EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0284, dated December 20, 2018 (EASA AD 2018-0284), to correct an unsafe condition for Airbus Helicopters Deutschland GmbH (AHD) Model EC135 P1, EC135 P2, EC135 P2+, EC135 P3, EC135 T1, EC135 T2, EC135 T2+, EC135 T3, EC635 P2+, EC635 P3, EC635 T1, EC635 T2+, and EC635 T3 helicopters. Model EC635 P2+, EC635 P3, EC635 T1, and EC635 T3 helicopters are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those helicopters in the applicability.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Model EC135P1, EC135P2, EC135P2+, EC135P3, EC135T1, EC135T2, EC135T2+, and EC135T3 helicopters. The NPRM published in the Federal Register on March 30, 2021 (86 FR 16550). The NPRM was prompted by a report of increased control force in the collective axis on an AHD Model EC135 helicopter. Subsequent inspections determined that a nut on a piston of the MRA had cracked and separated from the piston rod. The NPRM proposed to require a one-time visual inspection of the MRA, as specified in an EASA AD.

The FAA is issuing this AD to prevent failure of the MRA and subsequent loss of control of the helicopter. See EASA AD 2018-0284 for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The FAA received no comments on the NPRM or on the determination of the cost to the public.

The FAA reviewed the relevant data and determined that air safety and the public interest require adopting this final rule as proposed.

EASA AD 2018-0284 describes procedures for a one-time visual inspection of the MRA and depending on the results, replacing the affected parts.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The EASA AD requires contacting Airbus Helicopters or replacing an affected part, whereas this AD requires performing the corrective action in accordance with FAA-approved procedures or removing the affected parts from service instead. Where the EASA AD specifies a compliance time for the inspection in terms of calendar time or flight hours, this AD requires a compliance time in terms of hours time-in-service instead. Where the EASA AD specifies a compliance time of 15 days for reporting the inspection results, this AD requires that the findings be reported within 30 days.

The FAA considers this AD interim action. If final action is later identified, the FAA might consider further rulemaking then.

The FAA estimates that this AD affects 331 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates that operators may incur the following costs in order to comply with this AD.

Inspecting the nuts on the MRA pistons takes about 1 work-hour for an estimated cost of $85 per helicopter and $28,135 for the U.S. fleet. Replacing the MRA takes about 7 work-hours and parts cost $325,081 for an estimated cost of $325,676 per helicopter. Repairing the MRA takes up to about 8 work-hours and parts cost about $110 for an estimated cost of up to $790 per MRA. Reporting information takes about 1 hour for an estimated cost of $85 per helicopter and $28,135 for the U.S. fleet.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Pkwy., Fort Worth, TX 76177-1524.

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

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

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

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

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

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

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Bell Model 505 helicopters with a truss assembly part number (P/N) SLS-030-056-015 with a serial number (S/N) listed in Attachment A of Bell Alert Service Bulletin (ASB) 505-19-12, Revision A, dated July 11, 2019 (505-19-12 Rev A). The NPRM published in the Federal Register on March 22, 2021 (86 FR 15146). In the NPRM, the FAA proposed to require the following within 100 hours time-in-service (TIS):

• Accessing and cleaning the lower attachment hardware securing the restraint to the truss assembly, loosening the torque on each lower nut to measure the tare, and adding a torque value of 20 inch-lbs to the measured tare of each nut and torqueing each nut to this new total value.

• Inspecting for a gap around the circumference between the nut and the washer and between the washer and the truss assembly clevis lower lug mounting surface of the right-hand (RH) and left-hand (LH) sides, and if there is a gap, measuring the gap.

• If there is a gap that is less than 0.003 inch (0.076 mm), installing the hardware using the original torque value of 40 to 58 foot-pounds (55 to 78 Nm) plus tare and completing the installation of the attachment point.

• If there is a gap that is 0.003 inch (0.076 mm) to 0.020 inch (0.508 mm) inclusive, installing the hardware with a decreased torque value limit of 20 to 60 inch-pounds (2.3 to 6.8 Nm) plus tare and completing the installation of the attachment point. The NPRM also proposed to require updating records for your helicopter to indicate the new torque limits on one or both sides. Thereafter, within 100 hours TIS, and thereafter at intervals not to exceed 100 hours TIS, the NPRM proposed to require inspecting the assembly for fretting between the washer and truss lower lug mounting surface, the security of the pitch restraint attachment hardware to make sure it does not turn freely, and the torque seal lacquer between the nut and the washer to make sure the torque seal is intact on the RH and LH sides. Depending on the inspection results, the NPRM proposed to require removing the cotter pin from service and removing the nut, washer, and bolt, and inspecting the bolt and the lower surface of the truss assembly clevis lower lug. Depending on these inspection results, the NPRM proposed to require removing the bolt from service; reworking and cleaning the lower surface of the clevis lower lug and inspecting for any cracks; removing the clevis lower lug from service; or applying primer and final paint. The NPRM then proposed to require installing the hardware with a decreased torque value limit of 20 to 60 inch-pounds (2.3 to 6.8 Nm) plus tare and completing the installation of the attachment point.

• If there is a gap that is more than more than 0.020 inch (0.508 mm), removing the nut, washer, and bolt from service and repairing or replacing the truss assembly clevis lower lug in accordance with FAA-approved procedures.

The NPRM was prompted by Canadian AD CF-2019-35, dated October 2, 2019 (Transport Canada AD CF-2019-35), issued by Transport Canada, which is the aviation authority for Canada, to correct an unsafe condition for Bell Model 505 helicopters, S/Ns 65011 and subsequent. Transport Canada advises of a gap between the transmission restraint assembly aft attachment hardware lower washer and the lower lug of the truss assembly clevis identified during quality control activity of a helicopter in final assembly. This gap can occur on the RH and LH sides of the truss assembly clevis. Subsequent investigation revealed that this condition may exist on in-service helicopters. Transport Canada advises that excessive gapping at either of these locations will result in increased stress when fasteners are installed and that the increased stress may result in cracking on the clevis lower lug and subsequent failure of one or both clevis lower lugs. Transport Canada further advises that this condition, if not corrected, could lead to loss of pylon pitch stiffness, excessive pylon pitch motions leading to unknown cyclic inputs to the main rotor, and consequent loss of control of the helicopter.

Accordingly, Transport Canada AD CF-2019-35 requires identifying the S/N of the installed truss assembly, and for a helicopter with an affected truss assembly installed, performing an initial inspection of the transmission restraint aft attachment hardware installations for a gap. Depending on the inspection results, Transport Canada AD CF-2019-35 requires reducing the torque to the attachment hardware, updating records, and repetitive inspections of the attachment hardware for wear and fretting because of the reduced friction between the mating surfaces; reporting findings to Bell and accomplishing corrective actions specified by Bell; or completing the installation of the attachment hardware and updating records.

The FAA received no comments on the NPRM or on the determination of the costs.

These helicopters have been approved by the aviation authority of Canada and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with Canada, Transport Canada, its technical representative, has notified the FAA of the unsafe condition described in its AD. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these helicopters.

The FAA reviewed 505-19-12 Rev A. This service information specifies procedures for an inspection of the restraint hardware installation for the presence of a gap and if needed, reducing the torque to the affected attachment hardware, a repetitive 100-hour inspection of the pitch restraint attachment hardware, and repair of fretting damage on the truss assembly clevis lower lug.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA also reviewed Bell ASB 505-19-12, dated June 27, 2019. This original version of the service information contains the same procedures as 505-19-12 Rev A, except 505-19-12 Rev A corrects a torque value.

The applicability of the Transport Canada AD is by helicopter S/N and requires identifying the S/N of the installed truss assembly P/N SLS-030-056-015 to determine if the helicopter is affected by the unsafe condition, whereas the applicability of this AD is by helicopters with certain serial-numbered truss assembly P/N SLS-030-056-015 installed instead. The compliance time of the initial inspections required by the Transport Canada AD is within 100 hours air time or 6 months, whichever occurs first, whereas the compliance time in this AD is within 100 hours TIS. The Transport Canada AD requires reporting information to Bell to obtain certain corrective action, while this AD requires repairing or removing affected parts from service instead.

The FAA estimates that this AD affects 87 helicopters of U.S. registry. Labor costs are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.

Measuring tare and inspecting for a gap between the transmission restraint assembly aft attachment hardware lower washer and the truss assembly will take about 1 work-hour for an estimated cost of $85 per helicopter and $7,395 for the U.S. fleet. If required, inspecting a pitch restraint attachment point will take about 1 work-hour for an estimated cost of $85 per attachment point per inspection cycle.

The FAA estimates the following costs to do any necessary repairs or replacements based on the results of the inspections:

• Updating records to indicate the new torque limits will take about 0.25 work-hour for an estimated cost of $21.

• Replacing a bolt will take a minimal additional amount of time after inspecting and the part will cost about $50.

• Reworking the lower surface of the clevis lower lug will take about 1 work-hour for an estimated cost of $85.

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

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

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

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

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

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

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

The FAA issued AD 2019-25-13, Amendment 39-21011 (84 FR 71770, December 30, 2019), (AD 2019-25-13), for all EA GP7270 and GP7277 model turbofan engines with a certain LPC 1st-stage fan blade installed. AD 2019-25-13 required an ultrasonic inspection of the affected LPC 1st-stage fan blades and replacement of any affected fan blades that fail the inspection. AD 2019-25-13 resulted from a report of an IFSD of an engine due to the fracture of multiple LPC 1st-stage fan blades. After an analysis of these fractures, the manufacturer determined the fan blades experienced cracks that originated on the internal surface of the convex airfoil and propagated to the point of failure. The cracks originated in a microtexture area that can result in a low-cycle fatigue debit that may allow a crack to initiate and propagate to failure. The FAA issued AD 2019-25-13 to prevent failure of the fan blade.

Since the FAA issued AD 2019-25-13, the manufacturer performed analysis of a fractured LPC 1st-stage fan blade and determined the fracture resulted from a fatigue crack. The manufacturer determined that repetitive ultrasonic inspection for cracks on the LPC 1st-stage fan blade convex airfoil is necessary to decrease the risk of fracture event. As a result of this analysis, the manufacturer published EA Alert Service Bulletin (SB) EAGP7-A72-444, dated November 18, 2020. This service information specifies lower initial inspection thresholds for performing ultrasonic inspections of affected LPC 1st-stage fan blades and contains procedures for performing repetitive ultrasonic inspections of affected LPC 1st-stage fan blades. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA is issuing this AD because the agency determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

The FAA reviewed EA Alert SB EAGP7-A72-444, dated November 18, 2020. The Alert SB describes the inspection thresholds and procedures for performing an ultrasonic inspection of the LPC 1st-stage fan blades. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in ADDRESSES .

This AD requires initial and repetitive ultrasonic inspections of the affected LPC 1st-stage fan blades and replacement of any LPC 1st-stage fan blade that fails the inspection.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

The FAA has found the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because no domestic operators use this product. It is unlikely that the FAA will receive any adverse comments or useful information about this AD from any U.S. operator. Accordingly, notice and opportunity for prior public comment are unnecessary, pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the foregoing reason, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days.

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0445 and Project Identifier AD-2021-00268-E” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Stephen Elwin, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because FAA has determined that it has good cause to adopt this rule without prior notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 0 engines installed on airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary replacements that would be required based on the results of the inspection. The agency has no way of determining the number of aircraft that might need these replacements.

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

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

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

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

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

(2) Will not affect intrastate aviation in Alaska.

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

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0255, dated November 13, 2020 (EASA AD 2020-0255) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for certain Airbus SAS Model A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212, -213, -311, -312, -313, -541, -542, -642, and -643 airplanes. Model A340-542 and A340-643 airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those airplanes in the applicability.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus SAS Model A330-200, A330-300, A340-200, A340-300, A340-500, and A340-600 series airplanes. The NPRM published in the Federal Register on March 11, 2021 (86 FR 13836). The NPRM was prompted by reports that, for certain LDMCR units, the connection of a certain halon outlet tube to the outlet of a certain fire extinguisher bottle may be incorrect. The NPRM proposed to require replacing each affected halon outlet tube with a flexible hose, as specified in EASA AD 2020-0255.

The FAA is issuing this AD to address the possible incorrect connection of the halon outlet tube as described previously, which, in case of a fire inside the LDMCR, could lead to disconnection of the tube, possibly resulting in reduced concentration of fire suppressing agent at any location inside the LDMCR. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The FAA has considered the comment received. The Air Line Pilots Association, International (ALPA), stated that it supports the NPRM.

The FAA reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

EASA AD 2020-0255 describes procedures for replacing each affected halon outlet tube in the LDMCR with a flexible hose. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 123 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators. The FAA does not control warranty coverage for affected operators. As a result, the FAA has included all known costs in the cost estimate.

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

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

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

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

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

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

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0145, dated July 1, 2020 (EASA AD 2020-0145) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for all Airbus SAS Model A300 series airplanes; Model A300-600 series airplanes; and Model A300F4-608ST airplanes. EASA AD 2020-0145 supersedes EASA AD 2018-0170, dated August 6, 2018 (which corresponds to FAA AD 2019-03-10, Amendment 39-19562 (84 FR 5595, February 22, 2019) (AD 2019-03-10)). Model A300F4-608ST airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those airplanes in the applicability.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2019-03-10. AD 2019-03-10 applied to all Airbus SAS Model A300 and A300-600 series airplanes. The NPRM published in the Federal Register on December 8, 2020 (85 FR 78971). The NPRM was prompted by reports of cracks in MLG leg components, and a determination that additional actions (including inspections, modifications, and out-of-roundness checks) are needed to address the unsafe condition. The NPRM proposed to continue to require the actions required by AD 2019-03-10. For certain airplanes, this AD also requires modification of the MLG hinge arm by installing improved MLG hinge arm/barrel pins; an out-of-roundness check of removed pins; repetitive inspections of any affected pins and the associated connecting rod bushes, and replacement of the MLG leg if cracked components are found; and installation of an improved spacer; as specified in an EASA AD.

The FAA is issuing this AD to address cracking of certain components in the MLG leg, which could result in an MLG collapse, and consequent damage to the airplane and injury to the airplane occupants. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

The Air Line Pilots Association, International (ALPA) and an anonymous commenter indicated support for the NPRM.

United Parcel Service (UPS Airlines) asked that the proposed AD be revised to add a statement to clarify that the general visual inspection (GVI) for Group 2 airplanes begins within 30 months after the effective date of the FAA AD. UPS Airlines stated that it has been accomplishing Airbus Service Bulletin A300-32-6120 at gear overhaul, which replaces the old hinge arm barrel pin with a new hinge arm barrel pin, prior to release of Airbus Service Bulletin A300-32-6121. UPS Airlines further pointed out that Airbus Service Bulletin A300-32-6121 was released after Airbus Service Bulletin A300-32-6120 (pin replacement), and added installation of a new spacer during gear overhaul. UPS Airlines added that EASA AD 2020-0145 does not have clear instructions for the initial inspection start date for airplanes with modifications accomplished using Airbus Service Bulletin A300-32-6120 that have not accomplished Airbus Service Bulletin A300-32-6121. Further, UPS Airlines asserted that this request is in line with the 30-month pin replacement threshold for airplanes equipped with the older pin. Airplanes with the newer pins installed in the past three years without the spacer installation, UPS Airlines also asserted, are less prone to any safety or operational concerns than those with the older pins.

The FAA does not agree with the commenter's request. In developing an appropriate compliance time for this AD, the FAA considered the urgency associated with the subject unsafe condition as well as the recommendations of the manufacturer. The compliance time for the initial GVI for Group 2 airplanes is “Within 30 months after pin replacement,” as specified in EASA AD 2020-0145. Airbus Service Bulletin A300-32-6120, which provides instructions for pin replacement, was issued September 24, 2019. Therefore, the earliest possible compliance time for the inspection would be 30 months from September 24, 2019. The FAA has not changed this AD in this regard.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

EASA AD 2020-0145 describes procedures for repetitive detailed visual inspections of the MLG leg components and replacement of the MLG leg if cracked components are found. EASA AD 2020-0145 also describes procedures, for certain airplanes, for modification of the MLG hinge arm by installing improved pins, which would terminate the repetitive detailed inspections required by AD 2019-03-10; an out-of-roundness check of removed pins; repetitive inspections of affected pins and the associated connecting rod bushes for cracking, and replacement of the MLG leg if cracked components are found; and installation of an improved spacer, which would terminate the repetitive pin and rod bushes inspections. EASA AD 2020-0145 also describes procedures for reporting results of the out-of-roundness check to Safran.

Safran Landing Systems has issued Safran Service Bulletin 470-32-840, dated December 3, 2019. This service information describes procedures for inspecting the hinge arm pins of the MLG barrel to detect local out-of-roundness.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 128 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates that it would take about 1 work-hour per product to comply with the reporting requirement in this AD. The average labor rate is $85 per hour. Based on these figures, the FAA estimates the cost of reporting the inspection results on U.S. operators to be $85, or $85 per product.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

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

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

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

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

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

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

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2016-11-21, Amendment 39-18548 (81 FR 36137, June 6, 2016), (AD 2016-11-21) which applied to Airbus Helicopters Model EC135P1, EC135P2, EC135P2+, EC135T1, EC135T2, and EC135T2+ helicopters. The NPRM published in the Federal Register on March 8, 2021 (86 FR 13237). In the NPRM, the FAA proposed to require, before further flight, establishing a life limit for the tail rotor hub body of 27,400 hours time-in-service (TIS) or using Airbus Helicopters service information if the history of the tail rotor hub body is not known or cannot be identified. The NPRM also proposed to require establishing life limits for certain swashplate and mixing lever gear unit parts in the Airworthiness Limitations Section (ALS) of the existing maintenance manual for your helicopter, and recording the revised life limit on the component history card or equivalent record. Additionally, the NPRM proposed to require continuing to record the life limit of certain parts that have not reached their life limit. Finally, the NPRM proposed to require removing from service any part that reached or exceeded its life limit.

The NPRM was prompted by EASA AD 2017-0243, dated December 6, 2017 (EASA AD 2017-0243), issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition Airbus Helicopters Model EC135P1, EC135P2, EC135P2+, EC135P3, EC135T1, EC135T2, EC135T2+, EC135T3, EC635P2+, EC635P3, EC635T1, EC635T2+, and EC635T3 helicopters. EASA AD 2017-0243 superseded EASA AD 2013-0178, dated August 7, 2013 (EASA AD 2013-0178), which was prompted by Airbus Helicopters revising the airworthiness limitations for the Model EC135 and EC635 helicopters' type design as published in the Master Servicing Manual (MSM) EC135 Chapter 04—ALS documents. Revision 14 of the MSM contains these new airworthiness limitations. EASA stated that failure to comply with these limitations could result in failure of a critical part, which could result in loss of control of the helicopter. Accordingly, EASA AD 2013-0178 required revising the ALS to include the new life limits and replacing each part that has reached its life limit. Superseding EASA AD 2017-0243 expands the applicability to include Airbus Helicopters Model EC135P3, EC135T3, EC635P3, and EC635T3 helicopters. New life limits were also added for some parts.

The FAA received comments from one commenter. The following presents the comments received on the NPRM and the FAA's response.

The individual commented that the NPRM sets the life limit for the hinged support part number (P/N) L671M7003210 at 8,400 hours TIS but that the life limit of this component is at 19,000 hours per ALS Rev 01 chapter 04-10-00. The individual also commented that the NPRM sets the life limit for the bolt P/N L671M7001220 at 8,400 hours TIS but that the life limit of this component is at 19,000 hours per ALS Rev 01 chapter 04-10-00. The FAA agrees and has changed this AD to the revise the life limit to 19,000 hours TIS for the hinged support and the bolt.

These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA reviewed the relevant data, considered the comments received, and determined that air safety requires adopting this AD as proposed except for increasing the life limit for the hinged support and bolt. These changes will neither increase the scope of the AD nor increase the economic burden on any operator. Accordingly, the FAA is issuing this AD to address the unsafe condition on these helicopters.

The FAA reviewed Airbus Helicopters Alert Service Bulletin ASB EC135-04A-012, Revision 0, dated September 11, 2017, which specifies incorporating life limits for the tail rotor hub body into the tail rotor hub log card and into the list of life-limited parts. Airbus Helicopters reports the addition of the tail rotor hub body into the tail rotor hub log card was prompted by a new, recently manufactured, serial-numbered hub.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The EASA AD applies to Model EC635P2+, EC635P3, EC635T2+, and EC635T3 helicopters, whereas this AD does not because these model helicopters are not FAA type-certificated. The EASA AD requires revising the Aircraft Maintenance Program with new or revised life limitations within 12 months after the EASA AD's effective date. This AD requires revising the life limit for certain parts in the ALS of the existing maintenance manual for your helicopter before further flight.

The FAA estimates that this AD affects 272 helicopters of U.S. Registry. The FAA estimates that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work-hour.

Revising the component history card or equivalent record will take about 2 work-hours, for an estimated cost of $170 per helicopter and $46,240 for the U.S. fleet.

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

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

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

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

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

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

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace area extending upward from 1,200 feet above the surface over the State of Michigan and removes the enroute domestic airspace at Upper Peninsula, MI; Iron Mountain, MI; and Newberry, MI, which become redundant, to correct, simplify, and close gaps in the Class E airspace extending upward from 1,200 feet above the surface over the State of Michigan; provide transitional airspace to support IFR operations to and from the terminal and enroute environments within the state; and improve air traffic services over the state.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register (86 FR 20469; April 20, 2021) for Docket No. FAA-2021-0325 to amend the Class E airspace area extending upward from 1,200 feet above the surface over the State of Michigan and remove overlapping and redundant enroute domestic airspace areas within these boundaries. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 and 6006, respectively, of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71:

Amends the Class E airspace area extending upward from 1,200 feet above the surface within the boundary of the State of Michigan by removing the limitation of “south of parallel 45°45′ ” from the airspace legal description; and

Removes the enroute domestic airspace area over the Upper Peninsula, MI; Iron Mountain, MI; and Newberry, MI, as they are redundant with the amendment of the Class E airspace area extending upward from 1,200 feet above the surface within the boundary of the State of Michigan.

This action corrects, simplifies, and closes gaps in the Class E airspace extending upward from 1,200 feet above the surface over the State of Michigan; provides transitional airspace to support IFR operations to and from the terminal and enroute environments within the state; and improves air traffic control services over the State of Michigan.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace extending upward from 700 feet above the surface at Dubois Regional Airport, Dubois, PA, to support instrument flight rule operations at this airport.

The FAA published a notice of proposed rulemaking in the Federal Register (86 FR 17754; April 6, 2021) for Docket No. FAA-2021-0221 to amend the Class E airspace extending upward from 700 feet above the surface at Dubois Regional Airport, Dubois, PA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71 amends the Class E airspace extending upward from 700 feet above the surface to within a 7.3-mile (decreased from a 9.2-mile) radius of Dubois Regional Airport; adds an extension 2.1 miles either side of the 062° bearing from the Dubois RGNL: RWY 25-LOC extending from the 7.3-mile radius of Dubois Regional Airport to 9.2 miles northeast of the Dubois Regional Airport; and updates the name of Penn Highlands Healthcare-Dubois Heliport (previously Penn Highlands Healthcare-Dubois Heliport Point In Space Coordinates) to coincide with the FAA's aeronautical database and the airspace reference point.

This action is the result of an airspace review caused by the decommissioning of the Clarion VOR, which provided navigation information for the instrument procedures these airports, as part of the VOR MON Program.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class D airspace, the Class E surface airspace, and the Class E airspace extending upward from 700 feet above the surface at Sioux Gateway Airport/Brigadier General Bud Day Field, Sioux City, IA, to support instrument flight rule operations at this airport.

The FAA published a notice of proposed rulemaking in the Federal Register (86 FR 15445; March 23, 2021) for Docket No. FAA-2021-0176 to amend the amend the Class D and Class E airspace at Sioux Gateway Airport/Brigadier General Bud Day Field, Sioux City, IA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and E airspace designations are published in paragraph 5000, 6002, and 6005, respectively, of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71:

Amends the Class D airspace at Sioux Gateway Airport/Brigadier General Bud Day Field, Sioux City, IA, by adding an extension 1 mile each side of the 001° bearing from the airport extending from the 4.3-mile radius to 4.4 miles north of the airport; updates the name (previously Sioux Gateway/Col. Bud Day Field) and geographic coordinates of the airport to coincide with the FAA's aeronautical database; removes the cities associated with the airports to comply with changes to FAA Order 7400.2M, Procedures for Handling Airspace Matters; and updates the outdated term “Airport/Facility Directory” to “Chart Supplement”;

Amends the Class E surface airspace at Sioux Gateway Airport/Brigadier General Bud Day Field by adding an extension 1 mile each side of the 001° bearing from the airport extending from the 4.3-mile radius to 4.4 miles north of the airport; updates the name (previously Sioux Gateway/Col. Bud Day Field) and geographic coordinates of the airport to coincide with the FAA's aeronautical database; removes the cities associated with the airports to comply with changes to FAA Order 7400.2M; and updates the outdated term “Airport/Facility Directory” to “Chart Supplement”;

And amends the Class E airspace extending upward from 700 feet above the surface at Sioux Gateway Airport/Brigadier General Bud Day Field by removing the Sioux City VORTAC and associated extension from the airspace legal description; amends the extension northwest of the airport to within 3.9 miles (decreased from 4 miles) either side of the 316° (previously 001°) bearing from the Sioux Gateway/Brig. General Bud Day FLD: RWY 13-LOC (previously Sioux Gateway Airport/Col. Bud Day Field) extending from the 6.8-mile radius of the Sioux Gateway Airport/Brigadier General Bud Day Field to 14.4 miles northwest of the Sioux Gateway Airport/Brigadier General Bud Day Field; adds an extension 3.9-miles each side of the 316° bearing from the airport extending from the 6.8-mile radius of the airport to 7.1 miles northwest of the airport; removes the city associated with the airport to comply with changes to FAA Order 7400.2M; and updates the name (previously Sioux Gateway Airport/Col. Bud Day Field) and geographic coordinates of the airport to coincide with the FAA's aeronautical database.

This action is necessary due to an airspace review caused by the decommissioning of the Sioux City VOR, which provided navigation information for the instrument procedures this airport, as part of the VOR MON Program.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace extending upward from 700 feet above the surface at Doylestown Airport, Doylestown, PA, to support instrument flight rule operations at this airport.

The FAA published a notice of proposed rulemaking in the Federal Register (86 FR 13670, March 10, 2021) for Docket No. FAA-2021-0113 to establish Class E airspace extending upward from 700 feet above the surface at Doylestown Airport, Doylestown, PA, to accommodate area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures (SIAPs) serving this airport.

Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in Paragraph 6005, of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic routes, and reporting points.

The FAA is amending 14 CFR part 71 by establishing Class E airspace extending upward from 700 feet above the surface at Doylestown Airport, Doylestown, PA, to accommodate area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures (SIAPs) serving this airport. These changes are necessary for continued safety and management of IFR operations in the area.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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 minimal. Since this is a routine matter that only affects air traffic procedures an air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E surface airspace and the Class E airspace extending upward from 700 feet above the surface at Huron Regional Airport, Huron, SD, to support instrument flight rule operations at this airport.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register (86 FR 18487; April 9, 2021) for Docket No. FAA-2021-0227 to amend the Class E airspace at Huron Regional Airport, Huron, SD. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6002 and 6005, respectively, of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71:

Amends the Class E surface airspace to within a 4.2-mile (decreased from a 4.5-mile) radius of Huron Regional Airport, Huron, SD; and updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

And amends the Class E airspace extending upward from 700 feet above the surface at Huron Regional Airport by removing the Huron VORTAC, Beady NDB, and all extensions from the airspace legal description as they are no longer required; and updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

This action is necessary due to an airspace review caused by the decommissioning of the Huron VOR, which provided navigation information for the instrument procedures this airport, as part of the VOR MON Program.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace extending upward from 700 feet above the surface at Anna Jaques Hospital Heliport, Newburyport, MA, to support instrument flight rule operations at this heliport.

The FAA published a notice of proposed rulemaking in the Federal Register (86 FR 3893, January 15, 2021) for Docket No. FAA-2020-1164 to establish Class E airspace extending upward from 700 feet above the surface at Anna Jaques Hospital Heliport, Newburyport, MA, to accommodate area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures (SIAPs) serving this heliport.

Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments concerning this airspace were received.

Class E airspace designations are published in Paragraph 6005, of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic routes, and reporting points.

The FAA is amending 14 CFR part 71 by establishing Class E airspace extending upward from 700 feet above the surface at Anna Jaques Hospital Heliport, Newburyport, MA, to accommodate area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures (SIAPs) serving this heliport. Subsequent to publication of the Notice of Proposed Rulemaking, the FAA found the geographic coordinates of Anna Jaques Hospital Heliport, were incorrect. This action corrects the error. These changes are necessary for continued safety and management of IFR operations in the area.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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 minimal. Since this is a routine matter that only affects air traffic procedures an air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace extending upward from 700 feet above the surface at Neosho Hugh Robinson Airport, Neosho, MO, to support instrument flight rule operations at this airport.

The FAA published a notice of proposed rulemaking in the Federal Register (86 FR 15447; March 23, 2021) for Docket No. FAA-2021-0177 to amend the amend the Class E airspace at Neosho Hugh Robinson Airport, Neosho, MO. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71 amends the Class E airspace extending upward from 700 feet above the surface to within a 6.5-mile (decreased from a 7-mile) radius of Neosho Hugh Robinson Airport, Neosho, MO; and removes the Neosho VOR/DME and associated extension from the airspace legal description.

This action is necessary due to an airspace review caused by the decommissioning of the Neosho VOR, which provided navigation information for the instrument procedures this airport, as part of the VOR MON Program.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it amends Class D and Class E airspace, and establishes Class E airspace in Worcester, MA, to support IFR operations in the area.

The FAA published a notice of prosed rulemaking in the Federal Register (86 FR 10886 February 23, 2021) for Docket No. FAA-2020-1188 to amend Class D airspace and Class E surface airspace, for Worcester Regional Airport (formerly Worcester Municipal Airport), Worcester, MA, to amend the Class D and Class E surface areas, and amend the Class E airspace extending upward from 700 feet above the surface, and update the airport's name. In addition, the action proposed to establish Class E airspace extending upward from 700 feet above the surface at UMass Memorial Medical Center-University Campus Heliport.

Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and E airspace designations are published in Paragraphs 5000, 6002, and 6005, respectively of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic routes, and reporting points.

The FAA is amending 14 CFR part 71 by amending Class D and Class E surface airspace for Worcester Regional Airport (formerly Worcester Municipal Airport), Worcester, MA. This rule increases the radius of the Class D and Class E surface airspace to 5.1 miles (from 4.2 miles). Also, the airport's Class E airspace extending upward from 700 feet above the surface is increased to a 7.6-mile radius (from 6.7 miles). This action also updates the airport's name. In addition, the FAA establishes Class E airspace extending upward from 700 feet above the surface for UMass Memorial Medical Center—University Campus Heliport, Worcester, MA, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for IFR operations at the heliport. This action also replaces the outdated term Airport/Facility Directory with the term Chart Supplement in the legal description of associated Class D and Class E airspace.

Class D and E airspace designations are published in Paragraphs 5000, 6002, and 6005, respectively, of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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. Since this is a routine matter that only affects air traffic procedures an air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

We are making technical corrections to 17 CFR 240.17a-4 and 17 CFR 240.17a-12 under the Securities Exchange Act of 1934, and Parts II and IIC of Form X-17A-5 (referenced in 17 CFR 249.617). The release resulting in the technical inaccuracies was published in the Federal Register on December 16, 2019 [84 FR 68550], and adopted by the Commission in Exchange Act Release No. 87005 on September 19, 2019.

Accordingly, 17 CFR parts 240 and 249 are corrected by making the following correcting amendments:

We are issuing a final rule to revoke the standards of identity for lowfat yogurt and nonfat yogurt and amend the standard of identity for yogurt in numerous respects. This action is in response, in part, to a citizen petition submitted by the NYA. This action modernizes the yogurt standard to allow for technological advances while preserving the basic nature and essential characteristics of yogurt and promotes honesty and fair dealing in the interest of consumers.

The final rule revokes the standards for lowfat yogurt and nonfat yogurt. Consequently, lowfat yogurt and nonfat yogurt are covered under the general definition and standard of identity in § 130.10 (21 CFR 130.10), which sets out requirements for foods that deviate from other standardized foods due to compliance with a nutrient content claim. The final rule provides a modern yogurt standard to allow for technological advances, preserves but simplifies the basic nature and essential characteristics of yogurt, and promotes honesty and fair dealing in the interest of consumers.

The final rule amends the standard of identity for yogurt by making certain technical changes, permitting reconstituted forms of basic dairy ingredients (cream, milk, partially skimmed milk, and skim milk used alone or in combination) and the use of any optional safe and suitable milk-derived ingredient under certain conditions. The final rule also establishes functional classes of safe and suitable ingredients including cultures, flavoring, color additives, stabilizers, emulsifiers, and preservatives, and replaces the list of nutritive sweeteners with the term “nutritive carbohydrate sweeteners.” The final rule permits the optional labeling statement “contains live and active cultures” or similar statement if the yogurt contains specified amounts of live and active cultures. For yogurt treated to inactivate viable microorganisms, the final rule requires a statement of “does not contain live and active cultures” on the label.

This final rule is issued pursuant to our authority under sections 401, 403(a)(1), 201(n), and 701(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341, 343(a)(1), 321(n), and 371(e)).

Under section 701(e) of the FD&C Act, any action for the amendment or repeal of any definition and standard of identity under section 401 of the FD&C Act for any dairy product ( e.g., yogurt) must be begun by a proposal made either by FDA under our own initiative or by petition of any interested persons, showing reasonable grounds therefore, filed with the Secretary. The NYA submitted such a citizen petition on February 18, 2000, requesting that we, among other things, revoke the standards of identity for lowfat yogurt (§ 131.203 (21 CFR 131.203)) and nonfat yogurt (§ 131.206 (21 CFR 131.206)) and amend the standard of identity for yogurt (§ 131.200 (21 CFR 131.200)).

Because we are publishing this rule in accordance with the formal rulemaking provisions of 5 U.S.C. 556 and 557, this rule is exempt from the economic analysis requirements of Executive Order 12866. However, we have examined the economic implications of this rulemaking on small businesses. On a per firm, per year basis, estimated costs are between approximately $0.3 million and $2.7 million per small yogurt manufacturer per year in 2019 dollars discounted at 3 percent and between approximately $0.4 million and $2.7 million per small yogurt manufacturer per year discounted at 7 percent. The rule will likely benefit some manufacturers by modernizing the yogurt standard to allow for technological advances in food processing and to incorporate flexibility in yogurt manufacturing while preserving the basic nature and essential characteristics of yogurt. Because this rule may generate compliance costs for some small firms, we believe that this rule would have a significant economic impact on a substantial number of small entities.

Section 401 of the FD&C Act directs the Secretary to issue regulations fixing and establishing for any food a reasonable definition and standard of identity whenever, in the judgment of the Secretary, such action will promote honesty and fair dealing in the interest of consumers. Section 403(a)(1) of the FD&C Act deems food to be misbranded if its labeling is false or misleading in any particular. Labeling may be misleading due to affirmative representations made or suggested by statement, word, design, device, or any combination thereof; labeling may also be misleading due to failure to reveal facts material in light of such representations (see section 201(n) of the FD&C Act).

Under section 701(e)(1) of the FD&C Act, any action for the amendment or repeal of any definition and standard of identity under section 401 of the FD&C Act for any dairy product ( e.g., yogurt) must begin with a proposal made either by FDA under our own initiative or by petition of any interested persons. The NYA submitted a citizen petition on February 18, 2000 (Docket No. FDA-2000-P-0126, formerly Docket No. 2000P-0685), under our procedural regulations in 21 CFR 10.30, requesting, among other things, that we revoke the standards of identity for lowfat yogurt (§ 131.203) and nonfat yogurt (§ 131.206) and amend the standard of identity for yogurt (§ 131.200). In the Federal Register of July 3, 2003 (68 FR 39873), FDA issued an advance notice of proposed rulemaking (ANPRM), publishing the proposals in NYA's petition consistent with section 701(e)(1) of the FD&C Act. The ANPRM requested comment on whether the actions proposed in the petition would promote honesty and fair dealing in the interest of consumers. FDA subsequently issued a proposed rule in the Federal Register of January 15, 2009 (74 FR 2443) in part to respond to the citizen petition. FDA is now acting pursuant to section 701(e) of the FD&C Act to finalize the rule.

In the Federal Register of January 30, 1981 (46 FR 9924), we published a final rule establishing standards of identity for yogurt (§ 131.200), lowfat yogurt (§ 131.203), nonfat yogurt (§ 131.206), certain milk products (21 CFR 131.111, 131.112, 131.136, 131.138, 131.144, and 131.146)), and eggnog (21 CFR 131.170)). Interested persons were given until March 2, 1981, to file objections and request a hearing on the final rule. Twenty-one responses were filed objecting to specific provisions of the final rule and, in most cases, requesting a hearing. In response to those objections, we stayed the effective date for provisions regarding certain milk products and eggnog. In addition, we stayed the following provisions in the standards of identity for yogurt, lowfat yogurt, and nonfat yogurt: (1) Provisions that restricted the type of milk-derived ingredients that may be used to increase the milk solids not fat content (§§ 131.200(c)(1), 131.203(c)(1), and 131.206(c)(1) (redesignated as §§ 131.200(d)(1), 131.203(d)(1), and 131.206(d)(1), respectively)); (2) provisions that excluded the use of reconstituted dairy ingredients as basic ingredients (§§ 131.200(a), 131.203(a), and 131.206(a)); (3) provisions that excluded the addition of preservatives (§§ 131.200(c), 131.203(c), and 131.206(c) (redesignated as §§ 131.200(d), 131.203(d), and 131.206(d), respectively)); (4) provisions that set a minimum titratable acidity of 0.9 percent, expressed as lactic acid (§§ 131.200(a), 131.203(a), and 131.206(a)); and (5) § 131.200(a) specifying that the 3.25 percent minimum milkfat level applies after the addition of one or more of the optional sources of milk solids not fat listed in § 131.200(c)(1) (redesignated as § 131.200(d)(1)) (47 FR 41519 at 41523, September 21, 1982).

Due to competing priorities and limited resources, we did not hold a public hearing to resolve these issues, and the effective date for these provisions has been stayed since September 21, 1982. Therefore, these provisions have never been in effect, and yogurt, lowfat yogurt, and nonfat yogurt sold in interstate commerce have not been required to conform to them. Consequently, yogurt, lowfat yogurt, and nonfat yogurt have varied with respect to the type of milk-derived ingredients used to increase the milk solids not fat content, the use of reconstituted dairy ingredients as basic ingredients, addition of preservatives, level of acidity, and application of the minimum milkfat level. These products have, however, been required to conform to the non-stayed provisions in §§ 131.200, 131.203, and 131.206.

In 1990, the Nutrition Labeling and Education Act (NLEA) (Pub. L. 101-535) amended the FD&C Act and established the circumstances in which claims that describe the nutrient content of food could be made. In response to the NLEA, we published a final rule on January 6, 1993, entitled “Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definitions of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food” that established definitions for specific nutrient content claims in part 101 (21 CFR part 101) together with principles for their use (58 FR 2302) (the 1993 final rule). At the same time, we published a final rule entitled “Food Standards: Requirements for Foods Named by Use of a Nutrient Content Claim and a Standardized Term” (58 FR 2431) that established the general definition and standard of identity in § 130.10 for foods that substitute for a standardized food but deviate from the standard of identity due to compliance with an expressed nutrient content claim defined by FDA regulation, including the expressed nutrient content claims “no fat” and “low fat” (see § 101.62(b)) and “light” or “reduced calorie” (see § 101.60(b)).

We noted in the 1993 final rule (58 FR 2302 at 2314) that the common or usual names of certain foods with existing standards of identity include nutrient content claims. Lowfat yogurt and nonfat yogurt are among these foods. We further noted that these foods are exempt under section 403(r)(5)(C) of the FD&C Act from compliance with nutrient content claim definitions established by regulation, provided that the foods were subject to a standard of identity on November 8, 1990. As such, nonfat yogurt and lowfat yogurt are subject to the fat content requirements specified in their respective standards of identity rather than the requirements in § 101.62(b)(1) for “no fat” and § 101.62(b)(2) for “low fat.” In 1995, we proposed to revoke the standards of identity for lowfat yogurt and nonfat yogurt, along with the standards of identity for other dairy foods, so that the foods would be covered under § 130.10 and subject to the nutrient content claim definitions in part 101 (60 FR 56541). This action was intended to provide for consistency in the nomenclature and labeling of food products.

We deferred action on our proposal to revoke the standards of identity for lowfat yogurt and nonfat yogurt (61 FR 58991, November 20, 1996), citing economic considerations and technical difficulties for the yogurt industry if required to fortify lowfat yogurt and nonfat yogurt in accordance with the nutritional equivalence requirement in § 130.10(b) (61 FR 58991 at 58999). We later withdrew the proposed rule on November 26, 2004 (69 FR 68831).

In the Federal Register of January 15, 2009 (74 FR 2443), we published a proposed rule to revoke the standards of identity for lowfat yogurt (§ 131.203) and nonfat yogurt (§ 131.206) and amend the standard of identity for yogurt (§ 131.200). The proposal was, in part, in response to a citizen petition submitted by the NYA on February 18, 2000, and our ANPRM (68 FR 39873; July 3, 2003) in which we asked for comments and information concerning the NYA petition (Docket No. FDA-2000-P-0126, formerly Docket No. 2000P-0685).

We proposed to revoke the standards of identity for lowfat yogurt (§ 131.203) and nonfat yogurt (§ 131.206) so that yogurt (under proposed § 130.200) could be modified according to the “low fat” and “no fat” nutrient content claim definitions in § 101.62(b), thereby bringing lowfat yogurt and nonfat yogurt within the coverage of § 130.10. Consequently, lowfat yogurt and nonfat yogurt would be standardized foods under the general definition and standard of identity, rather than standardized foods under §§ 131.203 and 131.206.

We also proposed numerous changes to the standard of identity for yogurt in § 131.200. In brief, we proposed to modify the description of the standardized food yogurt; define basic dairy, optional dairy, and other optional ingredients used in the manufacture of yogurt; revoke the provisions for optional addition of vitamins A and D and the associated labeling requirements; update or provide the methods of analysis for milk solids not fat, titratable acidity, pH, and live and active cultures; and modify nomenclature, including required and recommended descriptors based on the manufacture of the product.

We further discussed our disagreement with some of the requests in the NYA citizen petition, including the requests to require that yogurt contain a specified amount of live and active cultures; permit the addition of optional milk-derived ingredients after culturing; permit the use of whey protein concentrate as a basic dairy ingredient; require a minimum amount of dairy ingredients; and permit a broad category of safe and suitable ingredients for nutritional or functional purposes (see 74 FR 2443 at 2449 through 2453).

We requested comments on the proposed rule by March 31, 2009. We later extended the comment period to April 29, 2009 (Ref. 1). We received over 6,200 comments (including more than 6,000 form letters) from consumers, industry, trade associations, a scientific organization, and academia.

Some comments supported one or more of the proposed requirements. Other comments opposed certain proposed requirements, suggested changes to the proposed requirements, or asked us to clarify the proposed requirements. Comments from several trade associations representing food manufacturers and ingredient suppliers supported the need to modernize the yogurt standard to allow for recent technological advances in food processing and to incorporate flexibility in yogurt manufacturing while preserving the basic nature and essential characteristics of yogurt. However, other comments urged us not to revoke or change the standards of identity for yogurt, expressing concerns that the proposal would reduce the requirements for yogurt, including those provisions regarding nutrition, quality, safety, and labeling.

In this section, we discuss the issues raised in the comments on the proposed rule and our responses, and we describe the final rule. For ease of reading, we preface each comment discussion with a numbered “Comment,” and each response with a corresponding numbered “Response.” We have numbered each comment to help distinguish among different topics. The number assigned to each comment is for organizational purposes and does not signify the comment's importance or the order in which it was received.

We did not respond to comments outside the scope of this rulemaking, such as comments related to the safety of domestic versus imported ingredients, or country of origin labeling. The final rule is limited to defining the standard of identity for yogurt and revoking the standards for lowfat yogurt and nonfat yogurt.

(Comment 1) Several comments requested that we not change the standard of identity for yogurt. The comments asserted that the proposed rule lowers the requirements for yogurt, yields substantially to the NYA petition, and provides yogurt manufacturers too much flexibility in the manufacture of yogurt.

(Response 1) We disagree with the comments. The final rule does not lower the requirements for yogurt, but rather modernizes the yogurt standard to allow for technological advances while preserving the basic nature and essential characteristics of yogurt and promotes honesty and fair dealing in the interest of consumers. Technological advances in food science and technology allow for a wider range of milk-derived ingredients developed with advances in membrane processing technology in the dairy industry. The final rule permits the use of emulsifiers and preservatives to prevent separation, improve stability and texture, and extend the shelf-life of yogurt. The final rule also allows for modern methods for measuring acidity (pH in addition to titratable acidity) and analysis for milkfat, total solids content, milk solids not fat, titratable acidity, and a method to measure the characteristic live and active cultures or microorganisms in yogurt.

As described in our responses to comments 14, 21, 22, and 30, the final rule modifies some requirements to best preserve the integrity and economic value that consumers expect of yogurt. In addition, the final rule provides regulatory clarity, aligns the standard with products on the market, reflects industry practices, and promotes honesty and fair dealing in the interest of consumers:

Although we considered the NYA petition mentioned in section III.C., we also considered multiple factors, such as new processing technology and ingredients before proposing to amend the yogurt standards.

We also disagree that the rule provides yogurt manufacturers too much flexibility in the manufacture of yogurt. Providing flexibility in manufacturing may increase efficiency while maintaining the basic nature and essential characteristics of yogurt in terms of the taste, flavor, and texture expected by consumers. For example, the variety of yogurt products increased greatly over the years, with thicker Greek-style yogurt becoming as popular as regular yogurt. Permitting optional functional dairy ingredients achieves a desired protein content for Greek-style yogurt prior to culturing/fermentation, and allows for manufacturing without the production of the undesirable acid whey that is potentially a disposal problem. This flexibility also allows the use of technological advances without compromising safety or quality.

(Comment 2) Several comments said that the proposed rule would lower the quality and safety standards for yogurt by specifically allowing non-Grade “A” dairy ingredients to be used in the manufacture of yogurt.

(Response 2) The comments may have misinterpreted the current standards and proposed rule. The current standards for yogurt (§ 131.200), lowfat yogurt (§ 131.203), or nonfat yogurt (§ 131.206) do not specify the use of either Grade “A” or non-Grade “A” dairy ingredients in the manufacture of these products. Nor did we propose or discuss the specific use of non-Grade “A” dairy ingredients in the manufacture of yogurt in the proposed rule. Thus, there is no change between the current standards and the standard of identity for yogurt in this final rule with respect to the use of non-Grade “A” ingredients. The use of safe and suitable milk-derived ingredients as described in the final rule does not lower the value, grade, or safety or attribute requirements for yogurt and its ingredients.

The proposed rule, at § 131.200(a), would require yogurt to contain a minimum of 3.25 percent milkfat, a minimum of 8.25 percent milk solids not fat, and a minimum of 0.7 percent titratable acidity expressed as lactic acid or maximum pH of 4.6, before the addition of bulky flavoring ingredients. The proposed rule also would require yogurt that is labeled with the optional phrase “contains live and active cultures” or another appropriate descriptor to contain a minimum of 10 7 colony forming units per gram (CFU/g) of live and active cultures at the time of manufacture with a reasonable expectation of 10 6 CFU/g throughout the manufacturer's assigned shelf life of the food.

(Comment 3) Some comments supported the proposal requiring yogurt to have a minimum milkfat of 3.25 percent and minimum milk solids not fat of 8.25 percent before the addition of bulky flavoring ingredients. However, one comment would replace the minimum 3.25 percent milkfat requirement with a requirement of 3 g of fat (including milkfat and other fat present in the bulky flavoring ingredients) in the finished product per reference amount customarily consumed (RACC). The comment said that requiring 3.25 percent milkfat before the addition of bulky flavoring ingredients can cause inconsistency because the amount of total fat in the finished product can vary depending on the amount and/or type of added flavoring ingredients. The comment suggested that some flavoring ingredients, such as chocolate, nuts, and coconut, can contribute to total fat in the finished product. The comment stated that a fat requirement based on the finished product would also provide manufacturers the flexibility of adding cream after culturing.

(Response 3) As discussed in the proposed rule (74 FR 2443 at 2448), we do not believe it is appropriate to change the minimum milkfat content to 3 g fat per 255 g, or 1.3 percent, because the yogurt standard with the minimum 3.25 percent milkfat requirement appears to be used in the manufacture of full-fat yogurts available in the marketplace and is consistent with the basic nature and essential characteristics of yogurt. According to the U.S. Department of Agriculture (USDA) FoodData Central (2019), the total fat content of “yogurt, plain, whole milk” is 3.25 g/100 g serving (3.25 percent) (Ref. 2). This is consistent with the minimum milkfat requirement of the current standard of identity for yogurt.

We emphasize that the minimum fat requirement of 3.25 percent is specifically for milkfat. Allowing fat from nondairy ingredients to count towards the minimum fat level deviates from the basic nature and essential characteristics of yogurt as other types of nondairy fats or oils could contribute to variances in the taste, texture, color, or aroma of yogurt (Refs. 3 and 4).

In addition, as discussed in response 15, we are not allowing the addition of optional dairy ingredients, such as pasteurized cream, after culturing. Therefore, it is appropriate to specify a minimum milkfat level of 3.25 percent before the addition of bulky flavoring ingredients.

(Comment 4) Some comments asked us to clarify whether the phrase “bulky flavoring ingredients” in proposed § 131.200(a) has the same meaning as the phrase “bulky flavors” used in § 131.200(a). One comment asked us to use the term “bulky flavors” in the final rule.

(Response 4) We consider the two terms, “bulky flavors” and “bulky flavoring ingredients,” to have similar meaning. Examples of bulky flavoring ingredients are fruit and fruit preparations. To be consistent with most of the dairy standards, we have revised the rule to adopt the term “bulky flavoring ingredients.”

(Comment 5) Currently, the stayed provisions in §§ 131.200(a), 131.203(a), and 131.206(a) specify that yogurt have a titratable acidity of not less than 0.9 percent, expressed as lactic acid. We stayed this provision of the standard on September 21, 1982 (47 FR 41519 at 41522). Titratable acidity and pH can both be used to measure the acidity of a food product. In the proposed rule (74 FR 2443 at 2449), we proposed that yogurt have either a titratable acidity of not less than 0.7 percent, expressed as lactic acid, or a pH of 4.6 or lower.

Several comments agreed that the stayed requirement of 0.9 percent titratable acidity, expressed as lactic acid, should be changed. One comment supported the minimum titratable acidity of 0.7 percent or maximum pH of 4.6. Other comments would modify the minimum titratable acidity to 0.6 percent measured in the cultured and fermented yogurt before the addition of bulky flavor ingredients.

One comment said that a minimum titratable acidity of 0.7 percent in the proposed rule is still too high for yogurt products with chocolate or delicate fruit flavors. Another comment claimed that a lower acidity requirement helps industry develop “light” yogurt products. Other comments pointed out that a minimum 0.6 percent titratable acidity is consistent with the Codex Standard for Fermented Milks (CXS 243-2003) (Ref. 5). Codex Alimentarius (Codex) is an international body established by the Food and Agriculture Organization of the United Nations and the World Health Organization.

Some comments asked us to revise the rule so that the maximum pH of 4.6 applies to finished product within 24 hours after filling. The comments said that, for yogurt that continues to ferment in the final container, such as “cup set” and “warm fill” yogurt, the product pH continues to drop during the cooling step. The comments also argued that, based on our own safety evaluation, we allow all yogurt products to be filled with an initial pH of 4.80 if the product pH reaches 4.6 or below within 24 hours of filling.

(Response 5) We disagree with the comments that would modify the minimum titratable acidity to 0.6 percent or that a minimum titratable acidity of 0.7 percent is still too high for certain yogurt products. Providing for the measurement of acidity in yogurt as a determination of its pH as well as its titratable acidity will introduce flexibility in the yogurt standard and gives manufacturers the flexibility to choose a method that best suits their product. As we noted in the proposed rule, the NYA citizen petition recommended a maximum pH of 4.6, and we believe that allowing a minimum titratable acidity of 0.7 percent or an equivalent maximum pH of 4.6 is appropriate as it reflects current industry practice and better meets some consumers' taste preferences (74 FR 2443 at 2448).

The final rule's requirement of a minimum titratable acidity of 0.7 percent is similar, but not identical, to requirement or position by Codex. We acknowledge that the Codex Standard established a minimum composition for yogurt of 0.6 percent titratable acidity expressed as percent lactic acid. However, yogurt products produced in compliance with our requirement of 0.7 percent titratable acidity would comply with the Codex Standard with respect to titratable acidity. Based on our observation of chocolate yogurt products and yogurt flavored with a variety of fruit flavors currently on the market that have a 0.7 percent titratable acidity, we do not believe that the differences between our final rule and the position taken by Codex will adversely affect the ability of manufacturers to produce yogurt with chocolate or delicate fruit flavors or “light” yogurt products, while maintaining the basic nature and essential characteristics of yogurt.

As for the comments that would revise the rule so that the maximum pH applies to finished products within 24 hours after filling, we view the fill pH as an in-process product characteristic for yogurt products. Requiring a maximum pH of 4.6 in the cultured and fermented yogurt before the addition of bulky flavor ingredients ensures the inhibition of growth and toxin formation of Clostridium botulinum (the pathogenic organism responsible for foodborne botulism). The manufacturer controls the condition after filling to ensure that the characterizing bacterial culture continues to ferment the product to produce a yogurt product with a maximum pH of 4.6 before the addition of bulky flavoring ingredients.

If the yogurt contains bulky flavoring ingredients, the finished product pH reflects the equilibrium pH of the cultured and fermented yogurt including the bulky flavoring ingredients. Some bulky flavoring ingredients ( e.g., fruit preparations) can lower the pH of the cultured and fermented yogurt. Applying the pH requirement to finished product after the addition of these ingredients could indirectly allow the use of acidulants to achieve the desired pH. The yogurt standard does not permit the use of food grade acidulants to meet the acidity or pH requirements (see response 6). To uphold the basic nature and essential characteristics of yogurt while maintaining product safety and attributes, the yogurt standard must ensure that the cultured and fermented yogurt reaches the desired titratable acidity of 0.7 percent or maximum pH of 4.6 solely by the fermentation action of bacterial culture and not through the additions of acidulants or bulky flavoring ingredients like fruit preparations. Thus, we do not agree that the maximum pH of 4.6 should apply only to the finished product.

The final rule, therefore, requires, at § 131.200(a), that yogurt have a titratable acidity of not less than 0.7 percent, expressed as lactic acid, or a pH of 4.6 or lower. We emphasize that both the titratable acidity and the pH requirements apply to yogurt before the addition of bulky flavoring ingredients.

(Comment 6) Several comments stated that the term “culturing” as used in § 131.200(a) should only refer to milk fermentation by the characterizing cultures ( Lactobacillus delbrueckii, subspecies bulgaricus, and Streptococcus thermophilus ) and other additional cultures allowed as optional ingredients. The comments asked us to clarify that “culturing” does not refer to the addition of lactic acid or other acidulants in modifying the standard to allow the use of a broad category of safe and suitable ingredients that serve a nutritional or functional purpose.

(Response 6) We agree that “culturing” as used in § 131.200(a) refers to milk fermentation by the characterizing cultures ( L. delbrueckii, subspecies bulgaricus, and S. thermophilus ), and other cultures as described in § 131.200(d)(1). “Culturing” does not refer to the addition of lactic acid or other acidulants. Lactic acid or other acidulants are not permitted as other optional ingredients under § 131.200(d).

(Comment 7) A few comments said we should not require yogurt to contain a specified amount of live and active cultures and should permit heat treatment of yogurt after culturing to extend shelf life. However, many comments stated that a unique and defining characteristic of yogurt is the presence of live and active cultures and these live and active cultures provide health benefits. These comments indicated that an important health benefit of live and active cultures in yogurt is their ability to break down lactose to allow lactose intolerant individuals to consume yogurt without uncomfortable side effects. One comment stated that over 80 percent of the yogurt products sold in the United States in the time around 2009 declared the presence of live and active cultures either on the labels or on company websites. Another comment provided consumer survey results to contend that consumers expect yogurt products to contain live and active cultures. Other comments indicated that the requirement of live and active cultures is consistent with the Codex standard.

Other comments disagreed whether yogurt can be heat-treated after culturing. Some comments strongly opposed heat treatment after culturing and indicated that labeling the resultant product as “yogurt” is misleading and deceptive because consumers expect yogurt to contain live and active cultures. Other comments did not object to heat treatment after culturing if the package states that the product does not contain live and active cultures.

Some comments opposed any changes to the heat treatment provisions in the existing yogurt standard. The comments argued that, with extended shelf life, heat-treated yogurt gives consumers an additional option for a healthy dairy product. The comments also claimed that neither the presence nor the number of living bacteria in yogurt has any demonstrated health benefit. Some comments also suggested that some yogurt manufacturers may want to market their yogurt products with the claim “contains live and active cultures.” Many comments expressed interest in knowing whether a yogurt product contains live and active cultures.

(Response 7) We analyzed survey data submitted by the NYA and found that, while a majority of respondents expected to find live and active cultures as an ingredient in yogurt, the absence of a discussion in the survey on the response rates raises questions regarding potential bias in the results (Ref. 6). Consequently, we are unable to conclude, based on this survey, that yogurt should necessarily contain live and active cultures or that heat treatment after culturing should be prohibited.

Based on the comments discussing live and active cultures, we believe that many consumers are interested in knowing whether the yogurt products they purchase contains live and active cultures and that this information may impact their purchasing decisions. We therefore conclude that the labeling of yogurt should disclose the absence of live and active cultures rather than the use of heat treatment after culturing. The disclosure statement in § 131.200(f)(1)(ii) has been changed in the final rule to require an accompanying statement of “does not contain live and active cultures” on the product label. Thus, the rule permits the treatment of yogurt after culturing to inactivate viable microorganisms and extend shelf life of the product, provided that the label bears this accompanying statement. We discuss the labeling requirements for such treated yogurt in more detail in responses 27, 28, and 29.

We note that, in the future, new technologies other than heat treatment ( e.g., high pressure processing) may be used to inactivate viable microorganisms in yogurt and extend yogurt shelf life. Therefore, the final rule, at § 131.200(a), states that, to extend the shelf life of the food, yogurt may be treated after culturing to inactivate viable microorganisms rather than limiting yogurt specifically to heat treatment after culturing to extend the shelf life of the food. Such treated foods require an accompanying statement of “does not contain live and active cultures” on the product label.

In a summary and analysis of the consumer survey results submitted by one comment, we did not find that the consumer research results provided evidence that consumers expect all yogurt products to contain live and active cultures (Ref. 6).

Given consumer interest in knowing the presence of live and active cultures in yogurt, manufacturers may wish to affirmatively convey to consumers that live and active cultures are present. Therefore, the final rule, at § 131.200(f)(2), permits the optional labeling statement “contains live and active cultures” or another appropriate descriptor if the yogurt product contains a minimum level of live and active cultures as explained further in response 8.

As for the comments regarding the Codex standard, the final rule is consistent with the Codex standard, which also does not require live and active cultures in heat treated yogurt. For yogurt that is not heat treated, the requirement to permit the optional labeling statement “contains live and active cultures” is consistent with the Codex standard.

(Comment 8) Many comments supported setting a minimum level of live and active cultures. Some comments provided general support without mentioning any specific levels of live and active cultures. Other comments addressed the issue of what level of live and active cultures must be present when the label bears a statement to this effect. Among these comments, some agreed with our proposed levels of live and active cultures. Some supported the minimum level of 10 7 CFU/g of live and active cultures at the time of manufacture but did not support the inclusion of “reasonable expectation of 10 6 CFU/g throughout the manufacturer's assigned shelf life of the product.” One comment stated that manufacturers do not always have control over the storage conditions at retail levels. One comment requested that we not set a minimum level of live and active cultures in the final rule because, for yogurt that is not heat-treated, the provisions on fermentation, minimum titratable acidity, and maximum pH already ensure that the bacterial culture is above 10 7 CFU/g after culturing.

(Response 8) The proposed rule specified a minimum level of live and active cultures of 10 7 CFU/g at the time of manufacture with a reasonable expectation of 10 6 CFU/g through the manufacturer's assigned shelf life of the product. We have included these minimum levels in the final rule under § 131.200(f)(2) for the optional labeling statement “contains live and active cultures.” We decline to revise the rule to specify the minimum level of live and active cultures only at the time of manufacture. The time of manufacture is not the point when consumers purchase or consume their yogurt products. Even though manufacturers do not always have full control over the storage conditions at retail level, yogurt products should be properly refrigerated throughout the distribution channel. Studies generally indicate that the characterizing yogurt cultures survive well during cold storage and at lowered pH levels (Refs.7 through 9). One study shows that, when commercial yogurt products were stored at 4 °C, levels of characterizing yogurt cultures remained relatively stable over the study period of 4 weeks, with 1.0 or less log reduction (Ref. 8). Studies also show that, in non-heated yogurt, the mixture of S. thermophilus and L. bulgaricus is typically well above the minimum 10 6 CFU/g at the end of refrigerated storage, even though some reduction occurred during storage depending on the specific culture used, the storage temperature, and other factors (Refs. 7 through 9). Given these data indicating the minimum of 10 6 CFU/g of live and active cultures will likely exist throughout the shelf life of the food, and to promote honesty and fair dealing in the interest of consumers, the final rule permits the optional labeling statement “contains live and active cultures” or another appropriate descriptor if the yogurt product contains a minimum of 10 7 CFU/g of live and active cultures at the time of manufacture with a reasonable expectation of 10 6 CFU/g throughout the manufacturer's assigned shelf life of the product (§ 131.200(f)(2)).

We also do not agree that the provisions of fermentation, minimum titratable acidity, and maximum pH can replace the requirement of the levels of live and active cultures in the finished product. Although the culturing of yogurt is achieved by milk fermentation by the characterizing culture as described in § 131.200(a) and other cultures as described in § 131.200(d)(1) (see response 6), the optional labeling statement “contains live and active cultures” or another appropriate descriptor refers specifically to the presence of live and active cultures in the finished product. The minimum level of live and active cultures at the time of manufacturing and a reasonably expected level throughout the assigned shelf life provide a uniform production standard. Therefore, the final rule, at § 131.200(f)(1)(ii), requires that, if the yogurt product is labeled with the phrase “contains live and active cultures” or another appropriate descriptor, the yogurt product must contain a minimum of 10 7 CFU/g of live and active cultures at the time of manufacture with a reasonable expectation of 10 6 CFU/g throughout the manufacturer's assigned shelf life of the product.

On our own initiative, for added clarity, we relocated the provisions in proposed § 131.200(a) regarding the minimum number of live and active microorganisms yogurt may contain, to § 131.200(f), “Nomenclature,” describing the number of live and active microorganisms necessary for the product to be labeled with the phrase “contains live and active cultures.”

(Comment 9) One comment opposed heat treatment after culturing and said that, if we permit such practice in the final rule, we should require all non-heat-treated yogurt to contain the proposed minimum levels of live and active cultures regardless of whether any “live and active cultures” label claims are made for the product. The comment reasoned that, under the proposed rule, there were at least three classes of yogurt products: (1) Heat-treated yogurt after culturing; (2) yogurt with live and active cultures and labeled with the voluntary live and active cultures claim; and (3) yogurt with live and active cultures but without any live and active cultures claim. The comment said that these different classes of yogurt can create consumer confusion and that, if we allow heat treatment of yogurt, we should require all non-heat-treated yogurt to contain the minimum levels of live and active cultures to reduce consumer confusion.

(Response 9) We disagree that these categories of products will cause consumer confusion. As discussed in responses 7 and 8, it is not evident that consumers always expect yogurt to contain live and active cultures. As such, labeling appears to be a better approach to informing consumers about the absence or presence of live and active cultures. The labeling provisions in § 131.200(f)(1)(ii) and (2) of the final rule will allow consumers to identify products that do not contain live and active cultures (which is a consequence of treatment after culturing) and products that contain a meaningful amount of live and active cultures. The disclosure statements specified in the provisions are required to accompany the name on the principal display panel of the product label and therefore readily inform consumers about the absence or presence of live and active cultures.

(Comment 10) One comment asked us to clarify that nonstandardized products that use yogurt as an ingredient are not required to meet the minimum level of 10 7 CFU/g live and active cultures. The comment gave examples of nonstandardized products, such as frozen yogurt, yogurt-coated cereal, and dried yogurt powder. The comment also asked us to clarify whether foods that do not meet the standard of identity for yogurt can continue to use the descriptive term “yogurt” as part of the food's name on the label.

(Response 10) Any food that purports to be or is represented as yogurt, must conform to the definition standard of identity for yogurt and its label must bear the name “yogurt” (see 21 U.S.C. 343(g)). Foods that do not purport to be or are not represented as yogurt, are not subject to these requirements. In our experience, products such as frozen yogurt, yogurt-coated cereal, and dried yogurt powder are not represented as and do not purport to be yogurt. Instead, they are nonstandardized foods, and their labels must bear their common or usual names in accordance with section 403(i)(1) of the FD&C Act. Common or usual names are generally established by common usage, though in some cases, common or usual names for nonstandardized foods have been established by regulation (see 21 CFR part 102, subpart B). Because no such regulation for these nonstandardized foods exists, they should be labeled with their common usage names ( e.g., “frozen yogurt), provided that the names do not mislead consumers (see 21 U.S.C. 343(a)(1)).

When “yogurt” is used as part of the name of products such as frozen yogurt, yogurt-coated cereal, and dried yogurt powder, we generally expect that yogurt, or a substance derived from yogurt ( i.e., yogurt powder) is used as an ingredient in their manufacture. The ingredient must be or be derived from yogurt that complies with § 131.200. For example, we expect that an ingredient used in a yogurt drink is yogurt made in accordance with § 131.200, which is then combined with other ingredients to produce a drink product. The ingredient must be declared by its common or usual name in the ingredient statement on the product label in accordance with section 403(i)(2) of the FD&C Act, and § 101.4(a) and (b).

The proposed rule, at § 131.200(b), would state that cream, milk, partially skimmed milk, skim milk, and the reconstituted versions of these ingredients may be used alone or in combination as the basic dairy ingredients in yogurt manufacture. The portion of § 131.200(b) that excluded the use of reconstituted versions of the basic ingredients in yogurt was stayed in 1982, so we could not take compliance action against the use of these ingredients until the stay was formally resolved. Although requested by the NYA petition, we did not propose to permit the use of whey protein concentrate as a basic dairy ingredient in yogurt manufacture (see 74 FR 2443 at 2453).

(Comment 11) Some comments opposed the use of reconstituted forms of basic dairy ingredients but did not provide data to support their assertions of any potential safety or technical concerns. Other comments supported the use of reconstituted forms of basic dairy ingredients and stated that these ingredients are already permitted in the manufacture of other standardized dairy foods, have been routinely used by the yogurt industry due to the stay of § 131.200(c), and do not adversely impact the safety or characteristics of yogurt. One comment would allow the use of all types of safe and suitable milk-derived ingredients to meet the minimum required 8.25 percent milk solids not fat.

(Response 11) The comments opposed to reconstituted forms of dairy ingredients did not provide any data nor do we have any information to indicate any technical or safety concern or that use of these ingredients affects the basic nature and essential characteristics of yogurt or does not comport with consumer expectations about the food. Although the comments provided no data to support that yogurt containing reconstituted forms of dairy ingredients are less acceptable or differ in taste, flavor, or texture to yogurts produced with other basic dairy ingredients, the use of reconstituted forms of dairy ingredients and other optional dairy ingredients in yogurt throughout the marketplace indicates that the basic nature and essential characteristics of yogurt are maintained in producing acceptable and desired yogurt products. Therefore, the final rule includes the reconstituted versions of cream, milk, partially skimmed milk, and skim milk among the basic dairy ingredients in § 131.200(b).

(Comment 12) One comment asked us to expand the list of basic dairy ingredients to include ultrafiltered (UF) milk, its resulting dried products (which were stated to include milk protein concentrate and isolate), and skim milk powder (SMP). The comment described SMP as an ingredient nearly identical to skim milk except for the removal of water and the standardization of protein. The comment stated that allowing UF milk as a basic dairy ingredient for yogurt is consistent with our proposed rule that allows the use of UF milk in standardized cheese and cheese products (70 FR 60751, October 19, 2005). The comment said that the addition of these ingredients does not adversely affect yogurt characteristics or safety.

(Response 12) The current yogurt standard (§ 131.200(c)) lists cream, milk, partially skimmed milk, or skim milk as the basic dairy ingredients. Proposed § 131.200(b) would expand the list by allowing the reconstituted versions of these ingredients. Reconstituted versions are concentrated or dry forms of milk to which water may be added, in a sufficient quantity to reconstitute the dry or concentrated material to fluid form.

The use of fluid UF milk and its dried products as basic ingredients in yogurt is not consistent with the basic nature of yogurt. Fluid UF milk and its dried products are distinctly different from milk and dried milk, respectively. The process of ultrafiltration selectively removes not only water, but also lactose, minerals, and water-soluble vitamins, resulting in a compositionally different ingredient. The use of UF milk also affects the essential characteristics of yogurt, which is a fermented product from milk. The lactose in milk, which is significantly reduced in UF milk, is the substrate for the fermentation process by the bacterial culture in the production of yogurt. In addition, the rationale underlying our 2005 proposal for use of fluid UF milk in standardized cheeses and related cheese products (70 FR 60751) is not applicable to the use of fluid UF milk as a basic ingredient in yogurt because cheese and yogurt have fundamentally different production procedures and are different in their basic nature and essential characteristics. Moreover, the data and evidence the Agency relied on to support its tentative conclusions in the 2005 proposal were specific to standardized cheeses and related cheese products. For these reasons, we decline to revise § 131.200(b) to add fluid UF milk and its dried products for use as basic dairy ingredients in yogurt.

We wish to make clear that the concentrated or dried ingredient used for reconstitution must be such that the reconstituted form does not differ significantly from the respective cream, milk, partially skimmed milk, or skim milk ( i.e., has reestablished the same specified water:solids ratio). For example, concentrated milk (§ 131.115) and dry whole milk (§ 131.147) are appropriate ingredients to reconstitute to produce reconstituted milk. Nonfat dry milk (§ 131.125) is an appropriate ingredient to be used with water to produce reconstituted skim milk. Although fluid UF milk, its resulting dried derivatives, and SMP are not basic dairy ingredients under § 131.200(b), if safe and suitable, they can be used in yogurt as optional dairy ingredients under § 131.200(c). Moreover, limiting the basic dairy ingredients to those in § 131.200(b) is consistent with producing yogurt with the taste, flavor, and texture that consumers expect.

(Comment 13) Two comments agreed on limiting the use of whey and whey ingredients only as optional dairy ingredients in § 131.200(c). In addition, one comment strongly opposed the use of whey protein concentrates as a basic dairy ingredient, citing negative impacts on yogurt quality. One comment supported the use of whey protein concentrate and whey protein isolate as basic dairy ingredients in yogurt making, citing their nutritional, functional, and taste properties. However, the comment did not provide data or evidence to support these assertions.

(Response 13) As discussed in the proposed rule (74 FR 2443 at 2453), the use of whey protein concentrates, whey protein isolate, or other similar products as the basic dairy ingredients for yogurt may result in products that are not consistent with the taste, flavor, or texture expected by consumers. There are no new data or information from our own research or provided in the comments to cause us to change this position. Therefore, as noted in response 12, the final rule permits only the use of cream, milk, partially skimmed milk, skim milk, or the reconstituted versions of these ingredients as the basic dairy ingredients in the manufacture of yogurt under § 131.200(b).

The proposed rule at § 131.200(c) would allow the optional use of other safe and suitable milk-derived ingredients to increase the nonfat solids content of the food, provided that the ratio of protein to total nonfat solids of the food and the protein efficiency ratio of all protein present are not decreased as a result of the use of such ingredients.

Proposed § 131.200(a), would specify that yogurt is a food produced by culturing one or more of the basic dairy ingredients (§ 131.200(b)) and any of the optional dairy ingredients (§ 131.200(c)) with the characterizing bacterial culture. We discussed that any optional safe and suitable milk-derived ingredients can be used to increase the milk solids not fat of the food above the minimum required 8.25 percent (74 FR 2443 at 2450 through 2451).

(Comment 14) The proposed rule, at § 131.200(c), would allow the use of other safe and suitable milk-derived ingredients to increase the nonfat solids content of the food, provided that the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present is not decreased as a result of adding such ingredients.

Several comments agreed with the proposed limit on the use of optional dairy ingredients. However, other comments opposed the use of ingredients other than fluid milk in the manufacture of yogurt. Some comments said that, without a defined list of optional safe and suitable milk-derived ingredients, processors would make determinations based on financial advantages rather than consumer preferences.

Many comments strongly opposed the use of milk-derived ingredients such as milk protein concentrate (MPC) and whey products. The comments expressed concerns about the safety and nutritional quality of such ingredients, the adverse effect on yogurt quality, and the negative economic impact on the U.S. dairy farmers. Some comments opposed the use of MPC, which the comments considered to be an inferior, unregulated, and mostly imported dairy ingredient. Further, the comments opposing the use of MPC questioned whether we performed sufficient evaluations to understand the safety and nutritional quality of MPC. The comment argued that, because MPC is not allowed in other standardized dairy foods, it should not be allowed in yogurt. Some comments indicated that MPC has not been classified as “generally recognized as safe” (GRAS) (21 CFR 170.3 and 170.30; sections 201(s) and 409 of the FD&C Act) and that, according to a 2001 report from the U.S. Government Accountability Office, MPC is not nutritionally equivalent to fluid milk (Ref. 10).

(Response 14) Like any other food ingredient, optional milk-derived ingredients (§ 131.200(c)) used in yogurt must be safe and suitable. Section 130.3(d) (21 CFR 130.3) defines safe and suitable ingredients used in the manufacture of standardized foods. The safe and suitable ingredient must perform an appropriate function in the food when used (§ 130.3(d)(1)) and be used at a level no higher than necessary to achieve its intended purpose in that food (§ 130.3(d)(2)).

We disagree with the comments that only permitting the use of fluid milk or establishing a defined list of optional dairy milk-derived ingredients is necessary to manufacture the taste, aroma, appearance, and nutritional characteristics of yogurt. We do not find a technical reason to exclude one or more types of milk-derived ingredients as optional dairy ingredients if the use of these ingredients complies with all our applicable regulations, including § 130.3(d)(1) and (2).

We disagree with comments regarding safety or the GRAS status of MPC. Under FDA's GRAS notification program, a person may notify FDA of a conclusion that a substance is GRAS under the conditions of its intended use in human food (21 CFR part 170, subpart E). FDA has evaluated GRAS notices for certain functional uses of MPC in food, including yogurt, and did not question the notifier's conclusion that these uses are GRAS (Ref. 11). FDA is not aware of any information at this time that calls into question the safety of the use of MPC in yogurt. We note that it is a manufacturer's responsibility to ensure that food ingredients are safe and are otherwise in compliance with all applicable requirements. Furthermore, any optional dairy ingredients, such as MPC, must be “safe and suitable” according to our regulations whether they are sourced domestically or imported. This means, in relevant part, that any use must be authorized under section 409 of the FD&C Act or be exempt from regulation as a food additive (§ 130.3(d)).

We likewise disagree with the comment's position that MPC is a substandard ingredient. MPC and other non-milk dairy ingredients can be used as optional ingredients, provided the protein efficiency ratio of all protein present must not be decreased as a result of adding optional ingredients. Milk protein concentrates are made by concentrating fluid skim milk using ultrafiltration and spray drying. Because both casein and whey proteins are concentrated in this process, the ratio of casein to whey protein remains nearly the same as the ratio of these components in fluid milk (Ref. 12). Although the comments provided no data to support that yogurt containing MPC in addition to the required dairy ingredients are less acceptable or differ in taste, flavor, or texture to yogurts produced with other optional dairy ingredients, the longtime use of MPC and other optional dairy ingredients in yogurt throughout the marketplace indicates that the basic nature and essential characteristics of yogurt are maintained in producing acceptable and desired yogurt products.

Regarding the use of imported ingredients, we have programs in place, for example inspecting foods that are imported to the United States from other countries, to make sure they comply with government standards and meet the same safety requirements as foods produced within the United States. In general, a foreign or domestic facility that manufactures, processes, packs, or holds food for consumption in the United States and has to register with FDA under section 415 of the FD&C Act (21 U.S.C. 350d) is subject to the requirements related to preventive controls of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117). Compliance with these regulations helps ensure that imported dairy ingredients, including imported MPC, are as safe as domestically produced dairy ingredients.

The comment stating that the use of MPC or whey products as an optional dairy ingredient in yogurt would have a negative economic impact on U.S. dairy farmers did not provide specific information as to how the use of these ingredients would have a negative economic impact. In addition, we note that Congress did not include economic consequences for industry (such as suppliers or manufacturers) as the statutory basis for establishing standards of identity. Section 401 of the FD&C Act permits FDA to establish food standards, and consequently to amend or revoke them, only when doing so “promotes honesty and fair dealing in the interest of consumers.”

Regarding the comment concerning MPC's effect on nutritional quality, the use of MPC does not diminish the nutritional quality of yogurt. Under the proposed rule, at § 131.200(c), the ratio of protein to total nonfat solids of the food and the protein efficiency ratio of all protein present in yogurt must not be decreased as a result of adding the optional dairy ingredients. This provision ensures that the milk protein amount and protein quality are not reduced after the addition of optional dairy ingredients and should address the other concerns regarding the use of MPC on nutritional quality. This provision is now codified at § 131.200(c) in the final rule.

Although the proposed rule would require the minimum of 8.25 percent milk solids not fat at § 131.200(a), and as discussed in the preamble (74 FR 2443 at 2448), the proposed rule at § 131.200(c) did not specify this minimum when describing other safe and suitable milk-derived ingredients that may be used to increase the nonfat solids content of the food. Thus, on our own initiative, for added clarity, in § 131.200(c) we specify the minimum of 8.25 percent milk solids not fat above which other safe and suitable milk derived ingredients may be used to increase the milk solids not fat content of the food as required in § 131.200(a).

Additionally, we note that the phrase “nonfat solids content” in proposed § 131.200(c) would mean the same as the phrase “milk solids not fat” in the proposed § 131.200(a). Therefore, to be consistent in the terms used, we have, on our own initiative, revised § 131.200(c) to use the phrase “milk solids not fat.”

(Comment 15) One comment said that the addition of optional dairy ingredients after culturing should not be permitted for safety concerns, such as microbial contamination. Other comments asked us to permit the addition of optional dairy ingredients after culturing if the optional dairy ingredients are pasteurized and handled in a manner to prevent post-pasteurization contamination. The comments gave cottage cheese as an example of a standardized food in which optional dairy ingredients may be added after culturing; for example, pasteurized cottage cheese dressing is added to the cultured curd.

One yogurt producer stated that adding pasteurized milk-derived ingredients after culturing would conserve water and energy and would provide production flexibility. The comment stated that characterizing the yogurt, e.g., by adjustment of the fat content, at the end of the process rather than the beginning, would reduce water usage for cleaning blend storage silos and flushing lines between blends. The comment also stated that energy costs would be reduced because the pasteurizer could operate more efficiently with fewer stoppages for changeovers between blends.

(Response 15) We decline to revise the rule to permit optional dairy ingredients after culturing, regardless of whether the optional dairy ingredients are pasteurized and handled in a manner to prevent post-pasteurization contamination. The goal of the standard of identity is to preserve the basic nature and the essential characteristics of yogurt consistent with consumer expectations. Yogurt has long been considered a cultured dairy product where the dairy ingredients are combined and cultured together. As we explained in response 5, the yogurt standard must ensure that the cultured and fermented yogurt reaches the desired titratable acidity 0.7 or maximum pH of 4.6 solely by the fermentation action of bacterial culture. This ensures not only the taste and texture characteristics of yogurt are developed, but also maintains the product's safety and characteristics. Unlike cottage cheese, adding optional dairy ingredients after culturing is not consistent with the development of yogurt's characteristic flavor and acidity. Because more than 90 different compounds are responsible for the flavor and aroma of fermented yogurt (Ref. 3), it is essential that the dairy ingredients be cultured together.

Likewise, regardless of the potential to conserve water and energy in manufacturing, the addition of pasteurized milk-derived ingredients after culturing at the end of the process, rather than the beginning, may negatively affect the essential characteristic flavor and aroma of yogurt. Therefore, we decline to revise the rule to permit the addition of milk-derived ingredients after culturing.

(Comment 16) One comment agreed with our proposal to not require a minimum amount of dairy ingredients. Another comment stated that we should set a percentage higher than 51 percent because, according to the comment, yogurt should be mostly made of dairy ingredients.

(Response 16) As explained in the proposed rule, the yogurt standard requires a minimum milkfat of 3.25 percent and a minimum of milk solids not fat of 8.25 percent before the addition of bulky flavoring ingredients (74 FR 2443 at 2447). As noted previously, the 3.25 percent minimum milkfat requirement is consistent with the USDA FoodData Central database for the total fat content of “yogurt, plain, whole milk” (3.25 grams/100 gram serving or 3.25 percent) (Ref. 2). With respect to the minimum milk solids not fat, a minimum of 8.25 percent is consistent with the standards found in fluid milk. Both of these minimum requirements contribute to yogurt's characteristic texture. We noted in the proposed rule that the yogurt standard currently requires that the basic ingredients of yogurt be either milk or certain milk-derived ingredients and that yogurt must contain a specified minimum amount of milk solids not fat (74 FR 2443 at 2453). We did not propose to require a minimum amount of dairy ingredients in yogurt because the existing yogurt standard (§ 131.200(a), (b), and (c)) adequately ensures that appropriate amounts of dairy ingredients are used in the manufacture of yogurt (id.). Therefore, we decline to require a minimum percentage amount of dairy ingredients in yogurt.

The proposed rule, at § 131.200(d), would allow other optional safe and suitable ingredients in the manufacture of yogurt, specifically cultures in addition to the characterizing bacterial cultures, sweeteners, flavoring ingredients, color additives, stabilizers, emulsifiers, and preservatives. In addition, the proposed rule would revoke the provisions on optional addition of vitamins A and D (74 FR 2443 at 2454).

(Comment 17) Most comments generally supported the use of safe and suitable ingredients, specifically cultures, in addition to the characterizing bacterial cultures. The comments stated that explicitly providing for the use of other optional safe and suitable bacterial cultures provides regulatory clarity for the use of microorganisms such as probiotic strains in yogurt products. One comment also stated that the proposal provides industry flexibility while maintaining the product's basic nature and essential characteristics.

(Response 17) We are finalizing § 131.200(d)(1) without change.

(Comment 18) The proposed rule, at § 131.200(d)(2), would allow the use of “sweeteners” (rather than “nutritive carbohydrate sweeteners”) as an optional ingredient, to permit the use of any safe and suitable sweetening ingredient rather than certain nutritive carbohydrate sweeteners. We explained that the proposed changes would allow consumers to still be informed of the presence of the sweetening ingredient through its declaration by its common or usual name in the ingredient statement of the yogurt (74 FR 2443 at 2452). However, in response to the NYA petition's request for the “sweetener being declared in the ingredient statement of the food so that non-nutritive sweeteners may be used in yogurt without a specific declaration of its presence in the name of the food,” we tentatively concluded that there is no basis to make this change (74 FR 2443 at 2451 through 2452).

Several comments supported the change to “sweeteners,” stating that there should be no requirement for the declaration of nonnutritive sweeteners in the name of the food because consumers would be adequately informed of the presence of a sweetening ingredient through the declaration by its common or usual name in the ingredient statement of the yogurt. The comments also stated that amending the rule to refer to sweeteners rather than a specific list of nutritive carbohydrate sweeteners would provide manufacturing flexibility, encourage more low-calorie yogurt options for consumers, and be consistent with the sweetener provision in the standard of identity for ice cream and frozen custard (21 CFR 135.110), which refers to “safe and suitable sweeteners.”

However, other comments opposed a change to “sweeteners” as an optional ingredient. Some comments opposed the use of nonnutritive sweeteners in the yogurt standard of identity because of perceived safety concerns, with some opposing the use of specific artificial sweeteners in yogurt. For example, some comments said that people with sensitivities to a specific artificial sweetener would be unaware the product contained the specific artificial sweetener and could be adversely affected. Other comments stated that, if nonnutritive sweeteners are used, they must be labeled in such a way that consumers are adequately and accurately informed. Several comments would require listing nonnutritive sweeteners in the ingredient statement.

(Response 18) We have decided not to revise § 131.200(d)(2) to specify the use of “sweeteners” in yogurt rather than “nutritive carbohydrate sweeteners.” If we were to amend § 131.200(d)(2) to refer to “sweeteners,” then both nutritive carbohydrate sweeteners and nonnutritive sweeteners would be optional ingredients under the yogurt standard. Consequently, manufacturers could use nonnutritive sweeteners in yogurt to reduce calories without making a nutrient content claim. This is not what we had intended under the regulatory framework of § 130.10 after NLEA was enacted.

We have decided that nonnutritive sweeteners should only be permitted when making a nutrient content claim and therefore when the product is subject to the general definition and standard in § 130.10. As such, products containing nonnutritive sweeteners, but that otherwise comply with the requirements in § 131.200, are not the standardized food “yogurt” and are different standardized foods ( e.g., “reduced calorie yogurt”) under § 130.10. The name of each of these foods must be prominently displayed in the statement of identity on the product label in accordance with § 101.3. We note that this approach is consistent with the approach under our current regulations as § 130.10 permits deviations to §§ 131.200, 131.203, and 131.206 in order to comply with a nutrient content claim defined by regulation ( e.g., “reduced calorie”).

We further note that, under this approach, products deviating from § 131.200 due to the use of nonnutritive sweeteners are not required to declare the presence of the nonnutritive sweeteners in the name or statement of identity of the food. Instead, § 130.10 requires them to bear the nutrient content claim achieved by use of nonnutritive sweeteners in the name or statement of identity. We believe this approach will address comments concerning the presence and disclosure of artificial sweeteners while also providing manufacturers flexibility to make modified yogurt products with nonnutritive sweeteners. Unlike the proposed rule, the final rule does not permit the use of nonnutritive sweeteners in yogurt under § 131.200(d)(2). However, under § 130.10, products marketed with a nutrient content claim in the name of the food ( e.g., “reduced calorie yogurt”) will signal to consumers that the food differs from “yogurt,” “lowfat yogurt,” and “nonfat yogurt” and contains nonnutritive sweeteners. Consumers will continue to be informed about the presence of specific nonnutritive sweeteners by their declaration under their common or usual names in the ingredient statement on the label, as required by § 101.4(a).

We have also considered comments concerning safety. We consider the safety of nonnutritive sweeteners as part of the food additive review process or GRAS notification process. There is no evidence to indicate that nonnutritive sweeteners, either as approved food additives or as GRAS substances in yogurt, are unsafe when used in modified yogurt products. We understand that some consumers may have sensitivities to artificial sweeteners. As explained above, the name or statement of identity of the product will put consumers on notice about the presence of artificial sweeteners and the particular sweetener can be confirmed by referencing the ingredient statement.

(Comment 19) Some comments asked us to require prominent declaration or display ( e.g., in large type on the principal display panel) of nonnutritive sweeteners on yogurt containers in addition to listing the nonnutritive sweeteners in the ingredient statements.

(Response 19) We do not agree that the name of the nonnutritive sweetener should be prominently displayed on the yogurt containers because, under § 130.10, a yogurt product with nonnutritive sweeteners will bear a nutrient content claim, such as “reduced calorie,” in its statement of identity. Section 101.3(d) requires that the statement of identity be presented in bold type on the principal display panel, in a size reasonably related to the most prominent printed matter on such panel, and in lines generally parallel to the base on which the package rests as it is designed to be displayed. The nutrient content claim will signal to consumers the presence of nonnutritive sweeteners and prompt consumers to check the ingredient statements for the types of nonnutritive sweeteners used. Disclosure of nonnutritive sweeteners in the ingredient statement, rather than the name or statement of identity, is consistent with the labeling of other foods made with nonnutritive sweeteners. Nonnutritive sweeteners are declared by their common or usual names in the ingredient statement on the food labels in accordance with § 101.4(a).

In some instances, specific requirements are necessary for the safe use of a nonnutritive sweetener. The conditions for including this information on the label and how and where this information is to be presented on the label are established in the relevant food additive regulations. For example, labels of food that contain aspartame must bear the statement “PHENYLKETONURICS: CONTAINS PHENYLALANINE,” either on the principal display panel or on the information panel, in accordance with § 172.804 (21 CFR 172.804).

Other than what is provided in these regulations, we do not see a basis to require disclosure of nonnutritive sweeteners other than in the ingredient statement. Therefore, we decline to require the name of the nonnutritive sweetener be prominently displayed on the yogurt container. However, manufacturers may declare, voluntarily, on the principal display panel that the product is artificially sweetened or is made with nonnutritive sweeteners as long as the declaration is truthful and not misleading.

(Comment 20) One comment opposed the use of high fructose corn syrup (HFCS) in yogurt.

(Response 20) HFCS is a nutritive carbohydrate. HFCS is affirmed as GRAS and can be used in food with no limitation other than current good manufacturing practice (§ 184.1866 (21 CFR 184.1866)). The comment did not provide any data or other information to support prohibiting the use of HFCS in yogurt, so we decline to revise the rule to exclude HFCS as a sweetener.

(Comment 21) The proposed rule would revise § 131.200(d)(5) to permit the use of safe and suitable emulsifiers in addition to stabilizers as optional ingredients in the manufacture of yogurts.

A few comments opposed the use of emulsifiers and questioned the need for these ingredients in yogurt. Other comments supported the use of emulsifiers in yogurt, indicating that this would allow industry more flexibility in formulating products.

(Response 21) There are no data suggesting that emulsifiers pose any safety or characteristic concerns in yogurt, provided they are used within good manufacturing practice as described in 21 CFR 172.5(a) and within limitations specified by our relevant food additive regulations or are GRAS. Therefore, we decline to remove emulsifiers as an optional ingredient in yogurt. However, to clarify that stabilizers and emulsifiers are two different functional classes, we have, on our own initiative, decided to list stabilizers and emulsifiers separately as § 131.200(d)(5) and (6), respectively. We also have renumbered § 131.200(d)(6) as § 131.200(d)(7).

(Comment 22) The proposed rule, at § 131.200(d)(6), would permit preservatives as an optional ingredient in yogurt. Some comments supported permitting the use of safe and suitable preservatives as optional ingredients in the manufacture of yogurt and stated that the use of preservatives should not be limited only to heat-treated yogurt. Other comments opposed the use of any preservatives.

(Response 22) The proposed rule would not limit the use of preservatives to heat-treated yogurt and would, instead, allow the use of preservatives for all types of yogurt. The comments that opposed the use of preservatives did not provide any data or information to support their opposition, and we do not have any data that indicate that appropriate use of preservatives has an adverse effect on the characteristics of yogurt, particularly in the case of yogurt that is heat-treated after culturing to have an extended shelf-life. Therefore, we decline to revise § 131.200(d)(6) regarding the use of preservatives as an optional ingredient in yogurt, but we have renumbered the section in the final rule as § 131.200(d)(7) (see response 21).

(Comment 23) The proposed rule would revoke § 131.200(b), which provides for optional addition of vitamins A and/or D in yogurt, and revoke § 131.200(f)(1)(iii),which pertains to labeling of yogurt that contains added vitamins A and D. The proposed rule explained, in part, that the provision for the optional fortification of yogurt with vitamins A and D was established in 1981 before the implementation of the NLEA and the adoption of the certain nutrient content and relative claims regulations, including § 101.54. We explained in the proposed rule that we believed it was appropriate to apply the provisions of § 101.54(e) to vitamins A and D fortification of yogurt (74 FR 2443 at 2454).

We invited comment on whether we should retain the current optional vitamin addition provisions of § 131.200(b) and, if so, what the justification for retaining these provisions would be, and the appropriateness of applying § 101.54(e) to yogurt fortified with vitamins A and/or D. One comment agreed with removing the provisions pertaining to optional addition of vitamins A and D.

However, other comments asked us to retain the current optional vitamin fortification provisions and the associated labeling provision. The comments said that, even though such provisions are not consistent with the NLEA and the nutrient content claim regulations, optional vitamins A and D fortification is a longstanding practice for the yogurt industry and is consistent with the standards of identity for other milk products in 21 CFR part 131.

Another comment said we should revise the amounts of vitamins A and D fortification based on percentages of recommended Daily Values (DV) rather than specific levels per quart. The comment recommended we modernize the optional vitamin A addition of not less than 10 percent DV per RACC and optional vitamin D addition of not less than 25 percent DV per RACC in the final rule.

(Response 23) Given the yogurt industry's current fortification practice and apparent consumer acceptance of optional fortification with corresponding ingredient declaration, the final rule does not remove the provisions concerning the optional addition of vitamins A and D. For these reasons, the provisions for optional addition of vitamins A and D remain part of the yogurt standard; however, because the final rule also reorganizes and renumbers the provisions in § 131.200, we have placed the provisions regarding optional vitamin addition in § 131.200(d)(8).

We believe that modernization of the yogurt standard of identity should include bringing the outdated vitamins A and D fortification provisions in conformity with the way in which vitamins are now referenced based on percentages of recommended DV rather than specific levels per quart. Therefore, the final rule, at § 131.200(d)(8), provides for the optional addition of vitamin A if added at not less than 10 percent Daily Value per RACC, and/or the optional addition of vitamin D if added at not less than 25 percent Daily Value per RACC.

In addition, we decline to revoke the labeling requirements associated with optional vitamins A and/or D addition. To inform consumers about the optional addition of vitamins A and/or vitamin D, these requirements remain part of the yogurt standard in § 131.200(f)(1)(iii).

(Comment 24) The proposed rule discussed that the standards of identity for yogurt, lowfat yogurt, and nonfat yogurt do not permit the optional use of any safe and suitable ingredient for a nutritional or functional purpose. We explained that while the NYA petition asked us to revise our regulations to allow for such ingredients and while comments to the ANPRM both favored and opposed the NYA recommendation, we decided that there was not a need for a broad provision to permit any safe and suitable ingredient for a nutritional or functional purpose (74 FR 2443 at 2453).

The comments to the proposed rule were mixed on whether we should add a broad provision permitting the use of any safe and suitable ingredient that serves a nutritional or functional purpose. Some stated that such an approach would help maintain the integrity of yogurt. Other comments said that any safe and suitable ingredient should be allowed to provide flexibility and to promote innovation. One comment was concerned that yogurt bearing nutrient content claims would no longer fall under the standard of identity without a provision that would allow the use of any safe and suitable ingredient for a nutritional or functional purpose. Another comment emphasized that lactic acid and other acidulants as functional ingredients should not be allowed.

(Response 24) As we explained in the proposed rule, our existing regulatory framework governing standardized foods already provides for the addition of substances for a nutritional purpose (74 FR 2443 at 2453). As for the use of ingredients for a functional purpose, the final rule, at § 131.200(c), provides for the use of optional dairy ingredients to increase the nonfat solids content of food under certain conditions. The final rule, at § 131.200(d), also provides for the use of specific functional categories of ingredients such as emulsifiers and stabilizers. We revised § 131.200 to retain the optional addition of vitamins A and/or D. Section 131.200(d)(8) now provides for optional addition of these vitamins as in our current standard of identity for yogurt but has been revised to specify the amounts of added vitamins A and D based on percentages of DV per RACC rather than International Units per quart.

Although § 131.200(c) and (d) permit the use of certain optional ingredients for nutritional or functional purposes in yogurt, lactic acid and other acidulants are not permitted as other optional ingredients under § 131.200(d). Yogurt is produced by culturing the basic dairy ingredients and any optional dairy ingredients with a characterizing lactic acid-producing bacterial culture, and not through the addition of lactic acid or other acidulants (see response 6).

The current standard of identity for yogurt lists the methods of analysis for milkfat content, total solids content, and titratable acidity that are from the “Official Methods of Analysis of AOAC International,” 13th Ed. (1980). The proposed rule, at § 131.200(e), would update the referenced methods of analysis to “Official Methods of Analysis of AOAC International (AOAC Methods),” 18th edition, 2005. The AOAC Methods have been updated twice since the publication of the proposed rule. The latest version is the 21st edition, 2019. Therefore, on our own initiative, we have revised § 131.200(e) to refer to the 21st edition of the AOAC Methods.

The proposed rule inadvertently deleted the milkfat method of analysis from § 131.200(e). Therefore, on our own initiative, we have revised § 131.200(e) by restoring the method of analysis for milkfat referencing the updated modified Mojonnier ether extraction method in section 33.2.26 of the AOAC Methods: Official Method 989.05. Thus, we have revised § 131.200(e)(1) by adding paragraph (i) to identify the AOAC Official Method 989.05 for milkfat content and renumbering the remaining paragraphs accordingly.

The proposed rule, at § 131.200(e)(1)(i) and (ii), would establish the methods of analysis for milk solids not fat and for titratable acidity, respectively.

We did not receive comments on these provisions. However, as explained previously, we have renumbered these provisions as § 131.200(e)(1)(ii) and (iii), respectively, because we have restored the inadvertent deletion of the method of analysis for milkfat at § 131.200(e)(1)(i).

Proposed § 131.200(e)(2) would adopt the potentiometric method for pH as described in § 114.90(a) (21 CFR 114.90(a)).

We did not receive comments on the method for pH that indicated a need to change methodology, and we have finalized § 131.200(e)(2) without change.

(Comment 25) Proposed § 131.200(e)(3) would discuss the measurement of live and active cultures and refer to the use of the aerobic plate count method described in Chapter 3 of FDA's Bacteriological Analytical Manual, January 2001 edition (the BAM method) (Ref. 13). Several comments objected to the use of the BAM method. The comments indicated that the BAM method is not appropriate for the accurate enumeration of live and active cultures in yogurt. The comments recommended that, for accuracy and repeatability, live and active cultures should be determined by the method described in the International Organization for Standardization (ISO) 7889/International Dairy Federation (IDF) 117:2003 (ISO 7889/IDF 117:2003), “Yogurt-Enumeration of characteristic microorganisms—colony count-technique at 37 °C” (Ref. 14).

(Response 25) We evaluated the BAM method and the ISO 7889/IDF 117:2003 method. We agree that the BAM method is a general reference for determining plate counts and is not designed specifically for the measurement of characterizing cultures in yogurt products. We also agree that the ISO 7889/IDF 117:2003 method, which is specifically designed to measure the characteristic microorganisms in yogurt, is the appropriate method. The ISO 7889/IDF 117:2003 method is also referenced as the appropriate method to enumerate characterizing microorganisms in yogurt in the Standard Methods for the Examination of Dairy Products (Ref. 15). Therefore, we have revised § 131.200(e)(3) and replaced the proposed BAM method with the ISO 7889/IDF 117:2003 method incorporated by reference in the final rule.

(Comment 26) One comment said that, for other safe and suitable organisms, individual yogurt manufacturers should bear the responsibility of using validated methods to enumerate such bacteria to substantiate label claims.

(Response 26) We agree that manufacturers using other safe and suitable bacterial cultures have or should have the knowledge to determine the most appropriate method to enumerate these organisms. Therefore, the final rule does not specify methods to measure other safe and suitable bacterial cultures to substantiate label claims.

The proposed rule would revise § 131.200(f) by: (1) Stating that the word “sweetened” must accompany the name of the food wherever it appears on the principal display panel or panels if a “sweetener” (rather than a nutritive carbohydrate sweetener) is added without the addition of characterizing flavor; and (2) providing for the optional labeling of “contains live and active cultures.”

As discussed in responses 18, 19, and 20, we have decided to retain the term “nutritive carbohydrate sweeteners” in § 131.200(d)(2) instead of using the term “sweeteners.” Likewise, we have decided to retain “nutritive carbohydrate sweetener” in § 131.200(f)(1)(i) rather than use the term “sweetener.” The requirement in § 131.200(f)(1)(i) continues to apply only to nutritive carbohydrate sweeteners and is not amended under this final rule. Under § 130.10, nonnutritive sweeteners can be used in the manufacture of yogurt products that deviate from the standard of identity for yogurt in order to meet an expressed nutrient content claim defined by regulation ( e.g., “reduced calorie”). The nutrient content claim is part of the name or the statement of identity of the food ( e.g., “reduced calorie yogurt”) and signals to consumers that the food differs from yogurt and contains nonnutritive sweeteners.

As discussed in responses 27, 28, and 29 regarding the labeling of yogurt containing live and active cultures, the final rule revises the proposed nomenclature provisions relating to heat-treated yogurt. Changes in the final rule at § 131.200(a), (b), (c), and (d) necessitate additional changes in § 131.200(f) regarding nomenclature provisions in the final rule.

(Comment 27) Currently, § 131.200(f)(1)(ii) requires that, if the yogurt product is heat-treated after culturing, the parenthetical phrase “(heat-treated after culturing)” must follow the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half of the height of the letters used in such name. The proposed rule would revise § 131.200(f)(1)(ii) by requiring the parenthetical phrase “(heat-treated after culturing)” to appear after the name of the food if the dairy ingredients have been heat-treated after culturing.

One comment opposed modifying the labeling requirements for heat-treated yogurt. The comment also opposed the requirement of any phrase on the label of heat-treated yogurt that would classify it as one that does not contain live and active cultures, arguing that there is no difference in the effect on the human body between the consumption of yogurt with live and active cultures and those without. Other comments expressed concerns that consumers may not understand the statement “heat-treated after culturing,” although one comment did agree with the proposed rule. Another comment cited a consumer survey that evaluated consumer understanding of the phrase “heat-treated after culturing.” The comment claimed that the cited survey indicated that the meaning of this phrase is not clear to most consumers and does not inform consumers that the treatment destroys some or all the bacterial cultures.

Many comments opposed heat treatment after culturing but said that, if heat treatment after culturing is allowed, the product should be clearly labeled (see comment 7). One comment would require a statement on the package to indicate that the product “does not contain live and active cultures.”

(Response 27) As discussed in response 7, many consumers are interested in knowing whether the yogurt product they purchase contains live and active cultures. The term used in the proposed rule “heat-treated after culturing” is a description of a manufacturing process and does not directly inform consumers how the manufacturing process affects the properties of finished yogurt product. Apart from the nutritional aspect, the beneficial effect of yogurt or yogurt cultures is reportedly either lost (Ref. 16) or reduced (Refs. 17 to 20) when the yogurt is heat-treated after culturing. In the proposed rule, we recommended that manufacturers may consider using additional truthful and non-misleading statements, such as “does not contain live and active cultures,” in the labeling of their heat-treated yogurt products to help consumers distinguish heat-treated yogurt from traditional yogurt (74 FR 2443 at 2450). We evaluated the consumer survey results and conclude that the survey findings support the belief that many consumers do not understand the meaning of the term “heat-treated after culturing” (Ref. 6). We find that the term “heat-treated after culturing” does not adequately inform consumers whether the yogurt still contains live and active cultures in the final product. To prevent the labeling of yogurt from being misleading under section 403(a)(1) and 201(n) of the FD&C Act, the phrase “does not contain live and active cultures” should appear on the label of yogurt instead of “heat-treated after culturing” when the final product does not contain live and active cultures. Therefore, we have revised § 131.200(f)(1)(ii) to require the phrase “does not contain live and active cultures” if the dairy ingredients have been treated after culturing to inactivate viable microorganisms.

(Comment 28) One comment stated that new and emerging thermal treatment technologies that are less severe than pasteurization conditions have been used to enhance the sensory profile of a product or for acidity purposes. The comment asked us to clarify that, if these heated yogurt products still contain a minimum of 10 7 CFU/g live and active cultures at the time of manufacture, they do not have to bear the statement indicating that they have been heat-treated or do not contain live and active cultures.

(Response 28) We understand that the impact of a heat treatment will vary depending on heating temperature and holding time. We agree that it would not be appropriate to require heated yogurt products with 10 7 CFU/g live and active cultures to bear the “does not contain live and active cultures” statement. As discussed in response 7, we realize that, in the future, new technologies other than heat treatment may be developed to inactivate viable microorganisms and thus extend a product's shelf life. The “does not contain live and active cultures” statement should not be limited to only heat-treated yogurt. It would be appropriate for products that have not been heat-treated but have been treated with other alternative technologies to inactivate viable microorganisms, to bear the “does not contain live and active cultures” statement to adequately inform consumers. Therefore, we have revised § 131.200(f)(1)(ii) to require that the phrase “does not contain live and active cultures” accompany the name of the food if the yogurt has been treated after culturing to inactivate viable microorganisms.

(Comment 29) A few comments requested that we require the statement “does not contain live and active cultures” to appear prominently on the label or in the same size, font, and color as the name of the food and in close proximity to the name of the food without intervening material.

(Response 29) Under § 131.200(f)(1)(ii), the phrase “does not contain live and active cultures” is required to accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half of the height of the letters used in the name. We do not agree with the comments that the phrase “does not contain live and active cultures” must appear in the same size, font, and color as the name of the food. The comments did not demonstrate why use of the same size, font, and color as the name of the food would improve consumer attention to or understanding of the phrase.

(Comment 30) Some comments supported revoking the standards of identity for lowfat yogurt and nonfat yogurt such that the standardized food yogurt under proposed § 131.200 could be modified to produce lower-fat versions of yogurt under § 130.10. (For purposes of this preamble, “lower-fat” versions of yogurt refers to products with less than 3.25 percent minimum fat level specified in § 131.200(a).) Other comments were concerned that there will be no standard of identity for these lower-fat versions of yogurt.

(Response 30) Revocation of § 131.203 and § 131.206 will result in lowfat yogurt and nonfat yogurt being covered under the general definition and standard of identity in § 130.10. This action will provide for consistency in the nomenclature and labeling of “lowfat” and “no fat” food products and help ensure “lowfat” yogurt meets consumer expectations. These foods, along with other lower-fat versions of yogurt, will be standardized foods with a standard of identity under this regulation. Because § 130.10 only permits specific deviations from the standardized food for which a lower-fat version substitutes, many requirements in the yogurt standard of identity will apply to lower-fat versions and will help maintain the basic nature and essential characteristics of these products.

(Comment 31) The proposed rule did not discuss when a final rule would become effective or when the compliance date for a final rule would occur.

One comment requested a 2-year implementation date for necessary label changes after the final rule. The comment indicated that revoking the standards of identity for lowfat yogurt and nonfat yogurt would require these products to be fortified to achieve nutrient equivalency. The comment also stated that the 2-year implementation date is consistent with the Uniform Compliance Date for label changes and will provide enough time for processors to deplete existing packaging inventory, reformulate products, install fortification equipment, and make the necessary label changes. Another comment asked us to align the compliance timeline of the final yogurt rule with that of a then-unpublished final rule to revise our Nutrition and Supplement Facts Label requirements (79 FR 11880, March 3, 2014). The comment said that companies could revise yogurt labels much more efficiently by making a single set of changes in response to both sets of requirements and minimize the economic impact of label changes.

(Response 31) The final rule is effective on July 12, 2021. The compliance date of this final rule is January 1, 2024, consistent with Uniform Compliance Date for final food labeling regulations that are issued in calendar years 2021 and 2022 (see 86 FR 462, January 6, 2021).

We decline to align the compliance date with that for the final Nutrition and Supplement Facts Label regulations. We note that the compliance date for the final Nutrition and Supplement Facts Label regulations is January 1, 2020, for manufacturers with $10 million or more in annual food sales and January 1, 2021, for manufacturers with less than $10 million in annual food sales (83 FR 19619, May 4, 2018). Thus, these compliance dates for the Nutrition and Supplement Facts Label regulation have already passed.

Revoking the standards of identity for lowfat yogurt and nonfat yogurt brings these foods under the coverage of the general definition and standard in § 130.10. For foods covered under the general definition and standard, § 130.10(b) requires nutrients to be added to restore nutrient levels so that the product is not nutritionally inferior to the standardized food as defined in 21 CFR parts 131 to 169. As discussed in the proposed rule, lowfat yogurt and nonfat yogurt have a lower vitamin A content than yogurt and therefore would be required under § 130.10(b) to be fortified with vitamin A to the same level as yogurt.

(Comment 32) One comment supported nutritional equivalence of lowfat yogurt and nonfat yogurt with yogurt under § 130.10(b), noting that the requirement would make these foods consistent with other foods modified under the general definition and standard. Another comment opposed mandatory fortification of lowfat yogurt and nonfat yogurt with vitamin A based on the costs of compliance for industry.

(Response 32) Requiring vitamin A fortification of lower-fat yogurt products under § 130.10(b) would not necessarily make these products consistent with other modified dairy foods. FDA has not enforced § 130.10(b) with respect to vitamin A fortification of lower-fat milk products covered under the general definition and standard (see South Mt. Creamery, LLC v. United States FDA, 438 F. Supp. 3d 236 (2020)). Moreover, as noted in the proposal, the contribution of yogurt to daily vitamin A intake is not expected to be altered significantly if the nutritional equivalency requirement in § 130.10(b) were to apply to lowfat yogurt and nonfat yogurt. Although yogurt consumption has increased in recent years, the contribution of vitamin A that would result from fortification of lower-fat yogurt products remains insignificant (Ref. 21). Thus, in light of our enforcement policy regarding vitamin A fortification of lower-fat milk products and the lack of public health impact from vitamin A fortification of yogurt, we are amending § 130.10(b) to exempt lower-fat yogurt products from vitamin A fortification.

This final rule revises § 130.10(b) to provide for the exemption. Manufacturers may choose to fortify lowfat yogurt and nonfat yogurt with vitamin A to the level in yogurt; however, they are not required to do so. If they choose to fortify with vitamin A under § 130.10(b), then vitamin A must be declared in the ingredient statement.

The final rule incorporates two references. As we explained in part IV.G, FDA is incorporating by reference three methods from the “Official Methods of Analysis of AOAC International,” 21st edition (2019). You may purchase a copy of the material from AOAC INTERNATIONAL, 2275 Research Blvd., Suite 300, Rockville, MD 20850-3250, USA, 301-924-7077 ext. 170. https://www.aoac.org/official-methods-of-analysis-21st-edition-2019/. The AOAC Methods have undergone rigorous scientific review and validation to determine the performance characteristics for the intended analytical application and fitness for purpose. Each of the following three methods includes specific instructions for performing the chemical analysis of a substance in a particular matrix.

• AOAC Official Method 947.05, Acidity of Milk Titrimetric Method, 21st edition, 2019, Vol. 1.

• AOAC Official Method 989.05, Fat in Milk Modified Mojonnier Ether Extraction Method, 21st edition, 2019, Vol. 1.

• AOAC Official Method 990.21, Solids-Not-Fat in Milk by Difference between Total Solids and Fat Contents, 21st edition, 2019, Vol. 1.

Also, FDA is incorporating by reference the International Organization for Standardization 7889:2003(E)/International Dairy Federation 117:2003(E) (ISO 7889:2003(E)|IDF 117:2003(E)), Yogurt—Enumeration of Characteristic Microorganisms—Colony-Count Technique at 37 °C, First edition, 2003-02-01. You may purchase a copy of the material from the International Organization for Standardization, ISO Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland. +41 22 749 01 11. central@iso.org. ISO 7889|IDF 117:2003 specifies a method for the enumeration of characteristic microorganisms in yogurt by means of the colony-count technique at 37 degrees Celsius. The method is applicable to yogurts in which both characteristic microorganisms ( L. delbrueckii subspecies bulgaricus and S. thermophilus ) are present and viable.

This rule is issued in accordance with the formal rulemaking provisions of 5 U.S.C. 556 and 557, and is, therefore, exempt from the economic analysis requirements of Executive Order (E.O.) 12866 and E.O. 13563. We have examined the economic implications of this rulemaking on small businesses.

The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule may generate compliance costs for some small firms, we believe that this rule would have a significant economic impact on a substantial number of small entities and is therefore subject to a final regulatory flexibility analysis (5 U.S.C. 604). The following analysis, in conjunction with the remainder of the preamble, constitutes our final regulatory flexibility analysis.

One requirement of the Regulatory Flexibility Act is a succinct statement of any objectives of the rule. As stated previously in the preamble, with this rule, we intend to amend the yogurt standard of identity and revoke the lowfat yogurt and nonfat yogurt standards of identity to promote honesty and fair dealing in the interest of consumers. The amendments are intended to modernize the current yogurt standard and allow for lowfat yogurt and nonfat yogurt to be covered under the general definition and standard to permit flexibility and provide for technological advances in yogurt production, while preserving the basic nature and essential characteristics of yogurt, lowfat yogurt, and nonfat yogurt consistent with consumer expectations and protecting consumer interests.

This rule would affect yogurt manufacturing firms in the Standard Industrial Classification (SIC) code 20260208 (“Yogurt Manufacturing”). The equivalent North American Industry Classification System (NAICS) code is 311511 (“Fluid Milk Manufacturing”). The Small Business Administration (SBA) defines a small business in NAICS code 311511 as a business with 500 or fewer employees. This rule will not affect firms that manufacture products such as frozen yogurt, dried yogurt-style mixes, or products that contain yogurt as an ingredient.

We searched the Dun and Bradstreet database for U.S. firms in SIC code 20260208 (“Yogurt Manufacturing”) and identified 450 firms. To exclude firms not engaged in the manufacture of yogurt, we performed an internet search of the name of each firm and identified frozen yogurt manufacturers. After excluding frozen yogurt manufacturers, we estimate that there are approximately 31 U.S. yogurt manufacturers, of which approximately 9, or 29 percent (= 31 × 0.29), are small businesses per SBA definition.

We expect that three provisions of the final rule may require some small firms to change their current activity. The other provisions of the final rule provide additional flexibility to firms beyond that available under current requirements. For this analysis, we estimate costs for those provisions that may require some small firms to change their current practices. We do not estimate costs for changing manufacturing practices in ways that would be newly permitted by the final rule as costs of the final rule.

The three provisions that we estimate will require some small firms to change their current practices are:

1. The requirement that yogurt have either a titratable acidity of not less than 0.7 percent expressed as lactic acid or a pH of 4.6 or lower (“Acidity Requirement”).

2. The requirement that yogurt bearing optional labeling statements such as “contains live and active cultures” must contain a minimum of 10 7 CFU/g of live and active cultures at the time of manufacture with a reasonable expectation that the yogurt will contain live and active cultures at a level of 10 6 CFU/g through the manufacturer's assigned shelf life of the product, as well as the requirement that yogurt that is treated after culturing bear on its label the statement “does not contain live and active cultures” (“Claims Requirements”).

3. The revocation of the standards of identity for lowfat yogurt (§ 131.203) and nonfat yogurt (§ 131.206) (“Standards of Identity Revocation”).

The following analysis estimates the costs of each provision to small manufacturers.

The final rule requires that yogurt have either a titratable acidity of not less than 0.7 percent expressed as lactic acid or a pH of 4.6 or lower. We stated that we believed that all or nearly all yogurt currently on the market had a titratable acidity above the then-proposed minimum cutoff of 0.7 percent, usually in the range of 1.0 to 1.3 percent, and a pH level below the proposed maximum level of 4.6, usually ranging from 4.1 to 4.3. At the time, we estimated that the proposed acidity requirements would generate minimal or no compliance costs. We received no comments on this.

In the final rule, we require that yogurt have either a titratable acidity of not less than 0.7 percent expressed as lactic acid or a pH of 4.6 or lower. We still believe that all or nearly all yogurt currently on the market has a titratable acidity above the minimum cutoff of 0.7 percent titratable acidity, usually ranging from 1.0 to 1.3 percent, and a pH level below the proposed maximum level of 4.6, usually ranging from 4.1 to 4.3. We estimate that the Acidity Requirement would generate minimal or no compliance costs.

Yogurt manufacturers who want to include the optional statement “contains live and active cultures” or similar claims on labels will be required to show that their yogurt contains at least 10 7 CFU/g of live and active cultures at the time of manufacture of the yogurt using analytical testing methods. Otherwise, such a claim cannot be made. In addition, yogurt products that are treated to inactivate viable microorganisms after culturing but do not currently bear the claim “does not contain live and active cultures” will be required to add this claim to labels. This was modified for clarity as the proposed rule would require yogurt products that are heat-treated after culturing to bear the claim “heat-treated after culturing” on their label and it would advise, but not require, that such yogurt products also bear the claim “does not contain live and active cultures” on their label.

Based on an analysis of yogurt UPCs using the online grocery shopping platform Peapod®, approximately 85 percent of yogurt UPCs currently make a “contains live and active cultures” or similar claim. Approximately 15 percent of yogurt UPCs make no such claims. We estimate that approximately 1,972 UPCs manufactured by small yogurt manufacturers, or equivalently 8 small yogurt manufacturers, will be affected by the Claims Requirement related to the “contains live and active cultures” or similar claim (“Claims Requirement A”) and approximately 348 UPCs manufactured by small yogurt manufacturers, or equivalently 1 small yogurt manufacturer, will be affected by the Claims Requirement related to the “does not contain live and active cultures” claim (“Claims Requirement B”).

Based on further analysis of yogurt UPCs using Peapod®, 56 percent of yogurt UPCs that make a “contains live and active cultures” or similar claim also make a claim that they meet the NYA standard for live and active cultures. The NYA's standard of at least 10 8 CFU/g at the time of manufacture is higher than our standard of at least 10 7 CFU/g. We estimate that approximately 1,105 of the 1,972 UPCs that are affected by Claims Requirement A and are manufactured by small yogurt manufacturers will only need to incur analytical testing costs related to this Claims Requirement.

We do not know how many of the remaining 868 small manufacturer yogurt UPCs that are affected by Claims Requirement A meet this Claims Requirement. Therefore, we conservatively estimate that none do, so that some of these UPCs will need to incur analytical testing costs and reformulation costs to prove that they meet the 10 7 live and active cultures standard. Others will need to incur relabeling costs associated with removing the “contains live and active cultures” or similar claims from labels. As we are not aware of data on these proportions, we estimate an even split between these possibilities, with approximately 434 UPCs incurring analytical testing and reformulation costs and approximately 434 UPCs incurring relabeling costs. Finally, we do not know how many of the 348 small manufacturer yogurt UPCs that do not make any kind of a “contains live and active cultures” or similar claim undergo heat treatment after culturing and would be subject to Claims Requirement B. Therefore, we conservatively estimate that all undergo heat treatment after culturing and estimate the relabeling costs associated with adding the phrase “does not contain live and active cultures” to their labels.

We estimate analytical testing costs using information on formula and UPC counts from 2014 Nielsen Scantrack data, as well as information gathered on published prices from various testing laboratories. This information was gathered by RTI International as part of its development of the FDA Labeling Cost Model. We estimate that the total number of yogurt formulas is approximately 6,070 and the total number of yogurt UPCs is approximately 8,002, yielding a formula-to-UPC ratio of 0.759 (6,070/8,002 = 0.759). The total number of UPCs that will require analytical testing is approximately 1,539 and the total number of formulas subject to analytical testing is approximately 1,167. Analytical tests designed to detect pathogens in food cost between $25.72 and $60.81 in 2019 dollars per formula. These costs represent an estimate of the costs of measuring the amount of CFU/g in yogurt. We estimate that two samples per formula are tested and that labor costs to prepare samples are approximately $29.58 and shipping costs related to shipping the samples to the testing laboratory are approximately $70.81 in 2019 dollars. Therefore, we estimate analytical testing costs to be between approximately $177,206 and $259,105 per year.

The number of small yogurt UPCs that will reformulate related to Claims Requirement A is approximately 434 and the total number of formulas subject to reformulation is approximately 329. We estimated reformulation costs by multiplying the number of formulas by estimates of per-formula costs. We obtain per-formula cost estimates from the FDA Reformulation Cost Model (Ref. 22), which allows the incorporation of a variety of potential reformulation costs associated with idea generation, product research and process development, coordinating activities, product testing, packaging development, market testing, and production/manufacturing. We estimate that the addition of live and active cultures to yogurt batches represents a critical minor ingredient with functional effects, yielding per-formula reformulation costs ranging from approximately $28,530 to $289,845 in 2019 USD. We estimate that some manufacturers will be able to coordinate a required reformulation with a scheduled reformulation, resulting in lower reformulation costs than if they were unable to coordinate. However, the extent to which manufacturers can undertake such coordination depends on the compliance period. For a 24-month compliance period, we estimate that 20 percent of reformulations can be coordinated with a scheduled reformulation. Combining this information, we estimate one-time reformulation costs related to the Claims Requirement to be between approximately $7.5 million and $76.3 million in 2019 dollars. Annualized over 10 years and discounted at 3 percent, reformulation costs range from approximately $855.1 thousand to $8.7 million per year in 2019 dollars. Annualized over 10 years at 7 percent, reformulation costs range from approximately $1.0 million to $10.2 million per year.

We previously estimated that 434 small yogurt UPCs will undergo relabeling related to removing their “contains live and active cultures” or similar claims and 348 small yogurt UPCs will relabel related to the addition of the phrase “does not contain live and active cultures” to their label, for a total of 782 small yogurt UPCs affected by relabeling under the Claims Requirement. We estimate the one-time cost of changing all yogurt labels using the FDA Labeling Cost Model. The removal and addition of claims is a major label change. Using the Labeling Cost Model and using a 24-month compliance period, the estimated one-time labeling cost lies between approximately $4.9 million and $12.4 million in 2019 dollars. Annualized over 10 years at 3 percent, relabeling costs range from approximately $558.3 thousand to $1.5 million per year. Annualized over 10 years at 7 percent, relabeling costs range from approximately $633.7 thousand to $1.7 million per year.

In total, for a 24-month compliance period, we estimate that the Claims Requirement would cost small yogurt manufacturers between approximately $1.6 million and $10.4 million per year in 2019 dollars, or between $0.2 million and $1.2 million per small yogurt manufacturer per year, discounted at 3 percent. We estimate that costs are between approximately $1.8 million and $12.1 million per year in 2019 dollars, discounted at 7 percent. Costs per small yogurt manufacturer are between approximately $0.2 million and $1.3 million per year. These estimates are summarized in table 1.

We are revoking the standards of identity for lowfat yogurt (§ 131.203) and nonfat yogurt (§ 131.206). The revocation will result in lowfat yogurt and nonfat yogurt being covered under the general definition and standard of identity in § 130.10. Section 130.10 sets out requirements for foods that substitute for a standardized food but that deviate from the standard due to compliance with an expressed nutrient content claim defined by FDA regulation.

Under § 131.203 and § 131.206, lowfat yogurt must contain not less than 0.5 percent milkfat nor more than 2 percent milkfat, and nonfat yogurt must contain less than 0.5 percent milkfat. If the fat content of yogurt is modified to meet the expressed nutrient content claims, “low fat” and “no fat” in § 101.62(b), lowfat yogurt must contain less than or equal to 3 grams of fat per RACC, and nonfat yogurt must contain less than 0.5 grams per RACC. The RACC for yogurt is 170 grams. In other words, when yogurt is modified to comply with the expressed nutrient content claims “low fat” and “no fat,” the resultant products are standardized foods under § 130.10, and as such, “lowfat yogurt” must contain less than or equal to 1.76 percent (= 3g/170g) milkfat and “nonfat yogurt” must contain less than 0.29 percent (= 0.5g/170g) milkfat. As acknowledged by comments we received, once this final rule is in effect, some lowfat yogurt and nonfat yogurt products that currently meet the milkfat content requirements in §§ 131.203 and 131.206 will have to be reformulated to meet the fat content requirements for “low fat” and “no fat” under § 101.62(b). For example, a lowfat yogurt product with 2 percent milkfat will need to be reformulated to contain no more than 1.33 percent milkfat to comply with § 101.62(b) and be covered as a standardized food under § 130.10.

To estimate the percentage of lowfat yogurt and nonfat yogurt products affected by the Standards of Identity Revocation, we use data from the USDA's National Nutrient Database for Standard Reference (Ref. 2). We estimate that approximately 21 percent of lowfat yogurts and 19 percent of nonfat yogurts are affected by the Standards of Identity Revocation and will need to reformulate to reduce the fat content of their yogurts to meet the 1.76 percent and 0.29 percent thresholds. We estimate that there are approximately nine small yogurt manufacturers. Using data from the International Dairy Foods Association, we estimate that 52 percent of yogurt sales are of lowfat yogurt and 43 percent are of nonfat yogurt. We estimate that the number of small lowfat yogurt manufacturers affected by the Standards of Identity Revocation is approximately one and the number of small nonfat yogurt manufacturers affected by the Standards of Identity Revocation is approximately one. We estimate that there are 8,002 yogurt UPCs and that small yogurt manufacturers comprise roughly 29 percent of all yogurt manufacturers. We estimate that the number of small lowfat yogurt and nonfat yogurt manufacturer UPCs affected by the Standards of Identity Revocation are approximately 350 and approximately 200, respectively, for a total of 550 UPCs.

We estimate reformulation costs using the FDA Reformulation Cost Model (Ref. 22). Using the yogurt formula-to-UPC ratio of 0.759, we estimate that the total number of small yogurt manufacturer formulas subject to reformulation is approximately 417. We estimate reformulation costs by multiplying the estimated number of formulas by estimates of per-formula costs obtained from the FDA Reformulation Cost Model. We estimate that yogurt manufacturers that need to reduce the fat content of their yogurt will substitute lower fat milk for higher fat milk in the production process and that this is a critical minor ingredient with functional effects, yielding per-formula reformulation costs ranging from approximately $28,530 to $289,845 in 2019 dollars. For a 24-month compliance period, we estimate one-time reformulation costs related to the Standards of Identity Revocation to be between approximately $11.9 million and $120.9 million in 2019 dollars. Annualized over 10 years at 3 percent, reformulation costs range from approximately $1.4 million to $13.8 million per year. Annualized over 10 years at 7 percent, reformulation costs range from approximately $1.6 million to $16.1 million per year.

Because small yogurt manufacturers must change the fat content of their lowfat yogurt and nonfat yogurt, they also must change the amount of fat declared on the Nutrition Facts Label. Using the FDA Labeling Cost Model, we estimate the one-time cost of this minor label change to be between approximately $1.4 million and $4.1 million in 2019 dollars for small yogurt manufacturers. Annualized over 10 years, labeling costs for small yogurt manufacturers are estimated to be between approximately $161.3 thousand and $471.4 thousand per year, discounted at 3 percent. Labeling costs for small yogurt manufacturers are estimated to be between approximately $188.6 thousand and $551.1 thousand per year, discounted at 7 percent.

In total, for a 24-month compliance period, we estimate that revoking the standards of identity for lowfat yogurt and nonfat yogurt would cost small yogurt manufacturers between approximately $1.4 million and $13.8 million per year in 2019 dollars, or between approximately $1.6 million and $16.1 million per small yogurt manufacturer per year, discounted at 3 percent. Discounted at 7 percent, we estimate that costs are between approximately $1.8 million and $16.6 million per year. Per small yogurt manufacturer range between approximately $1.5 million and $16.9 million per year. These estimates are summarized in table 2.

The total cost of the final rule to small yogurt manufacturers for a 24-month compliance period is approximately $3.7 million to $25.1 million per year in 2019 dollars, discounted at 3 percent. Discounted at 7 percent, estimated annual total costs are between approximately $4.2 million and $29.2 million. On a per firm per year basis, estimated costs are between approximately $0.4 million and $2.8 million per small yogurt manufacturer per year in 2019 dollars, discounted at 3 percent. Discounted at 7 percent, estimated annual total costs are between approximately $0.5 million and $3.2 million per small yogurt manufacturer. These estimates are summarized in table 3.

The Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4) (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. We do not expect this rule to result in any 1-year expenditure that will meet or exceed this amount.

We estimate that the annual costs of the final rule to small yogurt manufacturers will be between approximately $3.1 million to $24.6 million, discounted at 3 percent in 2019 dollars. At a 7 percent discount rate, we estimate that the annual costs of the final rule will be between $3.6 and $28.8 million. Based on our analysis, we do not expect the final rule to reach the current UMRA threshold of $158 million. We also do not expect the estimated costs of the rule to be disproportionately incurred by any State, local, or tribal government.

The full analysis of economic impacts is available in the docket for this final rule and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

We have analyzed the final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive Order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.”

Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express preemption provision. Section 403A(a) of the FD&C Act provides that: “* * * no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce—(1) any requirement for a food which is the subject of a standard of identity established under section 401 that is not identical to such standard of identity or that is not identical to the requirement of section 403(g). * * *”

The final rule makes changes to the standards of identity for yogurt, lowfat yogurt, and nonfat yogurt. The final rule has preemptive effect under section 403A(a)(1) of the FD&C Act in that it precludes States from issuing any requirements for yogurt that are not identical to the requirements of the final rule. Section 403A(a)(1) of the FD&C Act displaces both State legislative requirements and State common law duties ( Riegel v. Medtronic, 128 S. Ct. 999 (2008)). In addition, as with any Federal requirement, if a State law requirement makes compliance with both Federal law and State law impossible, or would frustrate Federal objectives, the State requirement would be preempted. See Geier v. American Honda Co., 529 U.S. 861 (2000); English v. General Electric Co., 496 U.S. 72, 79 (1990); Florida Lime & Avocado Growers, Inc., 373 U.S. 132, 142-43 (1963); Hines v. Davidowitz, 312 U.S. 52, 67 (1941).

We have determined under 21 CFR 25.32(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

The final rule contains no collection of information. Therefore, clearance by Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required.

This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES ) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register .

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction, or they are available as published articles and books. Please contact either person identified in the FOR FURTHER INFORMATION CONTACT section to schedule a date to inspect references without asterisks. Some may be available at the website address, if listed. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Therefore, 21 CFR parts 130 and 131 are amended as follows:

USAID sought public comment on a proposed rule published on March 1, 2021, to revise its regulations under 22 CFR part 213, USAID's claim-collection regulation. The final rule's purpose is to conform to a statutory requirement that Federal Departments and Agencies must refer all past-due, legally enforceable, non-tax debt that is delinquent for more than 120 days, including non-tax debt administered by a third party that is acting as an agent for the Federal Government, to the Secretary of the Treasury for the purposes of administrative offset. The final rule also updates claims-collection definitions to align with the Debt Collection Improvement Act of 1996 and specifies that the Bureau of the Fiscal Service is the Agency within the U.S. Department of the Treasury to which USAID refers delinquent debts.

USAID published a proposed rule in the Federal Register at 86 FR 11905 (March 1, 2021) to revise its regulation on claims collection in its entirety to incorporate applicable statutory and regulatory provisions and to make other changes. The public comment period for this proposed rule ended on March 31, 2021.

There were no relevant public comments submitted in response to the proposed rule and no changes were made to the final rule.

USAID has drafted this rule in accordance with Executive Orders (E.O.s) 12866 and 13563, which direct Federal Departments and Agencies to assess all the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equality). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. USAID has reviewed the regulation to ensure its consistency with the regulatory philosophy and principles set forth in E.O.s 12866 and 13563 and finds that the benefits of issuing this rule outweigh any costs, which the Agency assesses to be minimal. The Office of Information and Regulatory Affairs within the Office of Management and Budget (OMB/OIRA) has determined that this rule is not a “significant regulatory action” as defined in E.O. 12866 and, accordingly, has not reviewed it. OMB/OIRA also has determined that this rule is not an “economically significant regulatory action” under Section 3(f)(1) of E.O. 12866. This final rule is not subject to the requirements of E.O. 13771 because OMB has determined it to be non-significant within the meaning of E.O. 12866.

USAID certifies that this rule will not have a significant economic impact on a substantial number of small entities. Consequently, the Agency has not prepared a regulatory-flexibility analysis.

This rule is not a “major rule” as defined by the Small Business Regulatory Enforcement Fairness Act of 1996 (Section 804(2) of Title 5 of the United States Code [U.S.C.]). This rule will not result in an annual effect on the U.S. economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign-based companies in domestic and import markets.

This final rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year, and it will not significantly or uniquely affect small governments. Therefore, USAID has deemed no actions were necessary under the provisions of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 et seq. ).

This rule will not have a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. In accordance with E.O. 13132, USAID has determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Summary Impact Statement.

In accordance with E.O. 12988, the Office of the General Counsel at USAID has determined that this rule does not unduly burden the judicial system and meets the requirements of Sections 3(a) and 3(b)(2) of the Executive order.

USAID has determined that this rule would not have substantial direct effects on one or more Indian Tribes, the relationship between the Federal Government and Indian Tribes, or the distribution of power and responsibilities between the Federal Government and Indian Tribes (E.O. 13175).

This rule does not contain information-collection requirements, and therefore a submission to OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) is not required.

Accordingly, the Agency for International Development amends 22 CFR part 213 as follows:

Section 205 of the Taxpayer Certainty and Disaster Tax Relief Act of 2019, enacted as Division Q of the Further Consolidated Appropriations Act, 2020, Public Law 116-94, 133 Stat. 2534, 3226, amended section 7508A of the Code, relating to the discretionary authority of the Secretary of the Treasury or her delegate (Secretary) to postpone certain time-sensitive tax deadlines by reason of a federally declared disaster, by adding section 7508A(d). This provision provides qualified taxpayers a mandatory 60-day period that is to be disregarded “in the same manner as a period specified under [section 7508A(a)].”

On January 13, 2021, the IRS published in the Federal Register a notice of proposed rulemaking (REG-115057-20, 86 FR 2607) to interpret and implement sections 165(i)(5) and 7508A(d). Five responsive written comments were received. No commenter requested a public hearing, so none was held.

As described more fully in the preamble to the proposed regulations, section 7508A(d) is ambiguous in at least two important respects—the time-sensitive acts to be postponed (beyond the pension-related actions described in section 7508A(d)(4)) are not specified and it is unclear how the mandatory 60-day postponement period is to be calculated when the disaster declaration specified in section 7508A(d) does not contain an incident date. The legislative history is also insufficient to explain these areas of ambiguity.

These final regulations amend the Procedure and Administration Regulations (26 CFR part 301) under section 7508A and the Income Tax Regulations (26 CFR part 1) under section 165 to clarify the definition of the term “federally declared disaster.” As described further below, the Department of the Treasury (Treasury Department) and the IRS have modified proposed § 301.7508A-1(g)(4)(iii), Example (3), in these final regulations to better illustrate the calculation of the mandatory 60-day postponement period and to correct typographical errors. No other changes have been adopted.

The proposed regulations provided that a federally declared disaster includes both a major disaster and an emergency declared under sections 401 or 501, respectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act), Public Law 100-707,102 Stat. 4689 (1988).

One commenter said it approved of the proposed regulations including emergency declarations in the definition of a federally declared disaster under section 165(i)(5)(A). However, another commenter was critical of this portion of the proposed regulations and recommended that it be stricken. This second commenter said emergency declarations are governed by a different set of rules than major disaster declarations, pointing out that emergency declarations (i) do not need to be preceded by a governor's request for Stafford Act relief (but may instead be declared sua sponte by the President), (ii) may only result (if not followed up by a major disaster declaration) in Federal assistance to local governmental entities (as opposed to assistance to individuals), and (iii) may be issued before a disaster. This commenter further opined that President Trump's letter of March 13, 2020, declaring an emergency under the Stafford Act with respect to the COVID-19 pandemic, was not authorized by Congress to serve as a disaster declaration under sections 165(i)(5)(A) and 7508A of the Code.

The comment from the second commenter is not adopted in the final regulations. In the Explanation of Provisions section of the preamble to the proposed regulations, Part III. Federally Declared Disasters, this issue is already addressed in detail. There is no provision in the Stafford Act to declare a “disaster.” The legislative history of the Stafford Act indicates that the term “disaster” is an umbrella term that includes both an emergency and a major disaster. The Conference Report to the Disaster Relief and Emergency Assistance Act of 1974, Public Law 93-288, 88 Stat. 143 (1974), clarified the definitional section of the Stafford Act, stating: “It was the intention of the conferees not to define the term `disaster' specifically; whenever used in this legislation such term includes an emergency or a major disaster.” H.R. Rep. 93-1037, p. 26 (May 13, 1974).

The opening section of the Stafford Act, titled “Congressional findings and declarations,” uses the generic term “disaster” in laying out the key congressional findings and declarations that underlie the rest of the chapter's provisions. Stafford Act section 101(a), 42 U.S.C. 5121(a). In multiple revenue rulings, the IRS has provided that, for the purposes of section 165(i), a federally declared disaster includes an emergency or a major disaster declared under the Stafford Act. Several of these revenue rulings are cited in the preamble to the proposed regulations.

The differences noted by the commenter between emergencies and major disasters under the Stafford Act are not material to their treatment under sections 165(i)(5)(A) and 7508A of the Code. Most disaster declarations announced by the Federal Emergency Management Agency (FEMA) for particular states also provide only public assistance, and no individual assistance, to particular counties in the state under the Stafford Act. In addition, most emergency declarations announced by FEMA are under section 501(a) of the Stafford Act, and begin with a request from a governor or other chief executive of a state, territory, or tribal government. As noted in the preamble to the proposed regulations, it is rare for an emergency declaration to be made without such a request. The President is authorized to make an emergency declaration under section 501(b) of the Stafford Act when the United States will have the primary responsibility for response to the emergency. There is no difference in the need for affected persons in a state threatened with a disaster to receive relief from time-sensitive deadlines to perform specified acts under the Code when the request for such relief originates with the state's governor or is independently raised by the President. Consequently, the final regulations make no changes to this portion of the proposed regulations.

The proposed regulations provided that (excluding the pension-related acts described in section 7508A(d)(4)) the time-sensitive tax acts that are postponed for the mandatory 60-day postponement period are the acts, if any, that the Secretary determines to be postponed under section 7508A(a) or (b).

One commenter expressed a general concern that this provision had the potential to reduce section 7508A(d) to a nullity. A second commenter expressed its concerns specifically in terms of what it contended was a clear reading of the statute and its legislative history. This commenter said it was clear that Congress intended to postpone the timely performance of all of the time-sensitive tax acts, both taxpayer and government acts, listed in section 7508(a)(1) of the Code. However, this second commenter recommended that the final regulations provide that the government may take advantage of the postponement periods for government-initiated actions only if a taxpayer first acts in reliance on the “automatic” postponement periods for the taxpayer's time-sensitive tax acts.

A third commenter agreed with the Secretary's characterizations of the statute and legislative history as ambiguous on the issues of which time-sensitive tax acts (other than the pension-related tax acts described in section 7508A(d)(4)) are postponed under section 7508A(d) and of which declared disasters are subject to the mandatory 60-day postponement period under section 7508A(d). This commenter approved of the solution to these ambiguities that was reflected in the proposed regulations, in terms of which time-sensitive tax acts would be postponed. This commenter said section 7508A(d) was a poorly-worded statute, that the legislative history of the provisions contained contradictions, and the result was that section 7508A(d)(1) leaves no (non-pension) time-sensitive tax acts for section 7508A(d) to operate upon, unless or until the Secretary exercises her powers under section 7508A(a).

The third commenter noted also that for the year 2017, the IRS provided relief under section 7508A(a) in response to only 14 of the 59 major disaster declarations announced by FEMA that year. If all major disaster declarations automatically entitled all taxpayers in disaster areas to timing relief under section 7508A(d), the commenter noted that there would be a dramatic increase in the number of disasters leading to postponements of time-sensitive tax acts. On these issues, the third commenter concluded that the proposed regulations properly preserved the discretion of the IRS to determine which declared disasters should result in any type of disaster relief and of which time-sensitive tax acts should be postponed under section 7508A.

The comments from the first two commenters on this issue are not adopted in the final regulations, while the approving comments of the third commenter were already reflected in the proposed regulations. As explained more fully in the Explanation of Provisions section of the preamble to the proposed regulations, Part I. Time-Sensitive Tax Acts, and as noted by the third commenter described above, except for the rules regarding pensions described in section 7508A(d)(4), section 7508A(d), by its terms, does not specify the time-sensitive tax acts to be postponed during the mandatory 60-day postponement period. Instead, section 7508A(d)(1) provides that the mandatory 60-day postponement period “shall be disregarded in the same manner as a period specified under [section 7508A(a)].” Section 7508A(a) is not self-executing, but rather, requires a determination by the Secretary to specify the acts to be postponed. As a result, the cross-reference to section 7508A(a) in section 7508A(d)(1) operates to require the same determination by the Secretary as a prerequisite to determining the acts to which the mandatory 60-day postponement period applies. This interpretation gives full effect to the statutory language and does not reduce section 7508A(d) to a nullity, because that section still imposes a mandatory period for postponement and establishes a new category of persons eligible for relief—the “qualified taxpayers” defined in section 7508A(d)(2). The final regulations make no changes to § 301.7508A-1(g)(1) and (2) of the proposed regulations.

Section 301.7508A-1(g)(3)(i) of the proposed regulations tracked section 7508A(d)(1) and (d)(5) in describing how the mandatory 60-day postponement period for federally declared disasters will be calculated and how the calculation of that mandatory postponement period will interact with the Secretary's discretionary postponement period (if any) under section 7508A(a) and (b). The Explanation of Provisions section of the preamble to the proposed regulations, Part II. Calculation of the Mandatory 60-Day Postponement Period, identified a 120-day postponement period from the beginning incident date of a disaster announced by FEMA as the usual postponement period provided by the IRS for those disasters where the IRS exercises its discretion under section 7508A(a) or (b) to postpone any time-sensitive tax acts.

Consequently, most mandatory 60-day postponement periods under section 7508A(d) will be calculated to run concurrently with the 120-day postponement period the IRS generally provides under section 7508A(a) or (b). Two commenters noted that section 7508A(d)(1) and the proposed regulations did not provide a clear rule for calculating the mandatory 60-day postponement period when there was more than one disaster declaration issued for the same disaster in a particular state or when any disaster declaration was amended to provide any new or modified incident dates (earliest or latest) that were missing or different from when the first disaster declaration for a disaster in a state was announced by FEMA. Two commenters suggested potential alternative methods of making calculations of the mandatory 60-day postponement period more certain when there are multiple disaster declarations or disaster declarations that are amended by FEMA for the earliest or latest incident dates described in section 7508A(d)(1)(A) and (B).

One commenter claimed that a literal reading of section 7508A(d)(1) creates challenges for indefinite disasters, such as the COVID-19 pandemic, because the statute could be interpreted to postpone a taxpayer's deadlines “indefinitely until some unknown point in time that is long after the disaster began.” To avoid this “unworkable application” of the statute, this commenter recommended that if the initial disaster declaration does not expressly identify the latest incident date for a disaster, then section 7508A(d) should be interpreted as automatically providing a postponement period until the date that is 60 days after the earliest incident date specified in a disaster declaration. However, the statute mitigates the commenter's concern by directing that the postponement period under section 7508A(d) “shall be disregarded in the same manner as a period specified under subsection (a).” That provision ensures that the Secretary retains the same discretion as she has under section 7508A(a) to determine what time-sensitive tax acts, if any, will be postponed.

A second commenter noted what it characterized as a pick-and-choose problem and an amendment problem with the method of calculating the mandatory 60-day postponement period provided for in the proposed regulations and recommended the Secretary adopt one of several alternative bright-line rules it suggested for making the calculation period more predictable.

This second commenter noted there was a potential pick-and-choose problem among multiple potential FEMA-announced disaster declarations, because the Treasury Department and the IRS propose to treat FEMA-announced emergency declarations (as well as major disaster declarations) under the Stafford Act as federally declared disasters under sections 165 and 7508A of the Code. This commenter's recommendation to strike proposed amended regulation § 1.165-11(b)(1) is discussed and rejected in the preamble discussion of this issue above.

Alternatively, the second commenter recommended that the final regulations reflect a bright-line rule to address potential multiple declarations, such as a first-out rule (the first issued declaration controls), a rule that a later major disaster declaration controls over an earlier emergency declaration, or a rule that the issue date of an emergency declaration is the earliest incident date for section 7508A(d)(1)'s mandatory 60-day postponement period.

The second commenter further recommended in this section of the final regulations that the Treasury Department and the IRS provide a bright-line rule concerning the effect of potential amendments to an initial FEMA announced disaster declaration on how the mandatory 60-day postponement period is calculated. The additional potential bright-line alternatives suggested by the second commenter were that (i) future amendments will not affect how the mandatory period is calculated, or (ii) only amendments made within a certain amount of time (say one year) will affect the computation of the mandatory period.

The Treasury Department and the IRS appreciate the predictability offered by the bright-line rules suggested by the second commenter. Nevertheless, the statutory language providing for a mandatory period beginning on the earliest incident date specified in the disaster declaration and ending on the date which is 60 days after the latest incident date so specified is capable of being applied as written. While amendments to disaster declarations and shifting “latest” incident dates can cause confusion, the intent of the statute is to ensure that relief is provided throughout the disaster period, assuming such a period is identified in the disaster declaration and the Secretary has determined that postponement of time-sensitive tax acts is warranted. As a result, the comment on this issue is not adopted in the final regulations.

The proposed regulations provided that in no event will the mandatory 60-day postponement period be calculated to exceed one year. One commenter stated that this portion of the proposed regulations should be removed because it lacks any basis in the text or legislative history of section 7508A(d)(1) or (d)(4).

The comment on this issue is not adopted in the final regulations. As stated in the Explanation of Provisions section of the preamble to the proposed regulations, Part II. Calculation of the Mandatory 60-Day Postponement Period, it defies logic for the Secretary's discretionary postponement period under section 7508A(a) to be limited to “a period of up to 1 year,” and there be no limit on the mandatory 60-day postponement period under section 7508A(d). Interpreting section 7508A(d) to allow postponement periods for more than 1 year would be contrary to the directive of section 7508A(d)(1) that the mandatory 60-day postponement period must “be disregarded in the same manner as a period specified under [section 7508A(a)].” The final regulations make no change to § 301.7508A-1(g)(3)(ii)(A) of the proposed regulations.

The proposed regulations provided an Example (3) concerning a continuing disaster declaration involving wildfires that was later amended by a subsequent FEMA announcement of a latest incident date for the disaster. This example contained typographical errors, including a misnumbering—“(5)” instead of “(4)”—of the subparagraph for the four examples and referring to the taxpayer in the example variously as “Individual C” and “Individual D.”

One commenter further noted that the intended rules, if any, which Example (3) was meant to illustrate were not described in the portions of the proposed regulations which precede the Examples section.

Example (3) is intended to illustrate the calculation of the mandatory 60-day postponement period in the event of an ongoing disaster with multiple declarations and shifting “latest” incident dates described in § 301.7508A-1(g)(3) of these final regulations. The Treasury Department and the IRS have modified Example (3) in these final regulations, in consideration of the comment above as well as the comments received on § 301.7508A-1(g)(3)(i), to better illustrate the calculation of the mandatory 60-day postponement period and to correct typographical errors.

The proposed regulations provided that the final regulations shall apply to all disasters declared on or after December 21, 2019.

One commenter requested not only that the final regulations not be retroactive to the effective date of section 7508A(d), but that the final regulations provide relief to any individuals or employee benefit plans that took actions (or failed to take actions) based on a good faith and reasonable interpretation of the postponement relief provided in section 7508A. The commenter further requested that such good faith relief be available for at least 60 days after the final regulations are published in the Federal Register .

The Applicability Date discussion in the preamble to the proposed regulations clearly indicated the intention of the Treasury Department and the IRS to rely on the provisions of section 7805(b)(2) of the Code for the applicability date of these final regulations. Section 7805(b)(2) provides that regulations filed or issued within 18 months of the date of enactment of the statutory provision to which the regulations relate are not prohibited from applying retroactively to the date of enactment. Section 7508A(d) was enacted on December 20, 2019, and these final regulations have been filed or issued within 18 months of that date of enactment. The proposed regulations were clear in stating that the Treasury Department and the IRS intended for the final regulations to apply to any disasters that were declared on or after December 21, 2019. These final regulations do not adopt the commenter's request to modify § 301.7508A-1(h)(2) of the proposed regulations.

One commenter requested that the final regulations “confirm” that all forms of deadline relief requested under section 7508A are optional for affected taxpayers. In particular, the commenter focused on deadlines arising under employee benefit plans. In some cases, the application of these deadlines may affect both the plan and the participants. After consideration, the Treasury Department and the IRS have concluded that the suggestions made in this comment are beyond the intended scope of the proposed regulations. Consequently, the suggestions are not adopted in these final regulations.

Example (3) is modified to better illustrate the calculation of the mandatory 60-day postponement period in the event of multiple declarations and shifting “latest” incident dates, and to correct typographical errors.

For date of applicability for the amendment to the Procedure and Administration Regulations under section 7508A, see § 301.7508A-1(h), which provides that the regulations promulgated by this Treasury decision are applicable for federally declared disasters that are declared on or after December 21, 2019, as explained in the preamble to the proposed regulations (REG-115057-20) published in the Federal Register (86 FR 2607), because section 7805(b)(2) of the Internal Revenue Code (Code) provides that regulations filed or issued within 18 months of the date of the enactment of the statutory provision to which they relate may apply to taxable periods prior to those described in section 7805(b)(1) and these final regulations are being published within 18 months of the enactment of section 7508A(d) on December 20, 2019.

The date of applicability for the amendment to the Income Tax Regulations under section 165 of the Code to clarify the definition of the term “federally declared disaster” is June 11, 2021.

Certain IRS regulations, including these, are exempt from the requirements of Executive Order 12866, as supplemented and affirmed by Executive Order 13563. Therefore, a regulatory assessment is not required.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), it is hereby certified that these regulations will not have a significant economic impact on a substantial number of small entities. The regulations clarify how the Secretary may postpone certain time-sensitive tax deadlines by reason of a federally declared disaster. Such postponements provide more time for affected taxpayers to complete time-sensitive acts than they otherwise would have under the internal revenue laws. In addition, the regulations do not impose a collection of information burden on any person, including small entities, for purposes of the Regulatory Flexibility Act (5 U.S.C. chapter 6). Accordingly, the Secretary certifies that the regulations will not have a significant economic impact on a substantial number of small entities. Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking preceding these final regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comments on its impact on small business, and no comments were received.

The principal authors of these final regulations are Andrew C. Keaton and William V. Spatz of the Office of Associate Chief Counsel (Procedure and Administration). However, other personnel from the Treasury Department and the IRS participated in their development.

Accordingly, 26 CFR parts 1 and 301 are amended as follows:

The purpose of this regulatory action is to amend the Formula Grants Program implementing regulation at 28 CFR part 31, subpart A, authorized under title II, part B, of the Juvenile Justice and Delinquency Prevention Act (JJDP Act) and promulgated in 1996, to remove sections and/or provisions that (1) were rendered obsolete by amendments made to the JJDP Act in 2002 by Public Law 107-273 (the “2002 amendments”) or by Public Law 115-385 (the “2018 amendments”); (2) are redundant; or (3) are ultra vires. Additional technical corrections reflect an editorial reclassification of the United States Code, implemented on September 1, 2017, that reorganized certain existing provisions of the United States Code from title 42 into a new title 34, and citations are updated to reflect sections of the Act that were re-numbered by the 2002 amendments. Finally, the definitions in the regulation have been rearranged to be listed in alphabetical order. 1 OJP implements this rule pursuant to the rulemaking authority under 34 U.S.C. 11111.

As noted in the preamble above, this rule removes provisions of the Formula Grants Program regulation that (1) were rendered obsolete by amendments made to the JJDP Act in 2002 by Public Law 107-273 (the “2002 amendments”) or by Public Law 115-385 (the “2018 amendments”); (2) are redundant; or (3) are ultra vires. This rule also makes technical corrections to the regulation. These changes, overall, reasonably can be expected to save at least a de minimis amount of grantee staff time in understanding program requirements when compared to the current rule, and thus the rule is deregulatory. With respect to the provisions of the Formula Grants Program regulation to be removed as obsolete, States have been advised by OJJDP not to follow those provisions, and/or OJJDP has not been enforcing those provisions. Thus, removing those provisions will result in no additional or reduced burden on states. The removal of provisions that are redundant, because they simply parrot language in the JJDPA, do not impose or reduce requirements of state grantees, and accordingly neither increase nor decrease costs or burdens on states. This rule makes technical corrections to the Formula Grants Program regulation that reflect the 2002 and 2018 amendments, most of which reflect simple renumbering of sections or provisions of the JJDPA, but do not make changes that would impose additional requirements on states. Finally, the three provisions in the regulation that are being removed as ultra vires have not been enforced by OJJDP in recent years; their removal will not result in any additional costs, and may result in de minimis savings in grantee staff time, as noted above.

This rule amends the regulation implementing the JJDP Act Formula Grants Program at 28 CFR part 31, subpart A. OJJDP administers the Formula Grants Program, pursuant to title II, part B, of the JJDP Act, now codified at 34 U.S.C. 11131-11133, which authorizes OJJDP to provide an annual grant to each State to improve its juvenile justice system and to support juvenile delinquency prevention programs. Title II, part B, of the JJDP Act authorizes OJJDP to provide formula grants to states to assist them in planning, establishing, operating, coordinating, and evaluating projects directly or through grants and contracts with public and private agencies for the development of more effective education, training, research, prevention, diversion, treatment, and rehabilitation programs in the area of juvenile delinquency and programs to improve the juvenile justice system. The JJDP Act was originally enacted in 1974, authorizing the Formula Grants Program under title II, part B, and was reauthorized and/or amended in 1980, 2 1984, 3 1988, 4 1992, 5 2002, 6 and 2018. 7 It should be noted that this final rule, which is purely technical in character, does not reflect amendments made by the Juvenile Justice Reform Act of 2018 (Pub. L. 115-385), unless they are purely technical in nature, or reflect provisions that were rendered obsolete. Any substantive changes will be made in a future regulation that will be published for notice and public comment.

OJP's Formula Grants Program implementing regulation was first published on May 31, 1995, and amended on December 31, 1996. In the 2002 amendments to the JJDP Act, several statutory provisions were repealed, but those statutory amendments were not reflected in the only post-1996 amendment to the implementing regulation (promulgated in January 2017). This final rule, among other things, amends the regulation to reflect the repeal, in 2002, of those statutory provisions, as well as the repeal of statutory provisions based on the 2018 amendments. Finally, it should be noted that many provisions that currently exist in this regulation have been superseded by 2 CFR part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards), references to which are to be understood as references to part 200 as adopted for the Department of Justice by 28 CFR part 2800. In addition, it should be noted that, among other things, title II of the JJDP Act adopts by reference certain provisions of the Omnibus Crime Control and Safe Streets Act of 1968, making them applicable to the title II Formula Grants Program. See 34 U.S.C. 11182(b) and (c). These referenced provisions include, but are not limited to, the provisions found at 34 U.S.C. 10228(c) (prohibition on discrimination); 34 U.S.C. 10230(a) (recordkeeping requirement); 34 U.S.C. 10230(b) (access to records for audit and examination); 34 U.S.C. 10230(c) (audit and examination period after completion of program or project); 34 U.S.C. 10231(a) (research or statistical information; immunity from process; prohibition against admission as evidence or use in any proceedings).

The current regulation prescribes requirements that were pertinent to Formula Grants Program requirements that were repealed in the 2002 and 2018 amendments. Those provisions of the current regulation that purport to implement requirements that were repealed by the 2002 and 2018 statutory amendments are not valid. See, e.g., Hadson Gas Sys., Inc. v. FERC, 316 U.S. App. D.C. 98, 75 F.3d 680, 684 (D.C. Cir. 1996) (where Congress enacts a new statute or amends an existing one, administrative regulations may be rendered unnecessary or obsolete and the prior regulations need not be repealed by notice and comment); Messick ex rel. Kangas v. United States, 70 Fed. Cl. 319, 328 (2006) (holding that a regulation that had failed to keep up with statutory changes was to be “disregarded”), rev'd on other grounds sub nom. Amber-Messick ex rel. Kangas v. United States, 483 F.3d 1316 (Fed. Cir. 2007).

Several sections of the Formula Grants Program regulation do no more than parrot existing statutory provisions within the JJDP Act or provisions such as those in the Omnibus Crime Control and Safe Streets Act of 1968 that are noted above, and thus are unnecessarily repeated in the regulation.

The following three provisions of the regulation are being removed because they are contrary to specific provisions within the JJDP Act, or are generally outside the scope of the Administrator's authority, and are, therefore, “ ultra vires ”—“unauthorized; beyond the scope of power allowed or granted by a corporate charter or by law.” Black's Law Dictionary (10th ed. 2014).

This provision of the current regulation purports to describe how OJJDP may use funds that were originally allocated to a state that is subsequently determined to be ineligible for a formula grant award (including because it has not met one or more of the 33 eligibility requirements set forth at section 223(a) of the JJDP Act), or has chosen not to submit an application for a formula grant award. Section 223(d) of the JJDP Act, however, requires that OJJDP must “endeavor to make that State's allocation [excluding the allocation for the state advisory group authorized under 34 U.S.C. 11133(a)(3)] available to local public and private nonprofit agencies” within the state and goes on to provide that, if the Administrator is unable to make such an award, the funds must be made available “on an equitable basis and to those States that have achieved full compliance with the core requirements.” (Emphasis added.) Thus, by the express terms of this statutory provision, those funds may not be reallocated to states that were determined to be out of compliance. The third sentence of section 31.301(e) states that, upon “a request for extension, which demonstrates compelling circumstances” OJJDP may reallocate the formula grant funds “back to the State for which the funds were initially allocated,” and thus purports to provide something manifestly contrary to the plain language of section 223(d) of the JJDP Act (34 U.S.C. 11133(d)). Section 31.301(e) is, therefore, ultra vires and must be removed.

Section 31.303(f)(1)(i)(A) purports to require that a state identify in its monitoring universe “all residential facilities which might hold juveniles pursuant to public authority.” The word “residential” is deleted because, section 223(a)(14) of the JJDP Act (34 U.S.C. 11133 (a)(14)) requires that States monitor all “jails, lock-ups, detention facilities, and correctional facilities,” and, plainly, is not limited in scope to “residential” facilities. Accordingly, the language in this paragraph that purports to limit the reach of the statutory requirement is ultra vires. Consequently, section 31.303(f)(1)(i)(A) must be amended accordingly.

Among other things, section 223(a)(11)(A)(ii) of the JJDP Act provides that “a juvenile shall not be placed in a secure detention facility or a secure correctional facility” if the juvenile is (in common parlance) a “non-offender” who “is an alien[ ] or is alleged to be dependent, neglected, or abused.” A “non-offender,” pursuant to 28 CFR 31.304(i), is a “juvenile who is subject to the jurisdiction of the juvenile court . . . for reasons other than legally prohibited conduct of the juvenile ” (emphasis added); and violation of a valid court order is, as a matter of law, “legally prohibited conduct.” Thus, by definition, a juvenile who has violated a valid court order is not, and cannot be, a “non-offender.” Section 31.303(f)(3)(vii) of the current regulation, however, purports to provide that an erstwhile “non-offender . . . cannot [ sic ] be placed in secure detention or correctional facilities [ sic ] for violating a valid court order.” Consequently, section 31.303(f)(3)(vii) of the current regulation, which purports to extend section 223(a)(11)(A)(ii) of the JJDP Act (which relates only to “non-offenders”) to juveniles who are not “non-offenders” is ultra vires and must be removed.

Several amendments to the Formula Grants Program regulation reflect an editorial reclassification of the United States Code, implemented on September 1, 2017, that reorganized certain existing provisions of the United States Code from title 42 into a new title 34. Additionally, other citations in the current regulation are being updated to reflect sections of the JJDP Act that were re-numbered following the 2002 amendments.

The Regulatory Flexibility Act (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As noted in the discussion, below, regarding the applicability of the APA, this rule is exempt from the 553(b) notice and comment requirements. Consequently, the RFA does not apply.

Nevertheless, consistent with the analysis typically required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Office of Juvenile Justice and Delinquency Prevention has reviewed this regulation and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities. The Formula Grants Program provides funding to States pursuant to a statutory provision, which is not affected by this regulation. Because States have complete discretion as to which local governments and other entities will receive formula grant funds through subgrants, as well as the amount of any subgrants, this rule will have no direct effect on any particular local governments or entities.

This final rule was developed in accordance with the principles of E.O. 12866 and 13563. E.O. 12866, section 1(b), 58 FR 51, 735 (Sept. 30, 1993), which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866.

OJP has determined that this regulation is not a “significant regulatory action” under Executive Order No. 12866. As set forth above, this final rule will not have the economic effects described in E.O. 12866, sec. 3(f) ( e.g., annual effect on the economy of $100 million or more). It will not create any serious inconsistency or otherwise interference with an action taken or planned by another agency because this rule merely updates an OJJDP program rule. It does not materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof because it merely updates the program rule to conform to existing statutory law and makes technical corrections. For the same reasons, it does not raise novel legal or policy issues. Consequently, in accordance with the general principles of Executive Order No. 12866, the Office of Management and Budget has declined review.

This final rule is not a significant regulatory action under E.O. 12866, and it does not impose a cost greater than zero.

This rule issued by the Office of Justice Programs changes the regulations for the OJJDP Formula Grant Program, and thus concerns matters relating to “grants, benefits, or contracts,” 5 U.S.C. 553(a)(2). This rule is therefore exempt from the requirement of notice and comment and a 30-day delay in the effective date.

Moreover, the purpose of this final rule is (a) to remove provisions of the current regulation that are contrary to the statute upon which they purport to have been predicated when originally promulgated, or that merely parrot or repeat language in the JJDP Act or the Omnibus Crime Control and Safe Streets Act of 1968; and (b) to make technical corrections. Public comments on this final rule would have no effect on the legal necessity of removing the regulatory provisions that are contrary to statute, no effect on the legal redundancy of the parroting or repeating language, and no effect on the making of technical corrections. Finally, the rule would not adversely affect any segment of the public whatsoever, as it does not impose any burdens or requirements on any entities, including Formula Grants Program recipients, and therefore advance notice and public comment are unnecessary.

In addition, these rule amendments remove provisions of the regulation that were rendered null and void by subsequent amendments to the JJDP Act, (which repealed the predicate statutory provisions upon which the regulatory provisions were based), and “parroting” regulations that unnecessarily repeat other provisions of law, and otherwise make only technical corrections to U.S. Code citations in cross-references. Where provisions of the regulation are predicated on defunct or amended statutory provisions, it causes confusion as to the requirements that Formula Grants Program grantees must meet.

For these reasons, it is contrary to the public interest to delay implementation of this rule.

The Formula Grants Program does not impose any mandates on States; nor does it interfere with States' sovereignty, authorities, or rights. States, rather, participate in the Program voluntarily and, as a condition of receipt of funding to improve their juvenile justice systems and to operate juvenile delinquency prevention programs, agree to comply with the Program's requirements.

This rule will not have substantial direct effects on the States, on the relationship between the federal government and the States, or on distribution of power and responsibilities among the various levels of government. The rule will not impose substantial direct compliance costs on State and local governments, or preempt any State laws. Therefore, in accordance with Executive Order No. 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

This rule meets the applicable standards set forth in sections 3(a) and (b)(2) of Executive Order No. 12988. Pursuant to section 3(b)(1)(I) of the Executive Order, nothing in this or any previous rule (or in any administrative policy, directive, ruling, notice, guideline, guidance, or writing) directly relating to the Program that is the subject of this rule is intended to create any legal or procedural rights enforceable against the United States, except as the same may be contained within subpart A of part 31 of title 28 of the Code of Federal Regulations.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. The Formula Grants Program provides funds to States to improve their juvenile justice systems and to support juvenile delinquency prevention programs. As a condition of funding, States agree to comply with the Formula Grants Program requirements. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

This rule does not propose any new, or changes to existing, “collection[s] of information” as defined by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ) and its implementing regulations at 5 CFR part 1320.

Accordingly, for the reasons set forth in the preamble, part 31 of chapter I of title 28 of the Code of Federal Regulations is amended as follows:

OSHRC published revisions to its rules implementing the Equal Access to Justice Act on May 17, 2021 (86 FR 26658). This document makes a correction to the final rule.

Accordingly, 29 CFR part 2204 is amended by making the following correcting amendments:

On July 17, 2020, the Coast Guard published a final rule titled “Regulated Navigation Area: Harbor Entrances Along the Coast of Northern California” at 85 FR 43437 that added 33 CFR 165.1196. That rule established a RNA at the harbor entrance of Crescent City, California. Since publishing the previous rule, the Eleventh Coast Guard District was contacted by the National Oceanographic and Atmospheric Administration (NOAA) Marine Chart Division, part of the Nautical Data Branch of the Office of Coast Survey of the National Ocean Service. The NOAA Marine Chart Division brought to the Coast Guard's attention that the geographic coordinates for the RNA at the harbor entrance of Crescent City appeared to incorrectly capture the entirety of the harbor entrance. The Coast Guard agreed, and worked with the NOAA Marine Chart Division to develop new coordinates that properly capture the entirety of the harbor entrance of Crescent City. On November 30, 2020, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Regulated Navigation Areas; Harbor Entrances Along the Coast of Northern California” (85 FR 76502). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to the update of the geographic coordinates of the harbor entrance of Crescent City. During the comment period that ended December 30, 2020, we received no comments.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Commander of the Eleventh Coast Guard District has determined that there is a need to amend the Regulated Navigation Area: Harbor Entrances along the Coast of Northern California at 33 CFR 165.1196 to update the geographic coordinates of the harbor entrance to Crescent City.

As noted above, we received no comments on our NPRM published on November 30, 2020.

This rule corrects the geographic coordinates listed in the RNA of the harbor entrance to Crescent City. The updated coordinates do not materially affect the size or the general geographic location of the RNA. Instead, the updated coordinates correct an issue raised by the NOAA Marine Chart Division. Specifically, the updated coordinates fully and properly capture the entirety of the harbor entrance to Crescent City.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the limited economic impact of this rule's amendment. The final rule will merely update geographic coordinates. It has no bearing on the impact or the effective period of the current RNA.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received zero comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit through the RNA in the area represented by the updated coordinates at the harbor entrance of Crescent City may be small entities, for the reasons states in section V.A. above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a RNA that will prohibit the transit of maritime traffic in times of unsafe conditions. It is categorically excluded from further review under paragraph L60[a] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

On June 3, 2021, Skanska-Corman-McLean, Joint Venture, notified the Coast Guard that from 7 a.m. on June 14, 2021, to 9 p.m. on June 19, 2021, it will be setting the tub sections at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge at Pier 43, which is adjacent and to the west of the federal navigation channel. The operation requires using two large crane barges and other marine equipment positioned within the federal navigation channel. This operation will impede vessels requiring the use of the channel.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because construction operations, involving simultaneous crane heavy lifts, at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge must occur within the federal navigation channel. Immediate action is needed to respond to the potential safety hazards associated with bridge construction. Hazards from the construction operations include low-hanging or falling ropes, cables, large piles and cement cast portions, dangerous projectiles, and or other debris. It is impracticable and contrary to the public interest to publish an NPRM because we must establish this safety zone by June 14, 2021.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with construction operations at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge conducted within the federal navigation channel.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP Maryland-National Capital Region has determined that potential hazards associated with bridge construction starting June 7, 2021, will be a safety concern for anyone within the federal navigation channel at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge construction site. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the bridge is being constructed.

This rule establishes a safety zone from 7 a.m. on June 14, 2021, through 9 p.m. on June 19, 2021. The safety zone will cover all navigable waters of the Potomac River, encompassed by a line connecting the following points beginning at 38°21′50.5″ N, 076°59′25.6″ W, thence south to 38°21′42.6″ N, 076°59′23.8″ W, thence west to 38°21′41.0″ N, 076°59′34.9″ W, thence north to 38°21′48.9″ N, 076°59′36.8″ W, and east back to the beginning point, located between Charles County, MD and King George County, VA. The regulated area is approximately 300 yards in width and 270 yards in length.

This regulation requires that the bridge owner post a sign facing the northern and southern approaches of the navigation channel labeled “BRIDGE WORK—DANGER—STAY AWAY” affixed to the sides of the on-scene marine equipment and vessels operating within the area of the safety zone. This provides on-scene notice of the safety zone. This notice will consist of a diamond shaped sign (minimum 4 feet by 4 feet) with a 3-inch orange retro reflective border. The word “DANGER” will be 10 inch black block letters centered on the sign with the words “BRIDGE WORK” and “STAY AWAY” in 6 inch black block letters placed above and below the word “DANGER,” respectively, on a white background.

The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the tub sections are being set at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge at Pier 43, which is adjacent and to the west of the federal navigation channel. Except for marine equipment and vessels operated by Skanska-Corman-McLean, Joint Venture, or its subcontractors, no vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

The COTP will notify the public that the safety zone will be enforced by all appropriate means to the affected segments of the public, as practicable, in accordance with 33 CFR 165.7(a). Such means of notification may also include, but are not limited to, Broadcast Notice to Mariners. Vessels or persons violating this rule are subject to the penalties set forth in 46 U.S.C. 70036 (previously codified in 33 U.S.C. 1232) and 46 U.S.C. 70052 (previously codified in 50 U.S.C. 192).

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on size and duration of the safety zone. Vessel traffic not required to use the navigation channel will be able to safely transit around the safety zone. Such vessels may be able to transit to the east of the federal navigation channel, as similar vertical clearance and water depth exist under the next bridge span to the east. This safety zone will impact a small designated area of the Potomac River for approximately 110 hours, but coincides with the non-peak season for recreational boating.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only 110 total hours that will prohibit entry within a portion of the Potomac River. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest to do so. There is insufficient time to allow for a reasonable comment period prior to the event. The rule must be in force by June 27, 2021. We are taking immediate action to ensure the safety of spectators and the general public from hazards associated with the paddleboat event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to mitigate the potential safety hazards associated with a paddleboat event in this location.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Delaware Bay (COTP) has determined that potential hazards associated with a paddleboat event will be a safety concern for anyone within 50 yards in front of the lead safety vessel preceding the first event participants, to 50 yards behind the safety vessel trailing the last event participants, and at all times, extend 100 yards on either side of the safety vessels and participants. This rule is needed to protect personnel, vessels, and the public within the safety zone during the paddleboat event.

This rule establishes a temporary moving safety zone on the waters of Cape May Harbor, Cape May Inlet, Atlantic Ocean, Delaware Bay, and Cape May Canal located in Cape May, NJ, during a paddleboat event. The rule will be enforced from 8:30 a.m. to 1 p.m. on June 27, 2021. The moving safety zone will encompass all waters within 50 yards in front of the lead safety vessel preceding the first event participants, to 50 yards behind the safety vessel trailing the last event participants, and at all times extend 100 yards on either side of safety vessels and participants. No person or vessel will be permitted to enter, transit through, anchor in, or remain within the safety zone without obtaining permission from the COTP Delaware Bay or a designated representative. If authorization to enter, transit through, anchor in, or remain within the safety zone is granted by the COTP Delaware Bay or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP Delaware Bay or a designated representative. The Coast Guard will provide public notice of the safety zone by Broadcast Notice to Mariners and by on-scene actual notice from designated representatives. The regulatory text we are proposing appears at the end of this document.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the following considerations: (1) The moving safety zone would move at the pace of event patrol vessels and participants, thus only impacting certain waters of Cape May Harbor, Cape May Inlet, Atlantic Ocean, Delaware Bay, and Cape May Canal for a limited time allowing for transiting vessels to adjust; and (2) persons and vessels will still be able to enter, transit through, anchor in, or remain within the regulated area if authorized by the COTP Delaware Bay or a designated representative; and (3) the Coast Guard will provide advance notification of the moving safety zone to the local maritime community by Broadcast Notice to Mariners, or by on-scene actual notice from designated representatives.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a moving safety zone that will prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within a limited area on the navigable waters of Cape May Harbor, Cape May Inlet, Atlantic Ocean, Delaware Bay, and Cape May Canal located in Cape May, NJ, during a paddleboat event. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

On February 26, 2021, the Copyright Royalty Judges (Judges) published a notice of proposed rulemaking (notice) in the Federal Register seeking comments on a proposed rule to codify the fact that future hearings may be conducted physically, either at the Library of Congress or an alternative location, or virtually, at the Judges' discretion. 86 FR 1163 (Feb. 26, 2021). The Judges received one comment, from SoundExchange, a regular participant in Copyright Royalty Board proceedings, in favor of the proposed rule. SoundExchange cites to past hearings that the Judges conducted, in coordination and consultation with the participants, in alternate locations and virtually. It also anticipates the possibility that virtual hearings could make sense in the future, and notes that the proposed rule provides flexibility regarding the virtual platform. Therefore, for the reasons indicated in the February 26, 2021 notice, the Judges adopt the proposed changes to part 351, as detailed in this final rule.

For the reasons set forth in the preamble, the Copyright Royalty Judges amend 37 CFR 351 as follows:

This action affects the organization and function of the Environmental Appeals Board (EAB or Board) and the rules of practice governing administrative appeals. The rules of practice governing EAB appeals apply to any persons or entities who seek review of EPA final permit decisions under 40 CFR 124.19 by the EAB as well as persons or entities who appear before the Board in other matters.

This rule will become effective upon publication in the Federal Register . The Administrative Procedure Act's requirement, 5 U.S.C. 553(d), that substantive rules not be effective until at least 30 days after publication in the Federal Register is inapplicable because this rulemaking is procedural.

EPA is issuing this document under its general rulemaking authority, 5 U.S.C. 301, which provides that “[t]he head of an Executive department or military department may prescribe regulations for the government of this department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property.” EPA is not one of the 15 “Executive Departments” listed at 5 U.S.C. 101, however, EPA gained housekeeping authority through the Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 9, 1970).

EPA's authority to issue this procedural rule is also contained in the Resource Conservation and Recovery Act, 42 U.S.C. 6901 et seq.; Safe Drinking Water Act, 42 U.S.C. 300(f) et seq.; Clean Water Act, 33 U.S.C. 1251 et seq.; and Clean Air Act, 42 U.S.C. 1857 et seq. This rule does not expand the Board's authority beyond that of the Administrator in reviewing agency decisionmaking and making final agency determinations.

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b) (A), provides that “rules of agency organization, procedure, or practice” are exempt from notice and comment requirements. The action the Agency is taking in this document reverses certain amendments to the Environmental Appeals Board's procedural rules and replaces them with the prior regulatory text. These procedural revisions fall under the exemption provided in APA section 553(b)(3)(A), as did the rule originally establishing the EAB and its appeal procedures. 57 FR 5320, 5322 (February 13, 1992). Some of the changes in this rule affect the organization of the Agency as it pertains to the organization and function of the EAB, and some of the changes alter the procedures applicable to appeals submitted to the EAB for adjudication. With respect to the appeals process and procedures, this action does not alter the rights or interests of the parties who come before the Board; rather, it reinstates the prior process and procedures used by the Board to review the Agency decision being appealed. Accordingly, EPA is taking no comment on this action.

The Agency is rescinding certain changes made to EPA's Environmental Appeals Board and its appeal process that were promulgated on August 21, 2020 (85 FR 51650) (hereafter “2020 EAB Rule” or “2020 amendments”). Specifically, the EPA is reinstating the regulatory text at 40 CFR 1.25 and most of 40 CFR 124.19 that existed prior to the 2020 amendments. The 2020 EAB Rule is subject to review consistent with the Executive Order 13990, “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis,” section 2(a) (January 20, 2021) (86 FR 7037, January 25, 2021). Based on that review, the Agency has determined that the 2020 EAB Rule adversely affects the administration of the Agency's appeals process and procedures and, thus, rescission of the 2020 EAB Rule is warranted. This action does not, however, alter the revisions that the 2020 EAB Rule made to 40 CFR part 49 or 71, which made the permit appeal procedures in 40 CFR 124.19 applicable to permits issued to tribes in Indian Country under part 49 (for minor and non-attainment NSR permits) and to Title V permits issued under part 71. Applying the same appeal procedures to these types of permits makes the appeals process more consistent, efficient, and transparent.

The EAB was established by rule in 1992 as an impartial body, independent of other EPA components outside of the immediate Office of the Administrator, to conduct full and fair adjudications and to allow for a broader range of input into Agency decisions by the Administrator's express delegation of authority. 57 FR 5320 (February 13, 1992). This rule reinstates the regulatory provisions related to the establishment and function of the EAB and the permit appeals process as they existed prior to the 2020 amendments. In doing so, the Administrator is ensuring that the EAB can continue to uphold the integrity of the Agency's decisionmaking, including the advancement of environmental justice.

The 2020 EAB Rule altered regulatory text pertaining to EAB procedures governing permit appeals, which are informal adjudications under the Administrative Procedure Act. Specifically, the 2020 EAB Rule was intended to preclude the EAB's review of discretionary Agency actions and to make the Board's scope of review more akin to that of federal courts. To accomplish that goal, the 2020 EAB Rule removed regulatory text pertaining to the EAB's review of challenges based on the permit issuer's exercise of discretion, as well as the Board's discretion to review important policy considerations. The changes adversely affected the Board's ability to review—in the context of a permit appeal—a permit issuer's compliance with and application of important EPA policies and Executive orders (85 FR 51652), such as Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations,” 59 FR 7629 (February 16, 1994), which the Board has done in many prior cases. Additionally, the 2020 EAB Rule's stated aim of aligning the Board's standard of review with that of federal courts is not met by the 2020 EAB Rule, because the Administrative Procedure Act authorizes Federal courts to set aside any final agency action under review that is arbitrary, capricious, or an abuse of discretion. 5 U.S.C. 706. By limiting the Board's review to clearly erroneous findings of fact and conclusions of law, and excluding the review of discretionary Agency action and compliance with EPA policies and Executive orders, the 2020 EAB Rule injected uncertainty with respect to the Board's ability to review acts or omissions of the exercise of Agency discretion (and with respect to the applicability of prior related precedent). The effect of the 2020 EAB Rule also conflicts with the efficient and effective functioning of the EAB to administratively review Agency action before it is final, irrespective of a Federal court's scope or standard of review, and to ensure that Agency components consistently comply with Agency policies in a manner that comports with exercising the delegated functions of the Administrator. As such, these changes present obstacles for the Board in ensuring the integrity of Agency decisionmaking where the decision involves discretionary agency action and may impede the advancement of important polices, such as environmental justice. For this reason, this rule rescinds the changes to the EAB's standard for review in permit appeals.

The 2020 EAB Rule also adversely affected other aspects of the process for permit appeals. To purportedly “streamline the permitting appeal process,” the rule set deadlines for the EAB's review by imposing a 60-day requirement to issue permit decisions. The 2020 EAB Rule also restricted the number and length of extensions of time that parties may request. Given the wide range of issues and arguments raised in petitions for review by the EAB, these restrictions are overly prescriptive. Briefing schedules, extensions of time, and even the time it takes to issue a decision are more effectively managed on a case-by-case basis after considering the nature and circumstances present in the case balanced with the resources and demands of the EAB. Existing EAB rules provide the Board the authority, in exercising its duties and responsibilities, to “do all acts and take all measures necessary for the efficient, fair, and impartial adjudication of issues arising in an appeal.” 40 CFR 124.19(n). The ability of a tribunal to manage its docket—including granting extensions, setting deadlines, and determining procedural requirements—is essential to its ability to provide an efficient, fair, and impartial adjudication. Removing the ability of the EAB to manage its caseload based on the wide range of circumstances that may be presented runs counter to those goals.

Additionally, the stated objective to “streamline” the permitting process in the 2020 EAB Rule was not well-supported. The EAB review process not only provides a meaningful opportunity for affected communities to have their concerns addressed, it also expedites the process of obtaining a final, valid permit by facilitating a process that is faster and more certain for the applicant. Permit appeals to the EAB are resolved within a reasonable timeframe and the overwhelming majority of EAB decisions resolve the dispute without the need for federal court litigation, which generally takes considerably longer. On average, very few EAB decisions are appealed to Federal court and very few of those have been overturned. Over the years the EAB has continually refined and altered its processes to reduce the amount of time it takes to effectively resolve an appeal and to make it easier for people to use the appeals process, including the use of electronic filing, making the EAB docket publicly accessible and EAB decisions publicly searchable, implementing word limits on briefs, streamlining procedures for participation in permit appeals, improving internal processes, and implementing the EAB's highly successful Alternative Dispute Resolution process. The EAB has demonstrated a commitment to continuous improvement in the permit appeal process.

The 2020 EAB Rule also altered the deadline and page limit for Amicus participation. Amicus parties in EAB cases can include impacted States, Tribes, and Municipalities (when they are not a petitioner or respondent in the appeal), trade associations, and—when a non-EPA authority is the permit issuer—the EPA's Office of General Counsel. It is in the best interest of the appeals process to provide amicus parties with reasonable timeframes in which to file briefs in appeals, so long as the time allowed will not unduly interfere with the efficiency of the process. Requiring Amicus briefs to be submitted in all cases before the Permit Issuer responds to a Petition for Review, and limiting the length of such briefs to 15 pages, both of which the 2020 EAB Rule does, unnecessarily restricts the EAB's consideration of amici participation in a manner that may preclude the EAB from receiving fully informative briefing of the issues on appeal and, as such, may complicate rather than streamline or improve the permitting appeal process.

The 2020 EAB Rule also removed the Board's authority to decide on its own initiative, or sua sponte, to review any condition of a Resource Conservation and Recovery Act (RCRA), Underground Injection Control (UIC), National Pollutant Discharge Elimination System (NPDES), or Prevention of Significant Deterioration (PSD) permit decision reviewable under 40 CFR 124.19, even when that permit has not been appealed. Consistent with the delegated authority by the Administrator to review agency decisions, this final rule reinstates the Board's sua sponte authority, which has been in place since the Board was established.

With respect to the function of the Board, the 2020 EAB Rule modified the EAB's prior-existing delegation of authority by authorizing the EPA General Counsel, who frequently appears before the EAB in disputed matters as Counsel, or works closely with an EPA Region or EPA program office as “of Counsel,” to issue dispositive determinations on pending EAB matters. Specifically, the 2020 EAB Rule provides that the Administrator acting through the General Counsel can issue a dispositive legal interpretation in any matter pending before the EAB (including enforcement or permit matters) or on any issues addressed by the EAB. These revisions are inconsistent with the EAB's original establishment and function and undermine the transparency, fairness, and finality of EAB decisions. When the Board was established, the Administrator recognized the need to make clear that “the Administrator's adjudicative authority and the Administrator's enforcement authority (delegated to various Regional and Headquarters enforcement officers) are delegated to, and exercised by separate and distinct components of the Agency.” 57 FR 5322. For this reason, the rules expressly prohibit Board Members from being employed by the Office of General Counsel or any other office directly associated with matters that could come before the EAB. 40 CFR 1.25(e)(3). The EAB's independence from the various component offices outside the immediate Office of the Administrator is a critical element of inspiring confidence in the fairness and transparency of the Agency's appellate adjudication process. This includes independence from the Office of the General Counsel, which is not part of the immediate Office of the Administrator.

Additionally, administrative review by the EAB involves a review of the record of decision as it existed at the time the decision was made. A post-hoc interpretation of law that is issued while an appeal is pending, and that is binding on the EAB, injects confusion into the Agency decisionmaking process and conflicts with the EAB's review of the Agency's understanding or application of the law at the time the decision was made. Transparency and fairness in the review of Agency decisionmaking is better served by not injecting a newly issued interpretation of law from the Office of General Counsel while an appeal is pending before the Board. Additionally, because the Office of General Counsel is often counsel, “of counsel” or an amicus party in Board cases, the imposition of a new binding interpretation of law issued through the Office of General Counsel during the pendency of an appeal raises the very concerns that the EAB was established to address. Moreover, this modification was unnecessary because, among other reasons, a reconsideration process exists for EAB decisions and matters can be referred to the Administrator for decision. In sum, a legal interpretation binding on the EAB issued during the pendency of an appeal undermines the EAB's exercise of the Administrator's delegated adjudicative authority as well as confidence in the fairness of the process.

The 2020 EAB Rule also established a process for the Administrator to reverse the EAB's designation of a decision for publication. A decision designated for publication means the decision is slated to be reproduced in bound volumes of the Environmental Administrative Decisions and appear on the Board's website as a published decision. Practically speaking, re-designating a decision as unpublished does not alter the EAB's statutory obligation to publish all final decisions and orders on its website under 5 U.S.C. 552(a)(2)(A) ( i.e., both published and unpublished final orders). The intent of the rule change, however, was not necessarily to affect which decisions are made available to the public; rather, the intent was to indicate to reviewing courts that only published EAB decisions may warrant deference. 85 FR 51653 (August 21, 2020) (noting in the preamble that “it is the express policy of the Agency that only published decisions of the EAB represent EPA's official, authoritative position with regard to the issues addressed in such decisions” and that the intent of the change is to “indicate to reviewing courts that only published EAB decisions may warrant deference”). As revised, the regulatory text added in the 2020 EAB Rule regarding decisions for publication neither determines which decisions will be made available to the public nor forecloses a reviewing court from choosing to afford deference to an unpublished decision. Whether a decision is categorized as “published” versus “unpublished” is also not determinative of whether a party will rely on a case or cite a case to the Board. Consistent with the foundational legal principle of stare decisis, the Board generally follows its own prior applications of law where the same factual and legal principles are presented. The use of a system of precedential decisions makes the decisional process more transparent and consistent for all, including the public. Given all of the above, the provision providing for the Administrator to determine whether a decision should be re-categorized as unpublished or not followed in future cases could negatively affect the transparency and consistency of EAB decisionmaking, and interfere with the independence and function of the EAB to issue final decisions as delegated by the Administrator, which again is fundamental to inspiring confidence in the fairness of the Agency's appellate adjudication process.

Finally, the 2020 EAB Rule set 12-year term limits for EAB judges to serve on the Board. When the Board was established, it was created as a “permanent body with continuing functions.” 57 FR 5320. For twenty-nine years, the EAB judges have been career employees and members of the Senior Executive Service (SES), governed by a specific statute implemented by the Office of Personnel Management (OPM), specifically 5 U.S.C. 3395. The EAB judge position has been classified as Career Reserved, which means that the position is filled by a career appointee and designated as such to ensure impartiality, and the public's confidence in the impartiality, of the government. 5 CFR 214.402. The Career Reserved designation is particularly appropriate for positions, like this, that involve adjudication and appeals. Id. In addition, imposing a 12-year term limit is unnecessary given that the Administrator assigns and appoints career appointees to serve as EAB judges, and each judge acts on the express delegated authority of the Administrator and remains accountable to the Administrator. Further, pursuant to 3395 and 5 CFR 317.901, each judge, as a member of the SES, is subject to reassignment by the Administrator to any other SES position in the Agency for which he or she qualifies, if the Administrator so chooses. 5 U.S.C. 3395 (governing the reassignment or transfer of SES employees); 5 CFR 317.901 (setting forth procedures for effectuating SES reassignments or transfers). The added term limits neither expanded nor removed any authority that the Administrator has over the EAB judge positions. The Agency has benefited from judges who have served on the EAB for long terms because these judges have deep experience in EAB jurisprudence and provide important stability for the Board, as well as the Agency's administrative jurisprudence. Further, although the 2020 EAB Rule set 12-year term limits, it applied those limits on a “rolling basis” to the current judges, where the most senior judge's term expires three years from the effective date of the 2020 EAB Rule. 85 FR 51653. This “retroactive” application of the 12-year term limits to current judges conflicts with the “dignity and stature” that was originally intended for “the Agency's highest adjudicative body.” 57 FR 5320. Potentially rotating in a new judge every three years (or even more often if vacancies occur) could inject instability into the appeals process, may appear to politicize the position in a way that is antithetical to the career reserved designation, and does not serve the Agency's intent in creating the EAB as a specialized, impartial appellate Agency tribunal. Removing the term limits leaves in place the Administrator's authority to reassign any SES judge, consistent with relevant SES statutes and regulations, if the Administrator chooses.

In sum, by rescinding the 2020 EAB Rule and reverting the regulations pertaining to the EAB's function and process to the prior existing regulatory text, the Administrator is reaffirming the EAB's original function as an impartial body, independent of other EPA components, to conduct full and fair adjudications in the exercise of the Administrator's delegated authority. In modifying the Administrator's delegation of authority to the EAB, the 2020 EAB Rule weakened the administration of the Agency's appeals process and procedures. The reversion of the regulatory text will better safeguard the EAB's ability to efficiently and effectively manage the appeals process and ensure the integrity of Agency decisionmaking, advance environmental justice, and protect public health and the environment, in accordance with the mission of the Agency. The Agency intends to further consider the advisability of future revisions to the EAB's procedural rules to incorporate any other housekeeping revisions needed for efficiently and effectively processing appeals.

This action is exempt from review by the Office of Management and Budget (OMB) because it is limited to agency organization, management or personnel matters.

This action does not contain any information collection activities and therefore does not impose an information collection burden under the PRA.

This action is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule pertains to agency management or personnel, which the EPA expressly exempts from notice and comment rulemaking requirements under 5 U.S.C. 553(a)(2).

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1536, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.

This action does not have federalism implications. It will not have a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that 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 risk or safety risk.

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy.

This rulemaking does not involve technical standards.

This action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard.

This rule is exempt from the CRA because it is a rule relating to agency management or personnel; and is a rule of agency organization, procedure or practice that does not substantially affect the rights or obligations of non-agency parties.

For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR parts 1 and 124 as follows:

In FR Doc. 2020-09260, beginning on page 43946 in the Federal Register of Monday, July 20, 2020, the following corrections are made:

The Convention is concerned with the conservation and management of highly migratory fish stocks (HMS) and the management of fisheries for HMS. The objective of the Convention is to ensure, through effective management, the long-term conservation and sustainable use of HMS in the western and central Pacific Ocean (WCPO). To accomplish this objective, the Convention established the Commission, which includes Members, Cooperating Non-members, and Participating Territories (collectively referred to here as “members”). The United States of America is a Member. American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands are Participating Territories.

As a Contracting Party to the Convention and a Member of the Commission, the United States implements, as appropriate, conservation and management measures adopted by the Commission and other decisions of the Commission. The WCPFC Implementation Act (16 U.S.C. 6901 et seq. ), authorizes the Secretary of Commerce, in consultation with the Secretary of State and the Secretary of the Department in which the United States Coast Guard is operating (the Department of Homeland Security), to promulgate such regulations as may be necessary to carry out the obligations of the United States under the Convention, including the decisions of the Commission. The WCPFC Implementation Act further provides that the Secretary of Commerce shall ensure consistency, to the extent practicable, of fishery management programs administered under the WCPFC Implementation Act and the Magnuson-Stevens Fishery Conservation and Management Act (MSA; 16 U.S.C. 1801 et seq. ), as well as other specific laws (see 16 U.S.C. 6905(b)). The Secretary of Commerce has delegated the authority to promulgate regulations under the WCPFC Implementation Act to NMFS. A map showing the boundaries of the area of application of the Convention (Convention Area), which comprises the majority of the WCPO, can be found on the WCPFC website at: www.wcpfc.int/doc/convention-area-map .

On March 27, 2020, in response to public health concerns related to the COVID-19 pandemic, NMFS published an emergency rule providing authority to waive certain observer requirements (85 FR 17285). This rule was subsequently extended through March 26, 2022 (86 FR 16307; March 29, 2021). On April 8, 2020, in response to the international concerns over the health of observers and vessel crews due to COVID-19, the Commission made an intersessional decision to suspend the requirements for observer coverage on purse seine vessels on fishing trips in the Convention Area through May 31, 2020. The Commission subsequently extended that decision several times, and the current extension is effective until August 15, 2021.

NMFS regulations at 50 CFR 300.223(e) implement a WCPFC requirement for 100 percent WCPFC observer  1 coverage on purse seine vessels (with limited exceptions). Accordingly, in order to carry out the Commission's intersessional decision, NMFS has waived the requirement under 50 CFR 300.223(e) until August 15, 2021.

NMFS regulations at 50 CFR 300.216(b)(1) implement the WCPFC prohibition on at-sea transshipments for purse seine vessels. On April 20, 2020, in response to the international concerns over the health of vessel crews and port officials due to COVID-19, the Commission made an intersessional decision to modify this prohibition as follows—purse seine vessels can conduct at-sea transshipment in an area under the jurisdiction of a port State, if transshipment in port cannot be conducted, in accordance with the domestic laws and regulations of the port State. The Commission subsequently extended that decision and the current extension is effective until August 15, 2021.

NMFS regulations at 50 CFR 300.215(d) and 50 CFR 300.216(b)(2) implement WCPFC provisions regarding observer coverage for at-sea transshipments. On May 13, 2020, in response to the international concerns over the health of observers and vessel crews due to COVID-19, the Commission made an intersessional decision to suspend the requirements for observer coverage for at-sea transshipments. The Commission subsequently extended that decision and the current extension is effective until August 15, 2021.

NMFS anticipates that the Commission may make additional short-notice decisions in the near future that require immediate implementation and are temporary in nature. NMFS regulations at 50 CFR part 300, subpart O, implement multiple WCPFC decisions that are currently in force. The WCPFC Implementation Act authorizes NMFS to promulgate such regulations as may be necessary to carry out the United States' international obligations as a member of the Commission, including recommendations and decisions adopted by the Commission. However, NMFS does not currently have a process to quickly implement short-notice WCPFC decisions requiring immediate action that address relevant global or regional health, safety, and security concerns, as well as other international emergencies and crises.

This interim final rule establishes a framework through which NMFS may issue temporary specifications, each for a period less than one year in total, inclusive of all extensions, that promptly suspend or modify existing regulations in 50 CFR part 300, subpart O, which implement the United States' obligations under the Convention and WCPFC decisions. This framework allows NMFS to modify or suspend existing NMFS regulations in response to short-notice WCPFC decisions, including intersessional decisions that address relevant global or regional health, safety, and security concerns, as well as other international emergencies and crises. This framework helps ensure that NMFS regulations remain consistent with international obligations that may unexpectedly and quickly change in response to global events. NMFS does not intend to use this framework to implement WCPFC decisions that are routine and enter into effect at least 60 days after the decision is made, as specified in Article 20(5) of the Convention.

The process enables NMFS to implement short-notice WCPFC decisions through the issuance of temporary specifications that modify or suspend specific existing regulations at 50 CFR part 300, subpart O. As appropriate, temporary specifications may remain in effect up to 30 days after the expiration of the underlying WCPFC decision to allow NMFS adequate time to issue extensions or changes to the temporary specification, if needed, without unnecessarily exceeding the timeframe of the underlying WCPFC decision.

Any temporary specification issued pursuant to this framework will be published in the Federal Register and will include information regarding the basis for the modification or suspension ( i.e., a description of the WCPFC decision), the temporary modifications or suspension to the regulations, and the duration of the changes. Under the framework, NMFS may change (including extend, so long as the duration of the original temporary specification in addition to any extension is less than one year) any temporary specification by publishing a new temporary specification in the Federal Register . NMFS may revoke any temporary specification by publishing a notification in the Federal Register .

NMFS reviewed the regulations at 50 CFR part 300, subpart O, implementing the Convention and WCPFC conservation and management measures, to identify reasonably foreseeable temporary specifications to the regulations in response to short-notice WCPFC decisions, including intersessional decisions, that address relevant global or regional health, safety, and security concerns, as well as other international emergencies and crises.

Temporary specifications issued under the framework in this interim final rule shall be limited to the following:

(1) Modifications or suspensions of the purse seine observer coverage requirements at 50 CFR 300.223(e), including suspensions of some or all of the requirements on a fleet-wide or individual vessel basis, requiring the carrying of observers other than WCPFC observers, requirements to carry electronic monitoring devices in lieu of observers, and requirements to collect and submit photographic or written information;

(2) Modifications or suspensions of the regulations at 50 CFR 300.216(b)(1) prohibiting at-sea transshipment for purse seine vessels, including suspensions of some or all of the prohibitions, prior notification for an at-sea transshipment, and suspension of the prohibitions for particular transshipments; and

(3) Modifications or suspensions of the regulations at 50 CFR 300.215(d) and 50 CFR 300.216(b)(2) regarding at-sea transshipment observer requirements, including suspensions of some or all of the requirements, suspension of some or all of the requirements for particular transshipments, requiring the carrying of observers other than WCPFC observers, requirements to carry electronic monitoring devices in lieu of observers, and requirements to collect and submit photographic or written information.

NMFS is using the framework established under the interim final rule to implement by temporary specification the three recent WCPFC intersessional decisions (WCPFC decisions dated April 8, 2020, April 20, 2020, and May 13, 2020), described above, that are in effect until August 15, 2021. Accordingly, the requirements of the following regulations are waived. Such waiver shall remain in effect until September 14, 2021, unless NMFS earlier rescinds or extends this waiver by publication in the Federal Register :

• 50 CFR 300.223(e)(1). During the term of this waiver, U.S. purse seine vessels are not required to carry observers on all fishing trips in the Convention Area. However, the regulations at 50 CFR 300.215(c)(1) that require all vessels with WCPFC Area Endorsements or for which WCPFC Area Endorsements are required to carry observers when directed by NMFS to do so remain in effect;

• 50 CFR 300.216(b)(1). During the term of this waiver, U.S. purse seine fishing vessels are not prohibited from at-sea transshipment conducted within the national waters of the coastal state, in accordance with applicable national laws. Transshipment on the high seas remains prohibited; and

• 50 CFR 300.216(b)(2) and 50 CFR 300.215(d). During the term of this waiver, owners and operators of U.S. commercial fishing vessels fishing for highly migratory species in the Convention Area are not prohibited from at-sea transshipment without an observer on board the offloading or receiving vessel.

The Administrator, Pacific Islands Region, NMFS, has determined that this interim final rule is consistent with the WCPFC Implementation Act and other applicable laws.

There is good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment on the interim final rule and temporary measures included in this action, because prior notice and the opportunity for public comment would be contrary to the public interest. As stated above, three short-notice WCPFC decisions needing immediate implementation have already gone into effect and NMFS is implementing those three decisions through the framework process established under this interim final rule. In addition, it is likely that the WCPFC will agree upon additional short-notice decisions, which address relevant global or regional health, safety, and security concerns, as well as other international emergencies and crises, in the near future. The process established under this interim final rule would provide NMFS with the ability to carry out the obligations of the United States under the Convention, including promptly implementing the short-notice decisions of the Commission. NMFS will, however, consider and respond to public comments received on the interim final rule.

For the reasons articulated above, there is also good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective dates for the interim final rule and the temporary measures.

This interim final rule has been determined to be not significant for purposes of Executive Order 12866.

Because prior notice and opportunity for public comment are not required for the interim final rule by 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are inapplicable. Therefore, no regulatory flexibility analysis was required and none has been prepared.

This interim final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.

For the reasons set out in the preamble, 50 CFR part 300 is amended as follows: