Federal Register Vol. 82, No.8,

I. Background

The Inflation Adjustment Act,1 as amended by the Debt Collection Improvement Act of 1996 2 and further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,3 directs Federal agencies to adjust for inflation the civil penalty amounts within their jurisdiction not later than July 1, 2016, and then not later than January 15 every year thereafter.4 28 U.S.C. 2461 note. Each agency was required to make the 2016 one-time catch-up adjustments through an interim final rule published in the Federal Register. On June 14, 2016, the Bureau published its interim final rule to make the initial catch-up adjustments to civil penalties within the Bureau's jurisdiction.5 The June 2016 interim final rule created a new part 1083 and in § 1083.1 established the inflation-adjusted maximum amounts for each civil penalty within the Bureau's jurisdiction.6 The Inflation Adjustment Act also requires subsequent adjustments to be made annually, not later than January 15, and notwithstanding section 553 of the Administrative Procedure Act (APA).7

Specifically, Federal agencies are directed to adjust annually each civil penalty provided by law within the jurisdiction of the agency by the “cost-of-living adjustment.” 8 For annual adjustments after the initial catch up adjustments, the “cost-of-living adjustment” is defined as the percentage (if any) by which the Consumer Price Index for All Urban Consumers (CPI-U) for the month of October preceding the date of the adjustment, exceeds the CPI-U for October of the prior year.9 The Director of the Office of Management and Budget (OMB) is required to issue guidance (OMB Guidance) to agencies on implementing the annual civil penalty inflation adjustments by December 15, 2016, and December 15 every subsequent year.10 Pursuant to the Inflation Adjustment Act and OMB Guidance, agencies must apply the multiplier reflecting the “cost-of-living adjustment” to the current penalty amount and then round that amount to the nearest dollar to determine the annual adjustments.11

For the 2017 annual adjustment, the multiplier reflecting the “cost-of-living adjustment” is 1.01636.12 Pursuant to the Inflation Adjustment Act and OMB Guidance, the Bureau multiplied each of its civil penalty amounts by the “cost-of-living adjustment” multiplier and rounded to the nearest dollar.13

The new penalty amounts that apply to civil penalties assessed after January 15, 2017 are as follows:

The Bureau issues this final rule under the Inflation Adjustment Act,14 as amended by the Debt Collection Improvement Act of 1996 15 and further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,16 which requires the Bureau to adjust for inflation the civil penalties within its jurisdiction according to a statutorily prescribed formula.

Under the APA, notice and opportunity for public comment are not required if the Bureau finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest.17 Pursuant to this final rule, § 1083.1 is amended to update the civil penalty amounts. The 2017 adjustments to the civil penalty amounts are technical and non-discretionary, and they merely apply the statutory method for adjusting civil penalty amounts. These adjustments are required by the Inflation Adjustment Act. Moreover, the Inflation Adjustment Act directs agencies to adjust the civil penalties annually notwithstanding section 553 of the APA,18 and OMB Guidance reaffirms that agencies need not complete a notice-and-comment process before making the annual adjustments for inflation.19 For these reasons, the Bureau has determined that publishing a notice of proposed rulemaking and providing opportunity for public comment are unnecessary. Therefore, the amendment is adopted in final form.

Section 553(d) of the APA generally requires publication of a final rule not less than 30 days before its effective date, except (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) as otherwise provided by the agency for good cause found and published with the rule.20 At a minimum, the Bureau believes the annual adjustments to the civil penalty amounts in § 1083.1 fall under the third exception to section 553(d). The Bureau finds that there is good cause to make the amendments effective on January 15, 2017. The amendments to § 1083.1 in this final rule are technical and non-discretionary, and they merely apply the statutory method for adjusting civil penalty amounts and follow the statutory directive to make annual adjustments by January 15 of each year. Moreover, the Inflation Adjustment Act directs agencies to adjust the civil penalties annually notwithstanding section 553 of the APA,21 and OMB Guidance reaffirms that agencies need not provide a delay in effective date for the annual adjustments for inflation.22

Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.23

In accordance with the Paperwork Reduction Act of 1995,24 the Bureau reviewed this final rule. No collections of information pursuant to the Paperwork Reduction Act are contained in the final rule.

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part § 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part § 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

The full text of the Amended Emergency Restriction/Prohibition Order No. FAA-2016-9288 issued January 9, 2017, is as follows:

The Emergency Restriction/Prohibition Order (Order) issued by the United States Department of Transportation (DOT) on October 14, 2016, is hereby amended to remove the requirement for air carriers to alert passengers to the prohibition against air transport of a Samsung Galaxy Note 7 device, in particular, immediately prior to boarding. As discussed herein, DOT is removing this requirement due to the extensive efforts by Samsung and U.S. wireless providers to recall all Samsung Galaxy Note 7 devices and to make users aware the Samsung Galaxy Note 7 device is forbidden from transportation by air, as well as the deployment by major U.S. wireless providers of a software update that will ultimately render the phones inoperable as mobile devices. In addition, the hazardous materials regulations (HMR; 49 CFR parts 171-180) provide a systematic framework to protect the safe transportation of hazardous materials that includes procedures for notification, handling, and reporting of discrepancies and incidents at air passenger facilities and cargo facilities. All other requirements of the Order issued on October 14, 2016, remain in effect and are not impacted by this Amendment. The Order, as amended, reads in full as follows:

This Amended Emergency Restriction/Prohibition Order (Amended Order) is issued by the DOT pursuant to 49 U.S.C. 5121(d) and will be effective on January 9, 2017. This Amended Order is issued to all persons who transport or offer a Samsung Galaxy Note 7 device for air transportation in commerce within the United States. Individuals who own or possess a Samsung Galaxy Note 7 device may not transport the device on their person, in carry-on baggage, in checked baggage, nor offer the device for air cargo shipment. This prohibition includes all Samsung Galaxy Note 7 devices. Samsung Galaxy Note 7 devices are properly classified as lithium ion batteries contained in equipment, UN3481, Class 9 (49 CFR 172.101).

By this Amended Order, DOT is:

* Continuing to prohibit persons from transporting or offering for air transportation a Samsung Galaxy Note 7 device, by either carrying it on their person or in carry-on baggage when boarding an aircraft, placing the Samsung Galaxy Note 7 device in checked baggage, or shipping it via air as cargo;

* continuing to require air carriers to handle Samsung Galaxy Note 7 devices consistently with other forbidden hazardous materials under title 49 of the Code of Federal Regulations, and to deny boarding to a passenger in possession of a Samsung Galaxy Note 7 device unless and until the passenger divests themselves and their baggage, including carry-on and checked, of the Samsung Galaxy Note 7 device;

* continuing to require that persons who inadvertently bring a Samsung Galaxy Note 7 device onto an aircraft immediately power off the device, do not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight; and

* continuing to require that if an air carrier flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device, do not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

Upon information derived from the Samsung Galaxy Note 7 device recall under Order issued September 15, 2016, recent incidents of a dangerous evolution of heat with Samsung Galaxy Note 7 replacement devices, Samsung's October 11, 2016, decision to stop manufacturing and selling Samsung Galaxy Note 7 devices due to the inability to identify the root cause of the incidents, and the U.S. Consumer Product Safety Commission (CPSC) recall of all Samsung Galaxy Note 7 devices issued October 13, 2016, the Secretary of Transportation (Secretary) has found an unsafe condition and that an unsafe practice exists and constitutes an imminent hazard to the safety of air transportation. For more detailed information, see “Background/Basis for Order” below.

(1) Shall not transport, nor offer for transportation, via air a Samsung Galaxy Note 7 device. By virtue of the Order issued October 14, 2016, and the CPSC recalls, the Samsung Galaxy Note 7 devices are forbidden for transportation by air. For purposes of this Amended Order, transporting or offering for transportation includes bringing a Samsung Galaxy Note 7 device aboard an aircraft on your person (e.g., in your pocket), bringing a Samsung Galaxy Note 7 device aboard an aircraft in carry-on baggage, offering a Samsung Galaxy Note 7 device in checked baggage, and offering a Samsung Galaxy Note 7 device for air cargo shipment (e.g., FedEx or United Parcel Service).

(2) Shall ensure that a prohibited Samsung Galaxy Note 7 device inadvertently brought aboard an aircraft is immediately powered off, not used or charged while aboard the aircraft, protected from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and kept on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

By virtue of the Order issued October 14, 2016, this Amended Order, and the CPSC recalls, the Samsung Galaxy Note 7 device is a forbidden hazardous material. In accordance with 49 CFR part 175, air carriers must not accept these devices for air transportation by knowingly permitting a passenger to board an aircraft with a Samsung Galaxy Note 7 device. Damaged or recalled lithium ion batteries, including those contained in equipment, are not permitted to be transported by air, and a Samsung Galaxy Note 7 device is categorized as “forbidden.” 49 CFR 173.21(c). Upon inquiry from a passenger, air carriers are required to make passengers aware of the continuing prohibition against the transportation of Samsung Galaxy Note 7 devices aboard aircraft on their person, in carry on or checked baggage, and in cargo. If an air carrier representative identifies that a passenger is in possession of a Samsung Galaxy Note 7 device prior to boarding the aircraft, the air carrier must deny boarding to the passenger unless and until the passenger divests themselves, including on their person and in checked and carry-on baggage, of the Samsung Galaxy Note 7 device. If an air carrier flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

This Amended Order applies to all persons who transport Samsung Galaxy Note 7 devices, or offer them for transportation, by air in commerce (as defined by 49 U.S.C. 5102(1)) to, from, and within the United States, and their officers, directors, employees, subcontractors, and agents. This Amended Order is effective January 10, 2017, and remains in effect unless rescinded in writing by the Secretary, or until it otherwise expires by operation of regulation and/or law.

The Secretary has the authority to regulate the transportation of lithium ion batteries contained in equipment in commerce. 49 U.S.C. 5103(b). The Secretary has designated lithium ion batteries contained in equipment, UN 3481, as a hazardous material subject to the requirements of the HMR. 49 U.S.C. 5103(a); 49 CFR 172.101. Persons who offer for transportation, or transport, lithium ion batteries contained in equipment by air in commerce to, from, and within the United States are a “person,” as defined by 49 U.S.C. 5102(9), in addition to being a “person” under 1 U.S.C. 1 and a “person who offers” as defined by 49 CFR 171.8. “Commerce” is as defined by 49 U.S.C. 5102(1) and 49 CFR 171.8, and “transportation” or “transport” are as defined by 49 U.S.C. 5102(13) and 49 CFR 171.8. Accordingly, persons who transport or offer for transportation lithium ion batteries contained in equipment in commerce, including by air, are subject to the authority and jurisdiction of the Secretary including the authority to impose emergency restrictions, prohibitions, recalls, or out-of-service orders, without notice or an opportunity for hearing, to the extent necessary to abate the imminent hazard. 49 U.S.C. 5121(d).

An imminent hazard, as defined by 49 U.S.C. 5102(5), constitutes the existence of a condition relating to hazardous materials that presents a substantial likelihood that death, serious illness, severe personal injury, or a substantial endangerment to health, property, or the environment may occur before the reasonably foreseeable completion date of a formal proceeding begun to lessen the risk that death, illness, injury or endangerment may occur.

A Samsung Galaxy Note 7 device may cause an ignition or a dangerous evolution of heat or become a fuel source for fire. Samsung and CPSC acknowledged this fact with the September 15, 2016 recall, Samsung's October 11, 2016 announcement that it was suspending the manufacture and sale of the Samsung Galaxy Note 7 device, and the October 13, 2016 Samsung and CPSC expanded recall covering all Samsung Galaxy Note 7 devices. Furthermore, persons have experienced incidents of dangerous evolution of heat with the recalled Samsung Galaxy Note 7 devices. Just one fire incident poses a high risk of death, serious illness, severe personal injury, and danger to property and the environment. This risk is magnified when the fire or evolution of heat occurs aboard an aircraft during flight. Therefore, each offering and transportation of a Samsung Galaxy Note 7 device constitutes an imminent hazard.

On September 15, 2016, Samsung and the CPSC recalled certain Samsung Galaxy Note 7 devices sold prior to September 15, 2016. The recall was based on a finding that the lithium ion battery in a Samsung Galaxy Note 7 device “can overheat and catch fire.” Samsung offered either a refund or replacement Samsung Galaxy Note 7 device. Subsequently, there were reported incidents of the replacement Samsung Galaxy Note 7 devices overheating and/or catching fire. In a decision announced on October 11, 2016, Samsung stopped production and sale of Samsung Galaxy Note 7 devices. On October 13, 2016, Samsung and the CPSC expanded the recall to include all Samsung Galaxy Note 7 devices because they “can overheat and catch fire.” On December 9, 2016, Samsung reported that it would release a software update starting on December 19, 2016 that would prevent U.S. Samsung Galaxy Note 7 devices from charging and eliminate their ability to work as mobile devices.

In the wake of Samsung Galaxy Note 7 device incidents, the Federal Aviation Administration (FAA) and Pipeline and Hazardous Materials Safety Administration (PHMSA) have taken a number of steps to mitigate the safety risk of Samsung Galaxy Note 7 devices in air transportation. On September 8, 2016, the FAA issued a statement strongly advising passengers not to turn on or charge a Samsung Galaxy Note 7 device aboard an aircraft, nor stow a Samsung Galaxy Note 7 device in any checked baggage. On September 15, 2016, PHMSA issued a Safety Advisory Notice to inform the public about the risks associated with transporting damaged, defective, or recalled lithium batteries or portable electronic devices, including the Samsung Galaxy Note 7 device recalled by the CPSC. The Safety Advisory Notice required that persons who wish to carry the recalled Samsung Galaxy Note 7 device aboard an aircraft must (1) turn off the device; (2) disconnect the device from charging equipment; (3) disable all applications that could inadvertently activate the phone; protect the power switch to prevent its unintentional activation; and (4) keep the device in carry-on baggage or on your person.

On September 16, 2016, the FAA issued general guidance to airlines about the rules for carrying recalled or defective lithium batteries and lithium battery-powered devices aboard an aircraft. Specifically, the FAA noted that (1) U.S. hazardous materials regulations prohibit air cargo shipments of recalled or defective lithium batteries and lithium battery-powered devices; (2) passengers may not turn on or charge the devices when they carry them aboard the aircraft; (3) passengers must protect the devices from accidental activation; and (4) passengers must not pack them in checked baggage. On September 16, 2016, the FAA issued a Safety Alert for Operators (SAFO), recommending the following action by air operators: (1) Ensure that operator personnel responsible for cargo processing know and understand that damaged or recalled lithium batteries—including those installed in equipment and devices—are forbidden on aircraft as air cargo; and (2) ensure that operator personnel responsible for passenger processing and cabin safety know and understand that damaged or recalled lithium batteries—including those installed in devices—may be restricted from carriage or use on the aircraft. On October 10, 2016, the FAA issued updated guidance on the Samsung Galaxy Note 7 device, urging passengers aboard an aircraft to power down and not use, charge, or stow in checked baggage, any Samsung Galaxy Note 7 device.

Notwithstanding the above DOT actions, and in light of continued risks identified by Samsung and CPSC associated with Samsung Galaxy Note 7 devices, on October 14, 2016, DOT issued the Order to forbid transport of Samsung Galaxy Note 7 devices by air transportation in commerce within the United States. The Order outlined remedial action required, which remains unchanged in this Amended Order except for the requirement for air carriers to alert passengers to the prohibition against air transport of the Samsung Galaxy Note 7 device, in particular, immediately prior to boarding. Since the issuance of the Order, DOT has determined that the remedial action of air carriers alerting passengers to the prohibition against air transport of the Samsung Galaxy Note 7 device, in particular, immediately prior to boarding is no longer warranted, due to the extensive efforts by Samsung and U.S. wireless providers to recall all Samsung Galaxy Note 7 devices and to make users aware the Samsung Galaxy Note 7 device is forbidden from transportation by air. Moreover, on December 9, 2016, Samsung reported on its Web site that more than 93 percent of all recalled Samsung Galaxy Note 7 devices had been returned to Samsung and that it would release a software update starting on December 19, 2016 that would prevent U.S. Samsung Galaxy Note 7 devices from charging and eliminate their ability to work as mobile devices.1 We understand that major U.S. wireless providers will push out this update on or before January 8, 2017. T Mobile reported that it would push the software update on December 27, 2016.2 Verizon Wireless and AT&T both reported that they would push the software update on January 5, 2017,3 and Sprint reported that it would push the update on January 8, 2017.4 We think that these efforts to render U.S. Samsung Galaxy Note 7 devices inoperable, in addition to the ongoing recall and notification efforts, will decrease the likelihood that Samsung Galaxy Note 7 devices will be brought on board aircraft. In addition, the hazardous materials regulations (HMR; 49 CFR parts 171-180) provide a systematic framework to protect the safe transportation of hazardous materials that includes procedures for notification, handling, and reporting of discrepancies and incidents at air passenger facilities and cargo facilities.

To eliminate or abate the imminent hazard:

(1) Persons covered by this Amended Order shall not transport, nor offer for transportation, via air any Samsung Galaxy Note 7 device.

(2) Air carriers are required to handle Samsung Galaxy Note 7 devices consistently with other forbidden hazardous materials under 49 CFR parts 173 and 175, and to deny boarding to a passenger in possession of a Samsung Galaxy Note 7 device unless and until the passenger divests themselves and carry-on or checked baggage of the Samsung Galaxy Note 7 device.

(3) Persons covered by this Amended Order who inadvertently bring a prohibited Samsung Galaxy Note 7 device aboard an aircraft must immediately power off the device, leave it powered off until no longer aboard the aircraft, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

(4) When a flight crew member identifies that a passenger is in possession of a Samsung Galaxy Note 7 device while the aircraft is in flight, the crew member must instruct the passenger to power off the device, not use or charge the device while aboard the aircraft, protect the device from accidental activation, including disabling any features that may turn on the device, such as alarm clocks, and keep the device on their person and not in the overhead compartment, seat back pocket, nor in any carry-on baggage, for the duration of the flight.

This Amended Order remains in effect until the Secretary determines that an imminent hazard no longer exists or a change in applicable statute or federal regulation occurs that supersedes the requirements of this Amended Order, in which case the Secretary will issue a Rescission Order.

Any person failing to comply with this Amended Order is subject to civil penalties of up to $179,933 for each violation for each day they are found to be in violation (49 U.S.C. 5123). A person violating this Order may also be subject to criminal prosecution, which may result in fines under title 18, imprisonment of up to ten years, or both (49 U.S.C. 5124).

Pursuant to 49 U.S.C. 5121(d)(3) and in accordance with section 554 of the Administrative Procedure Act (APA), 5 U.S.C. 500 et seq., a review of this action may be filed. Any petition seeking relief must be filed within 20 calendar days of the date of this order (49 U.S.C. 5121(d)(3)), and addressed to U.S. DOT Dockets, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590 (http://Regulations.gov). Furthermore, a petition for review must state the material facts at issue which the petitioner believes dispute the existence of an imminent hazard and must include all evidence and exhibits to be considered. The petition must also state the relief sought. Within 30 days from the date the petition for review is filed, the Secretary must approve or deny the relief in writing; or find that the imminent hazard continues to exist, and extend the original Emergency Order. In response to a petition for review, the Secretary may grant the requested relief in whole or in part; or may order other relief as justice may require (including the immediate assignment the case to the Office of Hearings for a formal hearing on the record).

If you have any questions concerning this Amended Emergency Restriction/Prohibition Order, you should call PHMSA Hazardous Materials Information Center at 1-800-467-4922 or email at [email protected].

I. Regulatory Authorities

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments on May 28, 1976 (generally referred to as preamendments devices) are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as “postamendments devices”), are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval.

Under section 513(i) of the FD&C Act, a device is substantially equivalent if it has the same intended use and technological characteristics as a predicate device, or has the same intended use as the predicate device and has different technological characteristics, but data demonstrate that the new device is as safe and effective as the predicate device and does not raise different questions of safety or effectiveness than the predicate device. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification (510(k)) procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the FD&C Act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the FD&C Act, if the Agency determines that premarket notification is not necessary to assure the safety and effectiveness of the device.

On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device from rulemaking to an administrative order. Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify an eligible device type. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. See, e.g., Holland-Rantos Co. v. U.S. Dep't of Health, Educ., and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).

Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available authority. See Bell, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F. Supp. 382, 388-91 (D.D.C. 1991), or in light of changes in “medical science” (Upjohn, 422 F.2d at 951). Whether data before the Agency are old or new data, the “new information” to support reclassification under section 513(e) of the FD&C Act must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). See, e.g., Gen. Med. Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Ass'n. v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1986).

Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order for reclassifying a device under that section. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments to a public docket. FDA published a proposed order to reclassify this device type in the Federal Register of May 22, 2014 (79 FR 29387). FDA has held a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to antigen based rapid influenza diagnostic test (RIDT) systems and has also received and considered comments on the proposed order, as discussed in section II. Therefore, FDA has met the requirements under section 513(e)(1) of the FD&C Act.

On May 22, 2014, FDA published a proposed order to reclassify antigen based RIDTs intended to detect influenza virus antigen directly from clinical specimens that are currently regulated as influenza virus serological reagents under § 866.3330 (21 CFR 866.3330) from class I into class II with special controls and into a new device classification regulation (79 FR 29387).

The Agency received comments on the proposed order from several entities. Comments were received from device industry manufacturers, a consumer group, professional organizations, a health care organization, a device manufacturers association, and an individual consumer.

To make it easier to identify comments and our responses, the word “Comment” and a comment number appear in parentheses before each comment's description, and the word “Response” in parentheses precedes each response. Similar comments are grouped together under the same number. Specific issues raised by the comments and the Agency's responses follow.

(Comment 1) Commenters expressed support for the proposed order to reclassify antigen based RIDTs from class I to class II with special controls, noting that there is evidence that the currently available antigen based RIDTs, which are widely used in non-clinical laboratory settings such as physician office laboratories, are performing poorly, resulting in many misdiagnosed cases of influenza. Commenters noted that a misdiagnosis of influenza may have serious consequences, including: Inappropriate use of antibiotics and failure to use antiviral therapy, which may be critical for some patients, following false negative results; the unnecessary or inappropriate prescribing of antiviral drugs following false positive results; ineffective infection control measures; and an overall increased public health burden, such as increased rate of hospitalization and return doctor visits. Several commenters expressed a concern regarding frequent antigenic changes in the circulating strains as the influenza virus evolves and agreed with the new requirement that manufacturers conduct annual analytical testing of circulating strains in an effort to monitor the performance of these tests over time. Overall, there was a general consensus among the commenters that the proposed special controls address and mitigate the risks to health.

(Response) FDA agrees that reclassification of antigen based RIDTs into class II as outlined in this order will help to improve the overall quality of testing for influenza. The new minimum performance requirements for these tests detecting influenza virus antigens are expected to lower the number of misdiagnosed influenza infections by increasing the number of devices that can reliably detect the influenza virus. In addition, the special controls requiring annual and emergency analytical reactivity testing provide a process for continued monitoring of the performance of antigen based RIDTs. As part of that process, the Centers for Disease Control and Prevention (CDC) and FDA will collaborate in efforts to ensure that there is an influenza virus analytical reactivity test panel available to all manufacturers of antigen based RIDTs for evaluation of the analytical reactivity of their assays with circulating viruses on an annual basis.

(Comment 2) One commenter noted that under the FD&C Act, as amended by FDASIA, FDA is able to reclassify a device via an “order rather than rulemaking,” but the commenter expressed a concern that FDA seems to consider holding a panel meeting after the issuance of a proposed order as “discretionary rather than mandatory.” The commenter urged FDA to hold panel meetings after the issuance of proposed reclassification orders in order to allow the panel to discuss the proposal after it has been issued. The commenter stated that holding a panel meeting following issuance of a proposed reclassification order is a critical element of the process reforms enacted by Congress. In addition, the commenter expressed a concern that the Agency has not obtained sufficient feedback from physicians who commonly use the rapid influenza tests in their practice. Therefore, the commenter suggested that FDA should convene another panel meeting and include these physicians to provide critical expertise and perspective on the overall evaluation of FDA's proposed plans on test reclassification, including the analytical reactivity testing protocol, specifications, and qualification of specimens.

(Response) The June 13, 2013, Microbiology Advisory Panel (“Panel”) meeting considered all relevant scientific issues associated with the proposed order for the antigen based RIDTs and recommended reclassifying these devices into class II (special controls). The Panel included six physicians and seven researchers who provided input that FDA considered for purposes of the proposed order, including the proposed special controls. Each of the Panel members is considered an authority on matters of influenza infection, treatment, epidemiology, and/or biology. Representatives from CDC and the Association of Public Health Laboratories presented extensive data on the use of the currently available antigen based RIDTs and the outcomes related to patients that support the conclusion that there has been poor performance of antigen based RIDTs in the medical practice. The Panel recommended the reclassification of antigen based RIDTs. FDA is not aware of any significant changes in benefits or risks relating to the antigen based RIDTs that have been identified since the June 13, 2013, Panel meeting. Stakeholders had an opportunity to provide feedback to the proposed order in their comments, and that feedback has been largely positive. The public comments are addressed here and are also available to view by request or on https://www.regulations.gov.

The process followed by FDA in reclassifying antigen based RIDTs is in accordance with the applicable statutory provisions, which were amended by FDASIA. Section 608 of FDASIA amended section 513(e) of the FD&C Act by changing the reclassification process from rulemaking to an administrative order process. The amendments to section 513(e) of the FD&C Act made by FDASIA require, in relevant part, that issuance of an administrative order reclassifying a device be preceded by a proposed order and a meeting of a device classification panel.

As amended, section 513(e) of the FD&C Act does not prescribe when these two events (the panel meeting and proposed order) must occur in relation to each other. Therefore, under this provision, the Agency may hold a panel meeting either before or after the issuance of a proposed reclassification order. This approach is consistent with the prior panel provision in section 513(e) of the FD&C Act, which provided for FDA, at its discretion, to secure a panel recommendation prior to the promulgation of a reclassification rule. Generally, for future reclassifications under section 513(e) of the FD&C Act for which a meeting of a device classification panel has not yet occurred, FDA expects a proposed reclassification order will be issued prior to the panel meeting required under section 513(e).

(Comment 3) While one commenter expressed agreement that the proposed 1 year timeframe should be sufficient for manufacturers to bring devices already on the market into compliance with the special controls, another commenter suggested that FDA consider providing additional transition time for the implementation of the final order. The commenter suggested that this would assist manufacturers who are working in good faith to meet the new requirements to prepare submissions in advance of the influenza season and would provide for product continuity among health care providers. The commenter did not identify why 1 year would be an insufficient period of transition time.

(Response) The Panel recommended and FDA made the determination that special controls, including the new minimum performance requirements, are needed, in addition to general controls, to provide reasonable assurance of safety and effectiveness for antigen based RIDTs. We, therefore, do not believe, given the risk that poor performance of antigen based RIDTs pose to public health, a delay in implementation of more than 1 year is appropriate. FDA also understands the need for a balanced approach that takes into account the time it will take for manufacturers to come into compliance with the special controls and seeks to avoid disruption of access to these devices. With these considerations in mind, FDA believes that a period of 1 year from the publication date of this final order is appropriate for manufacturers to come into compliance with the special controls and for those manufacturers whose currently legally marketed devices do not meet the minimum performance criteria to prepare and submit a 510(k) for a new or significantly changed or modified device. Therefore, FDA does not intend to enforce compliance with the special controls with respect to currently legally marketed antigen based RIDT devices until 1 year after the date of publication of this final order. FDA believes this approach will help ensure the efficient and effective implementation of the final order.

(Comment 4) One comment recommended a transition to one common reference method comparator: A molecular nucleic acid-based method. The reasons cited for this recommendation included: (1) A level playing field for all manufacturers and (2) better clarity for users, industry, and the Agency. Another comment raised concerns about the unreliability of the culture results due to non-standardized culture practices. In addition, a commenter cautioned that providing two minimum performance standards, one when compared to viral culture and another when compared to a nucleic acid-based method, may have unintended consequences: (1) Users may make false assumptions and choose a method based strictly on the presented estimates of sensitivity and specificity without noting the comparator reference method that was used to derive the performance measures and (2) manufacturers may elect to conduct the method comparison using both types of reference methods and submit the results in support of a 510(k) even if only one of the comparisons meets the minimum performance bar.

(Response) FDA appreciates the concern over the potential consequences of allowing for the two performance levels based on different comparator methods. The Agency carefully considered the public feedback as well as the implications of eliminating the viral culture comparator method as an acceptable comparator method used in the evaluation of clinical performance of antigen based RIDTs. Some important considerations were: (1) A lack of standardization of viral culture methods among various laboratories, (2) an increasing difficulty in procuring the services of a laboratory that is equipped to perform viral culture procedures, (3) the wide availability of FDA-cleared nucleic acid-based comparator methods among laboratories, (4) the demonstrated high sensitivity of the nucleic acid-based methods when compared to viral culture method (when properly performed) for the detection of the influenza viruses, and (5) the reliability of the viral culture method when performed properly.

In addition, we recognize that performance evaluation based on two different comparators where each detects a different analyte (viral culture methods detect viable virus particles while nucleic acid-based methods detect the viral ribonucleic acids) requires two sets of performance criteria resulting in performance measures that may not allow for direct comparison between some devices. However, viral culture method, when performed correctly, has been shown historically to be accurate and remains a valid reference method for the detection of influenza viruses. There are many influenza detecting devices currently on the market that have been evaluated based on comparison with viral culture comparator methods and met the performance criteria set forth in § 866.3328(b)(1)(ii) (21 CFR 866.3328). FDA has also stated expressly in the special controls that a viral culture comparator method used to demonstrate that a device meets the minimum performance criteria at § 866.3328(b)(1)(ii) must be correctly performed.

At this time, the only currently appropriate and FDA accepted comparator methods are: (1) An FDA-cleared nucleic acid-based test or (2) a correctly performed viral culture method. However, FDA recognizes that a comparator method at least as accurate as FDA-cleared nucleic acid-based tests in the detection of the influenza viruses may be established in the future. Based on that recognition and the available information, the final order clarifies that other comparator methods, if currently appropriate and FDA accepted, could be used to demonstrate that the performance criteria requirements in § 866.3328(b)(1)(i) have been met. Therefore, if FDA determines at some point in the future that another comparator method at least as accurate as FDA-cleared nucleic acid-based tests has been established as a currently appropriate comparator method, sponsors of premarket submissions for antigen based RIDTs would have the option of demonstrating that their devices meet the minimum performance criteria at § 866.3328(b)(1)(i) based on a comparison to that additional currently appropriate and FDA-accepted comparator method.

(Comment 5) Another commenter cautioned that the performance estimates shown in the package inserts for these tests may be biased due to the fact that the data have been generated under closely controlled clinical trial procedures that use optimal sample types, a time of sample collection post onset of symptoms, proper sample storage, and time to testing. Because these conditions are often not maintained in daily clinical use, the true performance of these assays in “real life” settings may be different.

(Response) FDA acknowledges that the performance data in the device labeling are estimates. All assays are subject to variation under real-life circumstances when the assays are used in clinical practice. However, FDA believes that premarket studies demonstrating performance for these devices should include a variety of testing sites representative of the settings in which the device will be used and that a sufficient number of clinical specimens should be tested to arrive at reasonable measures of confidence in the calculated performance estimates (i.e., the lower bound of the two-sided 95 percent confidence interval (calculated by the Score method)), as outlined in the guidance document entitled “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses” (http://www.fda.gov/RegulatoryInformation/Guidances/ucm079171.htm) (“2011 Influenza Guidance document”).

(Comment 6) One commenter suggested that the proposed sensitivity criteria for influenza A for antigen based RIDTs, when using a molecular method as a comparator method, are less stringent than those recorded in the 2011 Influenza Guidance document. The commenter stated that it:

The commenter made a reference to the statement in section 9.B.iii, pages 26-27 of the 2011 Influenza Guidance document (3d bullet), that states: “Nucleic acid-based tests should demonstrate at least 90% sensitivity for each analyte and each specimen type with a lower bound of the two-sided 95% CI greater than 80%.” The commenter also questioned whether this determination was discussed and used to scientifically justify the different criteria for sensitive molecular methods, including polymerase chain reaction, which detect inactive virus in the absence of viable viral particles in a sample, and for viral detection in general when using a molecular comparative method.

(Response) The quoted statement from the 2011 Influenza Guidance document refers to the performance of nucleic acid-based devices, while the performance criteria stated in the May 22, 2014, proposed order (79 FR 29387 at 29390) (Section VIII. Special Controls: . . . If the manufacturer chooses to compare the device to an appropriate molecular comparator method: The positive percent agreement for the device when testing for Influenza A and Influenza B must be at least at the 80 percent point estimate with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent) refer to RIDTs based on antigen detection, which are historically known to have a more limited sensitivity due to the properties of the enzyme immunoassay (EIA) technology. The relevant citation pertaining to the performance of the rapid devices detecting influenza virus antigens may be found in section 9.B.iii, pages 26-27 (1st and 2d bullet) of the 2011 Influenza Guidance document, which states:

Nucleic acid-based assays that test for influenza are regulated under § 866.3980, Respiratory viral panel multiplex nucleic acid assay, and have been held to higher performance criteria than antigen based RIDTs because of their demonstrated ability to reach higher sensitivity for viral detection. By establishing special controls with minimum performance criteria for antigen based RIDTs, this final order raises the required minimum performance criteria for viral detection by the EIA based tests beyond the recommendations set forth in the 2011 Influenza Guidance Document. Nucleic acid-based tests continue to be subject to the document entitled “Class II Special Controls Guidance: Respiratory Viral Panel Multiplex Nucleic Acid Assay” (http://www.fda.gov/RegulatoryInformation/Guidances/ucm180307.htm), except when the device detects and differentiates Influenza A subtype H1 and subtype H3, in which case they are also subject to the document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays” (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm180310.pdf).

(Comment 7) One commenter criticized FDA for providing no specifications for how to design a clinical performance study for antigen based RIDT systems in terms of the proportion of samples that should be presented for each age group. In addition, the comment suggested that the performance estimates of different devices presented in their package inserts may be biased due to the actual proportions of age groups in the study (i.e., children vs. adults) and may not be truly reflective of the performance in the population overall. The commenter further suggested that the number of positive samples as well as sensitivity and specificity (or positive percent agreement (PPA)/negative percent agreement (NPA)) for each age group be presented in each device's Instructions for Use to ensure transparency.

(Response) FDA's current recommendations for appropriate study design can be found in the 2011 Influenza Guidance document, where section 9.B.ii mentions that there should be a representative number of positive samples (determined by the reference method) from each age group and [the data should be presented] stratified by age (e.g., pediatric populations aged birth to 5 years, 6 to 21 years, . . . adults aged 22-59, and greater than 60 years old) in addition to the overall data summary table.

In addition, the 2011 Influenza Guidance document recommends diversifying the location of the selected clinical sites and the anticipated prevalence of influenza at the time of the study. Depending on the site selection, the age composition of the subjects will vary, but it is difficult to predict the different age groups at the outset of a study. FDA evaluates assay performance estimates stratified by age groups and determines whether the performance among different age groups is similar before making the final decision regarding 510(k) clearance. FDA encourages sponsors to use the pre-submission program to discuss the premarket submission strategy and study design for their specific devices. The pre-submission program is described in the guidance document titled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” found on FDA's Web site at http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf.

(Comment 8) A commenter also suggested that the proposed special controls do not clearly state that data demonstrating that a device meets the clinical performance criteria be obtained using prospective, fresh samples and that this may be easily remedied by adding a statement in the final special controls document indicating that “clinical performance studies should be carried out on fresh, prospective samples.”

(Response) The 2011 Influenza Guidance Document, in section 9.B.iii Specimens, on p. 27, states that: “[w]e recommend that you assess the ability of your device to detect influenza viruses in fresh specimens collected from patients suspected of having an influenza infection who have been sequentially enrolled in the study (all-comers study)”. The guidance further states that “[f]rozen archived specimens may be useful for analytical performance evaluations, but are not recommended for studies to calculate clinical sensitivity or specificity”.

As the incidence of influenza varies from year to year and also from region to region, testing of archived specimens may be acceptable where fresh positive specimens are difficult to obtain. Performance data obtained from testing retrospective archived samples are generally evaluated and presented separately from data obtained with prospectively collected specimens in the final device labeling.

(Comment 9) A further recommendation was made that the proposed special controls include explicit wording to clarify that clinical performance criteria must be met for each sample type claimed in the proposed labeling submitted for clearance.

(Response) FDA agrees with this recommendation. The proposed special controls have been modified to clarify that clinical performance criteria must be met for each specimen type claimed in the intended use of the device.

(Comment 10) One commenter asserted that the proposed acceptance criteria for devices choosing to use viral culture as a comparator have been determined using certain generalizations that can confound the data. Referring to the Executive Summary document prepared for the Panel meeting (Ref. 1), the commenter states that, for example, all sample types and age ranges were included in the overall presentation of sensitivity for various devices. The commenter objected that the performance criteria, as presented in the Executive Summary document, appear to have been subjectively defined. The commenter further suggested that the purpose of tables 1 and 2 in the Executive Summary was to imply that any device cleared prior to 2008 is assumed to have variable and unacceptable performance, and that the performance criteria for antigen based RIDTs were chosen specifically with the intention of removing those devices from use. Additionally, the commenter stated that the information, as presented in the publicly available Executive Summary, did not make it clear that the data were confounded and created an unfair marketing advantage for some manufacturers.

(Response) The summary data tables presented in the Executive Summary document submitted to the Panel in June 2013 were compiled to illustrate the range in clinical performance among the antigen based RIDTs available on the market in support of the reclassification effort and were not aimed to remove devices cleared before 2008 from the market, as the commenter suggests. The data for each assay presented in table 1 in the Executive Summary document were based on the information provided to FDA in support of the 510(k) submissions for those devices and included results from all prospectively collected samples during the clinical study conducted by the manufacturer, regardless of the specimen type or the age of the patient (Ref. 1). The information in this table shows a wide range of assay performances.

The data presented in table 2 in the Executive Summary document were intended to illustrate the even broader range in sensitivity of these assays as reported in the scientific literature and derived from postmarket studies conducted in the field. The data in table 2 were also based on combined results, regardless of sample type, patient age and even influenza virus type. Although the commenter may consider the data “confounded,” they were not meant to demonstrate statistical validity but rather to illustrate that some of the currently available antigen based RIDTs have clinically poor sensitivity even under the controlled conditions of a clinical study conducted in support of a regulatory submission. More importantly, the clinical performance of these assays in the field, as reported in peer reviewed publications, is considerably worse for some of these assays than was demonstrated in the studies submitted to FDA to support their clearance. Overall, the data contained in the two tables were intended to help illustrate the sensitivity of the antigen based RIDTs available on the market, taking into consideration the limitations of the available technology. The data presented in both tables in the Executive Summary document support that improved influenza detection devices are needed to benefit public health in detection, treatment, and infection control with regard to the influenza viruses.

(Comment 11) Some commenters inquired about the process for notifying manufacturers that their assays do not meet the new performance criteria and expressed concern that manufacturers should be allowed sufficient transition time to develop new or modified influenza detection devices and to submit new 510(k)s for those products.

(Response) A manufacturer will not be individually notified that its product does not comply with the new special controls; each manufacturer of an antigen based RIDT is responsible for compliance with these special controls, including the minimum performance criteria. If an antigen based RIDT device does not meet the new performance criteria set forth in this final order, the device may be considered adulterated under section 501(f)(1)(B) of the FD&C Act (21 U.S.C. 351(f)(1)(B)), and manufacturers must cease marketing of the device. However, as outlined in section IV, “Implementation Strategy,” FDA does not intend to enforce compliance with the special controls with respect to currently legally marketed antigen based RIDT devices until 1 year after the date of publication of this final order. A manufacturer may contact the Center for Devices and Radiological Health's (CDRH) Division of Microbiology Devices in the Office of In Vitro Diagnostics and Radiological Health (OIR) with any specific questions.

(Comment 12) One commenter inquired whether there will be an appeals mechanism for manufacturers and what specific steps would be available for manufacturers.

(Response) No new appeals mechanisms will be implemented for those manufacturers whose assays do not comply with the new special controls. However, there are processes available to outside stakeholders to request additional review of decisions or actions by the CDRH. For more information, see the FDA guidance document entitled “Center for Devices and Radiological Health Appeals Processes—Guidance for Industry and Food and Drug Administration Staff” (http://www.fda.gov/RegulatoryInformation/Guidances/ucm284651.htm).

(Comment 13) Commenters expressed concerns about whether all manufacturers, regardless of their size or resources, will have equal access to the samples needed to conduct the annual analytical reactivity testing in compliance with the new special controls. One of the commenters noted that there may be challenges to specimen access for some manufacturers under the World Health Organization (WHO) Pandemic Influenza Preparedness (PIP) Framework as well as potential impact on accessing the influenza strains sourced by the WHO Global Influenza Surveillance and Response System (GISRS). The commenter asked if manufacturers required to perform the annual testing would need to participate in the PIP framework to access GISRS specimens. The commenter further stated that unless all companies are able to access specimens in a fair, timely and non-cost restrictive manner to comply with the new postmarket requirements, some innovators may be unable to continue to develop new influenza diagnostics.

(Response) CDC intends to make available an annual analytical reactivity test panel, which is an annual standardized seasonal influenza virus test panel, so that manufacturers can comply with the annual analytical reactivity testing requirement. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains. The selection of viruses in the CDC annual analytical reactivity test panels is expected to be largely based on the strains selected by WHO for the annual vaccine and will be distributed for annual analytical reactivity testing or analytical validation in support of new 510(k) submissions for antigen based RIDT devices. We expect that the panel will primarily consist of human viruses that circulated in the recent influenza seasons. FDA and CDC do not believe that manufacturers will need to enter agreements under the PIP Framework to access influenza viral strains in the manner described in this final order for the sole purpose of conducting testing to comply with the special controls at § 866.3328(b)(3) and (4). The annual analytical reactivity test panel will be made available to manufacturers at the same time, including those that require it for the annual analytical reactivity testing as well as those who are developing new or modified influenza assays. CDC and FDA are committed to facilitating equal access for manufacturers to the annual analytical reactivity test panel and are prepared to consider any unforeseen circumstances in an equitable manner.

(Comment 14) Another commenter expressed a concern regarding whether the requisite strain(s) will be made available in sufficient time to allow manufacturers to conduct the studies and have the data available in the labeling or on the manufacturer's Web site within the timeframe specified for both annual and emergency analytical reactivity testing. The comment stated that for most manufacturers, the process of testing and making a change in labeling would take a minimum of 90 days from receipt of samples.

(Response) Under the new special controls, the results of the last 3 years of annual analytical reactivity testing conducted from the date that the device was given marketing authorization by FDA must be incorporated into the device's labeling in the manner discussed in § 866.3328(b)(3)(iii) by July 31 of each calendar year. CDC and FDA are committed to making available or designating an alternative source for the annual analytical reactivity test panel with sufficient time for all manufacturers to conduct the testing and include the results in their device's labeling within the required timeframe.

Similarly, in the case of emergency analytical reactivity testing, as described in the special controls at § 866.3328(b)(4), after CDC makes the viral samples available for testing, FDA will notify the manufacturers of the availability of the samples. The manufacturers will have 60 days to perform the testing of the viral samples and to incorporate the results into the device's labeling in the manner discussed in § 866.3328(b)(4)(ii). If a manufacturer is concerned about meeting these timelines due to time needed to amend device labeling that physically accompanies the device, the manufacturer may pursue the § 866.3328(b)(3)(iii)(B) and (b)(4)(ii)(B) alternatives, which allow manufacturers to provide the results as electronic labeling via the manufacturer's public Web site that can be reached via a hyperlink found in the device's label or in other labeling that physically accompanies the device. If a manufacturer chooses the option to post analytical reactivity testing results on its Web site, it would be subject to the requirements of section 502(f) of the FD&C Act (21 U.S.C. 352(f)) that provides that required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means as long as the labeling complies with the law, and that the manufacturer affords users the opportunity to request the labeling in paper form, and that after a request, promptly provides the requested information without additional cost.

If a manufacturer provides the hyperlink to a public Web site at which annual analytical reactivity and emergency testing data may be viewed, generally no updates would be needed to the labeling that physically accompanies the device when meeting the annual analytical reactivity testing requirements under § 866.3328(b)(3) or the emergency analytical reactivity testing requirements under § 866.3328(b)(4). If annual or emergency analytical reactivity testing reveals that the device is unable to detect one or more strains, the manufacturer would need to include a limitation in the device labeling, as further discussed in our response to Comment 21.

(Comment 15) Commenters expressed concern about the logistics of the implementation of the new requirement for the annual analytical reactivity testing. One commenter stated that a clear mechanism was not outlined in the proposed order for activities leading to the reporting of results.

(Response) The activities leading to the reporting of results will include acquisition of the annual analytical reactivity test panel and analytical reactivity testing following the standardized protocol included with the test panel, which will be a standardized protocol considered and determined by FDA to be acceptable and appropriate. Results must be reported by updating the device's labeling in accordance with § 866.3328(b)(3)(iii). As previously stated, CDC and FDA are committed to working with the manufacturers of the influenza tests to facilitate timely and equitable access to the influenza virus annual analytical reactivity test panel. CDC has developed a Web site (http://www.cdc.gov/flu/dxfluviruspanel/index.htm) where the manufacturers can affirm their need for the annual analytical reactivity test panel, referred to by CDC as the “CDC Influenza Virus Panel,” to comply with the annual analytical reactivity testing requirement. The CDC panel will be distributed along with certificates of analyses for the viruses and a standardized testing protocol, considered and determined by FDA to be acceptable and appropriate, instructing the user on handling and testing of the provided virus stocks in the test panel. There are currently no plans to post the analytical reactivity testing data generated by the manufacturers on the CDC Web site. For any questions related to the test procedure, manufacturers may contact CDC or FDA as specified in the information included with the influenza virus analytical reactivity test panel. CDC will serve as the contact for questions pertaining to viruses, and FDA will serve as the contact for all regulatory and reporting issues.

(Comment 16) Commenters expressed concern about the continued availability of the test panel from CDC due to the future potential for limited resources at CDC or FDA.

(Response) In a case where the influenza virus analytical reactivity test panel is not available from CDC due to unforeseen limitations in resources, an alternate source of influenza strains for use in conducting the annual analytical reactivity testing will be identified by FDA, in consultation with CDC. An example of an alternate source could be a commercial vendor that specializes in acquisition, authentication, production, and preservation of microorganisms.

(Comment 17) Commenters suggested that the industry should be engaged for feedback in the development of the standardized testing protocol.

(Response) A standardized protocol has been developed by CDC in consultation with FDA and will be provided to manufacturers with the annual analytical reactivity test panel. The protocol uses basic principles for working with virus stocks and is general enough to allow for use with various devices. For any questions related to the testing procedure, manufacturers can contact CDC or FDA. CDC will serve as the contact for questions pertaining to viruses, and FDA will serve as the contact for all regulatory and reporting issues.

(Comment 18) One commenter inquired whether the analytical reactivity testing could be conducted using a modified limit of detection (LoD) protocol, where 60 replicates are tested over 3 dilutions with positivity rates between 80 and 99 percent followed by linear regression to calculate the specific concentration that corresponds to a positivity rate of 95 percent.

(Response) This approach is acceptable to use in the determination of a LoD of an antigen based RIDT assay. However, manufacturers must follow the protocol included with the influenza virus analytical reactivity test panel, which will be a standardized protocol considered and determined by FDA to be acceptable and appropriate. We believe the standardized protocol will be less burdensome than this commenter's proposal and will help ensure that the results generated allow for comparability between different devices, as all devices will have followed a common standardized testing protocol.

(Comment 19) One commenter asked whether interested manufacturers would have an option to have the testing conducted by an independent laboratory, such as a laboratory at a university.

(Response) Yes, a manufacturer may contract an outside laboratory to conduct the testing on its behalf.

(Comment 20) One commenter raised a concern that customers without access to a manufacturer's Web site may not be able to access the annual and/or emergency analytical reactivity testing information; therefore, the commenter suggested that an alternate method of contact should be provided in the product labeling.

(Response) All in vitro diagnostic devices are required by regulation to state on the label and in the product labeling the name and place of business of the manufacturer, packer, or distributor § 809.10(a)(8) and (b)(14) (21 CFR 809.10(a)(8) and (b)(14)), except where such information is not applicable, or as otherwise specified in a standard for a particular product class.

In addition, in accordance with § 866.3328(b)(3)(iii) the results of the annual analytical reactivity testing must either be in the § 809.10(b) compliant labeling that physically accompanies the device or be provided as electronic labeling via the manufacturer's public Web site that can be reached via a hyperlink prominently found in the device's label or in other labeling that physically accompanies the device. If the manufacturer chooses the Web site option, it would be subject to the requirements of section 502(f) of the FD&C Act, which provides that required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, as long as the labeling complies with the law, and that the manufacturer affords users the opportunity to request the labeling in paper form, and that after a request, promptly provides the requested information without additional cost. Therefore, a manufacturer is already required to provide an opportunity for a health care professional to request the annual analytical reactivity test results in paper form.

(Comment 21) One commenter raised a question about notifying the public when a test is non-reactive with any of the strains included in the influenza virus analytical reactivity test panel provided by CDC and whether the product labeling will be updated annually. In particular, the commenter questioned how labeling changes to reflect absence of reactivity would be communicated to users who have already purchased the test.

(Response) This final order requires that the results of the last 3 years of annual analytical reactivity testing conducted from the date that the device was given marketing authorization by FDA be included as part of the device's labeling by July 31 of each calendar year. Modification of the labeling solely to incorporate analytical reactivity testing results required under § 866.3328(b)(3)(iii) or (b)(4)(ii) can be made without an official submission to FDA. In a case where one or more strains are shown not to be detected by the device during annual analytical reactivity testing under § 866.3328(b)(3) or emergency analytical reactivity testing under § 866.3328(b)(4), the manufacturer will need to include a limitation in the device labeling regarding reactivity with the specific strain(s) that were not detected by the device. Without such a limitation, the device would not meet the labeling requirements of § 809.10(b).

(Comment 22) One commenter raised a question about whether there will be a guidance document issued on a yearly basis to interpret the results of the analytical reactivity testing for that year.

(Response) FDA does not intend to issue a guidance document on how to interpret the results of the analytical reactivity testing each year, as the result interpretations are stated in the CDC information sheet that will be distributed with the CDC annual analytical reactivity test panel. The annual analytical reactivity testing is intended to evaluate whether the assay detects each strain included in the annual analytical reactivity test panel; however, that testing does not provide direct information about how the assay performs when used with clinical specimens that are collected directly from patients. Any positive result obtained during analytical reactivity testing performed with the annual influenza virus analytical reactivity test panel, at any viral concentration/dilution, indicates that the assay is reactive with that virus; however, the minimal concentration of the virus that is needed for the detection (assay sensitivity) may vary. Since the difference in analytical reactivity does not necessarily translate into an appreciable difference in performance when testing clinical specimens, it is important to emphasize that the results should not be over-interpreted for clinical purposes.

(Comment 23) One commenter suggested further collaboration between the Agency and influenza test manufacturers in establishing the regulatory process for implementing the labeling change before a final “Notice to Industry” or other document is published. The commenter further recommended that FDA specify an interactive process, whereby individual manufacturers can seek guidance, particularly if they encounter issues that may impede timely publication of annual and emergency analytical reactivity testing data (e.g., if the matrix used in the preparation of the virus strains in the test panel causes invalid results with a particular device).

(Response) Interactive communication with manufacturers is common practice among the reviewers and the managers in CDRH. Manufacturers are encouraged to contact CDRH's OIR with questions or about issues related to the new requirements. In addition, the CDRH pre-submission program is designed to allow sponsors the opportunity to obtain targeted FDA feedback in response to specific questions related to product development, including planned non-clinical evaluations, proposed clinical study protocols, or data requirements prior to making a submission to the Agency.

(Comment 24) Similar concerns to those surrounding the annual reactivity testing requirement were raised in regard to the emergency testing of emergent strains. In addition, one comment expressed support for specifying a timeline for reporting the results after the samples become available.

