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-2023-0021; Project Identifier MCAI-2022-01618-E” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, 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 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 Kevin Clark, 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.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0256, dated December 19, 2022 (EASA AD 2022-0256) (also referred to as the MCAI), to correct an unsafe condition on all Safran Arriel 1C, Arriel 1C1, and Arriel 1C2 model turboshaft engines. The MCAI states that there were reports of false engine fire warnings. The subsequent investigation results identified a manufacturing non-compliance on the fire detectors, which caused a shift of the detection threshold towards temperature values that are lower than specified, potentially leading to a false engine fire warning. When two engines on a helicopter are fitted with an affected part, an engine fire warning could occur on both engines during the same flight. This condition, if not addressed, could lead to commanded in-flight engine shut-down, possibly resulting in damage to the helicopter and reduced control of the helicopter.

The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2023-0021.

The FAA reviewed EASA AD 2022-0256, which specifies procedures for replacing affected fire detectors. 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 ADDRESSES .

These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI described above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of these same type designs.

This AD requires accomplishing the actions specified in EASA AD 2022-0256, except for any differences identified as exceptions in the regulatory text of this AD. This AD also prohibits the installation of affected fire detectors.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2022-0256 is incorporated by reference in this AD. This AD requires compliance with EASA AD 2022-0256 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in EASA AD 2022-0256 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2022-0256. Service information required by EASA AD 2022-0256 for compliance will be available at regulations.gov under Docket No. FAA-2023-0021 after this AD is published.

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.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies foregoing notice and comment prior to adoption of this rule because fire detectors that do not conform to the type design could lead to false engine fire warnings. Safran was informed of three occurrences of illumination of the engine fire alarm without confirmed fire (untimely illumination) on airframes equipped with affected fire detectors. False engine fire warnings are an unsafe condition requiring urgent corrective action because, if a helicopter is equipped with two engines with an affected fire detector installed, an engine fire warning could occur on both engines during the same flight. This unsafe condition, if not addressed, could lead to commanded in-flight engine shut-down, possibly resulting in damage to the helicopter and reduced control of the helicopter. Replacement of the fire detectors must be accomplished within 30 flight hours or 60 days from the effective date of this AD, whichever occurs first. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).

In addition, 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, for the same reasons the FAA found good cause to forego notice and comment.

The requirements of the 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 the 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 30 engines installed on helicopters of U.S. registry. The FAA estimates the following costs to comply with this AD:

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

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:

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-2023-0020; Project Identifier MCAI-2022-01566-E” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, 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 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 Kevin Clark, 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.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2022-0244, dated December 8, 2022 (EASA AD 2022-0244), (also referred to as the MCAI), to correct an unsafe condition for all Safran Makila 1A and Makila 1A1 model turboshaft engines. The MCAI states that there were reports of false engine fire warnings. The subsequent investigation results identified a manufacturing non-compliance on the fire detectors, which caused a shift of the detection threshold towards temperature values that are lower than specified, potentially leading to a false engine fire warning. When two engines on a helicopter are fitted with an affected part, an engine fire warning could occur on both engines during the same flight. This condition, if not addressed, could lead to commanded in-flight engine shut-down, possibly resulting in damage to the helicopter and reduced control of the helicopter.

The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2023-0020.

The FAA reviewed EASA AD 2022-0244, which specifies procedures for replacing affected fire detectors. 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 ADDRESSES .

These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI described above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of these same type designs.

This AD requires accomplishing the actions specified in EASA AD 2022-0244, except for any differences identified as exceptions in the regulatory text of this AD. This AD also prohibits the installation of affected fire detectors.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2022-0244 is incorporated by reference in this AD. This AD requires compliance with EASA AD 2022-0244 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in EASA AD 2022-0244 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2022-0244. Service information required by EASA AD 2022-0244 for compliance will be available at regulations.gov under Docket No. FAA-2023-0020 after this AD is published.

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.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies foregoing notice and comment prior to adoption of this rule because fire detectors that do not conform to the type design could lead to false engine fire warnings. Safran was informed of three occurrences of illumination of the engine fire alarm without confirmed fire (untimely illumination) on airframes equipped with affected fire detectors. False engine fire warnings are an unsafe condition requiring urgent corrective action because, if a helicopter is equipped with two engines with an affected fire detector installed, an engine fire warning could occur on both engines during the same flight. This unsafe condition, if not addressed, could lead to commanded in-flight engine shut-down, possibly resulting in damage to the helicopter and reduced control the helicopter. Replacement of the fire detectors must be accomplished within 30 flight hours or 60 days from the effective date of this AD, whichever occurs first. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).

In addition, 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, for the same reasons the FAA found good cause to forego notice and comment.

The requirements of the 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 the 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 1 engine installed on a helicopter of U.S. registry. The FAA estimates the following costs to comply with this AD:

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

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:

Upon request, FDA has classified the computerized behavioral therapy device for treating symptoms of gastrointestinal conditions as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On April 30, 2020, FDA received Mahana Therapeutics, Inc.'s request for De Novo classification of the Parallel. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on November 25, 2020, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 876.5960. 1 We have named the generic type of device computerized behavioral therapy device for treating symptoms of gastrointestinal conditions, and it is identified as a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

At the time of classification, computerized behavioral therapy devices for treating symptoms of gastrointestinal conditions are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801, regarding labeling, have been approved under OMB control number 0910-0485.

Upon request, FDA has classified the intense pulsed light device for managing dry eye as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On April 20, 2020, FDA received Lumenis's request for De Novo classification of the Lumenis Stellar M22. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on February 23, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 886.5201. 1 We have named the generic type of device intense pulsed light device for managing dry eye, and it is identified as a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

At the time of classification, intense pulsed light device for managing dry eye is/are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 886 is amended as follows:

This final rule amends and repeals certain regulations for radiation emitting electronic products and medical devices because the FDA has identified the regulations as being outdated and duplicative of other means for reducing radiation exposure to the public. The Agency is updating the regulations to amend or repeal regulations that are outdated and otherwise clarify requirements for protecting the public health against radiation exposure from specific electronic products and medical devices. The regulations being finalized for amendment or repeal are the radiation protection recommendations for specific uses, records and reporting requirements for electronic products, applications for variances, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products.

This final rule updates FDA's radiological health regulations to amend or repeal the following provisions:

• Repeal the radiation protection recommendations that have become outdated and unnecessary;

• Removing or reducing some of the annual reports and test record requirements that are unnecessary or may be duplicative of other reporting requirements by FDA and State regulators;

• Revise the timing for submissions of reporting requirements for accidental radiation occurrences (AROs) to provide for quarterly reporting for AROs that are not associated with a death or serious injury;

• Amend the applications for variances processes to no longer require a manufacturer to submit two additional copies with the original documents;

• Amend the regulations to no longer require assemblers who install certified components of diagnostic x-ray systems to submit reports of assembly to the Agency;

• Amend the reporting requirements for manufacturers that incorporate a certified laser product to reduce reporting that is considered duplicative under certain conditions; and

• Repeal the performance standard for ultrasonic products because it is limited to a subset of physical therapy devices with an outdated standard.

The Agency believes the amendments and repeals will help to ensure that the requirements for radiation emitting electronic products and devices will continue to protect the public health and safety while reducing regulatory burdens.

FDA is issuing this final rule under the same authority under which FDA initially issued these regulations, the device and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA has the authority under the FD&C Act to amend the performance standard for diagnostic x-ray systems and their major components, amend the performance standard for laser products, and repeal radiation protection recommendations and the performance standard for ultrasonic therapy products, as provided for in this rule.

This final rule updates FDA's radiological health regulations by amending parts of the general provisions including records and reporting requirements for electronic products. Benefits are estimated in terms of cost savings. Industry cost savings are derived by estimating the savings in reduced labor resulting from the reduction in reporting, recordkeeping, and third-party disclosure requirements. Cost savings to FDA result from the reduction in labor hours required to review reports. The total present value cost savings over a 20-year time period are $69.71 million at a 7 percent discount rate and $97.89 million at a 3 percent discount rate. Annualized total cost savings are $6.58 million. We estimate the costs to read the rule for all reporting respondents. The present value costs are $1.60 million and the annualized costs calculated over a 20-year time period are $0.14 million at a 7 percent discount rate and $0.10 million at a 3 percent discount rate.

FDA recognizes that some records and reporting requirements for some radiation emitting electronic products and medical devices are not necessary to protect the public health and safety in compliance with the Electronic Product Radiation Control (EPRC) program (see sections 532, 534(a)(1), and 537(b) of the FD&C Act (21 U.S.C. 360ii, 360kk(a)(1), and 360nn(b))). In addition, some of the recommended protections against radiation and performance standards are now outdated and redundant to other Federal and State requirements, including professional guidelines that apply to the education and licensing of practitioners, as well numerous current radiation guidance documents and industry standards that practitioners and industry rely on to protect the public health and safety. For example, there are more recent standards that industry and FDA can rely on for the safety of ultrasonic therapy devices for physical medicine, for instance the International Electrotechnical Commission (IEC) standards 60601-2-5, Medical electrical equipment—Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment (August 6, 2013) and 61689, Ultrasonics—Physiotherapy systems—Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz (January 30, 2014). FDA also recognizes that submission of certain quarterly reports is unnecessary given certain annual reporting requirements. In addition, the submission of initial product reports for products that are also subject to premarket authorization prior to marketing is duplicative. The Safe Medical Devices Act of 1990 (Pub. L. 101-629), enacted on November 28, 1990, transferred the provisions of the Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602) (formerly 42 U.S.C. 263b through n(i) et seq. ) from Title III of the Public Health Service Act to Chapter V, subchapter C of the FD&C Act, EPRC (sections 531-542 of the FD&C Act (21 U.S.C. 360hh-360ss)). Under these provisions, FDA administers the EPRC program to protect the public health and safety. This authority provides for developing, amending, and administering radiation safety performance standards for electronic products.

FDA is responsible for protecting and promoting the public health regarding electronic product radiation from medical devices and electronic products. Voluntary consensus standards regarding safety and essential performance have been developed and continually improved to increase the safety of these devices and products (sections 514(c) (21 U.S.C. 360d) and 531-542 of the FD&C Act). FDA believes radiation emitting electronic products and devices that comply with Federal standards and Federally-recognized consensus standards, adequately protect the public health and safety and provide a reasonable assurance of safety and effectiveness, as applicable, when properly used by trained personnel, and concern has shifted to minimizing improper uses. FDA, patients, health workers, and industry recognize that medical products that emit radiation should be used only when medically justified to answer a clinical question or to guide treatment of a disease, and that the amount of radiation used should be limited to that necessary to accomplish the clinical task (Refs. 1, 2-4).

In 2010, FDA's Center for Devices and Radiological Health (CDRH) launched an “Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging” (Ref. 3) to protect public health by promoting the appropriate use of radiation and safety features to minimize unnecessary radiation exposure from medical imaging. Through this initiative, FDA collaborates with other agencies and the healthcare professional community to mitigate factors contributing to unnecessary patient exposure to radiation during medical procedures. The range of electronic products marketed today is diverse with regards to radiation emission levels, product complexity, consumer use, and sales volume. The public risk associated with exposure to radiation from these products also varies significantly; however, the risks to patients can be mitigated by medical personnel only performing exams using radiation when necessary to answer a medical question, treat a disease, or guide a procedure (Ref. 4).

In accordance with FDA's directive to carry out the EPRC program (see sections 532, 534(a)(1), and 537(b) of the FD&C Act), FDA prescribes and amends performance standards for electronic products to control the emission of electronic product radiation when necessary to protect the public health and safety. In establishing performance standards consistent with the statute, FDA consulted with the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) (section 534(f) of the FD&C Act) (Ref. 5). On October 26, 2016, a TEPRSSC meeting was held and FDA presented, for consultation with TEPRSSC, proposed certain amendments to the regulations for laser, sonic, x-ray, and other radiation emitting products to best align FDA's focus with the public health need and reduce or eliminate standards or reporting that were no longer considered necessary (Ref. 5). FDA also proposed to the TEPRSSC the removal of the ultrasonic therapy performance standard with continuing reliance on medical device review prior to marketing authorization. Items in these amendments have been considered in discussions by TEPRSSC as necessary. Therefore, FDA has determined that the regulatory requirements can be adjusted to take account of the wide range of electronic products currently on the market and focus on products that pose a higher risk to the public.

Many of the requirements in our radiological health regulations are over 30 years old. As described below and in the proposed rule (84 FR 12147, April 1, 2019) the final rule amends and repeals certain radiological health regulations to reduce regulatory requirements that are outdated and duplicative. Specifically, this final rule amends parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, applications for variances, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products while still assuring the public health and safety is protected against harmful exposure to radiation emitting electronic products and medical devices.

In the Federal Register of April 1, 2019, FDA published a proposed rule to amend the radiological health regulations (84 FR 12147). The comment period for the proposed rule closed on July 1, 2019. FDA received comments on the proposed rule from several entities including medical device associations, industry, medical and healthcare professional associations, public health advocacy groups, and individuals. While some comments object to particular sections or subsections of the proposed rule, almost all comments voice support for the objective intent of the proposed rule, to amend certain regulations to reduce regulatory burden while continuing to assure protection of the public health and safety against harmful exposure to radiation emitting electronic products and medical devices.

Some comments raise concerns or request clarification regarding:

• repealing the radiation protection recommendations,

• removing or reducing certain records and reporting requirements for electronic products,

• incorporating and expanding the policies described in FDA's Laser Notice 42 to higher powered laser products,

• amending the performance standards for laser products that incorporate certified laser systems,

• information on future technologies and other measures that may reduce or eliminate radiation exposure,

• document retention and responsibilities related to initial, supplemental, abbreviated and annual reports,

• assemblers' responsibilities for maintaining a record of report of assembly on file,

• the tracking and trending analysis related to the requirements for reports on accidental radiation occurrences, and

• additional amendments to performance standards for laser products.

FDA considered all comments received on the proposed rule and made changes, primarily for clarity and accuracy and to be consistent with the goal of reducing the burden of regulatory requirements for radiation emitting products and medical devices without compromising patient safety. On its own initiative, FDA is also making minor technical changes to improve clarity and consistency and reduce regulatory burden. Based on the comments received on the proposed rule, FDA has made changes from the proposed rule (84 FR 12147) to include the following revisions in the codified section of this final rule:

• Include the word “accidental” in the definition for radiation occurrence (§ 1000.3(a)),

• include a footnote in the records and reports table clarifying laser product certification (table 1 in § 1002.1),

• include language of information needed for quarterly reporting of accidental radiation occurrences (§ 1002.20(c)(2)(ii)),

• include a paragraph with language to identify when certification and reporting is duplicative and unnecessary for laser products under § 1040.10 that incorporate a certified laser system (§ 1010.2(e)),

• identify an alternative format for identification of the month and date of the manufacture of an electronic product (§ 1010.3(a)(2)(ii)),

• clarify the options for submissions for applications for variances (§ 1010.4(b)(1)), and

• revise the title and applicability for television receivers that contain a cathode ray tube (§ 1020.10).

FDA also decided on its own initiative to include the following additional amendments to this final rule for clarity and consistency and to reduce regulatory burden:

• remove the requirement for two copies of an application for exemption of warning labels for a microwave oven that are submitted to CDRH and correct the name of the CDRH office to submit a document (§ 1030.10(c)(iv)), and

• clarify and remove the requirement that x-ray assemblers for certified accessory components submit Reports of Assembly (Form FDA 2579) to CDRH (§ 1020.30(d)(2)).

FDA is issuing this final rule under the same authority under which FDA initially issued these regulations, the device and general administrative provisions of the FD&C Act (21 U.S.C. 321, 351, 352, 360, 360e-360j, 360hh-360ss, 371, 374, and 381). FDA has the authority under section 534 of the FD&C Act to amend the performance standard for diagnostic x-ray systems and their major components, amend the performance standard for laser products, and repeal radiation protection recommendations and the performance standard for ultrasonic therapy products, as provided for in this final rule.

We received several sets of comments on the proposed rule by the closure of the comment period, each containing one or more comments on one or more issues. We received comments from medical device associations, industry, medical and healthcare professional associations, public health advocacy groups, and individuals. We describe and respond to the comments in this section of the document. The topics for the comments are grouped based on the common themes identified below. We have grouped similar comments together under the same number so that FDA's responses could be addressed by topic, instead of each comment addressed independently, and, in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received.

(Comment 1) FDA received multiple comments that express support for the proposed rule and the proposals to remove outdated radiation protection recommendations and adjust the regulatory records and reporting requirements based on risk. The comments urged the Agency to maintain vigilance and continue to promote the health and safety of patients and healthcare practitioners.

(Response 1) FDA appreciates the public support for the rule. FDA intends to continue to utilize its regulatory authorities and collaborations with other governmental agencies, non-governmental organizations, and industry, among others, to promote the safe and effective use of radiation to best protect and promote public health.

(Comment 2) One comment referenced multiple publications that supported FDA's proposal that the recommendations in § 1000.50 for use of gonad shielding were inconsistent with current scientific evidence and should be removed.

(Response 2) FDA agrees with the recommendation and is removing the recommendations in § 1000.50 in this final rule.

(Comment 3) One comment raised concern that by repealing the radiation protection recommendations, end-users may have difficulty finding, analyzing, and applying the appropriate standards and practices to specific clinical healthcare situations. The comment requested that FDA list the specific regulations that are outdated or duplicative and provide direction as to the appropriate current standards or practice parameters that replace the repealed regulations.

(Response 3) FDA acknowledges the concern but does not believe that repeal of the recommendations will cause difficulty in locating and applying applicable standards and practices. This final rule identifies the § 1000.50 recommendations that are being removed. FDA believes these specific recommendations are outdated and no longer relied upon by healthcare providers. Removing the recommendations eliminates information that is no longer useful. FDA identified recent, consensus recommendations in the proposed rule (Refs. 1, 2, 6-9). FDA continues to recommend that medical professionals also seek continuing education through professional societies to remain current with new technologies, standards, and best practice guidelines.

(Comment 4) Multiple comments recognized the contributions of external stakeholders to develop and incorporate radiation protection into device design, practitioner training, and best practices for standards of care. Comments stated that diagnostic imaging is an important part of the standard of care, and training and continuing education are important so that healthcare professionals know the rules, regulations, safety procedures, and best practices to benefit patients and avoid harm. The comments requested that FDA support and reference the most relevant guidelines for healthcare professionals wherever feasible.

(Response 4) FDA recognizes the importance of training and continuing education for healthcare professionals and will continue to collaborate with, and reference the work of, external organization as appropriate to develop standards. FDA believes professional societies should have the resources and knowledge to provide the most up-to-date guidelines for their members. FDA recognizes the significant and ongoing contributions that external stakeholders, such as the American Association of Physicists in Medicine, the American College of Radiology, the Health Physics Society, the Image Gently Alliance, the International Atomic Energy Agency, the Medical Imaging Technology Alliance, the Society of Interventional Radiology, the World Health Organization, and many others, have made to incorporate radiation protection into device design, practitioner training, and best practices for standards of care. For example, in 2003, the National Council on Radiation Protection and Measurements (NCRP) updated its recommendations on radiation protection in dentistry (Ref. 6). In 2012, the American Dental Association, in conjunction with FDA, updated its selection criteria for dental imaging with guidelines for the frequency of dental radiographs and radiation exposure recommendations (Ref. 7). In 2014, the Environmental Protection Agency's (EPA) Working Group on Medical Radiation, with active FDA participation, published a document entitled “Federal Guidance Report No. 14. Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures” (Guidance Report No. 3), which provides comprehensive recommendations for radiation protection to medical and dental facilities (Ref. 1). Because safety procedures and best practices are continuously revised and improved, FDA believes that specifically referencing existing guidelines in the regulations is not appropriate because it may lead to confusion or unintended consequences as practice guidelines continue to be updated.

(Comment 5) One comment acknowledges that professional organizations play a key role in developing guidance for safe use of radiation, but such guidance may not be comprehensive. The comment recommended that FDA define the organizational credentials and processes to guide the development and format of radiation use standards.

(Response 5) FDA disagrees with the recommendation because the EPRC does not provide for defining and enforcing criteria by which standards organizations or professional societies operate (see sections 532, 534(a)(1), and 537(b) of the FD&C Act). FDA's standards program provides FDA with the opportunity to review and rely on appropriately developed standards within the scope of the FD&C Act. FDA actively participates in the development of voluntary standards and guidelines with other organizations. FDA encourages individuals and professional societies to join and participate in the development of safety recommendations and standards to address the diversity of clinical, scientific, and other needs that apply to their profession.

(Comment 6) One comment suggested that one national set of standards, regulations and training requirements for operators is preferable to differences by state or locality. The comment included a specific example that the quality of dental radiography may vary given the lack of national requirements, especially with the introduction of new technologies, such as cone-beam Computerized Tomography (CT). The lack of a national standard may result in different approaches to radiographer training, with the potential for increased radiation exposure to patients. The comment recommended that FDA designate a specific organization as the responsible entity on all aspects of dental imaging including training of all dental personnel who perform dental imaging examinations.

(Response 6) FDA disagrees with the recommendation. The EPRC does not provide for defining and enforcing criteria by which standards organizations or professional societies operate, or for designating an organization(s) to define or enforce such requirements. FDA notes that such standards and training are generally provided for by appropriate organizations and professions, and FDA frequently collaborates with these organizations and professions. FDA supports the continuation of such efforts by these entities to educate members on best practices for safe use of radiation in their profession. For dental imaging specifically, FDA, in collaboration with the Conference of Radiation Control Program Directors (CRCPD), recently completed a nationwide survey of the use of radiation in dental imaging facilities (Ref. 10). FDA staff participated in developing a report by the National Council on Radiation Protection and Measurements (NCRP) on radiation protection in dentistry (Ref. 11). FDA has also collaborated with the American Dental Association on guidelines for the selection of patients for dental radiographic examinations (Ref. 7). FDA hopes the results of these kinds of collaborations, and other work from similar organizations, will help inform FDA and other organizations of best practices and recommendations for training and equipment standards.

(Comment 7) One comment recommended FDA withdraw the rules and regulations for the lowest risk radiation emitting electronic products first. The commenter suggested removing reporting of assembly for wall mounted x-ray generators for intraoral radiography, while maintaining reporting for handheld portable x-ray generators for use in dentistry, which are relatively new and without the same safety record.

(Response 7) FDA disagrees with the comment. FDA has taken a risk-based assessment in amending the regulations. FDA considers submission to FDA of any report of assembly for certified components of diagnostic x-ray products to no longer be necessary, while continuing to facilitate the submission of such reports of assembly, where applicable, to State agencies and purchasers. Diagnostic x-ray systems still need to meet the product-specific performance standards under part 1020 (21 Code of Federal Regulations (CFR), part 1020), including the submission of any reports of assembly of installed certified components as applicable. Diagnostic x-ray systems, including handheld dental x-ray units, will also continue to be subject to applicable medical device regulations (see, e.g., 21 CFR parts 803, 807, 820, 872, and 892).

(Comment 8) Some comments support the use of international voluntary consensus standards to help ensure regulatory requirements are met. Commenters noted the benefits, including consistency in regulation, global harmonization, efficiencies, minimizing unnecessary costs and delays in patient access to innovative new devices and promoting safety, and consistency with the National Technology Transfer and Advancement Act (Pub. L. 104-113), and Office of Management and Budget's (OMB) directive Circular A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities (Ref. 12).

(Response 8) FDA agrees with these comments and will continue to participate in the development of international standards and their use for regulatory purposes as appropriate.

(Comment 9) One comment expressed interest in FDA providing information on future technologies and other measures that may reduce or eliminate radiation exposure.

(Response 9) FDA recommends that medical professionals seek continuing education through their appropriate professional societies to maintain knowledge of new technologies and best practice guidelines. With respect to medical devices, FDA's Q-Submission Program (Ref. 13) offers manufacturers the opportunity to receive feedback on their proposed regulatory pathway and test plans when developing new devices and technologies that may improve image quality and patient safety.

(Comment 10) One comment recommended reformatting table 1 of § 1002.1 for clarity by merging and shading the category rows.

(Response 10) FDA understands the concern for readability of the regulations; however, FDA is limited in the formatting tools available for display and printing of regulations in the Federal Register and the CFR, as such stylistic issues are determined by the U.S. Government Publishing Office for the entire Federal government. The information will continue to be displayed in table 1 as formatted and published in the proposed rule.

(Comment 11) One comment recommended clarifying in §§ 1002.20(b) and 1010.4(b) whether submission of both electronic and paper reports and variance requests are acceptable.

(Response 11) FDA agrees with the recommendation and is revising the language in §§ 1002.20(b) and 1010.4(b) to clarify that “either” electronic or paper submissions are appropriate.

(Comment 12) One comment recommended that the regulations allow for use of the International Organization for Standardization (ISO) standard date format (“YYYY-MM-DD”), which is required for medical devices in 21 CFR 801.18(a), as an alternative to the EPRC format specified in § 1010.3(a)(2)(ii).

(Response 12) FDA agrees with the recommendation and is revising the regulation to alternatively provide for use of a manufacturing symbol and date format that is in accordance with applicable FDA recognized consensus standards, such as ISO 7000: Graphical symbols for use on equipment and IEC 60417: Graphical symbols for use on equipment (Ref. 14) (see § 1010.3(a)(2)(ii) of this final rule).

(Comment 13) One comment requested clarification of the document retention requirements related to initial (§ 1002.10), supplemental (§ 1002.11), abbreviated (§ 1002.12), and annual reports (§ 1002.13). The Agency was asked to state clearly that manufacturers will no longer need to generate and retain these reports.

(Response 13) The proposed rule modified table 1 (§ 1002.1) to show that manufacturers of diagnostic x-ray products would no longer need to submit initial (§ 1002.10), supplemental (§§ 1002.11), abbreviated (§ 1002.12), and annual reports (§ 1002.13). In the final rule, we are maintaining this change. As a result, manufacturers of diagnostic x-ray systems will no longer need to generate and retain such reports related to diagnostic x-ray systems. To clarify, this modification would not remove these requirements for all products listed under table 1 (§ 1002.1 of this final rule). Many other reporting and recordkeeping requirements are unchanged including, as applicable based on the requirements in § 1002.1, the requirements for test and distribution records specified in § 1002.30.

(Comment 14) One comment requested that FDA clarify if an annual report would still be required for a diagnostic x-ray system that falls within this category due to its display being classified as a television product (§ 1020.10). The comment suggested removing the reporting requirements for such displays that are included in diagnostic x-ray systems.

(Response 14) FDA appreciates the comment and recognizes there may be confusion about reporting requirements for diagnostic x-ray systems that include television displays. FDA agrees that reporting should not be required for medical device manufacturers of diagnostic x-ray systems that use modern display technologies ( e.g., light emitting diode and liquid crystal display) that do not incorporate a cathode ray tube display. However, FDA believes that the reporting requirement should be maintained for displays that do contain a cathode ray tube, and were manufactured subsequent to January 15, 1970, because these types of displays generate ionizing radiation during use. FDA is therefore amending § 1020.10(a) to clarify that the television product performance standard (and thus reporting requirements) only applies to televisions/displays that contain a cathode ray tube. FDA believes EPRC reporting for such older technologies is necessary for the public health and safety to monitor the use of cathode ray tubes in televisions/displays. Given the outdated nature of the cathode ray tube technology, at this time, FDA believes this type of television display included in diagnostic x-ray systems is the only type that would continue to benefit from the annual reporting requirement. Therefore, FDA does not believe that excluding this type of television display product from the reporting requirements is appropriate at this time.

(Comment 15) One comment requested FDA to clarify how the changes in reporting would impact the process for manufacturers to receive accession numbers, which are used for customs clearance.

(Response 15) Manufacturers of diagnostic x-ray systems that are no longer required to submit product reports, and who therefore will no longer receive an accession number, will no longer need to submit an accession number when importing products (see § 1002.1, table 1 of this final rule). The import process for diagnostic x-ray systems will be the same as for other medical devices that do not require submission of product reports. Manufacturers can refer to FDA's website for more information on the imports process and program (Ref. 15).

(Comment 16) One comment mentioned the concern that if the records and reporting requirements for electronic products and medical devices are removed or reduced, then end-users will rely on state requirements, which may not have changed in many years. The comment raised concerns that in some states, repealing regulations for records and reporting requirements for electronic products and medical devices may be catastrophic if a recall on ionizing radiation equipment were issued.

(Response 16) FDA believes recordkeeping is important in case of recalls and that compliance with all applicable performance standards is important to ensure the protection of the public health and safety. The amendments do not change FDA's authority or a manufacturer's responsibilities if a product is defective or fails to comply with performance standards under section 534 of the FD&C Act. The final rule does not change any of the manufacturer, dealer, or distributer recordkeeping requirements under §§ 1002.1, 1002.30, 1002.40, or 1002.41 that are used to notify potentially impacted persons. The final amendments also do not change the reporting, notification, and requirements to perform corrective actions under part 1003 (21 CFR part 1003) for electronic product defects or failure to comply with a performance standard. Lastly, the amendments do not change any of the regulations applicable to the recall of medical devices under 21 CFR part 806. Therefore, FDA disagrees that it would be catastrophic if a recall on ionizing radiation equipment were issued following these amendments.

(Comment 17) Some comments supported amending the regulations to no longer require assemblers who install certified accessory components of diagnostic x-ray systems to submit reports of assembly (Form FDA 2579) to FDA.

(Response 17) FDA agrees with the comment. In this rulemaking, FDA is removing the requirement to submit a copy of Form FDA 2579 to FDA. Assemblers will still be required to submit a copy to the purchaser, and, where applicable, to state agencies responsible for radiation protection.

(Comment 18) One comment requested clarification on whether FDA will continue to make available Form FDA 2579 for manufacturers to use for submitting to states and purchasers. A comment also suggested that the form be made available in a PDF fillable format and that it retain a document control number field.

(Response 18) FDA agrees with this request and is revising § 1020.30(d)(1) to specify that Form FDA 2579 is available online. FDA intends to make the form PDF fillable and retain a field on the form for a document control number. However, FDA does not intend to generate or specify the format of document control numbers.

(Comment 19) One comment asked if the Agency will generate and/or require a unique document control number for each report of assembly, with a suggestion that manufacturers could develop a unique identification format for the document control numbers.

(Response 19) At this time, FDA will not generate document control numbers or define the format that manufacturers utilize. Manufacturers are welcome to develop a standardized scheme for the document control number if they wish.

(Comment 20) One comment requested FDA to clarify if manufacturers will need to keep a record of the report of assembly on file.

(Response 20) Assemblers, including manufacturers who are assembling diagnostic x-ray equipment, subject to the provisions of § 1020.30(d) will still be required under § 1002.1(c)(4) to maintain a copy of the report of assembly for 5 years.

(Comment 21) One comment requested FDA to specify what reporting guides, forms, and guidance will be removed from the FDA website.

(Response 21) The Paperwork Reduction Act (PRA) section of this final rule (section IX) identifies what forms will be removed or amended. The publication of the final rule coincides with updates to relevant FDA guidance documents for consistency with the amended regulations.

(Comment 22) Several commenters sought clarity on reporting and recordkeeping responsibilities associated with the changes in the proposed rule, including any need to document reliance on recognized consensus standards for diagnostic x-ray systems. While commenters understood some reports and forms that would no longer need to be submitted to FDA, there was uncertainty regarding certain requirements to generate and maintain test records and document compliance with the standards.

(Response 22) Manufacturers will no longer need to generate certain specific reports to submit to FDA. In finalizing the rule, FDA is withdrawing the reporting guides for reports that are no longer required to be submitted. Manufacturers will still need to maintain test and distribution records (§ 1002.30), where applicable. If a manufacturer chooses to conform to applicable recognized IEC standards in lieu of conforming to the performance standards as described in FDA guidance (Ref. 16), then manufacturers must include in their test records documentation specific to the scope of the corresponding standards.

(Comment 23) Several comments supported quarterly submission for AROs that are not associated with a death or serious injury. One comment suggested that the regulations be further amended so that manufacturers of medical devices that are also electronic products only need to comply with the Medical Device Reporting (MDR) requirements.

(Response 23) ARO reporting is critical for FDA to meet its responsibility to identify and reduce unnecessary sources of radiation exposure to the public for medical and non-medical devices. Medical device manufacturers are required to report once they are aware of information that reasonably suggests the medical device may have caused or contributed to death or serious injury or there is a malfunction that, if it were to recur, is likely to cause or contribute to a serious injury or death (part 803 (21 CFR part 803)). Medical devices that also meet the definition of an electronic product must also comply with the ARO reporting requirements in § 1002.20, which requires manufacturers to report a single event, or series of events, that resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a result of a malfunction due to the manufacturing, testing, or use of an electronic product. The ARO reporting program is intended to capture both serious malfunctions that require immediate action to prevent future death or injury (which overlaps with MDRs) and less-serious events (which may not overlap with MDRs) where periodic reporting would help identify unnecessary radiation exposure that may be addressed through manufacturer correction or through revisions to safety standards. For this reason, FDA believes ARO reporting requirements should be maintained even when the product is subject to part 803 reporting requirements to ensure the protection of the public health and safety under the EPRC program.

(Comment 24) One comment requested that FDA amend the regulations to state that instances in which an exposure made by a healthcare professional that is deemed to be clinically necessary is not an ARO even when it is a repeat scan or image caused by a system interruption.

(Response 24) The term “accidental radiation occurrence” under § 1000.3(a) includes two essential aspects to such an event. First, electronic product radiation must have been emitted. For ionizing radiation, FDA considers the use of the linear no-threshold model ( i.e., a threshold below the amount of ionizing radiation that is not “potentially injurious”) (Ref. 17) as a prudent and practical approach for radiation protection. Second, the radiation emission must have been accidental, by which the Agency means that the emission was unintended and unexpected. An intended and expected radiation emission, such as an intentional repeat scan or image, does not meet the criterion of “accidental” and is not an ARO. To improve clarity on this distinction, FDA is amending the definition of an ARO (§ 1000.3(a) in this final rule) to include the word “accidental” within the definition to more clearly indicate that an ARO is an accidental event resulting in radiation exposure. With this clarification, FDA does not believe it is necessary to further amend the regulation by providing specific examples involving radiation occurrences that are not considered to be accidental.

(Comment 25) A few comments asked FDA to clarify how the tracking and trending analysis relates to the requirements in § 1002.20(a) and (b) and what would be expected as part of this new requirement.

(Response 25) FDA acknowledges there may be confusion regarding how the quarterly summary reporting with tracking and trending analysis relates to the requirements under § 1002.20(a) and (b). FDA is therefore amending § 1002.20 to clarify that: (1) the quarterly report must include information required under § 1002.20(b)(1) through (7) for each occurrence where known to the manufacturer, (2) that accidental radiation occurrences may be grouped to identify the most common circumstances and potential cause(s), including but not limited to, design changes, manufacturing, or user, and (3) that planned mitigation(s) with an assessment of effectiveness, or a justification for why mitigation is not necessary, must be associated with each occurrence or grouping of similar occurrences (see § 1002.20(c)(2)(ii) in this final rule). Such incidents should also be evaluated to determine if the accidental radiation occurrence is the result of a defect as defined in § 1003.2 of this chapter or fails to comply with an applicable Federal standard (see § 1003.10). Medical device manufacturers may be able to rely on information already being generated as part of their corrective and preventive actions (21 CFR 820.100).

(Comment 26) A few comments asked FDA to clarify if the tracking and trending analysis applied to both immediate reports and quarterly reports.

(Response 26) The submission of the tracking and trending analysis only applies to quarterly reporting.

(Comment 27) Several comments stated that the proposed amendments to § 1040.10 were confusing and should be clarified. The comments raised concerns about creating a circular logic path between the text proposed in § 1040.10(a)(1), which indicates the standard is not applicable to an uncertified laser product that is incorporated into an electronic product that is then certified by the manufacturer, and the certification requirements in § 1010.2(a), which requires certification when the performance standard is applicable. Commenters stated that the term “uncertified” in proposed § 1040.10(a)(1), along with other edits, caused confusion because certain aspects of the standard appeared to be required/applicable, while certification was not required.

Multiple comments recommended that FDA either: (1) revise or keep the original language of certain paragraphs in § 1040.10, with removal or modifications to specific sections for clarity or (2) keep the existing language in § 1040.10(a) and instead modify §§ 1002.1(c), 1010.2, and 1010.3, which would have the effect of §§ 1040.10 and 1040.11 still being required even if certification, identification, and manufacturer's reports are not required.

(Response 27) FDA agrees with the latter recommended approach (#2) to keep the existing language in § 1040.10, and instead amend § 1002.1 in table 1 and § 1010.2, consistent with the amendments in the proposed rule, to clarify when and under what conditions reporting would not need to be duplicated. In those situations, the manufacturers would be considered distributors of certified laser products, and only subject to the applicable distribution recordkeeping requirements under §§ 1002.40 and 1002.41 for the certified products (see § 1002.1, table 1, fn. 9 in this final rule). Also, we are revising § 1010.2 to identify the conditions under which a manufacturer could incorporate a certified laser product without the requirement to re-certify or re-report the product (see § 1010.2(e) of this final rule).

(Comment 28) Some comments raised concerns that the proposed language in § 1040.10(a)(2) did not clearly require products to comply with the performance standards after a certified laser was incorporated.

(Response 28) The intent of the modifications in the proposed rule was to avoid duplicative reporting of information from manufacturers who incorporate a certified laser system into a product. The certified laser system, and the product into which it is incorporated, would still be required to conform with the performance standards. Products that incorporate a certified laser product are still required to comply with the FDA's performance standards. To clarify this, we are revising § 1010.2 to clearly identify under what conditions a product that incorporates a certified laser system would be considered certified, and thus not need to be re-certified. In this final rule, all of the following conditions must be met: (1) the incorporated laser system is not a laser product intended for use as a component or replacement as described in § 1040.10(a)(1) and (2); (2) the manufacturer of the incorporated laser system certifies such laser system and meets the reporting requirements under § 1002; (3) the product incorporating the certified laser system is not independently subject to additional reporting or performance standards requirements; (4) the incorporated laser system is not modified as defined in § 1040.10(i), and all performance features that apply to the incorporated laser system under § 1040.10(f) are available on the product incorporating the certified laser system; (5) all labeling requirements that apply to the incorporated laser system under §§ 1010.2, 1010.3, 1040.10(g), and 1040.11(a)(3) are visible on the outside of the product incorporating the certified laser system, with the exception that the certification or identification labels need not be visible on the outside of products incorporating a certified Class I laser; (6) the incorporated laser system is installed in the product in accordance with the instructions provided by the manufacturer of the incorporated laser system, including instructions for placing additional externally facing labels found in subsection (v), and meeting the other conditions in the subsections; (7) the manufacturer of the product that incorporates the laser system provides the end user with information required under § 1040.10(h)(1) as provided to them by the manufacturer of the incorporated laser system; and (8) the labeling requirements under part 1010 and § 1040.10(g) for the incorporated laser system would be met in any service configuration of the product incorporating the laser system or when the incorporated laser system is removed from the product into which it has been incorporated, and reproductions of such labels are found in the user information. Manufacturers of products that do not meet these conditions would need to certify and report the product that incorporates the certified laser system based on the class of the laser product as described in § 1002.1.

(Comment 29) One comment raised concerns regarding the criteria for the incorporated laser system to be installed in accordance with the instructions provided by the manufacturer of the incorporated laser system. The comment stated that it would be difficult for the manufacturer of the incorporated laser system to foresee all potential installation options by other manufacturers.

(Response 29) FDA does not expect the manufacturer of an incorporated laser system to foresee all potential installation options. FDA expects that a manufacturer planning to market a laser product specifically to be certified and incorporated into other systems would identify and specify any installation options and requirements, while taking into consideration how reasonable variations in the installation instructions should be provided to customers to ensure the conditions in § 1010.2(e) are met. However, ultimately, the manufacturer of the incorporated laser system is responsible for ensuring their finished product is in compliance with all applicable regulatory requirements when certified and marketed. The manufacturer of the product incorporating the laser system is responsible for complying with the conditions in § 1010.2(e). Otherwise, those manufacturers would need to complete the certification, reporting, and other applicable laser product requirements under §§ 1002 and 1040.10. For example, if the installation instructions would result in the laser product not meeting the conditions under § 1010.2(e) ( e.g., instructions that would result in a required safety interlock being unavailable), then the product incorporating the certified laser would not be considered to have met the certification requirements because all conditions in § 1010.2(e) must be met.

(Comment 30) FDA received comments expressing concern with the incorporation into regulation the policies described in FDA's Laser Notice 42, including expansion of those policies into regulation for higher powered laser products without the requirements that the products incorporating higher power lasers comply with the performance standards. A commenter questioned whether the reporting requirements and performance standard would be applicable to a product that incorporated a certified Class I laser along with an uncertified Class IV laser, and if the labeling or safety features of the final product would need to meet the Class IV performance standards. Similar comments recommended that FDA revise and extend policies of Laser Notice 42 for clarity with additional requirements to ensure safety of higher class products.

(Response 30) As noted in Response 28, this final rule is revising § 1010.2 to identify under what conditions a product that incorporates a certified laser system would be considered to have met the certification requirements. There are several conditions, all of which must be met, including that the product incorporating the certified laser system must not be independently subject to additional reporting requirements or performance standards (see § 1010.2(e)(iii) in this final rule). FDA added this clarification to the revisions under § 1010.2(e) of this final rule to ensure higher class products will continue to be subject to any applicable certification requirements, despite the incorporated laser system having met the certification requirements. For example, a Class IV laser product that incorporates a certified Class I laser does not meet the conditions in § 1010.2(e)(iii), as additional certification and reporting requirements associated with the Class IV laser still apply. In addition, the incorporated laser system must not be modified, as defined in § 1040.10(i), and all performance features that apply to the incorporated laser system under § 1040.10(f) must be available on the product incorporating the certified laser system (see § 1010.2(e)(iv) in this final rule). All labeling requirements that apply to the incorporated laser system under § 1040.10(g) must be visible on the outside of the product incorporating the certified laser system, with the exception that the certification or identification labels need not be visible on the outside of products that incorporate a certified Class I laser (see § 1010.2(e)(v) in this final rule). The incorporated laser system must be installed in accordance with the instructions provided by the manufacturer of the incorporated laser system, including ensuring any required safety features or labeling are available (see § 1010.2(e)(vi) in this final rule). The manufacturer of the product incorporating the laser system must also provide the end user with laser safety information as provided to them by the manufacturer of the incorporated laser system (see § 1010.2(e)(vii) in this final rule). In addition, the labeling requirements in part 1010 and § 1040.10(g) for the incorporated laser system must be met in any service configuration of the product that incorporates the laser system, including when the incorporated laser system is removed from the product into which it has been incorporated, and reproductions of such labels must be included in the user information (see § 1010.2(e)(viii) in this final rule).

(Comment 31) One comment recommended limiting the amendments only to the lowest class of laser products; or a subset of classes with additional clarification to address the visibility of the warning logo type and aperture label; or all classes with clarifications about the difference between “attaching” versus “assembling in, embedding in, or otherwise incorporating” a laser or laser system.

(Response 31) FDA believes that the revisions to §§ 1002.1 and 1010.2(e) that are being made in this final rule make it sufficiently clear that the manufacturer of the product incorporating the certified laser must not make modifications that would alter the availability of safety information or compliance with the standard if they wish to maintain the certification. FDA has added clarification to the revisions under § 1010.2(e)(v) and (vi) of this final rule to ensure that visibility of certain labeling requirements that apply to the incorporated laser system continue to be maintained. Any modifications that would modify the class of laser, compliance with the performance standard, visibility of required labeling, or accessibility to required safety information would not meet the conditions of § 1010.2(e) and the product would no longer be considered certified—meaning the manufacturer of the product incorporating the laser would need to complete the applicable certification and reporting requirements (see also Response 29).

This rule is effective 30 days after the date of publication in the Federal Register .

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

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. This rule will reduce regulations that are outdated and otherwise clarify existing requirements. Because this final rule does not impose any additional regulatory burdens, we certify that this final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in 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 $165 million, using the most current (2021) Implicit Price Deflator for the Gross Domestic Product. This final rule will not result in an expenditure in any year that meets or exceeds this amount.

We estimate the benefits of this rule in terms of cost savings. We derive the cost savings to industry from the reduction in labor associated with the reporting, recordkeeping, performance standards, and third-party disclosure requirements. Similarly, cost savings to FDA result from the reduction in labor hours required to review reports. The total present-value cost savings over a 20-year time period are $69.71 million at a 7 percent discount rate and $97.89 million at a 3 percent discount rate. Annualized total cost savings are $6.58 million. We estimate the costs to read the rule for all reporting respondents. The present value costs are $1.60 million, and the annualized costs calculated over a 20-year time period are $0.14 million at a 7 percent discount rate and $0.10 million at a 3 percent discount rate. A summary of the quantified cost savings and costs of the rule are presented in Table 1.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the rule does not impose any additional regulatory burdens, we certify that the final rule will not have a significant economic impact on a substantial number of small entities. This analysis, as well as other sections in this document and the Preamble of the final rule, serves as the Final Regulatory Flexibility Analysis, as required under the Regulatory Flexibility Act. The full preliminary analysis of economic impacts is available in the docket for this final rule (Ref. 18) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

The Agency has determined under 21 CFR 25.30(h) and (i) and 25.34(c) 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.

This final rule contains information collection provisions that are subject to review by the OMB under the PRA (44 U.S.C. 3501-3521). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual reporting, recordkeeping, and third-party disclosure burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title: Electronic Products; OMB Control No. 0910-0025—Revision

Description: FDA is amending its regulations for requirements for certain reporting and records of electronic products by removing specific reporting, as well as repealing outdated recommendations for radiation protection and performance standards, and removing submission requirements for copies of certain applications and forms to alleviate regulatory burden to both FDA and industry.

The records and reporting requirements for electronic products and medical devices include various reports and records depending upon the specific type of electronic product. FDA has determined upon review of the records and reporting requirements that some of the requirements are unnecessary or may be duplicative of other reporting requirements by FDA and State regulators.

Description of Respondents: The respondents to this information collection are electronic product manufacturers, importers, and assemblers of electronic products from private sector, for-profit businesses.

The estimates were generated from discussions with subject matter experts at FDA.

FDA is revising the applicability of the recordkeeping and reporting requirements for some products (§ 1002.1). We revised the burden estimates for product reports, supplemental reports, abbreviated reports, annual reports, manufacturer test and distribution records, and dealer and distributor records by reducing the number of respondents/recordkeepers to reflect the revised applicability of the recordkeeping and reporting requirements. We also revised Form FDA 3646 “Mercury Vapor Lamp Products Radiation Safety Report” (now listed under Abbreviated Reports consistent with the revision of § 1002.1) and removed the following forms:

The amended applicability of the recordkeeping requirements for dealer and distributor records (see §§ 1002.40 and 1002.41) results in a small decrease in the number of recordkeepers.

FDA is eliminating requirements for manufacturers to report model numbers of new models of a model family that do not involve changes in radiation emission or requirements of a performance standard in quarterly updates to their annual reporting (§ 1002.13(c)). We have removed the burden estimate associated with § 1002.13(c). Generally, other subsections require specified product manufacturers to submit annual reports to FDA which summarize certain manufacturing records (§ 1002.13(a) and (b)). FDA is not amending these annual report requirements.

FDA is amending the timing for submission of reporting requirements for AROs that are not associated with a death or serious injury (§ 1002.20). The amendment will allow manufacturers of a radiation emitting electronic product to submit quarterly summary reports of AROs that are not associated with a death or serious injury and not required to be reported under the medical device reporting regulations (§ 1002.20; part 803). FDA believes that amending the regulations to allow summary reporting for AROs for electronic products extends the approach of eliminating or reducing duplicative reporting requirements beyond the medical device arena and promotes harmonization between this reporting and the new voluntary malfunction summary reporting for medical devices (see part 803; “Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers” (83 FR 40973, August 17, 2018)).

FDA is also amending the applications for variances process (§ 1010.4(b)) to no longer require a manufacturer to submit two additional copies with the original documents. While this amendment would not generate any substantive change to the information collection, respondents may realize a small monetary savings from the usual and customary administrative expenses associated with the preparation of the copies.

FDA is amending the reports of assembly requirements for major components of diagnostic x-ray systems to no longer require assemblers who install certified components to submit a report of assemblies, Form FDA 2579, to CDRH (§ 1020.30(d)(1)). FDA is also withdrawing the language that requires submission to “the Director” in this subsection, but will still publish a PDF form online for assemblers to download, complete, and provide to applicable States and purchasers as required. We have moved the corresponding information collection burden estimate from reporting to third-party disclosure burden and revised Form FDA 2579.

FDA is amending the reporting requirements for manufacturers that incorporate a certified laser product to reduce reporting that is considered duplicative under certain conditions. Manufacturers that incorporate a certified laser system meeting the conditions of § 1010.2(e) are considered distributors of the certified laser and only subject to the applicable distribution recordkeeping requirements under §§ 1002.40 and 1002.41 for the certified products. Accordingly, we have reduced the number of respondents for “Laser products information—1040.10(h)(1)(i)-(vi)” and “Laser product service information—1040.11(h)(2)(i)-(ii).”

FDA is repealing the performance standards for ultrasonic therapy products (§ 1050.10). We have therefore removed the burden estimate associated with § 1050.10.

We received several comments related to the proposed rule. Descriptions of the comments and our responses are provided in Section V of this document, Comments on the Proposed Rule and FDA Response. Comments and responses related to the provisions that underlie the information collection are described in the following sections: section V.B, regarding general comments; section V.E, regarding records and reports; section V.F, regarding reports of assembly, forms and guidances; section V.G, regarding accidental radiation occurrences; and section V.H, regarding laser comments. We have not made changes to the estimated burden as a result of the comments.

The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507(d) of the PRA.

Before the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

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

We note that the current performance standards at § 1040.10 issued under section 534 of the FD&C Act preempt the States from establishing or continuing in effect any standard that is not identical to the Federal standard pursuant to section 542 of the FD&C Act. Those standards were issued before the E.O. We believe this preemption is consistent with section 4(a) of the E.O. which 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.” Federal law includes an express preemption provision at section 542 of the FD&C Act that preempts the States from establishing, or continuing in effect, any standard with respect to an electronic product which is applicable to the same aspect of product performance as a Federal standard prescribed pursuant to section 534 of the FD&C Act and which is not identical to the Federal standard. (See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)). Section 542 of the FD&C Act does allow States to impose a more restrictive standard regarding emissions of radiation from electronic products under certain circumstances.

This final rule does not impose any new performance standard requirements. This rule prescribes a reduction in Federal standards (through repeal of § 1050.10) pursuant to section 534 of the FD&C Act. This rule removes or excludes applicability of certain Federal standards, which no longer preempt any State issued performance standards to that same extent.

We have analyzed this final rule in accordance with the principles set forth in E.O. 13175. We have determined that the rule does not contain policies that would 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. 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.

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. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. They also can be purchased as a pdf or as hard copy (or both together, at a discounted price) from NCRP ( www.ncrponline.org ). 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, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 1000, 1002, 1010, 1020, 1030, and 1050 are amended as follows:

ITVERP is a Federal program that provides reimbursement to nationals of the United States and Federal Government employees (and certain family members of such individuals, under some circumstances), who are victims of international terrorism and who incur expenses as a result of such incidents. For further information, see the ITVERP website at http://www.ojp.usdoj.gov/ovc/intdir/itverp.

Pursuant to 34 U.S.C. 20106 and 34 U.S.C. 20110(a), OVC promulgated an interim-final rule to provide the Director of OVC with express discretionary authority to accept claims filed more than three years after the date that an incident is designated as one of international terrorism. Largely owing to considerations of administrative convenience, the original ITVERP rule (promulgated in 2006) among other things limited the period within which OVC would entertain waivers of claim-filing deadlines. In 2011, based on experience administering the program since it went into effect in 2006, OVC determined that this limit on waivers of late claims could lead to denials of reimbursement for victims with otherwise meritorious claims, even under circumstances where tolling of the deadline would be justified.

This rule adopts as final the interim rule published April 11, 2011, at 76 FR 19909, which allows the Director of OVC to toll or extend the deadline for a late-filed claim where the Director finds good cause to do so. In the ordinary course, a showing of good cause generally requires that the claimant submit a written explanation—satisfactory to the Director—for missing the deadline. Generally speaking, examples of good cause might include situations such as where a victim's treatment for injuries sustained in an incident were covered initially by collateral sources, but these sources later become unavailable after the filing deadline has expired; where outreach to overseas claimants has not been effective; and where a claimant's extended illness, living abroad in remote areas for extended periods of time, or barriers to accessing information about the program led to the late filing. Absent circumstances consonant with the foregoing, good cause would not exist; thus, for example, a claimant's missing the deadline due to mere inattentiveness to the program's deadlines would not be sufficient to establish good cause.

The interim final rule did not alter any then-existing regulatory deadlines, nor did it impose any new deadlines (or any burden whatsoever) on claimants, but instead merely operated to relieve an administrative restriction, in the then-existing rule, on claim filing (such rule having been promulgated largely for the administrative convenience of OVC, which had found it, over the course of four years of program administration, to be unnecessary). In these respects, the final rule is the same.

OVC had intended to finalize this interim-final rule as part of a larger revision of the program rules shortly after publication of the interim-final rule, but that effort ended up not moving forward. Other priorities, including updating program rules for the Victims of Crime Act of 1984 (“VOCA”) Victim Assistance Program, and administration and oversight responsibilities relating to the substantial increase in VOCA funding that started in FY 2015, took priority after that.

The non-substantive updates to the citations are to ensure that the citations accurately point to the substantive provision originally intended when subpart A was promulgated in 2006, and when subpart B was promulgated in 2016. In 2017, many citations to provisions in Title 42 of the United States Code were reclassified to Title 34. In addition, 2 CFR part 200 was amended in 2020, and certain sections were shifted by one number. The updates herein adjust the citations to reflect the new locations of the same substantive provisions.

This final rule has been drafted in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), The Principles of Regulation, and in accordance with Executive Order 13563, “Improving Regulation and Regulatory Review” section 1, General Principles of Regulation. Executive Orders 12866 and 13563 direct agencies, in certain circumstances, 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).

OVC has determined that this final rule is not a “significant regulatory action” under Executive Order 12866, Regulatory Planning and Review, section 3(f), and, accordingly, this rule has not been reviewed by the Office of Management and Budget. This rule finalizes the 2011 interim final rule, which OVC also determined was not a “significant regulatory action,” without change.

This regulation has no cost to state, local, or tribal governments, or to the private sector. It merely alleviates an administrative restriction on victim claim filing by permitting the OVC Director to allow late filing where the Director determines that this is appropriate. The ITVERP is funded by fines, fees, penalty assessments, and forfeitures paid by Federal offenders, as well as gifts from private individuals, deposited into the Crime Victims Fund in the U.S. Treasury, and set aside in the Antiterrorism Emergency Reserve Fund, which is capped at $50 million in any given year. The cost to the Federal Government consists both of administrative expenses and amounts reimbursed to victims. Both types of costs depend on the number of claimants, prospective as well as retroactive. This rule is not expected to significantly increase the number of eligible claimants, and therefore OVC has determined that the negligible cost potentially associated with allowing certain late-filed claims to be processed is outweighed by considerations of fairness in the program's administration and the benefit of ensuring that U.S. victims otherwise eligible for, and in need of, reimbursement for injuries and losses from overseas terrorism are provided such reimbursement. This rule has not, and is not expected to, materially increase the overall budgetary impact of the ITVERP.

This rule concerns matters relating to “grants, benefits, or contracts,” 5 U.S.C. 553(a)(2). It is therefore statutorily exempt from the requirement of notice and comment and a 30-day delay in the effective date. Moreover, to the extent that it “recognizes an exemption or relieves a restriction” on claimant filing, it is exempt from the 30-day delay in the effective date per 5 U.S.C. 553(d). Moreover, with regard to the citation corrections, OVC finds that notice and comment would be unnecessary because the citation updates are non-substantive—the underlying substantive provisions remain the same, and therefore good cause exists to dispense with notice and comment per 5 U.S.C. 553(b)(B), and a delayed effective date, pursuant to 5 U.S.C. 553(d).

Although it was not required to do so, upon publication of the interim-final rule in 2011, OVC provided for post-promulgation public comment. OVC received two comments, one of which was not responsive. The only responsive comment advocated for a statutory-definition change beyond the scope of this rulemaking, questioned the cost of the program, requested that information about payments be posted on the internet, and opposed “paying claims that are more than 3 years old and leaving that to the `discreation' [sic] of the director . . . .” OVC does, in fact, post detailed information on its website about program payments, with breakouts by number of claims, amounts paid in each expense category, and other claim processing information, and has done so since 2008. Moreover, the Director's discretion is limited to situations where a claimant shows good cause to waive the filing deadline. For example, in FY 2018, of the 36 new applications received during the reporting period, 4 were granted an extension; in FY 2019, of 33 new applicants, 1 was granted an extension. ITVERP is a very small program, both in terms of number of claims and amounts paid. It received an average of 35 claims per year from FY 2011 through FY 2019. The total amount paid for all claims added together in the FY 2017 reporting period was $264,734.07; in FY 2018 was $145,046, and in FY 2019 was $155,298. Consequently, the entire program has a de-minimis budgetary impact, and the limited number of extensions granted each year do not materially change that.

This rule finalizes that interim-final rule, which made a minor amendment to alleviate a procedural restriction on ITVERP claimants that might otherwise have led to the denial of meritorious claims from victims, even where such victims show good cause for delayed filing.

This regulation will not have a substantial direct effect on the states, on the relationship between the national government and the states, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Exec. Order No. 13132, 64 FR 43255 (Aug. 4, 1999), it is determined that this regulation does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, “Civil Justice Reform.”

This regulation will not have a significant economic impact on a substantial number of small entities. This regulation has no cost to State, local, or tribal governments, or to the private sector. The ITVERP is funded by fines, fees, penalty assessments, and bond forfeitures paid by Federal offenders, as well as gifts from private individuals, deposited into the Crime Victims Fund in the U.S. Treasury. Therefore, an analysis of the impact of this regulation on such entities is not required under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

This proposed rule contains no new information collection or record-keeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ).

This regulation 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. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by the Congressional Review Act, 5 U.S.C. 804. It will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

Accordingly, for the reasons set forth in the preamble, the Office of Justice Programs adopts the interim rule published April 11, 2011, at 76 FR 19909, as final without change and makes technical corrections to title 28, part 94 of the Code of Federal Regulations 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. The Coast Guard received the final details of the training on January 12, 2023. It is impracticable to publish an NPRM because we must establish this safety zone by January 21, 2023, and lack sufficient time to provide a reasonable comment period and consider those comments before issuing the rule.

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 contrary to the public interest because immediate action is needed to protect personnel, vessels, and the marine environment in the navigable waters around the potentially hazardous on-water training and associated operations involving vessels firing blank rounds.

The Coast Guard is issuing this rule under authority 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port San Francisco has determined that potential hazards associated with the Coast Guard PSU-312 training operations scheduled to occur on January 21, 2023, will be a safety concern for anyone within the designated exercise area. The on-water training will involve vessels firing blank rounds. For this reason, this temporary safety zone is needed to protect personnel, vessels, and the marine environment in the navigable waters surrounding the potentially hazardous activity.

This rule establishes a safety zone around the Coast Guard PSU-312 training operations in the waters of the San Francisco Bay, near Treasure Island, San Francisco, CA, on January 21, 2023, from 9 a.m. until 6:30 p.m. The safety zone will encompass the navigable waters, from surface to bottom, within a circle formed by connecting all points 1,000 yards from the circle center at approximate position 37°49′15.3″ N, 122°21′38.5″ W (NAD 83); or as announced via Broadcast Notice to Mariners.

This regulation is needed to keep persons and vessels away from the immediate vicinity of the training operations to ensure the safety of personnel, vessels, and the marine environment. No vessel or person will be permitted to enter the safety zone without obtaining permission from the Captain of the Port Sector San Francisco (COTP) or a designated representative. A “designated representative” means a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel or officer designated by or assisting the COTP in the enforcement of the safety zone.

The COTP or the COTP's designated representative will notify the maritime community of periods during which this zone will be enforced in accordance with 33 CFR 165.7, including but not limited to Broadcast Notice to Mariners.

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 duration and narrowly tailored geographic area of the safety zone. The zone encompasses approximately 0.75 square miles of the waterway for less than 10 hours. Although this rule restricts access to the water encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified to ensure the safety zone will result in minimum impact. The vessels desiring to transit through or around the temporary safety zone may do so upon express permission from the COTP or the COTP's designated representative.

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 temporary 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 that will prohibit entry to the area surrounding the potentially hazardous Coast Guard training operations. It is categorically excluded from further review under paragraph L60 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 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:

Background Significance of the Park

Mount Rainier National Park encompasses 236,381 acres in west central Washington, on the western and eastern slopes of the Cascade Range. About 83 percent of the park is located in Pierce County and 17 percent is located in Lewis County. The park's northern boundary is approximately 65 miles southeast of the Seattle-Tacoma metropolitan area and 65 miles west of Yakima. The elevations of the park range from about 1,400 feet at the Tahoma Woods Administrative Site to 14,410 feet at the summit of Mount Rainier. About two million people visit the park annually, with most visitation (75 percent) occurring between June and September. In 1988, Congress designated approximately 97 percent (228,480 acres) of the park as wilderness under the Washington Park Wilderness Act.

The focal point of the park is Mount Rainier, a towering snow- and ice-covered volcano that is a prominent landmark in the Pacific Northwest. Mount Rainier is the second most seismically active and the most hazardous volcano in the Cascade Range. The 26 major glaciers that flank the upper mountain cover 35 square miles. Steep glaciated valleys and ice-carved peaks dominate the park landscape. The Carbon, Mowich, White, West Fork White, Nisqually, South Puyallup, and North Puyallup rivers and their tributaries carry water from Mount Rainier to Puget Sound. The Ohanapecosh and Muddy Fork Cowlitz flow into the Cowlitz River and on into the Columbia River. There are approximately 470 mapped rivers and streams, including approximately 383 perennial streams and 84 intermittent streams. With very few exceptions, park rivers and streams originate within the park. There are approximately 382 lakes and ponds, and over 3,000 acres of other wetland types ( e.g., mineral geothermal springs, waterfalls) in the park.

The following 15 fish species are present in the rivers, streams and lakes within the park. Of these, eight are native and seven are nonnative.

Fish populations naturally occur within the park in the nine large valley bottom rivers and their tributary junctions up to natural fish barriers. These rivers bear native fish populations of rainbow (steelhead) trout ( Oncorhynchus mykiss ), coastal cutthroat trout ( Oncorhynchus clarkii clarkii ), bull trout ( Salvelinus confluentus ), coho salmon ( Oncorhynchus kisutch ), chinook salmon ( Oncorhynchus tshawytscha ), pink salmon ( Oncorhynchus gorbuscha ), mountain whitefish ( Prosopium williamsoni ) and shorthead sculpin ( Cottus confusus ). Nonnative sculpins present in the rivers include slimy sculpin ( C. cognatus ) and torrent sculpin ( Cottus rhotheus ).

Prior to stocking efforts, there were no naturally occurring fish populations in any of the approximately 382 mapped lakes and ponds in the park. With the exception of those mentioned above, most of the mapped streams were also originally fishless. Early in the park's history, the National Park Service (NPS) and others, including the State of Washington, introduced nonnative stocks of rainbow trout ( Oncorhynchus mykiss ), Yellowstone cutthroat trout ( Oncorhynchus clarkii bouvieri ), westslope cutthroat trout ( Oncorhynchus clarkii lewisi ), brook trout ( Salvelinus fontinalis ) and kokanee salmon ( Oncorhynchus nerka ) to enhance recreational fishing. According to unpublished NPS records, official stocking occurred from 1915 through 1964 (49 years) in 38 streams, and from 1915 through 1972 (57 years) in 44 lakes. Stocking fish resulted in reproducing populations of nonnative fish in naturally fishless lakes. It also resulted in reproducing populations of nonnative fish in some rivers and streams where they compete with native fish. Additional unauthorized introductions of nonnative fish, including threespined stickleback ( Gasterosteus aculeatus ), have occurred since stocking ended. Reproducing populations of nonnative fish are now present in approximately 35 lakes and all of the park watersheds, including many streams and the nine major rivers. All lakes with reproducing nonnative fish populations are in designated wilderness with the exception of Littorals Pond (White River watershed) and Tipsoo Lake.

The presence of nonnative fish in the park has had widespread adverse effects on the distribution, abundance, age structure, genetics, and behavior of native fish species, amphibians, and other aquatic life. Nonnative fish prey on and compete with native fish, particularly bull trout. As a result, over time, populations of native fish within and outside the park have likely diminished where brook trout and other nonnative fish populations have been established. The U.S. Fish and Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS) have listed populations of bull trout, chinook salmon, and steelhead within the park as threatened under the Endangered Species Act (ESA). In 2010, the USFWS designated approximately 30 miles of streams in the park as bull trout critical habitat. In 2015, the USFWS issued a Bull Trout Recovery Plan that identified actions the NPS should take to protect bull trout within the park.

The NPS has sole and exclusive jurisdiction over the lands and waters within Mount Rainier National Park. 16 U.S.C. 95. The park's enabling act directs the Secretary of the Interior, acting through the NPS, to make such regulations as the Secretary deems necessary or proper to care for the park, including regulations that provide against the wanton destruction of the fish and game found within the park, and against their capture or destruction for the purposes of merchandise or profit. 16 U.S.C. 92. The NPS administers the park as a unit of the National Park System and has the authority to regulate the use of the park as it considers necessary or proper. 54 U.S.C. 100751(a). This includes the authority to regulate activities on water located within the park that is subject to the jurisdiction of the United States. 54 U.S.C. 100751(b).

General NPS fishing regulations are found in 36 CFR 2.3 and apply to all units of the National Park System. For example, section 2.3(d)(4) prohibits commercial fishing in System units, except where specifically authorized by Federal statute. Recreational fishing is allowed within the System in accordance with state law, provided that the state law does not conflict with NPS fishing regulations. 36 CFR 2.3(a). Special fishing regulations are found in 36 CFR part 7 and apply only in specific System units that have promulgated special regulations for this purpose. Other closures and restrictions related to fishing are established by the Superintendent under his or her discretionary authority in 36 CFR 1.5. This authority allows Superintendents to close all or a portion of a park area to a specific use or activity or impose conditions or restrictions on a use or activity. Pursuant to 36 CFR 1.7(b), these actions do not appear in 36 CFR, but are compiled and maintained in what is commonly known as the Superintendent's Compendium. The Superintendent's Compendium is typically available on the System unit's website. Actions taken by the Superintendent under the authority in 36 CFR 1.5 may not conflict with regulations found in the CFR, including the general fishing regulations in section 2.3.

Special fishing regulations for the park are found in 36 CFR 7.5(a). The NPS promulgated these regulations in 1969 (34 FR 17520) and last amended them in 1976 (41 FR 14863). The regulations close the following areas to all fishing: (i) Tipsoo Lake; (ii) Shadow Lake; (iii) Klickitat Creek above the White River entrance water supply intake; (iv) Laughingwater Creek above the Ohanapecosh water supply intake; (v) Frozen Lake; (vi) Reflection Lakes; and (vii) Ipsut Creek above the Ipsut Creek Campground water supply intake. 36 CFR 7.5(a)(1). The special regulations also close the Ohanapecosh River and its tributaries to all fishing except for fishing with artificial flies. 36 CFR 7.5(a)(2). The regulations state that there shall be no minimum size limit on fish that may be possessed. 36 CFR 7.5(a)(3). The regulations state that the daily catch and possession limit for fish taken from park waters shall be six pounds and one fish, not to exceed 12 fish. 36 CFR 7.5(a)(4).

Other closures and restrictions related to fishing appear in the Superintendent's Compendium for the park, which is available on the park's website at https://www.nps.gov/mora/learn/management/lawsandpolicies.htm. Several of these closures and restrictions are intended to conserve native fish species and reduce or eliminate nonnative species. The Compendium states that all native fish species caught in rivers and streams must be released, but that kokanee and brook trout (both nonnative species) may be retained with no limit. The purpose of this Compendium action is to protect native fish species by requiring catch-and-release and to reduce populations of nonnative species by allowing them to be removed from the park. The Compendium prohibits multipoint hooks with barbs in rivers and streams to cause less injury to native species that will be released. The Compendium prohibits lead fishing tackle anywhere in the park to avoid poisoning aquatic biota and humans. The Compendium closes Fryingpan Creek above the confluence of the White River to all fishing. This closure protects native fish species (bull trout, chinook salmon, and steelhead) that are listed as threatened under the ESA. The Compendium also closes Ghost Lake and Edith Creek Basin above the Paradise water supply to protect the potable water supply for White River and Paradise. The Compendium establishes fishing seasons for rivers and streams to protect the spawning season of listed, native species. Where fishing is allowed in lakes, there are no seasonal closures or limits on retaining any fish species because, as noted above, fish are not native to lakes within the park.

In September 2017, the NPS published a Fish Management Plan/Environmental Assessment (the Plan). The purpose of the Plan is to direct long-term management for fish within lakes, rivers and streams within the park. During the development of the Plan, the NPS solicited information from the USFWS, the NMFS, the Washington Department of Fish and Wildlife (WDFW), the Washington State Historic Preservation Office, and six affiliated American Indian tribes: the Nisqually Tribe of Indians, the Muckleshoot Indian Tribe, the Cowlitz Indian Tribe, the Puyallup Tribe of Indians, the Squaxin Island Tribe, and the Confederated Tribes and Bands of the Yakama Nation. The U.S. Forest Service, Mount Baker-Snoqualmie National Forest, also submitted comments during the public scoping period that occurred before the Plan was published. The Plan was open for a 30-day public comment period.

On August 28, 2018, the Regional Director for Department of the Interior Unified Regions 8, 9, and 10 (formerly the Pacific West Region) approved a Finding of No Significant Impact (FONSI) selecting Alternative 2 in the Plan for implementation. This alternative calls for site-specific management actions to encourage recreational fishing opportunities for nonnative species and to protect native fish and habitat. In addition to increasing recreational angling opportunities for nonnative species, the alternative calls for suppressing or eradicating nonnative fish populations through administrative actions such as gillnetting, seining, electrofishing, and piscicides in selected locations. The selected alternative is consistent with actions required by the 2015 Bull Trout Recovery Plan issued by the USFWS. The NPS expects the eradication or suppression of nonnative fish to result in the increased survival and abundance of threatened and endangered species (bull trout, chinook salmon and steelhead) and improved habitat for native species. The Plan, which contains a full description of the purpose and need for taking action, the alternatives considered, and the environmental impacts associated with the considered alternatives, and the FONSI may be viewed on the park's planning website at https://parkplanning.nps.gov/mora by clicking on the link entitled “Archived Projects” and then clicking the link entitled “2018 Mount Rainier National Park Fisheries Management Plan Environmental Assessment and Finding of No Significant Impact” and then clicking the link entitled “Document List.”

This rule removes special fishing regulations for the park that interfere with the successful implementation of the fish management strategy identified in the FONSI. These include the following closures and restrictions that limit the take of nonnative fish: (1) closures at Ipsut Creek and (except for artificial flyfishing) the Ohanapecosh River; and (2) a daily catch and possession limit of six pounds and one fish, not to exceed 12 fish. Removing these closures and restrictions will create new angling opportunities for nonnative species that are currently not authorized by 36 CFR 7.5. The other closures and restrictions currently codified in the special regulations will be relocated to and maintained in the Superintendent's Compendium because either they are necessary to protect the domestic potable water supply for White River, Sunrise, Ohanapecosh, and Paradise (the closures of Frozen Lake and streams with identified water supply intakes); or to protect fragile riparian vegetation (the closures of Tipsoo Lake, Shadow Lake and Reflection Lakes). Closures and restrictions in the special regulations also apply to the take of native fish species. These will be retained or modified in the Superintendent's Compendium, consistent with the selected alternative in the FONSI, to help restore the natural abundance, diversity, dynamics, distribution, habitats and behaviors of native fish populations that were present in the park prior to the introduction of nonnative fish. The administrative flexibility offered by the Superintendent's Compendium, which in most circumstances can be modified without notice and comment rulemaking (see 36 CFR 1.5(b)), provides a feasible and responsive method to meet the strategic goals identified in the FONSI to utilize adaptive management to alter management activities when needed based on monitoring and best available science. NPS regulations at 36 CFR 1.7(b) require the Superintendent to update the Compendium at least annually. The NPS will ensure that the public has an opportunity to provide meaningful input prior to updating any closures or restrictions related to fishing in the Compendium.

Consolidating all fishing closures and restrictions in the Compendium will make them more accessible and user-friendly for the public. Instead of having to look in two different places (the special regulations in 36 CFR 7.5 and the Superintendent's Compendium on the park's website), the public will be able to find all closures and restrictions related to fishing in one place. The NPS has already done this, informally, by producing a fishing pamphlet that is available at the park's website at https://www.nps.gov/mora/planyourvisit/fishing-and-boating.htm. Moving all of the closures and restrictions related to fishing into the Compendium will consolidate the official versions of them in one place for legal purposes. Centralizing them in the Compendium will increase compliance, strengthen enforcement, and decrease public confusion and frustration. The NPS routinely responds to inquiries and requests for clarification from the State of Washington and members of the public regarding fishing opportunities and rules within the park. Placing all fishing closures and restrictions in the Compendium will help visitors understand the rules and become better stewards of fishery resource at the park. In order to direct the public to the Compendium, the NPS is replacing the existing language in paragraph (a) of section 7.5 with a general statement that the Superintendent will establish fishing closures and restrictions, based on management objectives described in the park's resource management plans, in accordance with the criteria and procedures in 36 CFR 1.5 and 1.7, including publication in the Superintendent's Compendium. The rule also states that fishing in closed waters or violating a fishing restriction established by the Superintendent is prohibited. Similar language is used in the special regulations for other NPS units, including Glacier National Park (36 CFR 7.3) and Rocky Mountain National Park (36 CFR 7.7).

The NPS published a proposed rule in the Federal Register on January 11, 2022 (87 FR 1374). The NPS accepted public comments on the proposed rule for 60 days via the mail, hand delivery, and the Federal eRulemaking Portal at https://www.regulations.gov. Comments were accepted through March 14, 2022. A total of 27 comments were submitted and reviewed. Many commenters supported the proposed rule and did not raise any issues or suggest any changes. Some commenters raised concerns or questions about the proposed rule that the NPS summarizes and responds to below. After considering the public comments and after additional review, the NPS did not make any changes in the final rule.

1. Comment: One commenter asked if there is oversight of management decisions implemented through the Superintendent's Compendium and whether the WDFW would be involved in such management decisions to ensure the protection of native fish species.

NPS Response: NPS regulations at 36 CFR 1.5 require the Superintendent to follow specific procedures and requirements in order to use discretionary authority to implement closures and restrictions related to visitor use of park areas. The Superintendent must prepare a written determination justifying each action and use appropriate methods to notify the public of any such closures or restrictions. All such actions must be listed in the Compendium, which must be available to the public and updated at least annually. Compendium actions must be consistent with federal law and policy and may not be highly controversial or otherwise significant without going through a public notice and comment review process.

A primary purpose of the Plan is to promote the recovery of native fish species in the park. The NPS will continue to collaborate with the WDFW as it implements the selected alternative in the FONSI to achieve this goal. Continued collaboration may include identifying barriers to restoration of native fish species and ecosystem recovery within the park and, where possible, addressing issues outside the park such as fish stocking practices and barriers to fish migration downstream of the park. The NPS will ensure that the public and its partners, including WDFW, have an opportunity to provide meaningful input prior to updating any closures or restrictions related to fishing in the Compendium.

2. Comment: Several commenters questioned how the NPS will enforce requirements to release native species that are incidentally caught in rivers and streams as bycatch. One commenter suggested that dynamic closures of park areas would more effectively reduce bycatch and be more easily enforced.

NPS Response: In some situations, catch and release requirements may be more difficult to enforce than closures that prohibit all fishing in certain locations; however, enforcing catch and release requirements is not unique and occurs in many park areas with recreational fishing. The NPS believes that placing all closures and restrictions related to fishing in the Compendium will increase compliance and strengthen enforcement because it will be easier for the public understand what is allowed. The NPS has implemented closures in areas where the probability of ESA-protected bycatch is high ( e.g., Fryingpan) and also seasonal restrictions to protect spawning native species. The NPS will evaluate and modify management actions as needed if monitoring shows unanticipated adverse effects on native fish species.

3. Comment: Several commenters emphasized the importance of educating anglers to increase compliance with fishing closures and restrictions. One commenter suggested the NPS develop and promote interactive educational classes and activities to inform visitors about fishing rules and aquatic resources in the park.

NPS Response: The NPS agrees that educating anglers is critical to compliance and has developed a robust educational strategy to communicate how closures and restrictions will help achieve the purpose and goals of the Plan. In addition to the continued use and distribution of the fishing pamphlet, the NPS is developing a software application and a fishing guide that will provide information about fishing in the park and the status of fish species and habitats. The NPS will also send roving interpreters throughout the park to provide information directly to recreational anglers.

4. Comment: One commenter asked whether the rule would adversely affect recreational fishing if less fish are present in the park.

NPS Response: Catch and release fishing opportunities will continue to be available in most rivers and streams for some time during implementation of the Plan. A few small lakes with small fish populations may be fished out by anglers. At the same time, there will be widespread benefits to native fish and amphibian populations in areas where nonnative fish are removed, which will increase the ability of anglers and other visitors to see and to interact with native fish, amphibians and other species in their habitats throughout the park. Because it will likely take decades before the NPS can implement fish removal programs throughout the park, diminished fishing opportunities would occur in stages over time, reducing the overall impact of this recreational loss. Because fishing has consistently been rated low on the scale of recreational activities that visitors engage in during visitor surveys, this loss would likely be imperceptible to most park visitors.

5. Comment: One commenter asked the NPS to support local businesses and restaurants by giving them preferential rights to fish in the park or allowing them to use nonnative fish that are removed through administrative actions such as gillnetting, seining and electrofishing.

NPS Response: NPS regulations at 36 CFR 2.3(d)(4) prohibit commercial fishing in National Park System units, except where specifically authorized by Federal statute The park's enabling act does not authorize commercial fishing. Instead, it directs the NPS to prohibit the capture of fish for merchandise or profit. As a result, the NPS cannot allow local businesses or restaurants to take fish in the park for commercial purposes. Most administrative actions capturing nonnative fish occur in backcountry locations where transportation of the fish outside of the park is not feasible. In most cases, the fish are too small to have value for local businesses and restaurants.

6. Comment: One commenter stated native fish populations could be restored more quickly if there are no catch limits on nonnative fish species except those that are vital for maintaining potable water in the White River, Sunrise, Ohanapecosh, and Paradise waterways.

NPS Response: The NPS agrees that through the capture of nonnative species, anglers can play an important role in the conservation and recovery of native species in the park. In many lakes, rivers and streams in the park, anglers are essential for suppressing nonnative species. For these reasons, the rule would remove the daily catch limit in the special regulations in order to allow the retention of brook trout and kokanee salmon from rivers and streams and all nonnative fish from lakes that are open to recreational fishing. Except for brook trout and kokanee salmon, anglers may not retain other nonnative species from rivers and streams because those species are too difficult to distinguish from native species that must be released. The Compendium will continue to close Tipsoo Lake, Shadow Lake and Reflection Lakes to all fishing in order to protect fragile riparian vegetation.

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

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

This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). This certification is based on information contained in the economic analyses found in the report entitled “Cost-Benefit and Regulatory Flexibility Threshold Analyses: Proposed Rule to Remove Special Regulations for Fishing at Mount Rainier National Park.” The document may be viewed on the park's planning website at https://parkplanning.nps.gov/mora by clicking on the link entitled “Archived Projects” and then clicking the link entitled “2018 Mount Rainier National Park Fisheries Management Plan Environmental Assessment and Finding of No Significant Impact” and then clicking the link entitled “Document List” and then clicking on the link entitled “Fish Management Plan FONSI.”

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

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

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

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

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule will not have a significant or unique effect on State, local or tribal governments or the private sector. It addresses public use of national park lands and imposes no requirements on other agencies or governments. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

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

Under the criteria in section 1 of Executive Order 13132, the rule will not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. This rule only affects use of federally administered lands and waters. It has no outside effects on other areas. A federalism summary impact statement is not required.

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

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

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

The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian tribes and recognition of their right to self-governance and tribal sovereignty. The NPS has evaluated this rule under the criteria in Executive Order 13175 and under the Department's tribal consultation policy and has determined that tribal consultation is not required because the rule will have no substantial direct effect on federally recognized Indian tribes. During scoping for the Plan, the NPS solicited comments from six affiliated American Indian tribes: the Nisqually Tribe of Indians, the Muckleshoot Indian Tribe, the Cowlitz Indian Tribe, the Puyallup Tribe of Indians, the Squaxin Island Tribe, and the Confederated Tribes and Bands of the Yakama Nation. The NPS will continue to work with these tribes throughout the implementation of the selected alternative in the FONSI.

This rule does not contain information collection requirements, and a submission to the Office of Management and Budget under the Paperwork Reduction Act is not required. The NPS may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

The NPS has prepared the Plan to determine whether this rule will have a significant impact on the quality of the human environment under the NEPA. This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the NEPA is not required because of the FONSI. A copy of the Plan and FONSI may be viewed on the park's planning website at https://parkplanning.nps.gov/mora by clicking on the link entitled “Archived Projects” and then clicking the link entitled “2018 Mount Rainier National Park Fisheries Management Plan Environmental Assessment and Finding of No Significant Impact” and then clicking the link entitled “Document List.”

This rulemaking is not a significant energy action under the definition in Executive Order 13211; the rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy, and the rule has not otherwise been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. A Statement of Energy Effects is not required.

In consideration of the foregoing, the National Park Service amends 36 CFR part 7 as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2021-0787 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before March 21, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2021-0787, by one of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov//send-comments-epa-dockets.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

In the Federal Registers of March 22, 2022 (87 FR 16133) (FRL-9410-11) and June 22, 2022 (87 FR 37287) (FRL-9410-02), EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 1F8940 and PP 2F8996, respectively) by SePRO Corporation, 11550 N. Meridian Street, Suite 600, Carmel, IN 46032. The petitions requested that 40 CFR part 180.420 be amended by establishing tolerances for residues of the herbicide fluridone in or on the raw agricultural commodities of Berry and small fruit, group 13-07; Fruit, citrus, group 10-10; Fruit, pome, group 11-10; Tropical and subtropical, small fruit, edible peel subgroup 23A; Tropical and subtropical, medium and large fruit, smooth, inedible peel, subgroup 24B; Hop, dried cones; Nut, tree, group 14-12; and Rice, grain at 0.1 parts per million (ppm) (PP 1F8940); Animal feed, nongrass, group 18 and Grass, forage, fodder and hay, group 17 at 0.15 ppm (PP 1F8940); and Peanut at 0.1 ppm and Peanut, hay at 0.15 ppm (PP 2F8996). The petitions also requested to remove the existing tolerances for indirect or inadvertent residues of the herbicide fluridone, including its metabolites and degradates, from 40 CFR 180.420(d) in or on Berry, group 13; Fruit, citrus, group 10; Fruit, pome, group 11; Hop, dried cones; Nut, tree, group 14 at 0.1 ppm; Animal feed, nongrass, group 18 and Grass, forage at 0.15 ppm (PP 1F8940); and the existing time-limited tolerances for residues of the herbicide fluridone, including its metabolites and degrades, from 40 CFR 180.420(b) in or on Peanut and Peanut, hay at 0.1 ppm (PP 2F8996). Those documents referenced summaries of the petitions prepared by SePRO Corporation, which are available in the docket, https://www.regulations.gov. Comments were received in response to the March 22, 2022, Notice of Filing (PP 1F8940). EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is removing the following individual commodities from 40 CFR 180.420(a)(2), because the new crop group/subgroup tolerances established in this action will cover these commodities: pistachio (in crop group 14-12), tangerine (in crop group 10-10), pomegranate (in crop subgroup 24B), and avocado (in crop group 24B). Additionally, based on standard commodity definitions, EPA is updating the petitioned-for commodity definition “Tropical and subtropical, medium and large fruit, smooth, inedible peel, subgroup 24B” to “Tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B.”

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fluridone, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluridone follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections of the rule that would repeat what has been previously published in tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published tolerance rulemakings in 2016, 2020, and 2022 for fluridone in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to fluridone and established tolerances for residues of that chemical. EPA is incorporating previously published sections from these rulemakings as described further in this rule, as they remain unchanged.

Toxicological profile. For a discussion of the toxicological profile for fluridone, see Unit III.A. of the May 18, 2020, final rule (85 FR 29633) (FRL-10007-09).

Toxicological points of departure/Levels of concern. For a summary of the toxicological points of departure and levels of concern for fluridone used for the human health risk assessment, see Unit III.B. of the February 17, 2016, final rule (81 FR 7982) (FRL-9941-69).

Exposure assessment. EPA's dietary exposure assessments have been updated to include the additional exposure from the petitioned-for tolerances for fluridone. Acute and chronic unrefined dietary exposure assessments were performed for fluridone that incorporated tolerance-level residues, 100% crop treated (PCT) assumptions, default processing factors, and empirical processing factors where available. These assessments were revised to reflect the updated Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID), Version 4.02, which incorporates 2005-2010 consumption data from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The acute and chronic estimated drinking water concentrations (EDWCs) of 150 parts per billion (ppb) and 107 ppb, respectively, are unchanged from the May 18, 2020, final rule and were directly incorporated into the dietary assessments. A cancer dietary assessment was not conducted as fluridone is classified as “not likely” to be a human carcinogen. The residential exposure assessment also has not changed since the May 18, 2020, final rule because there are no proposed new residential uses. For a summary of the dietary exposure from drinking water and non-dietary exposure, see Unit III.C. of the May 18, 2020, final rule.

Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not found fluridone to share a common mechanism of toxicity with any other substances, and fluridone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluridone does not have a common mechanism of toxicity with other substances.

Safety factor for infants and children. EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit III.D. of the May 18, 2020, final rule for a discussion of the Agency's rationale for that determination.

Aggregate risks and determination of safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population-adjusted dose (aPAD) and chronic population-adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure (POD) to ensure that an adequate margin of exposure (MOE) exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.

Acute dietary risks are below the Agency's level of concern: 2.5% of the aPAD for all infants (<1 year old), the population group receiving the greatest exposure. Chronic dietary risks are below the Agency's level of concern: 7.6% of the cPAD for all infants (<1 year old), the population group receiving the greatest exposure. The combined short-term food, water, and residential exposures result in aggregate MOEs of 1,300 for adults and 1,800 for children. The Agency's level of concern for fluridone is an MOE of 100 or below, and these MOEs are therefore not of concern. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for fluridone. Finally, EPA has concluded that fluridone is not expected to pose a cancer risk, given the lack of evidence of carcinogenicity in the database.

Therefore, based on the risk assessments and information described above, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to fluridone residues. Detailed information on this action can be found in the document titled “Fluridone. Human Health Risk Assessment for the Section 3 Registration Action on Pome Fruit (Crop Group 11-10); Berry and Small Fruit (Crop Group 13-07); Grass Forage (Crop Group 17); Non-grass Animal Feed (Crop Group 18); Tropical and Subtropical, Small Fruit, Edible Peel (Crop Subgroup 23A); Rice; Peanut; Hops; and Crop Group Conversions/Expansions.” in docket ID EPA-HQ-OPP-2021-0787.

Adequate enforcement methods are available in the Pesticide Analytical Manual (PAM) Volume II to enforce the tolerance expression in plant and animal commodities. A Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) multiresidue method (Method No. A0013-02) is also available for determining residues of fluridone in various crop commodities, except acidic commodities. This QuEChERS method is considered marginally adequate for determining residues in acidic commodities. These methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). Codex has not established MRLs for fluridone.

Two comments were received in response to the Notice of Filing published in the Federal Register of March 22, 2022 (87 FR 16133) (FRL-9410-11). Neither comment was accompanied by any substantiation nor data supporting a conclusion that the tolerances being established in this action do not meet the FFDCA safety standard. Although EPA recognizes that some individuals would oppose any use of pesticides on food, section 408 of the FFDCA authorizes EPA to set tolerances for residues of pesticide chemicals in or on food when it determines that the tolerance meets the safety standard imposed by that statute. Upon review of the available information, EPA concludes that these tolerances would be safe.

Therefore, tolerances are established for residues of fluridone under 40 CFR 180.420(a)(2) in or on the following raw agricultural commodities: Animal feed, nongrass, group 18 at 0.15 ppm; Berry and small fruit, group 13-07 at 0.1 ppm; Fruit, citrus, group 10-10 at 0.1 ppm; Fruit, pome, group 11-10 at 0.1 ppm; Grass, forage, fodder and hay, group 17 at 0.15 ppm; Hop, dried cones at 0.1 ppm; Nut, tree, group 14-12 at 0.1 ppm; Peanut at 0.1 ppm; Peanut, hay at 0.15 ppm; Rice, grain at 0.1 ppm; Tropical and subtropical, small fruit, edible peel subgroup 23A at 0.1 ppm; and Tropical and subtropical, medium to large fruit, smooth, inedible peel subgroup 24B at 0.1 ppm.

In addition, EPA is removing the established tolerances for indirect or inadvertent residues of fluridone under 40 CFR 180.420(d) in or on the following commodities: Animal feed, nongrass, group 18 at 0.15 ppm; Berry, group 13 at 0.1 ppm; Fruit, citrus, group 10 at 0.1 ppm; Fruit, pome, group 11 at 0.1 ppm; Grass, forage at 0.15 ppm; Hop, dried cones at 0.1 ppm; and Nut, tree, group 14 at 0.1 ppm. Additionally, EPA is removing the established Section 18 emergency exemption tolerances under 40 CFR 180.420(b) in or on Peanut and Peanut, hay at 0.1 ppm. Finally, EPA is removing the established tolerances from 40 CFR 180.420(a)(2) in or on the following individual raw agricultural commodities as they are redundant with the established crop group/subgroup tolerances being established in this rulemaking: Avocado, Pistachio, Pomegranate, and Tangerine at 0.1 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

This document announces that the Office of Management and Budget (OMB) approved the information collection requirements in § 64.1200(a)(3)(ii) through (v), (b)(2) and (3), and (d) on September 15, 2021.

The Commission publishes this document as an announcement of the effective date of the rules.

In a final rule (FCC 22-100), released on December 27, 2022, and published elsewhere in this issue of the Federal Register , the Commission amended rule 47 CFR 64.1200(a)(3) to allow callers the option of obtaining either oral or written consent if they wish to make more calls than the numerical limits on exempted artificial or prerecorded voice message calls to residential telephone lines and announced the compliance date for the amended rule.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice).

This is a summary of the Commission's Order on Reconsideration and Declaratory Ruling (Order on Reconsideration) in CG Docket No. 02-278; FCC 22-100, adopted on December 22, 2022, and released on December 27, 2022. The full text of document FCC 22-100 is available online at ECFS—Filing Details ( fcc.gov ) or https://docs.fcc.gov/public/attachments/FCC-22-100A1.pdf. To request this document in accessible formats for people with disabilities ( e.g., Braille, large print, electronic files, audio format) or to request reasonable accommodations ( e.g., accessible format documents, sign language interpreters, CART), send an email to fcc504@fcc.gov or call the FCC's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice).

The Order on Reconsideration contains non-substantive modifications to information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. On January 4, 2023, these modifications were submitted to the Office of Management and Budget (OMB) and approved as non-substantive changes. Because these changes are non-substantive, there is no new or modified information collection burden for small business concerns with fewer than 25 employees pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198.

The Commission sent a copy of document FCC 22-100 to Congress and the Government Accountability Office pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A).

1. On reconsideration of the Telephone Consumer Protection Act (TCPA) Exemptions Order, CG Docket No. 02-278, Report and Order, published at 86 FR 11443 (Feb. 25, 2021), we revise the Commission's rule requiring prior express written consent to make informational calls over the numerical limits to permit such callers to obtain the necessary consent either orally or in writing. We decline, however, to revise any of the numerical limitations on the number of exempt non-telemarketing calls to residential lines that we established in the TCPA Exemptions Order. We also conclude that the differing numerical limitations for different categories of exempt calls to residential lines are both constitutional and necessary to advance the health and safety of consumers. We also retain the opt-out requirements for exempt informational calls. Finally, we decline to revisit the limitations on package delivery notifications to wireless numbers that have been in place since 2015 and confirm that the Commission's 2016 declaratory ruling on calls by utilities to wireless numbers applies equally to similar calls made to residential lines.

2. We grant petitioners' request that we clarify that callers may obtain consent either orally or in writing to exceed the numerical limits on artificial or prerecorded voice calls to residential telephone lines made under the exemptions contained in § 64.1200(a)(3)(ii) through (v) of our rules. We agree with the petitioners and commenters, including both industry and consumer organizations, that the Commission did not intend to require that such callers obtain consent only in writing. While the text of the TCPA Exemptions Order did not specify that consent must be obtained in writing, we agree with petitioners that the amended rule implementing the numerical limitations appears to require prior express written consent to exceed those limitations. As a result, we amend § 64.1200(a)(3) to make clear that consent for informational ( i.e., non-telemarketing) calls to residential telephone numbers can be obtained orally or in writing, consistent with longstanding Commission rules and precedent, as discussed below.

3. We agree with petitioners and commenters that there is no reason for the consent requirements for informational calls to residential lines differ from the consent requirements for informational calls to wireless numbers, which allow for either oral or written consent. In addition, as some commenters note, to extend the written consent requirement to informational calls that include calls from utilities and healthcare providers could impair the ability of these callers to provide important public safety information to consumers, though we note that to the extent such calls are “necessary in any situation affecting the health and safety of consumers,” they would fall under the exemption for “calls made for emergency purposes” and thus would not require prior express consent.

4. The Commission's rules prior to adoption of the TCPA Exemptions Order did not require prior express written consent for artificial or prerecorded voice message calls made under any of the exemptions for calls to residential lines. The TCPA Exemptions Order expressed no intent to amend these rules to require written consent to make informational artificial or prerecorded voice calls to residential lines, and it provided no justification for such a requirement. In fact, the text of the TCPA Exemptions Order refers only to “prior express consent”: “callers can make more than three non-commercial calls using an artificial or prerecorded voice message within any consecutive thirty-day period by obtaining the prior express consent from the called party, including by using an exempted call to obtain consent.” The Commission's rules distinguish “prior express consent” from “prior express written consent.” Only the latter requires consent to be obtained in writing. To obtain consent by “using an exempted call” strongly suggests that the Commission contemplated that such callers could obtain consent orally while communicating with the called party.

5. In addition, the Commission's longstanding precedent has expressly limited the written consent requirement only to telemarketing calls. We note, for example, that the Commission did not amend the definition of “prior express written consent” in our rules, which is limited to “advertisements or telemarketing messages” to encompass exempted informational calls to residential lines. As a result, we agree with the petitioners and commenters that there is no indication that the TCPA Exemptions Order intended to change the Commission's longstanding rules and precedent that apply the written consent requirement only to telemarketing calls. As noted above, commenters, including several consumer organizations, unanimously support this conclusion, and none oppose it. We therefore amend § 64.1200(a)(3) of our rules accordingly to implement this clarification.

6. Effective Date. The effective date of the amended rule contained herein is six months after publication in the Federal Register . This timeframe allows the amended rule to take effect on the same date as the rules that were adopted in the TCPA Exemptions Order. The Commission published an announcement of the effective date for the rules adopted in the TCPA Exemptions Order elsewhere in this issue of the Federal Register . In the TCPA Exemptions Order, the Commission concluded that a six-month implementation period was warranted to allow callers an opportunity to take measures to comply with the numerical limits and opt-opt requirements on artificial or prerecorded voice calls made to residential lines.

7. Because the amended rule contained herein is interrelated with the rules from the TCPA Exemptions Order, we are establishing an effective date of six months after Federal Register publication of this rule such that all the amended rules can take effect on the same date. As a result, our Federal Register publication will set the same effective date for both the rules from the TCPA Exemption Order and for the amended rule contained herein.

8. We deny petitioners' request to reconsider the Commission's numerical limits on exempt informational calls to residential lines. We note that section 8(a) of the TRACED Act provides that the Commission “(I) shall ensure that any exemption under subparagraph (B) or (C) contains requirements with respect to— . . . (iii) the number of such calls that a calling party may make to a particular called party.” In response to the Commission's request on the matter, commenters generally opposed any limits on exempt calls, but did not submit any specific cost or benefit data on potential call limits or numerical limits that the Commission had imposed in other contexts, and offered little guidance on appropriate limits for different types of calls to meet the TRACED Act's requirements.

9. As the TCPA Exemptions Order emphasized, limiting the number of exempted calls to residential lines will greatly reduce interruptions from intrusive and unwanted calls and reduce the burden on residential telephone users to manage such calls. As Congress noted in enacting the TCPA, artificial and prerecorded voice calls are often a greater invasion of privacy than live calls because the call recipient cannot interact with the caller. And more recently, in passing the TRACED Act, Congress noted that “[u]nwanted or illegal robocalls threaten . . . critical communication[s] when frustrated recipients, fearing unwanted or illegal robocalls, are hesitant to answer their phones.”

10. Further, while the adoption of a numerical limit satisfies the requirements of the TRACED Act, it also brings the residential exemptions “in line with” exempted calls to wireless numbers, which contain a numerical limitation on the number of calls that can be made. We agree with the Joint Consumer Organizations that the adopted limits on artificial and prerecorded calls to residential lines will have “particularly profound benefits for consumers.” As the Joint Consumer Organizations note, the absence of any limits on prerecorded non-telemarketing calls to residential lines is a primary source of consumer frustration that has led to consumers abandoning their landline telephone service.

11. We continue to believe that—with respect to the exemptions for non-commercial calls, commercial calls that do not constitute telemarketing, and calls by tax-exempt nonprofit organizations—limiting the number of calls that can be made to a particular residential line to three artificial or prerecorded voice calls within any consecutive thirty-day period strikes the appropriate balance between these callers reaching consumers with valuable information and reducing the number of unexpected and unwanted calls consumers currently receive and thus restoring trust in the residential landline network and advancing health and the safety of life, as discussed further below.

12. We also believe a consistent limit for those three exemptions is appropriate. We therefore disagree with ACA International et al. (ACA) that we should impose different numerical limits for each type of informational call based on the content or purpose of the message. While petitioners characterize this as a “one-size fits all” approach, we find that such a consistent numerical limit for these three exemptions will benefit both callers and consumers.

13. In addition, contrary to ACA's assertion, there is ample support in the record for the adopted three-calls-per-thirty-day numerical limit. As discussed above, numerous consumer organizations supported this limit, arguing that the three-call-per-thirty-day limit is reasonable. We agree with the Joint Consumer Organizations who argue that, in the context of our federal debt collection rules adopted in 2016, “the Commission engaged in an extensive and thorough analysis of the appropriate number of unconsented-to calls that should be permitted,” and that “[a]fter a full proceeding in which interested parties were invited to provide comments and reply comments, the Commission adopted a limit of three calls per thirty days for these calls.” Nothing in the current record disturbs that analysis and thus gives us cause to change any of the numerical limits. We also note that the numerical limit for Health Insurance Portability and Accountability Act of 1996 (HIPAA)-related calls to residential lines is identical to the limit that has been in place for more than six years and functioned without any record evidence of unduly restricting the ability of callers to make autodialed or prerecorded voice calls under a similar exemption for wireless telephone numbers. The Commission thus has six years of experience of applying that numerical limit to this same category of calls to wireless numbers, and this experience has demonstrated that this numerical limit strikes an appropriate balance between these callers reaching consumers with valuable healthcare information and restoring trust in the residential landline network, which can help to advance health and the safety of life as discussed further below.

14. Further, we agree with the Joint Consumer Organizations that the three-calls-per-thirty-day numerical limit is also reasonable in light of the two exceptions that the TCPA already provides for artificial or prerecorded voice calls: all calls relating to emergencies are permitted, and all calls for which prior express consent has been provided are permitted. The limitations the Commission adopted in the TCPA Exemptions Order are narrowly tailored to advance the health, safety, and privacy of consumers, while still providing opportunities for callers to contact consumers in an emergency or when they have received prior express consent. If callers need to make the calls because of a health or safety emergency or pursuant to prior express consent, there is no limit on the calls. Thus, we disagree with ACA's position that we did not consider the needs of utilities to make emergency calls, as permitted in the rules and Commission precedent.

15. Moreover, as the Commission emphasized in the TCPA Exemptions Order, callers wishing to make more than three non-telemarketing calls using an artificial or prerecorded voice within any consecutive thirty-day period can obtain consumer consent to make more. Callers can use exempted calls to obtain consent if the calls satisfy other applicable conditions. And most significantly, as discussed above, now that we have made clear that callers can obtain consent orally from consumers, informational callers will more easily be able to obtain permission to exceed the numerical limits. We continue to believe that consumers who welcome such calls are likely to readily give such consent, and the record developed on reconsideration does not contradict this assertion. In addition, because the TCPA only restricts calls to a residential telephone number when they use an artificial or prerecorded voice, callers using a live agent to make such calls should not risk violating the TCPA rules.

16. While ACA and several commenters oppose the three-calls-per-thirty-day limit and argue such limit is arbitrary and will impede the ability of informational callers to deliver time-sensitive information to consumers, they neither offer a clear alternative limit to apply to all exempted callers nor suggest appropriate distinct limits for each and every various type of call. In addition, the petitioners offer no new facts or data on the calls they make that have changed since the last opportunity to present such matters to the Commission. “In the absence of additional data from commenters,” and to implement the statutory mandate, we conclude that these numerical limits adequately balance the privacy interests of consumers with the ability of informational callers to communicate with the public, and that there is no reason to revisit these limits at this time.

17. Given that we find the numerical limits to be reasonable, we decline to adopt what ACA describes as “important safeguards” to ensure that consumers receive the calls they expect. ACA argues that, if the Commission retains the existing numerical limits, it should apply them on a “per event” or “per account” basis rather than on a “per telephone number” basis. We believe a per-event or per-account condition is unnecessary in order for callers to deliver important information to consumers. We emphasize that informational callers need only obtain consent orally or in writing from a consumer to be able to make unlimited calls to that telephone number regarding any event—whether it be a utility service upgrade, a security threat on a financial account, or a scheduled medical appointment. Thus, callers can obtain consent from consumers who desire to receive more than three calls per thirty days; consent is an important safeguard to ensure not only that callers can make the calls they need to make, but that consumers are protected from repetitive nuisance calls. Moreover, ACA's argument in its reply comments for a “per event” or “per account” approach to call limits is new, but we see no reason why it could not have been presented during the rulemaking proceeding. In the absence of any clear reason that it is in the public interest to adopt ACA's alternative approach to numerical limits, we find this to be an alternative and independent reason not to grant ACA's late request.

18. Finally, we decline ACA's request for the Commission to revisit the numerical limit under the wireless exemption for package delivery notifications that has been in place since 2014. As the Commission stated in the TCPA Exemptions Order, such request, which was also made in response to the TRACED Act Notice of Proposed Rulemaking (NPRM), published at 85 FR 64091 (Oct. 9, 2020), is outside the scope of section 8 of the TRACED Act. In addition, we deny ACA's request to allow package delivery companies to send at least two additional follow-up messages, even when no signature is required. We find no reason to conclude that the existing exemption that allows for one notification (whether by voice call or text message) to notify a consumer about a package delivery is inadequate to address these situations as described in the record. To the extent that additional notifications may prove helpful in these situations, we note that callers may use their one exempted notification to obtain consent from recipients to make additional notifications or use a live caller to contact the recipient.

19. We also conclude that it is fully consistent with the First Amendment to retain the call limitation established in the TCPA Exemptions Order for the residential line exemption for healthcare calls subject to HIPAA and the distinct call limitation applicable to the residential line exemptions for noncommercial calls; commercial calls that do not include an unsolicited advertisement; and calls from tax exempt nonprofit organizations (collectively, the “non-HIPAA exemptions”). In its Petition, Enterprise Communications Advocacy Coalition (ECAC) argues that the different numerical limits adopted for the residential line exemption for healthcare calls subject to HIPAA (one call per day up, to three calls per week) and those adopted for the non-HIPAA exemptions (three calls per thirty days) constitute content-based restrictions that fail strict scrutiny and thus violate the First Amendment. NCTA—The internet & Television Association (NCTA) similarly argues that “the three-call limit [on exempted commercial informational calls] imposes overbroad restrictions on fully protected speech and violates the First Amendment.” ECAC and NCTA argue that because the distinction in the call limitations for the different residential line exemptions are content-based, that subjects the Commission's regulatory regime to strict First Amendment scrutiny, and that the Commission has not satisfied that standard. For the reasons explained below, we reject the claim that the call limitations violate the First Amendment and therefore deny requests for reconsideration premised on that theory.

20. Particularly in light of the Supreme Court's recent decision in Barr v. Am. Ass'n of Political Consultants ( AAPC ), we recognize that a court could view the Commission's approach to the residential line exemptions as implicating content-based regulation of speech subject to strict scrutiny. Strict scrutiny requires the “government [to] prove[] that the[ restrictions] are narrowly tailored to serve compelling state interests.” Evaluating the First Amendment concerns raised on reconsideration, we find that the call limitations for our residential line exemptions satisfy strict First Amendment scrutiny. As discussed below, we conclude that our call limitations are narrowly tailored to advance a distinct governmental interest—that is, restoring trust in the residential landline network and advancing the health and safety of life—and thus satisfy strict First Amendment scrutiny.

21. We conclude that the adopted call limitations for the residential line exemptions are narrowly tailored to advance the compelling governmental interest in health and safety of life. The landline telephone network—and the communication it enables—is an important tool in ensuring residential consumers receive the information they need to advance their own health and safety of life along with that of others. Yet the evidence reveals that the escalating problem of robocalls has undermined consumers' trust and willingness to rely on their landline telephone, leading consumers in many cases to simply not answer the phone. That communication breakdown can have significant health and safety of life implications for the many consumers who rely on residential landline service.

22. As a statutory matter, when calibrating the residential line exemptions, it is appropriate for the Commission to consider the health and safety of life implications of the use of the telephone network that our exemption rules would facilitate. Although the TCPA includes a special focus on consumer privacy, it nonetheless recognizes the importance of health and safety of life considerations through the statutory exemption from TCPA restrictions for calls made or initiated for emergency purposes. Congress likewise recognized that “privacy rights, public safety interests, and commercial freedoms of speech and trade must be balanced in a way that protects the privacy of individuals and permits legitimate telemarketing practices.” Further, the TCPA was enacted as part of the Communications Act, which established the Commission to, among other things, “promot[e] safety of life . . . through the use of wire and radio communications.”

23. Turning to the specific context at issue here, evidence supports the conclusion that the volume of robocalls landline consumers receive undermines their trust in, and willingness to rely on, the landline telephone network. There is evidence that the number of robocalls has increased dramatically in recent years. The Commission previously has cited “hundreds of comments from consumers [filed in a rulemaking] stating that they no longer answer their phone when it rings,” and has concluded that “[i]t is obvious that the volume of unwanted calls is reducing the value of telephony to anyone who makes or receives calls.” Commenters state that “[t]he unremitting nature of unwanted and unstoppable—even if technically legal—calls made to landlines has led to a wavering trust in voice calls.” Unwanted robocalls, for example, often are either delivered with inaccurate caller identification (caller ID) information or are delivered with caller ID information that is not familiar to a consumer, and thus are highly likely to be viewed by called parties with suspicion. The Joint Consumer Organizations also explain the practical consequences that flow from this state of affairs: “[p]eople have become so inured to the unwanted calls ringing their lines that they do not pick up—even when the calls are important.” There also is evidence that consumers' increasing reluctance to answer the phone undermines public health and safety of life that depends on the phone network. Exacerbating this concern is the fact that traditional residential voice service can be particularly important for vulnerable populations, such as the elderly. As the Joint Consumer Organizations observe, “[t]he Commission's new regulations provide a meaningful way to rebuild the fading trust in the usefulness of landlines by arming recipients with effective tools to stop many of the unconsented-to calls they receive.”

24. Importantly, we find that it is the overall volume of unauthorized robocalls that has led residential landline consumers increasingly to simply decline to answer the phone, even if a given call might, in the abstract, be subjectively desirable to a given consumer. It is reasonable to assume that callers generally, and specifically those callers who argue here to be able to make unlimited numbers of robocalls without consumer consent, have incentives to call repeatedly because the cost of repeated calling is trivial to the caller financially, and there exists only an incremental risk a consumer will not pick up their call. Thus, callers individually have little or no incentive to be concerned about the collective problem of unwanted robocalls undermining trust in the network. As a result, it is appropriate for us to take action to address the larger overall volume of robocalls. We expect that curtailing the number of calls to residential lines that can be made by virtue of FCC exemptions under section 227(b)(2)(B) will substantially reduce the total volume of calls consumers receive without their prior authorization, helping restore consumers' confidence in the calls they do continue to receive.

25. As a general matter, and in the absence of anything other than conclusory assertions to the contrary, we are not persuaded that a less restrictive limitation than three calls per thirty days would be a reasonable choice of call limitation for these residential line exemptions given the compelling governmental interests at stake. Indeed, one could argue that the need to address the volume of unauthorized calls and thereby restore trust in the telephone network could be addressed most effectively by eliminating these exemptions altogether. But we also must weigh First Amendment considerations, and in this proceeding we do not find a basis to restrict these calls further than a limit of three calls per thirty days under the residential line exemption. In particular, against the backdrop of the Commission previously having adopted, after a thorough and reasoned analysis, a three-call-per-thirty day limit for other types of unconsented-to calls, we conclude that, at least on this record, we do not find a sufficient justification for taking a more restrictive approach and either eliminating the exemptions entirely or adopting lower call limitations, given the need for an appropriate fit between the regulatory approach and the relevant governmental interest.

26. Notwithstanding those general findings regarding the call limits for residential line exemptions, we nonetheless find a less restrictive call limitation warranted for the exemption for healthcare calls as defined by HIPAA. The exemption for healthcare calls as defined by HIPAA is unique in that the governmental interest in health and safety of life cuts both ways with respect to such calls. In other words, curtailing unauthorized robocalls as a whole will help restore consumers' trust and willingness to rely on residential landline service, thereby advancing the governmental interest in health and safety of life—but, at the same time, allowing healthcare calls as defined by HIPAA to reach residential consumers is itself also a benefit to the governmental interest in health and safety of life.

27. On balance, the governmental interest in health and safety of life is best advanced in this unique scenario by allowing a higher number of calls under the exemption for healthcare calls as defined by HIPAA. This call limit matches the limit the Commission adopted for calls to wireless numbers in 2015, and the Commission found “no credible evidence it has unduly restricted healthcare providers' ability to communicate with their patients.” We thus conclude that the risk that a more restrictive call limitation could unduly restrict healthcare providers' ability to communicate with their patients—a possibility the Commission cannot rule out on this record—counsels against a lower call limitation. At the same time, in light of our experience with the prior limit for calls to wireless numbers, we also do not find a basis to conclude that a higher number of calls is warranted here, given the mixed effects of such calls when considered in conjunction with all the other calls made without prior consent under the residential line exemptions.

28. We also are not persuaded by commenters' objections to the Commission's call limitations for the residential call exemptions. Some commenters contend that other calls implicate health and safety of life just like health care messages as defined by HIPAA. These commenters appear concerned that the Commission's approach unduly restricts that speech by failing to apply the more generous call limitations that apply to healthcare calls as defined by HIPAA. But these claims do not account for the full range of calls that can be made notwithstanding the TCPA's restriction on calls to residential lines. In particular, in addition to the Commission-created exemption for health care calls as defined by HIPAA, section 227(b)(1)(B) expressly carves out any call made with “the prior express consent of the called party,” and any “call [] initiated for emergency purposes” from the scope of its prohibitions.

29. As discussed above, the TCPA's restrictions for calls to residential lines do not apply to calls unless they use an artificial or prerecorded voice. If callers need to make calls related to, for example, power outages or utility work, they can either obtain the consumer's consent to do so before using an artificial or prerecorded voice or use a live caller to make the call. Or, if the call is made for an “emergency purpose” as defined by the Commission's rules and orders, it is exempted by our rules. None of the examples in the record articulate a scenario for which distinct, more lenient call limitations practically could be crafted, that would apply to circumstances that both: (i) implicate the governmental interest in health and safety of life and (ii) is not already subject to either the FCC's exemption for health care messages as defined by HIPAA or one of the statutory exceptions. Indiscriminately expanding call limitations based on speculation that they conceivably might benefit such calls would also allow an array of other calls that undermine our goal of restoring greater consumer trust and confidence in the landline telephone network, to the benefit of health and safety of life. Consequently, the record does not reveal a plausible alternative approach to expanding the universe of calls subject to a higher call limitation under the theory that they are similarly situated to healthcare calls as defined by HIPAA.

30. Nor does the record identify a plausible alternative approach that would give more lenient call limitations for calls that commenters claim are delivered for important interests other than the interest in health and safety of life. ACA, for example, alludes to an example of political speech and cites examples of communications bearing on consumers' financial interests or safety of property. More generally, NCTA cites TCPA legislative history that “Congress did not intend the statute `to be a barrier to the normal, expected, or desired communications between businesses and consumers.'” These commenters largely do not contend, let alone provide persuasive evidence, that the other interests—such as commercial or financial interests or safety of property—are as compelling as the governmental interest in health and safety of life that we are seeking to advance, which would be undermined by allowing more calls to residential landline consumers without their prior consent. And in all cases, it is essential to keep the aggregate effects in mind—the higher volume of these other types of calls raised by commenters will contribute to the overall lack of trust in the telephone network—a fact undiminished if they at the same time advance some more narrow interest. Furthermore, the First Amendment only requires us to consider plausible alternatives, and the record here does not reveal alternatives that could target just that speech that advances the other identified interests without sweeping in other types of speech that would simply contribute to the call volume that undermines trust in the telephone network without any adequate countervailing benefit.

31. We also are not persuaded that our call limitations for the residential call exemptions are unnecessary in light of anti-illegal robocall measures as a result of the TRACED Act and prior Commission policies—namely: opt-out rights specified by rule; the required implementation of STIR/SHAKEN; and call blocking. As discussed below, we conclude that those other measures—while designed to address important aspects of the robocalls problem—do not obviate the need for our approach to call limitations.

32. Opt-Out. The consumer opt-out rights in our rules, while helpful for consumers, alone are not adequate to protect consumers who have lost trust in the telephone network and consequently are reluctant to answer the phone in the first place. If consumers do not answer a given call and learn who the caller is (assuming that the caller provides accurate information), they have no ability to opt out of future calls from that caller. Thus, despite the important protections they afford, opt-out mechanisms are unlikely to meaningfully reduce the volume of calls received by those consumers who already have lost trust in the telephone network.

33. STIR/SHAKEN. While voice service provider implementation of STIR/SHAKEN will combat robocalls and introduce additional trust into the network, it addresses a different problem than the rules at issue here. STIR/SHAKEN combats the problem of illegal spoofing—that is, the falsification of caller ID information by bad actors to deceive call recipients into believing a call is trustworthy. It accomplishes this goal by allowing terminating providers to verify that the caller ID information attached to a call is legitimate. By adding new information about the call originator and caller ID information displayed, widespread implementation of STIR/SHAKEN promotes call blocking and labeling, enables more effective enforcement, and restores trust in caller ID information.

34. STIR/SHAKEN combats scam spoofed calls, which is a subset of unwanted calls. All forms of unwanted robocalls undercut Americans' trust in the voice network in their own way. An estimate from YouMail found that scam robocalls were just 47% of all robocalls in 2019. The remainder totals an estimated 31 billion robocalls—comparable to the number of all robocalls in 2016. Other estimates also indicate that a large proportion of robocalls are not scams. Merely reducing the number of scam calls—while highly valuable as a form of consumer protection and significant progress relative to the status quo in terms a reduction to the volume of robocalls—is not sufficient in itself to restore trust that an incoming call is likely to be one the recipient wants to answer. Even if STIR/SHAKEN implementation—and the associated call blocking and consumer response—succeeds at eliminating all scam robocalls, a significant number of unwanted robocalls would remain. This, in turn, would continue to undermine trust in the telephone network unless it can be further addressed by the Commission in its calibration of residential line exemptions.

35. Call Blocking. In significant part, the call blocking analysis follows our analysis of STIR/SHAKEN. Even though call blocking measures need not focus solely on scam or illegal robocalls, measures currently in place for landline customers frequently are focused in that manner. To the extent that call blocking targets scam calls, that step—while important and beneficial—does not fully address the problem with lost confidence in the telephone network for the same reasons discussed above with respect to STIR/SHAKEN.

36. Although call blocking tools also can, in part, address legal but unwanted calls, the record here does not support a finding that such measures have the prevalence and degree of success needed to obviate the need for call limitations (or to enable the relaxation of call limitations) for the residential line exemptions. For one, the record does not demonstrate how successful blocking tools are today at blocking unwanted calls. For another, the Commission has acknowledged and emphasized on numerous occasions in its call blocking orders that any single solution will not be sufficient to address the full problem of unwanted robocalls, and that we therefore need to approach it from multiple angles. Thus, even accepting that some tools seek to block calls beyond scam or illegal calls, we are not confident yet that they would curtail such calls to an appreciable degree. This concern about the tools' design is exacerbated by the limited extent of the public's use of them today. Tools blocking unwanted calls (as distinct from scam or illegal calls) do not appear to be widely in use by consumers today, even if available (and even if available at no cost). In a number of cases, they appear to be offered on an opt-in basis and/or otherwise require affirmative steps by the consumer to set it up. Thus, although they are important tools even today, and have promise to become even more important over time, there is not sufficiently widespread use of tools that block unwanted calls that are not scam or illegal calls to adequately address the circumstances that have led to a loss of trust in the telephone network and associated risks to health and safety of life. Because these tools, however successful they may prove to be, will take substantial time to be deployed on a widescale basis by both internet Protocol (IP) and non-IP based providers, we do not find them to serve as an adequate remedy for the immediate scourge of illegal and unwanted robocalls that will continue to serve as a deterrent to residential telephone use today and in the immediate future. Thus, while blocking tools are incredibly valuable, additional steps to reduce the number of potentially unwanted calls overall: (1) reduce the risk that consumers will be disrupted by a high volume of such calls; and (2) reduce the risk that calls made under the TCPA exemptions will be blocked that, individually, may be wanted, but are not wanted at such high volumes. We will continue to monitor the success of blocking tools and reevaluate our numerical limits in light of our experience with these tools.

37. In sum, we conclude that our call limitations for the residential line exemptions are narrowly tailored to advance the compelling government interest in health and safety of life because they help restore residential landline consumers' trust and willingness to rely on the residential landline telephone network. Further, we do not find that other regulatory alternatives adequately meet this need. Indeed, not only do opt-out, STIR/SHAKEN, and call blocking each have a discrete sphere of likely impact, but even taken in the aggregate they do not address all aspects of the problem. This is sufficient to satisfy strict First Amendment scrutiny.

38. We deny ACA's request to reconsider the Commission's decision to extend to informational calls opt-out requirements that had previously applied only to telemarketing calls. These requirements mandate use of automated opt-out mechanisms, as well as opt-out lists and policies. Under the new rules, a consumer who wants to avoid further artificial or prerecorded informational calls can “opt out” by dialing a telephone number (required to be provided in the artificial or prerecorded voice message) to register his or her do-not-call request in response to that call. Our rules also require that the caller provide an automated, interactive voice- and/or key press-activated opt-out mechanism for the called person to make a do-not-call request. To effectuate an opt-out mechanism, callers must comply with the requirements of § 64.1200(d) of our rules, which governs the process for handling do-not-call requests. ACA argues that such requirements would be burdensome and that the former rules requiring informational callers to provide only caller identification and a telephone number at the beginning of prerecorded and artificial voice calls are sufficient to protect consumers. ACA further maintains that the Commission did not provide “any reasoned explanation, cost-benefit analysis, or assessment of the impact on the informational calls that might no longer be able to reach consumers.”

39. As the Commission explained in the TCPA Exemptions Order, an opt-out mechanism gives consumers more say in how many calls they receive. We believe consumers should be able to decide which types of calls they want to receive on their residential lines and which they wish to avoid. We agree with the Joint Consumer Organizations that requiring callers making exempt calls to provide an automated opt-out mechanism will significantly empower telephone call recipients to stop unwanted calls. In addition, eliminating opt-out requirements for prerecorded calls to residential lines, as the ACA Petition requests, would remove an additional tool that consumers can use to limit the number of artificial or prerecorded voice calls that they receive—a tool that is consistent with Congress's direction in the TRACED Act of placing limits on the number of calls made pursuant to exemptions—and would lead to more unwanted calls. While commenters argue that applying the same opt-out requirements that apply to telemarketers is a departure from longstanding precedent, they offer no persuasive reasons for why consumers should not be afforded the same tools to avoid unwanted informational calls as they have to combat unwanted telemarketing calls, particularly given the unrelenting number of unwanted robocalls consumers face today. NCTA argues that businesses “have every incentive to communicate efficiently with and respect the privacy of their customers, as any failure to do so could result in reputational harm and a loss of business.” And yet the evidence shows that consumers continue to be deluged with unwanted robocalls to their landlines.

40. Informational callers have a variety of alternative methods they may use to reach consumers, including the use of live operators on any calls they make. Our opt-out requirement prohibits only the use of an artificial or prerecorded voice message on future calls to the call recipient. It does not preclude further communication by any other means. To the extent that consumers consider such calls beneficial, they have the ability not to exercise the option to opt out from receiving them and even to consent to receiving unlimited calls from a particular caller. We thus disagree with ACA's assertion that the Commission did not fully consider the cost-benefit impact of precluding informational calls after a consumer opts out of such calls. To the contrary, the Commission recognized that requiring an opt-out mechanism for informational calls will provide a significant benefit—it will “empower consumers to stop unwanted calls made pursuant to an exemption under section 227(b)(2)(B)” and “give consumers more say in how many calls they receive”—and it also considered the burden that adopting an automated, interactive opt-out mechanism will impose on callers who make prerecorded message calls. In doing so, however, the Commission noted that “the technology that enables opt out is commonplace and easily accessible.” Nevertheless, “we recognize that this requirement will impose some additional burden,” and to alleviate that burden, we allowed for a six-month implementation period before the opt-out requirements took effect. We took that action to “ensure that affected calling parties can implement necessary changes in a cost-effective way that makes sense for their individual business models.” Thus, we reject ACA's argument that we failed to consider the costs and benefits associated with the new rule.

41. Furthermore, we continue to disagree with commenters who argue that opt-out requirements for exempt callers are overly burdensome. The Commission placed a similar condition on exemptions for calls to wireless numbers, and there is no evidence that callers have not been able to comply with such requirements in that context. The technology that enables opt-out mechanisms is commonplace and easily accessible; the Commission's rules have required telemarketers to use the available tools and equipment since 2012.

42. We grant ACA's request to confirm that an earlier Commission ruling on “prior express consent” for calls made by utility companies to wireless phone numbers applies equally to residential numbers. As discussed herein, we apply the guidance and compliance standards set forth in the Edison Electric Institute (EEI) Declaratory Ruling, FCC 16-88, released on August 4, 2016, which addressed utility calls to wireless telephone numbers, to calls made to residential lines. Specifically, we confirm that consumers who provide their wireless or residential telephone number to a company involved in the provision of their utility service when they initially sign up to receive utility service, subsequently supply the wireless or residential telephone number, or later update their contact information with their wireless or residential telephone number, have given prior express consent to be contacted by that company at that number with messages that are closely related to the utility service so long as the consumer has not provided instructions to the contrary.

43. In addition, at the request of several Texas utility companies, and consistent with the Commission's treatment of prior express consent in other contexts, we take this opportunity also to confirm that the provision of a telephone number to the subscriber's utility service provider reasonably evidences prior express consent by the subscriber to be contacted at that number by an upstream electric utility that: (1) provides electricity service to the subscriber's retail electricity provider, to whom the telephone number is given by the subscriber; or (2) is an affiliate of another utility company that provides some other type of utility service to the subscriber, to whom the telephone number is given by the subscriber. In some instances, the upstream electric utility provider may be best positioned to provide subscribers with more timely information regarding issues that may be affecting their service. This ensures that utility service providers involved in the provision of utility service to a subscriber but do not have a direct customer relationship with the subscriber can rely upon consent given to a retail utility provider to communicate with an affected subscriber on matters closely related to the utility service, such as situations in which the provision of electricity service is, or is scheduled to be, impacted due to issues related to the upstream utilities' generation or transmission of electricity.

44. Consistent with the Commission's precedent, we confirm that calls closely related to utility services include those that warn about planned or unplanned service outages; provide updates about service outages or service restoration; ask for confirmation of service restoration or information about lack of service; provide notification of meter work, tree trimming, or other field work that directly affects the customer's utility service; notify consumers they may be eligible for subsidized or low-cost services due to certain qualifiers such as, for example, age, low income or disability; or provide information about potential brown-outs due to heavy energy usage.

45. With regard to calls regarding payment for current utility service, we also incorporate the Commission's prior ruling. Specifically, in the absence of facts supporting a contrary finding, prior to the termination of a customer's utility service, a customer who provided a residential telephone number when he or she initially signed up to receive utility service, subsequently supplied the residential telephone number, or later updated his or her contact information with a residential telephone number, is deemed to have given prior express consent to be contacted by their utility company with messages that are closely related to the service, as described above, as well as calls to warn about the likelihood that failure to make payment will result in service curtailment. After a customer's utility service has been terminated, however, routine debt collection calls by utilities to those customers will continue to be governed by existing rules and requirements, and we leave undisturbed the existing legal and regulatory framework for those calls.

46. We agree with the petitioner and commenters who support this request that these types of informational communications from utility providers are critical to providing safe, efficient, and reliable service. In fact, the Commission has long recognized that “[s]ervice outages and interruptions in the supply of water, gas or electricity could in many instances pose significant risks to public health and safety, and the use of prerecorded message calls could speed the dissemination of information regarding service interruptions or other potentially hazardous conditions to the public.” There are a wide range of potential risks to public health and safety presented by the interruption of utility services, and the use of artificial or prerecorded voice message calls can be critically important in speeding dissemination of time-sensitive information to the public. We also note that no commenter opposes this request.

47. To ensure that utility companies call only those consumers who have consented to receive artificial or prerecorded voice calls and that such calls are closely related to the provision of service, we reiterate that the utility company is responsible for demonstrating that the consumer provided prior express consent, as it is in the best position to keep records in the usual course of business showing such consent, and the utility company will bear the burden of showing it obtained the necessary prior express consent. We also note that consumers have the right to revoke consent to such calls if they no longer wish to receive them, just as they can when these calls are made to wireless numbers. As a result, we believe this ruling balances important public safety communications with consumer privacy interests.

48. It is ordered , pursuant to the authority contained in sections 1-4, 227, and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 151-154, 227, 405, and §§ 1.2 and 1.429 of the Commission's rules, 47 CFR 1.2, 1.429, that the Order on Reconsideration and Declaratory Ruling is adopted .

49. It is further ordered that the Declaratory Ruling of the Order on Reconsideration and Declaratory Ruling shall be effective upon release. It is further ordered that rule amendments adopted in the Order on Reconsideration and Declaratory Ruling shall be effective six months after publication in the Federal Register , which shall be preceded by OMB approval of the modified information collection requirements adopted herein.

50. It is further ordered that, pursuant to 47 CFR 1.4(b)(1), the period for filing petitions for reconsideration or petitions for judicial review of any aspect of the Order on Reconsideration and Declaratory Ruling will commence on the date that a summary of the Order on Reconsideration and Declaratory Ruling is published in the Federal Register .

51. It is further ordered that the TCPA Exemptions Order adopted in CG Docket No. 02-278 on December 29, 2020, is affirmed in part and reversed in part to the extent indicated herein.

52. It is further ordered that the Petitions for Reconsideration filed by the ACA International et al. and Enterprise Communications Advocacy Coalition in CG Docket No. 02-278 on March 29, 2021, and March 17, 2021, respectively, are granted in part and denied in part to the extent indicated herein.

53. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Traced Act NPRM, CG Docket No. 02-278, Notice of Proposed Rulemaking, published at 85 FR 64091, October 9, 2020. The Commission sought written public comment on the proposals in the Traced Act NPRM, including comment on the IRFA. The Commission subsequently incorporated a Final Regulatory Flexibility Analysis (FRFA) in the TCPA Exemptions Order. This Supplemental FRFA conforms to the RFA and adopts by reference the FRFA in the TCPA Exemptions Order. It reflects changes to the Commission's rules arising from the Order on Reconsideration prepared in response to the Petitions for Reconsideration filed by ACA International et al. (ACA) and Enterprise Communications Advocacy Coalition (ECAC).

54. The Order on Reconsideration is part of the Commission's ongoing work to combat unwanted robocalls while permitting legitimate callers to deliver information consumers have consented to receive. Specifically, the Order on Reconsideration grants petitioners' request to clarify and amend the rules so that callers may obtain consent either orally or in writing to exceed the numerical limits on artificial or prerecorded voice calls to residential telephone lines made under the exemptions contained in § 64.1200(a)(3)(ii) through (v) of the Commission's rules. The Commission agrees with the petitioners and commenters, including both industry and consumer organizations, that the Commission did not intend to require that such callers obtain consent only in writing. While the text of the TCPA Exemptions Order did not specify that consent must obtained in writing, the Commission agrees with petitioners that the amended rule implementing the numerical limitations inadvertently appeared to require prior express written consent to exceed those limitations. As a result, the Commission now amends § 64.1200(a)(3) of its rules to make clear that consent for informational, non-telemarketing calls to residential telephone lines can be obtained orally or in writing, consistent with longstanding Commission precedent.

55. The Order on Reconsideration denies petitioners' request to reconsider the Commission's numerical limits on exempt non-telemarketing calls to residential lines. The Commission affirms that limiting the number of exempted calls to residential lines will greatly reduce the interruptions from unwanted calls and reduce the burden on residential telephone users to manage such calls. The Commission continues to believe that limiting the number of calls that can be made to a particular residential line to three artificial or prerecorded voice calls within any consecutive thirty-day period strikes the appropriate balance between these callers reaching consumers with valuable information and reducing the number of unexpected and unwanted calls consumers currently receive. In addition, the limit of three calls per thirty-day period is “in line with” the conditions for exempted calls to wireless numbers.

56. The Order on Reconsideration also denies petitioners' request to reconsider the Commission's decision to extend to informational calls opt-out requirements that had previously applied only to telemarketing calls. These requirements mandate use of automated opt-out mechanisms, as well as opt-out lists and policies. Under the new rules, a consumer who wants to avoid further artificial or prerecorded informational calls can “opt out” by dialing a telephone number (required to be provided in the artificial or prerecorded voice message) to register his or her do-not-call request in response to that call. The rules also require that the caller provide an automated, interactive voice- and/or key press-activated opt-out mechanism for the called person to make a do-not-call request. The Commission affirms that an opt-out mechanism gives consumers more say in how many calls they receive and that consumers should be able to decide which types of calls they want to receive on their residential lines and which they wish to avoid.

57. Finally, the Order on Reconsideration grants the request of ACA to confirm that the Commission's ruling on “prior express consent” for calls made by utility companies to wireless phones applies equally to residential landlines. The Commission confirms that consumers who provide their residential telephone number to a utility company when they initially sign up to receive utility service, subsequently supply the residential telephone number, or later update their contact information with their residential telephone number, have given prior express consent to be contacted by their utility company at that number with messages that are closely related to the utility service so long as the consumer has not provided “instructions to the contrary.” The Order on Reconsideration concludes that there are a wide range of potential risks to public health and safety presented by the interruption of utility services, and the use of prerecorded voice message calls can be critically important in speeding dissemination of time sensitive information to the public.

58. In the Traced Act NPRM, the Commission solicited comments on how to minimize the economic impact of the new rules on small businesses. There were no comments filed that specifically addressed the rules and policies proposed in the IRFA. In the TCPA Exemptions Order, however, the Commission described three comments that focused on the challenges certain entities might face in complying with the opt-out requirements, given their small staffs and limited resources. The FRFA addressed those concerns. The ACA Petition and ECAC Petition addressed in the Order on Reconsideration, and in associated comments, did not raise any concerns with the FRFA.

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

60. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the rules adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” small organization,” and “small government jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.

61. As noted above, the Commission incorporated a FRFA into the TCPA Exemptions Order. In that analysis, the Commission described in detail the various small business entities that may be affected by the final rules, including telemarketing bureaus and other contact centers. The Order on Reconsideration amends the final rules adopted in the TCPA Exemptions Order affecting entities that make calls to residential lines pursuant to an exemption in the Commission's rules. The Supplemental FRFA accompanying the Order on Reconsideration adopts by reference the description and estimate of the number of small entities from the IRFA in the Traced Act NPRM and FRFA in the TCPA Exemptions Order.

62. In Section E of the FRFA in the TCPA Exemptions Order, the Commission described in detail the projected reporting, recordkeeping, and other compliance requirements for small entities arising from the rules adopted in the TCPA Exemptions Order. This Supplemental FRFA adopts by reference the requirements described in Section E of the FRFA. In the Order on Reconsideration, however, the Commission modifies rules adopted in the TCPA Exemptions Order to make clear that callers may obtain consent either orally or in writing to exceed the numerical limits on artificial or prerecorded voice calls to residential telephone lines made under the exemptions contained in § 64.1200(a)(3)(ii) through (v) of the Commission's rules. This action should significantly reduce any compliance requirements for small entities. As the Commission emphasized in the TCPA Exemptions Order, callers can use exempted calls to obtain consent if the calls satisfy other applicable conditions. Such consent may be obtained verbally on the call. The Commission stated that consumers who welcome the calls would be likely to give such consent. Because the TCPA only restricts calls initiated with an artificial or prerecorded voice to a residential telephone, callers can use a live agent to make such calls without running afoul of the TCPA.

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

64. The Commission considered feedback in response to the ACA Petition and ECAC Petition in crafting the Order on Reconsideration. We evaluated the comments with the goal of removing regulatory roadblocks and giving industry the flexibility to continue to make calls pursuant to any exemption previously carved out by the Commission, while still protecting the interests of consumers who do not want to receive unlimited calls from such entities and allowing consumers to opt out of future calls from such entities. For example, in the TCPA Exemptions Order, the Commission retained all existing exemptions for calls to residential numbers, concluding that such exemptions satisfy the TRACED Act's requirements regarding the classes of parties that may make such calls and the classes of parties that may be called. In the Order on Reconsideration, the Commission takes further action to give industry even more flexibility to make calls to consumers by amending § 64.1200(a)(3) of the rules to make clear that consent for informational, non-telemarketing calls to residential telephone lines can be obtained orally or in writing, consistent with longstanding Commission precedent. This should significantly minimize any compliance costs and burdens on small entities that are subject to the TCPA rules.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 64 as follows: