) The first of the 5-year repeat tests must be conducted within 36 months of the effective date of the standards, by September 7, 2015, and thereafter within 60 months from the date of the previous performance test; and (2) the date to submit performance test data through ERT is within 60 days after the date of completing each performance test.

As stated in the proposed rule preamble, the EPA is taking a step to increase the ease and efficiency of data submittal and data accessibility. Specifically, the EPA is requiring owners and operators of pulp and paper facilities to submit electronic copies of required performance test reports.

As mentioned in the proposed rule preamble, data will be collected through an electronic emissions test report structure called the ERT. The ERT will generate an electronic report, which will be submitted to the EPA's CDX through the CEDRI. A description of the ERT can be found at:http://www.epa.gov/ttn/chief/ert/index.html,and CEDRI can be accessed through the CDX Web site:(http://www.epa.gov/cdx).

The requirement to submit performance test data electronically to the EPA does not create any additional performance testing and will apply only to those performance tests conducted using test methods that are supported by the ERT. A listing of the pollutants and test methods supported by the ERT is available at the previously mentioned ERT Web site. Through this approach, industry is expected to save time in the performance test submittal process. Additionally this rulemaking benefits industry by cutting back on recordkeeping costs as the performance test reports that are submitted to the EPA using CEDRI are no longer required to be kept on-site.

As mentioned in the proposed rule preamble, state, local and tribal agencies will benefit from more streamlined and accurate review of electronic data that will be available on the EPA WebFIRE database. Additionally, performance test data will become available to the public through WebFIRE. Having such data publicly available enhances transparency and accountability. The major advantages of electronic reporting are more fully explained in the proposed rule preamble (76 FR 81348).

In summary, in addition to supporting regulation development, control strategy development and other air pollution control activities, having an electronic database populated with performance test data will save industry, state, local, tribal agencies and the EPA significant time, money and effort, while improving the quality of emissions inventories and, as a result, air quality regulations.

As noted at proposal (76 FR 81344), the risk analysis performed for the pulp and paper source category indicated that the cancer risks to the individual most exposed are no higher than 10 in 1 million due to actual or MACT-allowable emissions. These risks are considerably less than 100 in 1 million, which is the presumptive upper limit of risk acceptability. The risk analysis also showed generally low cancer incidence (1 case every 100 years); no potential for adverse environmental effects or human health multipathway effects; no potential for chronic noncancer impacts; and, as explained in the proposal and further below, while a potential exists for some acute inhalation impacts, they are likely to be minimal because the potential impacts occur in uninhabited areas where terrain prevents ready access by the public. Also, we received comment on the risk assessment that is addressed in our comment response.5

The number of people exposed to cancer risks of 1 in 1 million or greater due to emissions from the source category was determined to be relatively low (76,000). The number of people exposed at the MIR cancer risk of 10 in 1 million or greater due to emissionsfrom the source category was significantly lower (40). Considering all of this health information and the uncertainties discussed in the proposal preamble (76 FR 81338-40), the risks from the pulp and paper source category were deemed to be acceptable. 76 FR 81344.

Our analysis of facilitywide risks showed five mills with maximum chronic cancer risks between 10 and 30 in 1 million and four mills with maximum chronic noncancer TOSHI between 1 and 2. For the facility with the highest facilitywide risk (i.e., 30 in 1 million), emissions from the pulp and paper (subpart S) source category only contributed 27 percent to the chronic cancer risk and 23 percent to the chronic noncancer risk.

As directed by section 112(f)(2), we conducted an analysis to determine if the standard provides an ample margin of safety analysis to protect public health. Under the ample margin of safety analysis, we first considered the health impacts for the source category. Then we analyzed the potential for emissions reductions within the source category by evaluating available control technologies and their capabilities for reduction of the residual risk remaining after the implementation of MACT controls. Then we evaluated the potential costs and energy impacts of these additional controls.6 Based on this analysis, we conclude that the current standard protects public health with an ample margin of safety. (76 FR 81344) We solicited comment on the proposal (76 FR 81349-51), asking for any additional data that may help to reduce the uncertainties inherent in the risk assessments and other analyses. We were specifically interested in receiving corrections to the mill-specific HAP emissions data used in the risk modeling. The mill-specific emissions data were available for download on the EPA's RTR web page at:http://www.epa.gov/ttn/atw/rrisk/rtrpg.html.Commenters on the subpart S proposal were asked to determine whether any of the data were unrepresentative or inaccurate and to submit their comments on the data downloaded from the RTR web page.

A total of 81 mills submitted specific revisions to their mill-specific data. The EPA reviewed the data revisions to determine whether they would influence the outcome of the risk assessment results as proposed. Specifically, the mills submitted data revisions that remove pollutants, change emission release point type from fugitive to stack and change stack/fugitive emission parameters. Our review indicated that these changes would reduce emissions and/or impacts. Consequently, we have determined that the results of the revisions would most likely adjust the risk results for the subpart S source category downward (i.e., reduce risk) if we were to remodel the category. Therefore, we have decided not to remodel risk for purposes of promulgating the subpart S residual risk review because our conservative approach at proposal overstates existing risk and reinforces the conclusions from the risk modeling conducted at proposal. A memorandum for the docket was prepared that summarizes the data revisions received and supports the decision not to remodel risk.7 A separate document presents the results of the EPA's risk analysis.8 We conclude based on the Residual Risk Assessment cited here that the risks from the subpart S pulp and papermaking source category are acceptable and that the current standard protects the public health with an ample margin of safety. Consequently, we are re-adopting the MACT standards for subpart S pursuant to our 112(f)(2) review.

As a result of our initial technology review, we proposed on December 27, 2011, to strengthen the kraft pulping process condensate standards in 40 CFR 63.446 by increasing the HAP removal requirement from 92 to 94 percent (or an equivalent pound/ODTP or ppmw limit). Several commenters opposed the proposed revisions to the kraft pulping process condensate standards, for reasons including calculation methodology issues, data misinterpretation, undetermined impacts on mills utilizing the clean condensate compliance alternative and additional steam and energy impacts for rule compliance. A detailed discussion of these comments can be found in the Response to Comment Document.9

In response to these comments, we have: (1) Re-analyzed the condensate collection information provided in the ICR; (2) evaluated the design criteria (and energy impacts) of the steam strippers and biotreatment units typically used by facilities to assure compliance with 40 CFR 63.446; (3) reviewed additional cost and control information that supplements the data collected in the ICR; and (4) considered the effects of the proposed standards on CCA mills.

In our re-analysis, we estimated the potential nationwide cost associated with increasing condensate treatment from 92 to 94 percent reduction would be $423 million (capital) and $85.1 million/yr. We estimated a HAP emissions reduction of 2,300 tpy, for a cost effectiveness of $37,000/ton of HAP. This estimate includes the costs associated with a repeat CCA demonstration and switching from CCA to HVLC pulping vent gas control at mills where the CCA approach would be adversely affected. Our revised cost estimates for a 94 percent reduction standard are significantly higher than the cost estimates that we developed at proposal for a 94 percent reduction standard because we determined that a greater number of mills would be affected after the potential impacts on CCA mills. Also, the cost-to-sales ratios for the three affected small businesses are also higher with one small business now estimated to have a ratio of 15 percent.10 For this reason alone, we would decline to revise the standard under (d)(6) because we find increasing the standard from 92 percent to 94 percent not cost effective. In addition, after review of the comments, we recognize that we failed to fully consider the energy and secondary air emissions impacts associated with the 94 percent reduction limit for these mills, due to increased steam demand for new and upgraded stripper systems. Upon review of the information in the record, we believe these factors also weigh against revising the MACT standards. In the proposal, we estimated energy and secondary emissions impacts based on increased electricity requirements for biological treatment. We did not assume there were any additional impacts from new and upgraded steam strippers because they were expected to be more energy efficient, however, commenters indicated that additional steam would be required for these facilities. We haveconsidered these energy and secondary air emissions impacts for steam strippers for the final rule as a result of the public comments.11

Similarly, we also analyzed the potential nationwide costs and impacts of increasing the 92 percent reduction standard to 93 percent reduction. For a 93 percent reduction standard, estimated capital costs would be $396 million and estimated annualized costs would be $74.4 million/yr, with a HAP emission reduction of 989 tpy, or approximately $75,000/ton of HAP. Additionally, the cost-to-sales ratio is nearly 6 percent for one of the three small businesses.12 For this reason alone, we would decline to revise the standard under (d)(6) because we find increasing the standard from 92 percent to 93 percent not cost effective. In addition, after review of the comments, we recognize that we failed to fully consider the energy and secondary air emissions impacts associated with the 93 percent reduction limit for these mills, due to increased steam demand for new and upgraded stripper systems. Upon review of the information in the record, we believe these factors also weigh against revising the MACT standards.

Based on this re-analysis, we do not consider the costs and impacts associated with the HAP reduction that would be achieved under either the 93 or 94 percent reduction options to be reasonable. Consequently we are not revising the MACT standards pursuant to section 112(d)(6).

In response to a comment, we have added language to clarify that the 5-year repeat testing is not required for: (1) Knotter or screen systems with HAP emission rates below the criteria specified in 40 CFR 63.443(a)(1)(ii); or (2) decker systems using fresh water or paper machine white water or decker systems using process water with a total HAP concentration less than 400 ppm by weight as specified in 40 CFR 63.443(a)(1)(iv).

Commenters requested clarification of the electronic reporting effective date since the proposed rule stated that performance test data must be submitted “[a]s of January 1, 2012 and within 60 days of completing each performance test * * *”. The commenters noted that the January 1, 2012, date would require submission of performance testing before the final rule was in effect. In response to this comment, we have deleted reference to January 1, 2012, from the final rule. Electronic reports would be submitted within 60 days after completing each performance test.

Some commenters expressed concern regarding the EPA's request for comment in the preamble to the proposed rule (76 FR 81346) as to whether to remove or modify the excess emissions allowance provisions in 40 CFR 63.443(e), 63.446(g) and 63.459(b)(11)(ii). We are deferring final action on the excess emissions allowances until a later date in order to analyze more recent information on the allowances that we have obtained from industry. After we have completed our analysis of the data, we expect to publish a proposed rule describing the changes to the excess emissions allowance provisions that we believe are warranted and provide a further opportunity for public comment before taking final action with respect to the excess emissions allowance provisions.

We have made certain changes to 40 CFR 63.456 for the final rule to clarify the circumstances under which a source may assert an affirmative defense. The changes to 40 CFR 63.456 clarify that a source may assert an affirmative defense to a claim for civil penalties for violations of standards that are caused by malfunctions. A source can avail itself of the affirmative defense when there has been a violation of the emission standards due to an event that meets the definition of malfunction under 40 CFR 63.2 and qualifies for assertion of an affirmative defense under § 63.456. In the proposal, we used terms such as “exceedance” or “excess emissions” in 40 CFR 63.456, which created unnecessary confusion as to when the affirmative defense could be used. In the final rule, we have eliminated those terms and used the word “violation” to make clear that the affirmative defense to civil penalties is available only where an event that causes a violation of the emissions standard meets the criteria for the assertion of an affirmative defense under § 63.456.

We have also eliminated the 2-day notification requirement that was included in 40 CFR 63.456(b) at proposal because we expect to receive sufficient notification of malfunction events that result in violations in other required compliance reports, such as the malfunction report required under 40 CFR 63.455(g). In addition, we have revised the 45-day affirmative defense reporting requirement that was included in 40 CFR 63.456(b) at proposal to require sources to include the report in the first compliance, deviation or excess emission report due after the initial occurrence of the violation, unless the compliance, deviation or excess emission report is due less than 45 days after the violation. In that case, the affirmative defense report may be included in the second compliance, deviation or excess emission report due after the initial occurrence of the violation. Because the affirmative defense report is now included in a subsequent compliance, deviation or excess emission report, there is no longer a need for the proposed 30-day extension for submitting a stand-alone affirmative defense report. Consequently, we are not including this provision in the final rule.

There are currently 171 major source pulp and paper mills operating in the United States. The affected source for kraft, soda, sulfite or semi-chemical pulping processes is the total of all HAP emission points in the pulping and bleaching systems. The affected source for mechanical, secondary or non-wood pulping processes is the total of all HAP emission points in the bleaching system. We estimate that 114 of the 171 major source mills operate subpart S processes that are affected by this final rule.

These final amendments will require an estimated 114 mills to conduct repeat testing for pulping and bleaching operations and all major sources with equipment subject to the subpart S standards to operate without the SSM exemption. We were unable to quantify the specific emissions reductions associated with repeat emissions testing or eliminating the SSM exemption. However, repeat testing will tend to reduce emissions by providing incentive for facilities to maintain their control systems and make periodic adjustments to ensure peak performance. Eliminating the SSM exemption will reduce emissions by requiring facilities to meet the applicable standard during SSM periods.

Section IV.B of this preamble presents estimates of the air quality impacts associated with the kraft pulping process condensate regulatory options that were not selected for inclusion in this final rule.

Pulp and paper mills will incur costs to conduct repeat testing and record malfunctions in support of the new affirmative defense in the rule. Costs associated with elimination of the startup and shutdown exemption were estimated as part of the reporting and recordkeeping costs and include time for re-evaluating previously developed SSM record systems. Nationwide capital costs are estimated to be $5.9 million. The total nationwide annualized costs associated with these new requirements are estimated to be $2.1 million per year.

Section IV.B of this preamble presents cost estimates associated with the kraft pulping process condensate regulatory options that were not selected for inclusion in this final rule.

We performed an EIA of the final rule for pulp and paper consumers and producers nationally. The EIA, which documents the data sources and methods used and provides detailed results, can be found in the docket for the final rule. This section provides an overview of key results.

The final rule induces minimal changes in the average national price of paper and paperboard products. Paper and paperboard product prices increase less than 0.01 percent on average, while production levels decrease less that 0.01 percent on average, as a result of the final rule. Consumers are estimated to experience a reduction in economic welfare of about $1.1 million as the result of slightly higher prices and slightly reduced consumption. Although producers' welfare losses are mitigated to some degree by slightly higher prices, market conditions limit their ability to pass on all of the compliance costs. As a result, they also are estimated to experience a loss in economic welfare of about $1.0 million as a result of the final rule.

Because this rulemaking is not likely to have an annual effect on the economy of $100 million or more, we have not conducted a RIA or a benefits analysis. Since we were unable to quantify the emissions reductions associated with the new requirements in the final rule (repeat testing and elimination of the SSM exemption), we were also unable to quantify the monetary benefits associated with these new requirements.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” because it raises novel legal and policy issues. Accordingly, the EPA submitted this action to OMB for review under Executive Order 12866 and 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB recommendations have been documented in the docket for this action.

The information collection requirements in this final rule have been submitted for approval to OMB under the PRA, 44 U.S.C. 3501,et seq .The ICR document prepared by the EPA has been assigned EPA ICR number 2452.02. The information collection requirements are not enforceable until OMB approves them. The information requirements are based on notification, recordkeeping and reporting requirements in the NESHAP General Provisions (40 CFR part 63, subpart A), which are mandatory for all operators subject to national emissions standards. These recordkeeping and reporting requirements are specifically authorized by CAA section 114 (42 U.S.C. 7414). All information submitted to the EPA pursuant to the recordkeeping and reporting requirements for which a claim of confidentiality is made is safeguarded according to agency policies set forth in 40 CFR part 2, subpart B.

This final rule includes new paperwork requirements for repeat testing for selected process equipment, as described in 40 CFR 63.457(a)(2). More specifically, we are requiring stack testing every 5 years for total HAP for chemical pulping operations and bleaching operations at pulp and paper mills. This final rule also includes new paperwork requirements for recordkeeping of malfunctions, as described in 40 CFR 63.454(g) (conducted in support of the affirmative defense provisions, as described in 40 CFR 63.456).

When a malfunction occurs, sources must report the event according to the applicable reporting requirements of 40 CFR part 63, subpart S. An affirmative defense to civil penalties for violations of emission limits that are caused by malfunctions is available to a source if it can demonstrate that certain criteria and requirements are satisfied. The criteria ensure that the affirmative defense is available only where the event that causes a violation of the emission limit meets the narrow definition of malfunction in 40 CFR 63.2 (sudden, infrequent, not reasonable preventable and not caused by poor maintenance and or careless operation) and where the source took necessary actions to minimize emissions. In addition, the source must meet certain notification and reporting requirements. For example, the source must prepare a written root cause analysis and submit a written report to the Administrator documenting that it has met the conditions and requirements for assertion of the affirmative defense.

The EPA is adding affirmative defense to the estimate of burden in the ICR. To provide the public with an estimate of the relative magnitude of the burden associated with an assertion of the affirmative defense position adopted by a source, the EPA has provided administrative adjustments to the ICR that show what the notification, recordkeeping and reporting requirements associated with the assertion of the affirmative defense might entail. The EPA's estimate for the required notification, reports and records for any individual incident, including the root cause analysis, totals $3,258, and is based on the time and effort required of a source to review relevant data, interview plant employees and document the events surrounding a malfunction that has caused a violation of an emissions limit. The estimate also includes time to produce and retain the record and reports for submission to the EPA. The EPA provides this illustrative estimate of this burden because these costs are only incurred if there has been a violation and a source chooses to take advantage of the affirmative defense.

Given the variety of circumstances under which malfunctions could occur, as well as differences among sources' operation and maintenance practices, we cannot reliably predict the severity and frequency of malfunction-related excess emissions events for a particular source. It is important to note that the EPA has no basis currently for estimating the number of malfunctions that would qualify for an affirmative defense. Current historical records would be an inappropriate basis, as source owners or operators previously operated their facilities in recognition that they were exempt from the requirement to comply with emissions standards during malfunctions. Of the number of excess emissions events reported by source operators, only asmall number would be expected to result from a malfunction (based on the definition above), and only a subset of violations caused by malfunctions would result in the source choosing to assert the affirmative defense. Thus, we expect the number of instances in which source operators might be expected to avail themselves of the affirmative defense will be extremely small. For this reason, we estimate no more than two such occurrences per year for all sources subject to subpart S over the 3-year period covered by this ICR. We expect to gather information on such events in the future and will revise this estimate as better information becomes available.

The estimated recordkeeping and reporting burden associated with subpart S after the effective date of the final rule is estimated to be 52,300 labor hours at a cost of $4.94 million per year and total non-labor capital and O&M costs of $841,000 per year. This estimate includes reporting costs, such as reading and understanding the rule requirements, conducting required activities (e.g., stack testing, inspections), and preparing notifications and compliance reports and recordkeeping costs associated with malfunctions, monitoring and inspections. The total burden for the federal government is estimated to be 6,870 hours per year at a total labor cost of $310,000 per year. Burden is defined at 5 CFR 1320.3(b).

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is approved by OMB, the agency will publish a technical amendment to 40 CFR part 9 in theFederal Registerto display the OMB control numbers for the approved information collection requirements contained in this final rule.

The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act, or any other statute, unless the agency certifies that the rule will not have a SISNOSE. Small entities include small businesses, small organizations and small governmental jurisdictions.

For purposes of assessing the impacts of this final rule on small entities, small entity is defined as: (1) A small business as defined by the SBA's regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. For this source category, which has the general NAICS subsector code 322 (i.e., Paper Manufacturing), the SBA small business size standard is 500 to 750 employees (depending on the specific NAICS code) according to the SBA small business standards definitions.

The EPA analyzed impacts on small businesses by comparing estimated annualized engineering compliance costs at the company-level to company revenue. The analysis found that the ratio of compliance cost to company revenue falls below 1 percent for the three small companies that are likely to be affected by the finalized rule. After considering the economic impacts of this final rule on small entities, I certify that this action will not have a SISNOSE. See the EIA in the docket for this rule for more details on this analysis.

Although this final rule will not have a SISNOSE, the EPA nonetheless has tried to reduce the impact of this rule on small entities. The proposed amendment tightening the kraft pulping process condensate standards was not finalized after the EPA re-evaluated the amendment and its costs and impacts in response to public comments (see section IV.B of this preamble for further information). The repeat testing requirement was established in a way that minimizes the costs for testing and reporting while still providing the agency the necessary information needed to ensure continuous compliance with the final standards. Also, the final malfunction recordkeeping requirement was designed to provide all pulp and paper companies, including small entities, with a means of supporting an affirmative defense in the event of a violation occurring during a malfunction.

This action does not contain a federal mandate under the provisions of Title II of the UMRA, 2 U.S.C. 1531-1538 for state, local or tribal governments or the private sector. This final rule is not expected to impact state, local or tribal governments. The nationwide annual cost of this final rule for affected sources is $2.1 million. Thus, this rule is not subject to the requirements of sections 202 or 205 of the UMRA.

This rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This rule does not apply to such governments and will not impose any obligations upon them.

This final rule does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. None of the facilities subject to this action are owned or operated by state governments and nothing in this final rule will supersede state regulations. The burden to the respondents and the states is less than $2.1 million for the entire source category. Thus, Executive Order 13132 does not apply to this final rule.

This final rule does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have substantial direct effect 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 action. However, the EPA did outreach and consultation on this rule. The EPA presented this information to the tribes prior to proposal of this rule via a call with the National Tribal Air Association. In addition, the EPA presented the information on the sources and the industry at the National Tribal Forum in Spokane, Washington. The EPA also offered consultation by letters sent to all tribal leaders. We held that consultation with the Nez Perce, Forest County Potowatomi and Leech Lake Band of Ojibewa on October 6, 2011. Additionally, a public outreach webinar was conducted during the comment period on January 31, 2012, to review the proposed rule. The webinar was coordinated with the tribal governments and the general public.

This final rule is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is noteconomically significant as defined in Executive Order 12866, and because the agency does not believe the environmental health risks or safety risks addressed by this action present a disproportionate risk to children. This action will not relax the control measures on existing regulated sources, and the EPA's risk assessment results—included in the preamble (76 FR 81344) and docket (EPA-HQ-OAR-2007-0544) for the proposed rule—demonstrate that the existing regulation is associated with an acceptable level of risk and an ample margin of safety to protect public health.

This action is not a “significant energy action” as defined under Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. This action will not create any new requirements for sources in the energy supply, distribution or use sectors.

Section 12(d) of the NTTAA, Public Law No. 104-113, 12(d) (15 U.S.C. 272 note), directs the EPA to use VCS in its regulatory activities, unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by VCS bodies. The NTTAA directs the EPA to provide Congress, through OMB, explanations when the agency decides not to use available and applicable VCS.

This final rulemaking involves technical standards. The EPA has decided to use three VCS in this final rule.

One VCS, ASME PTC 19.10-1981, “Flue and Exhaust Gas Analyses,” is cited in this final rule for its manual method of measuring the content of the exhaust gas as an acceptable alternative to EPA Method 3B of appendix A-2. This standard is available athttp://www.asme.orgor by mail at the ASME, Post Office Box 2900, Fairfield, NJ 07007-2900; or at Global Engineering Documents, Sales Department, 15 Inverness Way East, Englewood, CO 80112.

A second VCS, ASTM D6420-99 (2010), “Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography/Mass Spectrometry” is cited as an acceptable alternative to EPA Method 18. A third VCS, ASTM D6348-03 (2010), “Test Method for Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform Infrared (FTIR) Spectroscopy,” was determined to be an acceptable alternative to EPA Method 320. EPA Methods 18 and 320 are added as alternatives to EPA Method 308 in this final rule for measurement of methanol emissions. The two VCS alternatives are available for purchase from ASTM International, 100 Barr Harbor Drive, Post Office Box C700, West Conshohocken, PA 19428-2959; or ProQuest, 300 North Zeeb Road, Ann Arbor, MI 48106.

While the EPA has identified another 14 VCS as being potentially applicable to this final rule, we have decided not to use these VCS in this rulemaking. The use of these VCS would be impractical because they do not meet the objectives of the standards cited in this rule. See the docket for this rule for the reasons for these determinations.

Under 40 CFR 63.7(e)(2)(ii) and (f) and 63.8(f) of the NESHAP General Provisions, a source may apply to the EPA for permission to use alternative test methods or alternative monitoring requirements in place of any required testing methods, performance specifications or procedures in the final rule and any amendments.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on EJ. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make EJ part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies and activities on minority populations and low income populations in the United States.

The EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority, low income or indigenous populations because it does not affect the level of protection provided to human health or the environment.

These final standards will not relax the control measures on sources regulated by the rule and, therefore, will not cause emissions increases from these sources. In fact, as noted in section III.A of this preamble, the repeat testing provisions included in this final rule will tend to reduce emissions by providing incentive for facilities to maintain their control systems and make periodic adjustments to ensure peak performance. Also, eliminating the SSM exemption will reduce emissions by requiring facilities to meet the applicable standard during SSM periods.

Additionally, the agency has reviewed this rule to determine if there is an overrepresentation of minority, low income or indigenous populations near the sources such that they may face disproportionate exposure from pollutants that could potentially be mitigated by this rulemaking. Although this analysis gives some indication of populations that may be exposed to levels of pollution that cause concern, it does not identify the demographic characteristics of the most highly affected individuals or communities.

The demographic data show that while most demographic categories are below, or within, 2 percentage points of national averages, the African-American population exceeds the national average by 3 percentage points (15 percent versus 12 percent), or +25 percent. The facility-level demographic analysis results are presented in the November 2011 memorandum titled,Review of Environmental Justice Impacts: Pulp and Paper,a copy of which is available in the docket for this action (EPA-HQ-OAR-2007-0544).

The analysis of demographic data used proximity-to-a-source as a surrogate for exposure to identify those populations considered to be living near affected sources, such that they have measurable exposures to current HAP emissions from these sources. The demographic data for this analysis were extracted from the 2000 census data, which were provided to the EPA by the U.S. Census Bureau. Distributions by race are based on demographic information at the census block level and all other demographic groups are based on the extrapolation of census block group level data to the census block level. The socio-demographic parameters used in the analysis included the following categories: Racial (White, African American, Native American, Other or Multiracial, and All Other Races); Ethnicity (Hispanic); and Other (Number of people below the poverty line, Number of people with ages between 0 and 18, Number of people with ages greater than or equal to 65, Number of people with no high school diploma).

In determining the aggregate demographic makeup of the communities near affected sources, the EPA focused on those census blocks within 3 miles of affected sources and determined the demographic composition (e.g., race, income, etc.) of these census blocks and compared them to the corresponding compositions nationally. The radius of 3 miles (or approximately 5 km) is consistent with other demographic analyses focused on areas around potential sources.13 14 15 16 In addition, air quality modeling experience has shown that the area within 3 miles of an individual source of emissions can generally be considered the area with the highest ambient air levels of the primary pollutants being emitted for most sources, both in absolute terms and relative to the contribution of other sources (assuming there are other sources in the area, as is typical in urban areas). While facility processes and fugitive emissions may have more localized impacts, the EPA acknowledges that because of various stack heights, there is the potential for dispersion beyond 3 miles. To the extent that any minority, low income or indigenous subpopulation is disproportionately impacted by the current emissions as a result of the proximity of their homes to these sources, that subpopulation also stands to see increased environmental and health benefit from the emissions reductions that may result from this rule.

The EPA did outreach and consultation on this rule on the subject of federal actions to address EJ issues. The EPA requested input on EJ issues prior to proposal of this rule in regional conference calls and at the EPA's national EJ conference in 2011. Additionally, a public outreach webinar was conducted during the comment period on January 31, 2012, to review the proposed rule. As noted above, the webinar was coordinated with the tribal governments and the general public.

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. The EPA will submit a report containing this final rule and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General of the United States prior to publication of the rule in theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). The final rule will be effective on September 11, 2012.

For the reasons stated in the preamble, the Environmental Protection Agency is amending Title 40, chapter I of the Code of Federal Regulations as follows:

This is a summary of the Commission's First Report and Order, ET Docket No. 08-59, FCC 12-54, adopted May 24, 2012 and released May 24, 2012. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street SW., Room, CY-B402, Washington, DC 20554. The full text may also be downloaded at:www.fcc.gov.People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

1. This First Report and Order (R&O) expands the Commission's part 95 MedRadio rules to permit the development of new Medical Body Area Network (MBAN) devices in the 2360-2400 MHz band. The MBAN technology will provide a flexible platform for the wireless networking of multiple body transmitters used for the purpose of measuring and recording physiological parameters and other patient information or for performing diagnostic or therapeutic functions, primarily in health care facilities. This platform will enhance patient safety, care and comfort by reducing the need to physically wire sensors to essential monitoring equipment. As the numbers and types of medical radio devices continue to expand, these technologies offer tremendous power to improve the state of health care in the United States. The specific MBAN technology that can be deployed under our revised rules promises to enhance patient care as well as to achieve efficiencies that can reduce overall health care costs.

2. TheReport and Orderadopts rules for MBAN operations on a secondary, non-interference basis under our “license-by-rule” framework. To address spectrum compatibility concerns with respect to incumbent operations under this approach, the Commission is establishing a process by which MBAN users will register and coordinate the use of certain equipment. In a concurrent Further Notice of Proposed Rulemaking, the Commission proposes the criteria for designating the frequency coordinator who will manage these activities. Notably, the Commission bases many of these procedures on a joint proposal (hereinafter the “Joint Proposal”) submitted by representatives of incumbent Aeronautical Mobile Telemetry (AMT) licensees and the MBAN proponents—parties that, when the Commission issued theNotice of Proposed Rulemaking(NPRM) in this proceeding, strongly disagreed as to whether MBAN and AMT operations could successfully coexist in the same frequency band. Cooperative efforts such as this are beneficial in helping us realize the vital goal of promoting robust and efficient use of our limited spectrum resources.

3. The Commission concludes that there are significant public interest benefits associated with the development and deployment of new MBAN technologies. Existing wired technologies inevitably result in reduced patient mobility and increased difficulty and delay in transporting patients. Caregivers, in turn, can spend inordinate amounts of time managing and arranging monitor cables, as well as gathering patient data. The introduction of Wireless Medical Telemetry Service (WMTS) in health care facilities has overcome some of the obstacles presented by wired sensor networks. Nonetheless, the WMTS is restricted to in-building networks that are often used primarily for monitoring critical care patients in only certain patient care areas. The MBAN concept would allow medical professionals to place multiple inexpensive wireless sensors at different locations on or around a patient's body and to aggregate data from the sensors for backhaul to a monitoring station using a variety of communications media. The Commission concludes that an MBAN represents an improvement over traditional medical monitoring devices (both wired and wireless) in several ways, and will reduce the cost, risk and complexity associated with health care. The Commission also concludes that these benefits can be achieved with minimal cost. The only cost resulting from these new regulations is the risk of increased interference, and we are have minimizing that risk by adopting rules that permit an MBAN device to operate only over relatively short distances and as part of a low power networked system. This approach will permit us to provide frequencies where an MBAN can co-exist with existing spectrum users and engage in robust frequency re-use, which will result in greater spectral efficiency. As a result, the Commission believes that the risk of increased interference is low and is greatly outweighed by the substantial benefits of this new technology.

4. The rules adopted are based on and largely reflect the provisions of theJoint Proposalbut differ from them in certain respects. TheJoint Proposalis a comprehensive plan that draws from both the existing MedRadio and WMTS rules to specify MBAN operational requirements for body-worn sensors and hubs, but is drafted as a new subpart under part 95 of our Rules. It expands upon these rules, however, to include a detailed set of requirements for MBAN management within a health care facility. It also proposes that MBAN use in the 2360-2390 MHz band be limited mostly to indoor use and subject to specific coordination procedures and processes to protect AMT users in that band, whereas MBAN use in the 2390-2400 MHz band could occur at any location and without coordination. TheJoint Proposaldescribes an MBAN as consisting of a master transmitter (hereinafter referred to as a “hub”), which is included in a device close to the patient, and one or more client transmitters (hereinafter referred to as “body-worn sensors” or “sensors”), which are worn on the body and only transmit while maintaining communication with the hub that controls its transmissions. The hub would convey data messages to the body-worn sensors to specify, for example, the transmit frequency that should be used. The hub and sensor devices would transmit in the 2360-2400 MHz band. The hub would aggregate patient data from the body-worn sensors under its control and, using the health care facility's local area network (LAN) (which could be, for example, Ethernet, WMTS or Wi-Fi links), transmit that information to locations where health care professionals monitor patient data. The hub also would be connected via the facility's LAN to a central control point that would be used to manage all MBAN operations within the health care facility. To protect AMT operationsfrom harmful interference, theJoint Proposalwould have the Commission designate an MBAN frequency coordinator who would coordinate MBAN operations in the 2360-2390 MHz band with the AMT frequency coordinator. The control point would serve as the interface between the MBAN coordinator and the MBAN hub control operation in the 2360-2390 MHz band. The control point would receive an electronic key, which is a data message that specifies and enables use of specific frequencies by the MBAN devices. The control point, in turn, would generate a beacon or control message to convey a data message to the hub via the facility's LAN that specifies the authorized frequencies and other operational conditions for that MBAN.

5. The Commission's rules are based on the basic framework set forth in theJoint Proposal,particularly that an MBAN is comprised of two component devices—one that is worn on the body (sensor) and another that is located either on the body or in close proximity to it (hub)—that are used to monitor a patient's physiological functions and to communicate the data back to a monitoring station. Thus, the Commission will specify an MBAN to be a low power network of body sensors controlled on a localized basis by a single hub device, and use this framework as the context for our discussions. An MBAN shares many characteristics with other established medical radio services and applications. For example, MBAN devices would operate consistent with the definitions for body-worn devices in the MedRadio rules. Also, the data transmitted over the wireless link from the body-worn sensors to the nearby controlling hub would consist of physiological readings and other patient-related information that is transmitted via radiated electromagnetic signals, which follows the definition of medical telemetry in the WMTS rules. The Commission is therefore authorizing MBAN operations under our existing part 95 MedRadio rules, and the requirements adopted are limited to the operation of MBAN devices within the 2360-2400 MHz band.

6. The Commission adopted rules that focus primarily on the service and technical rules for operating MBAN sensors and hubs, as well as the registration and coordination requirements to protect primary AMT operations in the 2360-2390 MHz band. The adopted rules do not extend to the communications links between the hubs and central control points and the MBAN hubs and the MBAN frequency coordinator. The Commission recognizes that MBAN users will have to consider additional factors when they deploy their systems—such as how to relay the data collected at the MBAN hubs to control points at remote locations by technologies that do not use the 2360-2400 MHz band, and what method the users will use to establish communication links to an MBAN coordinator. However, the Commission also recognizes that each health care facility is unique and needs flexibility to decide how best to accomplish these backhaul/interface functions. Thus, the Commission does not include here theJoint Proposal'srecommendations to codify certain aspects of their vision—for example, requiring a health care facility to designate a central control point and specific communication procedures between the control point and the MBAN frequency coordinator or the hub. Instead, it expects that MBAN users, the frequency coordinators, and equipment manufacturers will work together cooperatively to utilize the technologies and procedures that will permit MBAN and AMT services to share spectrum while fully protecting AMT licensees' operations and while fully integrating MBAN use into the health care ecosystem.

7. In the Report and Order, the Commission first discussed MBAN spectrum requirements and determined that a secondary allocation in the 2360-2400 MHz band is best suited to support MBAN operations. Second, it concludes that MBAN operations would be most efficiently implemented by modifying our existing part 95 MedRadio rules. Third, the Commission discusses the service and technical rules that will apply to MBAN operations. Finally, it discusses the registration and coordination requirements for MBAN operation in the 2360-2390 MHz band. As part of our analysis, the Commission recognizes that theJoint Proposalhas been endorsed by parties that had previously objected to the original GEHC Petition, and that the record of this proceeding now contains conflicting pleadings by the same parties. In such cases, the Commission looked to those pleadings associated with theJoint Proposaland will not address any earlier, inconsistent submissions by the same party, based on our assumption that the earlier filings have been superseded by the more recent filings.

8. The Commission finds that the best way to promote MBAN development is by allocating the entire 40 megahertz of spectrum in the 2360-2400 MHz band proposed in theNPRMfor MBAN use, on a secondary basis. The Commission does so by adding a new footnote to our Table of Frequency Allocations (Table) as proposed. It concludes that the 2360-2400 MHz band is particularly well suited for MBAN use, given the ability of MBAN devices to be able to share the band with incumbent users. The Commission is also persuaded that the ready availability of chipsets and technology that can be applied to this band will promote quick development of low-cost MBAN equipment. This, in turn, will reduce developmental expenses, encourage multiple parties to develop MBAN applications, and will promote the widespread use of beneficial MBAN technologies. Such deployment will reduce health care expenses, improve the quality of patient care, and could ultimately save lives.

9. The Commission also concludes that the 40 megahertz of spectrum in the 2360-2400 MHz band it proposed to allocate in theNPRMis an appropriate allocation for MBAN use. Both General Electric Healthcare (GEHC) and Philips Healthcare Systems (Philips) discuss how peak MBAN deployments would require as much as 20 megahertz of spectrum to be available if on an exclusive basis, and assert that a full 40 megahertz allocation would maximize the opportunity for MBAN devices that operate on a secondary basis to avoid interference to and from primary users. The Commission finds these arguments persuasive. Any MBAN device designed to operate in the 2360-2400 MHz band will also have to be designed to operate in a manner that will protect incumbent licensees, and a 40-megahertz allocation will provide sufficient spectrum flexibility to serve this goal. In addition, this allocation will enable greater frequency diversity and promote reliable MBAN performance. This is particularly true given the Commission's decision, to allow an MBAN device to operate with an emission bandwidth up to 5 megahertz. Additionally, the Commission finds that the 40-megahertz allocation is appropriate because it will allow for reliable MBAN operations in high-density settings, such as waiting rooms, elevator lobbies, and preparatory areas, where multiple MBAN-equipped patients will congregate. For example, AdvaMed notes that a smaller spectrum allocation might not allow for the use of devices by multiple vendors in the same hospital and thereby drive up costs, and also claims that more limited spectrum access would not support all of the currently conceived MBAN device applications. It is clear that such a scenario would increase costs byreducing competition and effectively limiting the use of multiple MBAN devices; this, in turn, could deprive many patients of the health care and cost-saving benefits that MBAN operations are poised to deliver. For all of these reasons, the Commission agree that the 40 MHz of spectrum proposed in theNPRM“will maximize opportunities to avoid interference through frequency separation, support the coexistence of multiple and competitive MBAN networks, and provide the spectrum needed for future innovation.”

10. The Commission further concludes that an MBAN will be able to share the 2360-2400 MHz band with incumbent users. TheJoint Proposaloffers a way for MBAN devices to operate in a manner compatible with incumbent AMT licensees. By proposing unrestricted use of the 2390-2400 MHz band segment and a coordination process for MBAN users in the 2360-2390 MHz portion of the band along with suggesting the use of established engineering guidelines to determine if MBAN use can occur within line-of-sight of an AMT site without causing interference, theJoint Proposaldescribes how MBAN users could successfully operate in the band on a secondary basis. The commission concludes that it is necessary for us to establish a coordination process and related procedures and guidelines to ensure that the primary AMT operations in the band are adequately protected from MBAN users.

11. MBAN operators in the 2390-2400 MHz band will also have to account for amateur radio users, which are authorized on a primary basis in this spectrum. Both Philips and GEHC assert that interference from MBAN devices to amateur radio is unlikely, citing factors such as the low transmission power and low duty cycle proposed for MBAN devices, as well as geographic separation and the frequency agility of MBAN devices. ARRL, The National Association for Amateur Radio, (ARRL) does not anticipate that an MBAN would cause “a significant amount of harmful interference” to amateur users, but it cautions that some amateur operations—such as weak signal communications, that occur on a “completely unpredictable basis”- could receive interference. The Commission believes that MBAN devices can successfully share the band with the amateur service. These frequencies are part of the larger “13 cm band” in which amateur radio operators already share the adjacent 2400-2450 MHz portion of the band with low-powered equipment authorized under part 15 of our rules. The Commission expects that the amateur service will likewise be able to share the 2390-2400 MHz portion of the band with MBAN devices because the power limits for MBAN operations will be even lower than that allowed for the unlicensed equipment that operates in the 2400-2450 MHz range. It further believes that MBAN and amateur operations are highly unlikely to occur in close proximity to each other. An MBAN, which will use very low transmitted power levels compared to the amateur service, is not intended for mass market types of deployment and instead will be used only under the direction of health care professionals. The Commission also believes that the majority of MBAN operations in the 2390-2400 MHz band will be located indoors. It envisions that the most likely outdoor use will occur in ambulances or while patients are otherwise in transit, thus we do not believe that prolonged outdoor use in a single location is likely. In such a situation, any interference that might occur would likely be transitory in nature and would not seriously degrade, obstruct or repeatedly interrupt amateur operations and thus would not be considered harmful under our definition of harmful interference. In the unlikely event that an atypical scenario occurs where amateur operators do receive harmful interference from MBAN operations, the Commission notes that amateur operators would be entitled to protection from MBAN interference.

12. The Commission also addressed the potential for interference from licensed amateur operations to MBAN operations. ARRL states that amateur operation in the band is unpredictable. The “substantial power levels and exceptionally high antenna gain figures used by radio Amateurs in the 2390-2400 MHz band will provide no reliability of MBANs in this segment whatsoever,” it observes, calling the results of such interference “potentially disastrous.” MBAN proponents assert that MBAN devices will have built-in capabilities such as spectrum sensing techniques to detect in-band amateur signals and frequency agility capability to move MBAN transmissions to other available channels. As to ARRL's concerns about MBAN's reliability and the risk presented by interference caused by amateur operation, GEHC acknowledges that “medical device manufacturers seeking to develop equipment consistent with the MBAN rules would need to build robust products in order to satisfy FDA requirements and to ensure customer acceptance,” but does not view that as a barrier to its efforts to develop and deploy MBAN devices. The Commission finds that factors such as the incorporation of established techniques to avoid interference into MBAN devices, the use of low duty cycles, and the separation distances between MBAN devices and amateur operations that are likely to occur in real world situations will minimize any potential for interference to MBAN devices from amateur users. Nevertheless, MBAN operations will occur on a secondary basis and MBAN operators will thus be required to accept any interference they receive from primary amateur licensees operating in accordance with the rules.

13. The 2370-2390 MHz band is used for radio astronomy operations in Arecibo, Puerto Rico. Prior to the filing of theJoint Proposal,both GEHC and Philips suggested using an exclusion zone to protect the Arecibo site. Subsequently, the Joint Parties suggested that MBAN users simply notify theArecibo facility prior to operation in accordance with our existing rules. The Commission finds that the existing MedRadio Rules, which provide a prior notification requirement, are sufficient to ensure protection of radio astronomy operations at the Arecibo site.

14. Lastly, the Commission observes that, because MBAN operations will be permitted adjacent to other bands that host a variety of different services, MBAN users will have to take into account the operating characteristics of those adjacent-band services. The upper end of the band, 2400 MHz, is immediately adjacent to the spectrum used by unlicensed devices—such as Wi-Fi and wireless local area network (WLAN) devices—as well as industrial, scientific and medical (ISM) equipment operating under Part 18 of our Rules, both of which are widely used in health care settings. As MBAN users manage their facilities, they will need to consider the potential for adverse interaction between their MBAN, Wi-Fi, and ISM resources.

15. MBAN equipment will also operate immediately adjacent to the Wireless Communications Service (WCS) at 2360 MHz. As with any new service, it is incumbent on MBAN developers to evaluate and account for the operational characteristics of adjacent band services—in this case, WCS—when designing receivers and associated equipment. The Commission finds that it is unlikely WCS operations would preclude effective MBAN use given that MBAN operations near 2360 MHz will be in institutional settings under the control of a health care provider and because MBAN users willhave a large swath of spectrum in which to place their operations. Moreover, the record indicates that GEHC has already anticipated designing MBAN devices that use contention-based protocols and frequency agility to account for potential out of band emissions into the 2360-2400 MHz band. For these reasons, and notwithstanding filings made by the Wireless Communications Association, International (“WCAI”), the Commission finds no reason to adopt specific rules relating to adjacent-band WCS operations.

16. The Commission will add a new footnote US101 to the Table of Allocations to provide a secondary mobile, except aeronautical mobile, allocation in the 2360-2400 MHz band for use by the MedRadio Service. It is making this allocation through a unique footnote rather than a direct entry in the Table, or modification of the existing US276, in order to provide consistency across the entire band and to emphasize the limited nature of this allocation. It will place footnote US101 in both the Federal Table and non-Federal Table to facilitate MBAN use in a variety of settings such as in health care facilities operated by the Department of Veterans Affairs or the United States military, as well as non-Federal health care facilities. Because use of these frequencies will be on a secondary basis, MBAN stations will not be allowed to cause interference to and must accept interference from primary services, including AMT licensees operating under the primary mobile allocation in the 2360-2390 MHz and 2390-2395 MHz bands and Amateur Radio service licensees that operate on a primary basis in the 2390-2395 MHz and 2395-2400 MHz bands.

17. TheJoint Proposalwas based on secondary MBAN use of the 2360-2400 MHz band, and no commenters supporting either the 2360-2400 MHz band or any alternate spectrum proposals endorse giving MBAN operations primary status. The Commission's decision to provide 40 megahertz of spectrum in the 2360-2400 MHz band for MBAN use is based on our decision to require MBAN users to share the spectrum with incumbent users, as well as among different MBAN devices, and that, therefore MBAN devices require a larger spectrum block than would be the case if spectrum were allocated to MBAN use on an exclusive basis. A secondary allocation is consistent with our approach. The Commission is also confident that its decision to authorize MBAN service on a secondary basis will not adversely affect the usefulness of MBAN devices. The Commission notes that the supportive comments filed by numerous manufacturers indicate a readiness to produce devices capable of relaying essential patient data in a reliable manner within this regulatory framework.

18. This action affirms the tentative conclusion from theNPRMthat the Commission should allocate spectrum not currently used by existing medical radio services to support new MBAN operations. Although ARRL suggests that MBAN devices could make use of spectrum currently used by the WMTS, the Commission agrees with Philips that the WMTS bands are not suitable for MBAN devices because of the existing widespread use of WMTS applications in hospitals. The Commission does not believe that WMTS and MBAN devices would be able to successfully co-exist on the same frequencies simultaneously within the same facilities, leaving health care facilities with the dilemma of choosing between two valuable health care tools. A better course is to accommodate MBAN users in other frequencies. The Commission further notes that all of the other frequency bands identified in this proceeding for possible MBAN use have limitations that make them less desirable than the 2360-2400 MHz band. For example, Philips claims that the alternative bands are “substantially inferior to the 2360-2400 MHz band” for MBAN use, and predicts that “devices would be unlikely to succeed for both cost and technical reasons, and the opportunity to benefit from better healthcare using these devices likely would be substantially delayed or lost.” The Commission agrees, and briefly discusses each of the alternate band proposals.

19. The 2400-2483.5 MHz band is also unsuitable for widespread MBAN use, given the ISM equipment and unlicensed devices that operate in the band. While GEHC and Philips discussed the benefits of employing low-power technology and chipsets that have been widely deployed in the 2.4 GHz band and which can be readily modified to use the adjacent 2360-2400 MHz spectrum, they emphatically rejected the possibility of deploying MBAN operations above 2400 MHz. GEHC notes that the 2.4 GHz band is heavily populated by unlicensed intentional radiators and ISM devices deployed by hospitals and carried by patients, visitors, doctors and staff. The 5150-5250 MHz band which used by unlicensed national information infrastructure (U-NII) devices operating under Subpart E of the Commission's part 15 rules, is even less desirable. As with the 2.4 GHz band, many unlicensed devices already intensively use the 5150-5250 MHz band in health care settings. Moreover, as GEHC notes, use of 5150-5250 MHz band would require a higher transmit power and result in shorter battery life and it is not aware of readily available chipsets that could be incorporated into MBAN devices.

20. The Commission concludes that authorizing MBAN use on a license-by-rule basis within its part 95 rules is the best approach. These devices share many characteristics with medical radiocommunications technologies that are already authorized under a license-by-rule approach, and the Commission finds that this framework can promote the rapid and robust development of MBAN devices without subjecting users to an unnecessarily burdensome individual licensing process. Moreover, the Commission is adopting appropriate technical rules and coordination procedures to ensure that MBAN devices can successfully operated on a secondary basis in the 2.3 GHz band without the need for individual licenses.

21. While an MBAN may be similar to WMTS in purpose—both involve the measurement and recording of physiological parameters and other patient-related information—the Commission finds that they are closer to MedRadio devices in their implementation. Like MedRadio devices, MBAN devices will be designed to operate at low power levels. Moreover, the two MBAN components—the body-worn sensor and the nearby hub—are functionally analogous to the medical body-worn device and associated MedRadio programmer/control transmitter that are provided for in our MedRadio rules. Although the Commission recognizes that it could codify the MBAN rules as a separate rule subpart, it concludes that the best course is to modify the existing MedRadio rules. This is the same approach the Commission recently took when providing for the development of new ultra-low power wideband networks consisting of multiple transmitters implanted in the body that use electric currents to activate and monitor nerves and muscles. Moreover this approach avoids duplicating existing rules that logically apply to both MBAN and existing MedRadio devices. This, in turn, will ensure that any future rules that affect MBAN and other MedRadio applications will be updated in a comprehensive and consistent manner. Also, because the MedRadio rules already distinguishbetween each of the various types of MedRadio devices when necessary by, for example, setting forth particular operational rules and authorized frequencies, we will still be able to add MBAN-specific rules when and where appropriate.

22. TheNPRMsought comment on the definitions the Commission should apply to an MBAN and its components, and proposed four terms that it could codify in our final rules. Because the Commission has decided to authorize MBAN operations under our MedRadio rules, it is not necessary to adopt such a comprehensive set of definitions. The Commission instead modified the Appendix to Subpart E of Part 95 of our Rules to add a single new definition—Medical body area network (MBAN) to read as follows:

23. The Commission now sets forth the specific service and technical parameters that will define an MBAN. Because it has chosen to regulate MBAN devices under the MedRadio rules, the Commission has analyzed those rules to determine which need to be modified for MBAN devices and which are already suitable for MBAN use. The Commission focuses primarily on those service and technical rules that require further modification.

24.Operator Eligibility.In theNPRM,the Commission proposed that MBAN use be subject to the same operator eligibility requirements that are in place for the MedRadio Service. Section 95.1201 of our rules permits operation of MedRadio transmitters by duly authorized health care professionals, by persons using MedRadio transmitters at the direction of a duly authorized health care professional, and by manufacturers and their representatives for the purpose of demonstrating such equipment to duly authorized health care professionals. The Commission concludes that this rule should be applied to MBAN operations without further modification.

25. The Joint Parties ask that the Commission expand MBAN eligibility to permit manufacturers and vendors (and their representatives) to operate MBAN transmitters for developing, demonstrating and testing purposes. Although the Joint Parties state that this would mirror analogous provisions in the WMTS rules, in fact the WMTS rules permit manufacturers and their representatives to operate such equipment only for purposes of “demonstrating” such equipment. There is similar language in the current MedRadio rules that permits operation of MedRadio equipment by manufacturers “and their representatives.” This language permits vendors to demonstrate MBAN equipment as representatives of a manufacturer. Thus, the Commission is not modifying the current rule to state this specifically. It further notes that the current rule would not preclude authorized healthcare professionals from contracting for the services of third parties to operate an MBAN. Additionally, for the reasons discussed regarding the frequency coordinators' roles, the Commission did not modify this rule to include frequency coordinators as eligible operators of MBAN equipment. With respect to expanding the MedRadio rule to permit equipment operation by manufacturers for developing and testing purposes, it is not persuaded that such a rule revision is necessary. The Commission's experimental licensing rules provide the appropriate process for granting non-licensees operational authority for developing and testing MedRadio devices, including MBAN devices.

26.Permissible Communications.In theNPRM,the Commission observed that the existing rules allow a MedRadio device to be used for diagnostic and therapeutic purposes to relay non-voice data, and asked whether such requirements would be appropriate for MBAN operations. TheNPRMalso asked how communications should be structured within a particular MBAN. Specifically, the Commission asked whether communications between body-worn MBAN devices or communications between MBAN devices within one network with those in another should be allowed, and whether a single programmer/controller should be permitted to control body-worn devices associated with multiple MBAN networks simultaneously or those associated with more than one patient. The Commission adopted communications rules that are generally consistent with the existing MedRadio provisions and modified § 95.1209 of its rules accordingly.

27. As an initial matter, no commenter objected to allowing an MBAN to communicate both diagnostic and therapeutic information. The Commission will apply § 95.1209(a) of its rules, as written, to MBAN operations. While this rule provides considerable flexibility to provide data and visual information, it does not allow voice data, as requested by AT&T. The Commission believes that the current MedRadio and WMTS prohibitions regarding voice data arepart of a proven framework in which to base MBAN operations, and note that AT&T's suggestion relates to general speculation about potential future MBAN functionality as opposed to a specific application it intends to deploy.

28. The Commission will require an MBAN to consist of a single programmer/control transmitter (or hub) that controls multiple (i.e.,non-implanted) sensor devices. The intent of defining an MBAN in this way is to prevent direct communications between programmer/controllers which would facilitate mesh type networks using MBAN controllers to potentially extend the range of an MBAN beyond the confines of the medical facility. Consequently, it will not permit direct communications between body-worn sensors or direct communication between programmer/control transmitters. Under the existing § 95.1209(c), programmer/control transmitters will be able to interconnect with other telecommunications systems. This will allow backhaul from a single patient-based MBAN control transmitter to a monitoring station that receives and processes MBAN body sensor data from multiple patients using frequencies other than the 2360-2400 MHz band. The Commission recognizes that some commenters would have us allow one programmer/control transmitter to be controlled by a separate programmer/control transmitter or permit direct communications between body-worn sensor devices. It does not adopt these proposals. The Commission believes that the rules it adopted provide more certainty that an MBAN will operate in compliance with it rules or a coordination agreement because each programmer/control transmitter and its associated body-worn sensors will operate in response to a control message received over the facility's LAN. As the Commission gain further experience with MBAN operations, it may revisit these restrictions.

29. The Commission believes that there is no need to specify that each MBAN control transmitter be limited to controlling the body sensor transmitters for a single patient, nor that specific protocols should be associated with such transmissions. The low power levels permitted for MBAN transmitters will already limit the effective range for communications to a small number of patients, and thus such use does not raise any unique interference concerns. Consistent with the approach it has taken in the MedRadio proceeding, the Commission also declines to restrict an MBAN from performing functions that are “life-critical” or “time-sensitive.” The Commission continues to believe that these types of determinations are best made by health care professionals in concert with FDA-required risk management processes. Operators of MBAN systems and health care facilities are reminded that even the “life-critical” operation permitted on a secondary basis must accept interference from the primary spectrum users in the 2360-2400 MHz band.

30.Authorized Locations.The Commission sought comment on whether it would be appropriate to restrict the use of MBAN transmitting antennas to indoor locations in certain frequency bands, and noted that its WMTS rules restrict antennas to indoor use only, while the MedRadio rules provide for the use of temporary outdoor antennas. The Commission modified §§ 95.1203 and 95.1213 of the MedRadio rules to provide for indoor-only MBAN operation in the 2360-2390 MHz band and MBAN operation at any location in the 2390-2400 MHz band.

31. The Commission's decision on this issue is consistent with the approach suggested in theJoint Proposal.It finds that limiting MBAN operation in the 2360-2390 MHz band to indoor locations within health care facilities is a reasonable and effective way to limit potential interference and promote sharing between MBAN and AMT users. It is also consistent with the coordination procedures being adopted. Although AT&T suggests that any rule restricting use to indoors would limit the usefulness of an MBAN, the Commission disagrees and notes that GEHC and other likely equipment developers have not been deterred by the prospect of indoor-only operation. Moreover, in the 2390-2400 MHz band, where there are fewer AMT interference concerns, the Commission is able to provide MBAN users with the added flexibility of operating in any location. The Commission rejected the suggestion by the Joint Parties that it modify the rules to permit outdoor operation in the 2360-2390 MHz band in cases of a “medical emergency declared by duly authorized governmental authorities after emergency coordination with the AMT coordinator.” The Commission finds that the suggested exception does not clearly define “medical emergency” or “authorized governmental authorities” and would essentially delegate authority to unnamed third parties to determine when outdoor MBAN operation is permitted. Instead, the Commission observed that there are other approaches that would as readily address this issue. Health care facilities can consider using MBAN devices that are capable of shifting to the 2390-2400 MHz band—where it is not necessary to receive prior approval to operate outdoors—in anticipation of situations where there may not be time to perform a quick coordination, such as an emergency in a part of the health care facility that requires some patients to be temporarily moved outdoors. For extraordinary circumstances involving outdoor use of the 2360-2390 MHz band, MBAN licensees will have to follow the same course of action as other licensees when emergencies occur, and ask the applicable licensing bureau (in this case, the Wireless Telecommunications Bureau) for a temporary waiver to permit such operation. The Commission expects that, inbona fideemergency situations, the MBAN and AMT licensees and the frequency coordinators will all cooperate to identify frequencies that can be made available for emergency MBAN operations as quickly as possible while ensuring flight safety.

32.Equipment Authorization.In theNPRM,the Commission asked if each MBAN transmitter authorized to operate in the 2360-2400 MHz band should be required to be certificated, if manufacturers of MBAN transmitters should be subject to disclosure statement and labeling requirements that are analogous to those in the existing MedRadio rules (including the identification of MBAN transmitters with a serial number), and if MBAN transmitters should be required to be marketed and sold only for the permissible communications the Commission allows for the service. These provisions allow for the deployment and operation of existing MedRadio devices in a consistent and predictable manner, and the Commission concludes that they will do the same for MBAN equipment. The Commission therefore will apply the existing MedRadio provisions in §§ 95.603(f), 95.605, 95.1215, 95.1217, and 95.1219 of the Commission's rules to MBAN operations, modified as necessary to refer to MBAN devices and their associated frequency bands.

33. Although no commenter specifically addressed this issue, the Commission notes that the certification requirement in § 95.603(f) of the rules does not apply to transmitters that are not marketed for use in the United States, but are being used in the United States by individuals who have traveled to the United States from abroad and comply with the applicable technical requirements. This provision will apply to MBAN devices. The disclosure statement and labeling requirements, which are similar to those suggested in theJoint Proposal,are based on requirements that have been in placesince 1999. Although WCAI had expressed concern that similar labeling rules originally suggested by GEHC might be inadequate to notify MBAN users of their responsibilities as secondary licensees, the Commission concludes that the proposed labeling rules are appropriate. The Commission has analyzed the potential for interference to and from MBAN devices—including in the adjacent-band scenarios of interest to WCAI—and determined that its rules will support MBAN operation on a secondary basis. Moreover, because MBAN devices are similar to other MedRadio devices in that they will operate at low power and under the direction of a duly authorized health care professional, it is appropriate for us to apply the existing MedRadio labeling language for the programmer/controller transmitter that has served us well for many years. However, the Commission will modify the requirement for labeling a MedRadio transmitter with a serial number. The current rule requires that all MedRadio transmitters shall be identified with a serial number. GEHC has stated that “* * * It would not be appropriate to require that individual MBAN transmitters be equipped with a unique serial number, given the fact that individual sensor nodes may be disposable.” Although the Commission is not aware that this requirement has presented any problems for the manufacture and use of existing body-worn MedRadio devices, it will only require individual MBAN programmer/controller transmitters to be labeled with a unique serial number but not require individual MBAN body-worn sensor devices to be labeled this way due to their expected low-cost and disposable nature. Finally, as proposed in theNPRM,the Commission will allow the FCC ID number associated with the transmitter and the information required by § 2.925 of the FCC rules to be placed in the instruction manual for the transmitter in lieu of being placed directly on the transmitter. The size and placement of MBAN equipment may make it impractical to place this information directly on the transmitter, and the personnel responsible for overall MBAN operations within a health care facility are not likely to be physically located in patient care areas where MBAN transmitters will be used.

34.Other Service Issues.The Commission will also adopt the proposals in theNPRMthat MBAN devices will not be required to transmit a station identification announcement, and that all MBAN transmitters are made available for inspection upon request by an authorized FCC representative. These requirements are the same as the existing MedRadio rules, and no commenters objected to applying these provisions to MBAN users. The Commission also updated § 95.1211 of its rules (“Channel Use Policy”) to reference the 2360-2400 MHz band.

35.Authorized Bandwidth and ChannelAggregation. In theNPRM,the Commission sought comment on whether to apply the MedRadio approach of specifying only the maximum permitted bandwidth, but not any particular channel plan, with respect to MBAN devices in their authorized frequency band(s). The record reflects broad support for this approach, and the Commission modified § 95.633 to specify a 5-megahertz maximum authorized bandwidth for MBAN devices. This approach is consistent with the existing MedRadio rules.

36. The Commission's decision to specify a 5 megahertz authorized bandwidth is also consistent with recommendations from the Joint Parties and other commenters. Although theNPRMsuggested a 1 megahertz limit, the Commission agrees with the Joint Parties and other commenters that 5 megahertz is a more appropriate limit. By allowing the larger authorized bandwidth, we can still accommodate MBAN devices that use a 1 megahertz bandwidth, while also providing flexibility for the development of MBAN devices that can use higher data rates and that have higher throughput for applications that require larger amounts of data. The Commission will also permit device manufacturers to aggregate multiple transmission channels in a single device, so long as the total emission bandwidth used by all devices in any single patient MBAN communication session does not exceed the maximum authorized bandwidth of 5 megahertz. This, too, is consistent with the existing channel use provisions of the MedRadio Service.

37.Transmitter Operation and Power Limits.In theNPRM,the Commission sought comment on the appropriate maximum transmitter power for MBAN devices. It proposed to limit individual MBAN devices to a maximum transmit power of 1 mW equivalent isotropic radiated power (EIRP) measured in a 1 megahertz bandwidth, which followed GEHC's proposal. TheJoint Proposalsuggested use of a maximum EIRP of 20 mW measured in a 5 megahertz bandwidth for the 2390-2400 MHz band, but maintained the original 1 mW EIRP maximum for the 2360-90 MHz band. Based on the information provided in the record and the Commission's decision to adopt a maximum bandwidth of 5 megahertz, the Commission will modify § 95.639 of its rules to specify the power limits in theJoint Proposal.

38. The need for a different power limit in the upper portion of the MBAN band was addressed by Philips. The 2390-2400 MHz portion of the MBAN spectrum will have no restrictions regarding location or mobile use, and thus all in-home MBAN use will occur in this band. Philips provides a detailed discussion of the differences between home and hospital MBAN use, and contends that there are unique circumstances—such as the possibility that an adverse health event could result in the patient falling on the MBAN transmitter and the need to provide patients with full mobility within their homes—that warrant a higher power level for this 10 megahertz band. It also notes that the upper band's proximity to the ISM band means that the MBAN may have to overcome excess noise in some instances to ensure a reliable link budget. AdvaMed echoes Philips in support of a 20 mW maximum EIRP in the 2390-2400 MHz band. The Commission finds that there is good reason to make a distinction in the maximum power it authorizes in the lower 2360-2390 MHz and in the upper 2390-2400 MHz bands.

39. The Commission is adopting additional transmitter operation rules for MBAN devices to implement other MBAN requirements. MBAN devices may not operate outside the confines of a health care facility in the 2360-2390 MHz band. MBAN devices that operate in the 2360-2390 MHz band must comply with registration and coordination requirements, and operate in the band consistent with the terms of any coordination agreement. The Joint Parties proposed that these dual requirements—no outdoor use and compliance with a coordination agreement—could be met by requiring that the MBAN master transmitter receive a “beacon” signal or control message that conveyed the permitted scope of operation in the band and that the device cease operating in the band automatically if it could not receive the signal. In their proposal, the control point in the health care facility would transmit this beacon or control message to the MBAN master transmitter using the facility's LAN.

40. Although the Commission generally agrees with the Joint Parties' suggestions, because each health care facility's communications infrastructureand physical layout will present unique capabilities and challenges, it will not establish any requirements for how control messages are distributed within a health care facility. The Commission revised § 95.628 of the rules, which specifies the technical requirements for MedRadio transmitters, so that the MBAN programmer/controller transmitters must be capable of receiving and complying with a control message specifying its particular operating parameters within the band. Specifically, an MBAN programmer/control transmitter may not commence operation and must automatically cease operating in the 2360-2390 MHz band if it does not receive a control message. It must also comply with a control message that directs it to limit its transmissions to segments of the band or to cease operation in the band. The Commission notes that the Joint Parties did not propose a specific period of time within which the MBAN transmitter must receive a control message to begin or continue operating. The proposal also did not prescribe a specific format or protocol for the control message. It will require applicants for equipment certification to attest that they comply with the requirement that MBAN equipment receive the control message by describing the protocols that the devices employ including the expected periodicity for reception of control messages that will allow the MBAN transmitter to begin or continue operating in the band. Additionally, the Commission expects that the control message will be an electronic message since it is expected to be sent using the health care facility's LAN. This helps to ensure that the MBAN meets the requirement for operating indoors on the 2360-2390 MHz band, since it will have to be tethered to a wireline network or within signal range of a wireless network within the facility.

41.Unwanted Emissions.In theNPRM,the Commission noted that the part 95 MedRadio rules set forth limits on unwanted emissions from medical transmitting devices operating in the 401-406 MHz band and sought comment on the appropriateness of applying the same general limits to MBAN operations in the 2360-2400 MHz bands. The Commission finds that the provisions in § 95.635(d) of its rules, which specify limits on unwanted emissions, are appropriate. Accordingly, the Commission modified this rule to reflect the use of the 2360-2400 MHz band by MBAN devices. It notes that the Joint Parties' proposal supports using the proposed limits on unwanted radiation and no party objected to the use of these figures. In addition, use of the MedRadio limits is consistent with our approach of accommodating MBAN operations under the existing MedRadio rules where practical.

42.Frequency Stability.In theNPRM,the proposed to require that MBAN transmitters comply with the MedRadio rules and maintain a frequency stability of +/− 100 ppm of the operating frequency over the ambient environmental temperature range: (1) 25 °C to 45 °C in the case of MBAN transmitters; and (2) 0 °C to 55 °C in the case of MBAN control transmitters. GEHC states that +/− 100 ppm is an acceptable limit for MBAN devices, but does not discuss the temperature range over which that stability should be required. The Commission is using the existing MedRadio definitions to regulate the MBAN sensor and hub devices. Under this construction, the existing temperature range for MedRadio programmer/control transmitters set forth in § 95.628(d)(2) of the rules will apply to MBAN hub devices without modification. Because no MBAN sensor will be implanted, the Commission further concludes that the 25 °C to 45 °C range it has for implanted devices should not apply to sensors. Instead it will use the broader 0 °C to 55 °C specification.

43.RF Safety.In theNPRM,the Commission noted that portable radiofrequency (RF) transmitting devices are subject to § 2.1093 of the rules, pursuant to which an environmental assessment concerning human exposure to RF electromagnetic fields must be prepared under § 1.1307, and that these rule sections also govern existing MedRadio devices. The Commission also has an open RF safety proceeding (ET Docket No. 03-137) in which it proposed to conduct a comprehensive review of its rules regarding human exposure to RF electromagnetic fields. Thus, theNPRMonly sought comment on whether MBAN transmitters should be deemed portable devices. The Commission will apply existing § 95.1221 of its rules to MBAN devices, which will classify them as portable devices that are subject to §§ 2.1093 and 1.1307 of the rules. The record reflects support for treating MBAN devices in this manner. The Commission sees no reason to treat MBAN devices differently than existing MedRadio devices with respect to RF safety matters.

44.Frequency Monitoring.In theNPRM,the Commission sought comment on whether a frequency monitoring requirement should be required for MBAN devices to promote inter- and intra-service sharing and, if so, how it should develop such a protocol. The Commission encouraged commenters supporting implementation of a contention based protocol to discuss what kinds of contention protocols (i.e.,listen-before-talk (LBT) frequency monitoring, time slot synchronization, and frequency hopping) should or should not be utilized, and to explain in detail why or why not.

45. The Commission, citing an evolving record, finds that it is not necessary to specify protocols to ensure spectrum sharing among MBAN systems. Initial filings by GEHC as well as the Joint Parties indicated a desire to codify a sharing protocol requirement. Several parties that support contention protocols nevertheless have urged us to avoid adopting specific rules. In more recent pleadings, the Joint Parties state that, while manufacturers believe that MBAN devices are likely to incorporate a mechanism to avoid interference when operating in close proximity (such as within medical facilities), they do not wish for us to adopt detailed procedures that might inadvertently inhibit the development of innovative methods that would allow them to make more intensive use of the spectrum. The Commission believes that the best course is to refrain from mandating a sharing protocol requirement, particularly because it appears that these matters are already being addressed within the standards setting process. In addition, it believes that the relatively low power levels used by MBAN transmitters make it possible that the use of sharing protocols might be unnecessary in many situations. The Commission further concludes that MBAN manufacturers will determine the appropriate level of communications reliability through the risk management activities involved with medical device design that is subject to oversight by the Food and Drug Administration (FDA), and that they should be given the flexibility to meet that level of communications reliability through whatever means they find appropriate. The Commission also finds that because it is requiring frequency coordination for MBAN and AMT sharing, it is not necessary to adopt frequency monitoring rules to promote spectrum sharing between these services.

46.Duty Cycle.In theNPRM,the Commission sought comment on whether it should adopt specific duty cycle limits for MBAN transmitters in our rules and whether such limits would be needed to allow the functioning of a contention-based protocol for achieving reliable MBAN system performance, or for otherreasons. The Commission finds that it is not necessary to specify a duty cycle in its rules. The record indicates that manufacturers are likely to employ duty cycles even without a specific requirement to do so because it will allow them to achieve important operational goals. The Commission believes that the ongoing efforts of standards setting bodies to address MBAN use are adequate to address any relevant duty cycle considerations.

47. The Commission adopted registration and coordination rules for MBAN operations in the 2360-2390 MHz band. Registration and coordination are two separate but related processes. A health care facility that intends to operate an MBAN in the 2360-2390 MHz band must register the MBAN with a frequency coordinator (“the MBAN coordinator”) that the Commission will designate. The registration requirement will ensure that the locations of all MBAN operations in the 2360-2390 MHz band are recorded in a database. As part of the coordination process, the MBAN coordinator will first determine if a proposed MBAN in the 2360-2390 MHz band will be within line-of-sight of an AMT receiver. If the MBAN transmitter is within line-of-sight of an AMT receive site, the MBAN and AMT coordinators will work cooperatively to assess the risk of interference between the two operations and determine the measures that may be needed to mitigate interference risk. The MBAN coordinator will notify the health care facility when coordination is complete and the MBAN must operate consistent with the terms of any agreement reached by the coordinators. If no agreement is reached, the MBAN will not be permitted to operate in the band. The health care facility may not operate the MBAN in the band until it receives the appropriate operating parameters from the MBAN coordinator. The Commission also adopted procedures to accommodate new AMT receive sites as well as changes to MBAN deployment and operations.

48. The registration and coordination requirements adopted accomplish several key principles of the Joint Parties' proposal to protect AMT receive sites. First, an MBAN will not be allowed to operate in the 2360-2390 MHz band until the frequency coordinators determine the risk of interference between the two services and the MBAN coordinator notifies the health care facility whether the device can operate in the band and the terms and conditions of operation. Second, the parties agree that MBAN operation within the line-of-sight of an AMT receive facility should serve as the baseline criteria that would trigger an analysis of interference risk and mitigation techniques. The importance of this baseline is underscored in the Joint Parties' proposed rules which include an expectation that both MBAN and AMT licensees will avoid line-of-sight operations whenever possible. Finally, the Commission expects that the MBAN and AMT coordinators will work cooperatively to evaluate potential interference situations and thus the Commission will require that they reach mutually satisfactory coordination agreements before MBAN operation is allowed at any specific location. Nevertheless, the Commission recognizes that AMT operates under a primary allocation and is entitled to protection from MBAN operations that will occur on a secondary basis. The Commission anticipates that the AMT coordinator will only enter into agreements that ensure an appropriate level of protection for the primary AMT operations.

49. The Commission concludes that the use of frequency coordination procedures is an efficient and effective way for MBAN and AMT services to successfully share the 2360-2390 MHz band. Unlike exclusion zones, which would prohibit any MBAN operation within a specified distance of an AMT receive site, coordination provides the parties flexibility to determine whether and under what conditions both services could operate in the band at a given location. Because all MBAN operations in the band will be required to register and the information will be maintained in a database, a coordinator can readily identify those locations that are within line-of-sight of an AMT receive site and thus will require a coordination agreement with incumbent or new AMT receive sites.

50. The rules that the Commission is adopting incorporate many, but not all, of the suggestions made by the Joint Parties, including their determination that the rules governing MBAN use of the 2360-2390 MHz band will be sufficient to protect AMT operations. The rules adopted provide the flexibility manufacturers, licensees and coordinators need to accommodate changes in both AMT and MBAN operations and assurance to AMT users that their future access to the spectrum will not be hampered.

51. The Commission adopts a new rule, § 95.1223, which requires health care facilities to register all MBAN devices they propose to operate in the 2360-2390 MHz band with a frequency coordinator designated by the Commission. MBAN operation in the 2360-2390 MHz band prior to registration is prohibited. The Commission believes that registration of all MBAN operations in the band will create a regulatory environment that promotes MBAN use and protects AMT operations. In order to register MBAN devices that operate in 2360-2390 MHz frequency range, a health care facility must provide to the MBAN coordinator the following information:

• Specific frequencies or frequency range(s) within the 2360-2390 MHz band to be used, and the capabilities of the MBAN equipment to use the 2390-2400 MHz band;

• Effective isotropic radiated power;

• Number of programmer/controller transmitters in use at the health care facility as of the date of registration including manufacturer name(s) and model numbers and FCC identification number;

• Legal name of the health care facility;

• Location of programmer/controller transmitters (e.g.,geographic coordinates, street address, building);

• Point of contact for the health care facility (e.g.,name, title, office, phone number, fax number, email address). This would typically be an administrator or other official who has a high level of authority within the facility; and

• Contact information (e.g.,name, title, office, phone number, fax number, email address) for the party that is responsible for ensuring that MBAN operations within the health care facility are discontinued or modified in the event such devices have to cease operating in all or a portion of the 2360-2390 MHz band due to interference or because the terms of coordination have changed. This person would typically be an employee or contractor. The health care facility also must state whether, in such cases, its MBAN operation is capable of defaulting to the 2390-2400 MHz band and that it is responsible for ceasing MBAN operations in the 2360-2390 MHz band or defaulting traffic to other hospital systems.

52. To ensure that the registration data maintained by the MBAN coordinator is accurate and up to date, the Commission is requiring heath care facilities to keep their registration information current and to notify the MBAN coordinator of any material changes to the location or operating parameters of a registered MBAN.Because changes in MBAN location or operation could place that MBAN within line-of-sight of an AMT receive site, the Commission will prohibit the MBAN from operating under the changed parameters until the MBAN coordinator has determined if a new or revised coordination agreement with the AMT coordinator is required, and if so, coordination with the AMT coordinator is completed. The Commission will also require a health care facility to notify the MBAN coordinator whenever an MBAN programmer/controller transmitter in the 2360-2390 MHz band is permanently taken out of service, unless it is replaced with transmitter(s) using the same technical characteristics as those reported on the health care facility's registration.

53. The Commission does not adopt a suggestion by the Joint Parties to require health care facilities to implement a “transition plan” that they must file with the MBAN coordinator in order to register an MBAN operating in the 2360-2390 MHz band. The Commission is not persuaded that requiring a transition plan as suggested by the Joint Parties is necessary to ensure that interference with AMT operations, if it occurs, can be quickly resolved. Instead, the Commission adopts other requirements that would be less burdensome and provide some flexibility in accomplishing the same objective. In particular, it requires a health care facility, as part of the registration process with the MBAN coordinator, to state whether its MBAN is capable of defaulting its operations to the 2390-2400 MHz band or to other hospital systems. The Commission finds that this approach effectively puts the facility on notice that it is responsible for taking whatever actions necessary to prevent or correct any harmful interference with AMT operations and also appropriately leaves the responsibility of defining and ensuring patient safety in the hands of medical professionals rather than the Commission or Commission designated frequency coordinators. Also, the Commission is requiring that an MBAN transmitter not operate in the 2360-2390 MHz band unless it is able to receive and comply with a control message that notifies the device to limit or cease operations in the band. This requirement should ensure that MBAN devices always operate in compliance with any coordination agreement and quickly respond to any interference situation. The Commission also concludes that the rules it is adopting will provide health care facilities with sufficient flexibility to decide how best to manage its communication and medical networks because each situation is unique in terms of network capability and management capability.

54. The Commission does not believe that a frequency coordinator should be responsible for approving a health care facility's plans for complying with the rules or its plans for managing its internal systems for communications or patient care. The transition plan as described by the Joint Parties goes beyond the scope of the registration and coordination functions the Commission is requiring to ensure interference protection to AMT licensees, and those plans might overlap the risk assessment that is within the FDA's purview. The Commission does not believe that a frequency coordinator is an appropriate party for approving such plans or that the Commission should confer such approval authority on a frequency coordinator. The approach it adopts will allow health care facilities to manage their own MBAN systems or enter agreements as they determine to be appropriate for their individual situation, rather than adopting an approach that would require a health care facility to enter into service agreements with MBAN vendors. Finally, while the Commission does not require health care facilities to file a transition plan with the MBAN coordinator, it anticipates that health care facilities will create such plans in routine practice. The Commission encourages them to share such information with the MBAN coordinator to facilitate the coordination process.

55. The Commission has adopted a registration requirement for the 2360-2390 MHz band because it will facilitate coordination with AMT operations in that band; coordination is not needed and will not be required for an MBAN to operate in the 2390-2400 MHz band. The Commission's rules recognize that some MBAN equipment may operate across the whole 2360-2400 MHz band, but some equipment may be designed to operate only in the 2390-2400 MHz band which can be used for indoor or outdoor use without coordination. In the latter case, a registration requirement would unnecessarily burden hospitals that do not need assistance from the MBAN coordinator. Even if the Commission was persuaded that a registration requirement in the upper band would serve some useful purpose, the Commission's rules should not discriminate as to which facilities should be required to register. The rules require that any facility that registers MBAN equipment that operates in the 2360-2390 MHz specify whether its equipment can default to the 2390-2400 MHz band since this information will enable the coordinator to help the facility manage its MBAN operations consistent with any coordination agreements.

56. The Commission finds that use of a coordination framework that is based on the Joint Parties' proposal will allow for the operation of MBAN devices in the 2360-2390 MHz band while also providing adequate interference protection for AMT receivers, and the Commission will codify these coordination procedures in new § 95.1223(c) of our rules. As the first step in the coordination process, the MBAN coordinator will determine whether a proposed MBAN location is within line-of-sight of AMT operations. The Commission will require that the MBAN coordinator provide the AMT coordinator with the MBAN registration information and obtain the AMT coordinator's concurrence that the MBAN is beyond line-of-sight prior to the MBAN beginning operations in the band. If the MBAN is within line-of-sight, the MBAN and AMT coordinators will assess the risk of interference between the two operations and determine the measures that may be needed to mitigate interference risk. In determining compatibility between proposed line-of-sight MBAN and AMT operations, the coordinators will use ITU-R M.1459, subject to accepted engineering practices and standards that are mutually agreeable to both coordinators and that take into account the local conditions and operating characteristics of the AMT and proposed MBAN facilities. The Joint Parties have proposed specific analytical techniques for determining whether proposed MBAN locations are within line-of-sight and how to determine actual path loss. The Commission declines to specify these procedures in our rules. It recognizes that the MBAN and AMT coordinators will have to agree to the procedures they will use to determine when coordination is required and how it is done, but the Commission is also confident that the coordinators will be technically competent and will fully cooperate to develop mutually agreeable procedures to create coordination agreements. The Commission is also convinced that codifying specific procedures would potentially reduce flexibility on the part of both coordinators to adapt the coordination procedures as MBAN technologies mature.

57. The Joint Parties have suggested procedures to follow when AMT usersneed to expand their operations beyond existing receiver locations. Since they are authorized on a primary basis in the 2360-2390 MHz band, AMT users are entitled to expand as necessary to provide for aeronautical testing purposes. Because health care facilities need to be certain of their ability to rely on MBAN devices and also need time to adapt to the increased AMT requirements, the Joint Parties propose that an AMT licensee planning to expand its operations would first consider using locations that are not within line-of-sight to existing MBAN locations. If locations outside the line-of-sight to MBAN operations are not available, the AMT coordinator would give the MBAN coordinator at least seven days notice that MBAN users would have to cease or modify their operations. Under this proposal, the MBAN operator would still be eligible to enter into a new or modified coordination agreement with the new AMT operator, but the MBAN operator would nevertheless be required to vacate its operations at the end of the seven-day period if no coordination agreement is reached. The Commission adopts this proposal because it finds that it provides for the continuing requirements of the AMT community and preserves their growth potential, while also providing adequate notice to MBAN operators to adapt to any new AMT requirements.

58. The Joint Parties have also suggested procedures to follow when AMT users experience interference from MBAN operations. The Commission agrees that it is important to consider the possibility that unexpected interference situations may occur, and it adopted rules that will aid MBAN users in identifying and resolving interference complaints. The channel use policy rule the Commission adopted conditions MBAN use on not causing harmful interference to and accepting interference from authorized stations operating in the 2360-2400 MHz band. As part of the registration process for operating MBAN devices in the 2360-2390 MHz band, the Commission will also require an MBAN user to provide an MBAN coordinator with a point of contact for the health care facility that is responsible for making changes to MBAN operating parameters (such as discontinuing operations or changing frequencies), to state whether its MBAN operation is capable of defaulting to the 2390-2400 MHz band, and to acknowledge that it, in the event of interference, it is responsible for ceasing MBAN operations in the 2360-2390 MHz band or defaulting traffic to other hospital systems. The Commission requires the MBAN coordinator, as part of its duties, to work with the health care facility to identify an interference source in response to a complaint from the AMT coordinator. Together, these rules give MBAN users clear notice that they must be prepared to cease use of the 2360-2390 MHz band in the event of interference, require them to disclose the person who is able to modify or cut off MBAN use within a health care facility, and obligate the MBAN coordinator—the party who has a record of MBAN use and who will logically be contacted by the AMT coordinator about interference—to identify alternative frequencies for MBAN use or to direct the MBAN to cease operation. Under the procedures suggested by the Joint Parties, if a health care facility is notified of MBAN interference to an AMT receive antenna, the MBAN system should be required to immediately cease transmission. The Commission concludes that the rules it is implementing describes can accomplish the same overall goal of identifying and resolving interference to AMT from MBAN users in a way that also clearly sets forth the roles and responsibilities of the parties. The Commission fully expects that licensees will work together to resolve any instances of harmful interference under the rules it adopted and the procedures described.

59. To implement the registration and coordination requirements, the Commission will designate an MBAN coordinator(s) after resolution of the proceedings addressed in theFurther Notice. The Commission has directed the staff to act expeditiously to prepare a decision in response to the Further Notice and to initiate the selection of an MBAN coordinator(s), with a target of completing the process by June 2013. The Commission adopts a new rule, § 95.1225, which sets forth the specific functions that the MBAN coordinator will perform. The MBAN coordinator must:

• Register health care facilities that operate an MBAN in the 2360-2390 MHz band, maintain a database of these MBAN transmitter locations and operational parameters, and provide the Commission with information contained in the database upon request;

• Determine if an MBAN is within line-of-sight of an AMT receive facility in the 2360-2390 MHz band and coordinate MBAN operations with the designated AMT coordinator;

• Notify a registered health care facility when an MBAN has to change frequency within the 2360-2390 MHz band or to cease operating in the band consistent with a coordination agreement between the MBAN and the AMT coordinators; and

• Develop procedures to ensure that registered health care facilities operate an MBAN consistent with the coordination requirements.

• Regarding the AMT coordinator functions, in 1969 the Commission designated Aerospace & Flight Test Radio Coordinating Council (AFTRCC) as the AMT coordinator under its rules. AFTRCC performs coordination for non-Federal Government licensees and coordinates with the Federal Government Area Frequency Coordinators for day-to-day scheduling of missions. In theNPRM,the Commission acknowledged AFTRCC's role as AMT coordinator and sought comment on the organization's involvement in MBAN and AMT spectrum-sharing. The Commission expects that AFTRCC will represent both Federal and non-Federal AMT interests when coordinating with the MBAN coordinator, thereby eliminating the need for MBAN licensees to separately coordinate with Federal AMT systems. This should significantly reduce the time needed to complete coordination and should facilitate timely deployment of MBAN operations.

60. As required by the Regulatory Flexibility Act of 1980, as amended (RFA),1 an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Notice of Proposed Rulemaking (NPRM).2 The Commission sought written public comment on the proposals in theNPRM,including comment on the IRFA. No comments were received addressing the IRFA. This present Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.3

61. The Report and Order (R&O) expands our part 95 Medical Device Radiocommunication Service (MedRadio) rules to permit the development of new Medical Body Area Network (MBAN) devices. MBANdevices will be linked into wireless networks of multiple body transmitters used for measuring and recording physiological parameters and other patient information or for performing diagnostic or therapeutic functions, primarily in health care facilities. By reducing the need to physically connect sensors to essential monitoring equipment by cables and wires, MBAN technology will enhance patient care and promote efficiencies that can in turn reduce overall health care costs.

62. TheR&Oconcludes that the 2360-2400 MHz band is particularly well suited for MBAN use, given the propagation characteristics of these frequencies, the ability of MBAN devices to be able to share the band with incumbent users, and the ready availability of chipsets and technology that can be leveraged for MBAN development. TheR&Oestablishes a 40 megahertz secondary allocation for MedRadio, with use limited to MBAN operations, through the addition of a footnote to the Table of Frequency Allocations (Table). Because MBAN operation is authorized on a secondary basis, an MBAN must accept interference from and not cause interference to primary services that share the 2360-2400 MHz band. TheR&Oadopts technical and service rules to govern MBAN operation. MBAN devices will operate under existing part 95 MedRadio rules, as modified to account for device networking, wider bandwidth, and higher transmission power. TheR&Oadopts new registration and coordination rules to ensure protection of Aeronautical Mobile Telemetry (AMT) operations in the 2360-2390 MHz band.

63. No comments were filed in response to the IFRA in this proceeding. In addition no comments were submitted concerning small business issues.

64. Pursuant to the Small Business Jobs Act of 2010, the Commission is required to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed rules as a result of those comments. The Chief Counsel did not file any comments in response to the proposed rules in this proceeding.

65. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the rules and policies adopted herein.4 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.”5 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.6 A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.7 Nationwide, there are a total of approximately 27.5 million small businesses, according to the SBA. As an initial matter, the Commission notes that its decision will permit MBAN use of the 2390-2400 MHz band, which is also allocated to the Amateur Radio Service on a primary basis. Individuals who are the control operators of amateur radio stations are not “small entities,” as defined in the RFA.

66.Personal Radio Services.The MBAN devices will be subject to part 95 of our rules (“Personal Radio Services”). The Commission has not developed a small business size standard specifically applicable to these services. Therefore, for purposes of this analysis, the Commission uses the SBA small business size standard for the category Wireless Telecommunications Carriers (except Satellite), which is 1,500 or fewer employees.8 Census data for 2007 show that there were 1,383 firms that operated that year.9 Of those, 1,368 had fewer than 100 employees. Personal radio services provide short-range, low power radio for personal communications, radio signaling, and business communications not provided for in other services. The Personal Radio Services include spectrum licensed under part 95 of our rules and cover a broad range of uses.10 Many of the licensees in these services are individuals and thus are not small entities. In addition, due to the fact that licensing of operation under part 95 is accomplished by rule (rather than by issuance of individual license), and due to the shared nature of the spectrum utilized by some of these services, the Commission lacks direct information other than the census data above upon which to base an estimation of the number of small entities under an SBA definition that might be directly affected by the proposed rules adopted.

67.Wireless Communications Equipment Manufacturers.The Census Bureau does not have a category specific to medical device radiocommunication manufacturing. The appropriate category is that for wireless communications equipment manufacturers. The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are: Transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment.” The SBA has developed a small business size standard for Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing, which is: All such firms having 750 or fewer employees.11 According to Census bureau data for 2007, there were a total of 919 firms in this category that operated for the entire year. Of this total, 771 had fewer than 100 employees and 148 had more than 100 employees.12 Thus, under this size standard, the majority of firms can be considered small.

68. Aeronautical Mobile Telemetry (AMT). Currently there are 9 AMT licensees in the 2360-2395 MHz band. It is unclear how many of these will be affected by our new rules. The Commission has not yet defined a small business with respect to aeronautical mobile telemetry services. Therefore, for purposes of this analysis, theCommission uses the SBA small business size standard for the category Wireless Telecommunications Carriers (except Satellite), which is 1,500 or fewer employees.13 Census data for 2007 show that there were 1,383 firms that operated that year.14 Of those 1,368 had fewer than 100 employees. Thus, under this size standard, the majority of firms can be considered small. The rules we adopt provide the flexibility manufacturers, licensees and coordinators need to accommodate changes in both AMT and MBAN operations and assurance to AMT users that their future access to the spectrum will not be hampered.

69. Under the adopted rules, MBAN operators will not require individual licenses but instead will qualify for license-by-rule operation15 pursuant to Section 307(e) of the Communications Act (Act).16 While there is no requirement to file with the Commission, parties seeking to utilize the 2360-2390 MHz band must register with a frequency coordinator. The Commission will designate the MBAN frequency coordinator(s). The frequency coordinator will require the following information from an entity that seeks to operate an MBAN in the 2360-2390 MHz band:

• Specific frequencies or frequency range(s) within the 2360-2390 MHz band to be used, and the capabilities of the MBAN equipment to use the 2390-2400 MHz band;

• Effective isotropic radiated power;

• Number of programmer/controller transmitters in use at the health care facility as of the date of registration including manufacturer name(s) and model numbers and FCC identification number;

• Legal name of the health care facility;

• Location of programmer/controller transmitters;

• Point of contact for the health care facility; and

• Contact information for the party that is responsible for ensuring that MBAN operations within the health care facility are discontinued or modified in the event such devices have to cease operating in all or a portion of the 2360-2390 MHz band due to interference or because the terms of coordination have changed. The health care facility also must state whether, in such cases, its MBAN operation is capable of defaulting to the 2390-2400 MHz band and that it is responsible for ceasing MBAN operations in the 2360-2390 MHz band or defaulting traffic to other hospital systems.

70. The Commission imposes these notification requirements in recognition that MBAN device operations have the potential to interfere with the sensitive receivers and high gain antennas used by the primary AMT licensees. TheReport and Orderalso establishes a coordination procedure that will be used when the MBAN coordinator determines that MBAN devices in the 2360-2390 MHz band would be operating under conditions where such interference might occur—specifically, within the line-of-sight of AMT operations. The coordination process would allow the MBAN coordinator and the AMT coordinator to determine whether and under what circumstances MBAN equipment could be used without interfering with the primary AMT operations. TheReport and Orderconcludes that the adoption of reasonable coordination requirements will adequately protect AMT operations while enabling MBAN devices to be widely deployed in health care facilities. The Commission concludes that the registration and coordination requirements effectively balance the interests of the interested parties and are preferable to other options, such as using alternate frequency bands or establishing large exclusion zones around AMT locations.

71. TheR&Oadopts service and technical rules that apply to all entities that manufacture and use MBAN devices. The rules generally require that MBAN devices be able to operate in the presence of other primary and secondary users in these frequency bands. MBAN operations in the 2360-2390 MHz are restricted to indoor locations to protect AMT operations. The MBAN programmer/controller must ensure that its network operates in the 2360-2390 MHz band only if it is in receipt of a control message. As directed by a control message, the MBAN programmer/controller must be capable of: (1) Redirecting the MBAN to newly specified spectrum in the 2360-2390 MHz band; or (2) redirecting the MBAN to spectrum in the 2390-2400 MHz band. An MBAN programmer/controller that does not receive a control message within the timeframe programmed into the device by the manufacturer must ensure that its MBAN ceases operation in the 2360-2390 MHz band.17

72. MBAN use shall be restricted for use by persons only for diagnostic and therapeutic purposes and only to the extent that such devices have been provided to a human patient under the direction of a duly authorized health care professional.18 An MBAN consists of only body-worn devices. A single MBAN programmer/controller may direct more than one MBAN. MBAN programmer/controller devices may not directly communicate with each other and MBAN component devices may not directly communicate with each other.19

73. An MBAN may transmit in an authorized bandwidth of 5 megahertz.20 MBAN transmitters may transmit in the 2360-2390 MHz band, the maximum EIRP over the frequency bands of operation shall not exceed the lesser of 1 mW or 10*log (B) dBm, where B is the 20 dB emission bandwidth in MHz. MBAN transmitters may transmit in the 2390-2400 MHz band, the maximum EIRP over the frequency bands of operation shall not exceed the lesser of 20 mW or 16+10*log (B) dBm, where B is the 20 dB emission bandwidth in MHz. The MBAN must meet specific limits on unwanted emissions.21 MBAN transmitters will be required to maintain a frequency stability as specified in the current MedRadio rules of ± 100 ppm of the operating frequency over the range 0°C to 55°C.22

74. MBAN transmitters must be certificated except for such transmitters that are not marketed for use in the United States, are being used in the United States by individuals who have traveled to the United States from abroad, and comply with the applicable technical requirements. Manufacturers of MBAN transmitters must include with each transmitting device a disclosure statement and each MBAN programmer/controller must be labeled with a statement.23 An MBAN may be operated anywhere that CB station operation is authorized under § 95.405,except in the 2360-2390 MHz band MBAN use is restricted to indoor operation within a health care facility registered with the MBAN coordinator, and an MBAN is not required to transmit a station identification announcement. All non-MBAN transmitters must be made available for inspection upon request by an authorized FCC representative.24

75. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.25

76. The Commission adopted a license-by-rule approach for MBAN operations. This decision should decrease the cost of MBAN use for small entities as compared to a requirement that MBAN users apply for and obtain individual station licenses from the Commission because it will eliminate application expenses associated with the traditional licensing process.

77. The registration and coordination process for operation in the 2360-2390 MHz band, as well as the requirement that MBAN devices be capable of receiving and complying with a control message, will maximize the ability of MBAN devices to share spectrum with primary AMT users. Alternative approaches, such as the use of exclusion zones, would have categorically prohibited MBAN use in certain areas, even if it would be technically possible to operate MBAN devices without interference to AMT users. Other options would have made it more difficult to accommodate new or modified use by the primary AMT licensees that can affect the ability for MBAN users to operate without causing interference.

78. Permitting operation in the 2360-2400 MHz band will enable MBAN manufacturers to easily adapt the wide variety of equipment that is already produced for operation in the adjacent 2.4 GHz band, thus reducing MBAN equipment costs. Alternative higher spectrum bands would require increased power to provide adequate coverage, which would result in shorter battery life. This, along with the lack of readily available chipsets, indicates that adopting the other allocation options considered in the proceeding would likely have resulted in higher costs for MBAN users.

79. The Commission adopted various provisions regarding equipment certification, authorized locations, station identification, station inspection, disclosure policy, labeling requirements and marketing limitations that mirror the existing MedRadio rules. Taken as a whole, these requirements will ensure that (1) MBAN operations comply with our technical rules, (2) MBAN users are aware of pertinent interference requirements, and (3) equipment manufacturers market and sell MBAN devices only for the types of communications permitted under the Commission's rules. Utilizing our existing regulatory framework, which is familiar to both health care providers and medical device manufacturers, enables us to authorize MBAN devices without implementing new rule subparts or codifying a significantly more complex system management scheme into our existing rules. Thus, we are able to provide for MBAN deployment in a manner that protects incumbent users without passing any undue costs or regulatory burdens onto prospective MBAN users, many of whom may be small entities.

80. The Commission will send a copy of the Report and Order, including this FRFA, in a report to Congress pursuant to the Congressional Review Act.26 In addition, the Commission will send a copy of the Report and Order, including this FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of the Report and Order and the FRFA (or summaries thereof) will also be published in theFederal Register.

81. Pursuant to the authority contained in Sections 4(i), 301, 302, 303(e), 303(f), 303(r), and 307(e) of the Communications Act of 1934, as amended, 47 U.S.C. Sections 154(i), 301, 302, 303(e), 303(f), 303(r), and 307(e), this Report and Order IS ADOPTED and parts 2 and 95 of the Commission's rules are amended as set forth in Final rules will become October 11, 2012, except for §§ 95.1215(c), 95.1217(a)(3), 95.1223 and 95.1225, which contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13, that are not effective until approved by the Office of Management and Budget. The Federal Communications Commission will publish a document in theFederal Registerannouncing OMB approval and the effective date of these rules.

82. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center,shall senda copy of this Report and Order, including the Final Regulatory Flexibility Analysis in Appendix C, to the Chief Counsel for Advocacy of the Small Business Administration.

83. The Commission will send a copy of this Report & Order and Further Notice of Proposed Rulemaking to Congress and the Government Accountability Office pursuant to the Congressional Review Act,see5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 2 and 95 as follows:

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

NMFS closed directed fishing for Pacific cod by catcher vessels less than 60 feet LOA using hook-and-line or pot gear in the BSAI under § 679.20(d)(1)(iii) on February 17, 2012 (77 FR 10400, February 22, 2012).

NMFS has determined that as of September 5, 2012, approximately 1,134 metric tons of Pacific cod remain in the 2012 Pacific cod apportionment for catcher vessels less than 60 feet LOA using hook-and-line or pot gear in the BSAI. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C), and (a)(2)(iii)(D), and to fully use the 2012 total allowable catch (TAC) of Pacific cod in the BSAI, NMFS is terminating the previous closure and is opening directed fishing for Pacific cod by catcher vessels less than 60 feet LOA using hook-and-line or pot gear in the BSAI. The Administrator, AlaskaRegion, NMFS, (Regional Administrator) considered the following factors in reaching this decision: (1) the current catch of Pacific cod by catcher vessels less than 60 feet LOA using hook-and-line or pot gear in the BSAI and, (2) the harvest capacity and stated intent on future harvesting patterns of vessels in participating in this fishery.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of directed fishing for Pacific cod by catcher vessels less than 60 feet LOA using hook-and-line or pot gear in the BSAI. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet and processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 5, 2012.

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

Without this inseason adjustment, NMFS could not allow the fishery for Pacific cod by catcher vessels less than 60 feet LOA using hook-and-line or pot gear in the BSAI to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until September 21, 2012.

This action is required by § 679.25 and is exempt from review under Executive Order 12866.