(Response) Section 866.3328(b)(4)(ii) requires that, in certain emergency or potential emergency situations involving an influenza viral strain, the results of analytical reactivity testing with the emerging virus(es) must be made available within 60 days from the date that FDA notifies antigen based RIDT manufacturers that characterized viral samples are available. The results of the influenza emergency analytical reactivity testing must be disclosed in a tabular format in a similar manner as the results of the annual analytical reactivity testing (i.e., either by placing the table directly in the device's § 809.10(b) compliant labeling that physically accompanies the device in the section of the labeling devoted to analytical reactivity testing, or in a section of the device's label or in labeling that physically accompanies the device, by prominently providing a hyperlink to a part of the manufacturer's Web site where the analytical reactivity testing data can be found). As previously discussed, modification of the labeling solely to incorporate annual analytical reactivity testing results under § 866.3328(b)(3)(iii) or emergency analytical reactivity testing results under § 866.3328(b)(4)(ii) can be made without an official submission to FDA. In a case where one or more strains are shown not to be detected by the device during annual analytical reactivity testing under § 866.3328(b)(3) or emergency analytical reactivity testing under § 866.3328(b)(4), the manufacturer will need to include a limitation in the device labeling regarding reactivity with the specific strain(s) that were not detected by the device. Without such a limitation the device would not meet the labeling requirements of § 809.10(b).

FDA is also clarifying the special controls to be more precise regarding the situations in which emergency analytical reactivity testing is required. Under section 564(a)-(b) of the FD&C Act (21 U.S.C. 360bbb-3(a)-(b)), the Secretary of Health and Human Services (HHS) may authorize the introduction into interstate commerce of a drug, device, or biologic product intended for use in an actual or potential emergency (referred to as “emergency use”) after making a declaration, under section 564(b)(1) of the FD&C Act, that circumstances exist justifying the authorization. Such a declaration must be based on one of the following actions listed at section 564(b)(1)(A)-(D) of the FD&C Act:

• A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a chemical, biological, radiological, or nuclear (CBRN) agent or agents;

• A determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a CBRN agent or agents;

• A determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents; or

• The identification of a material threat, by the Secretary of Homeland Security under section 319F-2 of the Public Health Service (PHS) Act, that is sufficient to affect national security or the health and security of U.S. citizens living abroad.

If one of these four actions that can provide the basis for the Secretary of HHS to make a declaration under section 564(b)(1) of the FD&C Act occurs with respect to an influenza viral strain, then, after being notified that characterized viral samples are available from CDC, antigen based RIDT manufacturers must conduct analytical reactivity testing with those samples and make the results available in their device labeling within the timeframes set forth in § 866.3328(b)(4).

In addition, the Secretary of HHS may determine under section 319(a) of the PHS Act (42 U.S.C. 247d(a)) that a disease or disorder presents a public health emergency or that a public health emergency otherwise exists. In the event of such a determination under section 319(a) of the PHS Act with respect to an influenza viral strain, then, after being notified that characterized viral samples are available from CDC, antigen based RIDT manufacturers would also need to conduct analytical reactivity testing with those samples and make the results available in their device labeling within the timeframes set forth in § 866.3328(b)(4).

The final order also modifies the special controls to require that any emergency reactivity test results added to antigen based RIDT device labeling under § 866.3328(b)(4)(ii) remain in the labeling for a period of 3 years. Emerging influenza strains may still be circulating after the statutory actions described under section 564(b)(1)(A)-(D) of the FD&C Act and section 319(a) of the PHS Act have terminated. The change will align the period that emergency analytical reactivity test results must remain in device labeling with the requirement in § 866.3328(b)(3)(iii) that manufacturers provide the last 3 years of annual analytical reactivity testing in the device labeling. FDA believes that this makes the labeling requirements in the special controls more clear and consistent for industry.

As discussed previously, after reviewing the comments received along with the proposed order and the Panel's recommendations, FDA is making a few clarifications and modifications to the special controls for antigen based RIDTs. These include: (1) Clarifying that clinical performance criteria must be met for each specimen type claimed in the intended use of the device; (2) clarifying that manufacturers of future antigen based RIDT devices may use a currently appropriate and FDA accepted comparator method other than comparison to an FDA-cleared nucleic acid based-test or viral culture methods to demonstrate that those devices meet the clinical performance criteria, if such a comparator method is established; (3) clarifying that a manufacturer choosing to provide analytical reactivity testing results via its public Web site must prominently provide hyperlink to that Web site in the device's label or in other labeling that physically accompanies the device; (4) clarifying the circumstances in which emergency analytical reactivity testing is required under § 866.3328(b)(4); and (5) requiring results of such emergency analytical reactivity testing to remain in the device labeling for a period of 3 years.

Under section 513(e) of the FD&C Act, FDA is adopting its findings as published in the preamble to the proposed order, with the modifications discussed in section II of this final order. FDA is issuing this final order to reclassify antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus antigen directly from clinical specimens that are currently regulated as influenza virus serological reagents under § 866.3330 from class I into class II with special controls and into a new device classification regulation for “influenza virus antigen detection test systems.” Currently, antigen based RIDTs are mostly found under product codes GNX and GNT. However, any antigen based rapid influenza virus antigen detection test system intended to detect influenza virus antigen directly from clinical specimens that is currently regulated as influenza virus serological reagents under § 866.3330 is subject to this reclassification regardless of the product code to which it is currently assigned.

Section 510(m) of the FD&C Act provides that a class II device may be exempt from the premarket notification requirements under section 510(k) of the FD&C Act, if the Agency determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this device, FDA believes that premarket notification is necessary to provide reasonable assurance of safety and effectiveness. Therefore, this type of device is not exempt from premarket notification requirements.

In addition, FDA believes that special controls that: (1) Identify the minimum acceptable performance criteria; (2) require use of a currently appropriate and FDA accepted comparator method for establishing performance of new antigen based RIDTs; (3) require annual analytical reactivity testing of contemporary influenza strains; and (4) require analytical reactivity testing of newly emerging strains under certain situations involving an emergency or potential for an emergency, are necessary to provide reasonable assurance of safety and effectiveness of these devices.

The special controls identified in this final order are effective February 13, 2017.

• For antigen based RIDTs that have not been legally marketed prior to February 13, 2017, or that have been legally marketed but are required to submit a 510(k) under 21 CFR 807.81(a)(3) because the device is about to be significantly changed or modified, manufacturers must obtain 510(k) clearance, among other relevant requirements, and demonstrate compliance with the special controls included in this final order, before marketing their new or changed device. If a manufacturer markets such a device after February 13, 2017 without obtaining 510(k) clearance and demonstrating compliance with the special controls included in this final order, then FDA would consider taking action against such a manufacturer under its usual enforcement policies.

• For antigen based RIDTs that have been legally marketed prior to February 13, 2017, FDA does not intend to enforce compliance with the special controls until January 12, 2018. If a manufacturer markets such a device after January 12, 2018, and that device does not comply with the special controls, then FDA would consider taking action against such a manufacturer under its usual enforcement policies.

FDA believes that a period of 1 year from the publication date of this final order is appropriate for manufacturers to come into compliance with the special controls and for those manufacturers whose currently legally marketed devices do not meet the minimum performance criteria to prepare and submit a 510(k) for a new or significantly changed or modified device. FDA believes this approach will help ensure the efficient and effective implementation of the order.

The Agency has determined under 21 CFR 25.34(b) that this reclassification action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information 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 collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 regarding investigational device exemptions have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 801 and § 809.10 have been approved under OMB control number 0910-0485; and the collections of information regarding pre-submissions have been approved under OMB control number 0910-0756.

Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) of the FD&C Act, as amended, requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final order, we are codifying the reclassification of antigen based RIDTs into class II (special controls).

The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

On June 30, 2016, the President signed into law the FOIA Improvement Act of 2016 (2016 Act) (Pub. L. 114-185, 130 Stat. 538), which contains several substantive and procedural amendments to the Freedom of Information Act (FOIA). The 2016 Act addresses a range of procedural issues, including requirements that agencies establish a minimum of 90 days for requesters to file an administrative appeal, and that agencies provide dispute resolution services at various times throughout the FOIA process. The 2016 Act also codifies a “foreseeable harm” standard, amends Exemption 5 to the FOIA, creates a new Chief FOIA Officer Council within the Executive Branch, and adds two new elements to agency Annual FOIA Reports. The amendments apply to any request made after the date of enactment, which was June 30, 2016.

Section 3 of the 2016 Act requires agencies to review and issue updated regulations on procedures for the disclosure of records under the FOIA, in accordance with the amendments made by the 2016 Act, within 180 days of enactment. Accordingly, HUD revises its FOIA regulation to incorporate changes enacted by the 2016 Act.

The following is an overview of the changes made in this final rule.

The 2016 Act requires agencies to “make available for public inspection in an electronic format” records that, because of their subject matter, the agency determines “have become or are likely to become the subject of subsequent requests for substantially the same records,” or that have been requested 3 or more times. In response, HUD is amending §§ 15.101(a) and 15.101(b)(7) to comply with this requirement. The revisions mirror the language from the 2016 Act.

The 2016 Act also adds agency reporting requirements for agencies' annual FOIA reports. The 2016 Act requires that a report covering the preceding fiscal year is to be submitted to the Attorney General of the United States and to the Director of the Office of Government Information Services (OGIS). The raw statistical data used in each report must be made available without charge, license, or registration requirement; in an aggregated, searchable format, and in a format that may be downloaded in bulk. Both the report and the raw statistical data used in the report must be made available for public inspection in an electronic format. In response to this requirement, HUD is adding § 15.101(b)(8) in conformance with these new reporting requirements.

When a FOIA request involves “unusual circumstances,” agencies have long been required to provide written notice to the requester, and in those instances where an extension of time of more than ten working days is specified, agencies have been required to provide the requester with an opportunity to limit the scope of the request so that it can be processed more quickly or to arrange an alternative time to respond. The 2016 Act adds an additional requirement when unusual circumstances exist. Specifically, whenever agencies extend the time limits by more than ten additional working days, in the written notice to the requester they must notify the requester of their right to seek dispute resolution services from the OGIS. To address this requirement, HUD is revising § 15.103(c) to incorporate the change enacted by the 2016 Act.

HUD is also using this final rule to update several specific provisions of § 15.103 to more accurately reflect the statutory language in 5 U.S.C. 552(a)(6)(A)(i). First, HUD is revising § 15.103(a) to state that HUD will generally “make a determination whether to comply with a FOIA request within 20 working days.” Second, HUD is revising § 15.103(c), which addresses when HUD may extend the time periods for processing a FOIA request, to remove the sentence that limited extensions to 10 working days. HUD is removing this language as inconsistent with the plain reading of the statute, the logic of the rest of the language in § 15.103(c), and Department of Justice guidance. Finally, in accordance with 5 U.S.C. 552(a)(6)(B)(ii), HUD has updated § 15.103(c) to include the provision that HUD shall make available its FOIA Public Liaison, who shall assist in the resolution of any disputes between the requester and HUD.

When an agency makes a determination regarding whether to comply with a FOIA request, the 2016 Act provides that the agency is required to immediately notify the requester of such determination and the reasons therefore, and also notify the requester that they have a right to seek assistance from the agency's FOIA Public Liaison. For adverse determinations, the 2016 Act requires that agencies afford the requester no less than 90 days from the date of the adverse determination on the request to file an appeal. In addition, the 2016 Act requires that agencies notify the requester that they may seek dispute resolution services from the FOIA Public Liaison or from OGIS.

Consistent with this requirement, HUD has revised § 15.105(d) to provide that, once HUD makes a determination regarding compliance within the time line provided in § 15.103(a), HUD will immediately notify the requester of such determination, the reasons therefore, and their right to seek assistance from the FOIA Public Liaison.

For adverse determinations, HUD has added § 15.105(d)(2)(iv) to provide that HUD will notify the requester of their right to file an appeal no less than 90 days after the date of receiving the adverse determination. Finally, § 15.105(d)(2)(v) has been added to provide that HUD will notify the requester of their right to seek dispute resolution services from the FOIA Public Liaison or from OGIS.

The 2016 Act contains several new provisions regarding agencies' ability to assess search and duplication fees. First, the 2016 Act provides that an agency shall not assess any search fees, or in some cases, duplication fees, if the agency has failed to comply with any time limit described in § 15.103, with limited exceptions. Second, if an agency determines that unusual circumstances apply to the processing of a FOIA request, and the agency has provided timely written notice to the requester, then a delayed response time is excused for an additional ten days; if the agency fails to comply with the extended time limit, it may not charge search fees, or, in some cases, duplication fees, with limited exceptions. Third, the 2016 Act provides an exception allowing agencies to charge search fees, or in some cases, duplication fees, if unusual circumstances apply, more than 5,000 pages are necessary to respond to the request, timely written notice has been made to the requester, and the agency has discussed with the requester via written mail, electronic mail, or telephone (or made not less than 3 good-faith attempts to do so) how the requester could effectively limit the scope of the request. Fourth, the 2016 Act maintains that if a court determines that “exceptional circumstances” exist, as defined in 5 U.S.C. 552(a)(6)(C), the agency's failure to comply with a time limit “shall be excused for the length of time provided by the court order.”

In accordance with the first change, HUD is updating § 15.106(d) to provide that HUD will not assess search fees or, for requesters that are educational or noncommercial scientific institutions or representatives of the news media requesting records not sought for commercial use, duplication fees, if it fails to comply with the extended time limits as described in § 15.103. To comply with the second change, HUD is adding § 15.106(d)(5) to grant HUD an additional ten days when unusual circumstances apply and timely written notice has been provided to the requester and to terminate HUD's ability to assess search fees or duplication fees, as applicable, if HUD does not comply with the additional ten days. Regarding the third change, HUD is adding § 15.106(d)(6) to allow HUD to charge search fees when unusual circumstances apply and more than 5,000 pages are necessary to respond to the FOIA request. Regarding the fourth amendment, HUD is adding § 15.106(d)(7)(i) to excuse a failure to comply with any time limit if a court determines that exceptional circumstances exist; and § 15.106(d)(7)(ii), which provides the definition of “exceptional circumstances” as defined in 5 U.S.C. 552(a)(6)(C), has also been added for clarifying purposes.

The 2016 Act requires that agencies withhold information under FOIA “only if the agency reasonably foresees that disclosure would harm an interest protected by an exemption” or if disclosure is prohibited by law. The 2016 Act further directs agencies to consider whether partial disclosure of information is possible whenever the agency determines that a full disclosure of a requested record is not possible, and to take reasonable steps necessary to segregate and release nonexempt information. The 2016 Act does not require disclosure of information that is otherwise prohibited from disclosure by law, or otherwise exempted from disclosure under Exemption 3.

Consistent with these changes, HUD is restructuring § 15.107 and adding paragraph (a) to provide that HUD shall withhold information only if it is reasonably foreseeable that disclosure would harm an interest protected by an exemption, or if disclosure is prohibited by law. Paragraph (a) also emphasizes that HUD will consider whether partial disclosure of information is possible if it determines that a full disclosure of a requested record is not possible, and that HUD will take reasonable steps necessary to segregate and release nonexempt information.

In addition, the 2016 Act sunsets the deliberative process privilege, as protected from disclosure under Exemption 5 of the FOIA. Specifically, the 2016 Act amends Exemption 5 to provide that the deliberative process privilege does not apply to records created 25 years or more before the date on which the records were requested. In accordance with the 2016 Act, HUD is revising § 15.107(b)(5) to state that the deliberative process privilege “shall not apply to records created 25 years or more before the date on which the records were requested.”

In general, HUD publishes a rule for public comment before issuing a rule for effect, in accordance with HUD's regulations on rulemaking at 24 CFR part 10. Part 10, however, provides in § 10.1 for exceptions from that general rule where HUD finds good cause to omit advance notice and public participation. The good cause requirement is satisfied when the prior public procedure is “impracticable, unnecessary or contrary to the public interest.”

HUD finds that good cause exists to publish this rule for effect without first soliciting public comment because prior public comment is unnecessary. This final rule follows the statutory directive in Section 3 of the 2016 Act, which requires agencies to review and issue updated regulations on procedures for the disclosure of records under the FOIA, in accordance with the amendments made by the 2016 Act, within 180 days of enactment. The 2016 Act codifies a number of transparency and openness principles and enacts a number of procedural requirements, including requiring that agencies establish a minimum of 90 days for requesters to file an administrative appeal and that they provide dispute resolution services at various times throughout the FOIA process. This final rule reflects the changes required by the 2016 Act. Finally, the rule revises provisions § 15.103 to more accurately reflect the statutory language in 5 U.S.C. 552(a)(6)(A)(i).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if the regulation is necessary, to select the regulatory approach that maximizes net benefits. Because this final rule incorporates changes enacted by the 2016 Act, this rule was determined to not be a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and therefore was not reviewed by OMB.

This rule is categorically excluded from environmental review under the National Environmental Policy Act (42 U.S.C. 4321). The revision of the FOIA-related provisions of 24 CFR part 15 falls within the exclusion provided by 24 CFR 50.19(c)(1), in that it does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise, or provide for standards for construction or construction materials, manufactured housing, or occupancy.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. This final rule establishes procedures by which HUD will respond to requests for information under FOIA. Costs assessed by HUD for search, review, and duplication required to process the information requested by a requester are limited by FOIA to direct costs and are not significant. Accordingly, the undersigned certifies that this rule will not have a significant economic impact on a substantial number of small entities.

Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the rule preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This final rule does not have federalism implications and does not impose substantial direct compliance costs on state and local governments or preempt state law within the meaning of the Executive Order.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments, and on the private sector. This final rule does not impose any federal mandates on any state, local, or tribal governments, or on the private sector, within the meaning of the Unfunded Mandates Reform Act of 1995.

For the reasons stated in the preamble, HUD amends 24 CFR part 15 as follows:

In the final rule FR Doc. 2016-30708, published in the Federal Register on December 20, 2016 (81 FR 92626), the following correction is made:

On December 1, 2016, the Coast Guard was notified by the event organizer that the anticipated dates for the activities associated with the 58th Presidential Inauguration are scheduled from January 15, 2017, to January 24, 2017. The Coast Guard will enforce regulations in 33 CFR 165.508 for the zone identified in paragraph (a)(6). This action is being taken to protect government officials, mitigate potential terrorist acts and incidents, and enhance public and maritime safety and security immediately before, during, and after this event.

Our regulations for Security Zone; Potomac River and Anacostia River, and adjacent waters; Washington, DC, § 165.508, specifies the location for this security zone as an area that includes all navigable waters described in paragraphs (a)(1) through (a)(3). This zone includes (1) Security Zone 1; all navigable waters of the Potomac River, from shoreline to shoreline, bounded to the north by the Francis Scott Key (US-29) Bridge, at mile 113, and bounded to the south by a line drawn from the Virginia shoreline at Ronald Reagan Washington National Airport, at 38°51′21.3″ N., 077°02′00.0″ W., eastward across the Potomac River to the District of Columbia shoreline at Hains Point at position 38°51′24.3″ N., 077°01′19.8″ W., including the waters of the Boundary Channel, Pentagon Lagoon, Georgetown Channel Tidal Basin, and Roaches Run. (2) Security Zone 2; all navigable waters of the Anacostia River, from shoreline to shoreline, bounded to the north by the John Philip Sousa (Pennsylvania Avenue) Bridge, at mile 2.9, and bounded to the south by a line drawn from the District of Columbia shoreline at Hains Point at position 38°51′24.3″ N., 077°01′19.8″ W., southward across the Anacostia River to the District of Columbia shoreline at Giesboro Point at position 38°50′52.4″ N., 077°01′10.9″ W., including the waters of the Washington Channel. (3) Security Zone 3 all navigable waters of the Potomac River, from shoreline to shoreline, bounded to the north by a line drawn from the Virginia shoreline at Ronald Reagan Washington National Airport, at 38°51′21.3″ N., 077°02′00.0″ W., eastward across the Potomac River to the District of Columbia shoreline at Hains Point at position 38°51′24.3″ N., 077°01′19.8″ W., thence southward across the Anacostia River to the District of Columbia shoreline at Giesboro Point at position 38°50′52.4″ N., 077°01′10.9″ W., and bounded to the south by the Woodrow Wilson Memorial (I-95/I-495) Bridge, at mile 103.8.

As specified in § 165.508 (b), during the enforcement period, entry into or remaining in the zone is prohibited unless authorized by the Coast Guard Captain of the Port Maryland-National Capital Region. Public vessels and vessels already at berth at the time the security zone is implemented do not have to depart the security zone. All vessels underway within the security zone at the time it is implemented are to depart the zone at the time the security zone is implemented. To seek permission to transit the zone, the Captain of the Port Maryland-National Capital Region can be contacted at telephone number (410) 576-2693 or on Marine Band Radio, VHF-FM channel 16 (156.8 MHz). Coast Guard vessels enforcing this zone can be contacted on Marine Band Radio, VHF-FM channel 16 (156.8 MHz). The Coast Guard may be assisted by other Federal, state or local law enforcement agencies in enforcing this regulation. If the Captain of the Port or his designated on-scene patrol personnel determines the security zone need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to suspend enforcement and grant general permission to enter the security zone.

This notice of enforcement is issued under authority of 33 CFR 165.508 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the Federal Register, the Coast Guard will provide notification of this enforcement period via the Local Notice to Mariners and marine information broadcasts.

Background Proposed Rule and Public Comment Period

On January 13, 2016, the National Park Service (NPS) published the proposed rule in the Federal Register (81 FR 1592). The rule was open for public comment for 90 days, until April 12, 2016, to coincide with scheduled meetings of the NPS Subsistence Resource Commissions and Federal Subsistence Regional Advisory Councils. The NPS invited comments through the mail, hand delivery, and through the Federal eRulemaking Portal at http://www.regulations.gov. The NPS received 27 comments on the proposed rule during the public comment period. A summary of comments and NPS responses is provided below in the section entitled “Summary of and Responses to Public Comments”. After considering the public comments and additional review, the NPS made some changes in the final rule from what was proposed. These changes are summarized below in the section entitled “Changes from the Proposed Rule”.

In 1980, Congress enacted the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 410hh-410hh-5; 3101-3233) to preserve various nationally significant areas in Alaska. One of the purposes of ANILCA is “to provide the opportunity for rural residents engaged in a subsistence way of life to continue to do so.” 16 U.S.C. 3101(c). The subsistence take of fish and wildlife on (federal) public lands is governed by Title VIII of ANILCA (16 U.S.C. 3111-3126).

Title II of ANILCA established new National Park System units, added to existing units, and specified in which units that subsistence uses shall be allowed. 16 U.S.C. 410hh-2. Subsistence uses by local rural residents in Alaska are authorized in all national preserves and in the Alagnak Wild River (managed as a national preserve), Aniakchak National Monument, Cape Krusenstern National Monument, Gates of the Arctic National Park, Kobuk Valley National Park, Lake Clark National Park, Wrangell-Saint Elias National Park, 16 U.S.C. 410hh-(1)-(4), (6)-(10); and the additions to Denali National Park, 16 U.S.C. 410hh-1(3)(a).

ANILCA defines “subsistence uses” as:

This definition reflects that the creation of hand-made crafts from nonedible natural materials has long been a part of the cultural, social, and economic practices of those living a subsistence way of life in Alaska. These individuals requested that the NPS allow this customary and traditional practice.

NPS regulations for subsistence uses in park units in Alaska are found in 36 CFR part 13, subpart F—Subsistence. The regulations authorize local rural residents to take fish and to hunt and trap wildlife in specific park units for subsistence uses in compliance with state and federal law. 36 CFR 13.470 and 13.480. The Federal Subsistence Board (FSB) regulations governing the subsistence take of fish and wildlife on federal lands in Alaska are found at 50 CFR part 100. These part 100 regulations are limited to fish, wildlife and non-migratory birds. NPS regulations regarding the non-commercial subsistence use of timber and plant materials are located at 36 CFR 13.485. The non-commercial cutting of standing timber for firewood and house logs is authorized under 36 CFR 13.485(a) while the non-commercial gathering of plant materials such as fruits, berries, and mushrooms for subsistence uses without a permit is authorized by 36 CFR 13.485(b).

The NPS regulation at 36 CFR 13.420 defining the term “barter” is derived from the statutory definition of “subsistence uses” in section 803 of ANILCA (16 U.S.C. 3113). Barter means the exchange of fish or wildlife or their parts for other fish or game or their parts; or for other food or for nonedible items other than money if the exchange is of a limited and noncommercial nature. The term ”customary trade” is limited by definition to the exchange of furs for cash, and other activities designated for a particular NPS unit by special regulation. These definitions recognize the traditional cultural, social, and economic practices of non-cash exchange of subsistence resources among those living a “genuine subsistence lifestyle”, and that trapping was an “integral and longstanding part of the subsistence lifestyle in many regions in Alaska.” See 1981 U.S. Fish and Wildlife Service interim regulations interpreting similar definitions of “barter” and “customary trade” (46 FR 31824, June 17, 1981).

Since the June 1981 rulemaking, two NPS units in Alaska where such customary trade was known to have occurred, Gates of the Arctic National Preserve and Kobuk Valley National Park, have promulgated special regulations that expand the definition of “customary trade” in those units to include the sale of handicrafts made from plant material taken by local rural residents of the park area. These special regulations do not require any written authorization from the superintendent. 36 CFR 13.1006 and 13.1504, respectively.

Except for these specific and limited authorizations for barter and customary trade of handicrafts in Gates of the Arctic National Preserve and Kobuk Valley National Park in Alaska, National Park System-wide regulations at 36 CFR 5.3 generally prohibit engaging in any business without authorization. This means that other forms of sale, barter, and trade that are customary and traditional uses of wild, renewable resources by rural Alaska residents are not allowed under current NPS regulations. In addition, National Park System-wide regulations at 36 CFR 2.1(a)(1) prohibit the collection of wildlife, plants, or parts thereof. There is a limited authorization for the hand-collection of fruits, berries, nuts, or unoccupied seashells for personal use or consumption, and a separate limited authorization for members of federally-recognized tribes to collect plants for traditional purposes under an agreement with the NPS, but the sale or commercial use of the products collected under these authorities is prohibited. 36 CFR 2.1(c) and (d).

The NPS prepared an Environmental Assessment (EA) to analyze the impacts of various alternatives that would address the collection of plant materials and nonedible animal parts to make handicrafts for barter and customary trade. On April 14, 2014, the Regional Director for the Alaska Region signed a Finding of No Significant Impact (FONSI) that selected a modified version of the preferred alternative (Alternative D) in the EA as the selected action. In the FONSI, the Regional Director determined that written authorization from the NPS would be required to collect both animal parts and plant materials for making handicrafts for barter and customary trade. On December 2, 2016, the NPS amended the FONSI to exempt plant materials from this requirement. The provisions in this rule about the capture, collection, or possession of live wildlife and restrictions on the types of bait that may be used to take bears for subsistence purposes were categorically excluded from further environmental analysis.

This rule implements the selected action identified in the amended FONSI and applies to all NPS units in Alaska where subsistence uses by local rural residents are authorized by ANILCA. The rule allows NPS-qualified local rural residents to collect and use the following items to make and sell handicrafts:

• Plant Materials; and

• nonedible animal parts (e.g., antlers, horns, bones, teeth, claws, hooves, skins, hides, fur, hair, feathers, or quills) that are naturally shed or discarded, lawfully taken, or that remain on the landscape due to the natural mortality of an animal.

While ANILCA does not expressly address making and selling of handicrafts out of plant materials, the NPS concludes it falls within this definition, and that it is not otherwise prohibited. Making and selling handicrafts out of plant materials is clearly use of a wild renewable resource for barter or customary trade. The omission of plant materials from the statute's specific provision on handicraft articles does not indicate any intent to prohibit their use. That definition provides that fish and wildlife-based handicraft articles for subsistence purposes are only made from “nonedible byproducts” to avoid the take of fish and wildlife solely for the purpose of making handicrafts out of them. Plant materials fall within the definition's more general provision of wild, renewable resources and the making and selling of plant-based handicrafts is a customary and traditional use of wild, renewable resources for barter or customary trade.

Feathers may only be collected if such collection is not prohibited by the Bald and Golden Eagle Protection Act, the Migratory Bird Treaty Act, or other applicable law. Collection and use of bird feathers remains subject to any applicable federal and state laws.

Eligibility to collect plants or nonedible animal parts follows the same criteria for other subsistence uses in national parks, monuments and preserves. Collection of nonedible wildlife parts is limited to NPS-qualified subsistence users who are residents of communities or areas with a federally recognized customary and traditional use determination (as listed in 50 CFR part 100) for each species in the game management unit within the affected area. Thus, if an NPS qualified subsistence user can lawfully harvest the wildlife species in a particular area for subsistence uses, then they are allowed to collect nonliving, nonedible parts of that same species they encounter in the area. Eligible persons must have written authorization from the superintendent to collect nonedible animal parts. The sale of raw unworked materials or parts remains prohibited because of concern about overuse and commercialization of the resource. The rule also allows NPS-qualified subsistence users to collect nonedible animal parts and plants on behalf of another NPS-qualified subsistence user or for cultural or educational programs that are qualified under FSB regulations at 50 CFR 100.25(g). The rule provides superintendents with authority to set conditions, limits, and other restrictions on collection activities to protect resources and values.

The rule allows the collection of nonedible animal parts and plants and their inclusion in handicrafts to be sold or exchanged through barter or customary trade. The regulatory definition of “barter” is amended to include exchange of handicrafts for fish or game or their parts; or for other food or nonedible items other than money if the exchange is of a limited and noncommercial nature. The regulatory definition of “customary trade” is amended to include exchange of handicrafts for cash to support personal or family needs, so long as these exchanges do not constitute a significant commercial enterprise.

The rule adds a definition of “handicraft” that is taken from the current federal subsistence regulations at 50 CFR 100.25(a). This definition clarifies that a handicraft must result from the alteration or manipulation of the shape and appearance of natural materials to create something of greater monetary or aesthetic value than the unaltered natural material alone.

In the proposed rule, the NPS stated that collecting or possessing living wildlife (including eggs and offspring) is prohibited in NPS units located in Alaska unless specifically authorized by federal statute or pursuant to (1) an NPS research specimen collection permit issued under 36 CFR 2.5; (2) federal subsistence regulations; or (3) special regulations for Glacier Bay National Park and Preserve. This proposal originated from public inquiries about the collection of live falcon chicks in national preserves that would be trained and then used for sport hunting.

The take of wildlife is generally prohibited on National Park System units. Although in Alaska hunting and trapping are allowed in national preserves in accordance with applicable federal and non-conflicting state laws and regulations, the NPS does not consider the capture or collection of live falcons to be hunting or trapping. The NPS concludes that the harvest of migratory birds (including their eggs) pursuant to the Migratory Bird Treaty Act and implementing regulations in 50 CFR part 92 is an appropriate “subsistence use” as defined in section 803 of ANILCA, 16 U.S.C. 3113. Similarly, the NPS concludes that the harvest of marine mammals in accordance with the Marine Mammal Protection Act and implementing regulations in 50 CFR part 18 by NPS-qualified subsistence users is also an appropriate “subsistence use” as defined by section 803 of ANILCA. Thus, in this final rule, the NPS clarifies the prior definition of “subsistence uses” to explicitly include harvest of migratory birds under the MBTA and the harvest of marine mammals under the MMPA by qualified individuals. Except for these subsistence uses, the final rule continues the previous prohibitions on collecting, capturing, or possessing living wildlife unless expressly authorized by federal statute or pursuant to a NPS research specimen collection permit. This rule does not affect the use of trained raptors for hunting activities where authorized by applicable federal and state law. It also does not affect the collection of gull eggs in Glacier Bay by the Huna Tlingit pursuant to Public Law 113-142, sec. 2, 128 Stat. 1749 (2014).

The NPS is adopting restrictions on the types of bait that may be used to take bears for subsistence uses under federal subsistence regulations in units of the National Park System in Alaska. Under this rule, bait is limited to (1) parts of legally taken native fish or wildlife that are not required to be salvaged; or (2) remains of native fish or wildlife that died of natural causes. The rule prohibits human-produced items such as dog food, grease, bread, and marshmallows, which are currently allowed and used to bait bears.

Baiting alters the natural behavior of bears by predictably attracting them to a specific location for harvest. The use of human-produced food as bait can result human food-conditioned bears that are more likely to be killed by agency personnel or the public in defense of life or property. Human food-conditioned bears are also more likely to cause human injury. Bait stations tend to be located in accessible areas due to the infrastructure (typically a 55 gallon drum) used for baiting, the quantity of bait used to engage in this activity, and the frequency it must be replenished. Because of the accessibility of these areas, they are typically used by multiple user groups, which contributes to the public safety concerns associated with baiting.1

The NPS recognizes that hunting black bears over bait has been authorized by the State since the 1980s. Taking brown or black bears over bait, however, is not a common activity in most NPS units in Alaska. The only NPS unit where taking bears over bait has traditionally occurred is Wrangell-St. Elias National Park and Preserve.2 The final rule has been modified to give the superintendent of Wrangell-St. Elias National Park and Preserve the discretion to allow the use of human-produced food as bait pursuant to an annual permit. Permits would only be issued upon a written finding that such use is compatible with park purposes and values and that the permit applicant does not have reasonable access to natural materials that can be used as bait under this rule. Permits will identify specific baiting locations and will not be issued for areas where user conflicts are likely (i.e., areas that receive higher visitation particularly by the nonhunting public). This provision is similar to practices at Kenai National Wildlife Refuge, where the FWS issues permits for bear baiting but only for certain areas. Permits will also help the NPS document the level of use and minimize user conflicts.

A summary of public comments received on the proposed rule and NPS responses is provided below followed by a table that sets out changes we have made to the rule based on the analysis of the comments and other considerations.

1. Comment: Some commenters asked the NPS to rescind or re-propose the rule without two of the proposed changes (the limit on types of bait that can be used to bait bears for subsistence uses and the prohibition on collecting live wildlife). The commenters stated that they were not properly notified of these changes because they are not related to subsistence collections, which was the title of the proposed rule, and were not included in the 2014 EA.

NPS Response: The NPS concludes the public was given sufficient notice for providing comments on all of the provisions in the proposed rule. In addition to publishing the proposed rule in the Federal Register, the NPS issued a press release and met with various interest groups and stakeholders during an extended 90-day comment period. Although the title of the proposed rule did not mention these other proposals, the summary on the first page of the proposed rule referred to these elements.

2. Comment: Some comments were received that said the proposed rule is inconsistent with ANILCA, which—according to the commenters—made Alaska NPS units “open unless closed.” Another commenter said the NPS does not have authority to permanently close areas to subsistence uses.

NPS Response: The commenters did not specify which section of ANILCA makes NPS units in Alaska open unless closed. NPS units are generally open to public uses unless they have been restricted or prohibited by law or regulation. The primary function of this rule is to authorize subsistence collection. This rule limits the type of bait that can be used for baiting bears, but it does not close any areas to taking fish or wildlife.

3. Comment: Some commenters stated that the proposed restrictions on bait and capturing live wildlife should have been considered by the FSB and the State of Alaska Board of Game prior to being proposed as an NPS regulation.

NPS Response: While the provisions on bait and collecting live wildlife could have been addressed by the FSB or the State, the NPS is implementing its responsibilities under ANILCA and the NPS Organic Act (54 U.S.C. 100101) using the well-established process for notice and comment rulemaking.

4. Comment: Some commenters stated there was insufficient consultation with Tribes, the State of Alaska, and the affected public. One commenter suggested the NPS should consult on the proposed rule in addition to the Environmental Assessment (EA) on subsistence collections. Another commenter suggested the NPS should consult with the State on the proposed baiting restriction since individuals are required to register bait stations with the State.

NPS Response: This rule was published for an extended comment period (90 days as opposed to 30 days) in order to coincide with scheduled meetings of the NPS Subsistence Resource Commissions and Federal Subsistence Regional Advisory Councils. NPS staff attended these meetings and gave presentations on the proposed rule. Following these presentations, several SRCs and RACs submitted formal written comments on the proposed rule. The NPS met with the State both during the comment period and after the comment period closed when the NPS was analyzing public comments and considering changes to the final rule. Specific issues addressed in those meetings included the proposed restrictions on bait for hunting bears and capturing falcon chicks, among other topics. The content of those discussions, along with written comments submitted by the State and others, helped inform this final rule. Consultation with Tribes, Native corporations, and others is addressed in the compliance section of this rule.

5. Comment: One commenter suggested retaining the reference to park-specific special regulations in the definition of customary trade. The existing definition states that the NPS can designate other activities as “customary trade” by promulgating a special regulation for a particular park unit.

NPS Response: The proposed change does not result in a substantive change to the regulations. Removing the reference to park-specific regulations in the definition of customary trade does not affect the ability of parks to establish such regulations in the future if found to be necessary.

6. Comment: Several commenters responded to the NPS's request for feedback on how the agency could better explain the phrase “significant commercial enterprise” in the definition of “customary trade”. Some commenters suggested the phrase was vague, while others stated that further defining this term was unnecessary. Some commenters suggested that “significant commercial enterprise” should not be based on the value of the handicrafts, which reflects the skill and time involved in their creation, but instead should be based upon the venue and quantity of sales (e.g., mass production and selling to a larger distributor for resale) or the use of paid employees in their production.

NPS Response: The NPS agrees that the value of the handicraft does not necessarily determine whether the sale of that handicraft is a “significant commercial enterprise.” While quantity of sales is related to the level of commercial activity, the NPS concludes that the venue where the item is sold is not relevant. The NPS also concludes that prohibiting the use of paid employees helps to ensure that handicraft production under these regulations is not a “significant commercial enterprise.” This is also consistent with an existing NPS regulation in Alaska (36 CFR 13.42(c)) that prohibits the use of employees in trapping activities in national preserves. The final rule has been modified to prohibit the use of paid employees—except by qualified educational or cultural programs—to collect plant materials and animal parts.

7. Comment: The NPS requested comment on how the term “substantially greater monetary and aesthetic value” could be further explained to provide more clarity to the public about what qualifies as a handicraft. Some commenters said this term was vague while others said no further clarification or definition was necessary. Other commenters suggested the NPS adopt the definition found in federal subsistence regulations.

NPS Response: The NPS finds it is in the best interest of the public to be consistent with federal subsistence regulations to the extent possible. The NPS has modified the definition of “handicraft” in the rule to refer to the definition used in federal subsistence regulations (50 CFR 100.25(a)). As a result, any modifications made by the FSB to this definition in the future will be automatically adopted in NPS regulation. If the FSB clarifies the term “substantially greater monetary and aesthetic value” in the definition of “handicraft”, that change will be adopted in NPS regulation without additional rulemaking by the NPS. The NPS definition of handicraft differs in two ways from the FSB definition. First, the NPS definition includes plants. Plants are not included in the definition in 50 CFR part 100 because the FSB does not have authority to regulate subsistence use of plants. Second, the NPS definition of handicraft specifically excludes trophy or European mounts of horns or antlers. Both state and federal subsistence regulations specifically prohibit the sale of trophies or mounts of horns or antlers. See 5 AAC 92.200, 50 CFR 100.25(j)(10).

8. Comment: One commenter stated that subsistence collections should be limited to Alaska Natives.

NPS Response: ANILCA provides for subsistence uses by rural residents of Alaska regardless of ethnicity. Limiting subsistence collections to Alaska Natives is inconsistent with ANILCA.

9. Comment: Several commenters objected to the requirement that subsistence users obtain written authorization for collecting animal parts and plants for the creation and sale of handicrafts.

NPS Response: The preferred alternative in the EA would require individuals to obtain a permit in order to collect plants or animal parts for the making and sale of handicrafts. In the FONSI, however, the NPS decided to require written authorization for all items except for plant materials gathered in Kobuk Valley National Park and Gates of the Arctic National Park and Preserve where existing special regulations allow this activity without written authorization. Because colleting plants for subsistence uses is already authorized by NPS regulations, the NPS has decided to let the superintendent determine whether to require written authorization for collecting plants for making handicrafts for customary trade. Because the final rule does not require written authorization for this activity, the special regulations for Kobuk Valley and Gates of the Arctic are no longer necessary and are removed.

10. Comment: Some commenters recommended the NPS issue written permission for the collection of plants and animal parts on a community-wide basis as opposed to issuing individual permits to each qualified subsistence user.

NPS Response: The written authorizations could take many forms, and they need not always be permits issued to individual subsistence users. Alternatives include written authorizations to resident zone communities or to entire resident zones, or annual authorizations documented in park compendia. Park superintendents will work with SRCs and, as appropriate, RACs, tribes and ANCSA corporations to determine the most appropriate type of written authorization for individual NPS units.

11. Comment: Some commenters said that requiring a permit or written authorization for subsistence uses was a closure. Other commenters stated that a permit requirement is burdensome and not justified in the absence of biological concerns.

NPS Response: Requiring a permit or otherwise putting conditions on an activity is not a closure. The NPS concludes that the incremental burden placed upon subsistence users to be required to obtain written authorization to collect animal parts is an appropriate and prudent mechanism for regulating the commercial use of these resources.

12. Comment: Some commenters stated that collected materials are sometimes exchanged before they reach an artist and are made into handicrafts, adding that it is too restrictive to say that materials must be modified before they can be exchanged. The commenters suggested that exchange of unworked material should be allowed to supply materials for elders to produce handicrafts and for qualified cultural and educational programs.

NPS Response: In the EA on subsistence collections, the NPS recognized that the person collecting the materials would not always be the person who uses them to make handicrafts. The final rule has been modified to clarify that permits may be issued to allow an NPS-qualified subsistence user to gather plants or animal parts for making handicrafts on behalf of another NPS-qualified subsistence user or for qualified cultural and educational programs.

13. Comment: Some commenters stated that the proposed limits on the types of bait that may be used to take bears under federal subsistence regulations would essentially eliminate the opportunity for hunters to harvest bears over bait in the spring. This is because hunters may not have access to the types of baits that would be allowed in the spring, such as parts and remains of fish and wildlife.

NPS Response: As discussed above, the NPS has made an allowance for other types of bait in certain circumstances in Wrangell-St. Elias National Park and Preserve. This is the only NPS unit where bear baiting traditionally occurred. The final rule allows for NPS qualified subsistence users who do not have reasonable access to natural bait to apply for a permit to use other types of bait. The NPS will issue this permit for specific locations in the park unit upon a finding that using other types of bait is compatible with park purposes and values (e.g. will not result in user conflicts, particularly in areas that receive higher visitation by the nonhunting public).

14. Comment: Some commenters stated that using natural bait will attract more brown bears than black bears and that hunters could end up baiting brown bears even if that was not their intent.

NPS Response: The NPS expects that natural bait will attract both brown and black bears, just as human-produced foods attract both species as well as other wildlife. The use of natural bait will help avoid conditioning brown and black bears to human-produced foods which can lead to more frequent interactions between humans and bears.

15. Comment: Some commenters stated that natural bait, such as a gut pile or furbearer carcasses, would be more difficult to clean up at the end of the baiting season than human-produced foods that are commonly used to bait bears, such as dog food or popcorn.

NPS Response: Federal subsistence regulations require that bait station sites be cleaned up when hunting is completed, including removing any litter, containers, chains, and other equipment used to set bait. The natural materials allowed by the rule—such as parts and remains of fish and wildlife—are not litter or equipment and thus would not be covered by this requirement.

16. Comment: Some commenters stated that inconsistent regulations about the types of bait that can be used will increase the possibility for confusion.

NPS Response: NPS acknowledges that this rule results in differences between the materials that can be used to harvest bears over bait under NPS-specific subsistence regulations and generally applicable federal subsistence regulations. In order to avoid the potential for confusion, the NPS will engage in outreach to local user groups, post information online, and make information available at park headquarters to inform local hunters of the rules that apply on NPS lands.

17. Comment: Some commenters stated that there is no biological data or other evidence demonstrating that baiting bears has the same effects as feeding wildlife, such as habituating bears to human foods or causing nuisance bear behavior.

NPS Response: Like feeding wildlife, baiting typically uses human or pet food to alter the natural behavior of bears to predictably attract them to a specific location for harvest. Food-conditioned bears are more likely to be killed by agency personnel or the public in defense of life or property. Food-conditioned bears are also believed more likely to cause human injury.3

18. Comment: Two commenters addressed subsistence harvest of migratory birds and their eggs, noting that the collection of eggs is allowed under the Migratory Bird Treaty Act (MBTA) and that the harvest of migratory birds and their eggs is a customary and traditional practice.

NPS Response: ANILCA authorized the harvest of fish and wildlife for subsistence uses in specific NPS units under Title VIII of ANILCA and pursuant to federal regulations applicable to NPS units. National preserves in Alaska are open to the harvest of fish and of wildlife for sport hunting and trapping under State of Alaska regulations. The FSB generally regulates subsistence harvest of fish and wildlife. It does not regulate the harvest of migratory birds for subsistence uses in Alaska which is provided for by law under the MBTA and implementing regulations at 50 CFR part 92. The NPS concludes that ANILCA's broad definition of subsistence uses authorizes NPS-qualified rural residents to harvest migratory birds, including eggs, in NPS units where subsistence is authorized in accordance with the MBTA and the migratory bird subsistence regulations at 50 CFR part 92. Collecting live wildlife, such as falcon chicks to raise and train for hunting, remains prohibited in NPS areas in accordance with national or Alaska-specific NPS regulations. 36 CFR 2.2(a)(2) or 13.35.

In considering this comment, the NPS notes that a similar issue exists with respect to harvest of marine mammals by Alaska Natives under the Marine Mammal Protection Act (MMPA). The NPS concludes that ANILCA's definition of subsistence uses includes the harvest of marine mammals by Alaskan Natives who are NPS-qualified rural residents in park areas where the take of marine mammals is authorized in accordance with the Alaska Native exemption in the Marine Mammal Protection Act and the marine mammal regulations at 50 CFR 18.23 and 18.26. The NPS has modified the definition of subsistence uses to reflect that NPS-qualified subsistence users who are eligible to harvest under the MBTA and the MMPA can do so in NPS areas open to subsistence uses.

After taking the public comments into consideration and after additional review, the NPS made the following substantive changes from the proposed rule:

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). This certification is based on the cost-benefit and regulatory flexibility analyses found in the reports entitled “Regulatory Flexibility Threshold Analysis: Special Regulations for National Park Areas in Alaska” and “Preliminary Cost/Benefit Analysis: Special Regulations for National Park Service Areas in Alaska” which can be viewed online at http://parkplanning.nps.gov/akro by clicking the link “Subsistence Uses of Horns, Antlers, Bones and Plants” and then clicking “Document List.”

This rule is not a major rule under 5 U.S.C. 804(2), the SBREFA. This rule:

a. Does not have an annual effect on the economy of $100 million or more.

b. Will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.) is not required.

This rule does not effect a taking of private property or otherwise have taking implications under Executive Order 12630. A takings implication assessment is not required.

Under the criteria in section 1 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. The proposed rule is limited in effect to federal lands managed by the NPS in Alaska and would not have a substantial direct effect on state and local government in Alaska. A Federalism summary impact statement is not required.

This rule complies with the requirements of Executive Order 12988. Specifically, this rule:

(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The Department of the Interior strives to strengthen its government-to-government relationship with federally recognized Tribes through a commitment to consultation with Tribes and recognition of self-governance and Tribal sovereignty. We have evaluated this rule under the criteria in Executive Order 13175 and under the Department's tribal consultation policy and Alaska Native Claims Settlement Act (ANCSA) Corporations consultation policy. Tribes were notified of the proposal regarding the subsistence collections provisions early in the process of developing the regulation. Because the provision on taking live wildlife is not a new prohibition, it will not have a substantial direct effect on federally recognized Tribes or ANCSA Corporation lands, water areas, or resources. The NPS concludes that the types of bait local rural residents can use for hunting bears will not have a substantial direct effect on federally recognized Tribes or ANCSA Corporation lands, water areas, or resources. This is based on previous consultation with Tribes on proposed restrictions related to taking wildlife, the limited nature of the restriction (hunting bears, including over bait, remains authorized), and the infrequent basis that local rural residents take bears over bait on NPS lands (records show three bears taken over bait by local rural residents between 1992-2010). Most of this limited activity has occurred in Wrangell-St. Elias National Park and Preserve. Tribes associated with Wrangell-St. Elias National Park and Preserve where invited to consult on the proposed bait restriction; no Tribes requested consultation.

This final rule does not contain any new collections of information that require approval by Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. Information collection requirements associated with the requirement for the Superintendent's written authorization to collect nonedible animal parts and for the designated gatherer permit are covered under OMB Control Number 1024-0026 (expires 12/31/2016 and in accordance with 5 CFR 1320.10, the agency may continue to conduct or sponsor this collection of information while the submission is pending at OMB). We estimate the annual burden associated with this information collection to be 2.5 hours per year. Information collection requirements associated with FSB customary and traditional use determinations have been approved under OMB Control Number 1018-0075 (expires 06/30/2019). We 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.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because we reached the FONSI. The EA and amended FONSI are available online at http://parkplanning.nps.gov/akro by clicking the link “Subsistence Uses of Horns, Antlers, Bones and Plants” and then clicking “Document List.” The other parts of this rule (collection/capture of live wildlife, bear baiting under federal subsistence regulations) are excluded from the requirement to prepare a detailed statement because they fall within the categorical exclusion covering modifications to existing regulations for NPS-administered areas that do not (a) increase public use to the extent of compromising the nature and character of the area or cause physical damage to it; (b) introduce non-compatible uses that might compromise the nature and characteristics of the area or cause physical damage to it; (c) conflict with adjacent ownerships or land uses; or (d) cause a nuisance to adjacent owners or occupants. (For further information see Section 3.3 of Director's Order #12 Handbook). We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects is not required.

The primary authors of this regulation are Mary McBurney and Andee Sears of the Alaska Regional Office, National Park Service; Barbara Cellarius of Wrangell-St. Elias National Park and Preserve, National Park Service; and Jay Calhoun and Russel J. Wilson of the Division of Regulations, Washington Support Office, National Park Service.

In consideration of the foregoing, the National Park Service amends 36 CFR part 13 as set forth below:

I. Background

Since 1990, Federal agencies have been required to issue regulations adjusting for inflation the statutory civil penalties 1 that can be imposed under the laws administered by that agency. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 (DCIA), required agencies to review their statutory civil penalties every 4 years, and to adjust the statutory civil penalty amounts for inflation if the increase met the DCIA's adjustment methodology. In accordance with the DCIA, EPA reviewed and, as appropriate, adjusted the civil penalty levels under each of the statutes the agency implements in 1996 (61 FR 69360), 2004 (69 FR 7121), 2008 (73 FR 75340), and 2013 (78 FR 66643).

The 2015 Act 2 requires agencies to: (1) Adjust the level of statutory civil penalties with an initial “catch-up” adjustment through an interim final rulemaking; and (2) beginning January 15, 2017, make subsequent annual adjustments for inflation. The purpose of the 2015 Act is to maintain the deterrent effect of civil penalties by translating originally enacted statutory civil penalty amounts to today's dollars and rounding statutory civil penalties to the nearest dollar.

As required by the 2015 Act, EPA issued a catch up rule on July 1, 2016, which was effective August 1, 2016 (81 FR 43091). This rule implements the annual penalty inflation adjustments mandated by the 2015 Act. Beginning in 2017, Section 4 of the 2015 Act requires each federal agency to publish annual adjustments to all civil penalties under the laws implemented by that agency. These annual adjustments are required to be published by January 15 of each year. The 2015 Act describes the method for calculating the adjustments. Each statutory maximum civil monetary penalty is multiplied by the cost-of-living adjustment, which is the percentage by which the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October 2016 exceeds the CPI-U for the month of October 2015.

With this rule, the new statutory maximum (or minimum 3 ) penalty levels listed in Table 2 to 40 CFR 19.4 will apply to all statutory civil penalties assessed on or after January 15, 2017, for violations that occurred after November 2, 2015, when the 2015 Act was enacted. The statutory civil penalty levels, as codified at Table 1 to 40 CFR 19.4, will continue to apply to: (1) Violations that occurred on or before November 2, 2015, and (2) violations that occurred after November 2, 2015, where the penalty assessment was made prior to August 1, 2016.

The formula for determining the cost-of-living or inflation adjustment to statutory civil penalties consists of the following steps:

Step 1: The cost-of-living adjustment multiplier for 2017, based on the CPI-U of October 2016, is 1.01636.4 Multiply 1.01636 by the current penalty amount. This is the raw adjusted penalty value.

Step 2: Round the raw adjusted penalty value. Section 5 of the 2015 Act states that any adjustment shall be rounded to the nearest multiple of $1. The result is the final penalty value for the year.

Section 4 of the 2015 Act directs federal agencies to publish annual adjustments no later than January 15, 2017. In accordance with section 553 of the Administrative Procedures Act (APA), most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the Federal Register. However, Section 4(b)(2) of the 2015 Act provides that each agency shall make the annual inflation adjustments “notwithstanding section 553” of the APA. According to OMB guidance issued to Federal agencies on the implementation of the 2017 annual adjustment,5 the phrase “notwithstanding section 553” means that “the public procedure the APA generally provides—notice, an opportunity for comment, and a delay in effective date—is not required for agencies to issue regulations implementing the annual adjustment.” Consistent with the language of the 2015 Act and OMB's implementation guidance, this rule is not subject to notice and an opportunity for public comment and will be effective immediately upon publication.

Under Executive Order 12866, OMB determined this final rule to be a “non-significant” regulatory action and, therefore, it did not undergo interagency review.6

I. Background and Overview

On June 2, 2010 (75 FR 35520, June 22, 2010), EPA revised the primary SO2 NAAQS to an hourly standard of 75 parts per billion (ppb) based on a 3-year average of the annual 99th percentile of 1-hour daily maximum concentrations. Pursuant to section 110(a)(1) of the CAA, states are required to submit SIPs meeting the applicable requirements of section 110(a)(2) within three years after promulgation of a new or revised NAAQS or within such shorter period as EPA may prescribe. Section 110(a)(2) requires states to address basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. States were required to submit such SIPs for the 2010 1-hour SO2 NAAQS to EPA no later than June 2, 2013.

EPA is taking final action to approve Alabama's April 23, 2013, submission that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2010 1-hour SO2 NAAQS, with the exception of interstate transport provisions pertaining to visibility protection requirements of section 110(a)(2)(D)(i)(II) (prong 4) and the state board requirements of section 110(a)(2)(E)(ii). With respect to the visibility protection requirements of section 110(a)(2)(D)(i)(II) (prong 4), EPA is not finalizing any action at this time regarding this requirement. With respect to Alabama's infrastructure SIP submission related to section 110(a)(2)(E)(ii) requirements respecting the section 128 state board requirements, EPA is finalizing a disapproval of this element of Alabama's submission in this rulemaking.

In a proposed rulemaking published on July 14, 2016, EPA proposed to approve in part and disapprove in part Alabama's 2010 1-hour SO2 NAAQS infrastructure SIP submission submitted on April 23, 2013. See 81 FR 45428. The details of Alabama's submission and the rationale for EPA's actions are explained in the proposed rulemaking. Comments on the proposed rulemaking were due on or before August 15, 2016. EPA received adverse comments on the proposed action.

EPA received two sets of comments, one of which was incomplete and therefore could not be addressed, on the July 14, 2016, proposed rulemaking on Alabama's 2010 1-hour SO2 NAAQS infrastructure SIP submission. A summary of the complete comment and EPA's response is provided below. A full set of these comments is provided in the docket for today's final rulemaking action.

Comment: The Commenter stated that EPA must disapprove element 110(a)(2)(C) unless Alabama's SIP provides that no new minor source or minor modification of a major source can cause or contribute to a violation of any NAAQS.

Response: EPA agrees that section 110(a)(2)(C) and the minor new source regulations at 40 CFR 51.160 through 51.164 require SIPs to includes procedures to prevent the construction of new minor sources and minor modifications of major sources if the new or modified source will interfere with attainment or maintenance of a NAAQS. EPA explained its approach to reviewing the minor source element of 110(a)(2)(C) in its proposed rulemaking for this action: “Thus, EPA evaluates whether the state has an EPA-approved minor NSR program and whether the program addresses the pollutants relevant to that NAAQS. In the context of acting on an infrastructure SIP submission, however, EPA does not think it is necessary to conduct a review of each and every provision of a state's existing minor source program (i.e., already in the existing SIP) for compliance with the requirements of the CAA and EPA's regulations that pertain to such programs.” See 81 FR 45431-45432 (July 14, 2016). In its 2010 1-hour SO2 NAAQS infrastructure SIP submission, Alabama certified that its SIP contains provisions to address the 110(a)(2)(C) requirements regarding new minor sources and modifications, and, as noted in EPA's proposed rulemaking, the following SIP-approved rules address the minor source element of section 110(a)(2)(C): ADEM Admin. Code r. 335-3-14-.01 General Provisions, 335-3-14-.02 Permit Procedure, and 335-3-14-.03—Standards for Granting Permits. These SIP-approved rules address NAAQS pollutants including SO2. While the Commenter did not specifically object to any aspect of Alabama's SIP submission with respect section 110(a)(2)(C), EPA notes that Alabama's SIP addresses this non-interference component for the minor new source/minor modification permitting element. Specifically relevant to this comment, these SIP-approved rules include provisions to prohibit the issuance of construction permits if the source at issue would result in a violation of any air quality standard. See ADEM Admin. Code r. 335-3-14-.03(1)(g).

With the exception of interstate transport provisions pertaining to visibility protection requirements of section 110(a)(2)(D)(i)(II) (prong 4), and the state board requirements of section 110(a)(2)(E)(ii), EPA is taking final action to approve Alabama's infrastructure submission submitted on April 23, 2013, for the 2010 1-hour SO2 NAAQS for the above described infrastructure SIP requirements. EPA is taking final action to approve Alabama's infrastructure SIP submission for the 2010 1-hour SO2 NAAQS because the submission is consistent with section 110 of the CAA. EPA is finalizing disapproval of section 110(a)(2)(E)(ii) of Alabama's infrastructure submission because the State's implementation plan does not contain provisions to comply with section 128 of the Act, and thus Alabama's April 23, 2013, infrastructure SIP submission does not meet the requirements of the Act.

Under section 179(a) of the CAA, final disapproval of a submittal that addresses a requirement of a CAA Part D Plan, or is required in response to a finding of substantial inadequacy as described in CAA section 110(k)(5) (SIP call), starts a sanctions clock. The portion of section 110(a)(2)(E)(ii) provisions (the provisions disapproved in today's notice) were not submitted to meet requirements for Part D or a SIP call, and therefore, no sanctions will be triggered. However, that final action will trigger the requirement under section 110(c) that EPA promulgate a Federal Implementation Plan (FIP) no later than two years from the date of this disapproval unless the State corrects the deficiency, and EPA approves the plan or plan revision before EPA promulgates such FIP.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. See 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 Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• 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 SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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 March 13, 2017. 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:

I. Background and Overview

On February 9, 2010 (75 FR 6474), EPA published a new 1-hour primary NAAQS for NO2 at a level of 100 parts per billion (ppb), based on a 3-year average of the 98th percentile of the yearly distribution of 1-hour daily maximum concentrations. Pursuant to section 110(a)(1) of the CAA, states are required to submit SIPs meeting the requirements of section 110(a)(2) within three years after promulgation of a new or revised NAAQS or within such shorter period as EPA may prescribe. Section 110(a)(2) requires states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance of the NAAQS. States were required to submit such SIPs for the 2010 1-hour NO2 NAAQS to EPA no later than January 22, 2013.

In a proposed rulemaking published on July 14, 2016, EPA proposed to approve Tennessee's infrastructure SIP submission for the applicable requirements of the 2010 1-hour NO2 NAAQS, with the exception of the PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of D(i), and (J), and the interstate transport provisions of prongs 1, 2, and 4 of section 110(a)(2)(D)(i). On March 18, 2015, EPA approved Tennessee's March 13, 2014, infrastructure SIP submission regarding the PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of D(i), and (J) for the 2010 1-hour NO2 NAAQS. See 80 FR 14019. Therefore, EPA is not taking any action today pertaining to these requirements. With respect to the interstate transport requirements of section 110(a)(2)(D)(i)(I) (prongs 1 and 2), EPA does not yet have a submission before the Agency for action. Additionally, EPA will address prong 4 element of Tennessee's March 13, 2014, SIP submission for the 2010 1-hour NO2 NAAQS through a separate rulemaking. The details of Tennessee's submission and the rationale for EPA's action are explained in the proposed rulemaking.

Comments on the proposed rulemaking were due on or before July 28, 2016. EPA received one comment, which is summarized below, on the proposed action.

Comment: The Commenter stated that EPA must disapprove element 110(a)(2)(C) unless Tennessee's SIP provides that no new minor source or minor modification of a major source can cause or contribute to a violation of any NAAQS.

Response: EPA agrees that section 110(a)(2)(C) and the minor new source regulations at 40 CFR 51.160 through 51.164 require SIPs to includes procedures to prevent the construction of new minor sources and minor modifications of major sources if the new or modified source will interfere with attainment or maintenance of a NAAQS. EPA explained its approach to reviewing the minor source element of 110(a)(2)(C) in its proposed rulemaking for this action: “EPA evaluates whether the state has an EPA-approved minor new source review program and whether the program addresses the pollutants relevant to that NAAQS. In the context of acting on an infrastructure SIP submission, however, EPA does not think it is necessary to conduct a review of each and every provision of a state's existing minor source program (i.e., already in the existing SIP) for compliance with the requirements of the CAA and EPA's regulations that pertain to such programs.” See 81 FR 45441 (July 14, 2016). In its 2010 1-hour NO2 NAAQS infrastructure SIP submission, Tennessee certified that its SIP contains provisions to address the 110(a)(2)(C) requirements regarding new minor sources and modifications, and, as noted in EPA's proposed rulemaking, the following SIP-approved rules address the minor source element of section 110(a)(2)(C): Tennessee Air Pollution Control Regulations 1200-03-09-.01, Construction Permits, and 1200-03-09-.03, General Provisions. These SIP-approved rules address NAAQS pollutants including NO2. While the Commenter did not specifically object to any aspect of Tennessee's SIP submission with respect section 110(a)(2)(C), EPA notes that Tennessee's SIP addresses this non-interference component for the minor new source/minor modification permitting element. Specifically relevant to this comment, these SIP-approved rules include provisions to prohibit the issuance of construction permits if the source at issue would result in a violation of any air quality standard. See Regulation 1200-03-09-.01(1)(e).

With the exception of the preconstruction PSD permitting requirements for major sources of section 110(a)(2)(C), prong 3 of (D)(i), and (J), and the interstate transport provisions pertaining to visibility of prong 4 of section 110(a)(2)(D)(i), EPA is taking final action to approve that Tennessee's March 13, 2014, SIP submission for the 2010 1-hour NO2 NAAQS because the submission is consistent with section 110 of the CAA.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. See 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 Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• 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 SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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 March 13, 2017. 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).

For the reasons stated in the preamble, 40 CFR part 52 is amended as follows:

I. Executive Summary A. Who does this action apply to?

You may be potentially affected by this action if you manufacture or process or intend to manufacture or process nanoscale forms (forms with particle sizes of 1-100 nm) of certain chemical substances as defined in section 3 of TSCA. You are not manufacturing or processing a TSCA chemical substance when you are manufacturing or processing a chemical for use as, e.g., a pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act), food, food additive, drug, cosmetic or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act). However, persons that manufacture or process, or intend to manufacture or process these chemical substances as part of articles, as impurities, or in small quantities solely for research and development will not be subject to this action. In addition, the discussion in Unit III. describes in more detail which chemical substances will and will not be subject to reporting under the rule. You may also consult 40 CFR 704.3 and 704.5, as well as the regulatory text in this document, for further information on the applicability of these and other exemptions to this rule.

The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document may apply to them:

• Chemical Manufacturing or Processing (NAICS codes 325).

• Synthetic Dye and Pigment Manufacturing (NAICS code 325130).

• Other Basic Inorganic Chemical Manufacturing (NAICS code 325180).

• Rolled Steel Shape Manufacturing (NAICS code 331221).

• Semiconductor and Related Device Manufacturing (NAICS code 334413).

• Carbon and Graphite Product Manufacturing (NAICS code 335991).

• Home Furnishing Merchant Wholesalers (NAICS code 423220).

• Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS code 423330).

• Metal Service Centers and Other Metal Merchant Wholesalers (NAICS code 423510).

On April 6, 2015 (80 FR 18330; FRL-9920-90) (Ref. 1), EPA proposed reporting and recordkeeping requirements for persons that manufacture (including import) or process certain chemical substances as described in the proposed rule. EPA received numerous public comments and conducted a public meeting on June 11, 2015 to obtain additional public input. This final rule is based on that proposal and the consideration of the public comments received.

This TSCA section 8(a) rule requires one-time reporting of certain information, including specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety information; as well as keeping records of this information for 3 years. EPA is finalizing the proposed requirements with changes to the definition of a reportable chemical substance, including a definition of unique and novel properties and a numerical value to replace the proposed term of trace amounts. There are also additional exemptions to reporting for certain biological materials, while zinc oxide and nanoclays are no longer exempt from reporting. The definition of a small manufacturer or processor exempt from reporting requirements has been changed. These changes, the reasons for the changes, and other clarifications are discussed in more detail in Unit III. EPA has also prepared a detailed response to public comments document (Ref. 2) that is available in the docket. EPA's responses to some of those comments are summarized in Unit III.

These reporting and recordkeeping requirements will assist EPA in its continuing evaluation of chemical substances manufactured at the nanoscale, informed by available scientific, technical and economic evidence. As with current new chemical reviews of chemical substances manufactured at the nanoscale, each nanoscale material derived from substances on the TSCA inventory would be evaluated on a case-by-case basis without a presumption of either harm or safety. Any evaluation will be based on the specific nanoscale material's own properties and those of any structural analogs.

As indicated in the proposed rule, the requirements of the rule are not based on an assumption that nanoscale materials as a class, or specific uses of nanoscale materials, necessarily give rise to or are likely to cause harm to people or the environment. Rather, any information gathered under this rule will facilitate EPA's determination of whether further action, including additional information collection, is needed for that specific nanoscale material. Consistent with the President's memorandums for Executive Agencies regarding Principles for Regulation and Oversight of Emerging Technologies and U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials (Ref. 3), this rule will facilitate assessment of risks and risk management, examination of the benefits and costs of further measures, and making future decisions based on available scientific evidence.

In addition, EPA will not publish an inventory of chemical substances manufactured at the nanoscale based on the information that will be collected pursuant to the rule. EPA will make non-confidential information reported under the rule available in ChemView (see http://www.epa.gov/chemview/).

As described in more detail in Unit II.A. of the proposed rule, the Toxic Substances Control Act as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA), 15 U.S.C. 2601 et seq., provides EPA with authority to require reporting, recordkeeping and testing, and impose restrictions relating to chemical substances and/or mixtures. The Government Paperwork Elimination Act (GPEA), 44 U.S.C. 3504, provides that, when practicable, Federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public.

EPA is issuing this rule under TSCA section 8(a), 15 U.S.C. 2607(a), in compliance with the requirements of section 8(a)(5). Under TSCA section 8(a)(5)(A) EPA is to the extent feasible: (A) Not require reporting which is unnecessary or duplicative; (B) minimize the cost of compliance with this section and the rules issued thereunder on small manufacturers and processors; and (C) apply any reporting obligations to those persons likely to have information relevant to the effective implementation of TSCA. As noted in the response to comments several elements of this rule address duplicative reporting such as the exemption for chemical substances that are nanoscale materials that have already been reported under section 5 of TSCA and for the exemption for information already submitted under the Nanoscale Materials Stewardship Program. The response also explains why this rule does not duplicate chemical data reporting (CDR) under 40 CFR part 711. EPA's economic analysis demonstrated that this rule would not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is summarized in Unit V.C. of this rule and is presented in the small entity impact analysis that EPA prepared for this action as part of the Agency's economic analysis in the public docket for this rule. This rule focuses on manufacturers and processors of chemical substances as nanoscale materials with unique and novel properties which are the persons likely to have relevant information on nanoscale materials in commerce.

EPA has evaluated the potential costs of this reporting and recordkeeping requirement for manufacturers and processors. This analysis (Ref. 4), which is available in the docket, is briefly summarized here.

Industry is conservatively estimated to incur a burden of approximately 360,000 hours in the first year and 40,100 hours in subsequent years, with costs of approximately $27.79 million and $3.09 million, respectively (see Chapter 3 in Ref. 4), while the Agency is expected to use approximately 16,300 hours in the first year and 1,800 hours in subsequent years, with costs of approximately $1.34 million and $0.15 million respectively (see Chapter 4 in Ref. 4). Discounted over a 10-year period at three and seven percent, total annualized social costs are estimated to be approximately $5.71 million and $6.26 million, respectively. (Ref. 4).

EPA is describing in this unit the reporting and recordkeeping requirements for manufacturers and processors of certain chemical substances pursuant to TSCA section 8(a). A processor is someone who prepares a chemical substance or mixture after its manufacture for distribution in commerce. Processor activities include a variety of activities. Some examples of processing of a chemical substance are developing or modifying formulations for additional processing or use in commercial applications, incorporating a chemical substance into articles, and using the chemical substance to form other chemical substances.

1. Reportable chemical substances. This rule applies to chemical substances, as defined in section 3 of TSCA, that are solids at 25 °C and standard atmospheric pressure; that are manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of 1-100 nanometers (nm) in at least one dimension; and that are manufactured or processed to exhibit one or more unique and novel properties. This rule does not apply to chemical substances manufactured or processed in forms that contain less than 1% by weight of any particles, including aggregates and agglomerates, in the size range of 1-100 nm. These parameters are for purposes of identifying chemical substances that are subject to the rule and do not establish a definition of nanoscale material.

EPA added a definition of unique and novel properties in the definitions section of the regulatory text (See 704.20(a)). Unique and novel properties means any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance, and such properties are a reason that the chemical substance is manufactured or processed in that form or size. A reportable chemical substance is not just a substance containing particles in the size range of 1-100 nm; it must also demonstrate a size-dependent property different from properties at sizes greater than 100 nm and is a reason the chemical is manufactured or processed in that form or size. Chemical substances manufactured or processed at the nanoscale that contain incidental amounts of particles in the size range of 1-100 nm are not reportable chemical substances. EPA used “trace amounts” in the proposed rule to define this concept. However, based on the public comments to better define trace amounts including several comments to establish a numerical value, EPA is now using a numerical value of less than 1% of particles from 1-100 nm by weight to define those chemical substances that are not reportable.

i. Discrete forms. Manufacturers and processors of multiple nanoscale forms of the same chemical substance will, in some cases, need to report separately for each discrete form of the reportable chemical substance. Reporting of these discrete forms are not the same as new chemical reporting under TSCA section 5. The rule distinguishes between discrete forms in three different ways. The first is based on a combination of three factors: (1) A change in process to effect a change in size, a change in properties of the chemical substances manufactured at the nanoscale, or both; (2) a change in mean particle size greater than 7 times the standard deviation of the measured values (±7 times the standard deviation); and (3) the change in at least one of the following properties, zeta potential, specific surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of the measured values (±7 times the standard deviation).

For example, if the specific surface area of one discrete form was measured to be 50 m2/g with a standard deviation of ±5 m2/g, then a change resulting in a new average specific surface area of 85 m2/g would result in a discrete form of a reportable chemical substance, if factors 1 and 2 were also met. While testing is not required, if performing the test EPA recommends using the same test medium and method when measuring the change in these properties, as even minor changes in the medium and methods can result in large differences in the measured results. EPA's intent for these reporting requirements is to focus reporting on chemical substances on the TSCA inventory that are intentionally manufactured at the nanoscale.

It is the combination of the above three factors, rather than simply size, which distinguishes between different forms of a chemical substance manufactured at the nanoscale, so that unintended variation in size range between production batches does not trigger separate reporting for each batch. The rule does not rely solely on process changes because there may be process changes that are not intended to change the material produced, but rather are intended to improve the efficiency of the process or to use a less expensive reactant. EPA is focusing on the properties of zeta potential, specific surface area, dispersion stability, and surface reactivity because these properties are of particular interest in health and safety evaluation. Other properties of chemical substances manufactured at the nanoscale (e.g., the wavelength at which light is emitted) may be important for how that form of the chemical substance functions but are less likely to be relevant to hazard, fate, exposure, or risk. The combination of the above three factors provides a clear and transparent way to distinguish among discrete forms of chemical substances manufactured at the nanoscale for purposes of TSCA section 8(a) reporting.

For the purposes of this rule, specific surface area is the ratio of the surface area of the nanoscale material to its mass (m2/kg), or the area of the surface of the nanoscale material divided by volume (m2/m3). This is an important factor because chemical reactions take place at the surface of the material. Thus, the higher the surface area, the greater the chemical reactivity, which is an important consideration for human health toxicity and environmental toxicity assessments.

Zeta potential is the electrostatic potential near the particle surface. It can be measured using various methods. See the International Organization for Standardization (ISO) ISO/TR 13014:2012 “Guidance on Physicochemical Characterization for Manufactured Nano-objects Submitted for Toxicological Testing” (Ref. 5) and the description of zeta potential by Colloidal Dynamics (Ref. 6) for examples. It is typically measured by electrophoresis. This is also an important factor as it measures chemical reactivity at the particle surface.

Dispersion stability is the ability of a dispersion to resist changes in properties over time and can be defined in terms of the change in one or more physical properties over a given time period. See ISO/TR 13097:2013 “Guidelines for characterization of dispersion stability” (Ref. 7) as an example. Changes in dispersion stability affect physical properties that in turn can affect the environmental fate and hazard properties of a chemical substance.

Surface reactivity is the degree to which the nanoscale material will react with biological systems. The surface reactivity of the form of a chemical substance is dependent upon factors such as redox potential, which is a measure of the tendency of a chemical species to lose or acquire electrons, and photocatalytic activity, including the potential to generate free radicals. Reactive oxygen species and free radicals are important in considering toxicity for these materials.

The second way of distinguishing a discrete nanoscale form of a particular chemical substance is by morphology or shape. Examples include spheres, rods, ellipsoids, cylinders, needles, wires, fibers, cages, hollow shells, trees, flowers, rings, tori, cones, and sheets. The third way is that forms of a reportable chemical substance that are coated with different chemical substances would be considered discrete forms for each chemical coating.

ii. Chemical mixtures. Chemical substances that are manufactured or processed in a nanoscale form for the purposes of being sold to others for use as a component of a mixture, encapsulated material, or composite are subject to reporting. Chemical substances at the nanoscale that are manufactured but are then incorporated into mixtures, encapsulated materials or composites by that manufacturer do not require separate reporting for their incorporation. However, the person reporting as to the chemical substance must report the information required as to each step of its manufacture, processing and use to the extent it is known or reasonably ascertainable.

2. Substances excluded from reporting. EPA is excluding from the requirements of this rule certain biological materials including DNA, RNA, proteins, enzymes, lipids, carbohydrates, peptides, liposomes, antibodies, viruses, and microorganisms.

EPA is excluding chemical substances which dissociate completely in water to form ions with a size of less than 1 nm. This exclusion does not apply to chemical substances manufactured at the nanoscale that release ions but do not dissociate in water to form those ions. Chemical substances that dissociate completely in water to form ions with a size of less than 1 nm do not exhibit new size-dependent properties because the same properties would manifest in the dissociated form regardless of whether the substance is at the nanoscale before dissociation. Manufacturing or processing such substances are therefore not subject to the reporting requirements of the rule.

EPA is excluding chemical substances formed at the nanoscale as part of a film on a surface. See the explanation in Unit III. for the changes from the proposed rule and the detailed response to comments in the docket for EPA's explanation and reasoning.

3. General exemptions to TSCA Section 8(a) reporting. The general exemptions to TSCA section 8(a) reporting at 40 CFR 704.5 are applicable to this rule. These include, among other exemptions, the exemption for research and development (R&D) under which a person who manufactures or processes a chemical substance only in small quantities for research and development is exempt from the reporting requirements of this rule. Examples of R&D activity are the analysis of the chemical or physical characteristics, the performance, or the production characteristics of a chemical substance. It can include production of a chemical substance for use by others in their R&D activities. R&D activity generally includes specific monitored tests undertaken as part of a planned program of activity.

There is also an exemption from reporting for TSCA section 8(a) rules for small manufacturers and processors. For purposes of this rule EPA is defining and exempting any small manufacturer or processor as a company that has sales of less than $11 million per year.

4. Other exceptions to reporting. The rule does not require manufacturers or processors to report certain information that has already been submitted to EPA. A person who submitted a notice under TSCA section 5 to EPA for a reportable chemical substance on or after January 1, 2005 is not required to report regarding the same substance under this rule, except where the person manufactured or processed a new discrete form of the reportable chemical substance. In addition, any person who has already reported part of or all of the information that is required under this rule for EPA's Nanoscale Materials Stewardship Program (NMSP) would not need to report that information again under this rule. If, however, information required by this rule was not reported under the NMSP (including information for each discrete form of a reportable chemical substance), then reporting of that information would be required under this rule. The purpose of these exemptions is to avoid duplicative reporting. For example, new chemical notices under TSCA section 5 that have been reviewed by EPA as nanoscale materials are not subject to reporting for the discrete form of a reportable chemical substance that was submitted and reviewed.

Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the final effective date of this rule must report to EPA one year after the final effective date of the rule. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule. These persons must report to EPA at least 135 days before manufacture or processing of that discrete form except where the person has not formed an intent to manufacture or process a discrete form of a reportable chemical substance 135 days before such manufacturing or processing, in which case the information must be filed within 30 days of the formation of such an intent. For example, if a person forms the intent on July 1 to manufacture a reportable chemical substance and intends to commence manufacture of the substance in less than 135 days, that person must report the required information as to the chemical substance no more than 30 days after forming the intent, which would be July 31.

This rule requires one-time reporting of certain information, including specific chemical identity, actual or anticipated production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety information.

EPA developed a form (Ref. 8) for reporting information including specific chemical identity, material characterization, physical chemical properties, production volume, use, methods of manufacturing and processing, exposure and release information, and existing information concerning environmental and health effects. Any person required to report under this rule must supply the information identified in the form to the extent it is known to or reasonably ascertainable by them. EPA intends to issue guidance for the final rule within six months of issuing the rule including guidance on the reasonably ascertainable standard, consolidating submissions and generic chemical names.

The rule requires electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA (see 704.20(e)). Submitters will use EPA's CDX, the Agency's electronic reporting portal, for all reporting under this rule. In 2013, EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d). (Ref. 9) The final rule follows two previous rules requiring similar electronic reporting of information submitted to EPA for TSCA Chemical Data Reporting and for Pre-Manufacture Notices. EPA expects that electronic reporting will save time, improve data quality and increase efficiencies for both the submitters and the Agency.

EPA developed the Chemical Information Submission System (CISS) for use in submitting data for TSCA sections 4, 8(a), and 8(d) electronically to the Agency. The web reporting tool is available for use with Windows, iOS, Linux, and UNIX based computers, using “Extensible Markup Language” (XML) specifications for efficient data transmission across the Internet. CISS, a web-based reporting tool, provides user-friendly navigation, works with CDX to secure online communication, creates a completed document in Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other information to be submitted easily as PDF attachments, or by other electronic standards, such as XML.

EPA is requiring submitters to follow the same submission procedures used for other TSCA submissions, i.e., to register with EPA's CDX (if not already registered) and use CISS to prepare a data file for submission. Registration enables CDX to authenticate identity and verify authorization. To submit electronically to EPA via CDX, individuals must first register with that system at http://cdx.epa.gov/epa_home.asp. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private Key Holder”) agrees to the Terms and Conditions, provides information about the submitter and organization, selects a user name and password, and follows the procedures outlined in the guidance document for CDX available at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf.

Users who have previously registered with CDX for other TSCA submissions, Chemical Data Reporting, or the Toxics Release Inventory TRI-ME web reporting flow, can add the “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX flow to their current registration, and use the CISS web-based reporting tool.

All submitters must use CISS to prepare their submissions. CISS guides users through the process of creating an electronic submission. Once a user completes the relevant data fields, attaches appropriate PDF files, or other file types, such as XML files, and completes metadata information, CISS validates the submission by performing a basic error check and makes sure all the required fields and attachments are provided and complete. Further instructions on submitting and instructions for uploading PDF attachments or other file types, such as XML, and completing metadata information are available through CISS reporting guidance.

CISS allows the user to choose “Print,” “Save,” or “Transmit through CDX.” When “Transmit through CDX” is selected, the user is asked to provide the user name and password that was created during the CDX registration process. CISS then encrypts the file and submits it via CDX. The user will log in to the application and check the status of their submissions. Upon successful receipt of the submission by EPA, the status of the submissions will be flagged as “Completed.” The CDX inbox is currently used to notify the users of any correspondence related to user registration. Information on accessing the CDX user inbox is provided in the guidance document for CDX at http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf. To access CISS go to https://cdx.epa.gov/ssl/CSPP/PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and for further instructions to go http://www.epa.gov/oppt/chemtest/ereporting/index.html. Procedures for reporting chemical substances under this rule are similar.

Any person submitting a reporting form could claim any of the information on the form as CBI. Any information which is claimed as confidential will be disclosed by EPA only to the extent and by the means of the procedures set forth in 40 CFR part 2.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016, and became immediately effective. This final rule contains one minor change to reflect the new statutory requirements for asserting confidentiality claims. Section 14(c)(1)(B) of the law now requires a supporting statement for confidentiality claims. This statement is similar to the certification currently required in 40 CFR 704.7, which is cross-referenced in the proposed rule. In this final rule, EPA is substituting the wording of the section 14(c)(1)(B) statement for the wording of the certification in § 704.7(d) so as to eliminate any possibility of doubt that the certification meets the statutory requirements. While this change was not discussed in the proposed rule, EPA finds there is good cause to make this change without notice and comment. Notice and comment are unnecessary because the new statement is required by statute, and the new language is sufficiently similar to that in the § 704.7(d) certification that EPA anticipates no significant effect of the change on companies reporting under the rule or on the public in general.

The law also requires that a generic chemical identity be provided when companies claim a specific chemical identity as confidential. No conforming change is necessary for this rule, because companies reporting under this rule will be claiming chemical identities as confidential only when there is already a generic identity on the confidential portion of the TSCA Chemical Substances Inventory. CISS will automatically populate the submission with the generic chemical name associated with the Inventory listing. This process provides the greatest degree of structural specificity that is practicable to afford at the current time. EPA will develop guidance regarding generic names as required by TSCA, and will determine appropriate procedures regarding their use and submission.

This unit summarizes EPA's responses to comments for several general areas of comments from multiple stakeholders, and where responses are particularly relevant to the requirements of the final rule. EPA also discusses any changes to and clarifications from the proposed rule. A separate document that summarizes the comments relevant to the proposal and EPA's responses to those comments has been prepared and is available in the docket for this rulemaking (Ref. 2).

Comment 1: Several commenters stated that TSCA applies to chemical substances, not different physical forms or different particle sizes of chemical substances, and that discrete forms or discrete physical forms are not “chemical substances” subject to reporting under section 8(a) of TSCA.

Response: TSCA section 8(a) authorizes EPA to promulgate rules for submission of such reports as the Agency “may reasonably require.” EPA believes that the information from this reporting will help EPA to determine whether chemical substances manufactured and processed at the nanoscale may exhibit behavior relevant to health and safety that is different from that of non-nanoscale forms of chemical substances. EPA thus has the authority to require reporting pertaining to different forms of chemical substances.

Comment 2: Several commenters stated that the proposed information requests are outside those allowed by section 8(a) of TSCA. Commenters specifically identified material characterization including particle size and morphology, methods of manufacture, weight percent of impurities, environmental release information, general population, consumer exposure, risk management practices, and engineering controls. One commenter wanted EPA to explain more clearly the basis of authority for requesting information that does not fall within the scope of the clear statutory authority of TSCA section 8(a).

Response: Section 8(a) gives EPA broad authority to collect information that the Administrator may reasonably require. Section 8(a)(1) authorizes EPA to require reporting of such information with respect to chemical substances as the Administrator may reasonably require. Although it contains limitations with respect to requirements to report with mixtures and to chemical substances manufactured in small quantities for experimentation, those limitations are not relevant to the requirements imposed by this rulemaking. Section 8(a)(2) is best interpreted as listing examples of the kinds of information EPA can require reporting on under section 8(a)(1), not as limiting EPA's authority. If Congress had intended to impose limitations on the kinds of information EPA can collect under section 8(a)(1), it would have added them to the limitations it included in section 8(a)(1). EPA has always interpreted section 8(a) in this fashion, see 58 FR 63134 (November 30, 1993)—an interpretation that is supported by the legislative history of section 8(a), H.R. Conf. Rep. 94-1679, at 80 (1976); S. Rep. No. 94-698, at 22 (1976), H.R. Rep. No. 94-1341, at 42 (1976). Further, the information required under the rule is consistent with the examples of information discussed in section 8(a)(2). For example, requiring weight percent of impurities is analogous to byproducts, material characterization including particle size and morphology is analogous to molecular structure of chemical substances manufactured and processed at the nanoscale, environmental release falls under methods of disposal, while methods of manufacture, risk management practices, engineering controls, general population and consumer exposure fall under estimates of individuals who would be exposed.

Comment 3: Several commenters noted that processors do not know about the particle size and other characteristics of formulations they process or use and should not be required to report.

Response: Reporting of information under TSCA section 8(a) is required only to the extent the information is known or reasonably ascertainable, and includes information that the Administrator may reasonably require. This standard applies both to the extent of an entity's obligation to determine whether it is required to report, and to the extent of information any entity is required to report. If processors do not know about specific physical properties of chemical substances, they must still take reasonable measures to ascertain the information that would determine whether they are subject to the rule. If processors do not know about specific properties such as particle size and other properties that would allow them to know if they are processing a chemical substance subject to the rule, it would be within the reasonably ascertainable standard to ask their suppliers for information that would enable the processor to determine whether the supplier is selling them a nanoscale material subject to reporting and if so provide them with what reportable information they have. Their supplier is not required to provide any additional information to the processor but might provide other supporting information, for example, whether their supplier has reported or intends to report the chemical substance under this rule. If the supplier provides information indicating that the substance is not reportable or if the processor lacks any other means of reasonably ascertaining whether the substance is reportable, the processor does not need to perform tests to determine whether the substance is reportable. Information developed in the normal course of business or that the processor chooses to develop must also be used. The processor may want to document the steps they took to determine if reporting was required. Companies that purchase formulations but do not change or modify those formulations and only use them are not considered processors and are not required to report.

If the information provided by the supplier indicates that reporting is required, the processor is required to report information that is known or reasonably ascertainable, which may include information obtained from the supplier. This would include situations where the processor may not know the exact chemical identity or some of its physical properties.

The obligations imposed by the reasonably ascertainable standard are discussed more fully in the Chemical Data Reporting final rule, 76 FR 50816, 50829 (August 16, 2011).

Comment 4: Several commenters also asked EPA if manufacturers and processors are only required to report available or reasonably ascertainable information, does this mean they need to develop information to comply with the rule. Other commenters asked EPA to clarify if manufacturers and processors need to develop information to comply with the rule.

Response: Manufacturers and processors are not required to conduct testing or develop new information under this rule. However, they are required to report information that is known or reasonably ascertainable.

Comment 5: Many commenters stated the proposal gives too much discretion to interpret compliance obligations. Commenters suggested clarifying the definition of unique and novel properties, adopting an alternative, or not using it at all. One commenter noted that if the requirement that reportable chemicals exhibit unique and novel attributes due to particle size is removed from the definition, the rule would not differentiate genuinely new nanoscale materials from traditional legacy products in commerce. Several commenters stated there should be some differentiation between genuinely new nanoscale materials in commerce and traditional products. Two commenters supported the proposed definition while one commenter supported a definition of 1-100 nm and unique or novel characteristics.

Response: Based on these comments, EPA agrees that what is a reportable chemical substance should be better defined and clarified. EPA is finalizing the rule with further explanation of “unique and novel properties” as described in the National Nanotechnology Initiative's definition. Some nanostructured materials are stronger or have different magnetic properties compared to other forms or sizes of the same material. Others are better at conducting heat or electricity. See http://www.nano.gov. They may become more chemically reactive or reflect light better or change color as their size or structure is altered. A property is novel when it is different from the properties associated with other forms or sizes of the same chemical substance. As also noted on http://www.nano.gov, when particle sizes of solid matter in the visible scale are compared to what can be seen in a regular optical microscope, there is little difference in the properties of the particles. But when particles are created with dimensions of about 1-100 nm, the materials' properties can change significantly from those at larger scales. See also comment 11 and the response for further clarification on what is considered a reportable chemical substance.

For purposes of this rule, EPA is defining unique and novel properties to include an element of intent, meaning that those properties are the reason why the chemical substance is manufactured in that form or size. The rule includes a definition of unique and novel properties in the definitions section of the regulatory text (See § 704.20(a)). Unique and novel properties means any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance, and such properties are a reason that the chemical substance is manufactured or processed in that form or size. In order to be reportable it's not sufficient that a chemical substance contains particles in the size range of 1-100 nm; it must also have a size-dependent property different from properties at sizes greater than 100 nm and those properties are a reason that the chemical substance is manufactured or processed in that form or size. Intentionally manufacturing or processing nanoscale gold so that it exhibits a red or purple color instead of a yellow color would create a unique or novel optical property seen at the nanoscale. Such a change would likely result in changes of other properties, such as specific surface area which can result in different health and safety impacts. Unique and novel properties which impact performance generally cannot be isolated from concurrent changes in properties that impact biological systems. For example, see the discussion in Unit II.B. of the proposed rule of the range of biological impacts of nanoscale materials. EPA is exempting certain biological materials, in part, because they do not exhibit different size-dependent properties in the size range of 1-100 nm.

Other chemical substances, including as an example some chemicals that commenters proposed that EPA exempt from reporting, such as pigments, polymers, and polymer dispersions, could be manufactured in nanoscale forms that both exhibit unique and novel properties and in forms that do not. In the concept paper for the NMSP (Ref. 10), EPA stated that many polymers or oligomers, particularly linear or planar polymers, should not be reported even though they have dimensions in the nanoscale. Those polymers did not demonstrate size-dependent properties. The paper did note that when conditions of polymerization or post-reaction processing create free particles that fit the general description of “engineered nanoscale material” those chemical substances should be reported under the NMSP. Please also refer to the comment and response to comment 12 in the response to comments document regarding the difference between enhanced and novel properties.

Comment 6: Several commenters suggested alternative definitions of trace amounts stating that the term in the proposed rule is not definitive and gives too much discretion to interpret compliance obligations. The commenters suggested including a numerical value to define trace amount. Most commenters did not suggest a specific value, although one commenter noted the original definition of the Agency's draft proposed rule submitted to OMB would have required reporting for those substances containing ≥10% particles in the range of 1-100 nm while another commenter suggested using a numerical value of less than 10% of particles as trace amount that would not be considered to be a reportable chemical substance. Commenters asked EPA to clarify if particle size was to be determined by weight, volume, or count. One commenter stated that EPA should not use weight based criteria to determine particle size as that measurement is sometimes skewed by the inclusion of very large particles. Several other commenters suggested using weight based criteria to identify particle size but did not give any reasons why.

Response: Chemical substances manufactured or processed at the nanoscale that contain incidental amounts of particles in the size range of 1-100 nm are not reportable chemical substances. EPA used trace amounts in the proposed rule to define this concept. However, based on the public comments to more clearly define trace amounts including several comments to establish a numerical cutoff, EPA is instead using a numerical value of less than 1% of particles from 1-100 nm by weight to more clearly define those chemical substances that would not be reportable. EPA has chosen this number because it is the percentage cut-off used in OSHA's hazard communication standard for all chemicals substances that are not OSHA carcinogens (for which there is a 0.1% cut-off) (Ref. 11). This 1% cut-off is a level that industry has used to identify chemicals in safety data sheets (and previously in material safety data sheets.) Industry is already using this cut-off to identify at least some nanoscale chemical substances, e.g., carbon nanotubes in mixtures. EPA is using the weight based method for measuring particles even though that measurement is sometimes altered by the presence of very large particles because it is the most widely used method, and more data will therefore be available. The final rule does not require reporting for any chemical substance where less than 1% percent of the particle size distribution by weight is less than 100 nm.

Changes to the Definition of a Reportable Chemical Substance in the Final Rule. EPA has added a definition of unique and novel properties in the definitions section of the regulatory text (See 704.20(a)). Unique and novel properties means any size-dependent property that vary from other properties associated with other forms or sizes of the same chemical substance, and such properties are the reason that the chemical substance is manufactured or processed in that form or size. A reportable chemical substance is not just a substance containing particles in the size range of 1-100 nm; it must also have a size-dependent property different from properties at sizes greater than 100 nm. The final rule no longer states that a reportable chemical substance does not include a chemical substance that only has trace amounts of primary particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the unique and novel characteristics or properties because of particle size. The final rule now states that a reportable chemical substance does not include a chemical substance that is manufactured or processed in a form where less than 1% of any particles, including aggregates and agglomerates, measured by weight are in the size range of 1-100 nm.

Comment 7: A variety of commenters stated that EPA should add additional exemptions for biological materials such as enzymes, lipids, carbohydrates, peptides, polypeptides, nucleotides, liposomes, antibodies, viruses, virus-like particles, viral based products, organelles, and microorganisms. The commenters stated that the additional biological materials should be exempted for the same reason EPA proposed to exempt DNA, RNA, and proteins, that the additional biological materials did not exhibit properties as a function of their size range.

Response: Because they meet the same criteria that EPA identified in the proposed rule, EPA is adding an exemption for enzymes, lipids, carbohydrates, peptides, liposomes, antibodies, viruses, and microorganisms in the final rule. The properties of all the exempted biological materials, which can be in the nanoscale, are not a function of the size range per se but rather of the precise nucleotide sequence (in the case of DNA and RNA), shape, and complex biological structures (living cells).

Comment 8: Several commenters identified additional possible exemptions for organic and inorganic pigments and dyes; polymers including polymer dispersions; and chemical substances used in adhesives, coatings and sealants and chemical substances when they are embedded in a polymer matrix or incorporated into a formulated product such as adhesives, cement, ink, coatings, glass, paint, plastic and rubber because they are well understood or characterized and present low risk and low potential for exposure. Commenters suggested that EPA include an exemption for polymers and polymer dispersions to be consistent with the polymer exemption under section 5 of TSCA. Commenters also noted TSCA section 5 regulations such as SNURs which exempted requirements for carbon nanotubes, silica, and pigments when incorporated into polymer matrices.

Response: A reportable chemical substance is not just a substance containing particles in the size range of 1-100 nm; it must also have a size-dependent property different from properties at sizes greater than 100 nm. The chemical substances or activities identified by commenters could be manufactured in nanoscale forms that both exhibit unique and novel properties and in forms that do not. If a chemical substance does not exhibit unique and novel properties, then no reporting would be required. EPA lacks information demonstrating minimal risk and exposure for nanoscale forms of the chemical substances or activities that commenters proposed for exemption. The polymer exemption under TSCA section 5 is not based on any consideration of the potential for impacts from polymers with size dependent properties and does not include all polymers. Most of the activities described by commenters for exemption would only require reporting for a reportable chemical substance before it is incorporated into a formulated product or polymer matrix. Reporting would not be required by persons who use the formulated product or polymer matrix. EPA is not including an exemption for these chemical substances and activities because doing so would exempt some of the nanoscale materials in commerce for which EPA is collecting information on health and safety effects which would allow EPA to better assess and manage risks of nanoscale materials.

Comment 9: Several commenters proposed limited or no reporting for nanoscale materials such as carbon black, silica, titanium dioxide, nanosilver, and nanocellulose, based on the proposed exemption for nanoclays and zinc oxide. The commenters asked EPA to better define the criteria it used to exempt nanoclays and zinc oxide as well-characterized so that the criteria could be applied to these chemical substances. One commenter noted that available information for commercial forms of nanocellulose demonstrate low hazard and risk. Several commenters also described the hazards and exposures of these chemical substances as well-characterized. Several commenters stated that EPA should not exempt zinc oxide and nanoclays as EPA had not identified and made available the data that demonstrated why they are well-characterized.

Response: EPA has decided to not exempt nanoclays and zinc oxide from reporting. When considering the comments to exempt other chemical substances based on its proposed exemption for zinc oxide and nanoclays, EPA realized that it had given too much weight to the available information on zinc oxide and nanoclays. While there is some available information on these chemical substances, EPA does not consider the available information sufficient to extrapolate to all other forms of these chemical substances to exclude information collection under TSCA. Further, this limited information is not a sufficient basis to create a broader exemption by analogy for other chemical substances. Thus, even for chemical substances manufactured as nanoscale materials that could be described as a group as well-characterized or demonstrating low hazard based on data not relating to nanoscale forms in particular, EPA lacks information on how much and what type of specific nanoscale materials are in commerce and what kind of information is available to assess the properties that can impact health and safety and thus potential risks of those nanoscale materials. The chemical substances that commenters and EPA stated were well characterized could be manufactured in nanoscale forms that both exhibit unique and novel properties and in forms that do not. EPA is not exempting from reporting any of the chemical substances proposed by commenters, including zinc oxide and nanoclays because doing so would exempt some of the nanoscale materials in commerce for which EPA is collecting information on health and safety effects which would allow EPA to better assess and manage risks of nanoscale materials. The type of information described by the commenter regarding nanocellulose is the type of information on health and safety effects which would allow EPA to better assess and manage risks of nanoscale materials.

Changes to Chemical Substances That are Exempt from the Final Rule: EPA added exemptions for enzymes, lipids, carbohydrates, peptides, liposomes, antibodies, viruses, microorganisms in the final rule. EPA did not add any other exemptions to the final rule. EPA did not include the proposed exemptions for nanoclays and zinc oxide in the final rule.

Comment 10: Several commenters stated that EPA cannot require information that violates the language under TSCA section 8(a) prohibiting “any reporting which is unnecessary or duplicative.” Commenters stated that requiring reporting of some of the information already reported to the NMSP would be duplicative, especially the large amount of health and safety information submitted for broad classes of chemical substances such as silica and carbon black. Commenters also asked EPA to explain why the proposed reporting requirements do not duplicate reporting required under CDR.

Response: The reporting required by this rule does not duplicate reporting EPA would receive under other TSCA regulations. Chemical data reporting (CDR) under 40 CFR part 711 does not require manufacturers to distinguish reporting for different forms of chemical substances including nanoscale materials. This rule also exempts reporting for chemical substances that are nanoscale materials that have already been reported under section 5 of TSCA since 2005 except for new discrete forms. As noted in the interim report on the NMSP (Ref. 12), EPA received limited reporting on nanoscale materials in commerce. The reporting for nanoscale materials such as silica and carbon black gave an overview of the entire industry but not information on individual nanoscale materials. A company reporting a silica or carbon black-based nanoscale material does not have to resubmit the information submitted under the NMSP. However, any reporting of silica or carbon black nanoscale materials would need to include any health and safety information that company possesses for the specific nanoscale material it is reporting. As already noted, CDR reporting does not distinguish between different nanoscale forms of chemical substances. Several commenters stated that EPA needs more information on nanoscale materials in commerce. In the full response to comments document, EPA addresses more specific comments about information required by the rule.

Comment 11: There were numerous comments to not include the 135 day reporting requirement for new discrete forms. This requirement was characterized by several commenters as de facto new chemical reporting. Commenters also asked EPA to clarify if persons subject to the rule had to wait until the 135 day period was completed before commencing manufacture or processing. The 135 day reporting requirement was supported by several commenters because it provides the Agency with more time to identify potential concerns and initiate appropriate action to address them.

Response: EPA did not intend to create de facto new chemical reporting for new discrete forms of nanoscale materials, because the 135-day period is not a formal review-period that prohibits manufacture before the end of the 135-day period. Rather, based on EPA's experience with the Premanufacture Notice (PMN) program, EPA believes that in most cases companies have the requisite intent to manufacture or process at least 135 days before manufacturing or processing will begin, and the rule requires reporting based upon this presumed intent. However, if a company does not form the requisite intent 135 days ahead of time, the company must report within 30 days of the formation of such an intent. Moreover, if a company desires to begin manufacture or processing less than 135 days after the submission for this rule is made, the company is free to do so. There is no obligation upon the company to wait 135 days after reporting to manufacture or process. EPA is revising the language in 704.20(f)(2) to clarify that the rule does not prevent manufacturing before the 135-day period has passed. If the company changes its schedule or does not form the intent until a later time, it may wish to document supporting facts.

Further, the comments made EPA realize that the regulatory text as written in the proposal created a result unintended by the Agency (and not commented upon): Because (1) the default period of 135 days is greater than the advance of periods required for various section 5 submissions, and (2) the reporting exemption for section 5 submissions in 704.20(c)(2) of the proposal would apply only where the company had already filed a section 5 submission, a company proposing to manufacture a discrete form of a reportable substance for which a section 5 submission had not been filed might conceivably be required to first file a section 8(a) report, followed by a section 5 submission. In such cases EPA only needs the section 5 submission and exercise whatever section 5 authority might be necessary in a specific case, rather than imposing an additional burden of requiring a duplicative section 8(a) submission. Therefore EPA is adding a new subcategory of non-reportable chemical substances to 704.20(c)(1), for chemical substances that are not on the TSCA Inventory at the time reporting would otherwise be required, to clarify the Agency's original intent in the NPRM. If a reportable chemical substance is not on the TSCA Inventory a manufacturer only needs to submit a new chemical notification under section 5 of TSCA.

Changes to the 135-day Reporting Requirement for Discrete Forms of a Reportable Chemical Substance: EPA has added language to 40 CFR part 704.20(f)(2): “except where the person has not formed an intent to manufacture or process that discrete form at least 135 days before commencing such manufacture or processing, in which case the information must be filed within 30 days of the formation of such an intent.” The language makes clear what companies must do if they do form an intent to manufacture or process a discrete form of a reportable chemical substance less than 135 days ahead of manufacture or processing.

Changes to Chemical Substances That Are Not Reportable: EPA has added language to 704.20(c)(1), exempting chemical substances that are not on the TSCA Inventory from reporting.

Comment 12: There is not standardized testing for the physical properties in the proposed rule identified for manufacturers and processors to determine if they qualify for the rule. EPA should identify test methods to be used to comply with the rule. Many processors will not know to test for these properties. EPA cannot require this testing until validated protocols are developed.

Response: Testing or developing new information is not required by the rule. Only known or reasonably ascertainable information needs to be reported. Companies are only required to report on known or reasonably ascertainable information. See the response to comment 3 for guidance as to situations in which a company does not know about the physical properties identified in the regulation. In the proposed rule, EPA supplied examples of testing guidelines that could be used for these types of properties should the company desire to do such testing.

Comment 13: Several commenters supported the $4 million dollar small business exemption. One commenter wanted an even smaller dollar amount so that more small businesses would be required to report. Other commenters supported just using the dollar amount but stated it should be increased to $9.5 million dollars to account for inflation since 1988 when the current small business amount of $4 million was established.

Response: Based on these comments and updated economic information, EPA is changing the definition of small business in the final rule to include any company with sales of $11 million dollars or less. In suggesting EPA change the value to $9.5 million, the commenter assumed the original $4 million was promulgated in 1988. However, the $4 million was initially promulgated in 1984 (49 FR 45425) with a base year of 1983. Therefore, it is appropriate to inflate the $4 million from $1983 to $2015. When accounting for inflation since 1983, EPA calculated the figure to be $11 million dollars.

In proposing this definition, EPA provided notice and comment on the criteria for small manufacturers and processors subject to this rule, and consulted with the Small Business Administration (SBA) in accordance with TSCA section 8(a)(3)(B). EPA's change to this definition is consistent with both public comments and the feedback we received from SBA.

EPA recognizes that recent amendments to TSCA include a new and separate obligation under amended TSCA section 8(a)(3)(C), which requires EPA, after consultation with the SBA, to review the adequacy of the standards for determining the manufacturers and processors which qualify as small manufacturers and processors for purposes of TSCA sections 8(a)(1) and 8(a)(3). TSCA furthermore requires that (after consulting with the SBA and providing public notice and an opportunity for comment) EPA make a determination as to whether revision of the standards is warranted. In the Federal Register of December 15, 2016 (81 FR 90840) (FRL-9956-03), EPA sought public comment on whether a revision of the current size standard definitions is warranted at this time; announced EPA's initiation of the required consultation with the SBA, and provided its preliminary determination that revision to the currently codified size standards for TSCA section 8(a) is indeed warranted. As part of this effort, EPA will review the adequacy of the standards for small manufacturers and processors in existing TSCA section 8(a) rules, including this one. Any changes resulting from the assessment will undergo consultation with SBA and will be proposed for notice and comment as required by TSCA section 8(a)(3)(C).

Changes to the Definition of a Small Manufacturer or Processor Exempt from the Reporting Requirements of the Rule: The final rule retains a small business exemption based only on sales, but a small manufacturer or processor will be defined as any company with sales of less than $11 million per year.

Comment 14: Several commenters asked EPA to clarify the objects and collections of objects to which the 1-100 nm measurement applies. In other words, does that mean any form with particles 1-100 nm or does that include aggregates and agglomerates greater than 100 nm but based on primary particles less than 100 nm?

Response: Chemical substances required to be reported would include any form with particles 1-100 nm but would not include aggregates or agglomerates greater than 100 nm even if they contain primary particles less than 100 nm. EPA has modified the description of particles that would be subject to reporting in the definition of reportable chemical substance to better reflect this understanding. The language in the reportable chemical substance definition now reads, “where any particles, including aggregates and agglomerates, are in the size range of 1-100 nm”

Comment 15: Several commenters suggested that EPA should better define particle. One commenter stated “The word `particle' is not a term with specific meaning. It is critical that EPA is clear about the definition of `particle' so that companies understand what materials require reporting. For example, does the term `particle' include solid objects that contain internal crystalline domains at the nanoscale? Does it include dispersions, suspensions, or aerosols? A definition of `particle' would provide an important starting point for determining whether a material is subject to reporting. It should take into account the ability of a `particle' to move freely in its environment.”

Response: EPA will use the definition of particle from ISO, which is a “minute piece of matter with defined physical boundaries.” The notes to the ISO definition should be used as guidance in applying this definition. Note 1: A physical boundary can also be described as an interface. Note 2: A particle can move as a unit. EPA is using this definition because there is international agreement on the definition; the definition addresses the commenter's questions about the ability of a particle to move in the environment and whether “particle” includes dispersions, suspensions, or aerosols.

Changes to the Final Rule to Clarify the Types of Particles to be Measured: EPA has added a definition of particle and modified the language in the definition of reportable chemical substance for the types of particles that will be measured.

Comment 16: Several commenters stated that the shape criteria for identifying reportable chemical substances are too vague and unworkable. The commenters asked what the criteria are to discern one shape from another. For example one commenter stated “For morphology, how would manufacturers and processors distinguish between the different morphologies identified in the proposed regulatory text: What definitions would distinguish for example a rod from an ellipsoid, needle, wire, and/or fiber as these shapes could be considered on a continuum? Another commenter stated “It is unclear how different the shapes of two forms would have to be in order to trigger the discrete forms requirement.”

Response: As noted in the proposed rule the different morphology could be any change in the shape of particles. Different morphology does not include random shape changes or natural variation in shapes of particles that are not definitive and that, as commenters have noted, occur in a continuum. Some nanoscale materials are engineered to give all the particles a certain morphology or shape. The change in shape needs to be a specifically engineered change in the shape of particles of a nanoscale material, to effect a change and form a unique and novel property for a chemical substance in the particle size range of 1-100 nm.

Comment 17: Several commenters objected to imposing the same reporting requirements on both processors and manufacturers stating that some processors will not be aware of information known to manufacturers such as for example chemical identity, physical-chemical properties, byproducts, impurities, health effects data, and general population exposure. In addition, the commenters speculated that processors may report uses and processes already reported by the manufacturer. The commenters felt the reporting requirements place impractical or burdensome obligations on processors without collecting information that would serve the intended purposes of the rule when manufacturers were in the best position to report information required by the rule. Commenters suggested limiting reporting to only manufacturers or limiting the information to be reported by processors.

Response: Processors are only required to submit information that is known or reasonably ascertainable. In addition, processors may have access to pertinent information that manufacturers do not have access to. Processors can often describe in greater detail how the nanoscale material is processed and used and any characteristics that change because of processing. Details on the processing and use of nanoscale forms of chemical substances with unique or novel properties will give EPA a better understanding regarding how to assess those chemical substances and whether any further actions are warranted under TSCA.

Comment 18: Several commenters stated that EPA should exempt naturally occurring or mined nanoscale materials. One commenter noted that CDR regulations exempt naturally occurring chemical substances as described at 40 CFR 710.4(b). Several commenters also stated naturally occurring nanoscale materials should be exempt from reporting as they do not meet the criteria of the definition of “manufactured or processed.” Another commenter suggested limiting reporting to engineered nanomaterials as they are “generated for a specific function” or “deliberately manipulated.”

Response: EPA did not exempt naturally occurring materials or limit reporting to chemical substances engineered at the nanoscale because some of these chemical substances meet the criteria of a reportable chemical substance and some of them do not. These chemical substances must be reported only if they meet the definition of containing particles in the size range of 1-100 nanometers and a size-dependent property different from properties at sizes greater than 100 nanometers. EPA expects that reportable chemical substances would usually be the result of processing of naturally occurring or mined materials by manufacturers and processors

Comment 19: A commenter stated that EPA should add an explicit exemption for nanoscale substances that are unintentionally generated during manufacturing and processing. Another commenter asked EPA to clarify if it matters if a nanoscale substance is intentionally added versus accidentally formed.

Response: If a nanoscale chemical substance is unintentionally generated or added and not intended to be part of the commercially manufactured or processed chemical substance, it may be considered a byproduct or impurity and would be exempt under 40 CFR 704.5(b) or (c). If a nanoscale chemical substance is unintentionally formed but is considered to be part of the function of the commercial product, it would be a reportable chemical substance. A chemical substance which is intentionally produced but is in total or in part unintentionally produced at the nanoscale is not an impurity or a byproduct. There are examples where a chemical substance is intentionally produced, but unintentionally produced at the nanoscale, and the manufacturer knows that it contributes to the function of their product. In those cases, where a company knows about its functionality, the chemical substance is still subject to TSCA reporting requirements. See, for example, EPA's PMN regulations at 40 CFR 720.30(h)(2), which exempts from reporting a byproduct not used for commercial purposes, but retains the reporting requirement if the byproduct is used for commercial purposes. The rule does not require a company to determine the functionality of every impurity or byproduct. A company is required to report that chemical substance when it knows the chemical substance has commercial functionality.

Other Changes to the Final Rule: EPA made other changes to the rule. See the Response to Comments Document (Ref. 2) for further details. EPA has modified the definition of zeta potential to address public comments that zeta potential was not accurately defined in the proposed rule. Because “chemical substances manufactured at the nanoscale as part of a film on a surface” did not adequately describe the films on a surface exemption that was proposed, EPA changed the wording of the exemption to state “chemical substances formed at the nanoscale as part of a film on a surface.”

Changes to the Reporting Form: EPA made the following changes to the reporting form. See the Response to Comments Document (Ref. 2) for further explanation. EPA removed the requirement for an overview of the life cycle in Section C of the reporting form, as that information duplicates information already identified in other parts of the form. Because not all enhanced properties are unique or novel properties, EPA replaced the word enhanced with novel in section C.5. of the reporting form. EPA added language to the form instructions that “You may want to consult with your customers or suppliers about the confidentiality of any information you report about them on this form” in response to comments that manufacturers or processors may not accurately identify confidential information obtained from suppliers or customers. In order to help facilitate continued work on sharing available information and to inform future alignment on activities pertaining to nanoscale materials, EPA included the option on the reporting form to share information with Environment and Climate Change Canada and Health Canada per one commenter's request to provide the option of sharing CBI.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB recommendations are documented in the docket. EPA prepared an economic analysis for this action (Ref. 4), which is available in the docket and discussed in Unit I.E.

The information collection activities in 40 CFR part 704 related to TSCA section 8(a) reporting rules are approved by OMB under the PRA and assigned OMB control No. 2070-0067 (EPA ICR No. 1198) (Ref. 13). Because this rule revises those information collection activities and the related collection instrument, additional approval by OMB is required. As such, EPA has prepared an addendum to the currently approved ICR; the addendum is identified under EPA ICR No. 2517.02 (OMB Control No. 2070—[new]) (Ref. 14). The ICR document provides the estimated burden and costs for the information collection activities contained in this final rule. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.

Respondents/affected entities: Chemical manufacturers (including importers) and processors.

Respondent's obligation to respond: Mandatory.

Estimated number of respondents: 2,681.

Frequency of response: Variable.

Total estimated burden: 146,855 hours (average per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated burden cost: $11.33 million (per year), includes $0 annualized capital or operation and maintenance costs.

Change in approved burden: The total burden in OMB's inventory for the existing, approved ICR (275 hours), will be increased by 146,855 hours, for a new total burden of 147,130 hours. If an entity were to submit a report to the Agency, the annual burden is estimated to average 164 hours per response. Burden is defined in 5 CFR 1320.3(b). As presented in the economic analyses and the ICR addenda, EPA estimates that the TSCA section 8(a) rule will create a total incremental industry burden of 440,566 hours over three years.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce that approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities contained in this final rule.

I certify under section 605(b) of the RFA, 5 U.S.C. 601 et seq., that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are small businesses, small governmental jurisdictions and small non-profits. A small business exemption exists under TSCA section 8(a) reporting rules, at 40 CFR 704.5(f). For this action, EPA is modifying the exemption. EPA analyzed potential small business impacts from this rule using both the SBA employee size standards and the TSCA sales-based definition of small business. The Agency has determined that up to 411 small businesses may be impacted and evaluated the number that may incur costs at below 1% and 3%, and above 3% of sales. EPA estimates that all 411 small businesses identified will incur costs below 1% of sales, which EPA has determined is not a significant adverse economic impact on a substantial number of small entities. Details of this analysis are presented in the small entity impact analysis that EPA prepared for this action as part of the Agency's economic analysis that is in the public docket for this rule (Ref. 4).

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Based on EPA's experience with proposing and finalizing rules under TSCA section 8(a), State, local and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local or Tribal government will be impacted by this rulemaking. In addition, this action will not result in annual expenditures of $100 million or more for the private sector.

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health or safety risk. Nevertheless, the information obtained by the reporting required by this rule will be used to inform the Agency's decision-making process regarding chemical substances to which children may be disproportionately exposed. This information will also assist the Agency and others in determining whether the chemical substances addressed in this rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, distribution, or use.

This action does not involve any technical standards, and is therefore not subject to considerations under NTTAA section 12(d), 15 U.S.C. 272 note.

This action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action does not affect the level of protection provided to human health or the environment. The information collected under this rule will, however, assist EPA and others in determining the potential hazards and risks associated with various chemicals manufactured processed, and used at the nanoscale. Although not directly impacting environmental justice-related concerns, this information will enable the Agency to better assess and protect human health and the environment, including in low-income and minority communities.

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

Section 118 of the MMPA requires NMFS to place all U.S. commercial fisheries into one of three categories based on the level of incidental mortality and serious injury of marine mammals occurring in each fishery (16 U.S.C. 1387(c)(1)). The classification of a fishery on the LOF determines whether participants in that fishery may be required to comply with certain provisions of the MMPA, such as registration, observer coverage, and take reduction plan requirements. NMFS must reexamine the LOF annually, considering new information in the Marine Mammal Stock Assessment Reports (SARs) and other relevant sources, and publish in the Federal Register any necessary changes to the LOF after notice and opportunity for public comment (16 U.S.C. 1387 (c)(1)(C)).

The definitions for the fishery classification criteria can be found in the implementing regulations for section 118 of the MMPA (50 CFR 229.2). The criteria are also summarized here.

The fishery classification criteria consist of a two-tiered, stock-specific approach that first addresses the total impact of all fisheries on each marine mammal stock and then addresses the impact of individual fisheries on each stock. This approach is based on consideration of the rate, in numbers of animals per year, of incidental mortalities and serious injuries of marine mammals due to commercial fishing operations relative to the potential biological removal (PBR) level for each marine mammal stock. The MMPA (16 U.S.C. 1362(20)) defines the PBR level as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population. This definition can also be found in the implementing regulations for section 118 of the MMPA (50 CFR 229.2).

Tier 1: Tier 1 considers the cumulative fishery mortality and serious injury for a particular stock. If the total annual mortality and serious injury of a marine mammal stock, across all fisheries, is less than or equal to 10 percent of the PBR level of the stock, all fisheries interacting with the stock will be placed in Category III (unless those fisheries interact with other stock(s) in which total annual mortality and serious injury is greater than 10 percent of PBR). Otherwise, these fisheries are subject to the next tier (Tier 2) of analysis to determine their classification.

Tier 2: Tier 2 considers fishery-specific mortality and serious injury for a particular stock.

Category I: Annual mortality and serious injury of a stock in a given fishery is greater than or equal to 50 percent of the PBR level (i.e., frequent incidental mortality and serious injury of marine mammals).

Category II: Annual mortality and serious injury of a stock in a given fishery is greater than 1 percent and less than 50 percent of the PBR level (i.e., occasional incidental mortality and serious injury of marine mammals).

Category III: Annual mortality and serious injury of a stock in a given fishery is less than or equal to 1 percent of the PBR level (i.e., a remote likelihood of or no known incidental mortality and serious injury of marine mammals).

Additional details regarding how the categories were determined are provided in the preamble to the final rule implementing section 118 of the MMPA (60 FR 45086; August 30, 1995).

Because fisheries are classified on a per-stock basis, a fishery may qualify as one category for one marine mammal stock and another category for a different marine mammal stock. A fishery is typically classified on the LOF at its highest level of classification (e.g., a fishery qualifying for Category III for one marine mammal stock and for Category II for another marine mammal stock will be listed under Category II). Stocks driving a fishery's classification are denoted with a superscript “1” in Tables 1 and 2.

The tier analysis requires a minimum amount of data, and NMFS does not have sufficient data to perform a tier analysis on certain fisheries. Therefore, NMFS has classified certain fisheries by analogy to other Category I or II fisheries that use similar fishing techniques or gear that are known to cause mortality or serious injury of marine mammals, or according to factors discussed in the final LOF for 1996 (60 FR 67063; December 28, 1995) and listed in the regulatory definition of a Category II fishery: “In the absence of reliable information indicating the frequency of incidental mortality and serious injury of marine mammals by a commercial fishery, NMFS will determine whether the incidental mortality or serious injury is `frequent,' `occasional,' or `remote' by evaluating other factors such as fishing techniques, gear used, methods used to deter marine mammals, target species, seasons and areas fished, qualitative data from logbooks or fisher reports, stranding data, and the species and distribution of marine mammals in the area, or at the discretion of the Assistant Administrator for Fisheries” (50 CFR 229.2).

Further, eligible commercial fisheries not specifically identified on the LOF are deemed to be Category II fisheries until the next LOF is published (50 CFR 229.2).

The LOF includes a list of marine mammal species and/or stocks incidentally killed or injured in each commercial fishery. The list of species and/or stocks incidentally killed or injured includes “serious” and “non-serious” documented injuries as described later in the List of Species and/or Stocks Incidentally Killed or Injured in the Pacific Ocean and the Atlantic Ocean, Gulf of Mexico, and Caribbean sections. To determine which species or stocks are included as incidentally killed or injured in a fishery, NMFS annually reviews the information presented in the current SARs and injury determination reports. The SARs are based upon the best available scientific information and provide the most current and inclusive information on each stock's PBR level and level of interaction with commercial fishing operations. The best available scientific information used in the SARs reviewed for the 2017 LOF generally summarizes data from 2009-2013. NMFS also reviews other sources of new information, including injury determination reports, bycatch estimation reports, observer data, logbook data, stranding data, disentanglement network data, fisher self-reports (i.e., MMPA reports), and anecdotal reports from that time period. In some cases, more recent information may be available and used in the LOF, but in an effort to be consistent with the most recent SARs and across the LOF, NMFS typically restricts the analysis to data within the five-year time period summarized in the current SAR.

For fisheries with observer coverage, species or stocks are generally removed from the list of marine mammal species and/or stocks incidentally killed or injured if no interactions are documented in the five-year timeframe summarized in that year's LOF. For fisheries with no observer coverage and for observed fisheries with evidence indicating that undocumented interactions may be occurring (e.g., fishery has low observer coverage and stranding network data include evidence of fisheries interaction that cannot be attributed to a specific fishery) species and stocks may be retained for longer than five years. For these fisheries, NMFS will review the other sources of information listed above and use its discretion to decide when it is appropriate to remove a species or stock.

The best available information on the level of observer coverage and the spatial and temporal distribution of observed marine mammal interactions is presented in the SARs. Data obtained from the observer program and observer coverage levels are important tools in estimating the level of marine mammal mortality and serious injury in commercial fishing operations. Starting with the 2005 SARs, each SAR includes an appendix with detailed descriptions of each Category I and II fishery on the LOF, including the observer coverage in those fisheries. The SARs generally do not provide detailed information on observer coverage in Category III fisheries because, under the MMPA, Category III fisheries are generally not required to accommodate observers aboard vessels due to the remote likelihood of mortality and serious injury of marine mammals. Fishery information presented in the SARs' appendices and other resources referenced during the tier analysis may include: Level of observer coverage; target species; levels of fishing effort; spatial and temporal distribution of fishing effort; characteristics of fishing gear and operations; management and regulations; and interactions with marine mammals. Copies of the SARs are available on the NMFS Office of Protected Resources Web site at: http://www.nmfs.noaa.gov/pr/sars/. Information on observer coverage levels in Category I, II, and III fisheries can be found in the fishery fact sheets on the NMFS Office of Protected Resources' Web site: http://www.nmfs.noaa.gov/pr/interactions/fisheries/lof.html. Additional information on observer programs in commercial fisheries can be found on the NMFS National Observer Program's Web site: http://www.st.nmfs.gov/observer-home/.

This rule includes three tables that list all U.S. commercial fisheries by LOF Category. Table 1 lists all of the commercial fisheries in the Pacific Ocean (including Alaska); Table 2 lists all of the commercial fisheries in the Atlantic Ocean, Gulf of Mexico, and Caribbean; and Table 3 lists all U.S.-authorized commercial fisheries on the high seas. A fourth table, Table 4, lists all commercial fisheries managed under applicable TRPs or take reduction teams (TRTs).

Beginning with the 2009 LOF, NMFS includes high seas fisheries in Table 3 of the LOF, along with the number of valid High Seas Fishing Compliance Act (HSFCA) permits in each fishery. As of 2004, NMFS issues HSFCA permits only for high seas fisheries analyzed in accordance with the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA). The authorized high seas fisheries are broad in scope and encompass multiple specific fisheries identified by gear type. For the purposes of the LOF, the high seas fisheries are subdivided based on gear type (e.g., trawl, longline, purse seine, gillnet, troll, etc.) to provide more detail on composition of effort within these fisheries. Many fisheries operate in both U.S. waters and on the high seas, creating some overlap between the fisheries listed in Tables 1 and 2 and those in Table 3. In these cases, the high seas component of the fishery is not considered a separate fishery, but an extension of a fishery operating within U.S. waters (listed in Table 1 or 2). NMFS designates those fisheries in Tables 1, 2, and 3 by a “*” after the fishery's name. The number of HSFCA permits listed in Table 3 for the high seas components of these fisheries operating in U.S. waters does not necessarily represent additional effort that is not accounted for in Tables 1 and 2. Many vessels/participants holding HSFCA permits also fish within U.S. waters and are included in the number of vessels and participants operating within those fisheries in Tables 1 and 2.

HSFCA permits are valid for five years, during which time Fishery Management Plans (FMPs) can change. Therefore, some vessels/participants may possess valid HSFCA permits without the ability to fish under the permit because it was issued for a gear type that is no longer authorized under the most current FMP. For this reason, the number of HSFCA permits displayed in Table 3 is likely higher than the actual U.S. fishing effort on the high seas. For more information on how NMFS classifies high seas fisheries on the LOF, see the preamble text in the final 2009 LOF (73 FR 73032; December 1, 2008). Additional information about HSFCA permits can be found at: http://www.nmfs.noaa.gov/ia/permits/highseas.html.

Starting with the 2010 LOF, NMFS developed summary documents, or fishery fact sheets, for each Category I and II fishery on the LOF. These fishery fact sheets provide the full history of each Category I and II fishery, including: When the fishery was added to the LOF; the basis for the fishery's initial classification; classification changes to the fishery; changes to the list of species and/or stocks incidentally killed or injured in the fishery; fishery gear and methods used; observer coverage levels; fishery management and regulation; and applicable TRPs or TRTs, if any. These fishery fact sheets are updated after each final LOF and can be found under “How Do I Find Out if a Specific Fishery is in Category I, II, or III?” on the NMFS Office of Protected Resources' Web site: http://www.nmfs.noaa.gov/pr/interactions/fisheries/lof.html, linked to the “List of Fisheries by Year” table. NMFS is developing similar fishery fact sheets for each Category III fishery on the LOF. However, due to the large number of Category III fisheries on the LOF and the lack of accessible and detailed information on many of these fisheries, the development of these fishery fact sheets is taking significant time to complete. NMFS began posting Category III fishery fact sheets online with the LOF for 2016.

Owners of vessels or gear engaging in a Category I or II fishery are required under the MMPA (16 U.S.C. 1387(c)(2)), as described in 50 CFR 229.4, to register with NMFS and obtain a marine mammal authorization to lawfully take non-endangered and non-threatened marine mammals incidental to commercial fishing operations. Owners of vessels or gear engaged in a Category III fishery are not required to register with NMFS or obtain a marine mammal authorization.

NMFS has integrated the MMPA registration process, implemented through the Marine Mammal Authorization Program (MMAP), with existing state and Federal fishery license, registration, or permit systems for Category I and II fisheries on the LOF. Participants in these fisheries are automatically registered under the MMAP and are not required to submit registration or renewal materials. In the Pacific Islands, West Coast, and Alaska regions, NMFS will issue vessel or gear owners an authorization certificate via U.S. mail or with their state or Federal license or permit at the time of issuance or renewal. In the West Coast Region, authorization certificates may be obtained from the Web site http://www.westcoast.fisheries.noaa.gov/protected_species/marine_mammals/fisheries_interactions.html. In the Alaska Region, authorization certificates may be obtained from the Web site https://alaskafisheries.noaa.gov/pr/mmapregistration. In the Greater Atlantic Region, NMFS will issue vessel or gear owners an authorization certificate via U.S. mail automatically at the beginning of each calendar year. Certificates may also be obtained by visiting the Greater Atlantic Regional Office Web site http://www.greateratlantic.fisheries.noaa.gov/Protected/mmp/mmap/. In the Southeast Region, NMFS will issue vessel or gear owners notification of registry and vessel or gear owners may receive their authorization certificate by contacting the Southeast Regional Office at 727-209-5952 or by visiting the Southeast Regional Office Web site http://sero.nmfs.noaa.gov/protected_resources/marine_mammal_authorization_program/ and following the instructions for printing the certificate.

The authorization certificate, or a copy, must be on board the vessel while it is operating in a Category I or II fishery, or for non-vessel fisheries, in the possession of the person in charge of the fishing operation (50 CFR 229.4(e)). Although efforts are made to limit the issuance of authorization certificates to only those vessel or gear owners that participate in Category I or II fisheries, not all state and Federal license or permit systems distinguish between fisheries as classified by the LOF. Therefore, some vessel or gear owners in Category III fisheries may receive authorization certificates even though they are not required for Category III fisheries. Individuals fishing in Category I and II fisheries for which no state or Federal license or permit is required must register with NMFS by contacting their appropriate Regional Office (see ADDRESSES).

In Alaska regional and Greater Atlantic regional fisheries, registrations of vessel or gear owners are automatically renewed and participants should receive an authorization certificate by January 1 of each new year. In Pacific Islands regional fisheries, vessel or gear owners receive an authorization certificate by January 1 for state fisheries and with their permit renewal for Federal fisheries. In West Coast regional fisheries, vessel or gear owners receive authorization either with each renewed state fishing license in Washington and Oregon, with their permit renewal for Federal fisheries, the timing of which varies based on target species, or via U.S. mail. Vessel or gear owners who participate in fisheries in these regions and have not received authorization certificates by January 1 or with renewed fishing licenses must contact the appropriate NMFS Regional Office (see FOR FURTHER INFORMATION CONTACT).

In Southeast regional fisheries, vessel or gear owners' registrations are automatically renewed and participants will receive a letter in the mail by January 1 instructing them to contact the Southeast Regional Office to have an authorization certificate mailed to them or to visit the Southeast Regional Office Web site http://sero.nmfs.noaa.gov/protected_resources/marine_mammal_authorization_program/ to print their own certificate.

In accordance with the MMPA (16 U.S.C. 1387(e)) and 50 CFR 229.6, any vessel owner or operator, or gear owner or operator (in the case of non-vessel fisheries), participating in a fishery listed on the LOF must report to NMFS all incidental mortalities and injuries of marine mammals that occur during commercial fishing operations, regardless of the category in which the fishery is placed (I, II, or III) within 48 hours of the end of the fishing trip or, in the case of non-vessel fisheries, fishing activity. “Injury” is defined in 50 CFR 229.2 as a wound or other physical harm. In addition, any animal that ingests fishing gear or any animal that is released with fishing gear entangling, trailing, or perforating any part of the body is considered injured, regardless of the presence of any wound or other evidence of injury, and must be reported.

Mortality/injury reporting forms and instructions for submitting forms to NMFS can be found at: http://www.nmfs.noaa.gov/pr/interactions/mmap/#form or by contacting the appropriate regional office (see FOR FURTHER INFORMATION CONTACT). Forms may be submitted via any of the following means: (1) Online using the electronic form; (2) emailed as an attachment to [email protected]; (3) faxed to the NMFS Office of Protected Resources at 301-713-0376; or (4) mailed to the NMFS Office of Protected Resources (mailing address is provided on the postage-paid form that can be printed from the web address listed above). Reporting requirements and procedures can be found in 50 CFR 229.6.

Individuals participating in a Category I or II fishery are required to accommodate an observer aboard their vessel(s) upon request from NMFS. MMPA section 118 states that the Secretary is not required to place an observer on a vessel if the facilities for quartering an observer or performing observer functions are so inadequate or unsafe that the health or safety of the observer or the safe operation of the vessel would be jeopardized; thereby authorizing the exemption of vessels too small to accommodate an observer from this requirement. However, U.S. Atlantic Ocean, Caribbean, or Gulf of Mexico large pelagics longline vessels operating in special areas designated by the Pelagic Longline Take Reduction Plan implementing regulations (50 CFR 229.36(d)) will not be exempted from observer requirements, regardless of their size. Observer requirements can be found in 50 CFR 229.7.

Table 4 in this rule provides a list of fisheries affected by TRPs and TRTs. TRP regulations can be found at 50 CFR 229.30 through 229.37. A description of each TRT and copies of each TRP can be found at: http://www.nmfs.noaa.gov/pr/interactions/trt/teams.html. It is the responsibility of fishery participants to comply with applicable take reduction regulations.

Information regarding the LOF and the MMAP, including: Registration procedures and forms; current and past LOFs; descriptions of each Category I and II fishery; and some Category III fisheries; observer requirements; and marine mammal mortality/injury reporting forms and submittal procedures; may be obtained at: http://www.nmfs.noaa.gov/pr/interactions/fisheries/lof.html, or from any NMFS Regional Office at the addresses listed below:

NMFS, Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930-2298, Attn: Allison Rosner;

NMFS, Southeast Region, 263 13th Avenue South, St. Petersburg, FL 33701, Attn: Jessica Powell;

NMFS, West Coast Region, Seattle Office, 7600 Sand Point Way NE., Seattle, WA 98115, Attn: Lynne Barre, Protected Resources Division;

NMFS, West Coast Region, Long Beach Office, 501 W. Ocean Blvd., Suite 4200, Long Beach, CA 90802-4213, Attn: Penny Ruvelas;

NMFS, Alaska Region, Protected Resources, P.O. Box 22668, 709 West 9th Street, Juneau, AK 99802, Attn: Suzie Teerlink; or

NMFS, Pacific Islands Regional Office, Protected Resources Division, 1845 Wasp Blvd., Building 176, Honolulu, HI 96818, Attn: Dawn Golden.

NMFS reviewed the marine mammal incidental mortality and serious injury information presented in the SARs for all fisheries to determine whether changes in fishery classification are warranted. The SARs are based on the best scientific information available at the time of preparation, including the level of mortality and serious injury of marine mammals that occurs incidental to commercial fishery operations and the PBR levels of marine mammal stocks. The information contained in the SARs is reviewed by regional Scientific Review Groups (SRGs) representing Alaska, the Pacific (including Hawaii), and the U.S. Atlantic, Gulf of Mexico, and Caribbean. The SRGs were created by the MMPA to review the science that informs the SARs, and to advise NMFS on marine mammal population status, trends, and stock structure, uncertainties in the science, research needs, and other issues.

NMFS also reviewed other sources of new information, including marine mammal stranding data, observer program data, fisher self-reports through the MMAP, reports to the SRGs, conference papers, FMPs, and ESA documents.

The LOF for 2017 was based on, among other things, stranding data; fisher self-reports; and SARs, primarily the 2015 SARs, which are based on data from 2009-2013 and the draft 2016 SARs, which cover 2010-2014. The SARs referenced in this LOF include: 2014 (80 FR 50599; August 20, 2015), 2015 (81 FR 38676; June 14, 2016), and draft 2016 (81 FR 70097; October 11, 2016). The SARs are available at: http://www.nmfs.noaa.gov/pr/sars/.

NMFS received four comment letters on the proposed LOF for 2017 (81 FR 54019; August 15, 2016). Comments were received from the Alaska Commercial Fisheries Entry Commission (CFEC), Alaska Trollers Association (ATA), Center for Biological Diversity (CBD), and West Coast Fisheries Consultants, LLC (WCFC). Comments on Commercial Fisheries in the Pacific Ocean

Comment 1: CBD recommends NMFS add Guadalupe fur seals to the list of species and/or stocks incidentally killed or injured in the Hawaii shallow-set longline fishery based on 2015 documented interactions.

Response: The 2017 LOF is based on information on marine mammals and fisheries from the 2015 SARs and draft 2016 SARs. The recently observed Guadalupe fur seal interaction from 2015 has not yet been included in the SARs and has not yet been evaluated as part of the tier analysis for this fishery. This species will be included in a future LOF, as appropriate.

Comment 2: CBD recommends that NMFS add Guadalupe fur seals to the list of species and/or stocks incidentally killed or injured in the CA drift gillnet and the gillnet fisheries that operate from Tillamook County, Oregon, to Jefferson County, Washington, such as the WA Willapa Bay drift gillnet, WA/OR lower Columbia River drift gillnet, and the WA Grays Harbor salmon drift gillnet based on seven documented interactions from 2010-2014.

Response: As described in the 2016 Sources of human-related injury and mortality for U.S. Pacific West Coast marine mammal stocks, 2010-2014, there have been 16 records of deaths and/or serious injuries to Guadalupe fur seals from stranding data from 2010-2014 (Carretta et al., 2016a). These strandings included entanglement in marine debris and gillnet of unknown origin, and shootings. The available data, including observer information from the CA drift gillnet fishery and the draft 2016 SAR, have been reviewed and the source(s) of those entanglements could not be determined; thus we have not made any changes to the LOF based on this information.

Comment 3: CBD concurs with NMFS that the CA spiny lobster fishery should be classified as Category II and recommends NMFS list humpback whale, CA/OR/WA stock, as a species/stock driving classification.

Response: NMFS agrees that the Category II reclassification of the CA spiny lobster fishery is warranted. In the proposed 2010 LOF (74 FR 27739; June 11, 2009), NMFS proposed to add humpback whale, CA/OR/WA stock, to the species or stocks incidentally killed or injured in the CA spiny lobster fishery and to reclassify the fishery as Category II due to a 2007 report of a humpback whale entanglement that had been attributed to the fishery. However, during public comment on the proposed 2010 LOF, NMFS received information from the California Department of Fish and Game (the agency that reported the entanglement) that the report of the gear type and fishery was not considered reliable. Further, the entanglement was observed in July and the CA spiny lobster fishery occurs October through March. Based upon these public comments, NMFS did not add humpback to the species or stock incidentally killed or injured in the CA spiny lobster fishery and did not reclassify it in the final 2010 LOF (73 FR 73032; December 1, 2008). The original 2007 entanglement report, attributing the entanglement to the spiny lobster fishery, was used in the SAR for the 2013 humpback whale, CA/OR/WA stock and includes a mortality/serious injury of humpback whale in this fishery. The entanglement information in the SAR was not updated following public comment on the 2010 LOF. Based upon NMFS' review of this entanglement and input from the reporting agency during the 2010 LOF process, we are not using this humpback whale entanglement to recategorize the CA spiny lobster fishery. NMFS agrees that the new distinct population segment listings may change the way we identify the humpback whale stock along the U.S. West Coast. However, at this time we continue to use the CA/OR/WA stock of humpbacks, and associated PBR, as described in the MMPA for the LOF.

Comment 4: CBD recommends NMFS add harbor seals to the list of species and/or stocks incidentally killed or injured in the CA spiny lobster fishery based on a 2010 documented injury.

Response: NMFS disagrees with this recommendation. We reviewed all sources of human-related injury and mortality of harbor seals from 2010 through 2014 and there were no interactions with pot/trap gear. Although the record for this specific incident does indicate that a piece of lobster trap gear was attached to the line on the animal, lobster trap was not indicated as the cause of the interaction, the interaction type was a hook and line fishery. Entanglement in hook and line, not pot/trap, gear is consistent with other documented interactions with harbor seals.

Comment 5: WCFC recommends NMFS classify CA spiny lobster as Category III. WCFC believes the 2008 bottlenose dolphin injury, which is driving the classification of this fishery, did not warrant serious injury designation. WCFC notes that there have been no documented interactions with bottlenose dolphins in the most recent five-year period.

Response: The commenter's first point is outside the scope of the LOF. Serious injury determinations are made by NMFS consistent with the current Guidelines for Assessing Marine Mammal Stocks (GAMMS) and the 2012 policy on assessing serious injury. The commenter should make any comments on injury determinations during the annual comment period for the relevant stock's SAR change. On the commenter's second point, there are no observers in the CA spiny lobster fishery. The interaction with the common bottlenose dolphin was based upon a stranding report and disentanglement effort. In 2015, there was an entanglement of a humpback whale in spiny lobster gear. This incident was not used in making our recommendations for the 2017 LOF because it was outside the 5-year data period (2009-2013) we relied upon. When the 2015 entanglement is included in the SAR and accounted for on the LOF, the entanglement will keep the spiny lobster trap fishery in Category II.

Comment 6: CBD recommends NMFS reclassify the Gulf of Alaska sablefish longline fishery as a Category II fishery and add the western U.S. stock of Steller sea lions to the list of species incidentally killed or injured in the fishery. CBD stated their proposed reclassification should be based on the total annual mortality and serious injury of this stock due to fisheries (31), which is more than 10 percent of the PBR (297). Therefore, the fishery should be listed as Category II. In addition, CBD reiterates its 2016 comment (81 FR 40874; June 23, 2016) about incidental take of sperm whales in the sablefish longline fishery. Four sperm whales were observed seriously injured incidental to the Gulf of Alaska sablefish longline fishery (two each observed in 2012 and 2013). However, NMFS did not provide extrapolated estimates of sperm whale mortality and serious injury. Nonetheless, using the extrapolation applied in 2012 for the mortality of western U.S. stock of Steller sea lions in this fishery would result in an estimated 11 sperm whales seriously injured in 2012. Observer coverage in 2013 (13 percent) was slightly less than in 2012 (14 percent), which according to CBD means that a conservative estimate of sperm whales seriously injured in 2013 would likely be approximately 11. CBD expressed concern that PBR is said to be unknown for this stock of sperm whales in the stock assessment report. CBD noted the response to their 2016 comment said that NMFS would “conduct a full evaluation of this stock and this fishery pursuant to the LOF” and predicted that it would be done “for the next annual LOF, likely the 2017 LOF.” CBD requests NMFS now consider the information.

Response: The single observed Steller sea lion mortality in 2012 referenced in this comment is extrapolated and averaged over five years to account for inter-annual variability in the 5-year window being considered for the 2017 LOF (2009-2013). Therefore, the 5-year average annual mortality and serious injury estimate for the western U.S. stock of Steller sea lions specific to the Gulf of Alaska sablefish longline is 1.1 (CV = 0.91). Please refer to the preamble supplementary information of this Rule for clarification on the complete process under which commercial fisheries are annually categorized for the LOF. In short, the LOF analysis is conducted in a two-tier process. The Tier 1 analysis assesses potential impacts to a particular marine mammal stock from all fisheries. NMFS compares the average annual mortality and serious injury estimates across fisheries to that stock's PBR. If the average annual mortality and serious injury estimate is greater than 10 percent of the PBR, NMFS considers the contribution of individual fisheries in the Tier 2 analysis. The Tier 2 analysis then compares mortality and serious injury by individual fisheries to that marine mammal stock's PBR and places the fishery in the appropriate LOF Category in accordance with established thresholds for Category I to III.

The Tier 1 analysis of the western U.S. stock of Steller sea lions indicates the annual mortality and serious injury estimate from all fisheries (31) is greater than 10 percent of the PBR (297). Therefore, fisheries that interact with this stock are subject to a Tier 2 analysis. The Tier 2 analysis for the Gulf of Alaska sablefish longline with an average annual mortality and serious injury of 1.1 western U.S. Steller sea lions (0.37 percent of PBR) results in the fishery being placed in Category III, as it is below the Category II threshold of 1 percent of PBR.

In regards to sperm whales, since the close of the proposed 2017 LOF comment period, NMFS published the draft 2016 SARs (81 FR 70097; October 11, 2016). The sperm whale SAR now includes an average annual mortality and serious injury estimate (2.2). NMFS will consider this new estimate and evaluate the fishery for the 2018 LOF when the 2016 SAR should be final.

Comment 7: CFEC and ATA recommend NMFS leave the AK miscellaneous finfish handline/hand troll and mechanical jig fishery classified as Category III. The commenters note that there is no documentation to link the vessel to a commercial fishing trip and that the vessel was at anchor in safe harbor and not involved in the act of commercial fishing.

Response: NMFS reviewed the available reports and data surrounding this incident. The vessel's crew identified themselves as Pacific cod jig fishermen, but it appears that this vessel did not land any Pacific cod fished by jig during the year that the incident took place (2013). Further, this vessel had only 7 reported landings in 2013, all in the Pacific cod pot fishery. However, these landings occurred outside the time frame of the incident. Specifically, the vessel landed Pacific cod (using pot gear) two weeks prior to the incident and not again until five months after the incident. Therefore, the interaction will not be assigned to the AK miscellaneous finfish handline/hand troll and mechanical jig fishery. This fishery will not be reclassified as Category II and will remain in Category III in the 2017 LOF Final Rule.

Comment 8: CFEC and ATA recommend NMFS consider re-characterizing the fisheries grouped together in the AK miscellaneous finfish handline/hand troll and mechanical jig fishery.

Response: NMFS agrees that AK miscellaneous finfish handline/hand troll and mechanical jig is currently grouped to include gear and fishing techniques too diverse to effectively evaluate potential risk to marine mammals. NMFS will review the characteristics of these fisheries and will propose a more appropriate characterization in the 2018 LOF.

Comment 9: CBD recommends NMFS add humpback whales to the list of species and/or stocks incidentally killed or injured in the Southeastern U.S. Atlantic shark gillnet fishery based on a 2012 injury.

Response: The 2012 gillnet entanglement of the humpback whale occurred in the Mid-Atlantic Gillnet Fishery (Waring et al., 2015). The humpback whale, Gulf of Maine stock is currently listed as a “marine mammal species and/or stock incidentally killed or injured” in the Mid-Atlantic gillnet fishery in the LOF.

NMFS retains AK miscellaneous finfish handline/hand troll and mechanical jig fishery as Category III and does not reclassify the fishery to Category II as proposed.

The following summarizes changes to the LOF for 2017, including the classification of fisheries, fisheries listed, the estimated number of vessels/persons in a particular fishery, and the species and/or stocks that are incidentally killed or injured in a particular fishery. NMFS re-classifies one fishery in the LOF for 2017. Additionally, NMFS adds one fishery to the LOF. NMFS is aware a new fishery, AK Gulf of Alaska sablefish pot, will be starting in 2017 and will characterize this fishery on the 2018 LOF. NMFS makes changes to the estimated number of vessels/persons and list of species and/or stocks killed or injured in certain fisheries. The classifications and definitions of U.S. commercial fisheries for 2017 are identical to those provided in the LOF for 2016 with the changes discussed below. State and regional abbreviations used in the following paragraphs include: AK (Alaska), BSAI (Bering Sea and Aleutian Islands), CA (California), DE (Delaware), FL (Florida), GMX (Gulf of Mexico), HI (Hawaii), MA (Massachusetts), ME (Maine), NC (North Carolina), NY (New York), OR (Oregon), RI (Rhode Island), SC (South Carolina), VA (Virginia), WA (Washington), and WNA (Western North Atlantic).

NMFS reclassifies the CA spiny lobster fishery from Category III to Category II. NMFS makes an administrative correction to list this fishery under Category II in Table 1. In the proposed rule, the fishery was mistakenly left as Category III.

NMFS updates the estimated number of vessels/persons in the Pacific Ocean (Table 1) as follows:

NMFS adds the Hawaii stock of pygmy killer whale and removes the Hawaii pelagic stock of pantropical spotted dolphin on the list of stocks incidentally killed or injured in the Category I Hawaii deep-set longline fishery.

NMFS adds the Hawaii stock of rough-toothed dolphin and removes the Hawaii stock of Kogia spp. on the list of stocks killed or injured in the Category II Hawaii shallow-set longline fishery.

NMFS adds the Northeast Pacific stock of fin whale to the list of stocks killed or injured in the AK miscellaneous finfish handline/hand troll and mechanical jig fishery.

NMFS adds the CA/OR/WA stock of short-finned pilot whale to the list of stocks incidentally killed or injured in the CA thresher shark/swordfish drift gillnet (≥14 in mesh) fishery.

NMFS adds the Northeast and Mid-Atlantic fyke net fishery to the list of Category III fisheries.

NMFS updates the estimated number of vessels/persons in the Atlantic Ocean, Gulf of Mexico, and Caribbean (Table 2) as follows:

NMFS removes the Western North Atlantic stock of harbor seal from the list of species incidentally killed or injured in the Category I Northeast/Mid-Atlantic American lobster trap/pot fishery.

NMFS removes Risso's dolphin, Western North Atlantic stock, and adds the Western North Atlantic stocks of harbor seal and gray seal to the list of species incidentally killed or injured in the Category II Mid-Atlantic Mid-water trawl fishery.

NMFS adds the Canadian East coast stock of minke whale to the list of species incidentally killed or injured in the Category II Northeast midwater trawl fishery.

NMFS removes the Canadian East coast stock of minke whale from the list of species incidentally killed or injured in the Category II Northeast bottom trawl fishery.

NMFS removes the Western North Atlantic stock of short-finned pilot whale from the list of species incidentally killed or injured in the Category II Northeast sink gillnet fishery.

NMFS removes the following stocks from the list of species incidentally killed or injured in the Category I Atlantic Ocean, Caribbean, Gulf of Mexico large pelagics longline fishery: Western North Atlantic stock of Atlantic spotted dolphin, Gulf of Mexico stock of Gervais beaked whale, Gulf of Mexico oceanic stock of killer whale, Western North Atlantic stock of Pantropical spotted dolphin, and Gulf of Mexico oceanic stock of sperm whale.

NMFS adds unknown stock (likely Northern migratory coastal or Southern migratory coastal) of bottlenose dolphin to the list of stocks incidentally killed or injured in the Category II Chesapeake Bay inshore gillnet fishery.

NMFS adds the Mississippi Sound, Lake Borgne, Bay Boudreau stock of bottlenose dolphin to the list of stocks incidentally killed or injured in the Category II Gulf of Mexico menhaden purse seine fishery.

NMFS adds the Florida Keys stock of bottlenose dolphin to the list of stocks incidentally killed or injured in the Category III Florida spiny lobster trap/pot fishery.

NMFS adds the Barataria Bay stock and the Mississippi Sound, Lake Borgne, Bay Boudreau stock of bottlenose dolphin to the list of stocks incidentally killed or injured in the Category III Gulf of Mexico blue crab trap/pot fishery.

NMFS updates the estimated number of vessels/persons on the High Seas (Table 3) as follows:

NMFS adds the Hawaii stock of pygmy killer whale and removes the Hawaii pelagic stock of pantropical spotted dolphin on the list of stocks incidentally killed or injured in the Category I Western Pacific pelagic longline (HI deep-set component) fishery.

NMFS adds the Hawaii stock of rough-toothed dolphin and removes the Hawaii stock of Kogia spp. on the list of stocks killed or injured in the Category II Western Pacific pelagic longline (HI shallow-set component) fishery.

NMFS adds the CA breeding stock of northern elephant seal to the list of stocks killed or injured in the Category II Western Pacific pelagic longline (HI shallow-set component) fishery.

The following tables set forth the list of U.S. commercial fisheries according to their classification under section 118 of the MMPA. Table 1 lists commercial fisheries in the Pacific Ocean (including Alaska), Table 2 lists commercial fisheries in the Atlantic Ocean, Gulf of Mexico, and Caribbean, Table 3 lists commercial fisheries on the high seas, and Table 4 lists fisheries affected by TRPs or TRTs.

In Tables 1 and 2, the estimated number of vessels or persons participating in fisheries operating within U.S. waters is expressed in terms of the number of active participants in the fishery, when possible. If this information is not available, the estimated number of vessels or persons licensed for a particular fishery is provided. If no recent information is available on the number of participants, vessels, or persons licensed in a fishery, then the number from the most recent LOF is used for the estimated number of vessels or persons in the fishery. NMFS acknowledges that, in some cases, these estimates may be inflations of actual effort. For example, the State of Hawaii does not issue fishery-specific licenses, and the number of participants reported in the LOF represents the number of commercial marine license holders who reported using a particular fishing gear type/method at least once in a given year, without considering how many times the gear was used. For these fisheries, effort by a single participant is counted the same whether the fisher used the gear only once or every day. In the Mid-Atlantic and New England fisheries, the numbers represent the potential effort for each fishery, given the multiple gear types for which several state permits may allow. Changes made to Mid-Atlantic and New England fishery participants will not affect observer coverage or bycatch estimates, as observer coverage and bycatch estimates are based on vessel trip reports and landings data. Tables 1 and 2 serve to provide a description of the fishery's potential effort (state and Federal). If NMFS is able to extract more accurate information on the gear types used by state permit holders in the future, the numbers will be updated to reflect this change. For additional information on fishing effort in fisheries found on Table 1 or 2, contact the relevant regional office (contact information included above in SUPPLEMENTARY INFORMATION).

For high seas fisheries, Table 3 lists the number of valid HSFCA permits currently held. Although this likely overestimates the number of active participants in many of these fisheries, the number of valid HSFCA permits is the most reliable data on the potential effort in high seas fisheries at this time. As noted previously in this rule, the number of HSFCA permits listed in Table 3 for the high seas components of fisheries that also operate within U.S. waters, does not necessarily represent additional effort that is not accounted for in Tables 1 and 2. Many vessels holding HSFCA permits also fish within U.S. waters and are included in the number of vessels and participants operating within those fisheries in Tables 1 and 2.

Tables 1, 2, and 3 also list the marine mammal species and/or stocks incidentally killed or injured (seriously or non-seriously) in each fishery based on SARs, injury determination reports, bycatch estimation reports, observer data, logbook data, stranding data, disentanglement network data, fisher self-reports (i.e., MMPA reports), and anecdotal reports. The best available scientific information included in these reports is based on data through 2012. This list includes all species and/or stocks known to be killed or injured in a given fishery but also includes species and/or stocks for which there are anecdotal records of a mortality or injury. Additionally, species identified by logbook entries, stranding data, or fishermen self-reports (i.e., MMPA reports) may not be verified. In Tables 1 and 2, NMFS has designated those species/stocks driving a fishery's classification (i.e., the fishery is classified based on mortalities and serious injuries of a marine mammal stock that are greater than or equal to 50 percent (Category I), or greater than 1 percent and less than 50 percent (Category II), of a stock's PBR) by a “1” after the stock's name.

In Tables 1 and 2, there are several fisheries classified as Category II that have no recent documented mortalities or serious injuries of marine mammals, or fisheries that did not result in a mortality or serious injury rate greater than 1 percent of a stock's PBR level based on known interactions. NMFS has classified these fisheries by analogy to other Category I or II fisheries that use similar fishing techniques or gear that are known to cause mortality or serious injury of marine mammals, as discussed in the final LOF for 1996 (60 FR 67063; December 28, 1995), and according to factors listed in the definition of a “Category II fishery” in 50 CFR 229.2 (i.e., fishing techniques, gear types, methods used to deter marine mammals, target species, seasons and areas fished, qualitative data from logbooks or fisher reports, stranding data, and the species and distribution of marine mammals in the area). NMFS has designated those fisheries listed by analogy in Tables 1 and 2 by a “2” after the fishery's name.

There are several fisheries in Tables 1, 2, and 3 in which a portion of the fishing vessels cross the exclusive economic zone (EEZ) boundary and therefore operate both within U.S. waters and on the high seas. These fisheries, though listed separately between Table 1 or 2 and Table 3, are considered the same fisheries on either side of the EEZ boundary. NMFS has designated those fisheries in each table by a “*” after the fishery's name.

Federal regulations at 50 CFR 648.82(n)(2)(ii) require the Regional Administrator to close a common pool Trimester Total Allowable Catch (TAC) Area for a stock when 90 percent of the Trimester TAC is projected to be caught. The closure applies to all common pool vessels on a groundfish trip using gear capable of catching that stock for the remainder of the trimester.

As of December 26, 2016, the common pool fishery has exceeded its annual TAC for Georges Bank (GB) cod by 0.3 mt, or 2.7 percent. Additionally, any overages in Trimesters 1 and 2 must be deducted from the Trimester 3 TAC. The combined overages in Trimesters 1 and 2 (4.7 mt) exceed the Trimester 3 TAC of 4.3 mt. As a result, there is no TAC available to be harvested in Trimester 3.

Effective January 9, 2017, the GB Cod Trimester TAC Area is closed for the remainder of the fishing year, through April 30, 2017, to all common pool vessels fishing on a groundfish trip with trawl gear, sink gillnet gear, and longline/hook gear. The GB Cod Trimester TAC Area consists of statistical areas 521, 522, 525, and 561. The area reopens at the beginning of fishing year 2017 on May 1, 2017.

Data indicates that common pool vessels have caught a significant portion of the total catch from outside the statistical areas that will be affected by the closure described above. The Regional Administrator is authorized under 50 CFR 648.86(o)(1) to adjust possession and trip limits for common pool vessels to prevent exceeding the pertinent common pool quotas during the fishing year. To prevent the common pool from further exceeding its quota and discourage fishing behavior that results in bycatch of GB cod in areas not affected by the closure, the possession of GB cod by all common pool vessels is prohibited, effective January 9, 2017, through April 30, 2017.

If a vessel declared its trip through the Vessel Monitoring System (VMS) or the interactive voice response system, and crossed the VMS demarcation line prior to January 9, 2017, it may complete its trip within the Trimester TAC Area. Additionally, such vessels are not subject to the new possession prohibition for that trip. A vessel that has set gillnet gear prior to January 9, 2017, may complete its trip by hauling such gear and will not be subject to the new possession limit on that trip for fish caught with that gear.

Weekly quota monitoring reports for the common pool fishery are on our Web site at: www.greateratlantic.fisheries.noaa.gov/ro/fso/MultiMonReports.htm. Because the common pool fishery has exceeded its annual quota for GB cod in the 2016 fishing year, the overage will be deducted from the common pool's annual quota for fishing year 2017. The final 2016 overage, and the adjustment to the 2017 common pool quota, will be announced as close to May 1, 2017, as possible, once final catch information for the 2016 fishing year are available. We will continue to monitor common pool catch through vessel trip reports, dealer-reported landings, VMS catch reports, and other available information.

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3) to waive prior notice and the opportunity for public comment and the 30-day delayed effectiveness period because it would be impracticable and contrary to the public interest.

Regulations require the Regional Administrator to close a trimester TAC area to the common pool fishery when 90 percent of the Trimester TAC for a stock has been caught. Updated catch information only recently became available indicating that the common pool fishery had exceeded its annual quota for GB cod. The time necessary to provide for prior notice and comment, and a 30-day delay in effectiveness, prevents the immediate closure of the GB Cod Trimester 3 TAC Area and prohibition of GB cod possession. Delaying the effective date of a closure and possession prohibition may increase the overage in fishing year 2016 that will need to be deducted from next year's quota. This would be to the detriment of the GB cod stock, and could undermine management objectives of the Northeast Multispecies Fishery Management Plan. Additionally, the overage of the common pool quota could cause negative economic impacts to the common pool fishery as a result of required catch limit deductions in the 2017 fishing year.