The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions is impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the Federal Register .

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.

On May 14, 2009, Embraer S.A. applied for a type certificate for its new Model EMB-550 airplane. The Model EMB-550 airplane is the first of a new family of jet airplanes designed for corporate flight, fractional, charter, and private owner operations. The airplane has a configuration with low wing and T-tail empennage. The primary structure is metal with composite empennage and control surfaces. The Model EMB-550 airplane is designed for eight (8) passengers, with a maximum of twelve (12) passengers. It is equipped with two Honeywell AS907-3-1E medium bypass ratio turbofan engines mounted on aft fuselage pylons. Each engine produces approximately 6,540 pounds of thrust for normal takeoff.

The Model EMB-550 will have a novel or unusual design feature associated with a satellite communication system that uses rechargeable lithium battery technology. Rechargeable lithium batteries are a novel or unusual design feature in transport category airplanes. This type of battery has certain failure, operational, and maintenance characteristics that differ significantly from those of the nickel-cadmium and lead-acid rechargeable batteries currently approved for installation on transport category airplanes. Because of rapid improvements in airplane technology, the applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, Embraer S.A. must show that the Model EMB-550 meets the applicable provisions of part 25 as amended through Amendments 25-1 through 25-127 thereto.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model EMB-550 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model.

In addition to the applicable airworthiness regulations and special conditions, the Model EMB-550 airplane must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92 574, the “Noise Control Act of 1972.”

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).

The Model EMB-550 airplane will incorporate the following novel or unusual design feature: A satellite communication system that uses rechargeable lithium battery technology. Rechargeable lithium batteries are a novel or unusual design feature in transport category airplanes for which the applicable airworthiness regulations do not contain adequate or appropriate safety standards. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

These special conditions provide additional safety standards to accommodate the unique features of rechargeable lithium battery technology. This type of battery has certain failure, operational, and maintenance characteristics that differ significantly from those of the nickel-cadmium and lead-acid rechargeable batteries currently approved for installation on transport category airplanes.

The current regulations governing installation of batteries in transport category airplanes were derived from Civil Air Regulations (CAR) part 4b.625(d) as part of the re-codification of CAR 4b that established 14 CFR part 25 in February 1965. The new battery requirements, 14 CFR 25.1353(c)(1) through (c)(4), basically reworded the CAR requirements.

Increased use of nickel-cadmium batteries in small airplanes resulted in increased incidents of battery fires and failures that led to additional rulemaking affecting transport category airplanes as well as small airplanes. On September 1, 1977, and March 1, 1978, respectively, the FAA issued § 25.1353(c)(5) and (c)(6), governing nickel-cadmium battery installations on transport category airplanes. At Amendment 25-123, effective December 10, 2007, the FAA issued a revised § 25.1353, which moved the battery requirements to § 25.1353(b)(1) through (b)(6).

The proposed use of rechargeable lithium batteries for equipment and systems on the Model EMB-550 has prompted the FAA to review the adequacy of these existing regulations. Our review indicates that the existing regulations do not adequately address several failure, operational, and maintenance characteristics of rechargeable lithium batteries that could affect the safety of the airplane and its passengers and crew.

At present, there is limited experience with use of rechargeable lithium batteries in applications involving commercial aviation. However, other users of this technology, ranging from wireless telephone manufacturers to the electric vehicle industry, have noted safety problems with rechargeable lithium batteries. These problems include overcharging, over-discharging, and flammability of cell components.

In general, lithium batteries are significantly more susceptible to internal failures that can result in self-sustaining increases in temperature and pressure (i.e., thermal runaway) than their nickel-cadmium or lead-acid counterparts. This is especially true for overcharging, which causes heating and destabilization of the components of the cell, leading to the formation (by plating) of highly unstable metallic lithium. The metallic lithium can ignite, resulting in a self-sustaining fire or explosion. Finally, the severity of thermal runaway due to overcharging increases with increasing battery capacity due to the higher amount of electrolyte in large batteries.

Discharge of some types of lithium batteries beyond a certain voltage (typically 2.4 volts) can cause corrosion of the electrodes of the cell, resulting in loss of battery capacity that cannot be reversed by recharging. This loss of capacity may not be detected by the simple voltage measurements commonly available to flight crews as a means of checking battery status—a problem shared with nickel-cadmium batteries.

Unlike nickel-cadmium and lead-acid batteries, some types of lithium batteries use liquid electrolytes that are flammable. The electrolyte can serve as a source of fuel for an external fire if there is a breach of the battery container.

These problems experienced by users of lithium batteries raise concern about the use of these batteries in commercial aviation. The intent of these special condition is to establish appropriate airworthiness standards for rechargeable lithium battery installations in the Embraer Model EMB-550, and to ensure, as required by §§ 25.1309 and 25.601, that these battery installations are not hazardous or unreliable.

As discussed above, these special conditions are applicable to the Embraer S.A. Model EMB-550 airplane. Should Embraer S.A. apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on one airplane model. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the Federal Register . The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Embraer S.A. Model EMB-550 airplane.

In lieu of the requirements of § 25.1353(b)(1) through (b)(4) at Amendment 25-123, all rechargeable lithium batteries and battery system installations on the Model EMB-550 must be designed and installed as follows:

(1) Safe cell temperatures and pressures must be maintained during any foreseeable charging or discharging condition and during any failure of the charging or battery monitoring system not shown to be extremely remote. The rechargeable lithium battery installation must preclude explosion in the event of those failures.

(2) Design of the rechargeable lithium batteries must preclude the occurrence of self-sustaining, uncontrolled increases in temperature or pressure.

(3) No explosive or toxic gases emitted by any rechargeable lithium battery in normal operation, or as the result of any failure of the battery charging system, monitoring system, or battery installation that is not shown to be extremely remote, may accumulate in hazardous quantities within the airplane.

(4) Installations of rechargeable lithium batteries must meet the requirements of 14 CFR 25.863(a) through (d).

(5) No corrosive fluids or gases that may escape from any rechargeable lithium battery may damage surrounding structure or any adjacent systems, equipment, or electrical wiring of the airplane in such a way as to cause a major or more severe failure condition, in accordance with § 25.1309(b) and applicable regulatory guidance.

(6) Each rechargeable lithium battery installation must have provisions to prevent any hazardous effect on structure or essential systems caused by the maximum amount of heat the battery can generate during a short circuit of the battery or of its individual cells.

(7) Rechargeable lithium battery installations must have a system to control the charging rate of the battery automatically, so as to prevent battery overheating or overcharging, and,

(i) A battery temperature sensing and over-temperature warning system with a means for automatically disconnecting the battery from its charging source in the event of an over-temperature condition, or,

(ii) A battery failure sensing and warning system with a means for automatically disconnecting the battery from its charging source in the event of battery failure.

(8) Any rechargeable lithium battery installation, the function of which is required for safe operation of the airplane, must incorporate a monitoring and warning feature that will provide an indication to the appropriate flight crewmembers whenever the state-of-charge of the batteries has fallen below levels considered acceptable for dispatch of the airplane.

(9) The Instructions for Continued Airworthiness required by § 25.1529 must contain maintenance requirements to assure that the battery is sufficiently charged at appropriate intervals specified by the battery manufacturer and the equipment manufacturer that contain the rechargeable lithium battery or rechargeable lithium battery system. This is required to ensure that lithium rechargeable batteries and lithium rechargeable battery systems will not degrade below specified ampere-hour levels sufficient to power the aircraft system, for intended applications. The Instructions for Continued Airworthiness must also contain procedures for the maintenance of batteries in spares storage to prevent the replacement of batteries with batteries that have experienced degraded charge retention ability or other damage due to prolonged storage at a low state of charge. Replacement batteries must be of the same manufacturer and part number as approved by the FAA. Precautions should be included in the Instructions for Continued Airworthiness maintenance instructions to prevent mishandling of the rechargeable lithium battery and rechargeable lithium battery systems that could result in short-circuit or other unintentional impact damage caused by dropping or other destructive means that could result in personal injury or property damage.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A330-200, A330-200 Freighter, and A330-300 series airplanes; and Model A340-200, A340-300, A340-500, and A340-600 series airplanes. The NPRM published in the Federal Register on December 26, 2013 (78 FR 78294).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2013-0175, dated August 2, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-1031-0002.

Since the NPRM (78 FR 78294, December 26, 2013) was published, we have received Airbus Alert Operators Transmission A24L001-13, Revision 01, dated March 6, 2014. We have determined that this service information does not add any additional actions to those proposed in the NPRM, therefore, we have revised paragraph (g) of this AD to refer to that service information. We have also added a new paragraph (h) to this AD to provide credit for actions performed before the effective date of this AD using Airbus Alert Operators Transmission A24L001-13, dated July 25, 2013, and redesignated the subsequent paragraphs accordingly. Additionally, we have added paragraph (k), Material Incorporated by Reference, to the end of this AD.

We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM (78 FR 78294, December 26, 2013) and the FAA's response to that comment.

Airbus requested clarification in the SUMMARY section and paragraph (e) of the NPRM (78 FR 78294, December 26, 2013). Airbus stated that it was not “failure of the generator control unit-constant speed motor/generator during a final assembly operational test” that caused the unsafe condition, but a non-connection of the CSM/G during an operational test in the final assembly line. Investigations revealed an incorrect locking of some contacts into connector 1XE-A of the GCU-CSM/G.

We agree to revise the SUMMARY section and paragraph (e) of this final rule to state that this AD was prompted by a non-connection of the CSM/G during a final assembly operational test.

Paragraphs (g)(1) and (g)(2) in the NPRM (78 FR 78294, December 26, 2013) have been combined into paragraph (g) in this final rule.

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD with 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 (78 FR 78294, December 26, 2013) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 78294, December 26, 2013).

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

We estimate that this AD affects 76 airplanes of U.S. registry.

We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $6,460, or $85 per product.

In addition, we estimate that any necessary follow-on actions will take about 1 work-hour and require parts costing up to $17,314, for a cost of up to $17,399 per product. We have no way of determining the number of aircraft that might need this action.

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.

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2013-1031; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to revise AD 2008-21-07, Amendment 39-15691 (73 FR 61346, October 16, 2008), (“AD 2008-21-07”). AD 2008-21-07 applied to the specified products. The NPRM published in the Federal Register on December 26, 2013 (78 FR 78290). The NPRM proposed to continue to require the inspection and replacement requirements of AD 2008-21-07 and provide an optional terminating action to those requirements.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (78 FR 78290, December 26, 2013). Since we issued the NPRM we received information that propeller blade, part number (P/N) 697071278-18, has not been implemented and that no parts were manufactured using this P/N. We removed propeller blade, P/N 697071278-18, from this AD.

We reviewed the available data and determined that air safety and the public interest require adopting this AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

We estimate that this AD affects 174 propellers installed on airplanes of U.S. registry. We also estimate that it will take about 4 hours per propeller to comply with this AD. The average labor rate is $85 per hour. Required parts cost about $352 per propeller. Based on these figures, we estimate the cost of this AD to U.S. operators is $120,408.

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 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 part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

On November 6, 2013, at 78 FR 66668, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 by adding an AD that would apply to Eurocopter (now Airbus Helicopters) Model SA-365N, SA-365N1, AS-365N2, and AS 365 N3 helicopters. The NPRM proposed to require, for helicopters that have a No. 9 frame that has had any repair or alteration made, within 10 hours time-in-service (TIS) and every 110 hours TIS thereafter, inspecting the left-hand (LH) and right-hand (RH) frame No. 9 for a crack in the areas of the latch support and stretcher support with a 10X or higher power magnifying glass. For all other helicopters, the NPRM proposed to require the inspection within 110 hours TIS and every 110 hours TIS thereafter. If there is a crack, the NPRM proposed to require, before further flight, repairing the crack. The proposed requirements were intended to detect a crack and prevent loss of structural integrity and subsequent loss of control of the helicopter.

The NPRM was prompted by AD No. 2012-0108-E, dated June 15, 2012 (AD 2012-0108-E), issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Eurocopter Model SA 365 N, SA 365 N1, AS 365 N2, and AS 365 N3 helicopters with a frame No. 9 installed, if certain “doublers or repairs have been installed.” EASA advises that a crack discovered during the “T” inspection of a Model AS365 helicopter started at a rivet hole of a doubler installed on the frame No. 9 in accordance with Eurocopter Alert Service Bulletin (ASB) No. 53.00.42, dated January 31, 2001. EASA further states that structural alteration of frame No. 9 by modifications or repairs can result in fatigue crack initiation under normal operational loads. According to EASA, this condition, if not corrected, could lead to crack propagation and failure of frame No. 9, which would adversely affect the structural integrity of the helicopter. For these reasons, AD 2012-0108-E requires repetitive inspections of frame No. 9 for a crack in the area of the doubler or any repair performed in the area of the latch support and stretcher support.

Since we issued the NPRM, Eurocopter France has changed its name to Airbus Helicopters. This AD reflects that change and updates the contact information to obtain service documentation.

We gave the public the opportunity to participate in developing this AD, but we did not receive any comments on the NPRM (78 FR 66668, November 6, 2013).

These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, 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 and that air safety and the public interest require adopting the AD requirements as proposed except for the minor change previously described. This change is consistent with the intent of the proposals in the NPRM (78 FR 66668, November 6, 2013) and will not increase the economic burden on any operator nor increase the scope of the AD.

The EASA AD requires contacting Eurocopter (now Airbus Helicopters) for repair instructions if there is a crack, and this AD does not. This AD applies to all Model 365 helicopters, not just those that were altered or repaired in accordance with specific Eurocopter modifications (MODs).

Eurocopter issued one Emergency ASB (EASB) with two numbers: EASB No. 05.00.63, Revision 1, dated June 18, 2012, for Model AS365 helicopters and EASB No. 05.00.30, Revision 1, dated June 18, 2012, for Model AS565 helicopters. The EASB applies to helicopters with a frame No. 9 that has not been modified by MOD 07 53C17 or MOD 07 53D02, and that has had doublers installed or repairs performed in accordance with certain service instructions. The EASB describes procedures to inspect the frame No. 9 for a crack, and for contacting Eurocopter for further procedures if there is a crack.

We estimate that this AD affects 37 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. At an average labor rate of $85 per work-hour, inspecting LH and RH frame No. 9 will require about 3 work-hours, for a cost per helicopter of $255 and a total cost to U.S. operators of $9,435 per inspection cycle. Repairing a cracked frame No. 9 will require about 20 work-hours, and required parts will cost about $10,000, for a cost per helicopter of $11,700.

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 helicopters 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 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.

We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to adding an AD that would apply to Costruzioni Aeronautiche Tecnam srl Model P2006T airplanes. The NPRM was published in the Federal Register on March 14, 2014 (79 FR 14447). The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (79 FR 14447, March 14, 2014) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (79 FR 14447, March 14, 2014) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 14447, March 14, 2014).

We consider this AD interim action. We are requiring inspection of the left hand and right hand engine mounts with a report to the manufacturer of the results if cracks or deformation is found. We will work with the type certificate holder to evaluate the report results to determine repetitive inspection intervals and subsequent terminating action. Based on this evaluation, we may initiate further rulemaking action to address the unsafe condition identified in this AD.

We estimate that this AD will affect 10 products of U.S. registry. We also estimate that it would take about 6 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $5,100, or $510 per product.

In addition, we estimate that any necessary follow-on actions would take about 18 work-hours and require parts costing $1,570 (per engine mount), for a cost of $3,100 per product. We have no way of determining the number of products that may need these actions.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591. ATTN: Information Collection Clearance Officer, AES-200.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

(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.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-0156; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Comments Invited

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.

On March 28, 2014, we issued EAD 2014-07-52, which requires, for certain helicopters, within 10 hours time-in-service (TIS) and within every 10 hours TIS thereafter, inspecting the right-hand reinforcement angles for a crack and repairing any cracked reinforcement angle. As an option to performing the 10 hour TIS repetitive inspections, the EAD allows an alternate 165 hour TIS repetitive inspection. The EAD was sent previously to all known U.S. owners and operators of these helicopters.

EAD 2014-07-52 was prompted by EAD No. 2014-0076-E, dated March 25, 2014, issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Airbus Helicopters Model AS350B, AS350BA, AS350BB, AS350B1, AS350B2, AS350B3, AS350D, AS355E, AS355F, AS355F1, AS355F2, AS355N, and AS355NP helicopters with Modification (MOD) 07 3215 or with at least one reinforcement angle, P/N 350A08.2493.21 or P/N 350A08.2493.23, installed. EASA advises that during the inspection of several AS355 helicopters, cracks were found in the reinforcement angles. EASA further states that a subsequent investigation revealed that cracks were initiated on the non-visible surface of the angle, which is the surface in contact with the frame, and that this condition, if not corrected, could lead to further crack propagation and subsequent loss of the tailboom, resulting in loss of the helicopter. The EASA EAD requires repetitive inspections of the reinforcement angles, and states that a terminating action is currently under investigation.

These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, EASA, its technical representative, has notified us of the unsafe condition described in the EASA EAD. 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.

Airbus Helicopters has issued Emergency Alert Service Bulletin (EASB) No. 05.00.70 for Model AS350B, BA, BB, B1, B2, B3, and D helicopters and EASB No. 05.00.62 for Model AS355E, F, F1, F2, N, and NP helicopters, both Revision 0 and dated March 24, 2014. EASB No. 05.00.70 and EASB No. 05.00.62 describe procedures for inspecting the angle reinforcements for a crack.

This AD requires, for helicopters with 640 or more hours time-in-service (TIS) since installation of MOD 07 3215 or since installation of an applicable reinforcement angle, within 10 hours TIS, and thereafter at intervals not exceeding 10 hours TIS, inspecting certain reinforcement angles for a crack. If there is a crack, this AD requires, before further flight, repairing the reinforcement angle. As an option to performing the 10-hour TIS repetitive inspections, this AD allows an alternate 165-hour TIS repetitive inspection.

This AD is not applicable to the AS350BB as that model is not type certificated in the U.S. This AD applies to Airbus Helicopters Model AS350C and AS350D1 helicopters because these helicopters have a similar design. The EASA EAD requires a 165 hour TIS repetitive inspection, this AD allows the 165 hour TIS inspection as an option. Finally, the EASA EAD requires operators to contact Airbus Helicopters if there is a crack, this AD does not, however it does require repairing the crack before further flight.

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

We estimate that this AD will affect 822 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. At an average labor rate of $85 per hour, inspecting the reinforcement angles for a crack will require 1 work-hour, for a cost per helicopter of $85 and a total cost of $69,870 for the U.S. fleet. If required, repairing a cracked reinforcement angle will require about 10 work-hours, and required parts will cost about $300, for a total cost per helicopter of $1,150.

Providing an opportunity for public comments before adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we found and continue to find that the risk to the flying public justifies waiving notice and comment prior to adopting this rule because the required corrective actions must be done within 10 hours time-in-service, a very short time period based on the average flight-hour utilization rate of these helicopters.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment before issuing this AD were impracticable and contrary to the public interest and good cause existed to make the AD effective immediately by EAD 2014-07-52, issued on March 28, 2014 to all known U.S. owners and operators of these helicopters. These conditions still exist and the AD is hereby published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons.

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.

We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

We are announcing the availability of a guidance for industry entitled “Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for `Eligible' Infant Formulas.” This guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents our current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

The guidance is intended to address questions regarding new requirements for eligible infant formulas in 21 CFR 106.96(i). A final rule amending part 106, and establishing the requirements under § 106.96(i), is published elsewhere in this issue of the Federal Register .

In the Federal Register of February 10, 2014 (79 FR 7609), we made available a draft guidance entitled “Draft Guidance for Industry: Demonstration of the Quality Factor Requirements for `Eligible' Infant Formulas” and gave interested parties an opportunity to submit comments by March 27, 2014, for us to consider before beginning work on the final version of the guidance. We received no comments on the draft guidance but have modified the final guidance where appropriate to correspond to requirements set forth in the final rule, “Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula,” published elsewhere in this issue of the Federal Register . For example, because the final rule revised the definition of an “eligible infant formula” from what was originally published in an interim final rule on February 10, 2014 (79 FR 7934), we revised the guidance to reflect that change. In addition, we revised the guidance to provide more detailed recommendations if a manufacturer includes proprietary information in its citizen petition submitted in accordance with § 106.96(i)(3). Furthermore, we made other edits so that the language in the guidance corresponds more closely to that used in the final rule. The guidance announced in this document finalizes the draft guidance dated February 2014.

This guidance refers to existing regulations in part 10 (21 CFR part 10) as well as the final rule, “Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula,” published elsewhere in this issue of the Federal Register , which amends parts 106 and 107 (21 CFR parts 106 and 107). The collection of information in part 10 has been approved under OMB control number 0910-0183. The collections of information in parts 106 and 107 have been approved under OMB control number 0910-0256. These collections of information amended by the final rule are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The Information Collection Request for the final rule is currently under review.

Interested persons may submit either electronic comments regarding the guidance to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES ). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov .

Persons with access to the Internet may obtain the guidance at http://www.fda.gov/FoodGuidances or http://www.regulations.gov . Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

We are issuing this final rule to establish requirements for quality factors for infant formulas and good manufacturing practices, including quality control procedures, under section 412 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350a). The final rule will help prevent the manufacture of adulterated infant formula, ensure the safety of infant formula, and ensure that the nutrients in infant formula are present in a form that is bioavailable.

Congress passed the Infant Formula Act of 1980 (the Infant Formula Act) (Public Law 96-359), which created section 412 of the FD&C Act. In 1986, Congress, as part of the Anti-Drug Abuse Act of 1986 (Pub. L. 99-570) (the 1986 amendments), amended section 412 of the FD&C Act to address concerns related to the sufficiency of quality control testing, current good manufacturing practices (CGMP), recordkeeping, and recall requirements for infant formula. The requirements in the final rule improve protection of infants consuming infant formula products by establishing greater regulatory control over the formulation and production of infant formula.

We previously implemented certain of the provisions in the Infant Formula Act and 1986 amendments. This final rule implements the remaining provisions of the 1986 amendments, including provisions for CGMPs and quality factor requirements.

This final rule generally affirms the IFR's changes to FDA's regulations at parts 106 and 107 (21 CFR parts 106 and 107) and provides additional modifications and clarifications to part 106. The final rule also responds to certain comments submitted in response to the request for comments in the IFR (79 FR 7934, February 10, 2014).

We are amending the definition of “eligible infant formula” in § 106.3. Eligible infant formula means an infant formula that could be lawfully distributed in the United States on December 8, 2014.

We are clarifying the definition of “quality factors” in § 106.3. Under this final rule, quality factors means those factors necessary to demonstrate the safety of the infant formula and the bioavailability of its nutrients, as prepared for market and when fed as the sole source of nutrition, to ensure the healthy growth of infants.

We are modifying the language in § 106.20(i) to permit doors to toilet facilities to open into the plant facilities where infant formula, ingredients, containers, or closures are processed, handled, or stored if alternate means have been taken to protect against contamination.

We are deleting § 106.30(e)(2)(ii)(A) and combining § 106.30(e)(2)(ii) from the IFR with § 106.30(e)(2)(ii)(B) from the IFR. The section is designated as § 106.30(e)(2)(ii). In the final rule, § 106.30(e)(2)(ii) states that “A manufacturer may maintain a cold storage area for an in-process infant formula or for a final infant formula at a temperature not to exceed 45 °F (7.2 °C) for a defined period of time provided that the manufacturer has scientific data and other information to demonstrate that the time and temperature conditions of such storage are sufficient to ensure that there is no significant growth of microorganisms of public health significance during the period of storage of the in-process or final infant formula product.”

We are amending § 106.35(a)(4) to clarify that validation can be accomplished through any suitable means, such as verification studies or modeling. We are also amending § 106.35(b)(1) to specify that requirements for the calibration, inspection, and checking of hardware apply at any point, step, or stage where control is necessary to prevent adulteration of infant formula.

We are deleting the word “drafted” from § 106.50(a)(2) in the final rule in response to a comment noting that persons other than a responsible official could draft changes to a master manufacturing order.

We are reducing the required frequency of stability testing for new infant formulas from every 3 months to every 4 months in § 106.91(b)(1)(i) of the final rule because we agree with a comment that explained that stability testing of new formulas every 3 months, as required by § 106.91(b)(1) in the IFR, would not provide additional public health protection over testing every 4 months.

We are modifying § 106.91(b)(1) to provide an exemption from the testing required by § 106.91(b)(1) of the IFR if the manufacturer of a new infant formula requests an exemption and provides analytical data that demonstrate that the stability of the new infant formula will likely not differ from the stability of formulas with similar composition, processing, and packaging for which there are extensive stability data. In doing so, we are renumbering § 106.91(b)(1) of the IFR as § 106.91(b)(1)(i) and creating § 106.91(b)(1)(ii) in the final rule to provide the exemption. The manufacturer would request the exemption in the 90-day notification for the new infant formula as required by new § 106.120(b)(7). If the manufacturer is exempted from the testing required by § 106.91(b)(1)(i), the manufacturer would then be required under § 106.91(b)(1)(ii) to test the first production aggregate of the new infant formula in accordance with the stability testing requirements for subsequent production aggregates in § 106.91(b)(2).

We are deleting the requirement to conduct stability testing at the midpoint of the shelf life for infant formulas tested under § 106.91(b)(2) in response to a comment that questioned how measuring nutrients at the midpoint of shelf life would provide additional assurance for formulas for which stability data have been established. We agree with the comment that the critical data are the nutrient levels present at the end of shelf life and that the midpoint data are not essential.

We are making a technical correction to § 106.91(b)(3) of the final rule to clarify our intent that manufacturers have the option to adjust the “Use by” date on an infant formula container so that such date is substantiated if the stability data from the testing required by § 106.91(b)(1) did not substantiate the anticipated shelf life of the formula. We are also changing § 106.91(b)(3) to provide flexibility for manufacturers to take other appropriate actions, in addition to conducting the testing required by § 106.91(b)(1) or adjusting the “Use by” date, when stability testing does not substantiate the shelf life of the formula. Further, we are clarifying that the manufacturer must address all production aggregates released and pending release for distribution that are implicated by the testing results.

We are making conforming changes to § 106.91(b)(4)(iii) to clarify that manufacturers also must address all production aggregates released and pending release for distribution that are implicated by testing results required by § 106.91(b)(2) that show that any nutrient that is not present in the production aggregate of infant formula at the level intended by the manufacturer.

We are making other conforming changes in § 106.91(b)(3) and (4) as a result of changes made to these provisions in the final rule.

We are revising the exemption in § 106.96(c)(2)(ii) so that it applies when a change to a formula does not impact normal physical growth. We are also adding section 106.96(g)(3), which states that FDA will exempt a manufacturer from the requirements of conducting a protein efficiency ratio (PER) rat bioassay if the manufacturer requests an exemption and provides assurances, as required under § 106.121(i), that demonstrate that an alternative method to the PER that is based on sound scientific principles is available to show that the formula supports the quality factor for the biological quality of the protein.

We are revising § 106.100(m) to require access to records “within 24 hours” in response to a comment.

As stated earlier in section II.F.1 of this document, we are providing an exemption in § 106.91(b)(1)(ii) from the testing required by § 106.91(b)(1) if the manufacturer of a new infant formula requests an exemption and provides analytical data that demonstrate that the stability of the new infant formula will likely not differ from the stability of formulas with similar composition, processing, and packaging for which there are extensive stability data. In doing so, we added § 106.120(b)(7), which states that if the manufacturer is requesting an exemption under § 106.91(b)(1)(ii), the manufacturer shall include the scientific evidence that the manufacturer is relying on to demonstrate that the stability of the new infant formula will likely not differ from the stability of formulas with similar composition, processing, and packaging for which there are extensive stability data.

We are making a change to § 106.121 by adding § 106.121(i) to the final rule, which states that if the manufacturer is requesting an exemption under § 106.96(g)(3), the manufacturer shall include a detailed explanation of the alternative method, an explanation of why the method is based on sound scientific principles, and the data that demonstrates that the quality factor for the biological quality of the protein has been met.

We provided an opportunity for comment in the IFR but indicated that comments submitted in response to the IFR “should be limited to those that present new issues or new information” (79 FR 7934 at 8056). The preamble to the IFR also stated that “Comments previously submitted to the Division of Dockets Management have been considered and addressed in this IFR and should not be resubmitted” (id).

We received a number of comments to the IFR. The comments were generally supportive of the rule. After considering all the comments submitted to this docket number, we are making minor technical corrections, clarifications to some provisions in response to comments that indicate some confusion on the part of industry, and modifications that increase flexibility with respect to certain requirements included in the IFR. In addition, we summarize and respond to relevant portions of comments.

To make it easier to identify comments and FDA's responses, the word “Comment,” in parentheses, appears before the comment's description, and the word “Response,” in parentheses, appears before FDA's response. Each comment is numbered to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance.

(Comment 1) One comment stated that FDA's definition of quality factors in the IFR introduced a novel concept, i.e., the “bioavailability . . . of the formula,” that is inconsistent with FDA's definition of bioavailability in the IFR and with the scientific and common meaning of “bioavailability,” which refers to absorption of particular nutrients. The comment continued that the concept of the bioavailability of a food should be subjected to external nutritional science input before being given the force and effect of law and recommended that the definition of quality factors in the 1996 proposed rule be restored.

(Response) We recognize that the wording of the definition of quality factors in the IFR inadvertently suggested a “novel” concept of “bioavailability.” To clarify and better align the wording in the definition of quality factors with the definition of bioavailability used by FDA and the scientific community, we are modifying the wording of the definition of “quality factor” in § 106.3 in the final rule.

The revised definition still speaks to the safety of the formula while clarifying that the term “bioavailability” refers to nutrients. We note, however, that the infant formula as a whole, i.e., the matrix that contains the nutrients, must be formulated, processed, and packaged such that the nutrients are bioavailable. Changes in an infant formula matrix can greatly influence nutrient bioavailability (see 79 FR 7934 at 8007). Because infants are fed formula as the sole source of nutrients, it is imperative that formulas have characteristics that allow the nutrients to be bioavailable.

We decline to restore the definition of quality factors from the 1996 proposed rule. As discussed in response to comment 23 of the IFR, the definition of quality factors in the proposed rule caused some people to interpret “healthy growth” as a separate quality factor (79 FR 7934 at 7950-7951).

(Comment 2) One comment expressed concern with defining quality factors to apply to bioavailability of the infant formula as a whole, but did not explain the basis for its concern. Another comment asserted that our explanation for why quality factors apply to the “bioavailability . . . of the formula” is inconsistent with the definition of “bioavailability” as understood by Congress and fails to consider other more plausible and well-precedented interpretations of Congressional intent. The comment stated that FDA's conclusion that quality factors pertain to the “bioavailability . . . of the formula” appears arbitrary in the context of the 1986 Amendments to the Infant Formula Act of 1980. The comment stated that the statutory language requiring that the Secretary of Health and Human Services (the Secretary) establish requirements for quality factors for infant formulas “including” quality factor requirements for the nutrients required to be contained in infant formula under section 412(i) of the FD&C Act demonstrates that Congress intended to grant FDA the authority to establish quality factor requirements for individual nutrients other than those specified in section 412(i) of the FD&C Act, as well as quality factor requirements relating to issues other than the quantitative levels of nutrients as prescribed in section 412(i) of the FD&C Act (e.g., the bioavailability of distinct forms of individual nutrients), but not the authority to establish quality factor requirements for the infant formula as a whole. The comment argued that the IFR's definition of “quality factors” fails the legal analysis provided by FDA in section VIII.A of the IFR because Congress was not silent about the meaning of the term quality factors.

(Response) To the extent that either comment relates to the explanation of bioavailability as set forth in the IFR and the suggestion that bioavailability relates to the infant formula as a whole, rather than to the bioavailability of individual nutrients, we address this issue in our response to comment 1. To the extent these comments assert that we lack authority to establish a definition of quality factors that relates to the infant formula as a whole, we disagree. We also disagree with the assertion that the legal analysis provided in section VIII.A of the IFR failed to consider all the possible interpretations of the statutory language or otherwise provides an insufficient or inaccurate analysis of FDA's authority.

Comment 195 in the preamble to the IFR explicitly challenged FDA's authority to establish the quality factor of normal physical growth, which relates to the formula as a whole rather than any individual nutrient (79 FR 7934 at 8003). In responding to comment 195, we provided a detailed interpretation of our authority based, in part, on section 412(b)(1) of the FD&C Act, and we summarize some of this argument below (79 FR 7934 at 8003 through 8006). We reaffirm our explanation of our authority as set forth in the response to comment 195 in the preamble to the IFR.

As discussed in the preamble to the IFR, section 412(b)(1) of the FD&C Act requires the Secretary to “by regulation establish requirements for quality factors for infant formulas to the extent possible consistent with current scientific knowledge, including quality factor requirements for the nutrients required by [section 412(i)].” This statutory language indicates that the Secretary must establish quality factors for (1) the individual nutrient components required under subsection (i) and (2) the infant formula as a whole to the extent possible consistent with current scientific knowledge. The language is silent regarding what the exact quality factors should be. The 1986 Amendments to the 1980 Infant Formula Act are consistent with our interpretation that quality factors extend beyond requirements for individual nutrients. The original language from the Infant Formula Act of 1980 authorized the Secretary to, by regulation, “establish requirements for quality factors for such nutrients [required by subsection (g)].” Infant Formula Act of 1980, Public Law 96-359, section 2, 94 Stat. 1190 (1980). (Subsection (g) of section 412 of the FD&C Act was subsequently redesignated as subsection (i) of section 412 of the FD&C Act as part of the 1986 Amendments. Anti-Drug Abuse Act of 1986, Public Law 99-570, section 4014(a)(1), 100 Stat. 3207 (1986).) In 1986, however, the infant formula provisions were amended to specify in revised section 412(b)(1) of the FD&C Act that the “Secretary shall by regulation establish requirements for quality factors for infant formulas, . . . including quality factor requirements for the nutrients required by subsection (i).” (Emphasis added). This amendment clarified that quality factor requirements apply to the “infant formula” as a whole as well as to the individual nutrients.

Further, requiring that quality factors relate to the safety of the infant formula as a whole is reasonable when considering the statutory scheme as a whole. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000) (explaining that the words of a statute must be read in the context of the overall statutory scheme). Our explicit statutory mission is, in part, to protect the public health by ensuring that foods (including infant formula) are safe, wholesome, sanitary, and properly labeled (section 903(b)(2)(A) of the FD&C Act) (21 U.S.C. 393(b)(2)(A)). Further, the FD&C Act touches “phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words.” United States v. Dotterweich, 320 U.S. 277, 281 (1943); see also United States v. Park, 421 U.S. 658, 668 (1975). The Infant Formula Act and the 1986 amendments were meant to ensure the “safety and nutrition” of infant formulas, and this purpose is achieved, in part, through the establishment of requirements for quality factors that help ensure the safety of the infant formula as a whole. See Public Law 96-359, 94 Stat. 1190, 1190 (1980).

(Comment 3) One comment expressed concern that the IFR is silent on what changes, other than major changes, should be submitted to FDA before processing for FDA's concurrence in the manufacturer's assessment. The comment stated that because the guidelines issued under 21 CFR 106.30(c)(2) (and incorporated by reference in the 1986 Infant Formula Act Amendments) discuss changes other than major changes and have the force and effect of law, we should honor those guidelines.

(Response) We disagree that the IFR is silent on what changes, other than major changes, a manufacturer should submit to FDA before first processing (BFP). We addressed this issue in response to comments 256 and 352 of the IFR (79 FR 7934 at 8021 and 8053). As discussed in the preamble to the IFR, a “before first processing” (BFP) notification under section 412(d)(3) of the FD&C Act must be submitted when the manufacturer determines that a change in the formulation of the formula or a change in the processing of the formula “may affect whether the formula is adulterated” under section 412(a) of the FD&C Act, e.g., when there are questions about whether a formula provides nutrients required by section 412(i) of the FD&C Act, meets quality factor requirements, or is in compliance with CGMP and quality control procedures.

As for the comment's assertion that we should honor the guidelines issued under 21 CFR 106.30(c)(2) with respect to changes other than major changes, the comment misinterprets the language in section 412(c)(2) of the FD&C Act. Section 412(c)(2) of the FD&C Act only incorporates the definition of “major change” as found in 21 CFR 106.30(c)(2) (as in effect on August 1, 1986) and the guidelines issued thereunder. Thus, FDA's decision not to codify portions of the guidelines related to changes other than major changes is not inconsistent with section 412(c)(2) of the FD&C Act.

(Comment 4) One comment requested that we clarify the notification requirements of an infant formula submitted after February 10, 2014 (90 days prior to May 12, 2014) under the current 90-day premarket notification requirements. The comment stated that the requirements for formulas submitted before July 10, 2014, and especially before May 12, 2014, need to be clarified.

(Response) We recognize the lack of clarity surrounding the notification requirements for infant formulas submitted after February 10, 2014, based on the definition of eligible infant formula as set forth in the IFR. To address the issue, we are amending the definition of “eligible infant formula” to mean an infant formula that could be lawfully distributed in the United States on December 8, 2014. The change should eliminate the confusion surrounding notification requirements for new infant formula products that are the subject of a new infant formula notification submitted after the publication of the IFR. Under the revised definition, new infant formulas that are the subject of a notification submitted prior to the compliance date of September 8, 2014 will be considered eligible.

(Comment 5) One comment stated that FDA had declined to accept comments submitted on the proposed rule that would limit the areas of production requiring establishment of specifications to those deemed to be critical and requested that wording be inserted in § 106.6(a) to align this section with other parts of the IFR (e.g., § 106.30(d)(1)).

(Response) The comment's assertion that we declined to accept recommendations to limit the areas of production that require specifications to be established to those deemed to be critical is incorrect. This issue is addressed in § 106.6(c), which limits the establishment of specifications to be met “to any point, step, or stage in the production process where control is necessary to prevent adulteration.” We indicated in the response to comment 41 in the preamble to the IFR (see 79 FR 7934 at 7957-7958) that “FDA does not intend that the control procedures established under § 106.6(c) would address every theoretical risk of technical adulteration” and further stated that “a manufacturer has a responsibility, as part of CGMP, to ensure quality in the finished product on a consistent basis. The way to ensure quality is to identify controls needed at various steps in the production process so that, in its final form, the formula complies with all requirements.” The response continued that “certain actions (e.g., the establishing of specifications) are not required at every step in the manufacturer's process . . . [and] it is the responsibility of the manufacturer to identify those points at which control is necessary to prevent adulteration of infant formula products.” (79 FR 7934 at 7958).

(Comment 6) One comment stated that specifications necessary to prevent adulteration during production are currently established and contended that additional controls such as warehousing conditions and trailer temperatures during distribution are not expected to cause adulteration and should be out of the scope of the IFR. The comment asked us to clarify whether additional non-process related specifications beyond what manufacturers currently do are required and, if so, which non-process related specifications, or the criteria to make this determination, are needed. The comment said that manufacturers need this information to assess their ability to comply and determine related costs. The comment further stated that compliance with § 106.6 of the IFR would not be feasible by the effective date of the IFR because, if additional specifications need to be developed for areas the comment asserted are not critical to preventing product adulteration, much more time than 150 days will be required to draft, finalize, implement, and train employees. The comment requested that we provide relief through an announcement and exercise of enforcement discretion, a delayed compliance date, or a formal delay for this provision to align with the compliance date for eligible infant formulas.

(Response) We do not agree that warehousing conditions and trailer temperatures during distribution can be dismissed as a potential cause of adulteration. For example, temperatures that are too cold during storage and distribution may result in breaking of the emulsion of an infant formula, causing separation of the fat and liquid portions of the products and rendering the products inappropriate/unfit for consumption by infants. Temperatures that are too hot may result in growth of thermophilic organisms (organisms that need high temperatures for proliferation or that thrive at high temperature) that render the products unpalatable and inappropriate/unfit for infant consumption. As another example, during storage and distribution, rats that may gain access to warehouses and/or trailers could gnaw through cardboard cartons and plastic containers containing infant formula, which would result in adulteration of the product under section 402(a) of the FD&C Act.

The comment did not define non-process related specifications or provide additional examples of non-process related specifications beyond what manufacturers currently do. Therefore, we cannot respond to the comment's request for additional information. However, we remind manufacturers that § 110.93 of Part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food requires that storage and transportation of finished food shall be under conditions that will protect food against physical, chemical, and microbiological contamination as well as deterioration of the food and the container. We expect that infant formula manufacturers have already instituted practices, whether or not they are currently identified as specifications, to prevent adulteration and maintain product integrity during storage and distribution as a necessary step in fulfilling their responsibility to ensure that their formulas reach the consumer in a condition that is safe and appropriate for consumption. Creating written specifications as required by § 106.6(b) for such practices should not involve extensive effort or extra cost, and we see no basis for announcing the exercise of enforcement discretion or a formal delay for this provision to align with the compliance date for eligible infant formulas. Nonetheless, with the exception of the compliance date for certain requirements related to quality factors for eligible infant formulas, the final rule adopts a compliance date of September 8, 2014 to facilitate manufacturer compliance with all requirements of this final rule.

(Comment 7) One comment said that the requirements of § 106.20(i), which addresses controls to prevent adulteration from in-plant toilet facilities, are more restrictive than the provisions for toilet facilities in the food GMPs (21 CFR 110.37(d)(4)), which allows for doors in in-plant toilet facilities to open into enumerated areas if alternate means have been taken to protect against contamination (such as double doors or positive air-flow systems). The comment continued that FDA did not establish a public health need for the more restrictive requirements and claimed that infant formula manufacturers will have to move or otherwise reconfigure their in-plant toilet facilities if the IFR is interpreted not to permit the alternate means in the food GMPs or exempt facilities in areas where product is not subject to airborne contamination. The comment further stated that compliance with § 106.20 of the IFR would not be feasible by the effective date of the IFR if the comment's proposed changes to § 106.20 were not accepted and requested that we provide relief through an announcement and exercise of enforcement discretion, a delayed compliance date, or a formal delay for this provision to align with the compliance date for eligible infant formulas.

(Response) We agree with the aspect of the comment that suggests that it should be permissible for doors in in-plant toilet facilities to open into certain areas if alternate means have been taken to protect against contamination. However, we disagree that airborne contamination is the only source of contamination from toilet facilities. Contamination can come from hands, clothing, and footwear of employees exiting the toilet facilities, and it is likely that measures such as foot baths and footwear and garment changes in addition to double doors and positive air-flow systems will be needed to prevent contamination from in-plant toilet facilities. We are revising § 106.20(i) to permit doors to toilet facilities to open into the plant facilities if alternate means have been taken to protect against contamination. With this change to § 106.20(i), we see no basis for announcing the exercise of enforcement discretion or a formal delay for this provision to align with the compliance date for eligible infant formulas. Nonetheless, with the exception of the compliance date for certain requirements related to quality factors for eligible infant formulas, the final rule adopts a compliance date of September 8, 2014 to facilitate manufacturer compliance with all requirements of this final rule.

(Comment 8) One comment agreed with FDA that controlling the temperature of infant formula is important to prevent adulteration, requested clarification regarding the equipment covered by § 106.30(e)(2), and requested that we modify the provision to apply only to cold bulk liquid storage. The comment stated that, with this change, ingredient receipt through blending would not be classified as in-process infant formula or finished infant formula until the components are mixed and introduced into the cold storage vessel. In support of the requested modification, the comment pointed to FDA's report “Analysis of Results for FDA Food Defense Vulnerability Assessments and Identification of Activity Types,” in which we defined liquid storage as follows: “Bulk liquid storage refers to any medium-long term storage silo or tank where liquid product may be stored prior to introduction into the product stream or to hold finished product prior to loading for outbound shipping.”

(Response) We do not agree with the modification recommended in this comment. The report to which the comment refers, “Analysis of Results for FDA Food Defense Vulnerability Assessments and Identification of Activity Types,” identifies liquid storage/hold/surge tanks as a key activity type found in most production environments. However, in addition to the category of bulk liquid storage described in the comment, the report describes a second category of non-bulk holding and surge tanks, which “refer to any storage tanks used to hold product for a short period or surge tanks. Non-bulk tanks can be used to store non-bulk liquid ingredients, hold liquid product for sample testing and other QC activity, or to control flow rates of liquid ingredients/product through the production system.” The report also specifies that liquid storage “refers to any processing step where liquid ingredient (emphasis added) or intermediate/finished liquid product is stored in either bulk storage tanks or smaller secondary holding tanks or surge tanks.” Thus, the report does not provide a basis for restricting cold storage in § 106.30(e)(2)(i) to cold bulk liquid storage, so we decline to revise § 106.30(e)(2)(i) as suggested by the comment.

(Comment 9) One comment asked us to allow a less restrictive approach to meet the showing required under§ 106.30(e)(2)(ii) (i.e., meeting both of the conditions listed in § 106.30(e)(2)(ii) of the IFR). Under § 106.30(e)(2)(ii) in the IFR, a manufacturer may maintain a cold storage area for an in-process infant formula or for a final infant formula at a temperature not to exceed 45 °F (F) for a defined period of time if the manufacturer has scientific data and other information to demonstrate that (a) compliance with § 106.30(e)(2)(i) (which established 40 °F or below as the temperature level for all areas of cold storage) would have an adverse effect on the quality of the in-process or final infant formula and (b) the time and temperature conditions of such storage are sufficient to ensure that there is no significant growth of microorganisms of public health significance during the period of storage. The comment argued that the changes we made in the IFR do not fully encompass our stated rationale for the provision “to minimize the growth of pathogens and the deterioration of liquid ingredients” (79 FR 7934 at 7964).

(Response) In response to the comment's concern, we have revised § 106.30(e)(2)(ii) of the IFR. We are deleting § 106.30(e)(2)(ii)(A) and combining § 106.30(e)(2)(ii) from the IFR with § 106.30(e)(2)(ii)(B) from the IFR. The section will be designated as § 106.30(e)(2)(ii) in the final rule. In the final rule, § 106.30(e)(2)(ii) states that “A manufacturer may maintain a cold storage area for an in-process infant formula or for a final infant formula at a temperature not to exceed 45 °F (7.2 °C) for a defined period of time provided that the manufacturer has scientific data and other information to demonstrate that the time and temperature conditions of such storage are sufficient to ensure that there is no significant growth of microorganisms of public health significance during the period of storage of the in-process or final infant formula product.”

(Comment 10) One comment requested that we align section § 106.30(e)(2)(ii) with the Pasteurized Milk Ordinance, which specifies 45 °F as the maximum storage temperature of pasteurized milk and milk products. The comment stated that any capital improvements to facilities needed to comply with § 106.30(e)(2) will take considerably longer than the 150 days until the effective date.

(Response) The language in § 106.30(e)(2)(ii) of this final rule (see response to comment 9) allows the 45 °F temperature permitted for pasteurized milk and milk products for in-process or final infant formula for a defined period of time provided that the manufacturer has scientific information to demonstrate that the time and temperature conditions of such storage are sufficient to ensure that there is no significant growth of microorganisms of public health significance during the period of storage of the in-process or final infant formula product. We discussed in the responses to comments 65 and 66 in the IFR our reasons why the time and temperature conditions established in the IFR are sufficient to ensure product safety and the reasons for the 40 °F requirement. Furthermore, because infant formula is consumed by a vulnerable population, food safety and public health considerations do not justify further relaxing of the requirements of § 106.30(e)(2)(ii) of this final rule.

With regard to the comment's concern that compliance will take considerably longer than 150 days, we disagree. Section 106.30(e)(2) of this final rule allows a manufacturer the flexibility to store in-process and final product at temperatures up to and including 45 °F, provided that the manufacturer has scientific data and other information to demonstrate that the time and temperature conditions of such storage are sufficient to ensure that there is no significant growth of microorganisms of public health significance during the period of storage of the in-process or final infant formula product. The comment provided no information that would lead us to believe that compiling such scientific data would prove difficult or burdensome.

(Comment 11) One comment noted that the concept under § 106.30(d)(1), which requires only those instruments and controls at points where control is necessary to prevent adulteration to be accurate and maintained, including by calibration, should be applied to § 106.35(b)(1).

(Response) To the extent this comment requests consistency between the language in the two provisions, we agree that the use of consistent language would be beneficial, and we are amending § 106.35(b)(1) to provide that a manufacturer shall ensure, at any point, step, or stage where control is necessary to prevent adulteration of infant formula, that all hardware is routinely inspected and checked according to written procedures and that hardware that is capable of being calibrated is routinely calibrated according to written procedures. We note, however, that we are not aware of hardware currently in use in the infant formula manufacturing process that is capable of calibration that is not used at a point, step, or stage where control is necessary to prevent adulteration of infant formula. Infant formula manufacturing plants contain many automatic measuring devices that are capable of being calibrated, and they must be calibrated at whatever frequency is necessary to ensure accurate measurement. No device should be providing inaccurate data that could lead to adulteration of the infant formula.

(Comment 12) One comment stated that § 106.35(b)(4) would require revalidation of any system that is modified and suggested an alternative definition of validation in § 106.35(a)(4) to add the phrase “either through validation or verification of all components or through the validation of the system.” The comment stated that industry supports the requirement for full system validation. The comment acknowledged that our response to comments in the IFR contains references to “appropriate regression testing” and “validation analysis” but said that the IFR ultimately points to revalidation of the entire system. The comment suggested revising the final rule to clarify that verification is a sufficient method of ensuring control for some components in a system.

(Response) The preamble to the IFR included an extensive discussion of validation of automatic equipment and FDA's reasons for establishing the definition of validation in § 106.35(a)(4) in the IFR (79 FR 7934 at 7968-7971). We do not agree with the alternative definition proposed because it would permit the initial validation of a system through verification of all components. Complete validation of an automatic system is required initially; however, FDA did not intend that a whole system would always need to be completely revalidated with every change. For example, there may be operations upstream from another part of a system that is being changed that are not affected when the part of the system that is downstream has changed. In such cases, it may be possible to revalidate those parts of the system that are being changed or impacted by the change by other means such as verification studies or modeling. In response to the comment, we are revising § 106.35(a)(4) to clarify that validation can be accomplished through any suitable means, such as verification studies or modeling. However, we note that such verification studies differ from the nutrient testing of the final product, which is a form of verification of a system's proper operation. Finished product testing for nutrients does not eliminate the need for system validation.

(Comment 13) One comment stated that 150 days is insufficient time to conduct all the validations required by § 106.35(b)(3). The comment stated that automation, validation, and change control that is currently used would meet the requirements of “consistently produces a product meeting predetermined specifications” and that validation analyses are performed to determine the extent and impact of the change on the system. The comment stated that this is further augmented by the ongoing monitoring of critical control points. The comment requested that, with regard to the requirements of § 106.35, we announce the exercise of enforcement discretion or a formal delay for this provision to align with the compliance date for eligible infant formulas. Nonetheless, with the exception of the compliance date for certain requirements related to quality factors for eligible infant formulas, the final rule adopts a compliance date of September 8, 2014 to facilitate manufacturer compliance with all requirements of this final rule.

(Response) We note that the validation requirement in § 106.35(b)(3) applies to new infant formulas that have not yet been released. As such, manufacturers will not need to conduct a complete system validation for formulas that are already on the market when this rule becomes effective. However, we also note that manufacturers will still need to ensure that all systems are designed, installed, tested, and maintained in a manner that will ensure that they are capable of performing their intended function and of producing and analyzing infant formula in accordance with the CGMP and quality control procedures as required by § 106.35(b). Given that the requirement in § 106.35(b)(3) applies to new infant formulas, complying with the section by the effective date of the rule should not be an issue. We therefore decline the request to announce the exercise of enforcement discretion, a delayed compliance date, or a formal delay for this provision to align with the compliance date for eligible infant formulas.

(Comment 14) One comment noted that § 106.50(a)(2) of the IFR could be interpreted to require a “responsible official” to draft changes to the master manufacturing order and recommended that we delete the term “drafted.”

(Response) Although a responsible official is required to review and approve changes in a master manufacturing order, we agree that persons other than a responsible official could draft changes to a master manufacturing order. Accordingly, we have deleted the word “drafted” from § 106.50(a)(2) in the final rule.

(Comment 15) One comment recommended adding some examples (e.g., physical separation or another system of segregation) to § 106.50(f)(4) to make it consistent with § 106.20(b)(2), which deals with facilities and separation of raw materials, in-process materials and final product. Section 106.50(f)(4) requires, in part, that rejected in-process materials be controlled under a quarantine system designed to prevent the use of the materials in manufacturing or processing operations.

(Response) Section 106.20(b)(2) requires separate areas or another system of separation such as a computerized inventory control, a written card system, or an automated system of segregation for holding raw materials, in-process materials, and final infant formula product after rejection for use in, or as, infant formula. As noted in the IFR, “section 106.40(e) describes the ways a manufacturer may quarantine material that has not been released for use due to failure to meet a specification, or that has been rejected for use in the manufacture of an infant formula” (79 FR 7934 at 7956). As such, we do not believe that adding examples is needed in § 106.50(f)(4) and, therefore, are not making the change recommended in the comment.

(Comment 16) A comment stated that a 95% level of confidence interval means that up to approximately 5% of C. sakazakii -contaminated production aggregates may test negative with FDA's proposed testing scheme and be released to market. The comment said that because thousands of production aggregates are released to market each year, this risk is not inconsiderable. The comment further stated that contamination can occur as clumps and clusters, and this contamination could be missed when the production aggregate is tested. The comment expressed concern that powdered infant formula presents a potential risk to the health of infants of all ages.

(Response) Although we consider the concerns expressed in this comment to be important, the comment appears to mischaracterize the meaning of confidence interval in the quantitative risk analysis. A confidence interval is a range of values in which there is a specified probability that the value of a parameter lies within it. The confidence level does not indicate the percentage of adulterated infant formula that will reach the market.

For purposes of our response, we assume that this comment is referring to the finished product testing required under § 106.55(c). Finished product testing under § 106.55(c) is but one means of assuring the safety of powdered infant formula. The purpose of CGMPs is to have a system that produces products that are consistent in quality and safety and to collectively provide additional safeguards. In the preamble to the IFR, we explained that the sampling plan is intended to help manufacturers identify unacceptable production aggregates at the finished product stage. The sampling plan is a statistical approach based on a quantitative risk analysis and was extensively discussed in the IFR (79 FR 7934 at 7984-7988).

(Comment 17) One comment noted that peer-reviewed articles published after 2011 are not cited and discussed in the IFR and that no articles published after 2011 appear to have been taken into consideration in formulating the IFR. The comment also noted that significant progress has been made in clarifying sources of and risk groups for Cronobacter, particularly C. sakazakii. The comment noted a 2012 publication in the American Association of Pediatrics to support this statement. The comment urged FDA to review publications after 2011, in particular with regard to C. sakazakii.

(Response) Although the IFR did not provide literature citations after 2011, we monitor the scientific literature closely with respect to data and studies that affect infant formula. The comment did not identify, and we are not aware of, any articles published after 2011, including the 2012 publication by Jason cited in the comment, that would have suggested a need to change the IFR's requirements or the requirements of this final rule.

(Comment 18) One comment recommends that the rule clarify that technologies currently used by manufacturers cannot produce a sterile formula but that there are technologies capable of producing a sterile powdered infant formula without damaging the product's nutritional value, if these technologies were applied by manufacturers.

(Response) We discussed in the preamble to the IFR (79 FR 7934 at 7980-7981) the use of technology to eradicate Cronobacter spp. To the extent this comment suggests we mandate which production method to use, we disagree. To a large extent, the IFR, as well as this final rule, gives manufacturers the flexibility to establish controls, specifications, and other operations and does not require the use of specific technologies. Given the pace at which technological changes can occur, we believe this more flexible approach is more practical to address the use of changing technologies and best practices.

(Comment 19) One comment agreed with FDA that audits should be performed by individuals who have as little bias as possible and who do not have a direct interest in the outcome of the audit. The comment also noted that the determination of who satisfies these criteria is largely subjective unless the audit is conducted by a third party, and the comment requested some examples of situations where an audit might be conducted by an individual that is not a third party (e.g., the Head of Quality Assurance auditing a facility) that would be acceptable to FDA.

(Response) As the comment noted, the determination of the objectivity of an in-house employee for performing audits involves subjective as well as objective evaluation of the suitability of the individual for a particular audit. Such assessments must be made on a case-by-case basis. As explained in response to comment 166 in the IFR (79 FR 7934 at 7994), in evaluating whether an audit might be conducted by an individual that is not a third party, the manufacturer should consider factors such as the scope of the employee's previous responsibilities, the time elapsed between the reassignment of the former responsibilities and the audit, and whether the audit will be conducted by this single individual or a team. Therefore, we decline to give examples as requested by the comment.

(Comment 20) One comment stated that infant formula manufacturers should be allowed to rely on a premix supplier's certificate of analysis to provide analytical information on all nutrients in a premix. The comment continued that our proposed rules on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (78 FR 3646 (January 16, 2013)) and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (78 FR 45729 (July 29, 2013)) (part of our implementation of the Food Safety Modernization Act (FSMA)) would require food manufacturers to conduct supplier verification activities with respect to their premix suppliers. The comment predicted that the FSMA-mandated supplier verification requirements will adequately address any potential concerns related to whether nutrient premixes comply with an infant formula manufacturer's specifications and should be taken into account in determining the extent of premix testing that should be required in the IFR.

(Response) We disagree that infant formula manufacturers should be allowed to rely on a premix supplier's certificate of analysis to provide information on the composition of a premix. Section 412(b)(3)(B) of the FD&C Act stipulates that “[e]ach nutrient premix used in the manufacture of an infant formula shall be tested for each relied upon nutrient required by subsection (i) which is contained in such premix to ensure that such premix is in compliance with its specifications or certifications by a premix supplier.” (Emphasis added.) The statutory language makes it clear that a premix manufacturer's certification is not to be relied upon by the manufacturer of the infant formula to establish the analytical composition of a premix. Further, the statute does not allow other options as substitutes for the testing of premixes by infant formula manufacturers. Therefore, we decline to revise § 106.91(a)(1) as suggested by the comment.

(Comment 21) One comment stated that the recipe (the manufacturing order) should be the unit of production used for setting stability testing requirements rather than the production aggregate required by § 106.91(b).

(Response) Under section 412(a) of the FD&C Act, an infant formula that does not provide nutrients as required by section 412(i) is deemed to be adulterated. Section 106.91(b) of the IFR established the production aggregate as the quantity of formula to be used for setting stability testing requirements to provide direct evidence that nutrient levels are maintained throughout the shelf life of all of the product in the marketplace. A requirement to use the recipe (manufacturing order) as the unit of production for setting stability testing requirements, as requested in the comment, could be interpreted to mean that after stability testing was conducted one time on the quantity of formula produced from the recipe, no more stability testing would be required for that formula. Using such a basis for stability testing would not provide evidence that nutrient levels are maintained throughout the shelf life in all formula in the marketplace. Therefore, we are not revising the unit of production to be used for setting stability testing requirements in response to this comment. The production aggregate is the quantity of infant formula from which manufacturers must take a representative sample for the stability testing required by § 106.91(b)(1) and (2) in the final rule.

(Comment 22) One comment asked us to clarify the frequency of stability testing needed for batch processing operations.

(Response) When manufacturers produce their formulas using batch production, they typically manufacture a “batch” during a single cycle of manufacture, which would correspond to what we have defined as the production unit in § 106.3 of the IFR (i.e., a specific quantity of an infant formula produced during a single cycle of manufacture that has uniform composition, character, and quality, within specified limits). The individual “batches” (i.e., production units) are stored in containers (often referred to as totes) until the formula is packaged. Comingling of the individual “batches” (production units) occurs when the contents of the individual storage containers are combined during the packaging process, thereby resulting in a larger quantity of formula that is intended to have uniform composition, character, and quality, consistent with the definition of “production aggregate” in the IFR. The larger quantity of the formula that is comingled and packaged in one packaging run would be considered the production aggregate for manufacturers using batch production. Each such production aggregate would be subject to the stability testing requirements as applicable under § 106.91.

(Comment 23) One comment stated that the requirement to conduct stability testing for every production aggregate of infant formula disregards extensive data from longstanding stability programs and treats each production aggregate as an independent sample.

(Response) FDA appreciates that infant formula manufacturers have been conducting stability testing on their infant formulas since the passage of the Infant Formula Act of 1980 and recognizes that a manufacturer may have extensive stability data for existing products that may be applicable to new infant formulas. We realize the potential value of such data and consider that manufacturers may be able to rely on such data in some instances rather than always conducting the de novo stability testing of new infant formulas required by § 106.91(b)(1). For this reason, and in order to reduce the amount of comprehensive stability testing required for new products, we are providing an exemption in § 106.91(b)(1)(ii) from the testing required by § 106.91(b)(1)(i) in this final rule if the manufacturer of a new infant formula requests an exemption and provides analytical data that demonstrate that the stability of the new infant formula will likely not differ from the stability of non-new formulas with similar composition, processing, and packaging for which there are extensive stability data. Under § 106.91(b)(1)(ii) of the final rule, the manufacturer would request the exemption in the 90-day notification for the new infant formula under § 106.120(b)(7). If the manufacturer is exempted from the testing required by § 106.91(b)(1)(i), the manufacturer would then be required under § 106.91(b)(1)(ii) of the final rule to test the first production aggregate in accordance with the requirements for routine stability testing of all subsequent production aggregates of infant formula under § 106.91(b)(2).

(Comment 24) One comment stated that stability testing of new formulas every 3 months as required by § 106.91(b)(1) of the IFR is unnecessary. The comment contended that an analytical value at an isolated point in time may misrepresent the shelf life of the product as determined through a manufacturer's existing stability programs. The comment also said that the rate of degradation early in shelf life is not relevant to product safety if the product meets nutrient specifications at the end of the shelf life period.

(Response) We agree that an unexpected analytical value at one point in time may not necessarily be predictive of the shelf life of the product. We disagree, however, that the rate of nutrient degradation early in shelf life is irrelevant to product safety. If the product does not meet nutrient specifications at the end of the shelf life period, the knowledge that nutrient degradation is occurring more rapidly than predicted by previous data provides a valuable early indicator that possible action may be required to avoid having an adulterated product in the marketplace. We have further considered the requirement that stability testing of new infant formulas be conducted every 3 months (four times a year) in § 106.91(b)(1) of the IFR and conclude that satisfactory data could still be obtained if the frequency of testing is reduced to every 4 months (3 times a year). Therefore, we have reduced the required frequency of stability testing for new infant formulas to every 4 months in § 106.91(b)(1)(i) of the final rule.

(Comment 25) One comment questioned the benefit in requiring that every production aggregate after the first undergo stability testing, as such requirement would represent a large increase in the number of samples undergoing stability testing on a routine basis. The comment stated this testing requirement would have a significant impact on the industry and questioned the value of such testing. Another comment questioned how measuring nutrients at the midpoint of shelf life will provide additional assurance for formulas for which stability data have been established.

(Response) The purpose of stability testing of subsequent production aggregates for nutrients as required by § 106.91(b)(2) is to confirm that the nutrients present in an infant formula at the finished product stage do not degrade below minimum levels over the shelf life of the product. Every production aggregate must be at or above such minimum levels at the end of the shelf life of the product. The evidence that nutrient levels have been maintained at or above such minimum levels in each production aggregate is provided by the results of stability testing at the end of the shelf life of each production aggregate. This testing requirement will provide direct evidence that nutrient levels are maintained throughout the shelf life of infant formula products. We agree that the critical data are the nutrient levels present at the end of shelf life and that the midpoint data are not essential in subsequent production aggregates. Therefore, we have deleted the requirement to conduct stability testing at the midpoint of the shelf life for infant formulas tested under § 106.91(b)(2).

(Comment 26) One comment stated that routine stability testing should not include analysis of nutrients that are not labile (i.e., easily broken down). The comment recommended that we limit routine stability testing to reliable indicator nutrients and supplement such testing with periodic comprehensive testing.

(Response) We do not agree that the routine stability testing required at the end of shelf life under § 106.91(b)(2) should include only labile nutrients or that the purpose of stability testing would be met by the comment's suggested approach. It is essential to have proof that all nutrients, including those that deteriorate more slowly, are present at or above the minimum required levels at the end of shelf life to demonstrate that the product is not adulterated. We note, however, that § 106.91(b)(5) waives evaluation of the levels of minerals from the testing required by § 106.91(b)(1) and (2) because these nutrients do not degrade in infant formula. We decline to revise the final rule in response to this comment.

(Comment 27) One comment stated that the requirements of § 106.91(b)(3) are too prescriptive and pointed out that market withdrawal of the product was another option. The comment further stated that the manufacturer should be allowed to determine the disposition of a product that does not maintain its required nutrient levels throughout shelf life and recommended that § 106.91(b)(3) be deleted.

(Response) We made an inadvertent error in the language of § 106.91(b)(3) by including the words “shelf life label statement.” We intended that manufacturers would have the option of making changes to the “use by” date, not the “shelf life label statement,” if the stability data from the testing required by § 106.91(b)(1) did not substantiate the anticipated shelf life of the formula. We have revised § 106.91(b)(3) accordingly.

We realize that there may be some situations when manufacturers may find that actions other than those provided for in § 106.91(b)(3) in the IFR may be appropriate when the stability testing of a new infant formula required by § 106.91(b)(1) does not substantiate the shelf life of the formula. Consequently, we have revised § 106.91(b)(3) of the final rule to clarify our intent that manufacturers have the option to adjust the “use by” date so that such date is substantiated if the stability data from the testing required by § 106.91(b)(1) did not substantiate the anticipated shelf life of the formula. FDA also is providing flexibility for manufacturers to take other appropriate actions in § 106.91(b)(3)—other than conducting the testing required by § 106.91(b)(1) or adjusting the “use by” date—when stability testing does not substantiate the shelf life of the formula. We also are clarifying in § 106.91(b)(3) that the manufacturer must address all production aggregates released and pending release for distribution that are implicated by the testing results.

We also are making a conforming change to § 106.91(b)(4)(iii) to clarify that manufacturers must address all production aggregates released and pending release for distribution that are implicated by testing results required by § 106.91(b)(2) that show that any required nutrient is not present in the production aggregate of infant formula at the level required by § 107.100 or that any nutrient added by the manufacturer is not present at the level declared on the labels for the finished products from the production aggregate of infant formula.

(Comment 28) One comment stated that FDA should give further consideration to periodic testing as a complement to stability testing rather than requiring stability testing of each production aggregate. The comment also requested that we change the requirement of the IFR to require that the manufacturer collect representative samples of formulas every 3 months for stability testing.

(Response) We considered whether to require periodic testing in establishing the requirements for quality control procedures in the IFR. However, we concluded that periodic testing was not necessary because the testing required by § 106.91(a) of the IFR “can serve as final product testing of each production aggregate and also fulfill the purpose of periodic testing by serving as a check on the proper operation of the controls used by a manufacturer to ensure the presence and proper concentration of all nutrients” (79 FR 7934 at 7993). Adding a requirement for periodic testing would result in unnecessary testing. Further, periodic testing (e.g., testing representative samples of formula every 3 months) would not provide sufficient evidence that nutrient levels in each production aggregate are being maintained. As stated in the response to comment 25, the purpose of routine stability testing for nutrients is to confirm that the nutrients present in an infant formula at the finished product stage do not degrade below minimum levels over the shelf life of the product. Every production aggregate must be at or above such minimum levels at the end of the shelf life of the product. Implementation of the approach requested in the comment would not provide evidence that nutrient levels have been maintained at or above such minimum levels in each production aggregate. Therefore, we are not making either of the changes requested by this comment.

(Comment 29) One comment stated that the requirement in § 106.91(b) to do stability testing on every production aggregate is overly burdensome and unnecessary. The comment stated that this requirement would generate redundant data and would add considerable costs for formulas.

(Response) We note that under § 106.91(a)(4), manufacturers must test every production aggregate of finished infant formula for all nutrients required by § 107.100 and any other nutrient added by the manufacturer before distribution of the product. Testing at this point is already mandated by section 412(b)(2)(B)(i) of the FD&C Act, and the results of this testing can also serve as the initial stability data. Under the final rule, manufacturers must also conduct stability testing on each subsequent production aggregate only at the end of shelf life. In addition, we are providing for an exemption in § 106.91(b)(1)(ii) from the comprehensive stability testing required for new infant formulas by § 106.91(b)(1)(i) if a manufacturer of a new infant formula requests an exemption and provides analytical data that demonstrate that the stability of the new infant formula will likely not differ from the stability of non-new formulas with similar composition, processing and packaging for which there exist extensive stability data.

As such, we do not consider that a requirement for testing of every production aggregate generates redundant data. Each production aggregate is produced independently and verification is needed that an infant formula is not adulterated when it reaches the end of its shelf life as well as at the time of production. Because infant formula serves as the sole source of nutrition for infants, we disagree that such a requirement is overly burdensome or unnecessary.

(Comment 30) One comment stated that the testing required in § 106.91(a)(4) and (b)(1) is limited to the nutrients in § 107.100 because section 412(b)(3)(D) of the FD&C Act specifies that if the Secretary adds a nutrient to the list of nutrients provided in section 412(i) of the FD&C Act, the Secretary shall by regulation require that the manufacturer of an infant formula test each batch of such formula for such new nutrient in accordance with subparagraphs (A), (B), and (C) of section 412(b)(3) of the FD&C Act. The comment argued that section 412(b)(3)(D) of the FD&C Act means that if FDA has not deemed the nutrient to be essential by requiring its addition to infant formula, then testing for the nutrient is also not essential.

(Response) To the extent this comment asserts that we intended to limit the testing required in § 106.91(a)(4) and (b)(1) to those nutrients specified in § 107.100, we disagree. We discuss this issue in detail in our response to comment 173 in the preamble to the IFR (79 FR 7934 at 7996). To the extent this comment suggests that we lack the authority to impose testing requirements on nutrients other than those specified in § 107.100, we also disagree. The statutory language in section 412(b)(3)(D) of the FD&C Act is not our sole authority to establish requirements for nutrient testing. As explained in the IFR, testing for nutrients not required under § 107.100 in each production aggregate of infant formula is consistent with CGMP and quality control procedures that must be established by section 412(b)(2)(A) of the FD&C Act. The preamble to the 1996 proposal explained why testing for these added nutrients is necessary for proper formulation of a formula as follows: “[I]t is important that the level of these added nutrients be controlled, and that the level of the added nutrient be consistent from batch to batch [production aggregate to production aggregate] and be uniform throughout the batch [production aggregate] of infant formula. The level of a nutrient needs to be controlled because some nutrients can be toxic to an infant if given at too high a level. Controlling the level of the added nutrient for consistency from batch to batch [production aggregate to production aggregate] and in a particular batch [production aggregate] of infant formula will ensure that the infant receives the essential nutrient on a consistent basis and will also ensure that the infant does not receive too high, or too low, a level of the nutrient because the nutrient was not uniform through the batch [production aggregate] of infant formula” (61 FR 36154 at 36176).

(Comment 31) One comment stated that compliance with § 106.91 by the effective date of the IFR cannot realistically be achieved and requested that we announce and exercise enforcement discretion, delay the compliance date, or formally delay the provisions of § 106.91 to align with the compliance date for eligible infant formula. The comment asserted that the requirements of § 106.91 are burdensome but did not provide specific information about why compliance with § 106.91 by the effective date of the IFR would be impractical.

(Response) As discussed in our responses to other comments relating to § 106.91, we are taking some steps in this final rule to increase flexibility and lessen the burden of some of the requirements in § 106.91. This increased flexibility should address any concerns about complying with § 106.91 by the effective date of this rule. Therefore, we are rejecting the request to announce and exercise enforcement discretion or formally delay the provisions of § 106.91 to align with the compliance date for eligible infant formula. Nonetheless, with the exception of the compliance date for certain requirements related to quality factors for eligible infant formulas, the final rule adopts a compliance date of September 8, 2014 to facilitate manufacturer compliance with all requirements of this final rule.

(Comment 32) One comment stated that FDA's expansion of the definition of “Quality Factors” in the IFR to require a growth monitoring study on the “bioavailability” of an infant formula as a whole was not consistent with current scientific knowledge, as specified in section 412(b)(1) of the FD&C Act. The comment included an extended discussion of current scientific knowledge of the effects of specific nutrients on infant growth and alternative methods for evaluating infant formulas, such as animal studies.

(Response) The preamble to the IFR (see 79 FR 7934 at 7951-7952) explored the concept of healthy growth and explained why normal physical growth as a quality factor is not flawed. As that discussion indicates, infant growth is steady and predicable, and physical growth and normal maturation should occur together. If the infant formula does not have all the nutrients needed by an infant in a form that is bioavailable, the infant will not grow. Monitoring of physical growth of infants has long been recognized as an indicator of healthy growth. For example, the 1980 report of the Committee on Nutrition of the American Academy of Pediatrics cited in the IFR stated that “growth of infants during the first few months of life is a determining factor for the pattern of development and quality of health in adult life” (79 FR 7934 at 7951), thereby recognizing the critical nature of this period of unparalleled growth. More recently, the 2004 report of the Institute of Medicine of the National Academy of Sciences concluded that “Growth is well recognized as a sensitive, but nonspecific indicator of the overall health and nutritional status of an infant” (79 FR 7934 at 8006).

In the preamble to the IFR, we stated that “the least invasive and most practical means to ensure that the formula, as a whole, delivers nutrients in a form that is bioavailable and safe is a growth monitoring study in which anthropometric measurements of infants fed a new infant formula are assessed (79 FR 7934 at 8008). Assessments described in the comment would require invasive procedures that would increase the level of risk associated with a human study of an infant formula applying such measures. The information provided in the comment also suggested that the evaluation of an infant formula should be accomplished by studying animals. We understand that animal studies can be very useful in determining the bioavailability of nutrients and establishing the safety of ingredients, as well as exploring metabolic pathways. However, as we concluded in the IFR, FDA is not aware of an animal model that is a suitable substitute for the infants in a growth monitoring study (79 FR 7934 at 8008), and the information provided in the comment did not discuss this issue. Therefore, we are maintaining the requirement to conduct a growth monitoring study in this final rule.

(Comment 33) One comment noted that the IFR identified two quality factors, normal physical growth and sufficient biological quality of the formula's protein component. The comment interpreted the IFR to mean that of the many different functional requirements, the only one to be assessed for infant formula is its efficacy in leading to adequate physical growth in the short term, and if the infant leads to adequate growth over a period of fifteen weeks, the infant formula is of good quality. The comment also stated that it should not be suggested that quality on a single dimension is sufficient when an infant must perform well on many different dimensions, and it is misleading to suggest that a short-term measure of infants' physical growth can reasonably be viewed as a measure of the overall quality of infant formula.

(Response) The quality factor requirements are meant to provide the assurance that, when fed as the sole source of nutrition, the infant formula in its entirety will support healthy growth. We understand that the quality factors of normal physical growth and sufficient biological quality of the formula's protein component have limitations and that there are other “dimensions” that are relevant to infant formula. The preamble to the IFR (79 FR 7934 at 7953) discussed the limitations of both quality factors, as demonstrated by the growth study and the PER. Although we are aware of these limitations, at this time other methods are not available or are impracticable. As discussed in the IFR, FDA will consider amending the quality factor regulations as new methodology and appropriate reference criteria become available (79 FR 7934 at 7950).

(Comment 34) One comment requested that we revise the designation of normal physical growth to limit the quality factor to changes in formulations that may have an effect on growth. The comment noted that § 106.96(b) sets the default requirement of a growth monitoring study (GMS) for all new formulas. The comment continued that although § 106.96(c) provides exemptions from the requirements of paragraph § 106.96(b) under three conditions, the condition set forth in § 106.96(c)(2)(ii)—that the change from the existing formula does not affect the bioavailability of the formula or bioavailability of nutrients in the formula—is circular because FDA defined the quality factor as normal physical growth, not as bioavailability of the nutrients in the formula. The comments stated that the exemption from the GMS requirement should be provided when there is evidence that a change to the infant formula would not affect physical growth. The comment stated that neither bioavailability of the infant formula nor the nutrients in the formula is directly measured in the GMS. The comment concluded that to require a GMS across all new formulas even when it is known that measurement of physical growth will not be able to detect inadequacies of many nutrients risks the institutionalization of an insensitive, unreliable measure of formula quality that does nothing to ensure the health of formula-fed infants.

(Response) FDA agrees that the exemption from the GMS study should be provided when a change to an existing infant formula would not affect the ability of the formula to support physical growth specifically, instead of when the change to the formula does not affect bioavailability. We agree that bioavailability of individual nutrients is not directly measured in the GMS. We understand that every formulation change may not need a GMS and clearly indicated in the preamble to the IFR that a GMS “may not be necessary to demonstrate normal physical growth for every new infant formula, including a change to a marketed formula that results in a new infant formula” (79 FR 7934 at 8005). We are revising the exemption in § 106.96(c)(2)(ii) so that it applies when a change to an existing infant formula would not affect the ability of the formula to support normal physical growth, and are also making conforming changes to the notification requirements in § 106.121(d).

(Comment 35) Two comments urged us to provide greater detail for studies supporting quality factors, particularly in areas of the size and representativeness of the population of infants studied. The comments requested that we develop additional guidance beyond what was published in February 2014 regarding the structure and methodology that should be used in the studies.

(Response) The preamble to the IFR provided a basis for structuring and conducting an adequate and well-controlled growth monitoring study to demonstrate that a new infant formula supports normal physical growth in infants when fed as the sole source of nutrition (79 FR 7934 at 8007-8021). This information provided the scientific basis for how a growth monitoring study should be designed and methodological concerns that included sample size considerations. We would consider future development of additional guidance to expand upon the information in the preamble of the IFR regarding conduct of a growth monitoring study. We are satisfied, however, that the standards set forth in the preamble to the IFR provide sufficient guidance with which to conduct adequate and well-controlled growth monitoring studies.

(Comment 36) One comment expressed concern regarding the voluntary citizen petition process by which manufacturers of eligible infant formula can provide to FDA the basis on which they have concluded that their eligible infant formulas satisfy the quality factors for physical growth and/or protein efficiency ratio (PER). The comment stated that the citizen petition option under § 106.96(i)(3) for eligible infant formulas would make information public to competitors, consumers, and others. The comment continued that it would be difficult for a manufacturer not to submit a citizen petition because there would be a public expectation that the manufacturers do so. The comment further stated that formulas on the market have been through FDA review and have had to satisfy all the requirements of the Infant Formula Act and subsequent amendments. The comment stated that if there is any additional information that the Agency feels is needed from manufacturers, the Agency should include such details in the new notification requirements in the provisions of § 106.120 and § 106.121, consistent with good administrative procedures for notice and comment. The comment requested clarification of the reasons an additional process was created and how manufacturers would receive a response from FDA. The comment also expressed concern about the manufacturers' ability to submit petitions for each formula by the November 2015 compliance date. The comment noted that because the citizen petition is a voluntary process, it provides no assurance that the Agency will obtain any outstanding information the Agency requires. The comment concluded that the citizen petition process is not necessary, is redundant, and provides no additional benefit to the Agency, the manufacturer, or the public, and that § 106.96(i)(3) should be deleted.

(Response) We disagree that § 106.96(i)(3) should be removed. The preamble to the IFR described the basis for the voluntary citizen petition process and further explained that all formulas, new or not new (i.e., currently marketed products), must meet the quality factors requirements (79 FR 7934 at 8028). We reiterate that the citizen petition process under § 106.96(i)(3) is voluntary and transparent; however, meeting the quality factor requirements is not voluntary. Meeting the quality factor requirements is mandatory under section 412(a)(2) of the FD&C Act, and an infant formula that does not meet quality factor requirements is an adulterated product.

We consider the citizen petition process to be a beneficial opportunity for the manufacturer of an eligible infant formula to describe how the quality factors have been met before the compliance date for eligible infant formulas (79 FR 7934 at 8005). We described in further detail in an accompanying draft guidance document how the process works, including information about how FDA will respond to petitioners. Additionally, we indicated that we are available to meet with manufacturers and discuss their particular concerns regarding the citizen petition process. We note that FDA will protect the confidentiality of information submitted through the citizen petition process in accordance with the Freedom of Information Act (5 U.S.C. 552) and FDA's regulations (see, e.g., 21 CFR 20.61). In addition, we are providing more detailed information regarding the process for submitting a citizen petition to meet the quality factor requirements for eligible infant formulas in a guidance document posted on FDA's Web site at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm400036.htm. However, we also note that because the citizen petition process is voluntary, we would not consider the absence of such a petition negatively. Finally, we note that new infant formula notifications submitted prior to the compliance date of September 8, 2014 would not necessarily have demonstrated satisfaction of the quality factor requirements in this final rule. As such, we disagree that providing this voluntary opportunity to describe how the quality factors have been met is redundant.

(Comment 37) One comment requested that additional language be added to § 106.96(f) regarding the methodology required to determine the biological protein quality. The comment suggested the addition of the phrase “or by other appropriate method(s)” be added to § 106.96(f) and § 106.96(i)(2)(ii). The comment continued that by incorporating this change of language into the final rule, there would be an opportunity for the use of other scientifically valid methods for determining protein quality beyond what exists currently and for the possibility of other methods that may be developed in the future.

(Response) FDA acknowledges that currently and in the future there may be other methods that could be used for determining protein quality. To address this issue, we added an exemption to § 106.96(g)(3) to allow manufacturers of new infant formulas to use alternative methods based on sound scientific principles to demonstrate protein quality. FDA is also adding language to § 106.121(i) of this final rule, consistent with this change, to explain the information that must be included in a new infant formula notification if the manufacturer is requesting this exemption.

(Comment 38) Several comments understood the protein efficiency ratio (PER) to be a quality factor and indicated this was not an appropriate quality factor.

(Response) We note that the comments have misidentified the quality factor as the PER. The quality factor is the biological quality of the protein, and the PER is a method used to assure such quality.

(Comment 39) One comment stated that the term “immediate” is unclear in § 106.100(m). Section 106.100(m) of the IFR described various means of recordkeeping and stated, in relevant part, that the records are to be maintained in a manner that ensures that both the manufacturer and FDA can be provided with “immediate access” to the records. The comment would revise § 106.100(m) by replacing “immediate” with “within 24 hours” to be consistent with records access in § 106.100(k)(5)(v).

(Response) We agree that access to records within 24 hours is reasonable and have revised the wording in § 106.100(m) in the final rule to require access within 24 hours.

In addition to the changes we are making in response to the comments, we are making minor technical corrections to § 106.96(c)(1) and (g) to provide more specific cross references to other provisions of the rule. Also, consistent with our discussion in the IFR explaining our decision to use the terms “production unit” and “production aggregate” instead of “batch” and “lot” (79 FR 7934 at 7942-7944), we are eliminating the use of the words “batch” and lot” in § 106.100(f)(4), (k)(5)(ii), and (o) to ensure consistency with the terminology used elsewhere in the IFR and final rule. Finally, we are deleting an unnecessary reference to § 106.3 from what was § 106.91(b)(1) in the IFR, which has been redesignated as § 106.91(b)(1)(i) in this final rule.

On February 10, 2014, FDA issued an IFR amending certain requirements in the regulation on the current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula (79 FR 7934). The Economic Impact Analysis in the IFR explained and further revised the analysis set forth in the proposed rule by addressing the economic impact of the changes to the regulations at parts 106 and 107. We did not receive any comments that would warrant further revising the economic analysis of the IFR.

FDA has examined the impacts of this final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that the final rule is not a significant regulatory action under Executive Orders 12866 and 13563.

The Regulatory Flexibility Act requires Agencies to determine whether a final rule will have a significant impact on small entities when an Agency issues a final rule “after being required . . . to publish a general notice of proposed rulemaking.” We certify that this final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $141 million, using the most current (2013) Implicit Price Deflator for the Gross Domestic Product. We do not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

Thus, this economic analysis affirms the economic impact analysis of the IFR. For a full explanation of the economic impact analysis of this final rule, we direct interested persons to the text of the economic impact analyses in the IFR (79 FR 7934, February 10, 2014, Ref. 92). The analyses that we have performed to examine the impacts of this final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of 1995 are included in the RIA for the final rule (Ref. 1).

A regulatory flexibility analysis is required only when an Agency must publish a notice of proposed rulemaking (5 U.S.C. 603, 604). FDA published the IFR after publishing a notice of proposed rulemaking in 1996 (61 FR 36154; July 9, 1996) and reopening of the comment period in 2003 (68 FR 22341; April 28, 2003) and 2006 (71 FR 43392; August 1, 2006). We have conducted such an analysis and examined the economic implications of this final rule on small entities. This final rule is not a significant regulatory action as defined by Executive Order 12866. FDA also certifies that this final rule will not have a significant impact on a substantial number of small entities.

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions with estimates of the annual reporting, recordkeeping, and third-party disclosure burden are included in the RIA in section IV, entitled “Paperwork Reduction Act of 1995” (Ref. 1). 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.

We had included a section titled “Paperwork Reduction Act of 1995” in the preamble to the IFR (79 FR 7934 at 8055-8056). Any comments on our analysis of the burdens presented in that section were submitted to OMB. We will not address these comments in this document. We are resubmitting the information collection provisions of this final rule to OMB because the final rule provides additional modifications and clarifications to 21 CFR part 106.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted the information collection provisions of this final rule to OMB for review. Interested persons are requested to submit comments regarding information collection to OMB (see DATES and ADDRESSES ).

We will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. 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.

We have carefully considered the potential environmental effects of this action. FDA has concluded under 21 CFR 25.30(j) and 25.32(n) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

The following reference has been placed on display in the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

Accordingly, the interim final rule amending 21 CFR parts 106 and 107, which was published at 79 FR 7933 on February 10, 2014, is adopted as a final rule with the following changes:

Table of Contents I. Introduction A. The Proposed Rule B. Changes to the Proposed Rule II. Summary of the Final Rule A. Electronic Submission of Postmarketing Safety Reports B. Safety Reports Not Covered by the Final Rule C. Waivers D. Individual Case Safety Report (ICSR)—Definition and Required Information E. Removal of Paper Format Provisions F. Section 745A of the FD&C Act and Electronic Format for Submissions G. Miscellaneous Changes III. Comments on the Proposed Rule A. Safety Reports Covered B. FDA Web-Based Submission Portal C. Waivers D. ICSR Submissions E. International Harmonization F. Technical Specifications IV. Legal Authority V. Environmental Impact VI. Analysis of Impacts VII. Paperwork Reduction Act of 1995 A. Reporting Costs B. Capital Costs VIII. Federalism IX. Reference I. Introduction

In the Federal Register of August 21, 2009 (74 FR 42184), FDA published a proposed rule to require that persons subject to mandatory postmarketing safety reporting requirements for human drug or biological products submit safety reports in an electronic format that the Agency can process, review, and archive.

When a drug or biological product is approved and enters the market, the product is introduced to a larger patient population in settings different from clinical trials. New information generated during the postmarketing period offers further insight into the benefits and risks of the product, and evaluation of this information is important to ensure the safe use of these products.

FDA receives information regarding postmarketing adverse drug experiences  1 from safety reports submitted to the Agency. For nearly 35 years, FDA has received these postmarketing safety reports on paper. Since 2001, many companies have voluntarily submitted reports for drug and nonvaccine biological products to the Agency in electronic format. Data from both the electronic and paper reports are entered into the FDA Adverse Event Reporting System (FAERS) database. FAERS is a computerized information database designed to support FDA's postmarketing safety surveillance program for drug and nonvaccine biological products. The FAERS database is used to store and analyze data received in postmarketing safety reports. Safety reporting data submitted on paper is first converted into an electronic format before being entered into FAERS. 2 In September 2012, the FAERS database replaced the previously used Adverse Event Reporting System (AERS) database described in the preamble to the proposed rule (74 FR 42184 at 42185). The transition to the FAERS database has been an important step in improving FDA's postmarketing surveillance capabilities. FAERS supports greater functionality and more sophisticated pharmacovigilance tools that enhance FDA's ability to analyze safety information.

The proposed rule proposed that use of an electronic format be mandatory for the submission of all required postmarketing safety reports for human drug and biological products, including vaccines, 3 a change to improve the Agency's systems for collecting and analyzing these reports.

In the preamble to the proposed rule (74 FR 42184 at 42187 to 42189), we set forth in detail the rationale for requiring electronic submission of postmarketing safety reports. Receiving postmarketing safety reports in electronic format will expedite access to safety information and facilitate international harmonization and exchange of this information. This, in turn, will lead to more efficient reviews of safety data and will enhance our ability to rapidly disseminate safety information to health care providers, consumers, applicants, sponsors, and other regulatory authorities in support of FDA's public health mission. In addition, the Agency will recognize a significant cost savings by converting the safety reporting system from a paper submission process to a predominantly all-electronic system that will increase the accuracy of information and reduce the need for manual data entry. We also believe this change will benefit industry by eliminating time and costs associated with submitting paper reports.

In the proposed rule, FDA proposed revising §§ 310.305, 314.80, 314.98, and 600.80 (21 CFR 310.305, 314.80, 314.98, and 600.80) to require that manufacturers, packers, and distributors, and applicants with approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs), and those that market prescription drugs for human use without an approved application, submit postmarketing safety reports (i.e., individual case safety reports (ICSRs) and any ICSR attachments) to the Agency in an electronic format that FDA can process, review, and archive. We stated that the proposal would apply to all postmarketing safety reports required to be submitted to FDA under §§ 310.305, 314.80, 314.98, and 600.80 (including vaccines) and would apply to any new postmarketing safety reports for drug or biological products implemented in the future. (The preamble to the proposed rule (74 FR 42184 at 42185 to 42186) describes current postmarketing safety reporting requirements.) We also proposed revising § 600.81 (21 CFR 600.81) to require the electronic submission of biological lot distribution reports.

The preamble to the proposed rule (74 FR 42184 at 42186 to 42187) also discussed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462), enacted on December 22, 2006, which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to create a new section 760 (21 U.S.C. 379aa), entitled “Serious Adverse Event Reporting for Nonprescription Drugs.” As noted in the preamble, section 760 of the FD&C Act requires manufacturers, packers, or distributors whose name appears on the label of nonprescription (over-the-counter or OTC) human drug products marketed without an approved application to report to FDA serious adverse events associated with their products. It does not apply to OTC drug products marketed under applications approved under section 505 of the FD&C Act (21 U.S.C. 355), which are subject to the reporting requirements under § 314.80, as are all other drugs marketed under approved NDAs or ANDAs. 4 The requirement went into effect in December 2007, and to assist entities in complying with the requirements, FDA issued a guidance for industry entitled “Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application” (available on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm). In the preamble to the proposed rule, we requested comment on whether to require the electronic submission of postmarketing safety reports required by section 760 of the FD&C Act (referred to in this document as section 760 reports). We noted that our decision would be informed by public comments received and our experience with the submission of these reports to date.

The proposed rule stated that FDA would periodically issue guidance on how to provide the electronic submissions (e.g., method of transmission, media, file formats, preparation, and organization of files). Currently, technical specifications referenced in guidance documents rely upon and adopt certain safety reporting and transmission standards recommended by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH was formed to facilitate the harmonization of technical requirements for the registration of pharmaceutical products among the three ICH regions: The European Union (EU), Japan, and the United States. The proposal reaffirmed our intention to continue to rely on ICH standards while also providing other options for providing electronic submissions to FDA.

In the preamble to the proposed rule, we explained that applicants, manufacturers, packers, and distributors had been voluntarily submitting postmarketing safety reports for drugs and nonvaccine biological products in electronic format by sending the reports to FDA either through FDA's Electronic Submission Gateway (ESG) or on physical media (e.g., CD-ROM (sent by mail). 5 The ESG is the central transmission point for sending information electronically to FDA. Among other things, the ESG allows ICH-compatible postmarketing safety report submissions to be transmitted directly from the company's database to FDA. 6 The direct database-to-database submissions may include ICSRs, any ICSR attachments, and descriptive information. Once received through the ESG, the ICSRs for drug and nonvaccine biological products are downloaded into the FAERS database. FDA has encouraged electronic submission of ICSRs because it is a cost-effective and efficient alternative to paper-based reporting, particularly for companies submitting large numbers of ICSRs. In addition, electronic submission of ICSRs enhances global pharmacovigilance by facilitating electronic transmission and exchange of appropriate information from ICSRs among regulatory bodies and regulated entities through use of common data elements and transmission standards.

In the preamble to the proposed rule, we also explained that we are developing a “Web-based submission portal” to collect and process safety information for FDA-regulated products. We anticipated that the Web-based submission portal would allow the secure electronic submission of postmarketing ICSRs directly into FDA's FAERS database once information was entered into a “Web-based electronic form.” We stated that the Web-based submission portal would allow submission of ICSRs consistent with ICH standards and could be used as an alternative method for reporting adverse drug experiences to FDA electronically. We noted that the Web-based system would be particularly useful for entities that submit a small number of safety reports because it would create a simpler and more efficient mechanism for reporting that would not require an internal database that is compatible with the ICH-based direct transmission system. (See section II.A for further discussion of the Web-based submission portal.)

Because in certain rare circumstances electronic submission of safety reports may not be feasible, we proposed (in §§ 310.305(e)(2), 314.80(g)(2), and 600.80(g)(2)) to allow for the submission of requests for a temporary waiver from the electronic format requirement and stated that waivers would be granted on a limited basis for good cause shown. We requested comments on circumstances under which a waiver should be granted. We stated that guidance would be issued describing the procedures for submitting a waiver request. Elsewhere in this issue of the Federal Register , we are announcing the availability of a draft guidance entitled “Providing Submissions in Electronic Format—Postmarketing Safety Reports” (the postmarketing safety reports guidance) (available on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ). It is intended to assist persons required to submit postmarketing safety reports in complying with the final rule. In addition, the draft guidance addresses procedures for submitting waiver requests and other information.

We proposed to delete the specific references to paper reporting forms in §§ 310.305, 314.80, and 600.80. Because the paper reporting forms would no longer be used, we proposed to add a list of the reportable elements to proposed §§ 310.305(d), 314.80(f), and 600.80(f). The list of reportable elements in the proposed rule was derived from the elements included in Form FDA 3500A, the paper reporting form. Moreover, the obligation to provide all applicable information described in the proposed rule would be the same as the obligation to complete Form FDA 3500A and VAERS-1. To facilitate the shift away from the paper reporting forms, we also proposed to adopt a generic term for the safety reporting vehicle: Individual case safety report (ICSR). Proposed §§ 310.305(b) and 314.80(a) define an ICSR as “a description of an adverse drug experience related to an individual patient or subject.” Proposed § 600.80(a) defines ICSR as “a description of an adverse experience related to an individual patient or subject.”

We received seven submissions containing comments on the proposed rule. Several commenters expressed support for requiring electronic submission of postmarketing safety reports, agreeing that it would help FDA to more rapidly review safety reports and identify emerging safety issues. Two commenters also expressed support for requiring the electronic submission of safety reports required by section 760 of the FD&C Act; no commenters opposed this requirement for the section 760 reports. Commenters also requested clarification of certain terms and requirements in the proposed rule. We address all of the comments in greater detail in section III.

After considering the comments and based on our experience with postmarketing safety reporting, we have concluded that certain revisions to the proposed rule are appropriate. However, we note that the provisions applicable to safety reporting under §§ 310.305, 314.80, and 600.80 are largely unchanged from the proposed rule.

We have concluded that the electronic submission requirement should extend to safety reports required by section 760 of the FD&C Act. Therefore, the final rule adds part 329 (21 CFR part 329), entitled “Nonprescription Human Drug Products Subject to Section 760 of the Federal Food, Drug, and Cosmetic Act” to chapter 21 of the Code of Federal Regulations to address the safety reporting requirements of section 760 of the FD&C Act described in section I.A. This addition responds to the two comments received on this issue, both of which supported requiring the electronic submission of section 760 reports. It also reflects FDA's determination that the electronic submission requirement should extend to these safety reports in furtherance of FDA's goal to more quickly review postmarketing safety reports and identify emerging safety issues.

The final rule adds new § 329.100 to require the electronic submission of section 760 reports. Section 329.100(a) states that safety reports required by section 760 of the FD&C Act must be submitted to FDA in electronic format. Section 329.100(b) explains that for purposes of safety reporting under section 760, an ICSR constitutes the “MedWatch Form” (the common name for Form FDA 3500A) required to be submitted in section 760(d) of the FD&C Act, and sets forth the elements that are reported in an ICSR under section 760. As noted previously in this document and in the preamble to the proposed rule, we have adopted the term “individual case safety report” (ICSR) because we will no longer be using the paper reporting forms for mandatory postmarketing safety reporting. New § 329.100(c)(1) states that the submissions must be in an electronic format that FDA can process, review, and archive; § 329.100(c)(2) provides for a good-cause waiver; and § 329.100(d) addresses patient privacy. All of these provisions are analogous to the provisions in this final rule for reports submitted under §§ 310.305, 314.80, and 600.80.

The final rule revises the proposed provisions entitled “Patient privacy” (in final §§ 310.305(f), 314.80(i), and 600.80(j)) to state, “the applicant should assign a unique code for identification of the patient.”  7 This addresses a comment expressing concern that the proposed rule was confusing because it used two different terms to refer to the code that must be assigned to protect patient privacy. Section 329.100(d) uses the revised language.

On our own initiative, we have made revisions that are described as follows. The final rule adds a definition for the term “ICSR attachments” to §§ 310.305(b), 314.80(a), and 600.80(a). In §§ 310.305(b) and 314.80(a), ICSR attachments are defined as “documents related to the adverse drug experience described in an ICSR, such as medical records, hospital discharge summaries, or other documentation.” In § 600.80(a), ICSR attachments are defined as “documents related to the adverse experience described in an ICSR, such as medical records, hospital discharge summaries, or other documentation.”

The final rule revises the proposed provisions addressing waivers in proposed §§ 310.305(e)(2), 314.80(g)(2), and 600.80(g)(2). The final rule deletes the statement that if the Agency grants a waiver, the person who requested the waiver must submit the required reports on paper within the required time periods and that FDA intends to issue guidance on how to provide the paper submission. This statement has been deleted so that the rule does not specify that safety reports that cannot be submitted in electronic format must be submitted on paper. We recognize that alternate formats for safety reports, other than paper, such as email or fax, may be appropriate when a waiver of the electronic submission requirement is granted. We will specify an acceptable alternate format at the time the waiver is granted. The final rule also modifies the language indicating that procedures for how to request waivers will be set forth in guidance. The proposed rule stated, “Procedures for how to request waivers of this requirement will be set forth in guidance.” The final rule states, “FDA will issue guidance on requesting a waiver of the requirements [for electronic submission].” We have made this change to indicate that the guidance addressing waivers may include information on other aspects of the waiver provision, such as circumstances under which FDA may grant waivers, not just the procedures for how to request waivers. (The waiver provision for biological products has been finalized in § 600.80(h)(2).) Section 329.100(c)(2), applicable to section 760 reports for nonprescription products marketed without an approved application, contains this revised language on waivers. It is important to note that the waiver referred to in the final rule (as in the proposed rule) pertains only to the electronic format requirements. It is not a waiver from the underlying safety reporting requirement.

On our own initiative, we have made additional changes to the provisions addressing patient privacy. The proposed provisions entitled “Patient privacy” (in proposed §§ 310.305(f), 314.80(i), and 600.80(i)) state that the preferred methodology for determining the identification code will be set forth in guidance. FDA does not believe that it is necessary to identify specific elements in the final rule for which we will be providing technical guidance or specifications. FDA currently provides and will continue to provide technical guidance and specifications for many different aspects of electronic ICSR submission. Accordingly, we are deleting that language from final §§ 310.305(f), 314.80(i), and 600.80(j). However, for drug and nonvaccine biological products, we recommend that no identifying information, such as initials or birthdate, be used as part of the patient identification code. At the same time, under new § 600.80(g), ICSRs for vaccine products will continue to include the patient's name.

In the patient privacy provisions, we proposed that the name of the reporter not be included when the reporter is also the patient. The proposed provision stated that the submitter should include the name of the reporter from whom the information was received, unless the reporter is the patient. FDA is not finalizing the proposal because we have concluded that those submitting mandatory safety reports should include the name of the reporter (in the reporter section of the ICSR), even when the reporter is the patient. It is important for FDA to have the name of the reporter so that we may contact the reporter, if necessary, to obtain followup information about the adverse event reported. To make clear that the name of the reporter should be provided (in the initial reporter information section of the ICSR), even when the reporter is the patient, we are amending the patient privacy provisions in the final rule to state, “the [submitter] should include the name of the reporter from whom the information was received as part of the initial reporter information, even when the reporter is the patient” (§§ 310.305(f), 314.80(i), 329.100(d), and 600.80(j)). FDA regulations prohibit the release of the names of patients, health care professionals, hospitals, and geographical identifiers in adverse event reports to the public, so it is unlikely that the patient's privacy will be compromised if the patient's name is provided in situations where the patient is the reporter.

The final rule modifies the language in proposed § 600.81(b)(1) describing the electronic format requirement for biological product lot distribution reports so that it reflects the language used in analogous provisions (§§ 310.305(e)(1), 314.80(g)(1), 329.100(c)(1), and 600.80(h)(1)).

As described later in this section, the final rule also makes some revisions to the proposed provisions that set forth the reportable elements included in an ICSR. Changes to the language describing certain elements, including the addition of descriptive phrases, have been made to clarify to what information those elements refer. The final rule also adds a new § 600.80(g) and adds certain elements to proposed §§ 310.305(d), 314.80(f), and 600.80(f) to more accurately describe the information currently reported on the VAERS-1 form and Form FDA 3500A. Accordingly, §§ 310.305(d), 314.80(f), 329.100(b), and 600.80(f) list ICSR elements, derived from Form FDA 3500A, for drug and nonvaccine biological products. Section 600.80(g) in the final rule lists ICSR elements for vaccine products derived from the VAERS-1 form.

The new § 600.80(g) has been added to the final rule to capture the information reported on the VAERS-1 form that was inadvertently omitted from the proposed rule. Section 600.80(f) applies only to nonvaccine biological products. Section 600.80(g) in the final rule lists ICSR elements for vaccines that are derived from the VAERS-1 form. The list of elements in § 600.80(g) (for vaccine products) is largely the same as the list of elements for nonvaccine biological products, but there are some variations, including certain additional elements applicable only to safety reporting for vaccine products. Reporting elements that have been included for vaccine ICSRs that are not applicable to ICSRs for nonvaccine biological products include, among others, patient name (in place of patient identification code), birth weight for children under 5, time of adverse experience, illness at the time of vaccination, anatomical site of vaccination, number of previous vaccine doses, time of vaccination, other vaccine(s) administered in the 4 weeks before the vaccination date, name of the person who administered the vaccine, and name of the responsible physician at the facility where the vaccine was administered. This information is currently reported on the VAERS-1 form and is important for FDA to evaluate adverse experiences associated with the administration of vaccines. In addition, because § 600.80(g) does not include patient identification code as a reporting element, FDA has revised § 600.80(c)(2)(ii)(A)(2) and (A)(4), which describe how to reference and index ICSRs in periodic reports, to note that ICSRs for nonvaccine biological products should be referenced and indexed by patient identification code, whereas ICSRs for vaccines should be referenced and indexed by unique case identification number.

The final rule removes from proposed §§ 310.305(d), 314.80(f), and 600.80(f) the element requiring applicants to report information on whether the initial reporter also sent a copy of the report to FDA. FDA does not often use that information to identify duplicate reports, and including that information is not consistent with international electronic reporting standards. The final rule adds to all sections that contain reporting elements the following elements to be reported: (1) Whether the report is a 15-day “Alert report” and (2) whether the ICSR is an initial report or a followup report. These two elements replace the element requiring the type of report (e.g., 15-day, periodic, followup). We believe that it is clearer to represent this information with two separate elements. The final rule adds to §§ 310.305(d), 314.80(f), and 600.80(f) the element requiring information on whether the product is a combination product as defined under § 3.2(e) (21 CFR 3.2(e)). 8 The final rule adds to §§ 310.305(d), 314.80(f), and 600.80(f) the element “whether the product is a prescription or nonprescription product.” Section 329.100(b) also lists “whether the product is a prescription or nonprescription product” as an element to be included in an ICSR. Even though § 310.305 only applies to prescription products and § 329.100 only applies to nonprescription products, for consistency, we use the same language in all sections to describe the information to be provided. The final rule removes from proposed § 310.305(d), “Basis for marketing if nonapplication product” because we are able to obtain that information based on the status of the drug as a prescription product and whether a drug application number is provided. The final rule adds to the ICSR elements for each product type (e.g., drug, nonvaccine biological product, vaccine) “unique case identification number,” which must be the same in the initial report and any subsequent followup reports. The unique case identification number is different from the “unique code [used] for identification of the patient.” The “unique case identification number” replaces the “Manufacturer Report Number” used on Form FDA 3500A and VAERS-1. Using a unique case identification number (that is the same in the initial ICSR and any followup reports) allows FDA to link the initial ICSR with any followup reports in the FAERS or VAERS database. This will allow FDA to track an individual case over its life cycle.

The final rule revises current §§ 310.305, 314.80, 314.98, and 600.80 to require that manufacturers, packers, and distributors, and applicants with approved NDAs, ANDAs, and BLAs and those that market prescription drugs for human use without an approved application submit postmarketing safety reports to the Agency in an electronic format that FDA can process, review, and archive. As addressed in section I.B of this document, the final rule also adds part 329 to address safety reports required by section 760 of the FD&C Act. Section 329.100 requires that reports required to be submitted to the Agency under section 760 of the FD&C Act be submitted in an electronic format that FDA can process, review, and archive.

Under the final rule, the following reports must be submitted to FDA in an electronic format: Postmarketing 15-day Alert report ICSRs and any ICSR attachments; periodic adverse (drug) experience reports (including the ICSRs, any ICSR attachments, and the descriptive information portion); and section 760 reports. A separate ICSR is to be submitted for each individual patient report of an adverse drug experience, just as separate paper forms have been submitted for each individual patient report of an adverse drug experience. Information on the formats the Agency is able to process, review, and archive is described in FDA guidance and associated technical specifications documents available on FDA's Web site.

For marketed products with an approved application, manufacturers, packers, or distributors that do not hold the application continue to have the option of submitting 15-day Alert reports directly to FDA or to the application holder under §§ 314.80(c)(1)(iii) and 600.80(c)(1)(iii). If they opt to submit reports directly to FDA, they are required to do so in electronic format. If they choose to report to the applicant, they may submit the report in any format acceptable to the reporter and applicant. The applicant, however, is required to use electronic reporting when it subsequently reports the information to FDA. Similarly, for marketed prescription drug products without an approved application, initial safety reports submitted to the manufacturer by packers and distributors under § 310.305 may be sent in any format agreeable to the reporter and the manufacturer, but all safety reports submitted to FDA must be in electronic format. Under section 760 of the FD&C Act, a retailer whose name appears on the label of a nonprescription (OTC) drug product marketed in the United States without an approved application, as a distributor, may, by agreement, authorize the manufacturer or packer of the nonprescription drug to submit the required reports to FDA (as long as the retailer directs to the manufacturer or packer all adverse events associated with the drug that are reported to the retailer as specified in section 760). The retailer may direct serious adverse event reports to the manufacturer or packer in any agreed-upon format. However, the manufacturer or packer must then send the required reports to FDA in an electronic format that the Agency can process, review, and archive.

This rule will apply to any new postmarketing safety reports for drug or biological products that are implemented in the future (e.g., once finalized, new postmarketing safety reports in the proposed rule to amend safety reporting requirements published in the Federal Register of March 14, 2003, 68 FR 12406). The rule also revises § 600.81, requiring the electronic submission of biological lot distribution reports. 9 The specific references to submission of postmarketing safety reports in paper format in §§ 310.305, 314.80, 600.2, and 600.80 have been deleted, and language has been added to these sections which states that FDA will issue guidance on how to provide the electronic submissions (e.g., method of transmission, media, file formats, preparation, and organization of files).

In the proposed rule, we stated that we were developing a Web-based submission portal (for submission of reports to FAERS) that we believed might be preferred by entities that submit a small number of safety reports. The Safety Reporting Portal (SRP) (available at http://www.safetyreporting.hhs.gov ) allows the secure electronic submission of ICSRs for drug and nonvaccine biological products directly into the FAERS database once information is typed into the Web-based electronic form. The SRP creates a simple and efficient mechanism for electronic reporting that does not require an internal ICH-compatible database. As described in the preamble to the proposed rule, use of the SRP does however require some administrative support to manually enter information for the ICSRs into a Web-based form.

To assist entities that submit a small number of safety reports for vaccines, FDA has made available an eSubmitter tool. The eSubmitter tool is a stand-alone application that can be downloaded free of charge from FDA's Web site at http://www.fda.gov/forindustry/fdaesubmitter . The eSubmitter application appears as a fillable form, and once the appropriate fields are filled in, an ICSR in electronic format is generated that can be transmitted through the ESG into the VAERS database. We believe that the eSubmitter tool generally offers the same benefits as the SRP. As noted in § 600.80(h), FDA will issue guidance providing further information about the electronic submission of vaccine reports.

Postmarketing safety reports for drugs, including vaccines, constitute the largest volume of paper safety reports received by the Agency and, consequently, require the most resources to input electronically. We anticipate that this final rule will permit FDA to manage these postmarketing safety reports more efficiently. The final rule only addresses electronic submission of postmarketing safety reports for drugs and biological products and does not apply to submission of the following reports:

• Investigational new drug application (IND) safety reports (§ 312.32 (21 CFR 312.32));

• Safety update reports for drugs (§ 314.50(d)(5)(vi)(b) (21 CFR 314.50(d)(5)(vi)(b));

• Approved NDA and BLA annual reports (§§ 314.81(b)(2) and 601.28 (21 CFR 314.81(b)(2) and 601.28));

• Biological product deviation reports (BPDRs) (§§ 600.14 and 606.171 (21 CFR 600.14 and 606.171));

• Reports of complications of blood transfusion and collection confirmed to be fatal (§§ 606.170(b) and 640.73 (21 CFR 606.170(b) and 640.73));

• Adverse reaction reports for human cells, tissues and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) (§ 1271.350(a) (21 CFR 1271.350(a)); and

• NDA-field alert reports (§ 314.81(b)(1) (21 CFR 314.81(b)(1)).

Although this final rule requires that all postmarketing safety reports be submitted to FDA in electronic format, new §§ 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), 600.80(h)(2), and 600.81(b)(2) allow for a temporary waiver from the electronic format requirement for “good cause” shown. 10 Details for submitting waiver requests, such as where to send the request and any supporting information, are provided in the postmarketing safety reports guidance issued today in conjunction with this final rule. When a temporary waiver has been granted, FDA intends to specify an acceptable alternate format for submitting the safety reports. FDA anticipates that temporary waivers of the requirement to submit postmarketing safety reports to the Agency in electronic format will be needed only in rare circumstances.

Companies experiencing technical difficulties with transmission of their electronic submissions to FDA should consult FDA for technical assistance rather than submitting a waiver request. Companies that normally use the direct database-to-database method to submit reports to FDA could use the SRP as a backup method for FAERS submissions and the eSubmitter tool as a backup method for VAERS submissions during short-term, temporary outages.

In this final rule, as in the proposed rule, the term “individual case safety report” (ICSR) is used to describe the information contained in either an initial or a followup report of an individual adverse drug experience, reported on a Form FDA 3500A, on a Council for International Organizations of Medical Sciences (CIOMS) I form, on a VAERS-1 form, or in electronic format. Because we are requiring that all postmarketing safety reports be submitted in electronic format, we proposed this term to describe the safety reporting vehicle generically, rather than by reference to the associated paper form. In addition, this term in now commonly used in international electronic reporting standards (e.g., ICH E2B, Health Level 7 (HL7)) in reference to such reports.

Accordingly, as proposed, §§ 310.305(b) and 314.80(a) have been revised to define an ICSR as a description of an adverse drug experience related to an individual patient or subject, and § 600.80(a) has been revised to define an ICSR as a description of an adverse experience related to an individual patient or subject. Because the items of information to be reported were specified on the paper reporting forms that will no longer be used for reports covered under this rule, we have added a list of the reportable elements to the regulations. Accordingly, §§ 310.305(d), 314.80(f), 329.100(b), 600.80(f), and 600.80(g) provide detailed lists of specific elements (in five broad categories for nonvaccine products and seven broad categories for vaccine products) that are to be reported in an ICSR, derived from the associated paper forms. The five categories applicable to all products, including vaccines, and examples of some of the types of information in each category, are as follows:

• Patient information (e.g., age, gender);

• Information about the adverse experience (e.g., date and description of the adverse drug experience);

• Information about the suspect medical product (e.g., drug name, dose, indication, National Drug Code (NDC) number);

• Information about the initial reporter (e.g., name and contact information); and

• Information about the drug's applicant or manufacturer or responsible person (e.g., name and contact information)

• Information about other vaccine(s) administered in the previous 4 weeks; and

• Information on the facility and personnel where the vaccine was administered (e.g., name of person who administered vaccine, name of responsible physician and facility where the vaccine was administered).

Though there are minor wording differences, the list of information to be reported is derived from the information reflected on Form FDA 3500A and VAERS-1 for postmarketing reporting for drugs and biological products. Codification of the ICSR reporting requirements is not intended to change the obligation of manufacturers, packers, or distributors to exercise due diligence for purposes of completing all of the applicable elements of an ICSR. The obligation to provide all applicable information described in §§ 310.305(d), 314.80(f), 329.100(b), 600.80(f), or 600.80(g) is the same as the obligation to complete Form FDA 3500A or VAERS-1.

We believe that it is no longer necessary to describe procedures for paper format submissions in the regulations because we anticipate that a paper format will be used on a limited basis, if at all. Accordingly, as proposed, this final rule removes from the regulations provisions describing the details for submission of safety reports in paper format, such as the number of required paper copies or specific markings or notations required on the paper forms. We have deleted in §§ 310.305(d), 314.80(f), and 600.80(f) the provisions specifically describing paper submissions and replaced them with a paragraph (§§ 310.305(e)(1), 314.80(g)(1), and 600.80(h)(1)), which states that ICSRs and any ICSR attachments must be submitted to FDA in an electronic format that we can process, review, and archive. Additional revisions to remove or modify references or provisions that are specific to paper formats include the following:

• References to the number of paper copies required for safety report submissions (§§ 310.305(c), 314.80(c), and 600.80(c));

• The requirement to mark paper reports to identify their contents as “15-day Alert report” or “15-day Alert report-followup,” (§§ 310.305(c)(4), 314.80(c)(1)(iv), 600.80(c)(1)(iv));

• The requirement to use Form FDA 3500A, CIOMS I form, or VAERS-1 form or to determine an appropriate alternative format for voluntary submission in electronic format (§§ 310.305(d)(1) and (d)(3), 314.80(f)(1) and (f)(3), and 600.80(f)(1) and (f)(3));

• The reference to Form FDA 3500A or other paper forms designated for adverse drug experience reporting by FDA for ICSRs that are submitted as part of periodic reporting requirements (§§ 314.80(c)(2)(ii)(b) and 600.80(c)(2)(ii)(B));

• The requirement for identifying reports of adverse drug experiences that occur in postmarketing studies by separating and marking them (§§ 314.80(e)(2) and 600.80(e)(2));

• The requirement to submit adverse experience reports by mail to CBER's mailing address (§ 600.2(a)) by deleting the phrase “adverse experience reports” from § 600.2(a);

• The requirement to submit adverse experience reports by mail to CDER's mailing address (§ 600.2(b)(2));

• The requirement to submit VAERS reports by mail to the VAERS mailing address (§ 600.2(d)); and

• The requirement to submit distribution reports on biological products by mail (§ 600.81) by deleting “(see mailing addresses in § 600.2)” from § 600.81.

As noted previously in this document, procedural and formatting recommendations, if applicable to electronic submissions, will be set forth in guidance. 11

Section 745A(a) of the FD&C Act (21 U.S.C. 379k-1), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides that submissions under section 505(b), (i), or (j) of the FD&C Act or section 351(a) or (k) of the PHS Act shall be submitted in such electronic format as specified by FDA in guidance. In section 745A(a) of the FD&C Act, Congress granted explicit statutory authority to FDA to implement the electronic format for submissions requirement by guidance. This grant of authority, however, does not preclude FDA from implementing such requirements by notice and comment rulemaking (5 U.S.C. 553). At this time, even though we conclude that certain submissions that are addressed in this final rule are also within the scope of section 745A(a) of the FD&C Act, FDA has determined that it is appropriate to amend the current regulations on the submission of postmarketing safety reports to remove references to paper submissions and to specify that such reports be submitted in an electronic format that FDA can process, review, and archive. FDA may consider, at a future date, whether certain electronic submission requirements should be specified in guidance pursuant to section 745A(a) of the FD&C Act.

As proposed, the final rule amends §§ 310.305, 314.80, 314.98, and 600.80 by replacing the word “shall” with the word “must” except in the first sentence of §§ 314.80(c)(1)(iii) and 600.80(c)(1)(iii), from which the word “shall” has been removed for editorial reasons. The final rule revises in § 314.80(c)(2) the paragraph designations that were not in correct format. We believe that these minor changes clarify the regulations and make them easier to read. The final rule, as proposed, also changes the term “licensed manufacturer” to “applicant” in §§ 600.80, 600.81, and 600.90.

The mailing addresses for the submission of postmarketing safety reports have been removed from §§ 310.305(c), 314.80(c), 314.98(b), and 600.80(c) because this information is no longer necessary in light of the requirement to submit safety reports electronically.

Final § 310.305(c)(1)(i) requires the submission of a current copy of the labeling in electronic format unless it is already on file with FDA. Previously, under § 310.305(c)(1)(i), each report was to be accompanied by a copy of the labeling. However, if the Agency already has the current labeling on file, we do not believe it is necessary for a current copy of the labeling to be submitted with each report. 12

For products with approved applications, currently, reports for all adverse experiences other than those submitted as 15-day Alert reports or followup reports to 15-day Alert reports (i.e., reports of adverse experiences that are both serious and expected or nonserious) are required to be submitted as a batch as part of the postmarketing periodic safety report for the reporting interval during which the applicant received the report. Although the ICSRs may be generated at any time from the beginning of the reporting interval through the date that the periodic report is submitted to FDA, they are currently retained by the applicant during this time period and submitted to FDA in a single batch, along with the other (descriptive) portions of the periodic report. The final rule includes language in §§ 314.80(c)(2)(ii)(B) and 600.80(c)(2)(ii)(B) to give applicants the option of submitting these ICSRs at any time up until the due date of the periodic report, rather than waiting to submit them in a single batch with the descriptive portion. All reports of adverse experiences that are both serious and expected or nonserious that the applicant received during the reporting interval must still be submitted to the Agency by the time the descriptive portion is due for that period, but the final rule permits them to be filed anytime up until the due date of the periodic report, rather than in a single batch with the descriptive portion of the periodic report. We have adopted this change, as proposed, because we understand that many applicants prefer this added flexibility of submitting the ICSRs on an ongoing basis.

To protect patient privacy, names of individual patients are not to be included in the patient identification portion of the ICSRs for drug and nonvaccine biological products. We instead require that a unique code be used for patient identification. As proposed, the final rule removes from the provisions entitled “patient privacy” the language specifying an eight character limit on the code. Although we also proposed that the name of the reporter not be included when the reporter is also the patient, we are not finalizing that proposal. FDA has determined that it is important for us to have the name of the reporter, even when the patient is the reporter, because it will allow us to contact the reporter, if necessary, to obtain followup information. Names of patients, health care professionals, hospitals, and geographical identifiers in adverse drug experience reports are not releasable to the public under FDA's public information regulations. These same requirements addressing patient privacy have been included in § 329.100(d), applicable to reports required by section 760 of the FD&C Act.

As proposed, we have revised §§ 310.305(c)(1)(i), 314.80(c)(1)(i), and 600.80(c)(1)(i) to state that 15-day Alert reports must be submitted as soon as possible, but no later than 15 calendar days from initial receipt of the information. FDA does not intend this change to have any substantive effect. It is being made solely to simplify the regulatory language and improve its readability.

We received written comments from three pharmaceutical companies, two associations representing the drug and biologic industries, a law firm representing a manufacturer of nonprescription drug products marketed without approved applications, and an individual (seven commenters total). A summary of the comments contained in the submissions received, and our responses, follow.

(Comment 1) In the preamble to the proposed rule, we requested public comment on whether we should require the use of an electronic format for reports of serious adverse events required by then newly enacted section 760 of the FD&C Act for nonprescription human drug products marketed without an approved application. Two commenters supported requiring the use of an electronic format for the submission of reports required by section 760 of the FD&C Act. No comments were opposed to such a requirement.

(Response) As discussed in section I.B, we agree that the requirement that postmarketing safety reports be submitted electronically should extend to safety reports required to be submitted by section 760 of the FD&C Act. Electronic submission of safety reports required to be submitted by section 760 of the FD&C Act will allow FDA to process, review, and archive such reports more efficiently. Therefore, as described previously in this document, we have added 21 CFR part 329 to cover nonprescription human drug products subject to section 760 of the FD&C Act. Section 329.100 sets forth information to be included in safety reports that are required to be submitted by section 760 of the FD&C Act and requires that the reports be submitted in an electronic format that FDA can process, review, and archive. As with safety reports required by §§ 310.305, 314.80, and 600.80, § 329.100 also includes a provision allowing requests for a temporary waiver from the electronic submission requirement for good cause. As noted in the preamble to the proposed rule, nonprescription (OTC) drug products that are marketed under approved applications (NDAs or ANDAs) are not covered under section 760 of the FD&C Act. Those products are subject to the reporting requirements of §§ 314.80 and 314.98.

(Comment 2) One comment suggested that we develop an option to allow IND safety reports to be submitted electronically. The comment states that this option would reduce the burden for companies that must use two different systems.

(Response) The comment is beyond the scope of this rulemaking. This rule addresses only the electronic submission of postmarketing safety reports. Premarketing safety reports are transmitted directly to the review division of FDA that has responsibility for review of the IND and are not uploaded into the FAERS database.

(Comment 3) Although this rulemaking does not apply to biological product deviation reports (BPDRs), in the preamble to the proposed rule, we requested comment on requiring the electronic submission of BPDRs (required by §§ 600.14 and 606.171) in the future. One comment supported requiring the electronic submission of BPDRs and also suggested that the current Web-based form available for the voluntary electronic submission of BPDRs be modified to allow more than 2,000 characters in the event description field to allow a complete description of the event.

(Response) We appreciate the comment. As addressed in section II.F, section 745A(a) of the FD&C Act provides that submissions under section 351(a) or (k) of the PHS Act, which include BPDRs, shall be submitted in such electronic format as specified by FDA in guidance. The Agency intends to address the implementation of section 745A(a) of the FD&C Act separately. In the meantime, parties wishing to submit BPDRs electronically are encouraged to do so through the existing Web-based system. We note that the current electronic system for BPDR reporting has been expanded to allow up to 3,999 characters for narrative entries.

(Comment 4) Two comments requested that we address the submission of postmarketing safety reports for combination drug and device products in the final rule. One comment noted specifically that reporting requirements for drugs and biologics differ from the reporting requirements of devices and therefore requested that we provide further information on how to submit safety reports for drug and device combination products.

(Response) These comments are beyond the scope of this rulemaking. This final rule requires electronic submission of required postmarketing safety reports for drugs and biological products (including vaccines). We note that on October 1, 2009, FDA published a proposed rule entitled “Postmarketing Safety Reporting for Combination Products” (74 FR 50744). When finalized, this new rule will clarify the safety reporting requirements for combination products such as drug and device combinations.

(Comment 5) One comment noted that the preamble to the proposed rule indicates that developments are underway for VAERS to receive ICSRs for vaccines through FDA's ESG. The comment stated, however, that no information is provided regarding how and when these submissions may be made to VAERS.

(Response) Modifications are still underway to permit VAERS to receive ICSRs through FDA's ESG, which will facilitate the submission of multiple reports without the need for manual data entry. FDA expects that VAERS will be able to receive ICSRs through the ESG by the time this final rule becomes effective.

In the preamble to the proposed rule, we explained that a “Web-based electronic submission portal” was under development to allow the secure electronic submission of postmarketing ICSRs directly into FDA's AERS database once information is entered into a “Web-based electronic form.” We noted that the Web-based submission portal would allow electronic submission of ICSRs consistent with ICH standards and could be used as an alternative method for reporting adverse drug experiences to FDA electronically. We noted that this alternative electronic reporting method would be particularly useful for entities that submit a small number of safety reports because it would create a simpler and more efficient mechanism for reporting that would not require an internal database that is compatible with the ICH-based direct submission system.

(Comment 6) One comment requested clarification of the terms “Web-based submission portal” and “Web-based form,” noting that both terms are used in the preamble to the proposed rule.

(Response) In the proposed rule, we used the term “Web-based submission portal” (now referred to as the Safety Reporting Portal (SRP)) to describe a Web-based system that any person subject to FDA's postmarketing safety reporting requirements could use to submit ICSRs to FDA electronically. (See section II.A for further discussion of the SRP.) We used the term “Web-based form” to describe the on-screen interface into which users would enter the ICSR data elements. Users “complete” the ICSR by filling in the appropriate fields in the Web-based form and then submit the ICSR to the FAERS database through the Web-based submission portal. 13

(Comment 7) One comment suggested that to eliminate any potential barriers for small companies, no charge should be associated with use of the Web-based system.

(Response) There will be no charge for electronic submission of safety reports to the FAERS database through the SRP. For submissions to VAERS using the eSubmitter tool, however, a digital security certificate will be necessary. These certificates allow users to sign and encrypt documents for transmission, ensuring that any electronic submissions are verifiable and secure. Digital certificates are available through many third-party vendors. A certificate generally lasts 1 to 3 years and typically costs $10 to $15. A digital certificate is also necessary to comply with FDA's electronic registration and listing requirements, so most companies already have digital certificates and will not need to obtain one to use the eSubmitter tool. Further information about digital security certificates is available on FDA's Electronic Drug Registration and Listing Instructions Web page at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm177328.htm.

(Comment 8) One comment asked whether training or some type of qualification will be required to submit ICSRs through the Web-based system.

(Response) The SRP creates a simpler mechanism for electronic submission of safety reports. No special training or qualification will be required. The information for the ICSR is entered into the Web-based form and then submitted to FDA. However, prior to initial use of the SRP, companies will need to contact the FAERS Electronic Submissions Coordinator at faersesub@fda.hhs.gov to establish an account to submit safety reports through the SRP. Having an SRP account allows for faster data entry because certain fields will be pre-populated by information from the user account. Having an account also allows users to save a report and complete it later, allows users to see a list of reports that have been submitted, and allows for followup submissions as more information about the adverse drug experience becomes available. Further information on submitting ICSRs through the SRP is included in the postmarketing safety reports guidance.

For vaccine products, the eSubmitter tool can be used, instead of the SRP, as an alternative method for the electronic submission of ICSRs to VAERS. The eSubmitter tool provides a user-friendly method for submission of these reports, and no special training or qualification will be necessary. Firms will, however, need to contact FDA's ESG Help Desk to establish an ESG account and will need to obtain a digital security certificate (as described in the previous response), if these two steps have not already been completed to comply with FDA's electronic drug registration and establishment listing requirements. The first time firms submit a report to the VAERS database, they will also need to contact the CBER Electronic Submissions Program at esgprep@fda.hhs.gov.

(Comment 9) One comment suggested that companies should be able to use both the Web-based portal and the ESG and should not have to choose one system.

(Response) FDA will not limit companies to one method for creating and transmitting ICSRs electronically to FDA. As described in this document, FDA offers both the direct database-to-database method and the SRP for submission of ICSRs into the FAERS database, and the direct database-to-database method and eSubmitter tool for submission of ICSRs into the VAERS database. FDA recommends that companies select the submission method that best suits their needs to submit a given report.

(Comment 10) One comment recommended that the Web-based portal provide a receipt or acknowledgement indicating whether the submission was successfully received or if the delivery failed. The comment noted that this will allow companies to take appropriate followup action.

(Response) When using the SRP to submit postmarketing safety reports, users will receive electronic acknowledgement indicating whether or not their submission was accepted into the FAERS database. 14 If notified that the submission was not accepted, users should resubmit the safety report to ensure that FDA receives the report. Further information about FAERS submission acknowledgement is provided in the postmarketing safety reports guidance.

(Comment 11) One comment stated that the Web-based portal should accept ICH-compliant XML files that may be generated and submitted to the Web-based portal and/or the ESG.

(Response) The SRP allows for the submission of ICH-compliant ICSRs. Once the data elements for the ICSR are entered into the Web-based form and submitted to FDA, the SRP generates an XML file which is then uploaded into the FAERS database (along with any ICSR attachments that may be included). The ESG will continue to accept ICH-compliant XML files. Similarly, for submission of vaccine reports, both the eSubmitter tool and the direct database-to-database transmission method generate ICH-compliant XML files that are submitted to FDA through the ESG.

(Comment 12) One comment asked whether followup links to the original report will be available when submitting the report through the Web-based system.

(Response) When the initial ICSR is submitted through the SRP, users will be able to return to the initial ICSR and submit followup reports as more information about the reported adverse experience becomes available. Users may log in to their SRP accounts, locate the ICSR record, and modify or add to the initial ICSR. Users may submit as many followup reports as necessary. More detailed information on how to modify or add to an initial ICSR is available on the SRP Web site.

Similarly, the eSubmitter tool, which can be used for the submission of vaccine reports through the ESG into VAERS, allows for the creation and submission of both initial reports and followup reports as more information regarding the adverse event becomes available. Use of the same unique case identification number for the initial ICSR and any followup reports will be essential to ensure that the reports are linked in the database.

In the proposed rule, we proposed allowing for the submission of requests for temporary waivers from the electronic format requirement and stated that waivers would be granted on a time-limited basis for “good cause” shown. While noting that the details for submitting waiver requests would be announced in guidance, we requested comment on what circumstances would constitute “good cause” justifying a waiver from the electronic submission requirement.

(Comment 13) One comment requested a categorical exemption from the electronic reporting requirement for small business entities, which the comment defined as any business with fewer than 100 employees and less than $10,000,000 in annual sales. The comment noted difficulties that these entities had with FDA's system for electronic establishment registration and drug listing and expressed concern that these businesses would have similar difficulties with the electronic submission of safety reports.

(Response) FDA has concluded that it will not grant a categorical exemption from the electronic safety reporting requirement for small business entities. We anticipate that receiving all required postmarketing safety reports electronically will allow us to more rapidly review the reports, identify emerging safety problems, and disseminate safety information. We believe that any categorical exemption from the electronic submission requirement will significantly limit these important benefits. As we stated in the preamble to the proposed rule, we believe a waiver will only be needed in rare circumstances.

We appreciate the commenter's concern about potential difficulties with the electronic submission of safety reports through FDA's system. We believe that the SRP provides a simple, user-friendly system for submission of ICSRs into the FAERS database. The SRP is similar to systems used for online purchases and other Web-based transactions. FDA has been receiving safety reports through the SRP for the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the Center for Tobacco Products since 2010. In addition, FDA intends to provide technical assistance to help resolve any problems.

We believe that the eSubmitter tool, which may be used for the electronic submission of ICSRs for vaccines, provides a simple and straightforward method for submitting these reports. Furthermore, submission testing is available so that users will have the opportunity to try out the system before the rule becomes effective.

FDA has been working with both large and small companies and has been successfully receiving voluntary electronic submissions of ICSRs through the ESG since 2001. We believe our experience to date with the electronic submission of safety reports will help us to minimize problems with electronic submission that regulated entities may have, especially entities new to the system. We also believe that the effective date adopted in this rule will permit the Agency and industry sufficient time to ensure that the systems are fully functional and that any technical problems are worked out by the time the requirements of this rule become effective.

(Comment 14) One comment recommended allowing a good cause waiver in cases of natural or manmade disaster. The same comment also suggested allowing a time-limited waiver for companies bringing their first commercially available product to market.

(Response) We agree that natural or manmade disasters may present situations where a waiver from the electronic submission requirement would be appropriate. For example, in these situations, electricity may be unavailable for an extended period of time, and electronic submission of safety reports would not be feasible. We do not agree that a time-limited waiver for companies bringing their first commercially available product to market will be necessary or appropriate. We believe the electronic submission systems are easy to use and will be fully functional by the time this rule becomes effective. Furthermore, as explained in the previous response, FDA is prepared to assist companies to ensure that any problems with electronic submission are resolved.

(Comment 15) One comment suggested that temporary waivers should be granted for unplanned, extended-duration ESG downtime; business continuity or disaster recovery situations where a company's pharmacovigilance system access may be down for a period of time and the volume of reports is too high to use the Web-based system requiring manual entry; or where human resources are greatly diminished, for example, as a result of pandemic or terror attack.

(Response) We agree that disaster recovery situations, pandemics, or terror attacks may present circumstances in which a waiver from the electronic submission requirement would be appropriate. We believe it is unlikely that the ESG would experience unplanned downtime of extended duration such that a waiver from the electronic submission requirement would be necessary. However, if such a situation were to occur, a waiver might be appropriate.

(Comment 16) One comment suggested that the components of a request for a waiver could include the nature of the inability to comply, the anticipated time to recover, and a crisis manager contact for the company who would be accountable to FDA for followup and resolution. The comment also requested that FDA include in its guidance the type of documentation that must be kept and the documentation FDA will provide as a record of the situation for future inspections or audits.

(Response) We agree with the suggestion that a waiver request should include the nature of the inability to comply, the anticipated time to recover, and a company contact. Though additional relevant information could also be included in a waiver request, the components suggested for inclusion would allow us to assess the reasonableness of a waiver request and would ensure that we are able to limit the waiver to the time necessary. Accordingly, in the postmarketing safety reports guidance issued today in conjunction with this rule, we have stated that a waiver request should include the reason for the request and a proposed end date for the waiver. To follow up with the company, FDA intends to contact the individual who submitted the request. Although not addressed in the postmarketing safety reports guidance, we believe that in the normal course of business, it would be usual and customary for companies to maintain adequate records of the situation leading to a waiver request and documentation related to the waiver request.

(Comment 17) Two comments stated that FDA should provide a telephone contact for requesting a temporary waiver, because during a crisis situation, it may be difficult to put together a comprehensive request. One of the comments also suggested fax as an alternative for submitting a waiver request.

(Response) Consistent with the procedures for requesting waivers of other FDA requirements, requests for waivers of the electronic safety reporting requirement should be submitted to FDA in writing by mail as described in the postmarketing safety reports guidance issued today. The Agency is exploring other methods that may facilitate submission of waiver requests, and we will update the postmarketing safety reports guidance, as appropriate, to reflect any changes in waiver request procedures.

(Comment 18) One comment requested clarification on the types of attachments that are required as part of an ICSR submission.

(Response) The final rule includes a definition of “ICSR attachments” for clarification, but the rule does not change the types of attachments that may be necessary as part of an ICSR submission. As noted previously in this document, in the proposed rule, and in final §§ 310.305(b), 314.80(a), and 600.80(a), examples of ICSR attachments that may be necessary include published articles that must accompany ICSRs based on scientific literature (§§ 314.80(d) and 600.80(d)) and other supporting information, such as hospital discharge summaries and autopsy reports.

(Comment 19) One comment asked whether the ICSR attachments will be made public and whether companies will be required to redact the patient information from the attachments. The comment noted that requiring the company to redact patient information, such as address and birth date would create a significant additional burden.

(Response) FDA will not publicly release names or any other identifying information about patients contained in ICSR attachments. FDA redacts patient names and other identifying information before publicly releasing information contained in postmarketing safety reports. Persons submitting reports should not redact information contained in ICSRs or ICSR attachments before submitting them to FDA. We understand that companies may receive documents from reporters that are already redacted. Those documents should be submitted to FDA as received from the reporter and should not be redacted any further.

(Comment 20) Proposed § 310.305(c)(1)(i) stated that each 15-day “Alert report” must be accompanied by the “current content of the labeling” in electronic format unless it is already on file at FDA. One comment requested clarification of what “content of the labeling” means, suggesting that it could refer to the entire label or only certain sections or certain types of information in the labeling.

(Response) As set forth in § 314.50(l)(1)(i), the “content of labeling” refers to the contents of the package insert or professional labeling. It is the information required by §§ 201.56, 201.57, and 201.80, in the format specified. For products subject to § 310.305(c)(1)(i), the content of labeling is submitted to FDA in Structured Product Labeling (SPL) format as part of the electronic drug listing process. Further information about electronic submission of content of labeling and SPL format is provided in the guidance for industry entitled ”Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing” and the draft guidance “SPL Standard for Content of Labeling—Technical Qs & As” (available on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm) which, when finalized, will represent the Agency's current thinking.

(Comment 21) Proposed §§ 310.305(d)(1)(i), 314.80(f)(1)(i), and 600.80(f)(1)(i) listed “patient identification code” as an element to be included in each ICSR. Proposed §§ 310.305(f), 314.80(i), and 600.80(i), entitled “Patient privacy,” stated: “An applicant should not include in reports under this section the names and addresses of individual patients; instead, the applicant should assign a unique code to each report.”  15 One comment requested that we clarify whether the term “patient identification code” (used in proposed §§ 310.305(d)(1)(i), 314.80(f)(1)(i), and 600.80(f)(1)(i)) and the term “unique code for each report” as used in the provisions addressing patient privacy (proposed §§ 310.305(f), 314.80(i), and 600.80(i)) are intended to be different codes.

(Response) The “patient identification code” listed as a reporting element to be included in ICSRs (in §§ 310.305(d)(1)(i), 314.80(f)(1)(i), and 600.80(f)(1)(i)) and the “unique code for each report” discussed in the provision on patient privacy (in proposed §§ 310.305(f), 314.80(i), and 600.80(i)) are referring to the same code. Entities that submit ICSRs for drug and nonvaccine biological products should not include names and contact information for patients in the ICSRs. Rather, a unique code should be used instead of the patient's name and contact information in the patient information section of the ICSR. 16 The intent of using such a code is to protect the privacy of patients who have experienced adverse events that are being reported to FDA, while allowing the submitter to know the patient's identity and contact information for reference purposes. We agree that as proposed, the requirement is unclear. Therefore, we are revising the sections entitled “Patient privacy” (§§ 310.305(f), 314.80(i), and 600.80(j)) to state: “. . . should not include in reports under this section the names and addresses of individual patients; instead, the applicant should assign a unique code for identification of the patient.” We believe this change to the final rule will make clearer that the “patient identification code” included in the list of ICSR reporting elements (for drug and nonvaccine biological products) and the code described in the sections on patient privacy are referring to the same code, which is intended to protect the identity of patients. Section 329.100(d) also uses the same language.

We note, however, that §§ 310.305(d), 314.80(f), 329.100(b), and 600.80(f) and (g) that set forth the ICSR reporting elements, as finalized, also require a “unique case identification number” for each ICSR. This unique case identification number is distinct from the patient identification code. The unique case identification number, which must be the same in the initial ICSR and any subsequent followup ICSR(s), was referred to as the Manufacturer Report Number on Form FDA 3500A and VAERS-1, and it allows FDA to track an individual case over its life cycle.

(Comment 22) One comment noted that, in the past, the ESG has accepted ICSRs for which the applicant does not have all categories of information. The comment sought to confirm that ICSRs would not be rejected by the ESG if there are any gaps in categories of information.

(Response) The ESG will continue to operate as it has and will accept ICSRs for which the applicant may not have all categories of information. Even though the ESG and SRP accept ICSRs for which there are gaps in certain categories of information, it is important for applicants to include all information about the reported event that is known to the applicant.

(Comment 23) One comment requested confirmation that the ESG will be available 24 hours a day, 7 days a week, and that ICSRs submitted outside of business hours will be considered timely (if submitted within the required time frame). The comment also requested that we provide guidance on procedures for planned and unplanned downtime of the ESG and how the downtime affects submission deadlines.

(Response) FDA intends to make the ESG available 24 hours a day, 7 days a week to receive electronic submissions. Additional information explaining how submission dates are calculated if the ESG and/or the FAERS database is temporarily unavailable is provided in the postmarketing safety reports guidance issued today. We note that FDA also intends to make the SRP available 24 hours a day, 7 days a week to receive submissions.

(Comment 24) One comment suggested that we reference the ICH Harmonized Tripartite Guideline instead of listing, in the rule, categories of information to be included in ICSRs.

(Response) We set forth the categories of information to be included in ICSRs because we believe that this is a clear and concise way to communicate the information to be included when reporting adverse events to FDA and to move away from reliance on paper forms. We considered the ICH guidelines when creating these categories and believe that the categories included are either consistent with international standards or can be accommodated as local requirements using international transmission standards.

(Comment 25) One comment asked what version of the ICH E2B standard (i.e., the ICH guideline on data elements for transmission of ICSRs) will be accepted.

(Response) It has been FDA's practice to accept both the latest version of the ICH E2B standard in addition to the previous version. This practice has allowed applicants reasonable time to transition to the updated ICH E2B standard. Any changes to submission standards will be provided in guidance, as appropriate. 17

(Comment 26) One comment noted that the EU Drug Regulatory Authorities Pharmacovigilance system (EudraVigilance) has different validators than FDA's reporting system. As a result, some ICSRs would be accepted by FDA that would not be accepted by the European Medicines Agency. The comment requested that if new validators are placed on the ESG they be aligned with the EudraVigilance validators so that both systems accept the same reports.

(Response) It would not be functionally workable or practical to commit, in advance, to incorporating changes made by other regulatory bodies to ensure complete consistency among the reporting systems. FDA will continue to work with international standards organizations when developing new technical specifications so that differences in those specifications are kept to a minimum.

The proposed rule indicated that standards and technical specifications will be addressed in guidance documents rather than set forth in the final rule.

(Comment 27) One comment noted that changes to technical standards or specifications can increase costs to companies. The comment expressed concern that by adopting changes in guidance documents, the changes can occur more quickly and more frequently, resulting in a greater burden to companies. The comment stated that it is important that required technical standards or specifications not be changed frequently and that when they are changed, adequate time be allowed for public comment.

(Response) We understand the concern that frequent changes in technical standards and specifications may increase the cost of compliance to companies. FDA does not anticipate frequent changes. However, it is important for FDA to retain flexibility so that we can be responsive to the rapidly changing technological environment. We believe that the use of guidance documents to communicate technical specifications will benefit both companies and the Agency. If FDA were to set forth technical specifications in regulations, the result could be that companies would be bound to standards and specifications that are outdated. Maintaining older systems can also be a resource burden to companies.

FDA's legal authority to amend its regulations governing the submission of postmarketing safety reports for human drugs and biological products derives from sections 201, 301, 501, 502, 503, 505, 505A, 506, 506A, 506B, 506C, 510, 701, 704, 705, 745A, 760, and 801 of the FD&C Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 356, 356a, 356b, 356c, 360, 371, 374, 375, 379k-1, 379aa, and 381); and the PHS Act (42 U.S.C. 241, 262, and 264).

The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). FDA believes that this final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the average small entity submits few safety reports and the Agency's Web-based system for submitting reports electronically will require little additional cost per report, the Agency believes that this final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $141 million, using the most current (2013) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

The final rule requires the submission of all postmarketing safety reports, including periodic reports, to FDA in an electronic format. In addition, manufacturers of products distributed under a biologic license are required to submit lot distribution reports electronically. The public health benefits of this final rule, quicker access to postmarketing safety information, were not quantified. The final rule will generate an annual savings for the Agency of about $0.8 million, which is primarily a savings in the cost of processing paper. Total one-time costs to industry will be between $5.9 million to $7.5 million; the costs are for changing standard operating procedures (SOPs) and for training personnel. Annualized over 10 years at a 7 percent discount rate, the costs are from $0.8 million to $1.1 million. At a 3 percent discount rate over 10 years, the annualized costs are $0.7 million to $0.9 million.

The full assessment of economic impacts is available in Docket No. FDA-2008-N-0334 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 1).

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown below with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title: Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements.

Description: The final rule amends FDA's postmarketing safety reporting regulations for human drug and biological products under parts 310, 314, and 600, and adds part 329, to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. Under §§ 310.305, 314.80, 314.98, and 600.80, manufacturers, packers, and distributors, and applicants with approved NDAs, ANDAs, and BLAs and those that market prescription drugs for human use without an approved application must submit postmarketing safety reports to the Agency. Section 760 of the FD&C Act requires manufacturers, packers, or distributors whose name appears on the label of nonprescription human drug products marketed without an approved application to report serious serious adverse events associated with their products. Under § 600.81, applicants with approved BLAs must submit biological lot distribution reports to the Agency. In this rule, FDA is requiring that these postmarketing reports be submitted to the Agency in an electronic format that FDA can process, review, and archive. The final rule also states that FDA will issue guidance on how to provide the electronic submissions (e.g., method of transmission, media, file formats, preparation and organization of files). This rule does not change the content of these postmarketing reports. It only requires that they be submitted in an electronic format. Under §§ 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), 600.80(h)(2), and 600.81(b)(2), we are also permitting those subject to mandatory reporting requirements to request a waiver from the electronic format requirement.

We currently have OMB approval for submission of postmarketing safety reports to FDA under parts 310, 314, and 600. The information collection for part 310 and part 314 is approved under OMB control numbers 0910-0291 (Form FDA 3500A) and 0910-0230. The information collection for part 600 is approved under OMB control numbers 0910-0291 (Form 3500A) and 0910-0308. The burdens currently estimated under parts 310, 314, and 600, for submission of postmarketing safety reports to FDA for human drugs and biological products, do not change as a result of this final rule. This is because: (1) Current burden estimates associated with these regulatory requirements have taken into account voluntary submission of these reports in an electronic format and those applicants, manufacturers, packers, and distributors that already submit these reports in an electronic format would have no new reporting burdens and (2) new burdens for establishing the means for submitting postmarketing safety reports in electronic form to comply with this final rule, including obtaining an electronic certificate, revising SOPs, and becoming familiar with the system, would be negated by the savings in burden from not having to print out the report and mail it to FDA. These assumptions also apply to applicants submitting biological lot distribution reports under § 600.81.

OMB has approved the burden associated with submissions required by section 760 of the FD&C Act under OMB control number 0910-0636.

In table 1 of this document, we have estimated the burdens associated with the submission of waivers, under §§ 310.305(e)(2), 314.80(g)(2), 329.100(c)(2), 600.80(h)(2), and 600.81(b)(2). We expect few waiver requests (see section II.C). We estimate that approximately one manufacturer will request a waiver annually under §§ 310.305(e)(2), 329.100(c)(2), and 600.81(b)(2), and five manufacturers will request a waiver annually under §§ 314.80(g)(2) and 600.80(h)(2). We estimate that each waiver request will take approximately 1 hour to prepare and submit to us.

Description of Respondents: Manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of approved applications, applicants with approved NDAs, ANDAs, and BLAs, and those that market nonprescription drugs for human use without an approved application.

Burden Estimate: Table 1 of this document provides an estimate of the new annual reporting burden for submitting requests under the waiver requirement in this final rule.

Based on the average hourly wage ($79) as calculated in section VI (Analysis of Impacts) of the final rule, the cost to respondents would be $1,027 (13 × $79).

Tables 2 through 5 of this document provide an estimate of the annual reporting burden currently covered under existing OMB control numbers 0910-0291, 0910-0230, 0910-0308, and 0910-0636. As explained previously, we believe that any burden increases associated with electronic reporting are offset by burden decreases associated with not printing out reports and mailing them to FDA. Therefore, we believe that the burden estimates for these information collections will not change.

Based on the average hourly wage ($79) as calculated in section VI (Analysis of Impacts) of the proposed rule, the cost to respondents would be $39,895,948 (505,012 × $79).

Based on the average hourly wage ($79) as calculated in section VI of the proposed rule, the cost to respondents would be $54,405,799 (688,681 × $79).

Based on the average hourly wage ($79) as calculated in section VI of the proposed rule, the cost to respondents would be $133,616,887 (1,691,353 × $79).

Based on the average hourly wage ($79) as calculated in section VI of the proposed rule, the cost to respondents would be $1,975,000 (25,000 × $79).

As explained in section VI (Analysis of Impacts), total one-time costs to industry would be between $5.9 million to $7.5 million; the costs are for changing standard SOPs and training personnel. Annualized over 10 years at a 7 percent discount rate, the costs will be from 0.8 million to $1.1 million. At a 3 percent discount rate over 10 years, the annualized costs are $0.7 million to $0.9 million.

The information collection provisions of this final rule have been submitted to OMB for review. Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. 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.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov .

Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 310, 314, and 600 are amended and a new part 329 is added as follows:

Purpose of Program: The purpose of the Disability and Rehabilitation Research Projects and Centers Program is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities, and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act).

The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas. These activities are designed to benefit rehabilitation service providers, individuals with disabilities, family members, policymakers, and other research stakeholders. Additional information on the RRTC program can be found at: http://www2.ed.gov/programs/rrtc/index.html.

Applicable Program Regulations: 34 CFR part 350.

We published a notice of proposed priority (NPP) for this program in the Federal Register on March 3, 2014 (79 FR 11738). That notice contained background information and our reasons for proposing the particular priority.

There are no differences between the proposed priority and this final priority.

Public Comment: In response to our invitation in the notice of proposed priority, six parties submitted comments on the proposed priority.

Generally, we do not address technical and other minor changes, or suggested changes the law does not authorize us to make under the applicable statutory authority. In addition, we do not address general comments that raised concerns not directly related to the proposed priority.

Analysis of Comments and Changes: An analysis of the comments and of any changes in the priority since publication of the NPP follows.

Comment: One commenter questioned the need for this priority.

Discussion: This priority, creating an RRTC on Health and Function of Individuals with Physical Disabilities, would help achieve the goals of, and improve the effectiveness of services authorized under, the Rehabilitation Act. By creating an RRTC on Health and Function for Individuals with Physical Disabilities, we are fulfilling the purposes established in NIDRR's Long-Range Plan for Fiscal Years 2013-2017 (Plan), which was published in the Federal Register on April 4, 2013 (78 FR 20299). More specifically, as we discuss in the NPP, there is a need to better understand how specific health problems are interrelated with optimal health and function; how they may affect community participation, work productivity, and quality of life; and how they may be prevented or mitigated. We believe this priority will focus research attention on this area of national need.

Changes: None.

Comment: One commenter recommended that the RRTC should focus on technology-based interventions to improve health and function outcomes of individuals with disabilities.

Discussion: NIDRR agrees that technology can be used to improve the health and function outcomes of individuals with physical disabilities. This is one of five broad areas described in the priority, under which applicants can propose research and related activities. NIDRR does not wish to limit applicants' ability to address the other areas in the priority by requiring a focus on technology, as recommended by the commenter. The peer review process will determine the merits of each proposal.

Changes: None.

Comment: One commenter noted that several research centers working in the area of health and function for individuals with physical disabilities have focused their efforts on analysis of existing data. The commenter recommended that NIDRR revise the priority to require the RRTC to collect new data in order to advance the field.

Discussion: Nothing in the priority precludes an applicant from proposing to engage in the collection and analysis of new data. However, NIDRR does not wish to revise the research requirements in the way suggested by the commenter because we believe the revisions would limit the number and breadth of applications submitted under this priority. The peer review process will determine the merits of each proposal.

Changes: None.

Comment: One commenter recommended that NIDRR revise the priority to require the RRTC to focus on at least two study populations or diagnostic groups, thereby promoting the generalizability of the RRTC's findings.

Discussion: Paragraph (a) of the proposed priority states that the RRTC can focus on individuals with physical disabilities as a group or on specific disability or demographic subpopulations of individuals with physical disabilities. NIDRR purposely does not require a minimum number of target populations because we do not want to limit the breadth and number of applications that can be submitted under this priority.

Changes: None.

Comment: One commenter asked NIDRR to further define and specify the limits of the term “physical disability.” The commenter noted that people with traumatic brain injury (TBI) or stroke, for example, have acquired cognitive or intellectual impairments, as well as physical impairments, and often receive clinical services from rehabilitation professionals with expertise in physical disabilities. The commenter requested clarification of the term “physical disability” to help applicants determine whether their proposed target population(s) are an appropriate fit within the priority.

Discussion: We agree that some individuals with disabling conditions such as TBI or stroke could be considered in multiple target populations, including individuals with physical disabilities. NIDRR purposely outlines broad categories of target populations in its Plan and its priorities to allow applicants the flexibility to choose the disability category that is most relevant to their research questions and purposes. With this priority, we allow applicants to define and justify their target population within the broad category of individuals with physical disabilities. The peer review process will determine the merits of each proposal.

Changes: None.

Comment: One commenter noted that paragraph (c)(ii) of the priority requires the RRTC to provide training to rehabilitation providers and other disability service providers in order to facilitate more effective delivery of services. The commenter suggested that by limiting the recipients of the required training to service providers, NIDRR may be limiting the knowledge that is available to consumers and reinforcing the knowledge barrier between service providers and consumers. The commenter suggested that NIDRR modify paragraph (c)(ii) to require the RRTCs to provide training to consumers and service providers.

Discussion: The requirements in paragraph (c)(ii) are based directly on the Federal regulations that govern administration of the RRTC program. The regulations in 34 CFR 350.22(b)(1) require that training be provided to rehabilitation personnel or rehabilitation research personnel. At the same time, nothing in the regulations or in the priority precludes applicants from proposing to provide training to individuals with disabilities in addition to rehabilitation or rehabilitation research providers (who may also have disabilities). It is up to the applicant to designate and justify training targets. The peer review process will determine the merits of each proposal.

Changes: None.

The Assistant Secretary for Special Education and Rehabilitative Services establishes a priority for an RRTC on Health and Function of Individuals with Physical Disabilities.

The RRTC must contribute to maximizing the health and function outcomes of individuals with physical disabilities by:

(a) Conducting research activities in one or more of the following priority areas, focusing on individuals with physical disabilities as a group or on individuals in specific disability or demographic subpopulations of individuals with physical disabilities:

(i) Technology to improve health and function outcomes for individuals with physical disabilities.

(ii) Individual and environmental factors associated with improved access to rehabilitation and health care and improved health and function outcomes for individuals with physical disabilities.

(iii) Interventions that contribute to improved health and function outcomes for individuals with physical disabilities. Interventions include any strategy, practice, program, policy, or tool that, when implemented as intended, contributes to improvements in outcomes for the specified population.

(iv) Effects of government practices, policies, and programs on health care access and on health and function outcomes for individuals with physical disabilities.

(v) Practices and policies that contribute to improved health and function outcomes for individuals with physical disabilities.

(b) Focusing its research on one or more specific stages of research. If the RRTC is to conduct research that can be categorized under more than one of the research stages, or research that progresses from one stage to another, those stages must be clearly specified. The research stages and their definitions are in the final priorities and definitions published in the Federal Register on May 7, 2013 (78 FR 26513).

(c) Serving as a national resource center related to health and function for individuals with physical disabilities, their families, and other stakeholders by conducting knowledge translation activities that include, but are not limited to:

(i) Providing information and technical assistance to service providers, individuals with physical disabilities and their representatives, and other key stakeholders.

(ii) Providing training, including graduate, pre-service, and in-service training, to rehabilitation providers and other disability service providers, to facilitate more effective delivery of services to individuals with physical disabilities. This training may be provided through conferences, workshops, public education programs, in-service training programs, and similar activities.

(iii) Disseminating research-based information and materials related to health and function for individuals with physical disabilities.

(iv) Involving key stakeholder groups in the activities conducted under paragraph (a) in order to maximize the relevance and usability of the new knowledge generated by the RRTC.

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register . The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing this final priority only on a reasoned determination that its benefits justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

The benefits of the Disability and Rehabilitation Research Projects and Centers Program have been well established over the years, as projects similar to the one envisioned by the final priority have been completed successfully. The new RRTC will generate and promote the use of new knowledge that is intended to the health and function of individuals with disabilities.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT .

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Summary

On January 13, 2014, the Postal Service published an interim final rule with request for comments to amend a categorical exclusion (CATEX) in the Postal Service's National Environmental Policy Act (NEPA) implementing procedures (79 FR 2102). As explained in that document, the amendment focuses the CATEX more clearly on activities that, absent extraordinary circumstances, do not normally have the potential for individual or cumulative significant impacts on the quality of the human environment. The amendment also makes the CATEX consistent with analogous CATEXs used by the General Services Administration (GSA) and other major federal landowners.

In response to the interim final rule, the Postal Service received five comment letters. Commenters included non-governmental organizations, a municipality, three Members of Congress, and an individual. The commenters expressed their concerns about the interim final rule, which the Postal Service discusses and responds to in this document. In short, the five comment letters received from the public have not raised issues prompting the Postal Service to modify or deviate from its interim final rule. This final rule thus confirms and adopts the interim final rule's amendment to the Postal Service's CATEX.

Some commenters note the rulemaking's timing given the preliminary injunction in National Post Office Collaborate v. Donahoe, No. 3:13cv1406, 2013 WL 5818889 (D. Conn. Oct. 28, 2013). That the court's reading of the Postal Service's previously-worded CATEX in that case differs from the Postal Service's own longstanding interpretation demonstrates the need for clarification, which brings the Postal Service's CATEX into accord with federal agencies' comparable CATEXs.

Regardless of its timing, the amended CATEX constitutes a reasonable interpretation of the Postal Service's obligations under NEPA. The United States Supreme Court has held that an “initial agency interpretation [of a statute] is not instantly carved in stone” and that any agency “must consider varying interpretations and the wisdom of its policy on a continuing basis.” Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 863-64 (1984). As noted in the interim final rule, the Council on Environmental Quality (CEQ) has recommended that agencies periodically review their CATEXs and benchmark them against other agencies' (75 FR 75628, Feb. 18, 2010).

One commenter asserted that the new CATEX would reinstate a process that was purportedly rejected or temporarily enjoined in National Post Office Collaborate. That portrayal of the court's order is inaccurate. The court did not find the Postal Service's application of its property disposal CATEX per se deficient under NEPA. Instead, the court found the Postal Service's application of the CATEX to be procedurally deficient based, in large part, on how the CATEX was worded prior to this rulemaking. National Post Office Collaborate, No. 3:13cv1406, 2013 WL 5818889, at 13-15. At no point did the Court dispute the validity of the CATEX. Thus, this rulemaking merely clarifies the Postal Service's intent by rewording its property disposal CATEX, which, due to its former wording, the court in National Post Office Collaborate read differently from the Postal Service's longstanding interpretation.

This rulemaking is not retroactive and does not affect actions taken under the prior CATEX. See generally, Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 (1988) (holding that agency regulations are not retroactive except as specifically authorized by Congress).

The Postal Service applies its NEPA process and implements its CEQ-approved NEPA regulations for every property disposal. The interim final rule has not changed that, nor would this final rule. Nevertheless, a group of commenters suggests that the interim final rule would offer the Postal Service a way to bypass the NEPA reporting requirements that apply when there is no significant effect on the human environment. As was the case before this rulemaking, however, even where a proposed property disposal does not require an environmental assessment (EA), the Postal Service's NEPA process will still result in NEPA documentation: Notably, the Facilities Environmental Checklist and the Record of Environmental Consideration ( see U.S. Postal Service, Facilities Environmental Guide Handbook RE-6 § 2-4.1 (Nov. 2004)). Those documents are a matter of public record. Rather than somehow bypassing NEPA, the Postal Service would continue to document its decisionmaking throughout the NEPA process, including where the Postal Service applies a CATEX, which itself is an application of NEPA.

Some commenters assert that the amended CATEX does not follow NEPA, because it emphasizes the surrounding property uses around the Postal Service property proposed for disposal. As discussed in the interim final rule document, however, other federal landowners have incorporated the same comparison as an important aspect of their NEPA processes (79 FR 2102). The Postal Service's amended CATEX mirrors the language of a long-standing and well-established CATEX used by the General Services Administration (GSA) ( see 65 FR 69558, Nov. 17, 2000). The amended CATEX also follows the lead of the United States Coast Guard (USCG), which similarly adopted a CATEX based on the GSA's language (78 FR 44140). The Postal Service is unaware of any authority suggesting those CATEXs are not valid exercises of the agencies' discretion in implementing NEPA.

Several groups' combined comment letter purports to contrast the Postal Service's current regulations, which deem historic status to be one of many factors considered in completing its “extraordinary circumstances” checklist, with analogous provisions in the GSA and USCG regulations. Upon careful review of these comparable regulations and discussions with responsible personnel at each agency, the Postal Service has confirmed that its approach to historic property disposals under NEPA is no less thorough than the approaches shared by those other two federal owners of historic properties. Like the Postal Service, both GSA and USCG include historic status as one factor in a more holistic review of the proposed action, such that the CATEX may remain applicable to a historic property in light of mitigating actions and other circumstances. In this regard, those agencies' procedures remain consistent with the Postal Service's own.

Some commenters assert that the Postal Service has not properly substantiated that property disposals under the revised CATEX would not normally result in significant environmental impacts. As explained in the interim final rule, CEQ has advised that an agency can substantiate its own CATEX by comparing another agency's experience promulgating and applying a comparable CATEX ( see 75 FR 75628). That—along with the Postal Service's experience described in the interim final rule and the experience of two federal agencies with comparable CATEXs—supports the Postal Service's decision to finalize its amended property disposal CATEX via this final rule.

All commenters convey the general notion that disposals of historic properties should warrant more NEPA review (not less). The Postal Service's revision to its CATEX in no way limits the Postal Service's NEPA review of historic properties. Like GSA and USCG, the Postal Service already has additional procedures specifically for reviewing proposed disposals of historic properties ( see, Facilities Environmental Guide Handbook RE-6 § 3-4.1 (“Historic and cultural resources are considered in the environmental planning processes, both environmental due diligence and NEPA[.]”). As explained with regard to the interim final rule (79 FR 2102, 2103), the Postal Service's procedural safeguards regarding historical properties remain an integral part of the Postal Service's property disposal process. See, e.g., Facilities Environmental Guide Handbook RE-6 § 3-4.3.4.4.4 (discussing circumstances prompting and requirements for implementing preservation covenants). Historic status remains a factor in determining whether “extraordinary circumstances” require further NEPA review, notwithstanding an otherwise applicable CATEX. This rulemaking does not diminish the significance of historic status as a factor in an overall assessment of potential environmental impacts and extraordinary circumstances.

Some commenters ask that the Postal Service couple its CATEX revision with an amendment making a property's historic listing an “extraordinary circumstance” that would automatically trigger an EA. This suggestion is at odds with CEQ guidance, however. According to CEQ, “the agencies may define their extraordinary circumstances differently, so that a particular situation, such as the presence of a protected resource [e.g., historic property], is not considered an extraordinary circumstance per se, but a factor to consider when determining if there are extraordinary circumstances, such as a significant impact to that resource” (75 FR 75628, 75629, Dec. 6, 2010). CEQ's guidance is consistent with the Postal Service's experience with sales of historical properties.

In a great many instances, the disposal of a historic Postal Service property does not result in significant environmental impacts. As described in the previous section, the Postal Service, GSA, and USCG each consider whether such potential issues exist and whether they could be sufficiently alleviated outside of the NEPA process, such as through historic preservation covenants. In other words, historic status may be a starting point to consideration of “extraordinary circumstances,” but it is not an immediate EA decision point under the regulatory scheme of the GSA, USCG, or USPS. The Postal Service's “extraordinary circumstance” regulations are consistent with those of the GSA and USCG in this regard, and the use of those agencies' CATEXs as models does not provide a basis for additional changes to other aspects of the Postal Service's CATEX regulations.

One commenter believes that any proposed action to move Postal Service activities from a downtown area should be subject to an environmental impact statement (EIS). Although this rulemaking's CATEX covers proposed actions to dispose of property rather than to move the Postal Service's operations from one place to another, both categories of decisions and others are subject to the Postal Service's NEPA process. Under the Postal Service's longstanding NEPA regulations, an EIS does not generally need to be performed for a Postal Service action, including a routine transfer of operations, absent extraordinary circumstances. See 39 CFR 775.5(a); 40 CFR 1508.27.

Although the National Historic Preservation Act (NHPA) and National Register of Historic Places are not immediately relevant to this NEPA rulemaking, commenters have discussed their application to federal entities' property disposals, particularly the GSA's. Several commenters state that the Postal Service must consider a property's listing on the National Register of Historic Places, which the Postal Service already does as part of its NEPA analysis. Commenters also make an effort to distinguish the Postal Service's requisite procedures for evaluating potential disposals of historical properties with GSA's.

As discussed above, the Postal Service already has special procedures for reviewing proposed disposals of historic properties ( Facilities Environmental Guide Handbook RE-6 §§ 3-4.1, 3-4.3.4.4.4), and this rulemaking does not change or otherwise affect those procedures or the significance of a property's historic status. The Postal Service voluntarily complies with the requirements of Section 106 of the NHPA (16 U.S.C. 470f) in making a finding that there would be no adverse effects to a historic property as a result of a disposal, or if an adverse effect is found, then consulting with the requisite parties to develop an agreement to mitigate adverse effects. These procedures remain effective notwithstanding this rulemaking, and they are generally similar to other Federal entities' corresponding procedures. As such, they do not affect the reasonableness of the Postal Service's amendment to its NEPA procedures on the basis of GSA's model.

One commenter offered an opinion that the common-law public trust doctrine affects the Postal Service's ability to modify a NEPA CATEX. While courts have applied the public trust doctrine to natural resources (particularly water-related resources), there does not appear to be authority for the proposition that the public trust doctrine applies to government-owned facilities and property. Such a proposition would seem contrary to the long history of disposals of governmental property. Nor does the Constitution pose any such limits on Congress's powers to provide for the disposal of federal property.

In fact, the Constitution explicitly vests Congress with the power “to dispose of any kind of property belonging to the United States . . . without limitation.” Alabama v. Texas, 347 U.S. 272, 273 (1954) (per curiam) (internal quotation marks and citation omitted). Congress has expressly delegated its disposal powers to the Postal Service. See 39 U.S.C. 401(5). Thus, even if the public trust doctrine somehow applied to the federal government as a general matter, the doctrine still would not encumber the Postal Service as a statutory matter. See 39 U.S.C. 410(a).

Even if the public trust doctrine had any relevance for disposals of government property, the public trust doctrine is a distinct area of state law that does not apply to a federal NEPA rulemaking. PPL Mont., LLC v. Montana, 132 S. Ct. 1215, 1235 (2012) (emphasizing that the public trust doctrine “remains a matter of state law”). As such, the Constitution's Supremacy Clause bars it from applying to the Postal Service.

One group of commenters asserts that the interim final rule would reduce public participation in the facility disposal process at a time when there is great national interest in historic Post Offices. Adoption of this final rule will have no adverse effect on the existing robust avenues for public participation in Postal Service processes for disposals of historic properties. The Postal Service, itself a historic institution, highly values its historic properties and takes seriously its voluntary compliance with sections 106, 110, and 111 of the National Historic Preservation Act and the historic preservation regulations.

In particular, with respect to the occasional sale of an historic post office, the Postal Service strictly adheres to the section 106 regulations (36 CFR part 800), which provide a comprehensive, consistent, transparent, consultative process. That process requires identifying historic properties, assessing the effects of Postal Service undertakings and, in consultation with local officials and with community input, seeking ways to avoid, minimize or mitigate any adverse effects on historic properties. Additionally, for real property disposals, under its regulations implementing applicable provisions of the Intergovernmental Cooperation Act (39 CFR part 778), the Postal Service provides opportunities for consultation by elected officials of those state and local governments that would be directly affected by the Postal Service's real property disposals.

For the reasons stated in the preamble, 39 CFR part 775 is amended as follows:

On October 17, 2006, (71 FR 61144), EPA established the 24-hour PM 2.5 NAAQS at 35.0 micrograms per cubic meter. On November 13, 2009 (74 FR 58688), EPA published its air quality designations and classifications for the 2006 24-hour PM 2.5 NAAQS based upon air quality monitoring data for calendar years 2006-2008. These designations became effective on December 14, 2009. The Knoxville Area was designated nonattainment for the 2006 24-hour PM 2.5 NAAQS.

Designation of an area as nonattainment starts the process for a state to develop and submit to EPA a SIP revision under title I, part D of the CAA. This SIP revision must include, among other elements, a demonstration of how the NAAQS will be attained in the nonattainment area as expeditiously as practicable, but no later than the date required by the CAA. On June 6, 2012 (77 FR 33360), EPA proposed that the Knoxville Area had attained the 2006 24-hour PM 2.5 NAAQS. The proposed determination of attainment was based upon quality-assured and certified ambient air monitoring data for the 2009-2011 time period. EPA published the final determination of attainment on August 2, 2012 (77 FR 45954). 1 In accordance with the final determination of attainment, the requirements for the Knoxville Area to submit an attainment demonstration and associated reasonably available control measures (RACM), a reasonable further progress (RFP) plan, contingency measures, and other SIP revisions related to attainment of the standard are suspended, so long as the Area continues to attain the 2006 24-hour PM 2.5 NAAQS.

The determination of attainment, however, does not suspend the emissions inventory requirement found in the CAA section 172(c)(3). On October 18, 2013, Tennessee submitted a 2008 base year emissions inventory for the 2006 PM 2.5 24-hour NAAQS in the Knoxville Area.

As discussed above, section 172(c)(3) of the CAA requires nonattainment areas to submit a comprehensive, accurate, and current inventory of actual emissions from all sources of the relevant pollutant or pollutants in such areas. Tennessee selected 2008 as the base year for the emissions inventory per 40 CFR 51.1008(b) because, at the time that the State submitted its October 18, 2013, SIP revision, it was the most recent calendar year for which the State had developed a comprehensive emissions inventory to meet the federal National Emissions Inventory requirements. The emissions inventory contained in TDEC's SIP revision covers the general source categories of point sources, non-road mobile sources, area sources, and on-road mobile sources of direct and precursor emissions of PM 2.5 . The precursor emissions included in the Knoxville Area emissions inventory include ammonia (NH 3 ), nitrogen oxides (NO X ), sulfur dioxide (SO 2 ), and volatile organic compounds (VOCs). A detailed discussion of the emissions inventory development can be found in Appendix A of the Tennessee submittal found in the docket of today's rulemaking. The table below provides a summary of the annual 2008 emissions of NH 3 , NO X , VOCs, SO 2 , and direct PM 2.5 included in the Tennessee submittal.

Tennessee developed the 2008 emissions inventory for the Knoxville Area by incorporating data from multiple sources. States were required to develop and submit to EPA a triennial emissions inventory according to the Consolidated Emissions Reporting Rule for all source categories (i.e., point, non-road mobile, area, and on-road mobile). This inventory often forms the basis of data that are updated with more recent information and data that also are used in the attainment demonstration modeling inventory. Such was the case in the development of the 2008 base-year emissions inventory that was submitted in TDEC's SIP revision for the Knoxville Area. The 2008 base-year emissions for the 2008 inventory included here were developed in a number of ways. Some of the information was developed at the local and state level. Some emissions data were developed by EPA as described in EPA's 2008 National Emissions Inventory, Version 2, Technical Support Document, June 2012, Draft documentation. Some data sets are a hybrid of the two—where local inputs are provided to EPA to generate emissions. Tennessee's emissions inventory data were developed according to the most recent EPA emissions inventory guidance available at the time that Tennessee submitted the October 18, 2013, SIP revision.

EPA has reviewed the 2008 base year emissions inventory for the Knoxville Area in Tennessee's October 18, 2013, SIP revision and determined that the process used to develop this inventory was consistent with the CAA, implementing regulations, and EPA guidance for emissions inventories. EPA has therefore determined that this emissions inventory is adequate for the purposes of meeting the emissions inventory requirement in section 172(c)(3).

EPA is taking direct final action to approve the 2008 base year emissions inventory portion of the attainment demonstration SIP revision for the Knoxville Area submitted by the State of Tennessee on October 18, 2013. EPA determined that this action is consistent with section 110 and 172(c)(3) of the CAA.

EPA is publishing this rule without prior proposal because the Agency views this as a non-controversial revision and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should relevant adverse comment be filed. This rule will be effective on August 11, 2014 without further notice unless the Agency receives relevant adverse comment by July 10, 2014. If EPA receives such comments, EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. EPA will address all relevant adverse comment received during the comment period in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so by July 10, 2014. If no such comments are received, this rule will be effective on August 11, 2014 and no further action will be taken on the proposed rule.

Under the 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. 3501 et 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. 601 et 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).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 11, 2014. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

EPA is approving a revision to the Jefferson County portion of the Kentucky SIP to incorporate revisions to Jefferson County Regulation 1.07, “Emissions During Startups, Shutdowns, Malfunctions and Emergencies” (referred to hereafter as “Rule 1.07”). The revision modifies all seven sections of the existing version of Rule 1.07 currently in the EPA-approved SIP for Jefferson County. These changes to Rule 1.07 became effective in Jefferson County on July 1, 2005. EPA believes that the changes to this rule are consistent with CAA requirements that apply to excess emissions during startup, shutdown and malfunction (SSM) events. In addition, EPA believes that these changes correct existing concerns about Rule 1.07 in the Jefferson County portion of the Kentucky SIP, as explained below. Please refer to the docket for this rulemaking for the complete text of the adopted provisions.

On March 22, 2011, KDAQ submitted a request for EPA approval of a SIP submittal containing proposed revisions to the Regulation entitled “Emissions During Startups, Shutdowns, Malfunctions and Emergencies” in the Jefferson County portion of the Kentucky SIP. In an action published on May 21, 2013 (78 FR 29683), EPA proposed to approve the proposed revisions. As noted in that proposal notice, the Louisville Metro Air Pollution Control District proactively adopted changes on June 21, 2005, with the intent of correcting inconsistencies between its rule and the CAA and EPA guidance regarding SIP provisions that apply to the treatment of excess emissions that may occur during source SSM events. The changes to Rule 1.07, which were included in the March 22, 2011, SIP revision provided to EPA by KDAQ, include: (1) Changing the name of the regulation from “Emissions During Startups, Shutdowns, Malfunctions and Emergencies” to “Excess Emissions During Startups, Shutdowns, and Upset Conditions”; (2) clarifying that excess emissions from a process or process equipment due to startup, shutdown, or upset (i.e., malfunction) condition shall be deemed in violation of the applicable emission standards; (3) removing the authority of the District to grant discretionary exemptions from compliance with SIP emission standards during SSM events; (4) augmenting the source excess emission reporting requirements to assist the District in evaluating whether ambient standards and goals have been exceeded and whether enforcement actions are needed to protect public health and welfare; and (5) removing the provisions that created exemptions for excess emissions during emergencies based upon factors comparable to an affirmative defense.

EPA received numerous comments on the May 21, 2013, rulemaking proposing to approve a revision to the Regulation entitled “Emissions During Startups, Shutdowns, Malfunctions and Emergencies” in the Jefferson County portion of the Kentucky SIP. Specifically, the Louisville Gas and Electric and Kentucky Utilities Energy Company (LG&E) provided comments adverse to the proposed rulemaking, and a number of environmental organizations and approximately 74 citizens provided comments supporting the proposed rulemaking. All of the comments received by EPA are included in the docket for today's final action using Docket ID EPA-R04-OAR-2013-0272. A summary of the comments and EPA's responses are provided below.

The adverse comments provided by LG&E consist primarily of technical concerns associated with the administration of the revised version of Rule 1.07 during SSM events. These technical concerns, however, do not appear to have been raised by LG&E at earlier stages of the rulemaking process when these revisions were being considered at the state level. 1 EPA notes that these types of concerns are more appropriately raised first during the rule development process undertaken by a state, rather than later during EPA's evaluation of a submitted SIP revision. Nevertheless, EPA has evaluated the specific technical concerns raised by the commenter, identified as comments 1 through 8 below, and provides detailed responses. EPA has determined that the revisions to Rule 1.07 are consistent with the CAA and applicable EPA guidance, and therefore the Agency is approving these revisions into the Kentucky SIP as it applies to Jefferson County.

Comment 1: The commenter asserted that the revised version of Rule 1.07 as “written and presently enforced” is “having a negative and unnecessary impact on LG&E and KU Energy LLC's operations and customers” and that “continued enforcement could have an escalated and even more detrimental impact on electric reliability and customer costs.”

Response 1: The commenter provided no specific information supporting its contentions that the revised rule is having negative or unnecessary impacts on LG&E's operations and customers. EPA is aware of one action taken by the District in recent years to enforce SIP requirements consistent with revised Rule 1.07 and two other Jefferson County rules at the LG&E Cane Run Power Plant in Louisville. That enforcement action resulted in a requirement that the source take corrective action and pay penalties pursuant to an administrative settlement. 2 Such enforcement actions are intended to encourage better source compliance with applicable environmental regulations that are in place for the protection of the environment and human health.

With respect to how the revised Rule 1.07 is written, the revisions reflect the District's decision to bring it into compliance with CAA requirements and thus warrant approval by EPA into the Commonwealth's SIP. With respect to how the District elects to enforce SIP requirements consistent with Rule 1.07, that likewise reflects the District's proper exercise of its enforcement discretion authority, consistent with CAA requirements. By contrast, EPA believes that SIP provisions that allow for automatic and discretionary exemptions for excess emissions during SSM events, such as those eliminated by the District in the revised version of Rule 1.07, allow facilities to be less diligent in minimizing pollutant emissions during such times and that this can result in unnecessary adverse impacts on citizens, including customers of LG&E. The commenter's concern that it may be required to comply with SIP requirements as a result of the revisions to Rule 1.07 through enforcement actions is not a basis for EPA to disapprove a SIP revision that complies with CAA requirements.

Comment 2: The commenter claimed that the District's assertion that an electric generating unit (EGU) should be able to operate in compliance with emission standards during startup, shutdown and upset periods is “technically infeasible and goes against past EPA actions and findings pertaining to emissions during these periods.”

Response 2: The commenter did not provide specific facts or information to support this broad claim regarding EGU operation. Furthermore, EPA disagrees with the basic premise stated by the commenter for multiple reasons. First, the commenter asserted that EGUs cannot operate in compliance with emission standards during startup and shutdown. EPA disagrees with this presumption. Startup and shutdown are normal modes of source operation, and it is technically feasible for sources to meet emission standards during such periods of operation. When appropriate, emission standards may entail imposition of different numerical levels or averaging periods allowed during startup and shutdown or may require imposition of different forms of emission control during startup and shutdown. Rather than allowing EGUs to have impermissible exemptions from applicable emission limits during SSM events, the District has elected to require sources to meet the applicable SIP emission limits at all times, and this decision is consistent with CAA requirements.

Second, the commenter claimed that the District's expectation that sources meet emission standards during startup and shutdown “goes against past Agency actions.” The commenter did not state which “Agency actions” it was referring to, and the commenter also failed to note that EPA's own recent regulations pertaining to various source categories do in fact impose numerical emission limits upon sources that apply at all times, including startup, shutdown and malfunction periods. For example, in 2012 EPA amended the National Emission Standards for Hazardous Air Pollutant (NESHAP) Emissions for Steel Pickling-HCl Process Facilities by adding provisions requiring that the emission limits of the rule apply at all times, including during SSM periods. 3 As a more recent example, EPA revised the NESHAPs for Group IV Polymers and Resins, Pesticide Active Ingredient Production, and Polyether Polyols Production by eliminating the exemption for SSM periods so that the emission standards in each rule apply at all times. 4

Third, the commenter disregarded EPA's longstanding interpretation of the CAA with respect to SIP provisions addressing emissions during SSM events. Since at least 1982, EPA's interpretation of the CAA has been that periods of startup and shutdown of process equipment are part of the normal operation of a source and should be accounted for in the design and implementation or the operating procedure for the process and control equipment. Accordingly, careful planning can be reasonably expected to eliminate violations of emission limitations during such periods. 5

Fourth, the commenter implied that because compliance with emission limits during malfunctions is “technically infeasible,” sources should be entitled to exemptions from applicable SIP emission limits and thus excused for violations due to excess emissions during such events. EPA has long interpreted the CAA to prohibit exemptions for excess emissions during malfunctions and to require that the excess emissions be treated as violations. 6 EPA's own recent regulations provide no such exemptions for excess emissions during malfunctions as the courts have held that no such exemptions are permissible because emission limits must apply continuously.

Finally, EPA notes that the District, in addition to be being correct that the CAA requires sources to be subject to emission limitations at all times, including during SSM events, has discretion to elect how to regulate air pollutant emissions, consistent with CAA requirements. The District has authority to develop SIP provisions that impose appropriate alternative emission limitations applicable during startup and shutdown, consistent with EPA's guidance for such provisions in the 1999 SSM Policy, but the District is not required to do so. In adopting this rule revision, the District has determined that sources do not need exemptions for SSM events and should be required to meet the otherwise applicable SIP emission limits at all times. By removing the exemptions for SSM events, the District may seek to limit the number of SSM events, the duration of such events, and the amount of excess emissions during such events in order to meet CAA requirements and to protect public health. For the District to elect to do so is reasonable and also consistent with CAA requirements. EPA's duty under section 110(k) of the CAA is to act upon submitted SIP revisions and to approve those that meet applicable CAA requirements.

Comment 3: The commenter stated that emission standards are developed as limits to assure a source does not create an issue with National Ambient Air Quality Standards (NAAQS) based on “full load normal operation.”

Response 3: EPA disagrees with the commenter's limited view of the purpose of emission limits in SIPs. The CAA requires the imposition of SIP emission limits on sources for a variety of purposes, including for attainment and maintenance of the NAAQS, protection of PSD increments, and protection of visibility. Even with respect to attainment and maintenance of the NAAQS, however, the commenter is incorrect concerning the way in which states may devise the required emission limits. Pursuant to the CAA, each state is required to adopt and submit to the Administrator a plan that provides for implementation, maintenance, and enforcement of the NAAQS within such state. Each such plan must include enforceable emission limitations and other control measures, means, or techniques, as well as schedules and timetables for compliance, as may be necessary or appropriate to meet the applicable requirements of the Act. See CAA sections 110(a)(1) and (2). Additional requirements apply in certain areas, such as requirements that sources meet a reasonably available control measure (RACM) or reasonably available control technology (RACT) level of control in areas designated nonattainment for purposes of the NAAQS. See, e.g., CAA sections 172(c), 188, and 189 (applicable to areas designated nonattainment for purposes of particulate matter NAAQS).

In particular, the Agency disagrees that states must develop all emission standards to limit emissions only during “full load normal operation.” States have discretion as to how they arrive at appropriately protective emission limitations, and their approach may or may not be based only upon evaluation of emissions during “full load normal operation.” Nevertheless, the otherwise applicable emission limitations adopted by the state and approved into the SIP apply at all times unless the applicable provisions include alternative emission limitations under specific circumstances, such as during startup or shutdown.

EPA also notes that, in accordance with CAA section 302(k), SIPs must contain emission limitations that “limit the quantity, rate, or concentration of emissions of air pollutants on a continuous basis.” EPA has reiterated these requirements of the CAA with respect to SIP provisions in a recent proposal. 7 Court decisions confirm that this requirement for continuous compliance prohibits exemptions for excess emissions during SSM events. 8 Exemptions from SIP emission limits would authorize sources to emit pollutants during such periods in quantities that could interfere with attainment and maintenance of the NAAQS, protection of PSD increments, and protection of visibility.

Comment 4: The commenter stated that “[d]uring periods of startup, certain emissions control equipment (i.e., electrostatic precipitator, selective catalytic reduction, pulsed jet fabric filters) cannot be activated until specific temperatures are reached from operation of the source.” Based on this assertion, the commenter argued, “[i]t follows that a source required to utilize such emission control equipment should not be held to a numerical standard that was developed for limiting emissions during full load, normal operation.”

Response 4: The main premise of the commenter's argument is that some existing control measures at a source may not function, or function as effectively, during all modes of source operation. EPA understands that certain emission control equipment at some sources are not fully operational in some circumstances, such as when sufficient temperatures have not been reached, as described by the commenter. EPA does not agree, however, that “it follows” automatically that sources should be excused from meeting any emission limitations during startup. As noted above, SIPs must contain emission limitations that apply on a continuous basis. EPA also does not necessarily agree that sources are incapable of meeting emission limitations that may have been developed based upon full load operation. Sources that have difficulty meeting existing emission limitations during startup should take steps to reduce emissions during such events. These steps may include changes to the facility's operations or installation of supplemental control measures. As also noted above, the District has the authority to establish appropriate alternative emission limitations to apply during startup periods but is not required to do so. The District has exercised its discretion to revise Rule 1.07 such that the SIP does not provide for exemptions to otherwise applicable emission limitations during startup events.

Comment 5: The commenter claimed that “during periods of startup, although an emission rate may be exceeded, the mass emissions are actually very low in comparison to normal operation because volumetric flow is very low during startup.” Based upon this assertion, the commenter argued that “concerns with emissions that affect the NAAQS are negated.”

Response 5: As noted above, EPA's interpretation of the CAA is that periods of startup are part of the normal operation of a source. Here, EPA interprets the commenter's reference to “normal operation” to mean full load operation. EPA disagrees with the basis of the commenter's argument—that emissions rate exceedances are of less concern when they occur during periods of startup than during full load operation because the mass emissions may be lower in comparison to full load operation. The relatively lower flow and lower gas stream temperatures that may be associated with a startup period could result in less dispersion and transport of pollutants. As a result, communities located close to the facility could experience greater adverse impacts during startup than during full load operation, even if the rate of total pollutant emissions is lower by mass. The District's revisions to Rule 1.07 eliminated impermissible exemptions that precluded the District, the Commonwealth, EPA and citizens from taking legal action to require sources to make reasonable efforts to reduce these emissions.

Comment 6: The commenter advocated that EPA should make clear that “certain measures, including good engineering combustion and pollution control practices, are an appropriate limitation to apply during startup, shutdown and upset condition periods.” The commenter asserted that EPA has promulgated work practice standards to minimize emissions during these periods in both the utility Mercury and Air Toxics Standards (MATS) and the boiler Maximum Achievable Control Technology (MACT) rules and should, to the extent possible, address such emissions in a consistent manner under all CAA regulatory programs. The implication of the commenter's statements is that EPA should require the District to adopt some other mode or means of control of sources to apply during SSM events.

Response 6: EPA agrees that states have discretion to determine how to regulate emissions during startup and shutdown events in most SIP provisions, consistent with CAA requirements, but SIP emission limits may not include exemptions for emissions during startup and shutdown events. Instead, states may include alternative emission limits for such modes of source operation so long as they are consistent with CAA requirements. EPA's 1999 SSM Policy includes guidance to states that elect to develop such alternative limits to apply during startup and shutdown. EPA notes that emission limits that apply during specific modes of source operation such as startup and shutdown do not necessarily need to be expressed as a numerical limit, so long as they meet other CAA requirements with respect to enforceability and the requisite level of control (e.g., RACT or RACM). Similarly, the emission limits applicable during startup and shutdown do not necessarily have to be set at the same numerical level as during other modes of source operation, so long as they otherwise meet all CAA requirements. By contrast, however, EPA considers it impracticable to develop alternative SIP emission limits (whether stated numerically or as requirement for a particular control or technique) that apply specifically during malfunctions because, by definition, malfunctions are events that are not reasonably foreseeable, are not avoidable through appropriate source design, operation and maintenance, and are not controllable. Accordingly, sources are required to meet the otherwise applicable SIP emission limits during malfunctions, and any excess emissions during such events are considered violations. To the extent, however, that the commenter suggests that EPA should require states to develop alternative emission limits that apply during startup and shutdown, in lieu of the otherwise applicable SIP emission limits, EPA disagrees that its role is to require states to do so.

The commenter also suggests that SIP rules should be consistent with federally promulgated standards and points to, as examples, the rules often referred to as the MATS and Boiler MACT rules. The MATS rule established standards for hazardous air pollutant (HAP) emissions from coal- and oil-fired electric utility steam generating units (40 CFR part 63 subpart UUUUU). See 77 FR 9304 (February 16, 2012). In the same rulemaking that promulgated the MATS rule, EPA also finalized changes to the New Source Performance Standards (NSPS) that apply to coal- and oil-fired EGUs, industrial-commercial-institutional steam generating units, and small industrial commercial-institutional steam generating units (40 CFR part 60 subparts D, Da, Db, and Dc), often referred to as the Utility NSPS rule. 9 The major source Boiler MACT rule was published on March 21, 2011 (76 FR 15608), and applies to industrial, commercial, and institutional boilers and process heaters that are located at, or are part of, a major source  10 of HAP emissions (40 CFR 63 subpart DDDDD). The area source Boiler MACT, also published on March 21, 2011 (76 FR 15554), applies to industrial, commercial, and institutional boilers that are located at, or are part of, an area source  11 of HAP emissions (40 CFR 63 subpart JJJJJJ). 12

Under the MATS, Utility NSPS, and Boiler MACT rules, numeric emission limits generally apply for all relevant air pollutants and their surrogates (except organic HAPs) and for all periods of operation. For periods of startup and shutdown, however, these rules require facilities to comply with work practice standards  13 for minimizing emissions in lieu of numeric emission limits.

EPA understands the commenter's suggestion that regulatory requirements applicable to sources for purposes of SIPs should be consistent, “to the extent possible,” with the requirements of other CAA programs. On this point, EPA notes that the rules established under the NSPS and NESHAP programs are designed to achieve different objectives of the CAA than that of SIPs. They are technology-based, industry-specific standards that are nationally uniform in limiting the amount of emissions allowed from sources. Under section 111 of the CAA, an NSPS must reflect the degree of emission limitation and the percentage reduction achievable by new sources or modified existing sources through application of the best technological system of continuous emission reduction that the Administrator determines has been adequately demonstrated. Similarly, under section 112 of the CAA, a NESHAP must require the maximum degree of reduction in emissions of hazardous air pollutants achievable by new sources and existing sources as determined by the Administrator. In setting standards under sections 111 and 112, the Administrator must take into consideration the cost of achieving such emission reductions and any non-air quality health and environmental impact and energy requirements; under section 112, the statute requires a minimum stringency standard for existing sources based on the average emission limitation achieved in practice by the best controlled 12 percent of sources and a minimum stringency standard for new sources based on the best controlled similar source.

In contrast to the NSPS and NESHAP programs, SIPs are EPA-approved state plans to provide for the attainment and maintenance of the NAAQS and to meet other requirements such as protecting PSD increments and visibility. Under section 110 of the Act, each state must adopt a plan that it determines will provide for air quality that meets the primary and secondary NAAQS within the state. Consequently, SIPs must be consistent with attainment and maintenance of the NAAQS and prevention of significant deterioration of air quality throughout the state. Exemptions from SIP emission limits, such as that allowed under the prior version of Rule 1.07, are not appropriate because any emissions above the SIP allowable rate may cause or contribute to violations of the ambient air quality standards and interfere with enforcement of those SIP limits. Thus, EPA's interpretation of the CAA, upheld by the courts, is that all periods of excess emissions must be considered violations.

While the NSPS and NESHAP may provide good models of emission control technology and emission limits, they do not necessarily address all of the issues relevant to SIP provisions and they do not dictate state choices with respect to control measures or emission limitations. To the extent that a particular NSPS or NESHAP imposing a specific control measure or emission limit is relevant to a given source category, states may elect to consider imposing comparable controls to meet SIP requirements, as appropriate. In addition, to the extent that imposition of a specific control measure or emission limit in an EPA regulation helps to establish that a given control measure is technologically or economically feasible for a given source category, states may need to take such controls into account when evaluating emission limits for SIP purposes. EPA emphasizes, however, that any such consideration would need to be based on the specific facts and circumstances of a given source category, as the considerations relevant to the development of the NSPS or NESHAP may or may not be useful for SIP purposes.

Further, while some emission sources may have difficulty complying with emission standards during startup, shutdown and upset periods, there are other sources of similar type that are capable of complying continuously during such events, especially events that are planned for in advance, such as startups and shutdowns. Thus, an appropriately protective SIP rule encourages compliance by all sources at all times through generally applicable emission limits that apply during full load operation as well as during startup and shutdown events. Where such generally applicable limits are not feasible for an emission source during startup or shutdown events, the SIP may contain appropriately established alternative emission limitations that apply during those events. In instances in which an exceedance of an emission limit is truly unavoidable because of a malfunction, exercise of enforcement discretion by potential enforcers, or exercise of discretion with respect to penalties by courts in the event of citizen enforcement, consistent with the provisions of CAA section 113, allows for proper consideration of the relevant circumstances during the event.

Comment 7: The commenter expressed concerns about the accuracy of emission rates that are calculated for startup and shutdown periods. The commenter stated that:

Response 7: EPA does not dispute that emission rates calculated for a coal-fired EGU during startup and shutdown may be less accurate than during full load operation, assuming that the formula used for the calculations only reflects full load operation. In some instances, a calculated emission rate may indicate exceedance of an applicable SIP emission limit only because existing parameters, such as combustion airflow, are not consistent with the assumptions inherent to the calculation method.

To the extent that the commenter advocates that calculated emission rates should be adjusted so that they more accurately reflect the emissions that may occur during startup and shutdown, EPA believes such an approach would be appropriate and would serve to assure that emissions estimates are more accurate for the purposes of compliance determination and emissions inventories. EPA notes that some existing Federal rules provide options for dealing with the concern expressed by the commenter. For example, for computing nitrogen oxide emission rates and using CO 2 as a diluent, the continuous emission monitoring procedures of 40 CFR Part 75 allow boiler operators to substitute a minimum concentration of 5.0 percent CO 2 whenever the measured concentration is less than 5.0 percent. See 40 CFR Part 75, Appendix F, paragraph 3.3.4.1. This prevents the calculation of disproportionately high emission rates due to very a low CO 2 concentration, which, as indicated by the commenter, is a factor in the denominator of the calculation.

As noted in response to Comment 2 above, an appropriately protective SIP provision is designed to impose appropriate emission limits or controls and to require compliance at all times. However, if a source cannot demonstrate compliance based upon the applicable method in use, enforcement discretion may be used to determine whether to bring an enforcement action and, in the event that there is enforcement, the extent of any actual violation will be based upon all relevant factual information that is credible evidence. By eliminating the impermissible exemptions in the prior version of Rule 1.07, the District has taken steps to properly account for all emissions.

Comment 8: The commenter expressed concerns about the accuracy of PM CEMS for determining compliance with PM emission limits during startup and shutdown events. The commenter argued that:

Response 8: EPA disagrees that the output of the PM CEMS during periods of startup and shutdown cannot be considered representative of actual emissions, regardless of whether Reference Method stack testing has been performed during startup and shutdown periods. The accuracy of PM CEMS data would be questionable if those data were recorded when the response of the PM CEMS falls outside the correlation range obtained during Reference Method testing. During periods of startup and shutdown, at times some PM CEMS responses may fall outside the correlation range, but any data measurements recorded within that range would be considered useful in assessing PM control device performance.

Furthermore, the subject rule of this action does not require that PM CEMS data must be used to determine compliance status during startup and shutdown periods; it merely requires that that the applicable emission limit applies at all times, including SSM periods. PM CEMS data is not the only type of information that a court may find credible when evaluating whether or not a source would have been in violation of an emission standard. For example, opacity data from continuous opacity monitors (which may be required by another provision of the statute or the SIP) and recordkeeping data on emission control equipment use may also provide relevant information. The validity of all data is a consideration that must be taken into account, along with all other available credible evidence, when evaluating whether a source is in compliance with SIP emission limits.

Comment 9: One commenter, a national environmental group, submitted comments in support of EPA's proposed approval of the District's revisions to Rule 1.07. The commenter provided its own analysis of the merits of the revisions to Rule 1.07 and its own explanation of why these revisions are consistent with CAA requirements and EPA's interpretation of the CAA with respect to proper treatment of excess emissions during SSM events. In particular, the commenter supported the clarification that excess emissions are violations of emission standards, the elimination of the prior discretionary exemptions for excess emissions, and the improved notification and reporting requirements.

In addition, the commenter emphasized that these revisions to Rule 1.07 will help to reduce excess emissions during SSM events from sources that “jeopardize[] public health and quality of life in nearby communities.” As an example, the commenter stated that an environmental justice community in Kentucky has been impacted by such emissions from specific sources. The commenter supported the District's revisions to Rule 1.07 and EPA's approval of those revisions as a means “to help mitigate the impacts of large pollution events on local communities in Jefferson County, directly improving people's lives.” EPA notes that 74 individual citizens from Kentucky also filed supportive comments, echoing the key points raised by the environmental group.

Response 9: EPA agrees with the commenters who supported the Agency's approval of the District's revisions to Rule 1.07 on the grounds that this will help to assure that sources take appropriate action to reduce their emissions in order to meet CAA requirements and thereby help to protect public health and welfare. Although the commenters did not provide detailed information concerning the specific sources and specific events that they described, EPA agrees that exemptions for excess emissions during SSM events in SIP provisions have the potential to expose surrounding communities to higher levels of pollutants and to remove incentives for sources to control and minimize such emissions during SSM events. As a result of such exemptions, communities near such sources may have no adequate legal recourse to address these problems. For the protection of public health, the CAA imposes obligations upon both states and EPA. States are required to develop SIPs that meet CAA requirements; EPA is required to evaluate the SIPs to assure that they meet CAA requirements. A key CAA requirement for SIP provisions is that they must impose emission limitations upon sources that apply continuously, thereby precluding exemptions for excess emissions from sources during SSM events and allowing for effective enforcement by air agencies, EPA, and the public to assure that sources comply with CAA requirements.

EPA is approving part of a revision to the Kentucky SIP submitted by the Commonwealth of Kentucky, through KDAQ, on March 22, 2011. This approval includes the changes to Rule 1.07 in the Jefferson County portion of the Kentucky SIP noted in section II above. After review and consideration of the relevant information and data, including the comments received, EPA has determined that this portion of Kentucky's March 22, 2011, SIP revision is consistent with the CAA and EPA's SSM policy.

Under the 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. 3501 et 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. 601 et 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).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 11, 2014. 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 may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

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

On February 6, 2014 (79 FR 7118), EPA proposed to approve the 2012 Five Percent Plan, 1 which the State of Arizona submitted on May 25, 2012, as meeting all relevant statutory and regulatory requirements under the Clean Air Act (CAA). As discussed in our proposed rule, the Maricopa County (Phoenix) PM-10 nonattainment area is a serious PM-10 nonattainment area, and is located in the eastern portion of Maricopa County and encompasses the cities of Phoenix, Mesa, Scottsdale, Tempe, Chandler, Glendale, several other smaller jurisdictions, unincorporated County lands, as well as the town of Apache Junction in Pinal County. Arizona's obligation to submit the 2012 Five Percent Plan was triggered by EPA's June 6, 2007 finding that the Maricopa PM-10 Nonattainment Area had failed to meet its December 31, 2006 deadline to attain the PM-10 NAAQS. The CAA requires a serious PM-10 nonattainment area that fails to meet its attainment deadline to submit a plan providing for attainment of the PM-10 NAAQS and for an annual emission reduction in PM-10 or PM-10 precursors of not less than five percent until attainment. Our February 6, 2014 proposed rule provides the background and rationale for this action. 2

EPA provided a 30-day public comment period on our proposed action. The comment period ended on March 10, 2014. We received 12 public comment letters from State and local agencies, industry, congressional representatives and environmental groups. 3 All of the submitted comment letters are in our docket. We respond to all the comments below.

Comment: The Arizona Center for Law in the Public Interest (ACLPI) commented that EPA's proposed action did not discuss or analyze requirements under CAA 189(b)(1)(B) for best available control measures (BACM) or requirements under CAA 188(e) for most stringent measures (MSM). ACLPI stated that these requirements apply to the Maricopa County PM-10 nonattainment area because it is a serious PM-10 nonattainment area that obtained a five-year extension of its attainment date pursuant to section 188(e) in 2001. ACLPI also asserts that EPA's 2002 approval of BACM and MSM requirements must be updated in light of EPA's statements in correspondence to ADEQ and in a proposed rulemaking in 2010 that new more stringent control measures have been adopted by air agencies in Nevada and California and that agricultural controls no longer represent BACM. ACLPI also states that addressing the question of whether existing control constitute BACM is necessary in order to evaluate ADEQ's claims that 135 exceedances qualify as exceptional events.

Response: EPA disagrees with the commenter's statement that EPA's proposed action on the 2012 Five Percent Plan did not discuss or analyze section 189(b)(1)(B) and 188(e) requirements for BACM and MSM. Our proposed action on the 2012 Five Percent Plan explained that the Maricopa County PM-10 nonattainment area was initially classified as moderate, and, when it failed to reach attainment by the attainment deadline for moderate areas, was reclassified, on May 10, 1996, as a serious PM-10 nonattainment area with a new attainment deadline of December 31, 2001. See 79 FR 7118-7119. Our proposed action on the 2012 Five Percent Plan also explained the criteria set forth in section 188(e) necessary to grant a five year extension of that deadline. In addition, our proposed action on the 2012 Five Percent Plan included the following statement: “On July 25, 2002, EPA approved the serious area PM-10 plan for the Maricopa PM-10 Nonattainment Area as meeting the requirements for such areas in CAA sections 189(b) and (c), including the requirements for implementation of best available control measures (BACM) in section 189(b)(1)(B) and MSM in section 188(e). In the same action EPA approved the submission with respect to the requirements of section 188(d) and granted Arizona's request to extend the attainment date of the area to December 31, 2006.” 4 79 FR 7119.

We understand the comment to be more specifically directed at the issue of whether our action on the 2012 Five Percent Plan requires EPA to “update” or re-evaluate the BACM and MSM determinations we made when we acted on the State's serious area plan and attainment deadline extension request in 2002. EPA does not agree that the CAA requires such a reevaluation in the context of acting on a state's submission of a new plan to meet the requirements of section 189(d). We interpret CAA section 189(b)(1)(B) to provide that the requirement for BACM is triggered by a specific event: The reclassification of a moderate PM-10 nonattainment area to serious. Similarly, we interpret section CAA 188(e) to provide that the requirement for MSM is triggered by a particular event: EPA's granting of a state's request for an extension of the attainment deadline for a serious nonattainment area. If a serious nonattainment area fails to reach attainment by the applicable deadline, CAA section 189(d) requires the state to submit “plan revisions which provide for attainment of the PM-10 air quality standard” and “for annual reduction in PM-10 . . . of not less than 5 percent . . .” The Act, however, does not contain a specific requirement that the state update the previously approved requirements for BACM and MSM as a consequence of failing to reach attainment by the applicable deadline for serious PM-10 nonattainment areas as an element of the plan revision required by section 189(d).

Consistent with the Act's structure of requiring increasingly stringent obligations as the severity of the air pollution problem increases, we interpret sections 189(b)(1)(B) and 188(e), as well as 189(d), as parts of a statutory scheme that imposes increasingly more stringent requirements when a PM-10 nonattainment area fails to reach attainment by applicable deadlines. See Addendum to the General Preamble, 59 FR 42010 (August 16, 1994). As stated previously, the Maricopa County PM-10 Nonattainment Area was initially classified as moderate. In 1996, when EPA determined that the Area failed to reach attainment by the moderate area attainment deadline, EPA reclassified the Area to serious. As a consequence of this reclassification, the Maricopa County PM-10 Nonattainment Area was subject to a new attainment deadline (December 31, 2001) as well as new requirements for a serious PM-10 attainment plan pursuant to CAA section 188(c) and for BACM pursuant to CAA section 189(b)(1)(B). Subsequently, the State's request for an extension of the serious area attainment deadline (December 31, 2006), and EPA's granting of that request in 2002, resulted in an obligation for the State to demonstrate that its SIP imposed MSM pursuant to section 188(e). In 2007, EPA's determination that the Maricopa County PM-10 Nonattainment Area had failed to reach attainment by the extended serious area deadline resulted in section 189(d)'s requirements for plan revisions and annual reductions in PM-10 of five percent until attainment. Thus, the CAA's requirements for BACM and MSM are tied to specific triggers in the Act: BACM by the reclassification to serious following the missed moderate area deadline, and MSM by the extension of the serious area deadline. For serious nonattainment areas that fail to reach attainment by an applicable deadline, the CAA specifies a particular consequence: A requirement for additional plan revisions that provide for attainment and annual five percent reductions. There is no explicit requirement in section 189(d) that a state with a serious nonattainment area that misses its attainment deadline must also reevaluate BACM and MSM provisions in its SIP that EPA has already approved. Indeed, the requirements of section 189(d) do not specify the requisite level of control and merely speak in terms of expeditious attainment and a set percentage of annual reductions from the most recent inventory, without regard to the level of control on sources needed to achieve those objectives. We note further that the commenter did not provide a legal rationale to support an interpretation of the Act that would require the state to reevaluate the existing BACM and MSM in its SIP as part of the explicit requirements of section 189(d). A state may elect to do so, and may elect to do so as a means of achieving additional emissions reductions to meet the five percent requirement, but that is not a specific requirement of section 189(d).

EPA notes that it has other discretionary authority under the CAA to address deficiencies in existing state SIPs, if that were necessary to address substantive concerns like those raised by the commenter. If EPA were to find a state SIP to be “substantially inadequate” to attain or maintain a standard or to meet any other requirements of the CAA, section 110(k)(5) provides a remedy by which EPA may require a state to revise its SIP to correct the identified inadequacies. In such a situation, EPA notifies a state of the inadequacies and can allow the state up to 18 months to submit revisions to the SIP to address the problems. See 42 U.S.C. 7410(k)(5). EPA has not made such a determination with respect to BACM or MSM for the Maricopa County PM-10 Nonattainment Area.

Finally, we note that Arizona was able to demonstrate attainment of the PM-10 NAAQS and provide for annual reductions of five percent until attainment without requiring additional BACM and MSM measures in its SIP. 5 Given that this area has demonstrated that it attained the PM-10 NAAQS by December 31, 2012 and has met the requirements of section 189(d), EPA does not see a need for the State to reevaluate its existing BACM and MSM as part of the action on the 2012 Five Percent Plan.

We address ACLPI's comments with respect to BACM and MSM as they relate specifically to agricultural controls and exceptional events below.

Comment: ACLPI commented that EPA should not approve the 2012 Five Percent Plan because it does not include adequate measures for agricultural emissions. ACLPI commented that EPA has stated that ACC R 18-2-611 [Ag BMP Rule] no longer qualifies as BACM because other nonattainment areas have stronger programs for controlling agricultural emissions and do not have an enforceability issue found in the rule. ACLPI also commented that the State's 2011 revisions to the Ag BMP Rule to address concerns identified by EPA are still clearly insufficient to qualify as BACM.

Response: As explained above, CAA section 189(d) does not require the State to reevaluate the BACM and MSM determinations that were addressed in its serious area PM-10 plan for the Maricopa County PM-10 Nonattainment Area.

In addition, the 2012 Five Percent Plan satisfied all requirements for an approvable section 189(d) plan without relying on additional emissions reductions from agricultural sources. The 2012 Five Percent Plan is based on the “2008 PM-10 Periodic Emissions Inventory for Maricopa County, Revised 2011 (2008 Inventory),” which EPA found to be comprehensive, accurate and current. 79 FR 7120-7121. The 2008 Inventory shows that the most significant sources of emissions in the Maricopa County Nonattainment Area are unpaved roads and alleys (21 percent), construction-related fugitive dust (17 percent), paved road dust (17 percent) and windblown dust (9 percent). 79 FR 7120. Section 189(d) requires an approvable plan to show annual five percent reductions in PM-10 or PM-10 precursors until attainment. The 2012 Five Percent Plan was able to satisfy this criterion without assuming additional reductions in agricultural emissions. 6 Similarly, the 2012 Five Percent Plan demonstrated that the area would attain the standard without additional reductions in agricultural emissions. 7 Instead, the 2012 Five Percent Plan predicts that decreases in emissions from other categories, primarily construction and windblown dust from vacant and open lands, would achieve the requisite 5 percent reductions. 8

Recent monitoring data support the attainment demonstration in the 2012 Five Percent Plan. 79 FR 7122. Finally, the State used no reductions in agricultural emissions for contingency measures. 9 Because the 2012 Five Percent Plan did not depend on additional emission reductions from agricultural sources and because EPA finds that the State is not required to reevaluate the BACM determinations we made in 2002 as part of meeting the requirements of section 189(d), the content of the Ag BMP rule does not determine the outcome of our action on the 2012 Five Percent Plan.

Nevertheless, EPA is continuing to work with ADEQ, Arizona stakeholders and the Governor's Agricultural BMP Committee to improve the Ag BMP rule. EPA anticipates that these improvements will be particularly important for addressing PM-10 emissions in Pinal County, a portion of which EPA re-designated as non-attainment in 2012. See 77 FR 32024 (May 31, 2012).

Comment: ACLPI commented that the 2012 Five Percent Plan relies on an estimate that the Dust Action General Permit (DAGP) will increase the rule effectiveness of Rule 310.01 by one percent, but argued that it is not clear that the DAGP achieves any measurable reduction in emissions. ACLPI stated that the structure of the DAGP means that its scope is unclear and that there is no way to gauge that issuance of the DAGP is actually impacting behavior in a way that reduces emissions. ACLPI stated that compliance is only measured by instances of lack of compliance discovered by inspectors who happen upon an owner or operator of a regulated activity who is not implementing a BMP. ACLPI stated that ADEQ has not yet issued a single Requirement to Operate (“RTO”), which means that it is possible that sources not already subject to permits have implemented BMPs as a result of the permit, but it is equally plausible that BMPs are not being implemented and that inspectors haven't discovered the violations, or that the universe of potential permittees under the DAGP was so small that the adoption of the permit had no practical effect whatsoever.

Response: The 2012 Five Percent Plan does not rely on assumptions regarding compliance with the DAGP per se; rather, the 2012 Five Percent Plan relies on an assumption that the DAGP will improve compliance with Rule 310.01. As the 2012 Five Percent Plan explains, “[e]missions reduction credit was taken for one new measure, the Dust Action General Permit . . . This new measure is expected to raise rule effectiveness for Rule 310.01 by one percent during high wind hours . . .”  10 This statement is consistent with Table 5-1 of the MAG 2012 Five Percent Plan, “Impact of Increased Rule Effectiveness on 2008-2012 PM-10 Emissions,” which shows that ADEQ estimated that the rule effectiveness for the category “windblown vacant, open, test tracts,” (the category of sources subject to Rule 310.01), would increase from 96% in 2010-2011 to 97% in 2012. 11 Table5-1 associates this improved rate of compliance with an annual reduction in PM-10 emissions of 149 tons per year. 12

The Maricopa County Air Quality Department's (MCAQD) compliance data for calendar year 2012 support the 2012 Five Percent Plan's assumptions that the DAGP will improve compliance with Rule 310.01. MCAQD reviewed its records of inspections during calendar year 2012, as documented in “Evaluation of Innovative Control Measures and Existing Maricopa County Control Measures Contained in the MAG 2012 Five Percent Plan for PM-10 for the Maricopa County Nonattainment Area, revised,” Maricopa County Air Quality Department, June 6, 2013 (2013 Evaluation Report). 13 It found that, out of a total of 5,431 sites inspected for compliance with Rule 310.01 in 2012, 149 citations were issued—amounting to a rule effectiveness rate of 97.62 percent. 2013 Evaluation Report at pages 3-4. This amount exceeds the compliance rate of 96% associated with previous years. MAG 2012 Five Percent Plan at p. 5-3, Table 5-1. EPA acknowledges that estimating rule compliance requires reliance on compliance information collected by reliable means. In this instance, EPA believes that the information gathered through the MCAQD's inspections program provides information to support the conclusion that most affected sources are complying with the requirements of Rule 310.01, and that compliance improved in 2012 as a result of those inspections.

The 2012 Five Percent Plan further describes the connection between Rule 310.01 and the DAGP. 14 The Plan explains that the DAGP is expected to increase compliance with Rule 310.01 because, whenever ADEQ issues a forecast of a high wind dust event, sources subject to Rule 310.01 (primarily open areas, vacant lots, and unpaved parking areas and roadways), 15 will take additional measures to stabilize open areas and unpaved surfaces by implementing the best management practices (BMPs) specified in Rule 310.01 and the DAGP. 16 Such measures might include restricting access to open areas and vacant lots, or by applying dust suppressants and/or maintaining surface gravel. 17 As specified in the DAGP, sources that fail to choose or implement a BMP when ADEQ issues a forecast of a high wind dust event may trigger applicability of the DAGP and the additional requirements it imposes. 18 Thus, the existence of the DAGP enhances compliance with Rule 310.01 because sources subject to Rule 310.01 associate noncompliance with Rule 310.01 with an adverse consequence—specifically, the obligation to apply for and comply with the DAGP. Again, MCAQD's study of the compliance rate of Rule 310.01 supports this assumption in the 2012 Five Percent Plan.

Comment: ACLPI stated that it was unable to reconcile some of the numbers of exceptional events cited by EPA. The commenter stated that the subtotals in EPA's concurrence letters add up to 131, but the subtotals in the tables in the supporting documentation add up to 135. The commenter added that if sites with double monitors are counted as only one exceedance, the total number of exceedances is 127.

Response: EPA acknowledges the discrepancy between the number of exceedances in concurrence letters and the tables in the TSDs. After closely re- reviewing the data, EPA has determined that the total number of exceptional events addressed by our concurrence letters dated September 6, 2012, May 6, 2013, and July 1, 2013 should be 135 exceedances. 19 These 135 exceptional event exceedances occurred on 25 days over the three year period, 2010-2012.

Comment: ACLPI commented that EPA's exclusion of such a large number of frequent and severe exceedances is unconscionable and misrepresents the extent of the particulate pollution in the Area. The commenter stated that the reported exceedances are “frequent” and “severe” within the meaning of EPA guidance, specifically, EPA's Interim Guidance on the Preparation of Demonstrations in Support of Requests to Exclude Ambient Air Quality Data Affected by High Winds Under the Exceptional Events Rule, May 2013 (Interim Guidance).

Response: We note that the 135 exceptional event exceedances occurred on 25 days over a three year period from 2010 to 2012. The determinations reflected in our concurrence letters and TSDs dated September 6, 2012, May 6, 2013 and July 1, 2013 are consistent with the EER and our Interim Guidance. We considered a range of relevant factors including whether anthropogenic sources had reasonable controls in place, meteorological data such as wind speed and direction, and the spatial extent of the events. The frequency and severity of the events were considered as part of this analysis, and although we agree that some of the excluded exceedances could meet the criteria for “frequent” and “severe” suggested in our Interim Guidance, that fact alone does not disqualify an exceedance from consideration as an exceptional event. See Interim Guidance at 12-13 (frequency and severity of past exceedances may be a factor considered in determining the reasonableness of controls). Also, the Interim Guidance acknowledges that events do not necessarily have to be rare to qualify as exceptional events. See Interim Guidance at 3 and 20.

Comment: ACLPI commented that EPA's analysis of whether the events are reasonably preventable or controllable should have been more probing and not a “cookie cutter” approach, given the frequency and severity of the exceedances, as well as the area's status as serious nonattainment and the State's previous withdrawal of its earlier Five Percent Plan.

Response: The State submitted documentation on March 14, 2012, January 28, 2013, and February 13, 2013 to demonstrate to EPA that exceedances of the PM-10 NAAQS on various dates in 2011 and 2012 meet the criteria for an exceptional event in the EER. The State's submittals comprise over 1750 pages of documentation of the facts supporting each of the identified exceptional events. Our TSDs accompanying our concurrence letters dated September 6, 2012, May 6, 2013, and July 1, 2013 reflect EPA's methodical and systematic review of the State's documentation of the events and EPA's technical expertise and judgment. EPA presented its conclusions in a standardized format that was appropriate, considering the volume of information presented and reviewed, as well as the purpose of informing the public. In addition, EPA notes that we also received several comments in this rulemaking regarding the process required to document exceedances as “exceptional events” contending that the level of resources required to prepare and submit such documentation to EPA was too onerous.

Comment: ACLPI commented that the events excluded by EPA were predictable and seasonal in nature and could be ameliorated if the State adopted appropriate control measures for windblown dust both in the attainment ( sic ) area and statewide.

Response: For each of the events that EPA concurred with, EPA found that the event was not reasonably controllable or preventable (nRCP). EPA's Interim Guidance states that, for anthropogenic sources of dust, “a high wind dust event may . . . be considered to be not reasonably controllable or preventable if: (1) The anthropogenic sources of dust have reasonable controls in place; (2) the reasonable controls have been effectively implemented and enforced; and (3) the wind speed was high enough to overwhelm the reasonable controls.” See Interim Guidance at 10.

EPA's determinations of nRCP were primarily based on consideration of the control requirements based on the Area's serious nonattainment classification for the PM-10 NAAQS. See Interim Guidance at 13. ADEQ provided detailed information of required controls (including BACM-level controls for significant sources previously approved by EPA for this area), as well as information on rule implementation, rule effectiveness, compliance and enforcement, alert systems and public notification activities. A typical example is the documentation ADEQ submitted in connection with the event that occurred on August 11, 2012. State of Arizona, Exceptional Event Documentation for the Event of August 11, 2012 for the Phoenix PM-10 Nonattainment Area, February 2013 (AZ EE Documentation for August 11, 2012). This submittal included a list of control measures regulating sources of dust in Maricopa and Pinal counties, information about rule effectiveness, and data regarding compliance and enforcement. See AZ EE Documentation for August 11, 2012, Section 5.

In addition, EPA's determinations of nRCP were based on ADEQ's documentation of wind speeds. For example, the exceedances that occurred on September 11 and 12, 2011 involved wind speeds of 20 miles per hour (mph) and 25 mph, respectively. See e.g., EPA Letter dated July 1, 2013, and accompanying TSD at p. 4. See also, e.g., TSD discussion of June 16, 2012 event at p. 10 (sustained wind speeds of 29 mph-32 mph); TSD discussion of June 27, 2012 event at p. 15 (sustained wind speeds of 31 mph-38 mph); TSD discussion of July 11, 2012 event at p. 20 (sustained wind speeds of 20 mph-25 mph). 20 Given the wind speeds associated with each of the events that EPA concurred upon, EPA believes ADEQ's controls assessment was appropriate and that the pre-existing and previously approved BACM level controls are adequate for meeting the requirement of “reasonable controls” for a PM-10 serious nonattainment area.

Additional information regarding EPA's consideration of reasonable controls can be found in EPA's TSDs for each event.

Comment: ACLPI commented that BACM level controls were not in place in the nonattainment area. ACLPI commented that EPA's Interim Guidance says that BACM measures may be insufficient if the SIP has not been recently reviewed and that EPA has indicated that it will consider windblown dust BACM to be reasonable controls for purposes of exceptional events claims if the measures have been reviewed and approved in the context of a SIP revision within the past three years and if the measures are specific to windblown dust. ACLPI commented that EPA's proposed action departs from this guidance because EPA last approved BACM for the area in 2002, with a supplemental analysis in 2006.

Response: EPA's Interim Guidance states: “Generally, the EPA will consider windblown dust BACM to constitute reasonable controls if these measures have been reviewed and approved in the context of a SIP revision for the emission source area within the past three years.” Interim Guidance at 15. Although our BACM determinations were made outside this recommended time frame, we believe that our determinations regarding nRCP were correct. First, the 2012 Five Percent Plan shows that the significant stationary source categories for PM-10 are: construction; unpaved roads and alleys; paved road dust; windblown dust (non-agriculture); unpaved parking lots; and off-road recreational vehicles. 21 Each of these source categories was included in our earlier BACM determinations. See 67 FR 48718 (July 25, 2002); see also, 67 FR 48733-34. Because the significant sources within the Phoenix PM-10 nonattainment area have not significantly changed since 2002, and the range of potential measures for controlling emissions from these source categories (e.g., stabilization of disturbed surface areas; spray bars to apply water or dust suppressants; track out, rumble grate and wheel washer requirements) have not significantly changed since 2002, we believe that our previous BACM determinations remain appropriate for the purposes of making exceptional event determinations, including determinations regarding nRCP.

Second, although the State has not prepared a new BACM analysis and EPA has not made new BACM determinations in the past three years, Arizona has adopted revisions to rules regulating sources of windblown dust that EPA has approved into the SIP because they are more stringent. Specifically, EPA has approved updated revisions of: Rule 310, which regulates sources of fugitive dust from dust generating operations such as construction; Rule 310.01, which regulates sources of windblown dust from open areas, vacant lots, unpaved parking lots, and unpaved roadways; and Rule 316, which regulates sources of dust from nonmetallic mineral processing. 22

Third, to the extent the commenter interprets the Interim Guidance as stating that a BACM determination that is older than three years cannot be relied upon in a demonstration of reasonable controls, the commenter is incorrect. The Interim Guidance provides a guideline to states preparing documentation to submit to EPA that more recent BACM determinations will generally satisfy EPA's consideration of reasonable controls. It does not disqualify measures that EPA determined to be BACM more than three years previously from consideration as reasonable controls, nor does it impose an obligation on the part of the state or EPA to re-evaluate BACM.

Comment: ACLPI commented that EPA found that the 2007 Maricopa BMP Rule no longer represents BACM for agricultural emissions (referencing statements in a 2010 proposed rulemaking and in a 2010 letter to the Arizona Agricultural Best Management Practices (BMP) Committee) and that although the 2007 Maricopa BMP Rule was revised in 2011, the revisions were not implemented until March 2012. The commenter states that 98 of the 217 exceedances at issue occurred in 2011 (i.e., prior to the implementation of the 2011 Maricopa BMP Rule revisions). The commenter argued that even into 2012, the “revised Maricopa BMP Rule” (which EPA understands to be a reference to the 2011 Maricopa BMP Rule) is not clearly BACM because it did not include EPA's recommendations for improvement. The commenter concludes that EPA's concurrence on exceptional events was erroneous because EPA relied on its prior approval of the State's previous BACM demonstration and did not attempt to determine whether the controls in place during the event were BACM.

Response: Our response above explains why the CAA does not require EPA to reevaluate its earlier BACM determination in connection with our action on the 2012 Five Percent Plan. We understand the commenter to be asserting another basis for EPA to reevaluate BACM, in particular, that EPA's concurrence on exceptional events may be a basis to require EPA to make a determination regarding BACM. EPA's Interim Guidance, however, states that BACM for windblown dust is a measure that EPA has identified as being “reasonable” for the purposes of exceptional events determinations. Interim Guidance at 15. The Interim Guidance acknowledges that “[h]aving BACM/RACM in place during the time of the event is an important consideration” for an exceptional event determination, but more justification may be necessary if, for example, the measures are not related to windblown dust, or if the SIP has not been recently reviewed. Id. For the reasons set forth below, EPA's reliance on the BACM determinations it made in 2002 was a reasonable basis to concur on the State's exceptional event claims. 23

First, the 2008 Inventory shows that agricultural sources are a very small contributor to windblown dust in Maricopa County. According to the 2008 Inventory, agricultural windblown dust comprises approximately 0.9% of the total annual windblown dust emissions in the nonattainment area (448 tons out of a total of 49,673.01 tons in 2012). 24 Other agricultural sources, such as tilling, harvesting, and cotton ginning, comprise approximately 1.8% of the total annual PM-10 emissions inventory (893 tons out of a total of 49,673.01 tons in 2012). 25 Thus, agricultural sources contribute only a relatively small percentage of the total emissions in the 2008 Inventory.

Second, in determining that the exceedances that occurred in 2011 and 2012 were nRCP, it was appropriate for EPA to find that the existing controls were “reasonable” because, as we explained above, the State met the requirements of section 189(d) in the 2012 Five Percent Plan without relying on additional reductions from agricultural sources. Significantly, no additional reductions from the Maricopa BMP Rule were needed to demonstrate that the area would attain the standard. 26 Therefore, our determination that existing BACM requirements were sufficient to find that emissions sources were reasonably controlled at the time the exceedances occurred was appropriate.

Third, we acknowledge that EPA has previously indicated to the State that improvements to controls on agricultural sources should be considered. It is important to note, however, that EPA's proposed 2010 rulemaking was a proposed action to disapprove a different section 189(d) plan, the State's 2007 Five Percent Plan, in part because of EPA's concerns regarding the accuracy of the State's 2005 Periodic Emission Inventory. (We also note that the proposed rulemaking was never finalized.) It is also important to note that EPA's comments to the Ag BMP Committee predate the finalization of the 2008 Emission Inventory (May 2012) in which emissions from agricultural sources are a small part of the PM-10 emissions inventory. Further, although the 2008 Inventory indicates that agricultural sources are relatively small contributors to PM-10 emissions in the Maricopa County PM-10 Nonattainment Area, EPA believes that agriculture is a significant source in certain portions of Pinal County, which EPA recently redesignated as a PM-10 nonattainment area. See 77 FR 32024 (May 31, 2012). Therefore, EPA believes that it is important to continue to improve the controls on agricultural sources, and EPA is working with ADEQ, stakeholders, and the Governor's Agricultural BMP Committee to improve these controls.

Comment: ACLPI commented that ADEQ and EPA did not adequately address the issue of whether the events were reasonably controllable or preventable with respect to sources outside the Maricopa County PM-10 Nonattainment Area. ACLPI stated that EPA's Interim Guidance says that a basic controls analysis should consider all upwind areas of disturbed soil to be potential contributing sources, and that the basic controls analysis should identify all contributing sources in upwind areas and provide evidence that such sources were reasonably controlled, whether anthropogenic or natural, and include inspection reports and/or notices of violation, if available. The commenter stated that ADEQ and EPA did not indicate that control measures outside of Maricopa County were evaluated for their “reasonableness.” ACLPI commented that Pinal County's controls are “minimalist rules” that do not require controls to address emissions caused solely by high wind events and that although Pinal County was only recently designated nonattainment, Pinal County should not be excused from the requirement to show that sources in the county were subject to reasonable controls.

Response: The comment concerns the level of controls imposed on sources outside the Maricopa County PM-10 Nonattainment Area, in particular, sources located in Pinal County. As noted in our proposed action, the Maricopa County PM-10 Nonattainment Area encompasses several cities within Maricopa County (including the cities of Phoenix, Mesa, Scottsdale, Tempe, Chandler, and Glendale), and several other smaller jurisdictions and unincorporated county lands. The Maricopa County PM-10 Nonattainment Area also includes the town of Apache Junction in Pinal County. Recently, EPA designated a portion of Pinal County (“West Pinal”) as a moderate PM-10 nonattainment area, which triggered nonattainment planning obligations that the State must fulfill. See 77 FR 32024 (May 31, 2012). 27

EPA's Interim Guidance contemplates that a basic controls analysis should include “a brief description” of upwind sources. The level of detail provided in describing the Pinal County sources was adequate given relevant factors such as wind speed. Moreover, ADEQ and EPA both indicated that they evaluated control measures outside of Maricopa County. For example, ADEQ's exceptional event documentation included an analysis of reasonable controls that identified measures that apply to sources located within the Maricopa County PM-10 Nonattainment Area, and measures applicable to sources in Pinal County, outside the Maricopa County PM-10 Nonattainment Area. 28 ADEQ specifically identified two Pinal County rules, Article 2, Fugitive Dust, and Article 3, Construction Sites—Fugitive Dust, as regulatory control measures. 29 EPA's TSDs also referenced this section of ADEQ's documentation, including the discussion of rules applicable to sources in Pinal County. 30

In addition, the level of detail describing Pinal County sources and controls was also adequate for an area such as Pinal County for which a portion was recently redesignated as a PM-10 nonattainment area and is currently undergoing the nonattainment planning process. As EPA's Interim Guidance states, an area's attainment status is an appropriate guideline for assessing the reasonableness of controls: “Generally, the EPA does not expect areas classified as attainment, unclassifiable, or maintenance for a NAAQS to have the same level of controls as areas that are nonattainment for the same NAAQS. Also, if an area has been recently designated to nonattainment but has not yet been required to implement controls, the EPA will expect the level of controls that is appropriate for the planning stage.” Interim Guidance at 15. EPA's recent redesignation of a portion of Pinal County as a moderate PM-10 nonattainment area triggered CAA planning obligations for the State to develop regulations to implement controls such as Reasonably Available Control Measures (RACM) for existing sources of PM-10 and a section 173 preconstruction permitting program for new and modified sources of PM-10. EPA concurred with exceedances that occurred in 2011 and 2012; the latest exceedance occurred on September 6, 2012, well before the CAA's deadline for Arizona to submit an implementation plan to EPA for approval into the Arizona SIP. See 77 FR 32030.

Comment: ACLPI commented that claims that events were caused by “winds transporting dust from desert areas of Pima and Pinal Counties” are not substantiated and that the State's demonstrations do not determine source locations, as required by EPA's 2013 Interim Guidance (referencing 3.1.5.1). ACLPI conducted its own analysis of the event that occurred on July 18, 2011. ACLPI commented that its analysis indicates that dust sources included agricultural sources in Pinal and Maricopa Counties, and that four downdrafts and four outflows impacted the monitors from multiple locations, in contrast to the State's assertion that one thunderstorm outflow transported dust from desert portions of Pinal and Pima counties into the Phoenix PM-10 nonattainment area. ACLPI stated that although the State claims that specific source areas are difficult to determine because of the less dense monitoring network in the general source area, ACLPI's analysis shows that likely source locations can be determined using meteorological modeling and observational data. Therefore, EPA should require the state to make a more concerted effort to identify the actual sources and adopt controls to avoid or ameliorate future events.

Response: Although a more refined analysis of the location of thunderstorm downdrafts and source areas is potentially helpful for certain high wind dust events, this additional analysis is not necessary to analyze the specific events that EPA concurred on. EPA reviewed the commenter's analysis and concluded that it does not contradict ADEQ's documentation, but rather corroborates the evidence presented in ADEQ's demonstration. ADEQ's documentation states that the contributing source regions were somewhat widespread, but that the “majority” of the PM that was transported into Maricopa County likely originated from areas within Pinal County to the south and southeast of Maricopa County. 31 ADEQ also explained that it is likely that some dust was generated within the Maricopa County PM-10 Nonattainment Area as gusts from the thunderstorm outflows passed through the area. 32 Thus, ADEQ did not claim that all the emissions were specifically caused by a single thunderstorm outflow. ADEQ's statement that the “majority” of the emissions were transported from areas of Pinal County and southeast Maricopa County is supported by the visualization of images from the Phoenix visibility camera included in the July 18, 2011 demonstration, which shows a large dust storm approaching from the south of the Maricopa County PM-10 Nonattainment Area. 33

Comment: ACLPI commented that the fact that some of the sources are located outside of the Maricopa County PM-10 Nonattainment Area does not absolve the State of its responsibility to ensure that they are reasonably controlled. The commenter stated that ADEQ is the single responsible actor for air quality control in Arizona and had the responsibility to address the public health risk presented by sources in Pinal County, particularly given high wind events experienced in 2008 and 2009.

Response: EPA agrees that the State has a responsibility to ensure that sources outside the Maricopa County PM-10 Nonattainment Area are reasonably controlled. Our action with respect to exceedances at Maricopa County PM-10 Nonattainment Area monitors does not absolve in any way the State's responsibility to address PM-10 emissions in the West Pinal PM-10 Nonattainment Area. Our July 2012 redesignation of West Pinal to nonattainment triggers Clean Air Act nonattainment planning obligations that Arizona must fulfill. See 77 FR 32030. We note that our action on the 2012 Five Percent Plan relates to our concurrences with the State's exceptional event claims for exceedances at monitors for the Maricopa County PM-10 Nonattainment Area dated September 6, 2012, May 6, 2013, and July 1, 2013, and does not depend on the treatment of data for monitors located within the newly redesignated West Pinal PM-10 Nonattainment Area.

Comment: ACLPI commented that the Maricopa County PM-10 Nonattainment Area experienced 30 exceedances over six days in 2013, which ADEQ has flagged and for which ADEQ is preparing EE documentation, and that EPA is simply assuming that it will concur with these EE demonstrations. The commenter stated that this is unsupportable, particularly in light of EPA's failure to require mitigation measures and that there are frequent and severe violations of the standard at multiple monitors, many of which are located in low income neighborhoods.

Response: The 2012 Five Percent Plan was based on a projection that that the Area would attain the NAAQS in 2012. If, upon review of the available evidence, EPA finds that the exceedances of the standard in 2013 constitute a new violation of the PM-10 NAAQS, we have the authority to require the state to submit a SIP revision with additional controls and a demonstration that the new controls will bring the area back into attainment with the standard. 34

Comment: ACLPI stated that EPA's proposal acknowledges that the contingency measures in the 2012 Five Percent Plan are already being implemented. The commenter stated that CAA (175(d)) envisions additional measures that are automatically and immediately implemented if a milestone for reasonable further progress or attainment is not met. The commenter stated that if contingency measures are already being implemented when a milestone is missed, continued implementation will not ensure that the situation will be corrected. The commenter argues that LEAN v. EPA is not binding on the 9th Cir. and is contrary to the plain language of the CAA. The commenter stated that approval of the 2012 Five Percent Plan without meaningful and appropriate contingency measures is contrary to law.

Response: EPA disagrees with the comment. Contingency measures must provide for additional emission reductions that are not relied on for RFP or attainment and that are not included in the attainment demonstration. Nothing in the statute precludes a state from implementing such measures before they are triggered. See, e.g., LEAN v. EPA, 382 F.3d 575 (5th Cir. 2004) (upholding contingency measures that were previously required and implemented where they were in excess of the attainment demonstration and RFP SIP).

EPA has approved numerous SIPs under this interpretation—i.e., SIPs that use as contingency measures one or more Federal or local measures that are in place and provide reductions that are in excess of the reductions required by the attainment demonstration or RFP plan. See, e.g., 62 FR 15844 (April 3, 1997) (direct final rule approving an Indiana ozone SIP revision); 62 FR 66279 (December 18, 1997) (final rule approving an Illinois ozone SIP revision); 66 FR 30811 (June 8, 2001) (direct final rule approving a Rhode Island ozone SIP revision); 66 FR 586 (January 3, 2001) (final rule approving District of Columbia, Maryland, and Virginia ozone SIP revisions); and 66 FR 634 (January 3, 2001) (final rule approving a Connecticut ozone SIP revision).

The scenario described by the commenter that already-implemented contingency measures will be a problem if the Maricopa County PM-10 Nonattainment Area misses a deadline for RFP or attainment is mitigated by the fact that monitoring data for 2010-2012 show that the Area already attained the 24-hour PM-10 NAAQS as of December 12, 2012. See 79 FR 7122. Our approval of the contingency measures is also consistent with EPA guidance that “the potential nature and extent of any attainment shortfall for the area” is relevant to the determining the level of required emission reductions and that contingency measures “should represent a portion of the actual emission reductions necessary to bring about attainment in area.” 72 FR 20586, 20643; see also PM-10 Addendum at 42015 (the emission reductions anticipated by the contingency measures should be equal to approximately one-year's worth of emission reductions needed to achieve RFP for the area.) EPA's approval of contingency measures that are already being implemented is particularly appropriate where, as is the case for the Maricopa County PM-10 Nonattainment Area, there are no future RFP or attainment deadlines.

Comment: ADEQ asked that EPA clarify that this action applies to the entire nonattainment area, including the portion in Pinal County, and not just to the Maricopa County portion.

Response: EPA has made this clarification.

Comment: Several commenters noted that the plan was developed through a cooperative discussion among the many stakeholders in the plan. According to the commenters, this process led to innovative strategies that are appropriate to the local conditions and consistent with EPA requirements.

Response: EPA acknowledges these comments.

Comment: Several commenters expressed concerns about the resources required to demonstrate that measured exceedances of the standard are due to exceptional events. These commenters recommended changing the Exceptional Events Rule to address this issue.

Response: EPA will consider these comments in future rulemakings on the Exceptional Events Rule.

As a result of our proposed rule and our response to comments above, we are finalizing our proposal to approve the 2012 Five Percent Plan as meeting the requirements of the CAA for the Maricopa County PM-10 nonattainment area. Specifically, we are approving:

(A) The 2008 baseline emissions inventory and the 2007, 2009, 2010, 2011 and 2012 projected emission inventories as meeting the requirements of CAA section 172(c)(3);

(B) the attainment demonstration as meeting the requirements of CAA sections 189(d) and 179(d)(3);

(C) the five percent demonstration as meeting the requirements of CAA section 189(d);

(D) the reasonable further progress and quantitative milestone demonstrations as meeting the requirements of CAA sections 172(c)(2) and 189(d);

(E) the contingency measures as meeting the requirements of CAA section 172(c)(9); and

(F) the motor vehicle emissions budget as compliant with the budget adequacy requirements of 40 CFR 93.118(e).

Under the 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 Clean Air Act. 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. 3501 et 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. 601 et 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 Clean Air Act; 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 it does not 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, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 11, 2014. 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 may not be challenged later in proceedings to enforce its requirements ( see section 307(b)(2)).

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

Tropospheric ozone, commonly known as smog, occurs when VOCs and nitrogen oxides (NO X ) react in the atmosphere. Because of the harmful health effects of ozone, EPA limits the amount of VOCs and NO X that can be released into the atmosphere. VOCs are those compounds of carbon (excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or carbonates, and ammonium carbonate) that form ozone through atmospheric photochemical reactions. Compounds of carbon (or organic compounds) have different levels of reactivity; they do not react at the same speed, or do not form ozone to the same extent.

It has been EPA's policy that compounds of carbon with negligible reactivity need not be regulated to reduce ozone. See 42 FR 35314, July 8, 1977. EPA determines whether a given carbon compound has “negligible” reactivity by comparing the compound's reactivity to the reactivity of ethane. EPA lists these compounds in its regulations at 40 CFR 51.100(s) and excludes them from the definition of VOC. The chemicals on this list are often called “negligibly reactive.” EPA may periodically revise the list of negligibly reactive compounds to add or delete compounds.

On February 12, 2013, EPA issued a final rule approving the addition of four HFPEs to the list of those compounds excluded from the regulatory definition of VOC. See 78 FR 9823. The four HFPEs—HCF2OCF2H (HFE-134), HCF2OCF2OCF2H (HFE-236cal2), HCF2OCF2CF2OCF2H (HFE-338pcc13), and HCF2OCF2OCF2CF2OCF2H(H-Galden 1040X and H-Galden ZT 130 (or 150 or 180)), have been used in some heat transfer applications (as refrigerants) and as fire suppressants. Because HFPEs do not contain chlorine or bromine, these compounds do not contribute to the depletion of the ozone layer and have ozone depletion potential values of zero. ADEM is updating its SIP to be consistent with federal regulations.

On September 3, 2013, ADEM submitted a SIP revision  1 to EPA for review and approval. The revision modifies the definition of VOCs found at Alabama Administrative Code section 335-3-1-.02(gggg). Specifically, the revision adds four HFPEs compounds—HCF2OCF2H (HFE-134), HCF2OCF2OCF2H (HFE-236cal2), HCF2OCF2CF2OCF2H (HFE-338pcc13), and HCF2OCF2OCF2CF2OCF2H(H-Galden 1040X and H-Galden ZT 130 (or 150 or 180)) to the list of those excluded from the VOC definition on the basis that these compounds make a negligible contribution to tropospheric ozone formation.

This action amends Rule 335-3-1-.02(gggg) to update the definition of VOC to be consistent with EPA regulations. These changes are consistent with the section 110 of the Clean Air Act (CAA or Act).

Pursuant to section 110 of the CAA, EPA is approving the revision to the Alabama SIP revising the VOC definition. EPA has evaluated Alabama's September 3, 2013, submittal and has determined that it meets the applicable requirements of the CAA and EPA regulations and is consistent with EPA policy. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective August 11, 2014 without further notice unless the Agency receives adverse comments by July 10, 2014. If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on August 11, 2014 and no further action will be taken on the proposed rule.

Under the 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. 3501 et 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. 601 et 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).

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 11, 2014. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. See CAA section 307(b)(2), 42 U.S.C. 7607(b)(2).

40 CFR part 52 is amended as follows:

This is a summary of the Commission's Report and Order, DA 14-671, adopted May 15, 2014, and released May 16, 2014. The full text of this Commission decision is available for inspection and copying during normal business hours in the Commission's Reference Center 445 12th Street SW., Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street SW., Room CY-B402, Washington, DC 20054, telephone 1-800-378-3160 or www.BCPIWEB.com . The Commission will not send a copy of this Report and Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the adopted rules are rules of particular applicability. This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

As stated in the preamble, the Federal Communications Commission amends 47 CFR part as follows:

Executive Summary

Why we need to publish a rule. Under the Act, a species or subspecies may warrant protection through listing if it is endangered or threatened throughout all or a significant portion of its range. Listing a species as an endangered or threatened species can only be completed by issuing a rule. On June 20, 2013 (78 FR 37363; 78 FR 37328), we proposed to list the New Mexico meadow jumping mouse under the Act as an endangered species and proposed to designate critical habitat. We found that the species currently faces numerous threats of high magnitude, and, therefore, qualifies for listing, and we requested additional information and comments on the proposed listing. This final rule considers all comments received by peer reviewers, tribes, State agencies, Federal agencies, and the public regarding the proposed rule to list the New Mexico meadow jumping mouse.

This rule will finalize the listing of the New Mexico meadow jumping mouse as endangered.

The basis for our action. Under the Act, a species may be determined to be an endangered or threatened species based on any of five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting its continued existence. We have determined that the New Mexico meadow jumping mouse meets the definition of an endangered species primarily because of the present or threatened destruction, modification, or curtailment of its habitat or range; the inadequacy of existing regulatory mechanisms; and other natural and manmade factors affecting its continued existence. Our consideration of these factors is described in section 5.1 “Habitat Loss” and section 5.3 “Protective Regulations” of the SSA Report. The other two of the five factors are not contributing to the current status of the species. See section 5.2 “Other Factors” in the SSA Report for our consideration of these factors.

Peer review and public comment. We sought comments from independent specialists to ensure that our designation is based on scientifically sound data, assumptions, and analyses. We invited these peer reviewers to comment on our listing proposal. We also considered all comments and information received during the comment period.

Please refer to the proposed listing rule for the New Mexico meadow jumping mouse (78 FR 37363, June 20, 2013) for a detailed description of previous Federal actions concerning this species.

We determined that critical habitat for the New Mexico meadow jumping mouse is prudent and determinable and will soon publish in the Federal Register our final determination designating critical habitat for the New Mexico meadow jumping mouse.

The Final New Mexico Meadow Jumping Mouse Species Status Assessment Report (SSA Report; Service 2014, entire), available online at www.regulations.gov, Docket No. FWS-R2-ES-2013-0023, provides a thorough assessment of New Mexico meadow jumping mouse biology and natural history, and assesses demographic risks (such as small population sizes), threats, and limiting factors in the context of determining viability and risk of extinction for the New Mexico meadow jumping mouse. In the SSA Report, we compile biological data and a description of past, present, and likely future threats (causes and effects) facing the species. Because data in these areas of science are limited, some uncertainties are associated with this assessment. Where we have substantial uncertainty, we have attempted to make our necessary assumptions explicit in the SSA Report. We base our assumptions in these areas on the best available information. Importantly, the SSA Report does not represent a decision by the Service on whether this taxon should be listed as a threatened or endangered species under the Act. The SSA Report does however, provide the scientific basis that informs our regulatory decision (see Summary of Biological Status and Threats ), which involves the application of standards within the Act and its implementing regulations, and Service policies (see Determination).

Our SSA Report documents the results of the comprehensive biological status review for the New Mexico meadow jumping mouse and provides a thorough account of the species' overall viability and, conversely, extinction risk (Service 2014, entire). The SSA Report contains the data on which this final rule is based. The following is a summary of the results and conclusions from the SSA Report.

The New Mexico meadow jumping mouse is a small mammal whose historical distribution likely included riparian wetlands along streams in the Sangre de Cristo and San Juan Mountains from southern Colorado to central New Mexico, including the Jemez and Sacramento Mountains and the Rio Grande Valley from Espanola to Bosque del Apache National Wildlife Refuge, and into parts of the White Mountains in eastern Arizona.

In conducting our status assessment we first considered what the New Mexico meadow jumping mouse needs to ensure viability. We generally define viability as the ability of the species to persist over the long term and, conversely, to avoid extinction. We next evaluated whether the identified needs of the New Mexico meadow jumping mouse are currently available and the repercussions to the subspecies when provision of those needs is missing or diminished. We then consider the factors that are causing the species to lack what it needs, including historical, current, and future factors. Finally, considering the information reviewed, we evaluate the current status and future viability of the species in terms of resiliency, redundancy, and representation.

Resiliency is the ability of the species to withstand stochastic events (arising from random factors such as drought, flooding, or wildfire) and, in the case of the New Mexico meadow jumping mouse, is best measured by habitat size. Redundancy is the ability of a species to withstand catastrophic events within part of its range, and can be provided by the duplication and distribution of resilient populations across the range of the New Mexico meadow jumping mouse. Representation is the ability of a species to adapt to changing environmental conditions and can be measured by the breadth of genetic diversity within and among populations, and the ecological diversity of populations across the species' range. In the case of the New Mexico meadow jumping mouse, we evaluate representation based on the extent of the geographical range as an indicator of genetic and ecological diversity. The main areas of uncertainty in our analysis include the minimum amount of suitable habitat needed to support resilient populations and the number of redundant populations needed to provide for adequate redundancy and representation.

Our assessment concluded that the New Mexico meadow jumping mouse has an overall low viability (probability of persistence) in the near term (between now and the next 10 years) and a decreasing viability in the long-term future (beyond 10 years). The New Mexico meadow jumping mouse occurs within eight geographic management areas, which are defined by the external boundaries of the geographic distribution of historical populations. We use the term geographic management area to describe the geographic region where populations of jumping mice are located. For the subspecies to be viable, the New Mexico meadow jumping mouse needs to have multiple resilient populations distributed throughout different drainages within the eight geographic management areas. In this summary, we present an overview of the comprehensive biological status review. A detailed discussion of the information supporting this overview can be found in the SSA Report (Service 2014, entire).

For the New Mexico meadow jumping mouse to be considered viable, individual mice need specific vital resources for survival and completion of their life history. One of the most important aspects of the New Mexico meadow jumping mouse's life history is that it hibernates about 8 or 9 months out of the year, which is longer than most other mammals. Conversely, it is only active 3 or 4 months during the summer. Within this short timeframe, it must breed, birth and raise young, and store up sufficient fat reserves to survive the next year's hibernation period. In addition, jumping mice only live 3 years or less, and have one small litter annually, with seven or fewer young, so the subspecies has limited capacity for high population growth rates due to this low fecundity (reproductive potential). As a result, if resources are not available in a single season, jumping mice populations would be greatly stressed and would likely have lower reproduction and over-winter survival during hibernation.

The New Mexico meadow jumping mouse has exceptionally specialized habitat requirements to support these life-history needs and maintain adequate population sizes. Habitat requirements are characterized by tall (averaging at least 61 centimeters (cm) (24 inches (in)), dense riparian herbaceous vegetation (plants with no woody tissue) primarily composed of sedges (plants in the Cyperaceae Family that superficially resemble grasses but usually have triangular stems) and forbs (broad-leafed herbaceous plants). This suitable habitat is found only when wetland vegetation achieves full growth potential associated with perennial flowing water. This vegetation is an important resource need for the New Mexico meadow jumping mouse because it provides vital food sources (insects and seeds), as well as the structural material for building day nests that are used for shelter from predators. New Mexico meadow jumping mice must have rich, abundant food sources during the summer so they can accumulate sufficient fat reserves to survive their long hibernation period. In addition, individual jumping mice also need intact upland areas (areas up gradient and beyond the floodplain of rivers and streams) adjacent to riparian wetland areas because this is where they build nests or use burrows to give birth to young in the summer and to hibernate over the winter. Some uncertainty exists about the particular location of hibernation sites relative to riparian areas.

These suitable habitat conditions need to be in appropriate locations and of adequate sizes to support healthy populations of the New Mexico meadow jumping mouse. Historically, these wetland habitats would have been in large patches (movements of 200 to 700 meters (m) (656 to 2,297 feet (ft)) to disperse to other habitat patches within stream segments) located intermittently along long stretches of streams. Connectivity between patches of suitable habitat is necessary to facilitate daily and seasonal movements, and dispersal to increase the likelihood of long-term viability of jumping mouse populations. The ability of New Mexico meadow jumping mouse populations to be resilient to adverse stochastic events depends on the robustness of a population and the ability to recolonize if populations are extirpated (the loss of a population or a species from a particular geographic region). Counting individual mice to assess population sizes is very difficult because the subspecies is trap-wary and hibernates for an extended time; thus, data are unavailable. We can best measure population health by the size of the intact, suitable habitat available.

Our assessment uses the best available information to estimate the minimum length of specific stream reaches or segments of ditches and canals, and the corresponding suitable habitat patch sizes that we think will provide a high likelihood of long-term persistence for the New Mexico meadow jumping mouse. Because the subspecies has limited daily and seasonal movements, dense riparian herbaceous habitat along streams, ditches, and canals needs to be of sufficient length to support large population sizes and multiple local populations dispersed throughout specific waterways. This continuous spatial arrangement is necessary to support breeding, nonbreeding, and daily and seasonal movements of New Mexico meadow jumping mice.

In considering the area needed for maintaining resilient populations of adequate size with the ability to endure adverse events (such as floods or wildfire), we estimate that resilient populations of jumping mice need connected areas of suitable habitat in the range of at least about 27.5 to 73.2 hectares (ha) (68 to 181 acres (ac)), along 9 to 24 kilometers (km) (6 to 15 miles (mi)) of flowing streams, ditches, or canals. The minimum area needed is given as a range due to the uncertainty of an absolute minimum and because local conditions within drainages will vary. This distribution and amount of suitable habitat would allow for multiple subpopulations of New Mexico meadow jumping mice to exist along drainages and would provide for sources of recolonization if some areas were extirpated due to disturbances. The suitable habitat patches must be relatively close together, no more than about 100 m (330 ft) apart, because the New Mexico meadow jumping mouse has limited movement and dispersal capacity for natural recolonization. Rangewide, we determined that the New Mexico meadow jumping mouse needs at least two resilient populations (where at least two existed historically) within each of eight identified geographic management areas. This number and distribution of resilient populations is expected to provide the subspecies with the necessary redundancy and representation to provide for viability.

The New Mexico meadow jumping mouse life history (short active period, short lifespan, low fecundity, specific habitat needs, and low movement and dispersal ability) makes populations highly vulnerable to extirpations when habitat is lost and fragmented. Based on historical (1980s and 1990s) and current (from 2005 to 2012) data, the distribution and abundance of the New Mexico meadow jumping mouse has declined significantly rangewide. The majority of local extirpations have occurred since the late 1980s to early 1990s, as we found about 70 formerly occupied locations are now considered to be extirpated.

Since 2005, researchers have documented 29 remaining populations spread across the 8 geographic management areas (2 in Colorado, 15 in New Mexico, and 12 in Arizona). Nearly all of the current populations are isolated and widely separated, and all of the 29 populations located since 2005 have patches of suitable habitat that are too small to support resilient populations of New Mexico meadow jumping mouse. None of them are larger than the needed 27.5 to 73.2 ha (68 to 181 ac), and over half of them are only a few acres in size. In addition, 11 of the 29 populations documented as extant since 2005 have been substantially compromised since 2011 (due to water shortages, excessive grazing, or wildfire and postfire flooding), and these populations could already be extirpated. Seven additional populations in Arizona may also be compromised due to postfire flooding following recent large wildfires. For example, the population at Sugarite Canyon State Park has been significantly impacted since the 2011 Track Wildfire (Frey and Kopp 2013, entire; Service 2013c, entire). Additionally, no New Mexico meadow jumping mice were captured at Bosque del Apache National Wildlife Refuge in 2013, despite intensive surveys within suitable habitat (Frey 2013, entire; Service 2013, entire; 2013a, entire; 2013b, entire). At this rate of population extirpation (based on known historical population losses and possible recent population losses) the probability of persistence of the subspecies as a whole is severely compromised in the near term.

Four of the eight geographic management areas have two or more locations known to be occupied by the New Mexico meadow jumping mouse since 2005, but all are insufficient (too small) to support resilient populations. The remaining four geographic management areas each have only one location of the New Mexico meadow jumping mouse known to be occupied since 2005, and each population is insufficient (too small) to be resilient. Therefore, although researchers have some uncertainty about population sizes of extant localities, the New Mexico meadow jumping mouse does not currently have the number and distribution of resilient populations needed to provide the needed levels of redundancy and representation (genetic and ecological diversity) for the subspecies to demonstrate viability.

We next analyzed the past, present, and likely future threats (causes and effects) that may put New Mexico meadow jumping mouse populations at risk of future extirpation. Because the New Mexico meadow jumping mouse requires such specific suitable habitat conditions, populations have a high potential for extirpation when habitat is altered or eliminated. In addition, because of the current conditions of isolated populations, when localities are extirpated, there is little or no opportunity for natural recolonization of the area due to the subspecies' limited movement and dispersal capacity.

We found a significant reduction in occupied localities likely due to cumulative habitat loss and fragmentation across the range of the New Mexico meadow jumping mouse. The past and current habitat loss has resulted in the extirpation of historical populations, reduced the size of existing populations, and isolated existing small populations. Ongoing and future habitat loss is expected to result in additional extirpations of more populations. The primary sources of current and future habitat losses include grazing pressure (which removes the needed vegetation) and water management and use (which causes vegetation loss from mowing and drying of soils), lack of water due to drought (exacerbated by climate change), and wildfires (also exacerbated by climate change). Additional sources of habitat loss are likely to occur from scouring floods, loss of beaver, highway reconstruction, residential and commercial development, coalbed methane development, and unregulated recreation.

These multiple sources of habitat loss are not acting independently, but produce cumulative impacts that magnify the effects of habitat loss on New Mexico meadow jumping mouse populations. Historically, larger connected populations of New Mexico meadow jumping mice would have been able to withstand or recover from local stressors, such as habitat loss from drought, wildfire, or floods. However, the current condition of small populations makes local extirpations likely more common. In addition, the isolated state of existing populations makes natural recolonization of impacted areas highly unlikely or impossible in most areas.

Considering the subspecies' biological status now and its likely status into the future, without active conservation (i.e., grazing management and water management) existing populations are vulnerable to extirpation (at least 11 have already undergone substantial impacts since 2011) and, therefore, the subspecies as a whole is currently at an elevated risk of extinction. None of the 29 populations known to exist since 2005 are of sufficient size to be resilient. Assuming this rate of population loss continues similar to recent years, the number of populations could be severely curtailed in the near term, eliminating the level of redundancy needed to withstand catastrophic drought and wildfire, along with the additive impacts of multiple threats. In addition to past sources of habitat loss, ongoing grazing, water shortages, and high-impact wildfire (the latter two exacerbated by climate change) will continue to put all of the remaining locations at considerable risk of extirpation in the near-term (between now and the next 10 years) and increasing over the long term. In considering the needed level of representation, while sufficient diversity likely still exists across the eight geographic management areas, the subspecies representation is relatively low because none of these geographic management areas currently have resilient populations. Therefore, we conclude that the overall probability of persistence is low in the near term and decreasing in the future due to the lack of adequate resiliency, redundancy, and representation.

We requested written comments from the public on the proposed rule during a comment period that opened on June 20, 2013 (78 FR 37363), and closed on August 19, 2013. We contacted appropriate Federal and State agencies, tribes, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. During the comment period, a newspaper notice inviting general public comment was published in the Albuquerque Journal. On August 15, 2013, we also held an informational meeting in Durango, Colorado, after receiving requests from interested parties. We did not receive any requests for a public hearing.

During the comment period, we received 24 comment letters, including 3 peer review comment letters, addressing the proposed listing of the New Mexico meadow jumping mouse. In this final rule, we address only the comments regarding the proposed listing of the New Mexico meadow jumping mouse. Comments addressing the proposed critical habitat designation will be fully addressed in a separate rulemaking action, and published in the Federal Register at a later date. All substantive information provided during the comment period has either been incorporated directly into this final determination, the SSA Report, or addressed below.

In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), we solicited expert opinion from four knowledgeable individuals with scientific expertise that are familiar with the subspecies, the geographic region in which the subspecies occurs, and conservation biology principles. We received responses from three of the four peer reviewers.

We reviewed all comments received from the peer reviewers for substantive issues and new information regarding the listing of the New Mexico meadow jumping mouse. All three of the peer reviewers agreed that the information presented in the proposed rule to list the New Mexico meadow jumping mouse as an endangered species is scientifically sound; that the assumptions, analyses, and conclusions are well reasoned; and that the information is complete and the best available, and the risks or threats to the subspecies are not undervalued. In addition, two of the three peer reviewers provided clarifications and suggestions to improve the final rule to list the New Mexico meadow jumping mouse as endangered. These comments are addressed in the following summary and incorporated into the final rule as appropriate.

(1) Comment: New information documents the possible extirpation of the Bosque del Apache National Wildlife Refuge population (Frey 2013, entire); the continued loss of New Mexico meadow jumping mice and habitat from the 2011 Track Wildfire in Sugarite Canyon (Frey and Kopp 2013, entire); additional survey efforts within the Sacramento Mountains that failed to document any new populations (Frey 2013c, entire); and new genetic data that continues to support the validity of the New Mexico meadow jumping mouse as a subspecies and its imperiled status (Malaney et al. 2012, entire; Malaney and Cook 2013, entire).

Our Response: We have incorporated this new information in the SSA Report (see 4.3 Population Estimates and Status in the SSA Report; Service 2014, entire). The data continue to support our determination that the subspecies is endangered.

(2) Comment: We received comments pertaining to dispersal distances. One suggestion, to plan for the interconnectivity of populations, was that the Service should consider dispersal distances from studies on the Preble's meadow jumping mouse ( Zapus hudsonius preblei ) of up to 4.3 km (2.7 mi), whereas another suggestion found our characterization of dispersal distances and home range sizes of the New Mexico meadow jumping mouse appropriate.

Our Response: Schorr (2003, p. 10; 2012, p. 1279) did report the Preble's meadow jumping mouse can move up to 4.3 km (2.7 mi). However, as stated in the SSA Report (Service 2014, entire), studies indicate that the New Mexico meadow jumping mouse does not appear to travel as great a distance as the Preble's meadow jumping mouse. Further, movement data is available on the New Mexico meadow jumping mouse. The maximum distance travelled between two successive points by all radio-collared jumping mice on Bosque del Apache National Wildlife Refuge was 744 m (2,441 ft), but most regular daily and seasonal movements were less than 100 m (328 ft) (Frey and Wright 2012, pp. 16, 109; Figure 9). See 2.6 Movements and Home Range in the SSA Report for additional information.

The conservation of New Mexico meadow jumping mice should plan for interconnectivity between populations using movement distances that are likely more common, rather than the maximum possible distance (see Trakhtenbrot et al. 2005, p. 175). As opposed to using the phrase, “maximum dispersal distance” in the draft SSA Report, we have clarified this as the distance between patches of suitable habitat to provide for population connectivity for the New Mexico meadow jumping mouse. In the SSA Report, we found that appropriately sized patches of suitable habitat should be no more than about 200 m (656 ft) apart within waterways, which would encompass the majority of regular (daily and seasonal) movements of individuals.

(3) Comment: The proposed rule and SSA Report provide virtually no information on the historical (pre-1980) distribution of the New Mexico meadow jumping mouse. These reports use only two time periods, historical (1980 to 1999) and current records (2005 forward). Almost no records of the subspecies obtained prior to 1980 were included in the SSA Report. The distribution and status of the 1980 to 1999 period was likely already significantly compromised.

Our Response: While the historical and current distributional data for the New Mexico meadow jumping mouse is categorized into two time periods in the SSA Report (Service 2014, entire), we did include all known distribution records. While we did not provide a map or table detailing the pre-1980 distribution of the subspecies in the SSA Report, we summarized the comprehensive reports of the New Mexico meadow jumping mouse's historical range and distribution (i.e., Frey 2008c, entire; Hafner et al. 1981). These authors (Frey 2008c, pp. 35, 46; Hafner et al. 1981, pp. 501-502) reported that the historical range and distribution of the New Mexico meadow jumping mouse likely included riparian wetlands along the Sangre de Cristo and San Juan Mountains from southern Colorado to central New Mexico and into parts of the White Mountains of Arizona.

We found no capture records of jumping mice between 1996 and 2005. Surveys conducted since 2005 documented locations where the subspecies was historically present, but is now apparently absent or at levels too low for detection. Based on this information and previous reviews, we continue to find that the comparison between historical (1980 to 1999) and current New Mexico meadow jumping mouse records (2005 forward) is appropriate and the pre-1980 records were sufficiently considered and incorporated in the SSA Report.

The Service agrees that the distribution and status of the subspecies was compromised by 1999. However, the Service's analysis of the five factors threat analysis listed in section 4(a)(1) of the Act includes the consideration of present threats and threats anticipated into the near future. We evaluated whether the subspecies is in danger of extinction throughout all or a significant portion of its range (endangered) or is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range (threatened).

(4) Comment: Snap traps have a higher capture success rate than live traps. As such, historical data collected by Morrison should not be compared with current data collected using nonlethal means.

Our Response: As noted in the SSA Report, use of live traps for inventory and monitoring are preferable, because some New Mexico meadow jumping mouse populations are likely extremely small, and killing and removal of even a few individuals from the population using snap traps could be detrimental. Further, the Service is required to use the best available scientific and commercial data. Data collected using live traps were not designed to estimate population size, but, to locate populations (Morrison 1988, pp. 47, 52; 1989, p. 3; 1990, p. 138; 1991, pp. 3-4). Frey (2005a, p. 68; 2011, p. 9; 2013d, pp. 24, 28) recommended targeted survey efforts to determine presence or absence of jumping mice should be 400 to 700 trap-nights over 3 consecutive nights using Sherman live traps baited with sweet grain mixture. Although Morrison used both Sherman and snap traps, these efforts resulted in locating populations (1988, pp. 47, 52; 1991, pp. 3-4). Consequently, we believe comparing data from Morrison's studies to current information on population presence is valid.

(5) Comment: Some surveys have not been completed on areas that contained suitable habitat because they were deemed too small or disjunct; yet, the Lincoln National Forest recently documented presence of the New Mexico meadow jumping mouse in areas that were thought to be “too small.”

Our Response: The Service does not have any records documenting the presence of the New Mexico meadow jumping mouse in areas that were considered too small or disjunct on the Lincoln National Forest or other areas. The information the Service has indicates the Lincoln National Forest has only documented the New Mexico meadow jumping mouse in two new areas, Cox Canyon and Mauldin Spring in Wills Canyon (United States Forest Service (USFS) 2012h, pp. 2-3, 2013a, entire), since Frey (2005, entire) completed surveys. The Cox Canyon site was surveyed in 2005 by Frey (2005, pp. 9, 20, 33), with no New Mexico meadow jumping mice captured at the time, likely because no suitable habitat was present. However, in 2012, New Mexico meadow jumping mice were captured at Cox Canyon, following the cessation of grazing for 2 years (USFS 2012h, pp. 2-4; Service 2012d, p. 2; U.S. Army Corps of Engineers 2012, entire; 2012a, entire). The Mauldin Spring area was not deemed to be too small during Frey's 2005 surveys, but is located in a remote area over 0.4 mi (0.6 km) from a road.

(6) Comment: Some sites on the Lincoln National Forest that had New Mexico meadow jumping mice in the 1980s (Morrison 1989, entire) have not been surveyed recently. The presence of New Mexico meadow jumping mice was confirmed in these areas in the 1990s by Ward (2001) and there is a still a high potential for New Mexico meadow jumping mice to be present. The most recent trapping efforts conducted on the Lincoln National Forest have demonstrated that the New Mexico meadow jumping mouse is present.

Our Response: Since 2005, all of the previously occupied sites on USFS lands from the 1980s have been resurveyed. The USFS did not provide information on who conducted the recent trapping efforts or the specific sites from the 1980s that were not surveyed. However, since 2005, we are aware of the following survey efforts on the Lincoln National Forest: (1) Frey (2005a, entire (2,375 trap nights of effort) and 2013c, entire (1,280 trap nights of effort)); and (2) USFS (2010, entire (1,310 trap nights of effort); 2012h, entire (3,480 trap nights of effort); and 2013, entire (2,494 trap nights of effort)). Through these surveys, all of the historical Morrison (1989, entire) sites on public lands and other areas that contained potentially suitable habitat were surveyed (Frey and Malaney 2009, p. 33; USFS 2010, entire; 2012h, entire; 2013, entire). Frey (2005, p. 38) only found the New Mexico meadow jumping mouse present at two historical locations, Silver Springs and Agua Chiquita. The Lincoln National Forest (2012h, entire; 2013a, entire) found the New Mexico meadow jumping mouse present at two additional locations, Cox Canyon and Mauldin Spring. Only the Cox Canyon population found by the USFS was a historical location reported by Morrison (1989, entire). Ward ((2005, entire) cited by Frey 2005a, pp. 9, 22, 73; Frey and Malaney 2009, p. 44)) confirmed New Mexico meadow jumping mice at only one location (Mauldin Spring) in the 1990s, and there is no longer suitable habitat present at this location. Consequently, all sites with suitable habitat on the Lincoln National Forest have been surveyed since 2005, and only 4 locations (3 historical and 1 new) have been confirmed as extant.

(7) Comment: What will the delisting factors be for the New Mexico meadow jumping mouse?

Our Response: We have not developed delisting criteria yet for the New Mexico meadow jumping mouse. Now that the subspecies is listed as endangered, a draft and final recovery plan will be prepared. The recovery plan will identify site-specific management actions, including measurable criteria that determine when the subspecies may be downlisted or delisted, and methods for monitoring recovery progress.

(8) Comment: The term “excessive grazing” is never clearly defined in the SSA Report or proposed rules.

Our Response: Our use of the phrase excessive grazing is in the context of suitable New Mexico meadow jumping mouse habitat. Excessive ungulate grazing in this context occurs when there is an inadequate amount of tall dense herbaceous riparian vegetation to support the New Mexico meadow jumping mouse (see “Specific Microhabitat Requirements” section in the SSA Report; Service 2014, entire). Indications of excessive grazing are: trampling of streambanks, loss of riparian cover, soil compaction, modification of riparian plant communities, lowering water tables, and the resulting changes to New Mexico meadow jumping mouse microhabitat. Excessive grazing in riparian areas can result in changes to the hydrology and soils, leading to downcutting or headcutting, which can further degrade New Mexico meadow jumping mouse habitat.

(9) Comment: There is no mention of whether feral hogs or wild horses are considered threats to the New Mexico meadow jumping mouse. What would be expected and allowed for trapping and removal of these animals?

Our Response: The USFS did not provide any specific information on feral hogs or wild horses for us to consider and we did not receive any information regarding this topic during the public comment period. We have no information concerning feral hogs or wild horses currently occurring within New Mexico meadow jumping mouse habitat. There are confirmed feral hog populations in Otero and Socorro Counties, New Mexico, but there is no information indicating their presence in New Mexico meadow jumping mouse habitat or of impacts to the subspecies (APHIS 2010, p. 10; USFS 2011d). We acknowledge that both animals have the potential to impact riparian areas and New Mexico meadow jumping mouse habitat, but have no data on if or where this is occurring or how much habitat may be affected now or in the future.

Under Section 7(a)(1) of the Act, Federal agencies, such as the USFS, could utilize their existing authorities by carrying out programs such as the removal of feral hogs or wild horses for the conservation of the New Mexico meadow jumping mouse.

(10) Comment: What will the herbicide use or non-use expectation be for non-native invasive plant control?

Our Response: Section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service. If a Federal agency proposes to use herbicide to control nonnative plants and it may affect the New Mexico meadow jumping mouse or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

The prohibitions of section 9(a)(2) of the Act make it illegal for any person to take (includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these), import, export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any listed species. We may issue permits to carry out otherwise prohibited activities involving endangered and threatened wildlife species under certain circumstances. A list of activities that could potentially result in a violation of section 9 of the Act is in this final rule under Available Conservation Measures section. This list is not comprehensive. The Service can also work with private landowners to provide technical assistance or we may issue permits for incidental take of a species in connection with otherwise lawful activities.

(11) Comment: What will be allowable for piping water from streams or springs to water troughs for wildlife or cattle? Will travel corridors that assist in moving cattle from winter to summer pastures be allowed across streams so that cattle can move and access water troughs?

Our Response: If a Federal agency implements, authorizes, or funds water use or livestock grazing activities that may affect the New Mexico meadow jumping mouse, then they must enter into consultation with the Service. Consultation would analyze and determine to what degree the subspecies is impacted by the proposed action. Each consultation is evaluated on a case-by-case basis following our regulations (50 CFR part 402). See our response to comment (10) above regarding the prohibitions of section 9(a)(2) of the Act.

(12) Comment: How does the Service intend to manage livestock grazing and associated actions such as fencing riparian areas and providing water points?

Our Response: The Service does not intend to manage livestock grazing or associated actions. Rather the Service will work with Federal agencies during consultation under section 7 of the Act, to ensure that any actions they fund, authorize, or carry out would not jeopardize the continued existence of the New Mexico meadow jumping mouse. These section 7 consultations will determine whether the management of a Federal livestock permit jeopardizes the continued existence of the New Mexico meadow jumping mouse. Our regulations require that we use the best scientific and commercial data available for consultations (50 CFR 402.14(d)). This information is used to update and analyze the effects of past and ongoing human and natural activities or events that have led up to the current status of the subspecies and its habitat. Consequently, any requirements to minimize the effects of livestock grazing and associated activities will be appropriately applied through section 7 provisions 7(a)(1) and 7(a)(2), which can be changed if new information reveals effects to the subspecies or critical habitat in a manner or extent not previously considered (see 50 CFR 402.16(b)).

The Service can also work with private landowners to provide technical assistance or we may issue permits for incidental take of a species in connection with otherwise lawful activities.

(13) Comment: Roads are not listed as a factor affecting the New Mexico meadow jumping mouse; however, dirt roads can cause indirect effects through sedimentation or by impeding spring flows.

Our Response: We acknowledge that it is possible for roads to indirectly or directly impact riparian areas, springs, or New Mexico meadow jumping mouse habitat. However, the USFS did not provide any specific information for us to consider and the best available scientific and commercial data does not indicate how or where dirt roads may be causing indirect effects to New Mexico meadow jumping mouse habitat through sedimentation or by impeding spring flows now or in the future.

(14) Comment: A lack of probabilistic sampling designs and estimation of detection probabilities for New Mexico meadow jumping mouse survey efforts prevents using occupancy data in determining distribution and populations trends through time.

Our Response: Counting individual mice to estimate population sizes is very difficult and data are currently unavailable. Recent surveys have relied on detection or nondetection (sometimes called presence or absence) data to determine whether New Mexico meadow jumping mice persist in areas that contained historical populations or areas that currently contain suitable habitat. As we found in the SSA Report, species-specific surveys have been useful for determining occupancy, but are limited in their usefulness for capture probabilities and, therefore, estimating population size. We recognize that detection or nondetection data may not provide conclusive evidence of the true population status at each of the 29 locations found since 2005; however, the failure to detect New Mexico meadow jumping mice in areas where they were located in the 1980s and loss of previously suitable habitat at over 70 historical sites since this period are likely representative of real population extirpations.

As a result, detection or nondetection surveys represent the best scientific and commercial data we have regarding the rangewide distribution and persistence of populations. Based on these data, we find that the New Mexico meadow jumping mouse has declined sharply due to the extirpation of populations and is generally restricted to small, isolated patches of suitable habitat. We acknowledge that research is needed to determine the size and demographics of remaining populations, but the best scientific and commercial data available on the threats to this subspecies is sufficient to make a listing determination (For a full discussion, see Summary of Factors Affecting the Species and Determination sections, below).

(15) Comment: Without conducting rigorous experiments, it is scientifically indefensible and speculative to attribute the loss of New Mexico meadow jumping mouse habitat to livestock grazing and recreation. There were no experimental controls used to make comparisons and too many extraneous variables to conclude that these activities were the cause of habitat and population loss.

Our Response: We agree that it would be useful to have more information on the New Mexico meadow jumping mouse. However, the best available scientific and commercial data indicate what the habitat requirements of the mouse are, including vegetation type and size. Further, it is evident that livestock grazing and recreational activities can negatively impact the required vegetation for mouse habitat, without doing further experimentation. In fact, such experimentation with a scarce, potentially endangered species may further imperil the species. In the SSA Report (Service 2014, entire), we present the best commercial and scientific data available, albeit observational evidence, to conclude that livestock grazing, recreation, and other causal factors have resulted in the alteration and destruction of New Mexico meadow jumping mouse habitat.

(16) Comment: The Service assumed a correlation between habitat patch size and New Mexico meadow jumping mouse populations without providing documentation.

Our Response: We acknowledge that the best available information regarding New Mexico meadow jumping mouse population abundance is not complete. However, because the New Mexico meadow jumping mouse requires specialized habitat requirements to support its life-history needs, they would not be found in areas that lack suitable habitat. Consequently, we estimated the size of intact, suitable habitat surrounding capture locations of jumping mice found since 2005 as a the best proxy to evaluate population viability. We think this is a reasonable approach, because it is probable that small areas of suitable habitat can support only a limited number of New Mexico meadow jumping mice, and small population sizes are more vulnerable to extirpation than large population sizes. Moreover, studies conducted on the similar Preble's meadow jumping mouse found smaller patches of habitat are unable to support as many Preble's as larger patches of habitat (Service 2003, p. 11). Schorr (2012, p. 1279) suggested that habitat connectivity and the incorporation of immigrants may be vital to the persistence of Preble's meadow jumping mouse populations, indicating that degradation of surrounding habitat and geographic isolation likely increase the vulnerability of some populations. Therefore, our conclusion that small isolated areas of New Mexico meadow jumping mouse habitat are expected to have small populations with a high risk of extinction is based upon Preble's meadow jumping mouse studies, general conservation biology principles, and metapopulation theory (Hanski 1999, entire; Service 2003, entire).

(17) Comment: A lack of knowledge about New Mexico meadow jumping mouse population sizes and dynamics should be a concern to the Service. Determinations of endangered or threatened status should use the best available scientific and commercial information and should not be based upon conjecture.

Our Response: It is often the case that data is limited for rare species, but we have used the best available scientific and commercial data. As we found in the SSA Report (Service 2014, entire), jumping mice population sizes are assumed to be naturally regulated by the amount of suitable habitat available to support them. Jumping mice populations probably expand and contract in response to fluctuations in riparian vegetation from flooding, inundation, drought, and the resulting changes in the extent and location of floodplains and river channels (Service 2002, pp. D13-D15). For populations to persist over the long term, habitat patches need to be of sufficient size and configuration to accommodate these fluctuations in habitat availability. When the suitable habitat patches are small and isolated, periods of drought or other disturbances can cause New Mexico meadow jumping mouse habitats to shrink or become fragmented and lead to reductions in population sizes or even extirpation of New Mexico meadow jumping mouse populations. Therefore, New Mexico meadow jumping mice need suitable habitat sufficient in size to support the natural fluctuations of populations as they expand and contract, to reduce the risk of local extirpation and extinction, and to attain the densities necessary to persist through catastrophic events and seasonal fluctuations of food resources (i.e., maintain healthy resilient populations). Based on our review of the best available scientific and commercial data, we conclude that the New Mexico meadow jumping mouse is currently in danger of extinction throughout all of its range, and therefore, meets the definition of an endangered species (see Determination, below). The analysis used to make this decision was subject to peer-review to ensure sound science and decisionmaking. See 2.7.2 Habitat Patch and Population Sizes in the SSA Report for additional information on this subject.

(18) Comment: The SSA Report contains “substantial areas of uncertainty” and is not a “thorough assessment.” The Service should not make assumptions; assumptions are not scientific data and should not be used in a listing determination.

Our Response: We did not base our listing decision on the areas of uncertainty. The main areas of uncertainty in our analysis include the minimum amount of suitable habitat needed to support resilient populations and the number of redundant populations needed to provide for adequate redundancy and representation. The proposed rule and SSA Report (Service 2014, entire) were peer reviewed, and found to be an accurate representation of the status of the New Mexico meadow jumping mouse. The peer reviewers agreed that the scientific and commercial data available on the threats to this subspecies is adequate to make a listing determination. As a result, we have found that the New Mexico meadow jumping mouse is presently in danger of extinction throughout all of its range based on the severity of threats.

(19) Comment: The SSA Report lists livestock grazing as a threat to the New Mexico meadow jumping mouse within Lake Dorothey State Wildlife Area in Colorado; however, the area is not grazed by domestic livestock and there are no plans to begin such a use.

Our Response: We understand that the Lake Dorothey State Wildlife Area in Colorado is closed to domestic livestock grazing, but unauthorized livestock use has occurred. The Lake Dorothey State Wildlife Area is in the Sugarite Canyon in Colorado and New Mexico, which burned in the 2011 Track Wildfire. The Lake Dorothey State Wildlife Area borders Sugarite Canyon State Park in New Mexico. The fire resulted in downed fences between private lands and Sugarite Canyon State Park, allowing cattle to access the area. Trespass cattle that entered Sugarite Canyon State Park in New Mexico accessed the Lake Dorothey State Wildlife Area. Employees of Sugarite Canyon State Park noted at least 30 trespass cattle within their park (Service 2013, pp. 1-2; Wildermuth 2012, entire). Trespass cattle have been consistently observed within Soda Pocket Creek Campground and Segerstrom Creek of the Sugarite Canyon State Park, sites that were previously occupied by the New Mexico jumping mouse (Service 2012c, pp. 2, 10; 2013, pp. 1-2). We have clarified this information in the SSA Report.

(20) Comment: The SSA Report lists livestock grazing and development as threats within the Sambrito Creek Geographic Management Area in Colorado. This area is within Navajo State Park and is not grazed by domestic livestock and unlikely to be developed due to ownership by the Bureau of Reclamation and management by Colorado Parks and Wildlife.

Our Response: We understand that Navajo State Park is closed to domestic livestock grazing, but unauthorized livestock use has occurred repeatedly at several locations within the geographic management area (Bureau of Reclamation 2008, p. 3-62; Colorado Natural Heritage Program 2006, p. 261). This unauthorized use is due to the lack of fences, incomplete fences, and poorly constructed or maintained fences. Areas with high incidences of livestock trespass include the Miller Mesa-Sambrito area, and the upper river arms (Bureau of Reclamation 2008, p. 3-62), which also includes New Mexico meadow jumping mouse locations and proposed critical habitat.

Sambrito Creek is surrounded on three sides by privately owned lands that are partially developed, including agricultural fields, pastures, residences, and oil and gas wells (Colorado Natural Heritage Program 2006, p. 261). We acknowledge that the occupied area of Sambrito Creek is within Navajo State Park; however, the potential for further residential or oil and gas development on the surrounding private lands is high, which would likely result in less hydrologic input, and, therefore, shrinking and drying of the wetland area (Colorado Natural Heritage Program 2006, p. 261) and New Mexico meadow jumping mouse habitat.

(21) Comment: The description of activities that could result in take under section 9 is too vague. The Service should provide specific dates for the active season of the jumping mouse. Further, the Service should clarify whether destruction of habitat by any means is illegal, which implies that a land owner would be responsible for controlling against natural modifications such as browsing by native wildlife, flooding, drought, wildfire, or the diversion of water rights, wildfire restoration, grazing, and spread of invasive plants, even if these actions were occurring on other properties within the watershed.

Our Response: The prohibitions of section 9(a)(2) of the Act, codified at 50 CFR 17.21 for endangered wildlife, in part, make it illegal for any person subject to the jurisdiction of the United States to take (includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these), import, export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any listed species. Under the Lacey Act (18 U.S.C. 42-43; 16 U.S.C. 3371-3378), it is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Section 9 applies to persons that carry out or attempt to carry out the actions listed above, not actions such as weather events and native wildlife foraging.

The intent of describing potential section 9 violations is to increase public awareness of the effect of a listing on proposed and ongoing activities within the range of a listed species. We have clarified the list of potential section 9 violations below (see Available Conservation Measures). These may include, but are not limited to, the alteration or removal of specific microhabitat components (as described in this rule or within the May 2013 SSA Report (Service 2013) through new construction, livestock grazing, or dredging or filling in streams or wetlands.

We may issue permits to carry out otherwise prohibited activities involving endangered and threatened wildlife species under certain circumstances. With regard to endangered wildlife, a permit must be issued for the following purposes: for scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities (including but not limited to grazing, construction, and wetland alterations). Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the Service's Ecological Services Field Office in the State where the proposed activities will occur.

We have generally defined the active season of the New Mexico meadow jumping mouse in the SSA Report (Service 2014, entire) as May through October.

(22) Comment: The size and stream length range of estimates for resilient populations of New Mexico meadow jumping mice have no citations, or justification of how these were determined.

Our Response: In the SSA Report (Service 2014, entire), we estimate how much suitable habitat is likely necessary to support healthy, resilient populations of the New Mexico meadow jumping mouse by considering information regarding the Preble's meadow jumping mouse and information from Frey (2006d, pp. 18-21; 2011, p. 29; 2012b, p. 16) for the New Mexico meadow jumping mouse. For examples, the Recovery Team for the Preble's meadow jumping mouse recommended that at least several medium-sized populations (at least 500 mice) should be protected with each population distributed along a 14- to 26-km (to 16-mi) network of connected streams whose hydrology supports riparian vegetation (Service 2003, pp. 24-25). Following fires, we found that, depending on fire intensity and the subsequent ash and debris flow within stream reaches, New Mexico meadow jumping mouse populations can be significantly affected and likely extirpated, even when 15 km (9 mi) of continuous suitable habitat existed prior to the fire (Sugarite Canyon; Frey 2006d, pp. 18-21; 2012b, p. 16). Therefore, we estimate that stream lengths should be at least two to three times of those characterized by Frey (2011, p. 29) in order to have adequate population sizes necessary to persist through these types of stochastic and catastrophic events. After reviewing this information, we conclude that current New Mexico meadow jumping mouse populations need connected areas of suitable habitat along at least 9 to 24 km (5.6 to 15 mi) of continuous suitable habitat to support viable populations of jumping mice with a high likelihood of long-term persistence. See 2.7.2 Habitat Patch and Population Sizes in the SSA Report for additional information on this subject.

(23) Comment: Is there observer bias associated with using primarily information from the Frey surveys and conclusions? Have there been any other groups or individuals providing data or information on the New Mexico meadow jumping mouse?

Our Response: The Act requires that we identify species of wildlife and plants that are endangered or threatened based on the best scientific and commercial data available. We did not primarily use information from Frey, but relied on a variety of information including State wildlife agencies, other researchers, and Federal agencies (e.g., see Museum of Southwestern Biology 1960, entire; 2007, entire; 2007a, entire; Findley et al. 1975, pp. 271-272; Hafner et al. 1981, pp. 501-502; Hink and Ohmart 1984, p. 96; Dodd 1987, entire; Morrison 1988, pp. 9-28; 1991, pp. 14-16; 1992, pp. 308-310; 2012, entire; VanPelt 1993, p. 8; Najera 1994, entire; Jones 1999, entire; Frey 2003, pp. 38-39; 2005a, pp. 6-10, 58-59; 2006, p. 54; 2006c pp. 1-2; 2006d, pp.65-78; 2007b, pp. 9-13, 25-27; 2008, p. 3; 2008c, entire; 2010, entire; 2011, entire; 2012a, entire; 2012, entire; 2012e, entire; 2013, entire; 2013a, entire; Frey et al. 2007a p. 1; Frey and Malaney 2009, pp. 33-34; Frey and Kopp 2013, entire; Frey and Wright 2012, pp. 22-23; Underwood 2007, pp. 1-4; USFS 2009, entire; 2012h, entire; 2013a, entire; AGFD 2012a, p. 3; Colorado Parks and Wildlife 2012, entire; 2013, entire; 2013a, entire; Malaney et al. 2012, entire; Service 2013, entire; 2013a, entire; 2013b, entire). Based on this information, we find there is unbiased and sound scientific and commercial data to reach our final determination that the species is endangered.

(24) Comment: The SSA Report indicates that the New Mexico meadow jumping mouse is difficult to capture because individuals are trap wary, but then uses the recent survey information to justify listing as endangered. This seems contradictory.

Our Response: Please see our responses to comments (4) and (14) above. Although the subspecies is difficult to capture, surveyors (Jones 1999, entire; Frey 2005a, pp. 6-10, 58-59; 2006d, pp. 65-78; 2007b, pp. 9-13, 25-27; 2008, p. 3; 2008c, pp. 36, 42; 2010, entire; 2011, entire; 2012, entire; Frey et al. 2007a, p. 1; Frey and Malaney 2009, entire; Museum of Southwestern Biology 2007, entire; 2007a, entire; Underwood 2007, entire; Frey and Wright 2012, pp. 22-23; Forest Service 2009, entire; 2010, p. 2; 2012a, entire; 2012b, entire; 2012h, entire; Colorado Parks and Wildlife 2012, entire, 2013, p. 1) have been able to provide information on presence or absence in specific areas, and using this best available information, we are able to make a status determination for the New Mexico meadow jumping mouse. Since 2003, New Mexico meadow jumping mouse surveys in New Mexico, Arizona, and Colorado involved 200 localities and 68,102 trap nights (over 100 historically occupied sites plus 136 localities that appeared to have the highest quality potentially suitable habitat) (see “Current Records of Localities Found Since 2005” in the SSA Report; Service 2014).

(25) Comment: Information is insufficient or lacking on the New Mexico meadow jumping mouse, and more research is needed prior to listing, including more surveys. The proposed rule and SSA Report are based on assumptions rather than the best scientific information available as required. Peer reviewing the information would ensure the listing decision and critical habitat determination are based on scientifically sound data, assumptions, and analyses.

Our Response: We acknowledge that additional study on some life-history aspects of the New Mexico meadow jumping mouse would be helpful, but as required by the Act, we based our proposal and this final rule on the best available scientific and commercial data. We requested new information on our June 20, 2013 (78 FR 37363; 78 FR 37328) proposed rule during the open public comment period. We reviewed information in our files and other available published and unpublished information, and we consulted with recognized species experts, State agencies, tribes, and other Federal agencies. Peer reviewers indicated that we used the best available science and our assessment correctly concluded the New Mexico meadow jumping mouse should be classified as an endangered species. We must make listing determinations on the basis of the best scientific and commercial information available at this time, and we may not delay our decision until more information about the subspecies and its habitat are available (see Southwest Center for Biological Diversity v. Babbitt, 215 F.3d 58 (D.C. Cir. 2000)).

(26) Comment: Livestock grazing has been reduced over the last 20 years on many areas of the Apache-Sitgreaves National Forest, Arizona, due to listing the southwestern willow flycatcher ( Empidonax traillii extimus ), loach minnow ( Tiaroga cobitis ), Little Colorado spinedace ( Lepidomeda vittata ), and spikedace ( Meda fulgida ); however, the New Mexico meadow jumping mouse has declined during this same period. What other actions could have caused its decline?

Our Response: Please refer to the SSA Report (Service 2014, entire) for review of the past, present, and likely future threats (causes and effects) to New Mexico meadow jumping mouse populations in Arizona and throughout its range. We found the primary sources of past and future habitat losses are from grazing pressure, water management and use, lack of water due to drought, and wildfires. Current USFS forage utilization guidelines are 30 to 40 percent, meaning 60 to 70 percent of forage should not be removed by livestock (USFS 2005, p. 4; 2013, entire; Service 2005a, entire). This amount of utilization has limited the availability of adequate vertical cover of herbaceous vegetation and significantly affected New Mexico meadow jumping mouse habitat in areas that are not protected from livestock (i.e., outside of livestock exclosures). Current grazing practices in many areas of the Apache-Sitgreaves National Forest, Arizona, have resulted in the removal of dense riparian herbaceous vegetation that historically provided New Mexico meadow jumping mouse habitat and caused the loss of historical populations (Frey 2011, entire). Additional sources of habitat loss are likely to occur from scouring floods, loss of beaver, highway reconstruction, and unregulated recreation.

(27) Comment: Recreation is a greater threat to the New Mexico meadow jumping mouse populations within the Jemez Mountains, New Mexico than livestock grazing as it is practiced on the San Diego Allotment along the Rio Cebolla and Rio de las Vacas within the Jemez Mountains.

Our Response: Throughout the Rio Cebolla and Rio de las Vacas drainages, riparian habitat is fragmented and isolated as a result of both livestock grazing and recreation (USFS 2003, entire; 2004a, entire; Frey 2005a, pp. 25-29, 58-63, 67; Service 2012a, entire). Current grazing practices in many areas have resulted in the removal of dense riparian herbaceous vegetation that historically provided New Mexico meadow jumping mouse habitat and caused the loss of historical populations. For example, the New Mexico meadow jumping mouse has been extirpated entirely from 3 of 13 (Jemez Mountains, New Mexico) historical montane riparian sites over the last 2 decades (Frey 2003, entire; 2005a, entire; 2011, entire; 2012a, pp. 42, 46, 52; Frey and Malaney 2009, entire; USFS 2012h, entire; Figure 15). Importantly, the presence of a functioning livestock exclosure has been reported as the best predictor of New Mexico meadow jumping mouse occupancy in montane riparian areas (Frey 2005a, pp. 59-60; Frey and Malaney 2009, pp. 35, 37). However, livestock grazing continues to be documented within many of the fenced exclosures surrounding the recently documented New Mexico meadow jumping mouse populations when fencing was cut or not maintained, gates were open, or wildfire burned and eliminated fences, and cattle entered the area (Frey 2005a, pp. 25-26, 29, 36; 2006, p. 1; 2011, pp. 41-42; Colorado Natural Heritage Program 2006, p. 260; U.S. Bureau of Reclamation 2008, pp. 3-62; USFS 2007, p. 1; 2010, p. 2; 2011c, pp. 1-5; 2012h, p. 2; ADGF 2012a, entire; Service 2012a, pp. 1-2; 2012c, pp. 1, 6-8; 2012d, p. 2). See 5.1.1 Livestock Grazing and 5.1.10 Recreation in the SSA Report (Service 2014, entire) for additional detail on these threats.

Within the Jemez Mountains Geographic Management Area for the New Mexico meadow jumping mouse, specific forms of management (e.g., fencing of riparian areas) may be required through formal consultation with the Forest Service to provide areas containing functionally connected patches of currently suitable or restorable habitat. Management may also be needed to address livestock use, the reduction in the distribution and abundance of beaver, and recreational use.

(28) Comment: The SSA Report (Service 2014, entire) indicates that climate change and drought affect the New Mexico meadow jumping mouse. How would listing the subspecies affect these threats?

Our Response: The Service acknowledges that listing the subspecies as endangered cannot fully address some of the natural threats facing the subspecies (e.g., climate change and drought). However, climate change and drought can exacerbate other threats such as wildfire and grazing, and can lower the resiliency of populations to withstand other threats. Listing of species can focus attention on these other threats to improve the overall status and increase the likelihood that the New Mexico meadow jumping mouse can be recovered.

Once a species is listed as either endangered or threatened, the Act provides many tools to advance the conservation of listed species; available tools include recovery planning under section 4 of the Act, interagency cooperation and consultation under section 7, grants to the States under section 6, and safe harbor agreements and habitat conservation plans under section 10. In addition, recovery funds may become available, which could facilitate recovery actions (e.g., funding for additional surveys, management needs, research, captive propagation and reintroduction, monitoring) (see Available Conservation Measures, below). Because we are listing the New Mexico meadow jumping mouse as endangered, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, under to section 6 of the Act, the States of Arizona, Colorado, and New Mexico would be eligible for Federal funds to implement management actions that promote the protection and recovery of this subspecies. Information on our grant programs that are available to aid species recovery can be found at http://www.fws.gov/grants.

(29) Comment: A plan in the 1990s removed dispersed recreation and limited campsites along the East Fork of the Black River, Arizona. Is the subspecies threatened by other activities in this area?

Our Response: The commenter does not identify a specific plan for us to reference. As noted in the SSA Report (Service 2014, entire), the New Mexico meadow jumping mouse is also threatened by climate change, wildfire, flooding, loss of beaver, and recreation in this area (Please see the SSA Report, Table 3).

(30) Comment: Contrary to what is presented in the SSA Report (Service 2014, entire), the adverse impacts from livestock grazing, water diversion, and recreation were halted in Arizona in 1980s and 1990s when other species were listed as endangered.

Our Response: The commenter did not provide information demonstrating that livestock grazing, water diversion, and recreation are not threats to the New Mexico meadow jumping mouse in Arizona. The best scientific and commercial information demonstrates the continuing threats of livestock grazing, recreation, and other sources of past and future habitat losses in Arizona. See the SSA Report for additional information.

We did identify water diversion as a threat to the New Mexico meadow jumping mouse in Arizona. However, reliance on such water sources for development and maintenance of suitable herbaceous riparian vegetation may be problematic because the availability (in quantity, timing, and quality) is often subject to dramatic changes based on precipitation and irrigation use patterns associated with water rights. Other recently located populations (e.g., Florida River, Sugarite Canyon, Coyote Creek in New Mexico) are located in areas where surface water is diverted into irrigation canals and ditches, rather than the natural flow remaining within the stream drainage (ADGF 2006, p. 473; Frey 2005a, p. 63; 2006d, p. 55; 2011, p. 19; U.S. Bureau of Reclamation 1995, entire). The suitable habitat along Sambrito Creek in Colorado is associated with wetlands that are fed by irrigation water return flows (Colorado Natural Heritage Program 2006, p. 261; U.S. Bureau of Reclamation 2008, pp. 3-23). These changes in hydrology degrade and eliminate potentially suitable New Mexico meadow jumping mouse habitat, to the point that so much water is being diverted in some streams that they no longer support an herbaceous zone of riparian habitat (Frey 2005a, p. 63; 2006d, p. 55).

(31) Comment: In the SSA Report, Figure 13 compares a grazed area to an ungrazed area. If a fire were to burn in the ungrazed area during drought conditions, the tall dense vegetation would burn completely, eliminating the riparian habitat and killing all of the New Mexico meadow jumping mice. Alternatively, the grazed area that lacks tall dense grass would not burn completely, suggesting grazing may be beneficial for the New Mexico meadow jumping mouse.

Our Response: Although the grazed area in Figure 13 is unlikely to burn completely, it does not provide suitable habitat for the New Mexico meadow jumping mouse, because grazing eliminated dense riparian vegetation. So, whether the grazed area burns or not, the subspecies will not be able to use this grazed area. Excessive livestock grazing has not only eliminated the fine fuel load that historically contributed to frequent low-intensity fires (see discussion in the SSA Report under “Livestock Grazing” section; Service 2014, entire)), but has also altered the suitability of habitat for the New Mexico meadow jumping mouse, which is a significant threat to the subspecies, demonstrated by Figure 13. Further, if the ungrazed portion burns and remains ungrazed this area will return to pre-burn vegetation conditions depicted in Figure 13, generally within a year.

(32) Comment: How would listing the New Mexico meadow jumping mouse complement or contradict consultation or recovery actions of other threatened or endangered species such as the southwestern willow flycatcher or Rio Grande silvery minnow ( Hybognathus amarus )?

Our Response: Some native species that share ecosystems often face a suite of common factors that may be a threat to them, and ameliorating or eliminating these threats for one species will benefit multiple species, often with the implementation of similar management actions. Effective management of these threats often requires implementation of complementary conservation actions to enhance or restore critical ecological processes and native habitat, and provide for long-term viability of those species in their native environment. In some of the geographic management areas, we will likely consider the need to address other listed species in our future recovery planning efforts for the New Mexico meadow jumping mouse. This will also be the case for section 7 consultations when a proposed action affects multiple species.

(33) Comment: Trapping and livestock grazing are not contributing factors to loss of beaver ponds.

Our Response: Baker and Hill (2003, p. 303) indicated that beaver are highly vulnerable to overharvest from trapping because their slow rate of reproduction and delayed sexual maturity preclude reproduction as a means to offset intensive annual harvest. As noted in the SSA Report (see 5.1.6 Loss of Beaver of the SSA Report; Service 2014, entire), the decline and near elimination of beaver due to overharvesting is well documented (Naiman et al. 1988, entire; Baker and Hill 2003, p. 288; Crawford et al. 1993, p. 39). Moreover, beaver continue to be subject to extensive management and removal (U.S. Department of Agriculture, Animal and Plant Health Inspection Service 2011, entire; Wild 2011, p. 5).

Limiting factors for beaver populations are typically related to the availability of food resources (e.g., trees, tubers, roots, shoots, and many herbaceous plants) (Boyle and Owens 2007, p. 21). Intense herbivory by ungulates or livestock can disrupt beaver populations (Baker et al. 2005, p. 117) because grazing can reduce or eliminate adequate herbaceous and riparian plants that are required for beaver food. Sufficient food is necessary to sustain beaver populations. Beaver continue to be lost from across the range of the New Mexico meadow jumping mouse; therefore, we consider this another causative factor in the ongoing loss of suitable New Mexico meadow jumping mouse habitat now and into the future (Please see the SSA Report for further information).

(34) Comment: If the New Mexico meadow jumping mouse is listed as endangered, are private landowners obliged to follow the Act? Is this a taking of private property rights?

Our Response: Section 9 of the Act makes it illegal for anyone to “take” (defined as harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, collect, or attempt any of these actions) an endangered species (see section 9 of Available Conservation Measures, below). However, the mere promulgation of a regulation, like listing a species under the Act, does not take private property, unless the regulation on its face denies the property owners all economically beneficial or productive use of their land, which is not the case with the listing of this subspecies. Programs are available to private landowners for managing habitat for listed species, as well as permits that can be obtained to protect private landowners from the take prohibition when such taking is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity. Private landowners may contact their local Service field office to obtain information about these programs and permits.

(35) Comment: There is a fixation on livestock grazing in the proposed rule and no consideration of other types of ungulate grazing such as feral horses or elk.

Our Response: In the SSA Report (Service 2014, entire, we found that livestock and elk grazing within New Mexico meadow jumping mouse habitat affects individual mice by reducing the availability of food resources (Morrison 1987, p. 25; Morrison 1990, p. 141; Frey 2005a, p. 59; 2011, p. 70). Cattle and sometimes elk, have contributed substantially to alterations of riparian ecosystems throughout the range of the New Mexico meadow jumping mouse. However, there is a strong tendency for livestock to congregate in riparian habitat, whereas elk may range farther from water sources and riparian areas than cattle (USFS 2006, pp. 76-77). Timing of livestock grazing also coincides with the active season of the New Mexico meadow jumping mouse. We note that grazing is only one of several concerns for the New Mexico meadow jumping mouse. Please see the SSA Report for further information. See our response to comment (9) above for additional information on feral horses.

(36) Comment: Some of the information used in the SSA Report comes from documents that indicate the New Mexico meadow jumping mouse is “endangered” (e.g., Frey, J.K. 2006. Capture of the endangered New Mexico meadow jumping mouse ( Zapus hudsonius luteus ) at Coyote Creek State Park, New Mexico. Frey Biological Research, Radium Springs, New Mexico). This report was produced prior to the Service considering the animal for endangered status. Because “endangered” was used in the title of the report, is there a potential for bias?

Our Response: Use of the term “endangered” in the Frey (2006) report does not indicate bias. The New Mexico meadow jumping mouse is classified as an endangered species under the New Mexico Wildlife Conservation Act of 1974 (i.e., State Endangered Species Act) (19 New Mexico Administrative Code 33.6.8). This is an entirely different process and statute than the Act. We adhered to the requirements of the Act in order to determine whether the New Mexico meadow jumping mouse meets the definition of an endangered species under the Act, based on our assessment of the five listing factors and using the best available scientific and commercial data.

(37) Comment: If the New Mexico meadow jumping mouse is listed as endangered, fuels treatments to reduce the risk of fire may be inhibited due to the complexity and additional time required to complete consultation with the Service. In this example, the Federal agency would likely reduce the size of the forest treatment (e.g., prescribed burn), or the project would be stopped altogether when the subspecies is listed.

Our Response: Listing the New Mexico meadow jumping mouse is unlikely to reduce proactive treatments necessary to alleviate the risk of catastrophic wildfire because the majority of treatments are likely to be confined to forested lands and not within riparian and adjacent upland habitat used by the species. However, the USFS or other Federal agency will need to determine whether any fuels treatments may affect the subspecies in accordance with section 7 of the Act. If a Federal agency funds, authorizes, or carries out an action that may affect the New Mexico meadow jumping mouse, the agency is required to consult with the Service. The regulatory requirements under the Act were determined by Congress to ensure that otherwise lawful actions that affect species listed under the Act are not likely to jeopardize the continued existence of those listed species. Consultations analyze and determine to what degree the species is impacted by a proposed action. Each consultation is evaluated on a case-by-case basis following our regulations (50 CFR part 402). In the SSA Report (Service 2014, entire), we identify opportunities for habitat improvement, which includes reducing fuels to minimize the risk of severe wildland fire.

(38) Comment: New Mexico meadow jumping mouse habitat has been lost in some areas following the Wallow Wildfire, but habitat for the subspecies has been gained in other areas. Although the Wallow Wildfire had a huge impact on the landscape, the New Mexico meadow jumping mouse continues to be found in areas following the fire. In fact, post-fire flooding carried sediments to some areas where herbaceous vegetation now meets 60-cm (24-in) stubble height.

Our Response: The commenter did not provide any specific information on areas where jumping mouse habitat may have been gained following the Wallow Wildfire. We also did not receive any information regarding this topic from the Arizona Game and Fish Department (AGFD 2012, entire; 2014, entire). New Mexico meadow jumping mouse habitat is located within riparian areas that are subject to dynamic changes from flooding such as the loss and regrowth in the quantity and location of dense riparian herbaceous vegetation over time. If suitable habitat has been gained or restored in some areas and the habitat is beyond the movement or dispersal capabilities of the New Mexico meadow jumping mouse, it is unlikely to become occupied. New Mexico meadow jumping mice are generally believed to have limited vagility (ability to move) and possibly limited dispersal capabilities (Morrison 1988, p. 13; Frey and Wright 2012, pp. 43, 109). Consequently, suitable habitat should be no more than about 200 m (656 ft) from existing populations, which would increase the likelihood of emigrating individuals repopulating sites that have been extirpated due to natural or manmade events or moving into areas where suitable habitat has been restored.

Severe wildland fires, such as the Wallow Wildfire, can have dramatic, long-lasting impacts on jumping mice and their habitat (See SSA Report for additional information). We continue to find that the 2011 Wallow and Track Wildfires have significantly impacted the New Mexico meadow jumping mouse, resulting in extirpation of some populations and further loss of habitat, including loss of beaver (AGFD 2012, entire; Colorado Parks and Wildlife 2013a, p. 1; Frey and Kopp 2013, entire; Service 2013c, entire).

(39) Comment: More sampling and surveys of the New Mexico meadow jumping mouse need to be completed to determine whether populations are confined to true livestock exclosures.

Our Response: Since 2003, New Mexico meadow jumping mouse surveys in New Mexico, Arizona, and Colorado involved 200 localities and 68,102 trap nights (over 100 historically occupied sites plus 136 localities that appeared to have the highest quality potentially suitable habitat) (see “Current Records of Localities Found Since 2005” in the SSA Report; Service 2014). In all but one case where the jumping mouse was found since 2005, livestock were being excluded (Frey 2005a, pp. 58-62; Frey 2006d, pp. 49, 55; Frey and Malaney 2009, p. 37; Frey 2011, pp. 41-42; 2012, entire; Colorado Parks and Wildlife 2012, entire; Service 2012a, pp. 1-2; 2012c, pp. 1, 6-8; 2012d, p. 2). The habitat conditions at this one locality where livestock grazing was occurring were suitable for New Mexico meadow jumping mice occupancy and similar to fenced New Mexico meadow jumping mouse localities because the presence of beaver naturally inhibited livestock grazing (Frey and Malaney 2009, p. 37).

Moreover, additional areas that contained potentially suitable New Mexico meadow jumping mouse habitat were also surveyed, with many of the survey locations outside of livestock exclosures in which no individuals were captured (Frey 2003, entire; 2005a, entire; 2007b, entire; 2011, p. 42; 2013c, entire; Chambers 2012, entire; USFS 2012h, entire). As we found in the SSA Report, the presence of a functioning livestock exclosure has been reported as the best predictor of New Mexico meadow jumping mouse occupancy in montane riparian areas (Frey 2005a, pp. 59-60; Frey and Malaney 2009, pp. 35, 37). However, unauthorized livestock grazing continues to be documented within 15 of 29 existing New Mexico meadow jumping mouse populations when fencing was cut or not maintained, gates were open, or wildfire burned and eliminated fences, and cattle entered the area (ADGF 2012a, entire; USFS 2007, p. 1; 2010, p. 2; 2011c, pp. 1-5; 2012h, p. 2; Frey 2005a, pp. 25-26, 29, 36, 58-62; 2006, p. 1; 2006d, pp. 49, 55; 2011, pp. 41-42; Frey and Malaney 2009, p. 37; Frey 2011, pp. 41-42; 2012, entire; Colorado Natural Heritage Program 2006, p. 260; Colorado Parks and Wildlife 2012, p. entire; Service 2012a, pp. 1-2; 2012c, pp. 1, 6- 8; 2012d, p. 2; U.S. Bureau of Reclamation 2008, pp. 3-62).

(40) Comment: Listing a species may reduce beneficial management activities or obstruct or prevent entities from executing conservation agreements and partnerships to protect the species. The Service should recognize ongoing conservation efforts.

Our Response: The Service does recognize ongoing conservation efforts. The Act requires us to make a determination using the best available scientific and commercial data after conducting a review of the status of the species and after taking into account those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation to protect such species, whether by predatory control protection of habitat and food supply, or other conservation practices, within any area under its jurisdiction. The only conservation actions implemented since the species became a candidate for listing in 2007 were the installation of Langemann water control structures and restoration of habitat on Bosque del Apache National Wildlife Refuge, and the replacement of one barbed-wire livestock exclosure with a pipe fence on the Lincoln National Forest. These few actions did not reduce or eliminate threats to the subspecies, and the jumping mouse still meets the definition of an endangered species under the Act.

Further, the listing of a species does not obstruct the development of conservation agreements or partnerships to conserve the species. Once a species is listed as either endangered or threatened, the Act provides many tools to advance the conservation of listed species. Conservation of listed species in many parts of the United States is dependent upon working partnerships with a wide variety of entities, including the voluntary cooperation of non-Federal landowners. Building partnerships and promoting cooperation of landowners are essential to understanding the status of species on non-Federal lands, and may be necessary to implement recovery actions such as reintroducing listed species, habitat restoration, and habitat protection. We promote these private-sector efforts through the Department of the Interior's Cooperative Conservation philosophy (see http://www.fws.gov/landscape-conservation/lcc.html for more information). Once a species is listed, for private or other non-Federal property owners we offer voluntary Safe Harbor Agreements that can contribute to the recovery of species, Habitat Conservation Plans that allows activities (e.g., grazing) to proceed while minimizing effects to species, funding through the Partner's for Fish and Wildlife Program to help promote conservation actions, and grants to the States under section 6 of the Act.

(41) Comment: The Service should recognize the economic impact of listing the New Mexico meadow jumping mouse. Listing the mouse could result in short-term, long-term, and cumulative impacts for species on human activities.

Our Response: The Act requires us to use the best scientific and commercial data available in our listing determinations. The Act does not allow us to consider the impacts of listing on economics or humans activities whether over the short term, long term, or cumulatively.

(42) Comment: Will recreation sites be shut down or Federal land use be greatly restricted if the New Mexico meadow jumping mouse is listed as endangered?

Our Response: Section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the subspecies or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service. During consultation with the Federal agency, we will analyze and determine to what degree the subspecies would be impacted by proposed recreational activities and will work with the Federal agency to determine necessary modification of planned activities, in order to avoid and minimize adverse impacts to the subspecies.

(43) Comment: There is no scientific justification for defining the historical (1980s and 1990s) baseline for the subspecies' distribution. There must have been some other challenging environmental changes that the New Mexico meadow jumping mouse survived to reach population levels in the 1980s. Therefore, what scientific basis is there for presuming the species could not survive now without endangered species protection?

Our Response: Please see our response to comment number (3), above. While the historical and current distributional data for the New Mexico meadow jumping mouse is categorized into two time periods in the SSA Report (Service 2014, entire), we included all known distribution records and summarized the comprehensive reports regarding the New Mexico meadow jumping mouse (i.e., Frey 2008c, entire; Hafner et al. 1981). We found no capture records of New Mexico meadow jumping mice between 1996 and 2005. Surveys conducted since 2005 in locations where the subspecies was historically present indicate that the subspecies is now apparently absent or at levels too low for detection. Based on this information and previous reviews, we continue to find that the comparison between historical (1980 to 1999) and current New Mexico meadow jumping mouse records (2005 forward) is appropriate, and the pre-1980 records were sufficiently considered and incorporated in the SSA Report.

We evaluated whether the subspecies is in danger of extinction throughout all or a significant portion of its range (endangered), or is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range (threatened). Also, please see our Determination section, below for a detailed explanation of why this subspecies meets the definition of an endangered species under the Act. Finally, see the SSA Report for our analysis of long-term viability and extinction risk for the New Mexico meadow jumping mouse. (see Chapter 6. Viability of the SSA Report)

(44) Comment: The Service should include a special 4(d) rule, similar to Preble's meadow jumping mouse that exempts take of the subspecies under section 9 of the Act for any continued use of water rights.

Our Response: Section 4(d) of the Act pertains only to threatened species, not endangered species. Section 4(d) of the Act reads that, whenever any species is listed as a threatened species, the Secretary shall issue such regulations, as she deems necessary and advisable to provide for the conservation of such species. Because we are listing the New Mexico meadow jumping mouse as endangered and not threatened, a 4(d) rule is not applicable.

(45) Comment: According to Wikipedia, the jumping mouse is capable of having two to three litters per year.

Our Response: Although jumping mice ( Zapus hudsonius ) in Minnesota and New York average two to three litters (Quimby 1951, p. 69; Whitaker 1963, p. 244), the New Mexico meadow jumping mouse only has one litter each year (Morrison 1987, pp. 14-15; 1989, p. 22; Frey 2011, p. 69; 2012b, p. 5).

(46) Comment: Over the last few years, mowing along irrigation ditches has ceased and the vegetation grows over the areas, especially along those in the middle Rio Grande.

Our Response: The commenter did not provide any information demonstrating mowing has ceased. The information we reviewed indicates that mowing continues to be part of regular maintenance activities along irrigation ditches and canals on Bosque del Apache National Wildlife Refuge and throughout the middle Rio Grande (Bureau of Reclamation 2013, pp. 55-59, 62; Frey and Wright 2012, pp. 6, 35; SSA Report pp. 88-91). Moreover, neither the Florida Water Conservancy District, nor the Middle Rio Grande Conservancy District indicated in their public comments that mowing has ceased as part of their normal maintenance operations (Florida Water Conservancy District 2013, entire; Middle Rio Grande Conservancy District 2013, entire).

(47) Comment: Were the jumping mice captured along the Florida River positively identified as New Mexico meadow jumping mice using genetic analyses?

Our Response: Yes. The Florida River individuals were confirmed as New Mexico meadow jumping mice using mitochondrial DNA (genetic) analyses (Museum of Southwestern Biology 2007, entire; 2007a, entire; Malaney et al. 2012, p. 695, Appendix S1).

(48) Comment: The Service fails to provide a scientific basis for the unrealistic vegetation cover requirements.

Our Response: Based on the best available scientific evidence, the New Mexico meadow jumping mouse has exceptionally specialized requirements for dense herbaceous riparian habitat as described in the “Specific Microhabitat Requirements” section of our SSA Report (Service 2014).

(49) Comment: There is no scientific historical baseline to compare habitat or populations to in order to determine whether New Mexico meadow jumping mouse populations have been impacted. The Service did not use actual population numbers or long-term trends to make a determination to list the New Mexico meadow jumping mouse as endangered.

Our Response: In the SSA Report (Service 2014, entire), we used historical and current data to determine that the distribution and number of populations of the New Mexico meadow jumping mouse has declined significantly rangewide with the majority of local extirpations occurring since the late-1980s and early 1990s. At least 70 former locations occupied by the New Mexico meadow jumping mouse are considered no longer occupied (Frey 2005a, pp. 6-10; 2007b, pp. 23-27; 2011, pp. 26-27; 2012e, entire; AGFD 2012, entire; Frey and Kopp, 2013, entire; Frey and Wright 2012, p. 28; Frey 2013, entire). See also our response to comment number 3 above.

(50) Comment: High predation rates or disease may cause high mortality and reduce New Mexico meadow jumping mouse populations.

Our Response: As we found in 5.2.2 Disease or Predation of our SSA Report (Service 2014), we did not identify predation and disease as significant risk factors for the New Mexico meadow jumping mouse.

(51) Comment: The Service has failed to address the conflict between the New Mexico meadow jumping mouse and already listed predators such as the Mexican spotted owl ( Strix occidentalis lucida ) and Mexican gray wolf ( Canis lupus baileyi ), which could be significant sources of mortality.

Our Response: We acknowledge that the Mexican spotted owl and Mexican gray wolf could eat jumping mice, because they can be highly sought-after food sources as prey for these species. However, the best scientific and commercial data available does not indicate that either of these species are significant predators on the New Mexico meadow jumping mouse. Nevertheless, predation is a naturally occurring event in the life history of the New Mexico meadow jumping mouse, and, as we found in 5.2.2 Disease or Predation of our SSA Report (Service 2014), predation is not a significant risk factor.

(52) Comment: No data are provided for the assumption that only limited portions of New Mexico meadow jumping mouse habitat would be affected by natural disturbances (flood, wildfire, or drought). These natural disturbances operate at the landscape scale, which would decimate habitat patches that are small and localized.

Our Response: As we noted in the 5.1 Habitat Loss section of the SSA Report (Service 2014), natural disturbances can vary from small to large-scale events. Large-scale disturbances can have dramatic, long-lasting impacts on New Mexico meadow jumping mice and their habitat, while small-scale disturbances may help maintain riparian communities in an early seral stage, which would provide suitable habitat for the New Mexico meadow jumping mouse. The New Mexico meadow jumping mouse may exhibit some natural resiliency to small disturbances when populations were larger and well-connected to one another, but there is cause for concern because many of the New Mexico meadow jumping mouse populations are either extremely small or highly fragmented. As a result, we found that these natural disturbances are an important causal factor in the ongoing and future loss of New Mexico meadow jumping mouse suitable habitat, making all of the remaining small and fragmented populations of the New Mexico meadow jumping mouse more vulnerable to extirpation.

(53) Comment: Coal bed methane development should be removed from the list of potential threats to the New Mexico meadow jumping mouse because there are no wellpads or associated non-well facilities near the populations in Colorado (Florida River, Sambrito Creek, or Sugarite Canyon). Moreover, existing regulations at the State (Colorado Oil and Gas Conservation Commission) and local levels (La Plata County land use code, Chapter 90; Archuleta County land use code, Section 9) have resulted in no oil or gas wells or facilities within these areas.

Our Response: The areas surrounding the Florida River and Sambrito Creek contain extensive gas fields, and, based on the best available scientific and commercial data, production from coalbed methane is projected to increase (Bureau of Land Management and USFS 2006, entire; Papadopulos and Associates 2006, entire). In 2005, there were about 1,650 production wells in production in the Colorado portion of the San Juan Basin (Papadopulos and Associates 2006, p. 1). Projections are that this number will increase because future gas production wells have already been permitted (Papadopulos and Associates 2006, p. 92, Figure 6-2; Bureau of Reclamation 2007, pp. 3-55-3-60). Similarly, coalbed methane development will likely continue to expand in the Raton Basin, which includes the Sugarite Canyon, New Mexico (Hoffman and Brister 2003, p. 110).

Future impacts may occur to riparian habitat in these watersheds or result in the alteration of hydrological regimes (Bureau of Land Management and USFS 2006, Appendix H, p. 27). For example, recent data indicates that existing coalbed methane development has depleted 80,176 cubic m (65 ac ft) of water per year from the Animas, Florida, and Pine Watersheds (Bureau of Land Management and USFS 2006, Appendix H, p. 27). We also queried the Colorado Oil and Gas Database ( http://cogcc.state.co.us/ ) and located at least 10 producing wells within 91 to 221 m (300 to 725 ft) of the active Florida River channel and 5 producing wells within 61 to 609 m (200 to 2,000 ft) of Sambrito Creek (Service 2013d, entire). These distances have the potential to affect New Mexico meadow jumping mouse habitat from ground disturbance for roads, drilling pads, pipelines, and other utilities and infrastructure (e.g., see Bureau of Reclamation 2007, pp. 3-55-3-60, 4-5, 4-26). There may also be longer-term water table issues, irrigation water changes, and nonnative plant infestations in areas that are developed for coal bed methane extraction, which would contribute to further loss of dense herbaceous riparian vegetation that constitutes jumping mouse habitat (National Park Service 2003, p. 2).

We found that La Plata and Archuleta Counties only provide protection to wildlife resources and floodplains, wherever it is reasonably practicable, to avoid, minimize, or mitigate adverse impacts from coal bed methane development (Colorado Oil and Gas Conservation Commission 2008, entire; La Plata County 2001, entire; Archuleta County 2012, entire). For example, the La Plata County land use code requires new development to be located no less than 15 m (50 ft) from wetlands, which may still result in indirect effects to wetland and riparian habitat (2001, pp. 6.7-6.8) that would then impact the New Mexico meadow jumping mouse and its habitat. Moreover, the regulations are intended to balance oil and gas development with wildlife conservation by incorporating best management practices (Colorado Oil and Gas Conservation Commission 2008, entire) or standard operating procedures (Archuleta County 2012, entire). Consequently, it is unclear whether this will fully or even partially protect the New Mexico meadow jumping mouse and its habitat. Finally, we found no regulations that might provide some protection to the New Mexico meadow jumping mouse population in Sugarite Canyon, New Mexico from coalbed methane development.

Based on this information, development of coalbed methane gas in the Raton and San Juan Basins is projected to continue into the future, potentially impacting the Florida River, Sambrito Creek, and Sugarite Canyon, Colorado, New Mexico meadow jumping mouse populations. All of this information demonstrates that coalbed methane development and related infrastructure have the potential to affect New Mexico meadow jumping mouse populations within the Florida River, Sambrito Creek, and Sugarite Canyon, Colorado.

(54) Comment: Rio Arriba County, New Mexico, has taken measures to protect and enhance the habitat required by the New Mexico meadow jumping mouse by adopting the Rio Arriba County Flood Damage Prevention Ordinance 2012-004 (Floodplain Ordinance).

Our Response: Although Rio Arriba County's comments indicate that the Floodplain Ordinance aims to foster sound land use activities in federally designated floodplains and riparian areas, we are not aware of any areas that are currently occupied by the New Mexico meadow jumping mouse within Rio Arriba County. The only critical habitat proposed for the New Mexico meadow jumping mouse in the County was located along the Rio Grande within Ohkay Owingeh, which would not be subject to the Floodplain Ordinance.

(55) Comment: The comment period was too brief. Local governments and interested individuals were not notified in writing of the proposal to list the New Mexico meadow jumping mouse.

Our Response: We provided the normal 60-day comment period associated with the publication of the proposed rule, which opened on June 20, 2013 (78 FR 37363), and closed on August 19, 2013. We sent letters to State congressional representatives, local governments, and interested parties; we published public notices in area newspapers; and we issued a news release on our Web site.

(56) Comment: One commenter encouraged the Service to invest additional resources in public outreach for the Florida River Geographic Management Area because most of the Florida River is under private ownership.

Our Response: On August 15, 2013, we held an informational meeting in Durango, Colorado, as part of our public outreach for the Florida River Geographic Management Area, to answer questions about the implications of the potential listing and critical habitat designation of the New Mexico meadow jumping mouse.

(57) Comment: The Service should not settle legal actions with activist groups that appear to create arbitrary listings of threatened or endangered species.

Our Response: On July 12, 2011, the Service filed a multiyear work plan as part of a settlement agreement with the Center for Biological Diversity and others, in a consolidated case in the U.S. District Court for the District of Columbia. A settlement agreement in In re Endangered Species Act Section 4 Deadline Litigation, No. 10-377 (EGS), MDL Docket No. 2165 (D.D.C. May 10, 2011) was approved by the court on September 9, 2011. The settlement enables the Service to systematically, over a period of 6 years, review and address the needs of more than 250 candidate species to determine if they should be added to the Federal Lists of Endangered and Threatened Wildlife and Plants.

Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. We adhered to the requirements of the Act, to determine whether a species warrants listing based on our assessment of the five-factor threats analysis using the best available scientific and commercial data. A species may be determined to be an endangered or threatened species due to one or more of the five factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. Listing actions may be warranted based on any of the above threat factors, singly or in combination. We already determined, prior to the court settlement agreement, that the New Mexico meadow jumping mouse warranted listing under the Act, but was precluded by the necessity to commit limited funds and staff to complete higher priority species actions. The New Mexico meadow jumping mouse has been included in our annual Candidate Notices of Review for multiple years, during which time scientific literature and data have and continue to indicate that the subspecies is detrimentally impacted by ongoing threats, and we continued to find that listing was warranted but precluded. The listing process is not arbitrary, but uses the best available scientific and commercial data and peer-review to ensure sound science and sound decisionmaking.

(58) Comment: The purpose of listing this highly specialized subspecies is only in support of the preservationists' philosophy of radical environmental organizations. Most often listing has forced land management agencies to totally abandon their missions in favor of a hands-off, do-nothing approach.

Our Response: The commenter did not provide any additional information for the Service to consider. Land management agencies continue to provide for multiple use activities on their lands, including the conservation of federally listed species.

Section 4 of the Act, and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(b)(1)(a), the Secretary is to make threatened or endangered determinations required by subsection 4(a)(1) solely on the basis of the best scientific and commercial data available to her after conducting a review of the status of the species and after taking into account conservation efforts by States or foreign nations. The standards for determining whether a species is threatened or endangered are provided in section 3 of the Act. An endangered species is any species that is “in danger of extinction throughout all or a significant portion of its range.” A threatened species is any species that is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” Per section 4(a)(1) of the Act, in reviewing the status of the species to determine if it meets the definitions of threatened or endangered, we determine whether any species is an endangered species or a threatened species because of any of the following five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting its continued existence.

Until recently, the Service has presented its evaluation of information under the five listing factors in an outline format, discussing all of the information relevant to any given factor and providing a factor-specific conclusion before moving to the next factor. However, the Act does not require findings under each of the factors, only an overall determination as to status (e.g., threatened, endangered, not warranted). Ongoing efforts to improve the efficiency and efficacy of the Service's implementation of the Act have led us to present this information in a different format that we believe leads to greater clarity in our understanding of the science, its uncertainties, and the application of our statutory framework to that science. Therefore, while the presentation of information in this rule differs from past practice, it differs in format only. We have evaluated the same body of information we would have evaluated under the five listing factors outline format, we are applying the same information standard, and we are applying the same statutory framework in reaching our conclusions.

We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the New Mexico meadow jumping mouse. Based on our review of the best available scientific and commercial information, we conclude that the New Mexico meadow jumping mouse is currently in danger of extinction throughout all of its range and, therefore, meets the definition of an endangered species. This finding, explained below, is based on our conclusions that the subspecies exhibits low viability as characterized by having no resilient populations, resulting in low overall representation across the subspecies' entire range and no redundancy. We found the New Mexico meadow jumping mouse to be at an elevated risk of extinction now and no data indicate that the situation will improve without significant conservation intervention. We, therefore, find that the New Mexico meadow jumping mouse warrants an endangered species listing status determination.

On the basis of our biological review documented in the SSA Report, we found that the subspecies is inherently vulnerable to population extirpations due to its short active period, short lifespan, low fecundity, specific habitat needs, and low movement and dispersal ability (Factor E). The subspecies is currently known to be limited to, at most, 29 small, isolated populations, all of which are incapable of withstanding adverse events, and, therefore, are not resilient (Factor E). This total is reduced from nearly 70 locations known historically. Of these 29 populations where the New Mexico meadow jumping mice have been found extant since 2005, at least 11 populations have been substantially compromised in the past 2 years and 7 others may have been affected by recent wildfires. Because these populations have been compromised, the actual current number of extant populations may already be less than 29, placing the subspecies at a higher risk of extinction. At this rate of population extirpation (based on known historical population losses and possible recent population losses) the probability of persistence of the subspecies as a whole is severely compromised in the near term.

The remaining small, isolated New Mexico meadow jumping mouse populations are particularly threatened with extirpation from habitat loss and modifications (Factor A). The main sources of habitat loss, degradation, and modification, include grazing pressure (which removes the needed vegetation), water management and use (which causes vegetation loss from mowing and drying of soils), lack of water due to drought (exacerbated by climate change), and wildfires (also exacerbated by climate change). Additional sources of habitat loss are likely to occur from floods, loss of beaver, highway reconstruction, residential and commercial development, coalbed methane development, and unregulated recreation.

Each of the 29 remaining locations where the jumping mouse has been found recently is vulnerable to at least 4 of these 10 sources of habitat loss. Some populations are at risk from as many as 8 of these sources (Service 2014, Table 3). As a result, these multiple sources of habitat loss are not acting independently, but may produce cumulative impacts that magnify the effects of habitat loss on jumping mouse populations. Historically larger connected populations of jumping mice would have been able to withstand or recover from local stressors, such as habitat loss from drought, wildfire, or floods. However, the current condition of small populations makes local extirpations more common. Further, the isolated state of existing populations makes natural recolonization of impacted areas highly unlikely or impossible in most areas. With each of these sources of habitat loss, the probability increases of the future reduction in size of existing populations of jumping mice and eventual additional losses of additional populations. With each population lost in the future, a decrease in viability of the subspecies will occur as species redundancy and representation are reduced.

The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become endangered throughout all or a significant portion of its range within the foreseeable future.” We evaluated whether the New Mexico meadow jumping mouse is an endangered species or a threatened species. The foreseeable future refers to the extent to which the Secretary can reasonably rely on predictions about the future in making determinations about the future conservation status of the species. A key statutory difference between a threatened species and an endangered species is the timing of when a species may be in danger of extinction, either now (endangered species) or in the foreseeable future (threatened species).

Because of the fact-specific nature of listing determinations, there is no single metric for determining if a species is “in danger of extinction” now. In the case of the New Mexico meadow jumping mouse, the best available information indicates that, while major range reductions (that is the overall geographic extent of the subspecies occurrences) have not happened, habitat destruction and isolation have resulted in significant loss of populations and reductions in total numbers of individuals. These losses are ongoing as at least 11 of the 29 known populations have been significantly compromised since 2011. Without substantial conservation efforts, this trend of population loss is expected to continue and result in an elevated risk of extinction of the subspecies. Many of the threats faced by the subspecies would not have historically been significant, but past reductions in population size and fragmentation (mainly due to habitat loss from grazing) causing isolation of populations makes the current threats particularly severe. As a result, the subspecies is currently at an elevated risk that stochastic events (e.g., drought, wildfire, and floods) will affect all known extant populations putting the New Mexico meadow jumping mouse at a high risk of extinction. Therefore, because no resilient populations currently exist to support persistence of the New Mexico meadow jumping mouse, it is in danger of extinction throughout all of its range now, and appropriately meets the definition of an endangered species (i.e., in danger of extinction). Therefore, on the basis of the best available scientific and commercial information, we determine endangered status for the New Mexico meadow jumping mouse in accordance with sections 3(6) and 4(a)(1) of the Act.

Under the Act and our implementing regulations, a species may warrant listing if it is threatened or endangered throughout all or a significant portion of its range. The threats to the survival of this species occur throughout its range and are not restricted to any particular significant portion of its range. Accordingly, our assessments and determinations apply to this species throughout its entire range.

In conclusion, as described above, the New Mexico meadow jumping mouse has experienced significant reductions in populations (based on habitat reductions and fragmentation), is especially vulnerable to impacts due to its life history and ecology, and is subject to significant current and ongoing threats now. After a review of the best available scientific information as it relates to the status of the subspecies and the five listing factors, we find the New Mexico meadow jumping mouse is in danger of extinction now. Therefore, on the basis of the best available scientific and commercial information, we determine endangered status for New Mexico meadow jumping mouse, in accordance with section 3(6) of the Act. We find that a threatened species status is not appropriate for the New Mexico meadow jumping mouse because the overall risk of extinction is high at this time because none of the existing populations are sufficiently resilient to support viable populations, and this subspecies is currently in danger of extinction.

Regulations at 50 CFR 424.18 require final rules to include a description of conservation measures available under the rule. Following is an explanation of the measures which may be implemented for the conservation of the jumping mouse under this final rule.

Conservation measures provided to species listed as endangered or threatened species under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness and conservation by Federal, State, tribal, and local agencies, private organizations, and individuals. The Act encourages cooperation with the States and requires that recovery actions be carried out for all listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.

The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Subsection 4(f) of the Act requires the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.

Recovery planning includes the development of a recovery outline shortly after a species is listed, preparation of a draft and final recovery plan, and revisions to the plan as significant new information becomes available. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. The recovery plan identifies site-specific management actions that will achieve recovery of the species, measurable criteria that determine when a species may be downlisted or delisted, and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (comprising species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the draft recovery plan and the final recovery plan will be available on our Web site ( http://www.fws.gov/endangered ), or from our New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ). We have completed a Recovery Outline that provides an interim strategy to guide the conservation and recovery of the New Mexico meadow jumping mouse until a final recovery plan is finalized. The Recovery Outline is based on the SSA Report, as well as preliminary objectives and actions needed for recovery. The Recovery Outline can be downloaded at: http://www.fws.gov/southwest/es/NewMexico/index.cfm, http://www.fws.gov/endangered, or http://www.regulations.gov.

Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribe, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may not occur primarily or solely on non-Federal lands. To achieve recovery of these species requires cooperative conservation efforts on private, State, and Tribal lands.

Because this subspecies is listed as endangered, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost-share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the States of Colorado, New Mexico, and Arizona would be eligible for Federal funds to implement management actions that promote the protection and recovery of the New Mexico meadow jumping mouse. Information on our grant programs that are available to aid species recovery can be found at: http://www.fws.gov/grants.

Please let us know if you are interested in participating in recovery efforts for this subspecies. Additionally, we invite you to submit any new information on this subspecies whenever it becomes available and any information you may have for recovery planning purposes (see FOR FURTHER INFORMATION CONTACT ).

Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as endangered or threatened and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any action that is likely to jeopardize the continued existence of a species proposed for listing or result in destruction or adverse modification of proposed critical habitat. If a species is listed subsequently, section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

Federal agency actions within the species habitat that may require consultation as described in the preceding paragraph include livestock grazing, irrigation ditch maintenance and repair, recreational activities associated with Federal agencies or State parks that may affect habitat or the species; issuance of section 404 Clean Water Act permits by the U.S. Army Corps of Engineers; and construction and maintenance of roads or highways by the Federal Highway Administration.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered wildlife. The prohibitions of section 9(a)(2) of the Act, codified at 50 CFR 17.21 for endangered wildlife, in part, make it illegal for any person subject to the jurisdiction of the United States to take (includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these), import, export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any listed species. Under the Lacey Act (18 U.S.C. 42-43; 16 U.S.C. 3371-3378), it is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to agents of the Service and State conservation agencies.

We may issue permits to carry out otherwise prohibited activities involving endangered and threatened wildlife species under certain circumstances. Regulations governing permits are codified at 50 CFR 17.22 for endangered species, and at 17.32 for threatened species. With regard to endangered wildlife, a permit must be issued for the following purposes: For scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities.

Our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), is to identify to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effect of a listing on proposed and ongoing activities within the range of listed species. The following activities could potentially result in a violation of section 9 of the Act; this list is not comprehensive:

(1) Unauthorized collecting, handling, possessing, selling, delivering, carrying, or transporting of the species, including import or export across State lines and international boundaries, except for properly documented antique specimens of these taxa at least 100 years old, as defined by section 10(h)(1) of the Act.

(2) Unauthorized modification or manipulation of riparian habitat, including mowing or prescribed burning of occupied habitats, especially during the active season (generally May through October).

(3) Activities that take or harm the New Mexico meadow jumping mouse on public or private lands by causing significant habitat modification or degradation such that the activities cause actual injury by significantly impairing the species' essential behavior patterns, without authorization or coverage under the Act for these impacts. This may include, but is not limited to, the alteration or removal of specific microhabitat components (as described in this rule or within the SSA Report) through new construction, livestock grazing, or dredging or filling in streams or wetlands.

(4) Unauthorized modification of any stream or water body or removal or destruction of herbaceous vegetation in any stream or water body in which the New Mexico meadow jumping mouse is known to occur.

(5) Unlawful destruction or alteration of New Mexico meadow jumping mouse habitats (e.g., unpermitted instream dredging, impoundment, water diversion or withdrawal, channelization, discharge of fill material) that impairs essential behaviors such as breeding, feeding, or sheltering, or results in killing or injuring a New Mexico meadow jumping mouse.

(6) Capture, survey, or collection of specimens of this taxon without a permit from us under to section 10(a)(1)(A) of the Act.

Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act of 1969, need not be prepared in connection with listing a species as an endangered or threatened species under the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes.

A complete list of references used in support of this rulemaking is available on the Internet at http://www.regulations.gov within the Final SSA Report (Service 2014, Literature Cited) and upon request from the New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this document are the staff members of the New Mexico Ecological Services Field Office.

Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below: